Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD

CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2015 All Day Program What PPS Hospitals Need to Know

Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD
President of Patient Safety and Education Consulting Board Member Emergency Medicine Patient Safety Foundation (no questions, phone) 2 2

You Don’t Want One of These

The Conditions of Participation (CoPs)
Many revisions since manual published in 1986 Manual updated more frequently now Many changes Sept 26, 2014, July 11, 2014, and Medication& Safe Opioid Use in June 6, 2014 and January 30, 2015 memo and in April 1, 2015 manual First regulations are published in the Federal Register then CMS publishes the Interpretive Guidelines and some have survey procedures 2 Hospitals should check this website once a month for changes 1 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

Subscribe to the Federal Register

CMS Survey and Certification Website
Click on Policy & Memos

Example of Survey Memo Glucose Monitoring

CMS Changes Phase II In final rule, CMS estimates cost safety to be nearly $660 million annually or $3.2 billion over five years The name of the federal rule was “Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II” The final rule is 201 pages long and effective July 11, and two final IG memos issued MS and Board section memo issued Sept 15, 2014 rest issued January 30, 2015 and in April 1, 2015 manual The rule explains the decision making process and addresses comments sent

Board and Medical Staff Final IGs

IG for Final Rules OP, NM, Dietary etc.

Changes to Hospital Sections
Governing Body (§ ) Medical Staff (§ ) Food and Dietetic Services (§ ) Nuclear Medicine Services (§ ) Outpatient Services (§ ) Special Requirements for Hospital Providers of Long-term Care Services (“swing-beds”) (§ )

Summary of Changes Medical Staff (MS) can grant hospital privileges for RD or nutrition specialist to write diet orders Includes diet orders, TPN, or supplemental feeding Board must consult with and individual responsible for the MS for each individual hospital regarding quality of medical care provided in the hospital and suggest at least twice a year Such as the chief medical officer or MS president Each hospital can have separate medical staff or shared which CMS calls a unified integrated medical staff with specific rules in a multi hospital system

Summary of Changes Allow in-house preparation of radiopharmaceuticals by trained nuclear medicine technicians in hospitals on off hours without a physician or a pharmacist being present Medical Staff can include PharmD, registered dieticians, PA, NP, dentist, podiatrist, speech pathologist, etc. Must be consistent with state scope of practice and state law

Summary of Changes Allow practitioners not on MS to order outpatient services Must have policy to specify which tests can be ordered Must be licensed in state where care is provided Must be acting within scope of practice under state law Must be allowed by the MS Confirms its prior interpretation regarding who can order outpatient orders under tag 1079 and 1080

Summary of Changes Made a change to the CLIA law regarding proficiency testing referrals Swing beds move to Part D so accreditation organizations TJC, AOA HCFA, DNV Healthcare or CIHQ Questions contact Lauren Oviatt at at CMS questions to

How to Keep Up with Changes
First, periodically check to see you have the most current CoP manual1 Once a month go out and check the survey and certification website 2 Once a month check the CMS transmittal page 3 Have one person in your facility who has this responsibility 1 2 3

Location of CMS Hospital CoP Manual
New website

Final Changes in April 1, 2015 Manual

Transmittals

CMS Survey Memos CMS has many recent memos of interest
Privacy and confidentiality 3 Ebola memos Luer misconnections, IV and blood and blood products Use of insulin pens issue, immediate use steam sterilization Single dose vials and safe injection practices 2 memos on Humidity in the OR, Reporting to internal PI program Complaint manual and reporting to AO Deficiencies of hospitals, Equipment Maintenance OPO, Medication and Safe Opioid Use Three worksheets finalized, Glucose Monitoring

Luer Misconnections Memo
CMS issues memo March 8, 2013 This has been a patient safety issues for many years Staff can connect two things together that do not belong together because the ends match For example, a patient had the blood pressure cuff connected to the IV and died of an air embolism Luer connections easily link many medical components, accessories and delivery devices

Luer Misconnections

PA Patient Safety Authority Article

June 2010 Pa Patient Safety Authority

ISMP Tubing Misconnections www.ismp.org

TJC Sentinel Event Alert #36 www,jointcommission.org

New Standards Prevent Tubing Misconnections
New and unique international standards being developed in 2014 for connectors for gas and liquid delivery systems To make it impossible to connect unrelated systems Includes new connectors for enteral, respiratory, limb cuff inflation neuraxial, and intravascular systems Phase in period for product development, market release and implementation guided by the FDA and national organizations and state legislatures FAQ on small bore connector initiative

Managing Risk During the Transition

Misconnections & How to Prepare

CMS Hospital Worksheets History
October 14, 2011 CMS issues a 137 page memo in the survey and certification section and it was pilot tested in hospitals in 11 states Memo discusses surveyor worksheets for hospitals by CMS during a hospital survey Addresses discharge planning, infection control, and QAPI (quality improvement performance improvement) May 18, 2012 CMS published a second revised edition and pilot tested each of the 3 in every state over summer 2012 November 9, 2012 CMS issued the third revised worksheet Final ones issued November 26, 2014

Final 3 Worksheets QAPI

CMS Hospital Worksheets
Hospitals should be familiar with the three worksheets Will use whenever a validation survey or certification survey is done at a hospital by CMS CMS says worksheets are used by State and federal surveyors on all survey activity in assessing compliance with any of the three CoPs Hospitals are encouraged by CMS to use the worksheet as part of their self assessment tools which can help promote quality and patient safety

And of course completing the forms helps the hospital to comply with those three CoPs Citation instructions are provided on each of the worksheets The surveyors will follow standard procedures when non-compliance is identified in hospitals This includes documentation on the Form CMS 2567 Not used in CAH but good tool for CAH to use Questions to:

Some of the questions asked might not be apparent from a reading of the CoPs So the worksheets are a good communication device It helps to clearly communicate to hospitals what is going to be asked in these 3 important areas Hospitals might want to consider putting together a team to review the 3 worksheets and complete the form in advance as a self assessment Hospitals should consider attaching the documentation and P&P to the worksheet

CMS Memo on Safe Injection Practices
Bottom line is you can not use a single dose vial on multiple patients CMS requires hospitals to follow nationally recognized standards of care like the CDC guidelines SDV typically lack an antimicrobial preservative Once the vial is entered the contents can support the growth of microorganisms The vials must have a beyond use date (BUD) and storage conditions on the label

Make sure pharmacist has a copy of this memo If medication is repackaged under an arrangement with an off site vendor or compounding facility ask for evidence they have adhered to 797 standards ASHP Foundation has a tool for assessing contractors who provide sterile products Go to Click on starting using sterile products outsourcing tool now

Safe Injection Practices www.empsf.org

CMS Memo May 30, 2014 CMS publishes 4 page memo on infection control breaches and when they warrant referral to the public health authorities This includes a finding by the state agency (SA), like the Department of Health, or an accreditation organization TJC, DNV Healthcare, CIHQ, or AOA HFAP CMS has a list and any breaches should be referred Referral is to the state authority such as the state epidemiologist or State HAI Prevention Coordinator

Infection Control Breaches

CMS Memo Infection Control Breaches
If any of the listed breaches are observed, then will take appropriate enforcement action And will make the public health authority aware Includes LTC, ASCs, hospice, hospitals, home health agencies, CAH, rural health clinics and dialysis facilities CDC is working closely with SA on HAI prevention List of breaches to be referred include: Using the same needle for more than one individual;

CMS Memo Infection Control Breaches
Using the same needle for more than one individual; Using the same (pre-filled/manufactured/insulin or any other) syringe, pen or injection device for more than one individual Re-using a needle or syringe which has already been used to administer medication to an individual to subsequently enter a medication container (e.g., vial, bag), and then using contents from that medication container for another individual Using the same lancing/fingerstick device for more than one individual, even if the lancet is changed

3 EBOLA Memos Issued

Access to Hospital Complaint Data
CMS issued Survey and Certification memo on March 22, 2013 regarding access to hospital complaint data Includes acute care and CAH hospitals Does not include the plan of correction but can request Questions to This is the CMS 2567 deficiency data and lists the tag numbers Updating quarterly Available under downloads on the hospital website at

Access to Hospital Complaint Data

Updated Deficiency Data Reports

Can Count the Deficiencies by Tag Number

Lists by State and Names Hospitals

Complaint Manual Update
CMS issues memo on April 19, 2013 CMS updates the Complaint Manual Hospital found to be in immediate jeopardy could have a full validation survey if the RO requests it Regional office has discretion GAO emphasized need to share complaint information and SA survey finding with the applicable accreditation agency and CMS agrees TJC, DNV,AOA, or CIHQ

Complaint Manual Update

TJC Revised Requirements
TJC has published many changes over the past two years Many of the changes reflected in their standards is to be in compliance with the CMS CoP Standards are for hospitals that use them to get deemed status to allow payment for M/M patients This means hospitals do not have to have a survey by CMS every 3 years Can still get a complaint or validation survey So now TJC standards crosswalk closer to the CMS CoPs Not called JCAHO any more

Mandatory Compliance Hospitals that participate in Medicare or Medicaid must meet the COPs for all patients in the facilities and not just those patients who are Medicare or Medicaid Hospitals accredited by TJC, AOA, CIHQ, or DNV Healthcare have what is called deemed status This means you can get reimbursed without going through a state agency survey States can still institute a survey and be more restrictive

CMS Hospital CoPs All Interpretative guidelines are in the state operations manual and are found at this website1 Appendix A, Tag A-0001 to A-1164 You can look up any tag number under this manual Manuals Manuals are now being updated more frequently Still need to check survey and certification website once a month and transmittals to keep up on new changes 2 1http:// 2

Location of CMS Hospital CoP Manual
All the manuals are at

Conditions of Participation (CoPs)
Important interpretive guidelines for hospitals and to keep handy A- Hospitals and C-Critical Access Hospitals C-Labs V-EMTALA (Rewritten May 29, 2009 and amended July 2010 and proposed changes 2014) Q-Determining Immediate Jeopardy I-Life Safety Code Violations All CMS forms are on their website

Contact for Questions questions to or Resource may be your state department of health or regional CMS office The American Hospital Association or state hospital association may be of assistance Note that when changes are published in the Federal Register or CMS Survey Memo there is always the name and phone number of a contact person at CMS to contact for questions

Compliance Recommendation
Assign each section of the hospital CoPs to the manager of that department Do a side by side gap analysis like the TJC PPR for each section Have standard on left side and go line by line and document compliance on the right side Keep a hard copy of CoP and analysis Designate someone in charge if a validation, complaint, or unannounced survey occurs Commonly referred to as the CoP king or queen

CMS Required Education
These will be discussed throughout presentation: Restraint and seclusion (annual-ongoing) Abuse, neglect and harassment (annual) Infection control, Advance directive Medication errors, drug incompatibility and ADR Organ donation, Standing orders & protocols IVs and blood and blood products P&P, Medication timing, safe opioid use ED common emergencies, IVs and blood and blood products for ED

What’s Really Important
Life Safety Code Compliance Infection Control and CMS received $50 million grant to enforce and HHS gets 1 billion Patient Rights especially R&S and grievances EMTALA Performance Improvement (CMS calls it QAPI) Medication Management Dietary and cleanliness of dietary Infection control issues in dietary is big!

What’s Really Important
Verbal orders, Policies and procedures History and physicals Need order for respiratory and rehab (such as physical therapy) Need order for diet, medications, and radiology Anesthesia (updated four times) Standing orders and protocols Medications, safe opioid use and blood transfusions Note the CMS quarterly Deficiency Memos

Survey Protocol First 37 pages list the survey protocol, including sections on: Off-survey preparation Entrance activities Information gathering/investigation Exit conference Post survey activities

Survey Protocol Survey done through observation, interviews, and document review Usually surveys are done Monday - Friday but can come on weekends or evenings Federal law allows CMS or department of health surveyors access to your facility CAH rehab or psych (behavioral health) is surveyed under this section even though CAH has a separate manual

Survey Team Mid-sized hospital with a full survey
Two to four surveyors for three or more days and at least one RN with hospital survey experience Team based on complexity of services offered SA (state agency) decides or RO (regional office) for federal teams Have an organized plan for an unannounced survey with designated persons to accompany surveyors Include education of security or those who attend to the front desk where surveyors could enter in the morning

Interpretive Guidelines
Starts with a tag number, example A-0001 “A” refers to the hospital CoPs Goes from 0001 to 1164 The three sections from Federal Register (CFR) include the regulation, interpretive guidelines and survey procedure Survey procedure Not in every section Explains survey process, policies that will be reviewed, questions that will be asked and documents reviewed

New website for all manuals

Compliance with Laws A-0020
The hospital must be in compliance with all federal, state, and local laws Survey procedure tells surveyor to interview CEO or other designated by hospital Refer non-compliance to proper agency with jurisdiction such as OSHA (TB, blood borne pathogen, universal precautions, EPA (Haz mat or waste issues), or Rehabilitation Act of 1973 Will ask if cited for any violation since last visit

Compliance with Laws , 0022 Hospital must be licensed or approved for meeting standards for licensure, as applicable Personnel must be licensed or certified if required by state (doctors, nurses, PT, PA, etc.) If telemedicine used must be licensed in state patient located and where practitioner is locate Federal law passed and 27 pages IGs by CMS Verify that staff and personnel meet all standards (such as CE’s) required by state law Review sample of personnel files to be sure credentials and licensure is up to date

Governing Body (Board) 43 2013 & 2014
Hospital must have an effective governing body that is legally responsible for the conduct of the hospital Can share a board in hospital system now Written documentation identifies an individual as being responsible for conduct of hospital operations Board makes sure MS requirements are met Board must determine which categories of practitioners are eligible for appointment to medical staff (MS), as allowed by your state law; CRNA, NP, PA’s, nurse midwives, chiropractors, podiatrists, dentists, registered dietician, clinical psychologist, PharmD, social worker etc.)

Governing Body (Board) 43 2013
No survey of hospital systems Can’t just have one policy for the system Each individual hospital can use a hospital system’s policy but they must individually adopt it Such as hospital A adopts the policy of XX Healthsystem Hospital must be clear that their hospital has elected to adopt any specific policy Minutes need to be clear of one board for two hospitals

Governing Body (Board) 43 2013 2014
Each hospital must have their own CNO Cannot have one integrated nursing service department between two separate hospitals just because they are in the same healthcare system It is possible to have one CNO to run two hospitals if able to carry out the duties of each hospital System may chose to operate QAPI program at the system level but each certified hospital must have its own PI data with AE and standardized indicators

Medical Staff and Board 2014
Board must determine what category of practitioners are eligible for appointment to the MS (44) Physicians which includes dentists, podiatrists, chiropractors, optometrists Should grant privileges and be appointed to the MS Non-physicians may include PA, NP, CNS, CNM, CRNA, CSW, clinical psychologist, AA, clinical pharmacist, RD or nutrition specialist Some others may be eligible for privileges based on state law and MS bylaws and R/R such as PT, OT, Speech language pathologist

Medical Staff and Board 2014
Board appoints individuals to the MS with the advice and recommendation of the MS (0046) Will review board minutes to make sure they are involved in appointment of MS Board must assure MS has bylaws and they comply with the CoPs (0047) Board must make sure they have approved the MS bylaws and rules and regulations (0048) and any changes TJC MS as to what goes into a bylaw or R/R

Medical Staff and Board
Board must ensure MS is accountable to the board for the quality of care provided to patients (0049) All care given to patients must be by or in accordance with the order of practitioner who is operating within privileges granted by the Board Need order for any medications Need to document the order even if there is a protocol approved by the medical board for it ED nurse starts IV on patient with chest pain and documents it in the order sheet Discussed later under section 405, 406, 457, and 450

Board and Medical Staff
Board ensures that criteria for selection of MS members is based on (0050) MS privileges describe privileging process and ensure there is written criteria for appt to MS Individual character, competence, training, experience and judgment Make sure under no circumstances is staff membership or privileges based solely on certification, fellowship, or membership in a specialty society (0051) TJC has a tracer now on this

Medical Staff 2013 Previous CMS regulations limited access by requiring physicians to co-sign all orders Changes eliminate some of the barriers This change will allow hospitals to more fully utilize practitioners skills such as NP or PharmD or RD Podiatrist could serve as president of the MS Others C&P still have to follow the MS bylaws and R/R Can have categories in MS but MS must still examine credentials

TJC Tracer MS Credentialing and Privileging
Will look at the design of the MS and look at verification of credentials, limitations or relinquishing privileges, health status, morbidity and mortality, peer recommendations etc Consistent process for all practitioners Scope of the MS process to determine if all LIPs and other practitioners are reviewed The link between results of ongoing professional practice evaluation and focused professional performance evaluation and the adherence to criteria.

TJC Tracer MS Credentialing and Privileging
How the organization is monitoring the performance of all licensed independent practitioners on an ongoing basis How does the hospital evaluates performance of LIPs who do not have current performance documentation (FPPE)? How does the hospital evaluate LIPs who performance has raised concerns regarding safe quality care? Will look to see if state opted out supervision with CRNAs, P&Ps for supervision of CRNAs, etc

Board and the Medical Staff
CMS Guidance issued to clarify it is a recommendation that MS must conduct appraisals of practitioners at least every 24 months Need to do every 24 months if TJC accredited MS must examine each practitioner’s qualifications and competencies to perform each task, activity, or privilege Included current work, specialized training, patient outcomes, education, currency of compliance with licensure requirements MS section repeated in tag so will not duplicate

Telemedicine Medical staff makes a recommendation to do use a distant site to C&P physicians Board agrees and must enter into agreement with distant site hospital (DSH) or distant site telemedicine entity (DSTE) CMS says what must be in the agreement to make sure the hospital is in compliance with the CoPs Must be licensed in that state Provide evidence of C&P and provides copy of their privileges

Telemedicine Hospital can rely on the C&P decision of the DSH or DSTE The hospital must report to the distant site any complaints received or information on adverse events Can have one file with telemedicine physicians or can keep separate file Surveyor will look at documentation indicated that it granted privileges to each telemedicine physician or that it relied on the distant site entity to do this

Board Consultation New 9-26-2014
The board must consult directly with person responsible for the conduct of the MS Such as the President of the MS or CMO or designee Must include matters related to the quality of medical care and must have P&P on this Can meet face to face or through telecommunication Suggests meet at least twice a year If multi-hospital system need to consult with each separate MS

CEO A-0057 Board must appoint a CEO who is responsible for managing the hospital Verify CEO is responsible for managing entire hospital Verify the board has appointed a CEO CEO is a very important position and CMS has only a small section TJC in the leadership standard has more detailed information on the role of the CEO

Care of Patients Board must make sure every patient has to be under the care of a doctor (or dentist, podiatrist, chiropractor, psychologist, et. al.) Practitioners must be licensed and a member of MS If LIPs can admit (NP, Midwives) still need to see evidence of being under care of MD/DO If state law allows needs policies and bylaws to ensure compliance Exception is a separate federal law where no supervision required by midwives for Medicaid patients

Care of Patients Evidence of being under care of MD/DO must be in the medical record Verify with your state department of health what documentation is required for inpatients Board and MS establish P&P and bylaws to ensure compliance Board must make sure doctor is on duty or on call at all times, doctor of medicine or osteopathy is responsible for monitoring care M/M patient Interview nurses and make sure they are able to call the on-call MD/DO and they come to the hospital when needed

Care of Patients Patient admitted by dentist, chiropractor, podiatrist etc., needs to be monitored by a MD/DO, as allowed by state law Each state has a scope of practice which talks about what they can do The board and MS must have policies to make sure Medicare/Medicaid patient is responsible for any care OUTSIDE the scope of practice of the admitting practitioner What is the scope of practice in your state for NP, CRNAs, Midwifes, and PAs?

Plan and Budget 0073-0077 Need institutional plan
Include annual operating budget with all anticipated income and expenses Provide for capital expenditures for 3 year period Identify sources of financing for acquisition of land improvement of land, buildings and equipment Must be submitted for review TJC has similar standards in its leadership chapter

Plan and Budget Need institutional plan Must include acquisition of land and improvement to land and building Must be reviewed and updated annually Must be prepared under direction of board and a committee of representatives from the Board administrative staff, and MS (077) Verify that all 3 participated in the plan and budget

Contracted Services Board responsible for services provided in hospital (0083) Whether provided by hospital employees or under contract Board must take action under hospital’s QAPI program to assess services provided both by employees and under direct contract Identify quality problems and ensure monitoring and correction of any problems TJC has more detailed contract management standards in LD chapter

Contracted Services Board must ensure services performed under contract are performed in a safe and efficient manner Increased scrutiny on contracted services Review QAPI plan to ensure that every contracted service is evaluated Maintain a list of all contracted services (85) Contractor services must be in compliance with CoPs Consider adding section to all contracts to address CoP requirements

Emergency Services 0091 Remember to see the EMTALA separate CoP
Revised May 29, and amended July 2010 and now 68 pages Consider doing yearly education on EMTALA to your ED staff and for on call physicians If hospital has an ED, you must comply with section requirements If no ED services, Board must be sure hospital has written P&P for emergencies of patients, staff and visitors

Emergency Services 0091 Qualified RN must be able to assess patients
Verify that MS has P&P on how to address emergency procedures Need P&P when patient’s needs exceed hospital’s capacity Need P&P on appropriate transport Train staff on what to do in case of an emergency Should not rely on 911 for on-campus and need trained staff to respond to the code or emergency

Emergency Services 0091 If emergency services are provided at the hospital but not at the off campus department then you need P&P on what to do at the off-campus department when they have an emergency Do whatever you can to initially treat and stabilize the patient etc Call 911 (off campus only!) Provide care consistent with your ability Includes visitors, staff and patients Make sure staff are oriented to the policy

Patient Rights Many standards related to grievances and restraint and seclusion (R&S) Sets forth standards regarding R&S staff training and education Sets forth standards on R&S death reporting TJC also has chapter on 14 patient rights or RI “Rights and Responsibilities of the Individual” starting with RI thru

Number of Deficiencies July 2014
Section Number Of Deficiencies Tag Number Restraint and Seclusion 1,115 Tag Care in a Safe Setting 578 Tag 144 Grievances 417 Tag Consent & Decision Making 247 Tag Freedom from Abuse & Neglect 232 Tag 145 Notice of Patient Rights 121 Tag 116 and 117 Care Planning 79 Tag 130

Number of Deficiencies July 2014
Section Number of Deficiencies Tag Number Privacy and Safety 100 142 and 143 Confidentiality 64 146 and 147 Visitation 23 Access to Medical Records Protect Patient Rights 16 308 148 115 Admission Status Notification 12 133 Exercise of Patient Rights 11 129 Total 3,323

Standard # 1 Notice of Rights
Notice of Patient Rights and Grievance Process Hospital must ensure the notice of patient rights are met Provide in a manner the patient will understand Remember issue of limited English proficiency (LEP) as with patients who does not speak English and low health literacy 20% of patients read at a sixth grade level Must have P&P to ensure patients have information necessary to exercise their rights

Notice of Patient Rights 117 12-11
Rule #1 - A hospital must inform each patient of the patient’s rights in advance of furnishing or discontinuing care Must protect and promote each patient’s rights Must have P&P to ensure patients have information on their rights and this includes inpatients and outpatients Must take reasonable steps to determine patient’s wishes on designation of a representative Must give Medicare patient IM Notice within two days of admission and in advance of discharge if more than two days

Designation of Representative 117
If patient is not incapacitated and has an individual to be their representative then the hospital must provide the representative with the notice of patient rights in addition to the patient Patient can do orally or in writing which author suggests If the patient is incapacitated then the notice of patient rights is given to the person who represents with an advance directive such as the DPOA If incapacitated and no advance directive then to the person who is spouse, domestic partner, parent of minor child, or other family member

Designation of Representative 117
This person is known as the patient representative You can not ask for supporting documentation unless more than one individual claims to be their representative If hospital refuses the request of an individual to be the patient’s representative then must document this in the medical record States can specify a state law for doing this Hospital must adopt P&P on this

Notice of Patient Rights
Confidentiality and privacy Pain relief Refuse treatment and informed consent Advance directives Right to get copy for Medicare patients of Important Message from Medicare such as the IM Notice or detailed notice Right to be free from unnecessary restraints Right to determine who visitors will be

Notify Patient of Their Rights
When appropriate, this information is given to the patient’s representative Document reason, patient unconscious, guardian, DPOA, parent if minor child et. al. Consider having a copy on the back of the general admission consent form and acknowledgment of the NPP Have sentence that patient acknowledges receipt of their patient rights Right to contact the QIO or state agency of problems

Interpreters Rule #2 - A hospital must ensure interpreters are available Make sure communication needs of patients are meet Recommend qualified interpreters Must comply with Civil Rights law Be sure to document that the interpreter was used See TJC Patient Centered Communications Standards

Interpreters Consider posting a sign in several languages that interpreting services are available Include in yearly skills lab for nurses to make sure your staff knows what to do and they understand P&P Review your policy and procedure If hospital owned physician practices ensure interpreters are present in prescheduled appointments

Grievance Process 118 Rule #3 - The hospital must have a process for prompt resolution of patient grievances Hospital must inform each patient to whom to file a grievance Provides definition which you need to include in your policy If TJC accredited combine P&P with complaint section complaint standard at RI in which is similar to CMS now with one addition Use the CMS definition of grievance

Grievance Process 118 Definition: A patient grievance is a formal or informal written or verbal complaint When the verbal complaint about patient care is not resolved at the time of the complaint by staff present By a patient, or a patient’s representative, Regarding the patient’s care, abuse, or neglect, issues related to the hospital’s compliance with the CMS CoP or a Medicare beneficiary billing complaint related to rights

Grievances 118 Hospitals should have process in place to deal with minor request in more timely manner than a written request Examples: change in bedding, housekeeping of room, and serving preferred foods Does not require written response If complaint cannot be resolved at the time of the complaint or requires further action for resolution then it is a grievance All the CMS requirements for grievances must be met

Patient or Their Representative
If someone other than the patient complains about care or treatment Contact the patient and ask if this person is their authorized representative Get the patient’s permission to discuss protected health information with designed person because of HIPAA Document in the file that the patient’s permission was obtained Some facilities get a HIPAA compliant form signed

Grievances 118 Not a grievance if patient is satisfied with care but family member is not Billing issues are not generally grievances unless a quality of care issue A written complaint is always a grievance whether inpatient or outpatient ( and fax is considered written) Information on patient satisfaction surveys generally not a grievance unless patient asks for resolution or unless the hospital usually treats that type of complaint as a grievance

Grievances 118 If complaint is telephoned in after patient is dismissed then this is also considered a grievance All complaints on abuse, neglect, or patient harm will always be considered a grievance Exception is if post hospital verbal communication would have been routinely handled by staff present If patient asks you to treat as grievance it will always be a grievance

Grievance Process Survey Procedure
Review the hospital policy to assure its grievance process encourages all personnel to alert appropriate staff concerning grievances Hospital must assure that grievances involving situations that place patients in immediate danger are resolved in a timely manner Conduct audits and PI to make sure your facility is following its grievance P&P

Grievance Process - Survey Procedure
Surveyor will interview patients to make sure they know how to file a complaint or grievance Including right to notify state agency (state department of health and QIO with phone numbers) Remember to add address and address of both Document that this is given to the patient Remember the TJC APR requirements Should be in writing in patient rights section

Grievance Process 119 Rule #4 – The hospital must establish a process for prompt resolution Inform each patient whom to contact to file a grievance by name or title Operator must know where to route calls Make form accessible to all

Grievance Process 119 Rule #5 – The hospital’s governing board must approve and is responsible for the effective operation of the grievance process Elevates issue to higher administrative level Have a process to address complaints timely Coordinate data for PI and look for opportunities for improvement Read this section with the next rule Most boards will delegate this to hospital staff

Rule #6 Board Review The hospital’s board must review and resolve grievances Unless it delegates the responsibility in writing to the grievance committee Board is responsible for effective operation of grievance process Grievance process reviewed and analyzed thru hospital’s PI program Grievance committee must be more than one person and committee needs adequate number of qualified members to review and resolve

Grievance Survey Procedure
Go back and make sure your governing board has approved the grievance process Look for this in the board minutes or a resolution that the grievance process has been delegated to a grievance committee Does hospital apply what it learns?

Grievance Process 120 Rule #7 – The grievance process must include a mechanism for timely referral of patient concerns regarding the quality of care or premature discharge to the appropriate QIO Each state has a state QIO under contract from CMS and list of QIOs1 CMS changing to have 2 QIOs cover complaints and grievance handling and have divided the states 1http://

IM and Detailed Notice Forms
Hospital to provide a Medicare patient with an Important Message from Medicare ( IM notice ) within 48 hours of admission The hospital must deliver to the patient a copy of this signed form again if more than two days and within 48 hours of discharge About 1% of Medicare patients voice concern about being discharge prematurely These patients must be given a more detailed notice and request the QIO to review their case New forms IM “You Have the Right” and “Detailed Notice” Website for beneficiary notices1 1www.cms.hhs.gov/bni

KEPRO and Livanta QIOs

Beneficiary & Family Centered Care QIOs
Area 1 – Livanta 9090 Junction Drive, Suite 10 Annapolis Junction, MD Toll-free: Area 2 – KEPRO 5201 W. Kennedy Blvd., Suite 900 Tampa, FL Toll-free: Area 3 – KEPRO 5700 Lombardo Center Dr., Suite 100 Seven Hills, OH Toll-free: Area 4 – KEPRO 5201 W. Kennedy Blvd., Suite 900 Tampa, FL Toll-free: Area 5 – Livanta 9090 Junction Drive, Suite 10 Annapolis Junction, MD Toll-free:

Beneficiary & Family Centered Care QIOs
Beneficiary and Family Centered Care (BFCC)-QIOs will manage: All beneficiary complaints, Quality of care reviews, EMTALA, And other types of case reviews To ensure consistency in the review process while taking into consideration local factors important to beneficiaries and their families

Grievance Procedure 121 Hospital must have a clear procedure for the submission of a patient’s written or verbal grievances Surveyor will review your information to make sure it clearly tells patients how to submit a verbal or written grievance Surveyor will interview patient to make sure information provided tells them how to submit a grievance Must establish process for prompt resolution of grievances

Hospital Grievance Procedure 0122
Rule #8 – Hospital must have a P&P on grievance Specific time frame for reviewing and responding to the grievance Grievance resolution that includes the patient with a written notice of its decision, IN MOST CASES The written notice to the patient must include the steps taken to investigate the grievance, the results and date of completion

Hospital Grievance Procedure
Facility must respond to the substance of each and every grievance Need to dig deeper into system problems indicated by the grievance using the system analysis approach Note the relationship to TJC sentinel event policy and LD medical error standards, CMS guidelines for determining immediate jeopardy, HIPAA privacy and security complaints, and risk management/patient safety investigations

Grievances 7 Day Rule Timeframe of 7 days would be considered appropriate and if not resolved or investigation not completed within 7 days must notify patient still working on it and hospital will follow up Most complaints are not complicated and do not require extensive investigation Will look at time frames established Must document if grievance is so complicated it requires an extensive investigation

Grievances Written Response 123
Explanation to the patient must be in a manner the patient or their legal representative would understand The written response must contain the elements required in this section - not statements that could be used in legal action against the hospital Written response must the steps taken to investigate the complaint Surveyors will review the written notices to make sure they comply with this section

Grievance 123 CMS says if patient ed you a complaint, you may back response Be careful as many hospital policy on security do not allow this since is not encrypted Under HIPAA patient can agree to increased risks Must maintain evidence of compliance with the grievance requirements Grievance is considered resolved when patient is satisfied with action or if hospital has taken appropriate and reasonable action

TJC Complaint Standard
TJC has complaint standard RI Will not cover but provided for reference TJC calls them complaints CMS calls them grievances TJC has eliminated several standards in that are still CMS standards More closely cross walked now

RI.01.07.01 Complaints & Grievances
Standard: Patient and or her family has the right to have a complaint reviewed, EP1 Hospital must establish a complaint and grievance (C&G) resolution process See also MS , EP1 EP2 Patient and family is informed of the grievance resolution process EP4 Complaints must be reviewed and resolved when possible

RI.01.07.01 Complaints & Grievances
EP6 Hospital acknowledges receipt of C&G that cannot be resolved immediately Hospital must notify the patient of follow up to the C&G EP7 Must provide the patient with the phone number and address to file the C&G with the relevant state authority EP10 The patient is allowed to voice C&G and recommend changes freely with out being subject to discrimination, coercion, reprisal, or unreasonable interruption of care

RI TJC Complaints EP 17 Board reviews and resolves grievances unless it delegates this in writing to a grievance committee (eliminated but still CMS requirement) EP 18 Hospital provides individual with a written notice of its decision which includes (DS); Name of hospital contact person Steps taken on behalf of the individual to investigate the grievance Results of the process Date of completion of the grievance process

RI TJC Complaints EP19 Hospital determines the time frame for grievance review and response(DS) EP20 Process for resolving grievances includes a timely referral of patient concerns regarding quality of care or premature discharge to the QIO EP21 Board approves the C&G process (eliminated but still CMS standard)

Have a Policy to Hit All the Elements

2cd Standard Exercise of Rights
Right to participate in the development and implementation of their plan of care Right to refuse care and formulate advance directives Right to have a family member or representative of his or her choice notified if requested Called support person in the final visitation regulations Right to have his or her physician notified promptly of the patient's admission to the hospital if patient requests this

Standard #2 Exercise of Rights 0130 12-11
Rule #1 – Patients have the right to participate in the development and implementation of their plan of care Includes inpatients and outpatients Includes discharge planning and pain management Requires hospital to actively include the patient in developing their plan of care including changes

Patient Representative
Repeats that hospital expected to take reasonable step to determine patient’s wishes on designation of a representative with same requirements Same standard and if patient is not incapacitated and has a representative then must involve both in development and implementation of a plan of care If incapacitated and AD then this person is involved If incapacitated and no AD then to who claims to be patient representative and can not ask for supporting documentation unless two claim to be the representative

Patient Representative
Same requirements about documenting any refusals to let someone be the representative in the medical record Same requirement to follow any specific state law Need P&P on this and should teach staff this section Policy must facilitate expeditious and non-discriminatory resolution of disputes about whether the person is the patient’s representative

Patient Participate in Plan of Care
If patient refuses to participate, document this Include patient’s legal representative if patient minor or incompetent Plan of care is frequently cited Do not need a separate plan of care for nursing if participates in interdisciplinary plan of care Patients needing post-hospital care are given choice home health or nursing homes in writing Includes choice to pain management, patient care issues, and discharge planning Section 1802 of SSA guarantees free choice by Medicare patients for LTC or home health and also in discharge planning section

Rule #2 Patients Have a Right:
To make informed decision regarding their care Being informed of their diagnosis To request or refuse treatment Right to sign out AMA Remember EMTALA requirements if patient is transferred Have patient sign the transfer agreement

Informed Consent CMS has 3 sections in the hospital CoP manual on informed consent Section on informed consent in patient rights on informed decisions, medical records and surgical services The patient has the right to make informed decisions Same provisions related to the patient representative as before so if competent patient has a patient representative then you give information to both regarding the information required to make an informed decision about the care

Patient Representative and Consent
CMS specifically states that the hospital must obtain the written consent of the patient representative of a patient who is not incapacitated Continues throughout the inpatient hospitalization or the outpatient encounter Same provisions related to the patient who is incapacitated as to whether they have a DPOA and if not then to their patient representative If no advance directives the hospital can not ask the representative for supporting documentation unless two people claim to be the representative

Informed Consent 131 Right to delegate the right to make informed decisions to another (DPOA, guardian) Patient has a right to an informed consent for surgery or a treatment Right to be informed of health status and to be involved in care planning and treatment Informed decision on discharge planning to post acute care Right to request or refuse treatment and P&P to assure patient’s right to request or refuse treatment

Informed Consent Right to informed decisions about planning for care after discharge Right to receive information in a manner that is understandable (issue of healthcare literacy) Right to get information about health status, diagnosis and prognosis Hospital has to have process to ensure these rights Required to have policies and procedures on all of these

Disclosures to Patients 131 10-7-11 & 2013
There are two disclosures that must be in writing If physician owned hospital Surveyor is suppose to ask to ensure disclosed Must give to inpatients and observation patients now and P&P required If a doctor or an ED physician is not available 24 hours a day to assist in emergencies Individual notice does not have to be given to the ED patients but must post a sign

Disclosures to Patients 131 2013
Posted sign in DED must says hospital does not have a MD/DO 24 hours a day Must discuss how hospital is going to meet the needs of the patient and hospital P&P required Patient must sign an acknowledgment if admitted Must provide information at beginning of inpatient stay or visit Physicians who refer patients to the hospital they have an ownership interest must disclose this and hospital requires this as a condition for the physician being credentialed or privileged Patients seen in PAT should receive this information then

Patient Rights 132 Patient has the right to make and have the advance directives followed when incapacitated Staff must provide care that is consistent with these directives P&P must include delegation of patient rights to representative if patient incompetent In addition patient may designate in the AD a support person to make decision on visitation Note rights as inpatient outpatient AD requirements of Joint Commission

Advance Directives Your policy should have clear statement of any limitations such as conscience At a minimum, clarify any difference between facility wide conscience objections and those raised by individual doctors But can not refuse to honor designation of a DPOA, support person or patient representative You must provide written information to the patient on their rights under state law, at time of admission as an inpatient Same notice to 3 types of outpatients; ED, observation or same day surgery Document whether or not they have an AD

Advance Directives 132 Cannot condition treatment on whether or not they have one Not construed as a mechanism to demand inappropriate or medically unnecessary care Ensure compliance with state laws on AD Inform patients they may file with state survey and certification agency Provide and document advance directives education Staff on P&P and community

Patient Rights Includes the right for DPOA to medical decisions when patient incapacitated such as informed consent or pain management Disseminate policy on advance directive, identify state authority permitting an objection Includes Psychiatric or behavioral health AD The visitation regulations are one of the newest patient rights

Family Member & Doctor Notified 133
The patient has a right to have a family member or representative notified and their physician notified on admission if not aware Must now ask every patient on admission and document Must do so promptly when patient responds affirmatively If patient incapacitated must identify a family member or representative to promptly notify If someone comes with patient or arrives after and asserts they are the patient’s representative then hospital accepts this Same if two people claim to be their representative & follow state law

Privacy & Confidentiality Memo 3-2-12 Tag 143

3rd Standard Privacy and Safety 143
Standard: The patient has a right to personal privacy while within the hospital To receive care in a safe setting To be free from all forms of abuse or harassment Rule #1 – The right to personal privacy Right to respect, dignity, and comfort Privacy during personal hygiene activities (toileting, bathing, dressing, pelvic exam)

Personal Privacy 143 Need consent for video/electronic monitoring
Must exist clinical need to do this Make sure patient is aware and can see camera Such as cameras in patient rooms (sleep lab, ED safe room, eICU) and not in hallways or lobbies Include in your general admission consent form that all patients sign on admission or make sure patients are aware such in ICU May use to monitor patients who are violent and or self destructive who are in both restraint and seclusion

Personal Privacy & Confidentiality 143
Person not involved with care may not be present while exam is being done unless consent required (medical students who are observing not those caring for patient) Information in directory may not be disclosed without informing patient in advance Visitor must ask for the patient by name Can use information for payment and healthcare operation Must have P&P that restrict access to MR to those who need to know such as nurse who takes care of patient

Personal Privacy & Confidentiality 143
Discusses incidental uses and disclosures Names on spine of chart Names on outside of rooms Whiteboards that list patient present in OR or PACU Take reasonable safeguards Ask waiting patients to stand back a few feet from a counter used for patient registration Speak quietly if patient in semi-private room Passwords on computers Limit access to areas with light boards or white boards

Personal Privacy Surveyor will conduct observations to determine if privacy provided during exams, treatments, surgery, personal hygiene activities, etc. Surveyor will look to see if names or patient information is posted in plain view Survey procedure will ask if patient names are posted in public view No white boards with patient names and other PHI

Privacy and Safety 144 Rule #2 – The right to receive care in a safe setting Includes following standards of care and practice for environmental safety, infection control, and security such as preventing infant abductions, preventing patient falls and medication errors Very broad authority for patient safety issue Right to respect for dignity and comfort

Care in a Safe Setting Includes washing hands between patients - see CDC or WHO hand hygiene and TJC Measuring Hand Hygiene Adherence Review and analyze incident or accident reports to identify problems with a safe environment Review policies and procedures How does facility have P&P to curtail unwanted visitors or contraband materials

Privacy and Safety 145 Rule #3 – The patient has the right to be free from all forms of abuse or harassment and neglect Must have process in place to prevent this Criminal background checks as required by your state law Must provide ongoing (yearly) training on abuse, harassment, and neglect

Privacy and Safety 145 Consider annual training in yearly skills lab
Must have P&P on this Adequate staffing section Have proactive approach to identify events that could be abuse TJC and CMS have definitions of what is abuse and neglect

Freedom From Abuse and Neglect
Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish Includes staff neglect or indifference to infliction of injury or intimidation of one patient by another Include state laws in your P&P on abuse and neglect Remember TJC has standard and definitions, RI

Neglect is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness Investigate all allegations of abuse or neglect Do not hire persons with record of abuse or neglect Report all incidents to proper authority, board of nursing, etc.

Includes freedom abuse from not just staff but other patients and visitors Hospital must have a mechanism in place to prevent this Effective abuse program includes prevention Adequate number of staff who have been screened Identify events that could lead to or contribute to abuse Protect during investigation Investigate and report and respond

Abuse and Neglect Make sure you have a policy in place for investigating allegations of abuse Make sure staffing sufficient across all shifts Make sure appropriate action taken if substantiated Make sure staff know what to do if they witness abuse and neglect

TJC Abuse and Neglect Remember to include Joint Commission’s standard, RI , and definitions of abuse and neglect into your policy also if accredited Patients have the right to be free from abuse, neglect, and exploitation This includes physical, sexual, mental, or verbal abuse and Joint Commission has definitions for all of these terms

TJC Abuse and Neglect Determine how you will protect patients while they are receiving care from abuse and neglect Evaluate all allegations that occur within the hospital Report to proper authorities as required by law

Standard #4 Confidentiality 147
Rule #1 – Patients have a right to confidentiality of their medical records and to access of their medical records (0146) Sufficient safeguards to ensure access to all information HIPAA compliant authorization for release Minimal necessary standard such as abstract out information on child abuse and don’t give protective services the entire chart MR are kept secure and only viewed when necessary by staff involved in care Do not post patient information where it can viewed by visitors

Standard #4 Confidentiality 147
TJC IM standard requires that hospital protects the privacy of health information, maintain security of same (white boards) If white board visible to public hospital may use first name and first initial of last name Must protect patient’s medical record information from unauthorized person Must have a policy and procedure on this Obtain patient or patient representative written authorization to disclose medical record information

Patient Records Rule #2 – Patients have the right to access the information contained within their medical records Right to inspect their record or to get a copy 30 day rule under HIPAA unless state law or P&P more stringent Limited exceptions such as psychotherapy notes, prisoners if jeopardize health of themselves or others, information could cause harm to another, under promise of confidentiality, etc.

Access to Medical Records (PHI)
Rule #3 – Access to the medical record must be within a reasonably time frame and hospitals can not frustrate efforts of patients to get records If patient is incompetent then to the personal representative and should sign as the personal representative such as guardian, parent, or DPOA Reasonable cost for copying, postage or summary No retrieval fee allowed under federal law

5th Standard Restraints 0154-0214
R&S standards are 50 pages long Report deaths in a restraint or within 24 hours of being in a restraint Report also to the regional office if restraint cause death within 7 days Do not need to report death if patient had on only 2 soft wrist restraints and deaths not due to the restraints Use revised R&S form

Restraint Patient Safety Brief www.empsf.org

Restraint Worksheet CMS has restraint worksheet1 which is an official OMB form Not required for two soft wrist restraints if does not cause death Must still notify regional office by phone the next business day Document this in medical record CMS has manual to address complaint surveys Put regional office contact information in your P&P1 1www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter06-31.pdf 1www.cms.hhs.gov/RegionalOffices/01_overview.asp

Reporting Deaths Unless 2 Soft Wrist Restraints

Type In Information and Print Off

Restraint Form CMS-10455

Restraints Regulations only affect regular hospitals and Critical Access Hospitals have own manual CAH do not have a patient rights section and not required to follow new R&S section CAH must have P&P so they can either use TJC standards or select some or all of hospital ones Some CAH have adopted all if in system with regular hospitals

Standard #5 Restraints Rule #1 – Patients have a right to be free from physical or mental abuse, and corporal punishment This includes that restraint and seclusion (RS) Will only be used when necessary Not as coercion, discipline, convenience or retaliation Only used for patient safety and discontinued at earliest possible time R&S guidelines from CMS apply to all hospital patients even those in behavioral health

Right to be Free From Restraint
Hospitals should consider adding it to their patient rights statement if not already there Patients are required to be provided a copy of their rights (staff must document or have patient sign that they received their rights) Could include information in admission packet If patient falls do not consider using R&S as routine part of fall prevention (154)

Rule #2 Hospital Leadership’s Role
Like TJC, leadership is responsible for creating a culture that supports right to be free from R&S LD must make sure systems and processes in place to eliminate inappropriate R&S and monitors use thru PI process LD makes sure only used for physical safety of patient or staff LD ensure hospital complies with all R&S requirements (154)

Restraints Protocols CMS previously did not recognize or allow the use of protocols like Joint Commission does Protocols are now not banned by the new regulations (168) but still need separate order for R&S Must contain information for staff on how to monitor and apply like intubation protocol

Restraint Standards If a patient becomes violent or has self destructive behavior (V/SD) in the ICU or ED, CMS has one set of standards that apply Decision to use R&S is not driven from diagnosis but from assessment of the patient TJC standards changed rewritten July 1, 2009 to be cross walked to the CMS guidelines 10 new standards adopted All the R&S standards were eliminated in 2009 except two (forensic and one on behavioral management) for hospital who use TJC for deemed status

Restraint Standards Medical Patients
Joint Commission calls it behavioral health and non-behavioral health CMS calls it violent and or self destructive (V/SD) and non-violent and non-self destructive CMS says it is not the department in which the patient is located but the behavior of the patient

Rule #3 Know Definition 159 New definition: Physical restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely Mechanical restraints include belts, restraint jackets, cuffs, or ties Manual method of holding the patient is a restraint

Restraint Definition A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or standard dosage for the patient's condition (160) Use of PRN drug is only prohibited if medication meets definition of drug Ativan for ETOH withdrawal symptoms is okay

When Drug is Not a Restraint
Medication is within pharmacy parameters set by FDA and manufacturer for use Use follows national practice standards Used to treat a specific condition based on patient’s symptoms Standard treatment would enable patient to be effective or appropriate functioning Includes these in your P&P

Definition of Seclusion
Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving (162) Seclusion may only be used for the management of violent or self-destructive behavior (V/SD behavior) that jeopardizes the immediate physical safety of the patient, a staff member, or others Is not being on a locked unit with others or for time out if patient can leave area (162)

Seclusion It is when they are alone in a room and physically prevented from leaving May only use seclusion for management of V/SD behavior that is danger to patient or others Time limits on length of order apply such as four hours for an adult One hour face to face evaluation must be done (183) Therapeutic holds to manage V/SD patients are a form of restraint

Restraints Do Not Include
Forensic restraints such as handcuffs, shackles, or other restrictive devices applied by law enforcement or police are not R&S (0154) Closely monitor and observe for safety reasons Orthopedically prescribed devices, surgical dressings or bandages, protective helmets (161) Methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests (161)

Protecting the patient from falling out of bed Cannot use side rails to prevent patient from getting out of bed if patient can not lower Striker beds, narrow gurneys, or the narrow carts and their use of side rails are not a restraint IV board unless tied down or attached to bed Postural support devices for positioning or securing (161) Device used to position a patient during surgery or while taking an x-ray

Recovery from anesthesia is part of surgical procedure and medically necessary (161) Mitts unless tied down or pinned down or unless so bulky or applied so tightly patient can not use or bend their hand (161) Mitts that look like boxing gloves are a restraint Padded side rails put up when on seizure precaution Giving child a shot to protect them from injury (161) Physically holding a patient for forced medications is a physical restraint

Restraints Do Include Tucking in a sheet so tight patient could not move (159) Use of enclosed bed or net bed unless the patient can freely exit the bed such as zipper inside the bed Freedom splint that immobilizes limb Remember that is it not the thing but what the thing does to the patient in which their movement is restricted

So, Is This a Restraint?

Restraint Chair Used by Law Enforcement
Emergency restraint chair Manufacturer states used for safe transports to hospital or court Safely restrains a combative or self destructive person

Restraints Devices with multiple purposes - such as side rails or Geri chairs, when they cannot be easily removed by the patient Restrict the patient’s movement constitute a restraint If belt across patient in wheelchair and he can unsnap belt or Velcro then it is not a restraint (159) If patient can lower side rails when she wants then it is not a restraint but document this If a patient can remove a device it is not a restraint

Restraints Stroller safety belts, swing safety belts, high chair lap belts, raised crib rails, and crib covers (161) are okay as long as age or developmentally appropriate Use of these safety intervention must be addressed in your policy Holding an infant or toddler is not a restraint

Weapons 154 CMS does not consider the use of weapons by hospital staff on patients as safe in the application of restraint (154) Could use on criminal breaking into building Weapons include pepper spray, mace, nightsticks, tazers, stun guns, pistols, etc. Okay if patient is arrested and use by law enforcement such as non-employed staff like police as state and federal laws Be sure to share this section with security

Assessment Should do comprehensive assessment and assess to reduce risk of slipping, tripping or falling To identify medical problems that could be causing behavioral changes (0154) such as increased temp, hypoxia, low blood sugar, electrolyte imbalance, drug interactions, etc. Use of restraint is not considered routine part of a falls prevention program (154)

Determine Reason for R&S
Surveyor will look to see if there is evidence that staff determined the reason for the R&S (154) This should be documented and be specific Consider a field on the order sheet to include this Usually to prevent danger to the patient or others Danger to self, maintain therapeutic environment such as to prevent patient from removing vital equipment, physically attempting to harm others or property, patient demonstrated lack of understanding to comply with safety directions

Reasons to Restrain (Check all that apply) Unable to follow directions
Aggressive Disruptive/combative History of hip fracture/falls Self injury Interference with treatments Removal of medical devices Other: ____________________________

Rule #4 Less Restrictive
Restraints can only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm (154, 164, 165,) Type or technique used must also be least restrictive Is what the patient doing a hazard? Allowing sundowners to walk or wander at night (154) Request from patient or family member is not sufficient basis for using if not indicated by condition of patient

Less Restrictive Must do an assessment of patient
Must document that restraint is least restrictive intervention to protect patient safety based on assessment What was the effect of least restrictive intervention You must train on what is least restrictive interventions

Least Restrictive Restraint to More

Rule # 5 Alternatives Alternatives should be considered along with less restrictive interventions (186) What are other things you could do to prevent using R&S such as sitter or family member stays with patient Distractions such as watching video games or working on a laptop computer Try nonphysical intervention skills (200) Considering having a list of alternatives in the toolkit

Consider Alternatives

Alternatives to Restraints
Be calm and reassuring Approach in non-threatening manner Wrap around Velcro band while in wheelchair (if can release) Relaxation tapes Do photo album Back rubs or massage therapist Wanderguard system Limit caffeine

Alternatives to Restraints
Watching TV Massage or family can hire massage therapist Punching bag Avoid sensory overload Fish tanks Tapes of families or friends

Restraints LIP Can Write Orders
Rule #6 LIPs can write orders for restraints Any individual permitted by both state law and hospital policy for patients independently, within the scope of their licensure, and consistent with granted privileges, to order restraint, seclusion NP, licensed resident, but not a medical student and CMS said usually not a PA Remember must specify who in your P&P (168)

Restraints Notify Doctor ASAP 170
Rule #7 - Any established time frames must be consistent with asap (not in 1 or 3 hours) Hospital MS policy determine who is the attending physician Hospital P&P should address the definition of asap (182,170) RN or PA who does 1 hour face-to-face must notify attending physician and discuss findings (182) Be sure to document if LIP or nurse notifies physician

Restraints Order Needed
Rule #8 An order must be received for the restraint by the physician or other LIP who is responsible for the care of the patient (168) Include in P&P use in an emergency P&P to include category of who can order (PA, NP, resident, can not be med student) PRN order prohibited if for medication used as a restraint, okay if not a restraint No PRN order for restraints either (167, 169), except for 3 exceptions (169)

PRN Order 3 Exceptions Repetitive self-mutilating behavior (169), such as Lesch-Nyham Syndrome Geri chair if patients requires tray to be locked in place when out of bed Raised side rails if requires all 4 side rails to be up when the patient is in bed Do not need new order every time but still a restraint

Rule #9 Plan of Care Restraints must be used in accordance with a written modification to the patient's plan of care (166) What was the goal of the plan of care Use of restraint should be in modified plan of care Care plan should be reviewed and updated in writing Within time frame specified in P&P (166) Plan reflects a loop of assessment, intervention, evaluation and reevaluation

Restraints - Plan of Care
Orders are time limited and this is included in the plan of care For patient who is V/SD may want to debrief as part of plan of care but not mandated by CMS Many states require for behavioral health department Debriefing no longer mandated by TJC for behavioral patients (deemed status)but de-escalation is in PC Can add information on debrief to R&S toolkit

Rule #10 End at Earliest Time
Restraints must be discontinued at the earliest possible time (154, 174) Regardless of the time identified in the order If you discontinue and still time left on clock and behavior reoccurs, you need to get a new order Temporary release for caring for patient is okay (feeding, ROM, toileting) but a trial release is seen as a PRN order and not permitted (169)

Restraints - End at Earliest Time
Restraints only used while unsafe condition exists The hospital policy should include who has authority to discontinue restraints (154, 174) Under what circumstances restraints are to be discontinued and who is allowed to take them off Based on determination that patients behavior is no longer a threat to self, staff, or others (put this in your P&P) Surveyors will look at hospital policy Policy should also include procedures to follow when staff need to apply in an emergency

Rule #11 Assessment of Patient
Staff must assess and monitor patient’s condition on ongoing basis (0154, 174, 175) Physician or LIP must provide ongoing monitoring and assessment also (175) One reason to determine is if R&S can be removed Took out word continually monitored except for V/SD patients and says at an interval determined by hospital policy

Rule #11 Assessment of Patient
Intervals are based on patient’s need, condition and type of restraint used (V/SD or not) CMS doesn’t specify time frame for assessment like TJC use to (TJC use to say every 2 hours for medical patients and every 15 minutes for behavioral health patients) CMS says this may be sufficient or waking patient up every 2 hours in night might be excessive This must be in your hospital P&P frequency of evaluations and assessments (175) and document to show compliance

Rule #12 Documentation Most hospital use special documentation sheet for assessment parameters, including frequency of assessment, and hospital policy should address each of these (175, 184) If doctor writes a new order or renews order need documentation that describes patients clinical needs and supports continued use (174) Document; fluids offered (hydration needs), vital signs Toileting offered (elimination needs) Removal of restraint and ROM and repositioning Mental status, circulation

Rule #12 Documentation Attempts to reduce restraints, skin integrity, and level of distress or agitation, et. al. Document the patient’s behavior and interventions used Behavior should be documented in descriptive terms to evaluate the appropriateness of the intervention (185) Example, patient states the Martians have landed and attempting to strike the nurses with his fists. Patient attempting to bite the nurse on her arm. Patient picked up chair and threw it against the window

Rule #12 Documentation Document clinical response to the intervention (188) Symptoms and condition that warranted the restraint must be documented (187) Have the restraint toolkit where you have the documentation sheet with the requirements, the order sheet, manufacturer instructions for the restraints, articles, etc. Many have separate order sheets for V/SD (behavioral health) and non V/SD (non behavioral health)

Document Type of Restraint

Not a Good Documentation Sheet

Log and QAPI Hospital take actions thru QAPI activities
Hospital leadership should assess and monitor use to make sure medically necessary Consider log to record use-shift, date, time, staff who initiated, date and time each episode was initiated, type of restraint used, whether any injuries of patient or staff, age and gender of patient

Rule #13 Use as Directed Restraints and seclusion must be implemented in accordance with safe, appropriate restraining techniques (167) As determined by hospital policy in accordance with state law Use according to manufacturer’s instructions and include in your policy as attachment Follow any state law provision or standards of care and practice Was there any injury to patient and if so fill out incident report

Rule #14 One Hour Rule The lighting rod for public comment and AHA sued CMS over this provision Standard for behavioral health patients or V/SD Time limits for R&S used to manage V/SD behavioral and drugs used as restraint to manage them(178) Must see (face to face visit) and evaluate the need for R&S within one hour after the initiation of this intervention

One Hour Rule 178 Big change is face to face evaluation can be done by physician, LIP or a RN or PA trained under (f) Physician does not have to come to the hospital to see patient now, telephone conference may be appropriate Training requirements are detailed and discussed later To rule out possible underlying causes of contributing factors to the patient’s behavior

One Hour Rule Assessment 482.13 (f)
Must see the patient face-to-face within 1-hour after the initiation of the intervention, unless state law more restrictive (179) Practitioner must evaluate the patient's immediate situation The patient's reaction to the intervention The patient's medical and behavioral condition And the need to continue or terminate the restraint or seclusion Must document this (184) and change documentation form to capture this information

One Hour Rule Assessment 482.13 (f)
Include in form evaluation includes physical and behavioral assessment (179) This would include a review of systems, behavioral assessment, as well as Patient’s history, drugs and medications and most recent lab tests Look for other causes such as drug interactions, electrolyte imbalance, hypoxia, sepsis etc. that are contributing to the V/SD behavior Document change in the plan of care Must be trained in all the above (196)

Rule #15 Time Limited Orders
Time limits apply- written order is limited to (171) 4 hours for adults 2 hours for children (9-17) 1 hour for under age 9 Related to R&S for violent or self destructive behavior and for safety of patient or staff Standard same now for Joint Commission time frame for how long the order is good for and closely aligned now

Rule #16 Renew Order The original order for both violent or destructive may be renewed up to 24 hours then physician reevaluates Nurse evaluates patient and shares assessment with practitioner when need order to renew (171, 172) Unless state law if more restrictive After the original order expires, the MD or LIP must see the patient and assess before issuing a new order

Rule #16 Renew Order Each order for non violent or non-destructive patients may be renewed as authorized by hospital policy (173) Remember TJC requires an order to renew non-behavioral health patients) according to your policy It could be daily or every 24 or 48 hours Different from patients who are violent and or self destructive which is every 24 hours CMS and TJC the same

Rule #17 Need Policy on R&S
Will interview staff to make sure they know the policy (154) Consider training on policy in orientation and during the annual in-service and when changes made Remember hitting restraints hard in the survey process Surveyor to look at use of R&S and make sure it is consistent with the policy

Rule #18 Staff Education New staff training requirements
All staff having direct patient contact must have ongoing education and training in the proper and safe use of restraints and able to demonstrate competency (175) Yearly education of staff as when skills lab is done Document competency and training Hospital P&P should identify what categories of staff are responsible for assessing and monitoring the patient (RN, LPN, Nursing assistant, 175)

Rule #18 Staff Education Patients have a right to safe implementation of RS by trained staff (194) Training plays critical role in reducing use (194) Staff, including agency nurses, must not only be trained but must be able to demonstrate competency in the following: The application of restraints (how to put them on), monitoring, and how to provide care to patients in restraints

Rule #18 Staff Education This must be done before performing any of these functions (196) Training must occur in orientation before new staff can use them on a patient Training must occur on periodic basis consistent with hospital policy Have a form to document that each of the education requirements have been met

Rule #18 Staff Education Again consider yearly during skills lab Remember that the Joint Commission PC and requires staff training and competency now The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require RS

De-Escalation Consider document in your tool kit although not required by CMS Required by TJC in PC Teach staff what is de-escalation and not just staff on the behavioral health unit Avoid confrontation and approach in a calm manner Active listening Valid feelings such as “you sound like you are angry” Some have personal de-escalation plan that lists triggers such as not being listening to, feeling pressured, being touched, loud noises, being stared at, arguments, people yelling, darkness, being teased, etc.

Staff Education The use of non-physical intervention skills (200)
Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition (201) The safe application and use of all types of R&S used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia, 202)

Staff Education Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary (204) Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation (205)

Staff Education Including respiratory and circulatory status, skin integrity, VS, and special requirements of 1 hour face to face The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification (206) Patients in R or S are at higher risk for death or injury All staff who apply, monitor, access, or provide care to patient in R must have education and training in first aid technique and certified in CPR To render first aid if patient in distress or injured Develop scenarios and develop first aid class to address these

Staff Education Staff must be qualified as evidenced by education, training, and experience Hospital must document in personnel records that the training and competency were successfully completed (208) Security guards respond to V/SD patients would need to train Many give a 8 hour CPI course Don’t want someone going into the room of a V/SD patient without training to prevent injury to staff and patient

Training Cost Individuals doing training program must be qualified
Trainers must have high level of knowledge and need to document their qualifications Train the trainer programs are done by many facilities CMS said need to revise your training program every year which should take person 4 hours to do Can have librarian do literature search for new articles on evidenced based restraint research

Training Time and Time Spent
National Association of Psychiatric Health Systems (NAPHS), initial training in de-escalation techniques, restraint and seclusion policies and procedures Recommended 7-16 hours of training but number of hours not mandated by CMS Just make sure your staff know the R&S requirements In fact, in Federal Register recommended sending one person to CPI training class as a train the trainer 1http://

Education Physicians and LIPs
Physician and other LIP training requirements must be specified in hospital policy (176) Consider having physician sign attestation and give them copy every two years when re-credentialing At a minimum, physicians and other LIPs authorized to order R or S by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion Hospitals have flexibility to determine what other training physicians and LIPs need

Rule #19 Stricter State Laws
The following requirements will be superseded by existing state laws that are more restrictive (180) State laws can be stricter but not weaker or they are preempted States are always free to be more restrictive Many states have a state department of mental health which has standards for patients that are in a behavioral health unit

Rule #20 1:1 Monitoring R&S 183 For behavioral health patients- which CMS now calls violent or self destructive behavioral that is a danger to self or others Can’t use R&S together unless the patient is visually monitored in person face to face or by an audio and video equipment Person to monitor patient face to face or via audio & visual must be assigned and a trained staff member Must be in close proximity to the patient (183) There must be documentation of this in the medical record

Rule #20 1:1 Monitoring RS 0183 Documentation will include least restrictive interventions, conditions or symptoms that warranted RS, patient’s response to intervention, and rationale for continued use This needs to be in hospitals P&P Modify assessment sheets to include this information Consider sitter policy to ensure does not leave patient unsupervised

Rule #21 Deaths Report any death associated with the use of restraint or seclusion Remember, the Safe Medical Devices Act (SMDA) also requires reporting Sentinel event reporting to Joint Commission is voluntary but need to do RCA within 45 days See Hospital Reporting of Deaths Related to RS, OIG Report, September 2006, OEI 1www.oig.hhs.gov

Rule #21 Deaths The hospital must report to CMS each death that occurs while a patient is in restraint or in seclusion at the hospital Must report every death that occurs within 24 hours after the patient has been removed from R&S Except if patient dies in one or two soft wrist restraints and the restraints did not cause the death Document in MR and complete internal log Each death known to the hospital that occurs within 1 week after R&S where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death

Rule #21 Deaths 0214 “Reasonable to assume” includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation Must be reported to CMS regional office by telephone no later than the close of business the next business day following knowledge of the patient's death This is in the regulation even though some of the regional offices are telling hospitals just to fax in the form

Soft Wrist Restraints 2013 Will need to include information in internal log Log must be done asap and never any later than 7 days Log must include patient’s name, date of birth, date of death, attending physician, primary diagnosis, and medical record number Name of practitioner responsible for patient could be used in lieu of attending if under care on non-physician practitioner CMS could request to review the log at anytime Would still require reporting of deaths within seven Need to rewrite policies and procedures and train all staff

Rule #21 Deaths 0214 Staff must document in the patient's medical record the date and time the death was reported to CMS This includes patients in soft wrist restraints Hospitals should revise post mortem records to list this requirement Hospitals need to rewrite their policies and procedures to include these requirements

Visitation Dec 2011 A hospital must have written P&P regarding the visitation rights of patient Must include any reasonable or clinically necessary restrictions Does not recommend restricting visitation in ICU Same day surgery patients may wish to have a support person present during pre-op and post-op recovery An outpatient may wish to have a support person present during examination by the physician

Visitation 215 Need written P&P to address patient’s right to have visitors Any restrictions must be clinically necessary or reasonable Can be restricted if interferes with the care of the patient or others Restrictions for child visitors Restrictions may include; infection control issue, court order, disruptive visitor, patient or room mate needs rest, inpatient substance abuse program, patient is having a procedure, etc.

Visitation Rights Notice 216
Hospital must have written P&P on visitation rights Policy includes the restrictions Hospital must inform each patient of any restrictions to visitation and must document it was given Inform patient of the right to receive visitors their choose and they can change their mind This includes spouse, same sex partner, friend, or family Support person may be the same or different from the patient representative Any refusal to honor must be documented in the chart

Patient Visitation Rights 217
The hospital policy must ensure that all visitors enjoy full and equal visitation rights no matter who they are Can not discriminate based on sex, gender, sexual orientation, race, or disability Surveyor will ask patients if visitors restricted against their wishes and if so was it in the P&P Hospital needs to educate the staff Consider in orientation and periodically Should have a culturally competent training program

Support Person

Adverse Event Reporting
Hospitals are required to track AE Several reports show that nurses and others were not reporting adverse events and not getting into the PI system OIG recommends using the AHRQ common formats to help with the tracking States could help hospitals improve the reporting process Encouraged all surveyors to develop an understanding of this tool

Report Adverse Events to PI

Hospital CoPs for QI CMS issued new hospital COPs for QA and Performance Improvement CMS issues Memo March 15, 2013 on AHRQ Common Formats Hospitals are required to track adverse events for PI Starts with tag number 0263 Short section because the hospital compare program is not part of the CMS CoP Hospital compare is the indicators that must be sent to CMS to receive full reimbursement rates

hwww.psoppc.org/web/patientsafety

Hospital Common Formats

2014 Changes to QAPI CMS issues a revised manual on March 21, 2014 and goes from 34 to 8 tags Rewrites 7 of the 8 Tags; 273, 283, 286, 297, 308, 309, and 315 Remember that QAPI is important to both CMS and TJC Recall that one of the three CMS worksheets is on QAPI QAPI starts at tag 263

March 21, 2014 Manual Rewrites 7 Tags

Hospital CoPs for QAPI 263 Standard: Must have PI program that is ongoing, data driven, and effective, Board must make sure that PI program reflects the complexity of the hospital’s organization and services Must involve all departments including contracted services Focus on indicators to improve health outcomes

Program Scope 273 Standard: PI program needs to be ongoing and show measurable improvements to improve health outcomes Must measure, analyze and track the quality indicators Must incorporate data to measure the effectiveness and safety of services and the quality of care How often the data is collected must be specified by the board

CMS Hospital CoPs 2014 Triggers can help hospitals find errors
Look at information submitted to or from QIO Use data to identify opportunities for improvement (283) Focus on high risk, high volume, or problem prone areas Consider the incidence, severity, and severity of problems in those areas Take action to improve and track the improvements made 1www.ihi.org

Patient Safety, Medical Errors, AE 286
Standard: PI program must include indicators to identify and reduce medical errors Track medical errors and ADE Analyze their causes and implement preventive actions Example would be a RCA or root cause analysis Board is responsible for the operations of the hospital Medical staff and administrative staff are accountable to make sure clear expectations for safety

QAPI Program 2014 So does the program show measurable improvements, that identifies and reduces medical errors Diagnostic errors, equipment failures, blood transfusion injuries, or medication errors Medical errors may be difficult to detect in hospitals and are under reported Make sure incident reports filled out for errors and near misses Make sure RCA done when indicated

PI Projects 297 Standard: Hospital must conduct PI projects
How many the hospital does depends on how big they are and what types of services are provided May develop and information technology system to improve patient safety and quality Document the projects and reasons for doing Can participate in a QIO project or do one that is of comparable effort

CMS Hospital CoPs QAPI QIO to advance quality of care for Medicare patients Every state has a QIO or Quality Improvement Organization under contract by CMS Sign up with your state QIO to get newsletters and other information CMS has a website on information about QIOs CMS has the mission to improve services provided to Medicare patients

Executive Responsibilities 309
Standard: Board assumes full legal authority and responsibility for the operations of the hospital Medical Staff and Administrative officials are responsible and accountable for the following: Ongoing PI program that includes patient safety including reducing medical errors Hospital wide PI and patient safety program A determination of the number of PI projects that is conducted annually

Adequate Resources 315 Standard: The board, Medical Staff, and Administrative Officials are accountable for measuring, assessing, improving and sustaining the hospital’s performance This also requires reducing risk to patients Example; hospitals created a process to ensure MI patients got their thrombolytics timely, that PCI was done before 90 minutes and pneumonia patients got their antibiotics and blood culture timely Process to make sure the improvements continue

QAPI Patient Safety This means people who can attend meetings, data so analysis can be made and other resources Safer IV pumps, new anticoagulant program, implement central line bundle, sepsis, and VAP bundle, preventing inpatient suicides, wrong site surgery, retained FB, new processes for neuromuscular blocker agents, implement policy on Phenergan administration and Fentanyl patches So what’s in your PI and Safety Plans?

Hospital CoPs for QAPI Must have PI program that is ongoing and shows measurable improvements, that identifies and reduces medical errors Diagnostic errors, equipment failures, blood transfusion injuries, or medication errors Medical errors may be difficult to detect in hospitals and are under reported Make sure incident reports filled out for errors and near misses Remember the QAPI Worksheet

Medical Staff Hospital must have an organized MS that operates under bylaws approved by Board Must have MS bylaws that apply equally to all See previous MS sections These have been discussed previously Each hospital can have a separate medical staff or a unified integrated (shared) medical staff if requirements are meet

Medical Staff Medical staff would have to pass a vote by the majority to have a unified integrated medical staff Hospitals must be part of the system The unified medical staff would have appropriate by-laws that would include a process where the voting members of each separate hospital are advised of their right to opt out and return to a separate and distinct medical staff

Medical Staff The unified integrated medical staff has P&Ps to ensure the needs of the separately certified hospitals are given consideration and that local issues are addressed MS may include doctors and other categories of physicians and non-physicians who are eligible for appointment to the MS (339) As long as consistent with state law and the state scope of practice (341) All practitioners privileged must follow and be evaluated under the by-laws and R/R of the MS Must examine their credentials

Medical Staff MS can include other categories of non-physicians determined to be eligible But must follow state scope of practice law such as dietician, PharmD, NP, or PA MS must periodically conduct appraisals of its members MS bylaws determine frequency of appraisals Recommends at least every 24 months (TJC C&P is 24 months) To be sure they are suitable for continued membership

Medical Staff 0340 Must evaluate MS qualifications and competencies, within scope of practice or privileges requested Look at special training, current work practice, patient outcomes, education, maintenance of CME, adherence to MS rules, certification, licensure and compliance with licensure requirements Want to be sure the MS is credentialed and privileged to do what they are competent to perform

Medical Staff Appraisals
Appraisal procedures must evaluate each member To determine if should be continued, revised, terminated or changed If requests for privileges goes beyond the specified list for that category of practitioners need appraisal by MS and approval by the board Must keep separate credentials file for each MS member If limit privileges must follow laws such as reporting to NPDB MS bylaws need to identify process for periodic appraisals

Medical Staff 0341 and MS must examine credentials and make recommendations to the board on appointment of the candidates and must look at the following Request for privileges, evidence of current licensure, training and professional education, documented experience, and supporting references of competence Can’t make a recommendation based solely on presence or absence of board certification although can require board certification MS must examine credentials of all eligible to be on the MS including non-physicians (NP, PA, PharmD etc.) Telemedicine standards repeated in tag 342 & 343

Medical Staff Organization 347 2014
MS is accountable to Board for quality of medical care provided whether single or shared MS If MS has executive committee, majority of members must be MD/DO Responsibility for the MS is assigned to MD, DO, dentist or podiatrist MS must be well organized-formalized organizational structure and lines are delineated between the MS and the Board & can have MEC Committee to represent MS MS must have bylaws and must enforce bylaws and Board must approve bylaws

Hospital Part of a System 348 2014
If hospital is part of a system and has a shared (unified integrated) MS each hospital must demonstrate It is not necessary for each of the hospitals to have its own MS bylaws and R/R Detailed section so just need to read the rules If had a shared MS before July 11, 2014 then evidence of the board’s election to do this Must still be consistent with state law & document this MS must still be informed of the right to change their minds and opt out of the shared MS

Hospital System If hospital is part of a hospital system, then can decide to have shared MS if consistent with state law MS must have voted by a majority who hold privileges to be a shared MS or to opt out and have a single MS Physicians who only hold telemedicine privileges are not eligible to vote Board must also approve Must amend bylaws and R/R

Hospital System & Shared MS 350 9-26-2014
Hospital systems that elects to have a shared MS must demonstrate that There are revised MS bylaws and R/R Describe the process for self governance, appointment, C&P, and oversight Must describe process for peer review P&P and due process rights Must include process to opt out later of the shared MS Will look for documentation of the above things

Hospital System & Shared MS 351 9-26-2014
If hospital is part of a system and decides to have a shared MS then must take into account each member hospital’s unique circumstances Must consider any difference in patient populations This could include rehab hospital, children’s hospital, acute care, LTC, or behavioral health hospital Hospitals with similar populations and located close to each other would have fewer challenges Leadership and MS must be able to explain decision How does MS approve standing orders, P&P, etc. (352)

Medical Staff MS must adopt and enforce bylaws (353)
Board must approve bylaws and any changes also (354) TJC has MS which tells when to put things in the by-laws, rules or responsibilities or policies TJC does C&P tracer since such an important area MS bylaws must include statement of duties and privileges in each category, ( eg. participate in PI, evaluate practitioner on objective criteria, promote appropriate use of health care resources, 355)

Medical Staff Privileges for each category ( eg. active, courtesy, consulting, referring, emergency case) Can not assume every practitioner can perform every task/activity/privilege that is specified for that category of practitioner Individual ability to perform each must be individually assessed (core privileging, 355)

Medical Staff MS bylaws must describe organizational structure of the MS (356) Lay out R&R which make it clear what are acceptable standards of patient care for diagnosis, medical, surgical care, and rehab Survey procedure-describe formation of MS leadership Survey procedure-verify bylaws describe who is responsible for review and evaluation of the clinical work of MS

Medical Staff MS bylaws must describe the qualifications to be met by a candidate for membership on the MS (eg. provide level of acceptable care, complete medical records timely, participate in QI, be licensed, Tag 357) Survey procedure-MS bylaws describe qualifications as character, training, experience, current competence, and judgment

H&P 358 Repeated in tag number 461 and 463 and in surgery section CMS changes standard to be consistent with TJC standard MS must adopt bylaws to carry out their responsibilities on H&Ps The bylaws must include a requirement that a H&P be completed no more than 30 days before or 24 hours after admission on each patient Must be on chart before surgery

H&P Admission There needs to be an updated entry in the medical record to reflect any changes Person who does the H&P must be licensed and qualified Example, family physician does H&P 2 weeks ago for patient having CABG today Surgeon would review, update, and determine if any changes since it was done and authenticate document

History and Physicals Can include in progress notes or has stamp sticker, check box, or entry on H&P form Should say that H&P was reviewed, the patient examined, and that “no change” has occurred in the patient’s condition since the H&P was completed There needs to be a complete H&P in the chart for every patient except in emergencies and can make entry in progress notes

History and Physicals New regulation expands the number of categories of people who can do a H&P If state law and the hospital allows (which most do) a PA or NP may perform Physician is still responsible for the contents and must sign off the H&P when done by one of these allied health professionals Need to do PI to make sure all H&P are on the chart especially when the patient goes to surgery

TJC PC H&P EP4 requires H&P no more than 30 days old and done within 24 hours EP5 if done within 24 hours update, update prior to surgery (also RC ) EP7 that requires an update to a history and physical (H&P) at the time of the admission RC EP3 document H&P in MR for operative or high risk procedure and for moderate and deep sedation MS requires H&P process be in MS bylaws

TJC MS H&P EP6 Specifies minimal content (can vary by setting, level of service, tx & services EP7 MS must monitor the quality of the H&Ps EP8 Medical staff requires person be privileged to do H&P and requires updates EP9 As permitted by state law, allow individuals who are not LIPs to perform part or all of the H&P EP10 MS defines when it must be validated and countersigned by LIP with privileges MS defines scope of H&P for non inpatient services

Autopsies 0364 MS should attempt to secure autopsies in all cases of unusual deaths Must define mechanism for documenting permission to perform an autopsy Must be system for notifying MS and attending doctor when autopsy is performed TJC has similar section

Nursing Services 0385 Must have an organized nursing service that provide 24 hour nursing services Must have at least one RN furnishing or supervising 24 hours SSA at 1861 (b) states you must have a RN on duty at all times (except small rural hospitals under a waiver) Survey procedures-determine nursing services is integrated into hospital PI Make sure there is adequate staffing Survey procedure - look for job descriptions including director of nursing

Director of Nursing Service
DON must be RN, A-386 Often referred to as chief nursing officer or CNO CNO responsible for determining types and numbers of nursing personnel CNO responsible for operation of nursing service Survey procedure-look at organizational chart May read job description of DON to make sure it provides for this responsibility May verify DON approves patient care P&P’s

Nurse Staffing 392 Nursing service must have adequate number of nurses and personnel to care for patients Answer call lights timely and check on patient if cardiac monitor alarms Must have nursing supervisor Every department or unit must have a RN present (not available if working on two units at same time) Survey procedure-look at staffing schedules that correlate number and acuity of patients

Nurse Staffing 392 There are 3 recent evidenced based studies that show the importance of having adequate staffing which results in better outcomes Study said patients who want to survive their new hospital visit should look for low nurse-patient ratio Nurse Staffing and Quality of Patient Care, AHRQ, Evidence Report/Technology Report Number 151, March 2007, AHRQ Publication No. 07-E0051 1http:// evidence/pdf/nursestaff/nursestaff.pdf

Nursing Linked to Safety
IOM study also linked adequate staffing levels to patient outcomes Limits to number of hours worked to prevent fatigue Suggests no mandatory overtime for nurses Never work a nurse over 12 hours or 60 hours in one week (or will have 3 times the error)

Nursing Linked to Safety
Also showed medication error rate, falls, pressure ulcers, UTI, surgery site infections, gastric ulcers, codes, LOS, increased unnecessary readmissions, patient experience or satisfaction rates etc. linked to staffing Important in value based purchasing Redesigning the work force See Keeping Patients Safe: Transforming the Work Environment of Nurses 20041 1www.nap.edu/openbook/ /html/23/html

Nursing Staffing Linked to Safety
AHRQ 2008 has published 3 volume, 51 chapter handbook for nurses at no cost Great resource that every hospital should have Nurse Staffing and Patient Care Quality and Safety Again shows that patient safety and quality is affected by short staffing Patient Safety and Quality: An Evidence-Based Handbook for Nurses, 20081 1http://

Verify Licensure 394 Must have procedure to ensure nursing personnel have valid and current license Survey procedure-review licensure verification P&P Can verify licensure on line by most state boards of nursing online Considered primary source verification Can print out information for employee file

RN for Every Patient 395 A RN must supervise and evaluate the nursing care for every patient RN must do admission assessment Must use acceptable standard of care Evaluation would include assessing each patient’s needs, health status and response to interventions

Nursing Care Plan Hospital must ensure that nursing staff develop and keeps a current, nursing care plan for each patient If nursing participates in interdisciplinary care plan then do not have to have separate nursing plan of care Starts upon admission, includes discharge planning, physiological and psychosocial factors Based on assessing the patient’s needs Care plan is part of the patient’s medical records and must be initiated soon after admission, revised and implemented

Agency Nurses 398 Agency nurses or traveling nurses (CMS calls them non-employee nurses) must adhere to P&P’s CNO must provide adequate supervision and evaluate (once a year) activities of agency nurses Includes other personnel such as volunteers Orientation must include to hospital and to specific unit, emergency procedures, nursing P&P, and safety P&P’s

Preparation/Admin of Drugs 405 2014
Drugs must be prepared and administered according to state and federal law 404 deleted and combined with 405 Need an practitioner’s order CMS changes to allow other practitioners who are allowed to order to sign off order such as PharmD as allowed by P&P and state scope of practice and MS bylaws/RR Surveyor will observe nurse prepare and pass medications Medications must be prepared and administered with acceptable national standards of practice (TJC MM chapter), manufacturer’s directions and hospital policy

CMS Changes to Medication Administration
CMS issued a survey and certification memo dated , and March 14, 2014 Tag 405 use to say that all medications must be given within 30 minutes of the scheduled time Now three blocks of time to give medications Included section on standing orders but most sections moved to tag 457

Changes to Tag 405 Medications 30 Minutes

Changes to 405 June 7, 2013

March 14, 2014 Memo Amends Tag 405

CMS Changes to CoPs Changed tag 405 which deals with orders of drugs and biologicals and safe opioid use Most sections on standing orders section was moved to 457 Added information on age and weight of patient especially weight based doses for children All drugs are administered under the supervision of nursing or other personnel Five rights of medication administration: right patient, medication, dose, route and time and references nine rights

Pharmacy Should Prepare Piggybacks & IVs

Administration of Meds 0405 2014
Medication management is a hot topic with CMS and TJC All drugs administered under the supervision of nursing or other personnel if permitted by law In accordance with approved medical staff P&P’s, state & federal laws, MS bylaws and R/R and scope of practice Surveyor will review sample of medication records to ensure it conforms to physician’s order

Administration of Meds 405
Need to have an order, make sure compliant with state and federal laws, and acceptable standards of practice Need to have a P&P with three time frames on timing of medications Must educate staff and policy must comply with the 10 page memo issued Include medications not eligible for scheduled dosing such as stat drugs, PRN, loading doses, drugs for scheduled procedure etc.

Administration of Meds 405
Medications that are eligible for scheduled times P&P to include time-critical scheduled medications given in 30 minutes with one hour window P&P that are non-time-critical scheduled medications 2 hours for medications prescribed more frequently than daily, but no more frequently than every 4 hours and 4 hours for medications prescribed for daily or longer administration intervals P&P on missed or late medications

Assessment & Monitoring of Patients 2014
Patients on medications needed to be carefully monitored May need clinical and lab data to evaluate medication Monitor respiratory status, pulse ox BP, end tidal CO2 with patients on opioids Evaluate clinical signs such as confusion, agitation, unsteady gait, itching etc. Know high risk medications policy and safe practices Know risk factors for ADE such as patient has liver or kidney failure, history of sleep apnea, obesity, smoking, drug-drug interaction and first time medication use

ISMP List of High Alert Medication

Assessment & Monitoring of Patients
ADE, such as anaphylaxis or opioid-induced respiratory depression may require timely and appropriate Post-medication monitoring in case of a high alert medication may include regular assessment of VS, pulse ox, and sedation levels of post surgery patient on PCA Such as Richmond agitation sedation scale (RASS) or the Pasero Opioid-Induced sedation scale (POSS), Inova Sedation Scale (ISS), Ramsey scale, Aldrete Scoring system

Assessment & Monitoring of Patients
Staff are expected to include patient reports of his experience with medication’s effect Patient should be instructed to notify nurse if there is difficulty breathing or a reaction to the medication Hospital needs P&P to address the manner and frequency of monitoring P&P should include information to be communicated at shift change Should include patient’s risk factors Document after medication administered

9 Rights of Medication Administration

Physician Order Standard: Drugs and biologicals must be prepared on the order contained within preprinted and electronic standing orders, order sets, and protocols if meet the standards in tag 457 Orders for drugs can be documented and signed by other practices if acting in scope of practice, state law, P&P, and MS bylaws and R/R CMS issues standing order memo Also includes standing orders, preprinted orders and use of rubber stamps

Physician Order Flu and pneumovax can be given by protocol approved by the MS after assessment of contraindications Orders for drugs must be documented and signed by practitioners allowed to write them Doctors and if allowed NP and PAs Rubber stamps - will not be paid for order for M/M patients and some insurance companies so many hospitals do not allow rubber stamps

Physician Order 406 Order must have name of patient, age and weight (if applicable), date and TIME of order, drug name, strength, frequency, dose, route, quality and duration, and special instructions for use, and name of pre scriber Have a culture so can ask questions Now allowed to have written protocol or standing orders with drugs and biologicals that have been approved by MS Can implement them but be sure provider signs, dates, and times the order

Physician Order 406 Chest pain protocol or asthma protocol with Albuterol and Atrovent are an example of initiation of orders Code teams gives ACLS drugs in an arrest Timing of orders should not be a barrier to effective emergency response Preprinted order - should send memo so doctors and providers are aware of new guidelines

Preprinted Order Sets Must date and time when the order set is signed
Must indicate on last page the total number of pages in the order set If want to strike out something in the order sheet or delete it or add order on blank line then physician needs to initial each place Should add this to the MR audit sheet to make sure there is compliance with this guideline Standing orders must address well-defined clinical scenarios involving medication Refers to tag 457 and 450 for more information

Verbal Orders 407 and 408 Verbal orders are a patient safety issue
Have lead to many errors Hospital must describe situations in which they can be used as well as limitations Must establish the identity and author of all orders Rewrite your P&P and Medical staff by-laws to be consistent with these standards Repeated VO section in MR starting with tag 454 and reiterated area of verbal orders offer too much room for error

Verbal Orders Must follow state law for time period to sign off such as 24 or 48 hours If no state law do not have to sign off in 48 hours anymore Must sign off orders within time frame set by hospital policy Many hospitals without a state law can choose to have signed off in policy but But still try and get them signed off ASAP Must still sign name and date and time the order

CMS Verbal Orders Emphasizes to be used infrequently and never for convenience of the physicians This means that physician should not give verbal orders in nursing station if he or she can write them Can be used in emergency or if surgeon is scrubbed in during surgery Regulation broadens category of practitioners who can sign orders off such as PA or NP Renewed any physician can sign off for any other physician on the case

Verbal Orders P&P Should Include
Limitations or situation on not using VO such as not for chemotherapy List the elements for a complete VO (such as patient name, drug, dose, frequency, name of person giving and taking order, et al.) Define who can receive VO and the method to ensure authentication Provide guidelines for clear and effective communications

Signing Off Verbal Orders
Person taking VO must document it in the chart Physician must sign off a verbal order, date, and time it when signed off Any physician on the case can sign off any VO This practice must be addressed in the hospital’s P&P Now a NP or PA may sign off a verbal order, if within their scope (where they had authority to write order) and allowed by state law, hospital policy and delegated to this by the physician

Verbal Orders Regulation states that verbal orders should be authenticated based on state law Some states require order to be signed off in 24 hours or 48 hour and if no state law then no longer a set 48 hours but what your hospital P&P dictate Need hospital P&P to reflect these guidelines Write it down and repeat it back

Joint Commission Verbal Orders
RC (IM 6.50) requires that qualified staff receive and record VO Define in writing who can receive and record VO Date and document identity of who gave, received, and implemented the order Authenticated within time frame law/regulation Write it down and read back the completed order or test result (NPSG 2009)

Blood Transfusions and IVs 409 2013 & 2014
Standard: Blood transfusions and IV medications must be administered with state law and MS P&P CMS previously issued a memo on May 13, 2011 Use to require special training for this and there was a long list of things that nurses had to be trained on CMS eliminated the regulations mandating training for non-physicians who administer IV medication and blood and blood products CMS says because this training is already standard practice but must still be competent in those areas Must follow your P&P and state scope of practice

Blood and IV Medication Training 2014
Must still follow state law requirements In some states an LPN can not hang blood Or the LPN can not push certain IV medications in some states Must show they are competent Must still have approved Medical Staff Policies and Procedures in place Staff must follow these which have most of the things that were previously required

Blood Transfusions and IVs
Hospital P&P for blood and IV medication must be based on state law and MS P&P and must address the following: Vascular access route such as central line, peripheral or implanted port and what medications can be given IV and via what type of access devices Basic safety practices for medication administration Tracing line and tubes prior to administration to be sure proper route Verify proper programming of infusion devices

Patient Monitoring Monitor for the effects of the medication since IV medications have a more rapid effect Monitoring to include assessment of risk factors that would influence type and frequency of monitoring Such as patient with renal failure on Vancomycin and dose is based on lab test P&P expected to address Monitoring for fluid and electrolyte balance Monitor patients on high alert meds including opioids and evaluate for over-sedation and respiratory depression

Risk factors for patients receiving opioids include Snoring or history of sleep apnea No recent opioid use or first-time use of IV opioids Increased opioid dose requirement or opioid habituation Longer length of time receiving general anesthesia during surgery Receiving other sedating drugs, such as benzodiazepines, antihistamines, sedatives, or other CNS depressants Preexisting pulmonary or cardiac disease Thoracic or other surgical incisions that may impair breathing

P&P must include who can conduct the assessments The frequency and duration of the assessments Under what circumstances practitioners prescribing IV opioids are allowed to establish protocols that differ from hospital P&P Assessment includes VS (TPR and BP), pain level, respiratory status, sedation level and ETCO2 Also mentions APSF monitoring of opioids including ETCO2

Blood Transfusions Confirm correct patient
Verify correct blood product Standard calls for two qualified persons, one who is administering the transfusion Document monitoring P&P include how frequent you monitor the patient and do vital signs How to identify and treat and report any adverse transfusion reaction

Blood Transfusions Staff must be competent in venipuncture
Competent in using vascular access devices Trained in early detection and intervention for opioid over-sedation Must document competency So make sure nursing education is aware and staff trained in orientation periodically Make sure staff educated on P&P

Blood Transfusions and IVs 2013/2014
Is there evidence that staff competent in; Maintaining fluid and electrolyte balance Venipuncture techniques Blood transfusion: blood components, administration policy, national standards of practice, patient monitoring requirements including frequency, documentation, verifying correct blood and patient Transfusion reactions; Identification, treatment and reporting requirements

Incident Reports Transfusions 2013
There must be procedure for reporting transfusion reactions, adverse drug reactions and errors in administration of drugs (410) Survey procedure - request procedure for reporting-they may review the incident reports or other documentation through QAPI program But must have a hospital P&P for reporting transfusion reactions such as an incident reporting system See tag number 508 which was updated May 20, 2011 on this issue

ADE and Drug Administration 410
Mentions similar standard in pharmacy section which is in tag 508 Wants to be all drug errors and ADE are reported This includes any blood transfusions AE Discusses symptoms of a transfusion reaction Need P&P for internal reporting of transfusion reactions since be life threatening Must be immediately reported to the practitioner responsible for the patient’s care and documented in the medical record and report to PI

Self Administration of Medication 412 2013
New tag number in 2013, Tag 412 and 413 Standard: Hospital may allow a patient or caregiver to self administer both hospital issued medication and the medication the patient brought from home As specified in the hospital P&P Revise your policy to include this section Add this to the education of your nursing and pharmacy staff

Self Administration of Medication 412 2013
Must have an order, must make sure patient is competent to do, must educate the patient P&P must address security of medication for each patient Must document in the MR so patient must let nurse know Visually inspect medication for integrity Previously this section was in the pharmacy section 502

CMS Self Administered Drugs 412 and 413

See Tag 412 and 413 March 2013

Medical Record Services 0432
Must have MR services and have an administrator responsible for MR and will sample 10% of daily census and at least 30 records Must keep MR on every patient and have one unified MR service responsible for all MR, both inpatient and outpatient MR includes radiology films and scans, pathology slides, computerized information, et al

Staffing of Medical Records 432
Organization must be appropriate for size and must employ adequate personnel to ensure prompt completion, filing, and retrieval Must have proper education, skills, qualifications and experience to meet state and federal law Ensure proper coding and indexing of records Surveyor will look at job descriptions and staffing schedules

Retention of Record 438 MR on each patient
Both inpatients and outpatients MR must be accurate Contains all orders, test results, care plans, treatment and response to treatment), complete, retained and accessible Accessible 24 hours a day Use a system of author identification and protect security of all records Protected from fire, water damage and other threats

Medical Records Must be promptly completed
Kept at least 5 years (439) in other legal reproducible manner Certain medical records may be retained longer if required by state or federal law (OSHA, EPA, FDA) See retention law memo from AHIMA Will request records from months ago

Retrieval 440 Must have a system of coding and indexing that allows timely retrieval of MR Must be able to retrieve by diagnosis and procedure to support medical care studies MR have to be accessible for departments that need them like the emergency department

Privacy & Confidentiality Memo 3-2-12 Tag 147

Privacy & Confidentiality Memo
Discusses privacy & confidentiality consistent with HIPAA HIPAA 526 pages of changes Sept 23, 2013 Discusses incidental uses and disclosures Allows name on spine of chart Allows name on outside of patient room Allows signs such as fall risk or diabetic diet Will cover later in the presentation

Tag 441 Confidentiality of Medical Records

Tag 442 and 443 Deleted

Confidentiality Standard: Must have a procedure for ensuring confidentiality of MR Hospital must ensure that unauthorized individuals can not gain access to or alter the medical records Copies may only be released to authorized individuals and written authorization by proper person, DPOA, guardian, etc. Release original only for court orders, subpoenas but usually will take a certified copy Surveyor will ask for policy

Confidentiality 441 Reiterated some of the things in tag 143 and 147
Must have P&P to ensure confidentiality of the MR May use for payment or healthcare operations without the patient’s authorization Financial, legal, PI, activities of the hospital to conduct business and support core functions, case management, audit, medical reviews, fraud and abuse detection, etc. P&P must limit disclose of MR to the minimum disclosure necessary Surveyor will observe to make sure MR protected

Content of Records A-449 Contain records, notes, reports assessment to justify Admission Continued hospitalization Support the diagnosis Describe the patient’s progress Describe response to medications and to interventions, care, and treatment Records must be promptly filed in chart

Legible and Authenticated 450
All entries must be legible, complete, dated and timed Must be authenticated by the person responsible for ordering, providing, or evaluating the service provided Specify in MS or hospital policy who can make entries in medical record Need method to identify author Written signatures, electronic signature, initials, computer key, or other code and a list of written signatures must be available

Legible and Authenticated
Must have P&P if electronic medical record If non MD does H&P or document exams, must be authenticated MS R&R address countersignature when required by policy or state law and this is defined in MS R&R Section on standing orders (preprinted order sets) Sign, date, and time the last page Include total number of pages such as page 3 of 3 Initial any changes, additions, or deletions

Medical Records 450 If rubber stamp used-must have signed statement only that individual will use it, but do not allow for signature or you may not be paid for care Just don’t allow stamps for signatures on orders Also CMS issued in a separate Program Integrity manual April 2010 stamps are not allowed If electronic MR must demonstrate how alterations are prevented Can’t use system of auto authentication that says can not review because not transcribed yet

CMS Signature Guidelines
April 16, 2010 CMS issues new signature guidelines and says no rubber stamps CMS issued a change request updating the Program Integrity Manual on signature guidelines for medical review purposes Requires legible identifier in form of handwritten or electronic signature Third exception is cases where national coverage determination (NCD), local coverage determination (LCD) or if CMS manual has specific guidelines takes precedence over above

Verbal Orders 454 and Recall verbal order section starting in NS section at tag number 407 and 408 is repeated and already discussed All doctor can sign VO for any other doctor on case or practitioner responsible for care if within scope and state law Person who takes VO must read it back and write it down with date and time When doctor or LIP authenticates and signs off order must date and time it also and do asap such as next time doctor sees patient Sign off as required by state law and if no state law then as required by your hospital P&P If state law says sign off in 24 or 48 hours you must follow If no state law then no longer 48 hours and many hospitals sign off within P&P but must still sign off, date and time the entry and want to sign off asap such as next time the physician sees the patient

Tag Standing Orders 2013 Standard: hospitals can use preprinted and electronic standing orders, order sets, and protocols for patient orders only if the hospital has the following 4 things: Make sure the orders and protocols have been reviewed and approved by the Medical Staff (such as the MEC) and the hospital’s nursing and pharmacy leadership Demonstrate that the orders and protocols are consistent with nationally recognized and evidenced based guidelines

Tag 457 Standing Orders 2013 No standard definition of standing orders
For brevity CMS uses standing orders to include pre-printed orders, electronic standing orders, order sets and protocols Said these are forms of standing orders States lack of standard definition may result in confusion Not all preprinted and electronic order sets are considered a standing order covered by this regulation

Tag Standing Orders 2013 Example; doctor or qualified practitioner picks from an order set menu and treatment choices can not be initiated by nurses or other non-practitioner staff then menus are not standing orders covered by this regulation Menu options does not create an order set subject to these regulations The physician has the choice not to use this menu and could create orders from scratch or modify it

Standing Order Requirements 457
Must be well-defined clinical situations with evidence to support standardized treatments Appropriate use can contribute to patient safety and quality care Can be initiated as emergency response Can be initiated as part of an evidenced based treatment regime where not practicable to get a written or verbal order Must be medically appropriate such as RRT

Standing Order Requirements 457
Triage and initialing screening to stabilize ED patients presenting with symptoms of MI, stroke, asthma Post-operative recovery areas like PACU Timely provisions of immunizations Can’t be used when prohibited by state or federal law so no standing orders on R&S CMS has set forth a number of minimum requirements for standing orders that must be present for a well-defined clinical scenario

Minimum Requirements for Standing Orders
Must be approved by MS, nursing and pharmacy leadership P&P address how it is developed, approved, monitored, initiated by staff and signed off or authenticated Must have specific criteria identified in the protocol for the order for a nurse or other staff to initiate Such as a specific clinical situation, patient condition or diagnosis Must include process to have them signed off

Minimum Requirements for Standing Orders
Hospital must document standing order is consistent with nationally recognized and evidenced based guidelines Burden is on the hospital to show there is sound basis for the standing order Must have regular review to ensure its still useful and a safe order P&P address how to correct it, revise or modify Must be placed in the order section of the chart Must be dated, timed, and signed

Tag Standing Orders 2013 Make sure there is periodic and regular review of the orders and protocols conducted by the MS, nursing and pharmacy leadership to determine the continued usefulness and safety Make sure they are dated, timed, and authenticated promptly in the medical record Signed off by the ordering practitioner of another practitioner on the case Could be signed off by non-physician if allowed by hospital policy, state law, the person state law scope of practice, and MS bylaws or R/R

History and Physical 458 and 461 2013
Repeats same provisions on H&P as in medical staff section under tag number 358 and 359 H&P done within 24 hours, not older than 30 days old and updated within 24 hours and updated and on chart before patient goes to surgery PA and NP can do if allowed by hospital and all state laws allow and physician reviews and authenticates with date, time, and signature

MR Must Contain 464 and Must have admitting diagnosis in chart (463) All consults and findings by clinical staff and others must be documented (464) Information must be promptly filed in the MR so staff has access to it (464) Must document complications and healthcare- associated infections (HAI) and unfavorable reactions to drugs and anesthesia (465) It is important for all practitioners to be aware of the need to document complications and how to do this correctly

Informed Consent Now three separate sections related to informed consent in patient rights, medical record and surgical services Properly executed informed consent for procedures and treatments specified by MS Need list of all surgeries As defined now by ACS and AMA Listed procedures with yes or no

Informed Consent MR Mandatory
Minimum elements in an informed consent Name of hospital Name of procedure or treatment Name of responsible practitioner who is performing Statement that benefits, material risks and alternatives were explained Signature of patient Date and time form is signed

Medical Records 466 CMS has list of optional elements which they call a well designed consent form Medical record must contain an informed consent for procedures and treatments specified as requiring on and MS by-laws should address this Consider state laws requiring informed consent such as for invasive procedures and any federal laws such as informed consent for research

Consider List of Procedures
Procedure Name Requires Informed Consent Ablations Yes Amniocentesis Yes Angiogram Yes Angiography Yes Angioplasties Yes Arthrogram Yes Arterial Line insertion (performed alone) Yes Aspiration Cyst (simple/minor) No

Consider List of Procedures
Procedure Name Requires Informed Consent Aspiration Cyst (complex) Yes Blood Administration Yes Blood Patch Yes Bone Marrow Aspiration Yes Bone Marrow Biopsy Yes Bronchoscopy Yes Capsule Endoscopy Yes

Informed Consent Forms
Need for all surgeries Exception is emergencies All inpatients and outpatients For all procedures specified Needs to reflect a process Form must follow policies Must include state or federal requirements Must contain minimum requirements (mandatory)

Medical Records Medical record must contain an informed consent for procedures and treatments specified as requiring one Medical staff by-laws should address this Consider state laws requiring informed consent such as for invasive procedures Consider any federal laws such as informed consent for research, and state laws on informed consent

Well Designed (Optional)
Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative It is required to tell the patient this but optional to put it in writing Date, time, and signature of witness Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative

Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner Still have to inform patient if someone is doing important parts of the surgery but having it in writing is optional

Statement, if applicable, that QMP who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under State law and regulation, and for which they have been granted privileges by the hospital

Survey Procedure Verify hospital has assured MS has list of procedures and treatments that require consent Verify informed consent forms six mandatory elements Compare the hospital standard informed consent form to the P&Ps to make sure consistent Make sure any state law requirements are included

Chart Must Contain 467 Medical record must contain all orders, nursing notes, reports, medication records, radiology, lab reports, and vital signs Orders must be authenticates or signed off All reports of treatment which includes complications Any other information used to monitor the patient’s condition

Discharge Summary 468 All medical records must have a discharge summary with outcome of hospitalization Disposition of the patient Provisions for follow up care Follow-up care includes post hospital appointments, how care needs will be met, and any plans for home health care, LTC, hospice or assisted living Can delegate to NP or PA if allowed by state law but physician must authenticate and date it and time it

Final Diagnosis 469 Every medical record has to have a final diagnosis
Medical records must be completed within 30 days (same as TJC) NQF Safe Practices recommends discharge summaries be dictated at discharge and sent promptly to PCP Includes inpatient and outpatient charts

Pharmaceutical Services 490
Hospital must have a pharmacy to meet the patient’s needs and need to promote safe medication use process Must be directed by registered pharmacist or drug storage area under constant supervision MS is responsible for developing P&P to minimize drug error Function may be delegated to the pharmacy service

Pharmacy 490 Provide medication related information to hospital personnel Medication Management is important to CMS and TJC and TJC has a medication management chapter Contains list of functions of the pharmacist Collect patient specific information, monitor effects, identify goals, implement monitoring plan with patient, et.al. Flag new types of mistakes

Pharmacy Policies Include:
High alert medication-dosing limits-packaging, labeling and storage (policy at and ISMP (Institute for Safe Medication Practice) and USP have list of high alert medications) Limiting number of medication related devices and equipment-no more that 2 types of infusion pumps (490) Availability of up to date medication information Pharmacist on call if not open 24 hours

Pharmacy Policies Avoid dangerous abbreviations
All elements of order; dose, strength, route, units, rate, frequency Alert system for sound alike/look alike (LASA) Use of facility approved pre-printed order sheets whenever possible “Resume pre-op orders” is prohibited Voluntary, non-punitive reporting system to monitor and report adverse drug events

Pharmacy Policies Preparation, distribution, administration and disposal of hazardous medications (chemotherapy) Drug recall Patient specific information that should be readily available TJC tells you exactly what this is, like age, sex, allergies, current medications, etc. Means to incorporate external alerts and recommendation from national associations and government for review and policy revision (Joint Commission, ISMP, FDA, IHI, AHRQ, Med Watch, NCCMER, MEDMARX)

Pharmacy Policies 490 Identification of weight based dosing for pediatric populations Requirements for review based on facility generated reports of adverse drug events and PI activities Policy to identify potential and actual adverse drug events (IHI trigger tool, concurrent review, observe med passes etc.) Must periodically review all P&P’s

Pharmacy Policies Include
Need a multidisciplinary committee - committee of medicine, nursing, administration, and pharmacy to develop P&P MS must develop P&P or have policy that this function is fulfilled by pharmacy Surveyors will make sure staff is familiar with all the medication P&P’s Need policies to minimize drug error

Pharmacy Management 491 Pharmacy or drug storage must be administered in accordance with professional principles (TJC and problematic standard) This includes compliance with state laws (pharmacy laws), and federal regulations (USP 797), standards by nationally recognized organizations (ASHP, FDA, NIH, USP, ISMP, etc.) Pharmacy director must review P&P periodically and revise

Pharmacy Management 491 Drugs stored as per manufacture’s instructions; refrigerate, freeze, room temperature, keep out of light etc. Pharmacy employees provide services within the scope of their licensure and education Sufficient pharmacy records to follow flow from order to dispensing/administration Maintain control over floor stock

Pharmacist 491 Ensure drugs are dispensed only by licensed pharmacist
Must have pharmacist to develop, supervise, and coordinate activities of pharmacy Can be part time, full time or consulting Single pharmacist must be responsible for overall administration of pharmacy

Pharmacist 491 Job description should define development, supervision, and coordination of all activities Must be knowledgeable about hospital pharmacy practice and management Must have adequate number of personnel to ensure quality pharmacy service, including emergency services Sufficient to provide services for 24 hours, 7 days a week

Pharmacy Delivery of Service 500
Keep accurate records of all scheduled drugs Need policy to minimize drug diversion Drugs and biologicals must be controlled and distributed to ensure patient safety In accordance with state and federal law and applicable standards of practice Accounting of the receipt and disposition of drugs subject to COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970

Delivery of Service 500 Pharmacist and hospital staff and committee develop guidelines and P&P to ensure control and distribution of medications and medication devices System in place to minimize high alert medication (double checks, dose limits, pre-printed orders, double checks, special packaging, et.al.) And on high risk patients (pediatric, geriatric, renal or hepatic impairment) High alert meds may include investigational, controlled meds, medicines with narrow therapeutic range and sound alike/look alike

Delivery of Service 500 All medication orders must be reviewed by a pharmacist before first dose is dispensed Includes review of therapeutic appropriateness of medication regime Therapeutic duplication Appropriateness of drug, dose, frequency, route and method of administration Real or potential med-med, med-food, med-lab test, and med-disease interactions Allergies or sensitivities and variation from organizational criteria for use

Delivery of Service 500 Sterile products should be prepared and labeled in suitable environment Pharmacy should participate in decisions about emergency medication kits (such as crash carts) Medication stored should be consistent with age group and standards (such as pediatric doses for pediatric crash cart) Must have process to report serious adverse drug reactions to the FDA

Delivery of Service 500 Policy to address use of medications brought in P&P to ensure investigational meds are safely controlled and administered Medications dispensed are retrieved when recalled or discontinued by manufacturer or FDA (eg. Darvocet N) System in place to reconcile medication that are not administered and that remain in medication drawer when pharmacy restocks Will ask why it was not used? Not the same as medication reconciliation as in the TJC NPSG which all hospitals should still do from a patient safety perspective although in worksheets mentions this

Compounding of Drugs 501 All compounding, packaging, and disposal of drugs and biologicals must be under the supervision of pharmacist Must be performed as required by state of federal law & compounding law passed in 2013 Staff ensure accuracy in medication preparation Staff uses appropriate technique to avoid contamination

Compounding of Drugs Use a laminar airflow hood to prepare any IV admixture, any sterile product made from non-sterile ingredients, or sterile product that will not be used within 24 hours (see USP 797) Meds should be dispensed in safe manner and to meet the needs of the patient Quantities are minimized to avoid diversion, dispensed timely, and if feasible in unit dose All concerns, issues, or questions are clarified with the individual prescriber before dispensing

Locked Storage Areas 502 Drugs and biologicals must be kept in a secure and locked area Would be considered a secure area if staff actively providing care but not on a weekend when no one is around Schedule II, III, IV, and V must be kept locked within a secure area (see also 503) Only authorized person can get access to locked areas

Locked Storage Areas 502 Persons without legal access to drugs and biologicals can have not have unmonitored access They can not have keys to storage rooms, carts, cabinets or containers with unsecured medications (housekeeping, maintenance, security) Critical care and L&D area staffed and actively providing care are considered secure Setting up for patients on OR is considered secure such as the anesthesia carts but after case or when OR is closed need to lock cart

Securing Medications So all controlled substances must be locked
Hospitals have greater flexibility in determining which non controlled drugs and biologicals must be kept locked Medications should not be stored in areas readily accessible to unauthorized persons such in a private office unless visitors are not allowed without supervision of staff P&P need to address security of any carts containing drugs

Securing Medications CMS made changes in the FR effective June 2013 to match the interpretive guidelines (See 412 & 413) May allow patients to have access to urgently needed drugs such as Nitro and inhalers Need P&P on competence of patient, patient education and must meet elements in TJC MM standard on self administration Measures to secure bedside medications Document when patient reports the medication was taken Inspect the integrity of the medication

Locked Storage Areas Saline flushes need to be secure to prevent tampering so under constant supervision or locked up (FDA does not consider as medication now) Consider having safe injection practices P&P and follow CDC 10 guidelines such as one needle, one syringe If medication cart is in use and unlocked, then someone with legal access must be close by and directing monitoring the cart, like when the nurse is passing meds Need policy for safeguarding, transferring and availability of keys

Policy and Procedure CMS states that they expect hospital P&P to address The security and monitoring of any carts including whether locked or unlocked if contains drugs and biologicals In all patient care areas to ensure safe storage and patient safety P&P to keep drugs secure, prevent tampering, and diversion

TJC Self Administered Meds
Self administered medications are safely and accurately administered If you allow self administration, need procedure to manage, train, supervise, and document process TJC MM stands for medication management standard MM 5.20 or MM CMS mentions this standard in the FR when changes were made and said to follow

TJC Self Administered Meds
If non-staff member administers (patient or family) must train and make sure competent to do so (give info on nature of med, how to administer, side effects, and how to monitor effects) Patient has to be determined to be competent before allowed to self administer Mentioned TJC in Federal Register but not in IG

Outdated or Mislabeled Drugs 505
Outdated, mislabeled or otherwise unusable drugs and biologicals must not be available for patient use Hospital has a system to prevent outdated or mislabeled drugs Surveyor will spot check individual drug containers to make sure have all the required information including lot and control number, expiration date, strength, etc.

No Pharmacist on Duty 506 If no pharmacist on duty, drugs removed from storage area are allowed only by personnel designated in policies of MS and pharmacy service Must be in accordance with state and federal law Routine access to pharmacy by non-pharmacist for access should be minimized and eliminated as much as possible E.g. night cabinet for use by nurse supervisor Need process to get meds to patient if urgent or emergent need

No Pharmacist on Duty 506 TJC does not allow nurse supervisor in pharmacy so would need to call the on call pharmacist Access is limited to set of medications that has been approved by the hospital and only trained prescribers and nurses are permitted access Quality control procedures are in place like second check by another or secondary verification like bar coding Pharmacist reviews all medications removed and correlates with order first thing in the morning

Medications Errors Drug errors, adverse drug reaction, and drug incompatibilities must be immediately reported to the attending physician and to the hospital PI program Definition of med error or ADE should be broad enough to include NEAR MISSES Recommend use of the broad definition by National coordinating council medication error reporting and prevention definition and ASHP definition of ADR Will make sure definition is based on national standards Must have a P&P for reporting

Medications Errors Must be documented in the medical record and reported to QAPI program CMS encourages non-punitive approach Hospital can not just rely on incident reports but must take step to identify these events Need to measure the effectiveness of systems to identify and report to the PI program which includes benchmarks and RCA when indicated Encouraged to externally report to FDA MedWatch program, ISMP medication error reporting program etc.

Medications Errors 509 Hospital must proactively identify med errors and ADE and can not rely solely on incident reports Proactive includes observation of med passes, concurrent and retrospective review of patient’s clinical record, ADR surveillance, evaluation of high alert drugs and indicator drugs (Narcan, Romazicon, Benadryl, Digibind, et al) or generate a review for potential ADE Remember FMEA (failure mode and effect analysis) and IHI adverse event trigger tool is great

Abuses and Losses 509 Abuses and losses of controlled substances must be reported pharmacist and CEO and in accordance with any state or federal laws Surveyor will interview pharmacist to determine their understanding of controlled substances policies What is procedure for discovering drug discrepancies?

Drug Interaction Information 510
Information on drug interactions and information on drug side effects, toxicology, dosage, indication for use and routes of administration must be available to staff Texts and other resources must be available for staff at nursing stations and drug storage areas Staff development programs on new drugs added to the formulary and how to resolve drug therapy problems

Formulary 511 Formulary system must be established by the MS to ensure quality pharmaceuticals at reasonable cost Formulary lists the drugs that are available Processes to monitor patient responses to newly added medication Process to approve and procure meds not on the list Process to address shortages and outages including communication with staff, approving substitution and educating everyone on this, and how to obtain medications in a disaster

Radiology 529 Hospital has radiology services to meet needs of patients Radiology services should be provided in accordance with accepted standards of practice Radiology, especially ionizing procedures, must be free from hazards for patients and personnel Must have policy that provides for safety of both

Safety Proper safety precautions maintained against radiology hazards (535) Including shielding for patients and personnel as well as storage, use, and disposal of radioactive materials (536) Need order of practitioner with privileges or practitioners outside the hospital who have been authorized by MS to order as allowed by state law Period inspection of equipment and fix any hazard (537) Check radiation workers by use of badge tests or exposure meters (538)

Personnel 545 Qualified radiologist must supervise ionizing radiology services (546) Must interpret those tests that are determined by the MS to require a radiologist’s specialized knowledge Written policy approved by MS to designate which tests require interpretation by radiologist If telemedicine is used, radiologist interpreting must be licensed and meet state law requirements (state medical board requirements), (546, see Tag 23)

Personnel 546 Supervision of radiology by radiologist who is member of the MS, Supervision should include the following Ensure reports are signed by the practitioner who interpreted them Assign duties to personnel based on their level of training, experience and licensure Enforce infection control standards Ensure emergency care if patient experience ADR to diagnostic agent

Radiology 547 Ensure files, records are kept in secure area and retrievable, train staff on how to operate equipment safely Written policy, approved by the MS on who can use radiology equipment and administer procedures Only qualified personnel may use radiology equipment Surveyor will review personnel folders to make sure they are qualified as established by the MS for the tasks they perform

Radiology Records Radiology records must be maintained for all procedures performed (553) Must contain copies of all reports and printouts and any films, scans, or other image records Must have written P&P that ensure the integrity of authentication and protect privacy of radiology records - must be secure and retrievable for five years (555) Radiologist or other practitioner who performs radiology services must sign the report of his or her interpretation They have to be signed by the one who read and evaluated the x-ray (not the partner who is reviewing the dictated report ), A-0554

Laboratory Services 576 Must have adequate lab services to meet the needs of the patient All lab services must in any hospital department has to meet these guidelines All services must be provided in accordance with CLIA requirements (Clinical Laboratory Improvement Act) and have CLIA certificate Can provide lab services directly or as contracted service

Lab Services All lab services, including contracted services, must be integrated into hospital wide PI Lab results are considered medical records and must meet all MR CoPs Must have lab services available either directly or indirectly Must meet needs of its patients and in each location of the hospital TJC has lab standards also

Emergency Lab-Services Available 583
Must provide emergency lab services 24 hours a day, 7 days a week - directly or indirectly (contracted) Hospital with multiple campuses must have available 24/7 at each campus MS must determine what lab tests will be immediately available Should reflect the scope and complexity of the hospital’s operations Written description of emergency lab services available Written description of test available are provided to MS on routine and stat basis

Tissue Specimens 584 Written instructions for the collection, preservation, transportation, receipts, and reporting of tissue specimen results MS and pathologist determine when tissue specimens need macroscopic (gross) and microscopic examination Need written policy on this TJC has a chapter on transplant safety and FAQs

Blood Banks 592 Potentially infectious blood and blood components
This section completely rewritten so have person in charge of P&P in this area and the look back program to review these changes Will need to update P&Ps TJC has similar sections in transplant safety chapter starting with TS through TS and PC chapter for blood and blood components

Blood and Blood Components
Potentially HIV infectious blood and hepatitis C virus (HCV) and blood products are collected from a donor who tests negative If on a later donation tests positive then more specific test or follow up testing is done as required by FDA If services provided by outside blood collecting establishment (blood bank) then need agreement to govern procurement, transfer and availability of blood and blood products Agreement with blood bank must require blood bank to notify hospital promptly (HIV and added HCV)

Blood Banks 592 Time depends on if tested positive on this unit or tested negative but on later donation tested positive Within 3 calendar days if blood tested is positive later Follow up of notification within 45 calendar days after reactive screening test was positive for additional tests See look back procedures required by 21 CFR et seq. and FDA regulations Hospital will dispose any contaminated blood from donor if not given (TJC PC )

Patient Notification If administered potentially HIV/HCV infected blood hospital must make reasonable attempts to notify patient over period of 12 weeks unless patient already notified or unable to locate in 12 weeks Records of the source and disposition of all units of blood and blood components must keep records ten years

Patient Notification A fully funded plan to transfer these records to another hospital if the hospital closes (TJC PC maintains records on receipt, testing and disposition of all blood and blood components and fully funded plan to transfer records to another organization if hospital ceases operation for any reason) Must have P&P that meet federal and state laws on notification of patients

Patient Notification Must document in MR
Must conform to confidentiality requirements Must have 3 things in the content of the notice; explanation of need for HIV and HCV testing and counseling Enough written or oral information so can make an informed decision List of programs where can get counseled and tested If minor or incompetent or deceased then notify legal representative

Food and Dietetic Services 618
Hospital must have organized dietary services Must be directed and staffed by qualified personnel If contract with outside company need to have dietician and maintain minimum standards and provide for liaison with MS on recommendations on dietary policies Dietary services must be organized to ensure nutritional needs of the patient are met in accordance with physician orders and acceptable standard of practice

CMS Changes CMS published some final changes to hospital CoP effective July 11, 2014 Interpretive guidelines published January 30, 2015 with changes to 628 (deleted), 629 and 630 Several are important to the CMS dietary CoPs Would permit registered dietitians or nutritional specialist to order patient diets independently, which they are trained to do, without requiring the supervision or approval of a physician or other practitioner when C&P

CMS Changes Food & Dietetic Services
CMS said it came to their attention that CMS CoPs were too restrictive and lacked the flexibility to allow hospitals to extend privileges to RD (Registered Dietician) in accordance with state law CMS believes RD are best qualified to assess patient’s nutritional treatment plan and design and implement a nutritional treatment plan in consult with the care team Used the term RD but noted that not all states call them RD and some states call them licensed dieticians (LD) and some states recognize other qualified nutrition specialists

CMS Changes Food & Dietetic Services
CMS includes a qualified dieticians ( such as a RD) as a practitioner who may be privileged to order patient diets (Enteral and parenteral nutrition, supplemental feedings and therapeutic diets) or order related lab tests CMS said this would free up time for physicians and other practitioners to care for patients Dietician or nutritional specialist can be granted nutrition ordering privileges by the Medical Staff (MS) This can be with or without appointment to the MS

Dietary Policies Required 618
Need the following 7 policies: Availability of diet manual and therapeutic diet menus Sometimes called Nutrition Care Manual (NCM) or Pediatric Nutrition Care Manual (PNCM) Frequency of meals served System for diet ordering and patient tray delivery Accommodation of non-routine occurrences Parenteral nutrition (tube feeding), TPN, peripheral parenteral nutrition, changes in diet orders, early/late trays, nutritional supplements etc.

Seven Dietary Policies Required 618
Integration of food and dietetic services into hospital wide QAPI and infection control programs Guidelines on acceptable hygiene practices of personnel Guidelines for kitchen sanitation Important to protect against germs and bacteria that cause illness Compliance with state or federal laws

Organization 620 Must have full time director who is responsible for daily management of dietary services Must be granted authority and delegation by the Board and MS for the operation of dietary services Job description should be position specific and clearly delineate authority for direction of food and dietary services Includes training programs for dietary staff and ensuring P&Ps are followed

Dietary Policies Safety practices for food handling
Emergency food supplies Orientation, work assignment, supervision of work and personnel performance Menu planning Purchase of foods and supplies Retention of essential records (cost, menus, training records, QAPI reports) Service QAPI program

Dietitian 621 Qualified dietician must supervise nutritional aspects of patient care and approve patient menus and nutritional supplements Patient and family dietary counseling Perform and document nutritional assessments Evaluate patient tolerance to therapeutic diets when appropriate Collaborate with other services (MS, nursing, pharmacy, social work) Maintain data to recommend, prescribe therapeutic diets

Personnel 622 Must have administrative and technical personnel competent in their duties Menus must be nutritional, balanced, and meet special needs of patients Screening criteria should be developed to determine what patients are at risk Once patient is identified nutritional assessment should be done (TJC PC ) Patient should be evaluated

Diets 628 Deleted 2015 Menus must meet the needs of the patient
Menus must be nutritional, balanced Menus must meet the special needs of patients Current menus should be posted in the kitchen Screening criteria should be developed to determine what patients are at risk Once patient is identified nutritional assessment should be done (TJC PC ) Patient should be re-evaluated as necessary to ensure their nutritional needs are met

CMS Rewrites Tag 629

Dietary Services 2015 The IOM’s Food and Nutrition Board’s DRI or Dietary Reference Intake 4 reference values includes: RDA or the recommended dietary allowance is average dietary intake of a nutrition sufficient of healthy people Adequate Intake (AI) for a nutrient is similar to the ESADDI and is only determine when an RDA can be determined Estimated Safe and Adequate Daily Intake (ESADDI) AI is based on observed intakes of the nutrient by a group of healthy persons

Dietary Services 2015 IOM’s Food and Nutrition Board’s DRI or Dietary Reference Intake 4 reference values (continued) Tolerable Upper Intake Level (UL) is highest daily intake of a nutrient that is likely to pose no risks of toxicity for most people As the UL increase, risk increases Estimated Average Requirement (EAR) is the amount of the nutrient that is estimated to meet the requirement of half of the health people

IOM DRI or Dietary Reference Intake

Dietary Guidelines for Americans

Watch for Changes in 2015

Interactive DRI Tool and Tables

Therapeutic Diet Therapeutic diets may help meet the patient’s nutritional needs Assess patients for risk of nutritional deficiencies Therapeutic diets refer to a diet ordered as part of the patient’s treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet(e.g., sodium or potassium), or to provide mechanically altered food when indicated

Therapeutic Diet Patients must be assessed to determine if they need a therapeutic diet for other nutritional deficiencies Include in patient’s care plan Include the need to monitor intake Include if need daily weights, I&O, or lab values Nursing does an admission assessment which includes a nutritional screen These are good things to determine the patient’s risk and if a dietary consult is needed

Nutritional Assessment Includes
Patient May Need Comprehensive Assessment if: Medical or surgical conditions or physical status interferes with their ability to digest or absorb nutrients Patient has S&S indicating risk for malnutrition Anorexia, bulimia, electrolyte imbalance, dysphagia, ESRD or certain medications Patient medical condition adversely affected by intake and so need a special diet CHF, renal disease, diabetes, etc.

Dietary 2015 Patient May Need Comprehensive Assessment if (continued):
Patient receiving artificial nutrition Tube feeding, TPN, or peripheral parenteral nutrition Need an order for diets, including therapeutic diet, from practitioner responsible for care Dietician or qualified nutritional specialist can be C&P to order diet as consistent with state law requirement

Therapeutic Diet Patients who refuse food should be offered substitutes of equal nutritional value in order to meet their basic nutritional needs Surveyor will ask dietician how the menus and nutritional needs of patient are being met such as rely on DRIs, including RDA, in developing menus Will ask how patients are monitored who are identified as having specialized needs Will look for order for therapeutic diet Will look at sample of patient records of patients identified with special nutritional needs

Diet Order Needed Standard: Need an order for all patient diets including therapeutic diets Must be by practitioner responsible for care (doctor, PA, NP) or qualified dietician or qualified nutritional professional Must be authorized in the medical staff bylaws Must be consistent with state law A few states hold it against state law for a dietician to prescribe a therapeutic diet

Patient Diets New Tag

Diet Order Needed Diets must be based on an assessment of the patient’s nutritional and therapeutic needs Must be documented in the medical record Including patient’s tolerance to the therapeutic diet Patient has a new diagnosis of CHF and put on a 2 gram low sodium diet and losses weight because she does not like the taste of the food without salt Board may permit the medical staff to grant privileges to dieticians or nutritional professionals

Diet Order Needed Many states have a specific statute that determines when someone is a qualified dietician Registered dietician may be defined to include one who is registered with Commission on Dietetic Registration or state law Terms such as “nutritionists,” “nutrition professionals,” “certified clinical nutritionists,” and “certified nutrition specialists” are also used to refer to individuals who are not dieticians, but who may also be qualified under State law to order patient diets.

Diet Order Needed Hospital must make sure person is qualified before appointing them to the medical staff or C&P If the hospital decides not to C&P, even if that state’s law allows it, the patient must have a diet ordered by the practitioner responsible for the patient’s care If not C&P the person can still do a nutritional assessment and make recommendations Surveyor will make sure diet is ordered and if dietician writes orders is C&P whether appointed to the medical staff or not

Nutritional Needs Survey Procedure 630
Surveyor is suppose to ask the hospital to show them what national standard they are using Surveyor to view patient medical records to verify diet orders are provided as prescribed by the practitioner Surveyor is to determine if patient’s nutritional needs have been met Will determine if dietary intake and nutritional status is being monitored

Utilization Review 652 Hospital must have a UR plan that provides for review of services furnished by the institution and the members of the MS to Medicare and Medicaid beneficiaries UR plan should state responsibility and authority of those involved in the UR process Surveyor will make sure activities performed as in UR plan UR important to determine medical necessity especially with increased RACs CMS issue UR CoP Memo June 22, 2007

Composition of UR Committee 654
Consists of 2 or more practitioners who carry out UR function At least 2 members must be doctors The UR committee must be either a staff committee of the hospital or an group outside that has been established by the local medical society for hospitals in that locale and established in a manner approved by CMS

UR 2015 There were no changes to this regulation,
But corrected a guidance to reflect statutory changes to SSA Section 1865 Based on these statutory changes, any AO seeking CMS approval of its hospital accreditation program must demonstrate that it has standards for UR and that its standards meet or exceed the Medicare standards. Thus, we are removing language indicating that UR CoP compliance must always be assessed by State Survey Agencies since this is no longer the case for deemed status hospitals.

UR Committee 654 A committee may not be conducted by an individual who has a direct financial or ownership interest (5% or more) Who was professionally involved in the care of the patient whose case is being reviewed Surveyor will look to see if the governing board has delegated UR function to a outside group if impracticable to have a staff committee

Frequency of Review 655 UR plan must provide review for Medicare/Medicaid (M/M) patients with respect to medical necessity Admissions (before, at, or after admission) Duration of stay Professional services furnished including drugs and biologicals

Scope of Reviews 655 Reviews may be on a sample basis except for reviews of cases assumed to outlier cases because of extended stay cases or high costs Surveyor will examine UR plan to determine if medical necessity is reviewed for admission, duration of stay and services provided If IPPS hospital there should be a review of the duration of stay in cases assumed to be outlier

Admissions or Continued Stay
Determination that admission or continued stay is not medically necessary is made by one member of UR committee if MD concurs with determination of fails to present their views when afforded the opportunity Must be made by two members in all other cases (656) Remember 2 midnight rule and importance of order and documentation Physician certification

Before determination not medically necessary, UR committee must consult the MD responsible for the care and afford opportunity to present their views Then committee must provide written notification no later than two days after determination to the hospital, patient and practitioner responsible for care

If attending doctor does not respond or contest the findings of the committee, the findings are final If physician of UR committee finds not medically necessary no referral of committee is necessary and he may notify the attending doctor If non-physician makes the determination it must go to the committee A non-physician can not make this final determination

Physical Environment 700 Hospital must be constructed, arranged, and maintained to ensure the safety of patient And to provide diagnosis and treatment and for services appropriate for the community This CoP applies to all locations of the hospital, all campuses, all satellites

Physical Environment Hospital’s maintenance and hospital departments responsible for the buildings and equipment must be incorporated into the QAPI program Must also be in compliance with the QAPI requirements Survey of physical environment should be conducted by one surveyor LIFE SAFETY CODE survey may be conducted by specially trained surveyor LS code very important and being hit hard in the surveys

Buildings 701 Condition of physical plant and overall hospital environment must be developed and maintained for the safety and well being of patients Making sure that a routine and PM activities are done, as manufacturer requires and by state and federal law Conduct ongoing maintenance inspections Routine and PM and testing activities should be incorporated into hospital QAPI plan

Buildings Emergency Preparedness 701
Includes developing and implementing emergency preparedness plans and capabilities Must coordinate with federal, state, and local emergency preparedness and health authority (dept of health) To identify risks for their area (natural disasters, bio-terrorism threats, disruption of utilities like water, sewer, electrical, communication, fuel, nuclear accident) Lists 14 things to consider in developing this

Proposed Changes to Emergency Preparedness

Emergency Preparedness Resources
There are many other organizations that have resources on emergency preparedness: The Joint Commission National Incident Management System (NIMS) Hospital Incident Command Systems (HICS)

Emergency Preparedness Checklist Updated

Emergency Preparedness
Transfer of hospital equipment to another facility Transfer or discharge of patients to home or other hospitals Security of patients and walk in patients and supplies from misappropriation Pharmacy, food, and other supplies and equipment that may be needed Communication among staff Training needed to implement emergency procedure

Emergency Gas and Water
Must be facilities for emergency gas and water supply (703) To provide care to inpatients Includes making arrangements with local utility company for emergency sources of gas/water One source of water is Federal Emergency Management Agency (FEMA) Gas includes propane, natural gas, fuel oil, as well as gases used such as oxygen, nitrous oxide, nitrogen

Trash 713 Proper storage and disposal of trash
Trash includes bio-hazardous waste Storage of trash must be in accordance with state and federal law (EPA, CDC, OSHA, state environmental health and safety regulations) Need policies for storage and disposal of trash H2E program - no fee (waste reduction, mercury, et al.)

Fire Control Plan 715 Need fire control plan
Must contain section on prompt reporting of fires, extinguishing fires, protection of patients and guests, evacuation and cooperation with fire fighting authorities Surveyor will review fire plan Verify all fires are reported to state officials Will interview staff to make sure they know what to do during a fire Amended for alcohol based hand dispensers

Facilities 722 Toilets, sinks, and equipment should be accessible
Keep written evidence of regular inspections and approval by state or local fire control agencies Maintain adequate facilities for its service - designed and maintained in accordance with federal, state, and local laws Toilets, sinks, and equipment should be accessible Make sure water acceptable for its intended use such as drinking, lab water, irrigation Review water quality monitoring

Facilities Standard: Facilities, supplies, and equipment must be maintained to ensure an acceptable level of quality and safety Must make sure condition of hospital is maintained in a manner to provide for acceptable level of safety for patients, visitors, and staff Need supplies to meet patient needs Ensure against theft of contamination of supplies Need emergency supplies such as when a disaster occurs

Facilities Need equipment when needed for patient care, emergency use, or if there is a disaster Includes elevators, generators, air compressors, medical equipment, vacuum, etc. Equipment inspected and tested before use Maintain records of who is competent to do preventive maintenance Need equipment maintenance policies and inventories of equipment Follow manufacturers recommendations and see alternative equipment management program (AEM)

Ventilation, Light, Temperature 2014
There must be proper ventilation, light, and temperature controls in pharmacy, food preparation and other appropriate areas Proper ventilation in areas using ethylene oxide, nitrous oxide, xylene, pentamidine, glutaraldehyde, or other hazardous substances Temperature controls in pharmacy and food preparation Amended

Ventilation where O2 is transferred from one container to another In isolation rooms and lab locations Adequate lighting in patient rooms and food and medication preparation areas (shown to reduce medication errors) Anesthetizing locations where nonflammable inhalation anesthetic agents are used Will review temp monitoring records

Temperature, humidity, and airflow in OR within acceptable standards to inhibit microbial growth Remember 2013 humidity memo & 2014 changes with humidity 20-60% and when waiver is needed if not 35% Each OR room should have a separate temperature control - have temp and humidity tracking logs Incorporate AORN – American Association of Perioperative Registered Nurses should be incorporated into hospital policy along with Facilities Guidelines Institute (FGI)

CMS Memo April 19, 2013 CMS issues memo related to the relative humidity (RH) AORN use to say temperature maintained between degrees and humidity between 30-60% in OR, PACU, cath lab, endoscopy rooms and instrument processing areas CMS says if no state law can write policy or procedure or process to implement the waiver Waiver allows RH between 20-60% In anesthetizing locations- see definition in memo

Humidity in Anesthetizing Areas

Impact of Lowering the Humidity
Lowering humidity can impact some equipment and supplies Can affect shelf life and product integrity of some sterile supplies including EKG electrodes Some electro-medical equipment may be affected by electrostatic discharge especially older equipment Can cause erratic behavior of software and premature failure of the equipment It can affect calibration of the equipment Follow the manufacturers instructions for use that explains any RH requirements

CMS Memo on Low Relative Humidity

Impact of Lowering the Humidity

Lowering Humidity Can Have Other Effects

Infection Control 747 Updated to reflect changing infectious and communicable disease threats Including current knowledge and best practices Very important in today’s healthcare environment CDC estimates there are 1.7 million HAI in hospitals every year and 99,000 deaths CMS gets $50 million dollar grant to enforce Interpretive guidelines are 12 pages long 1www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

Safe Injection Practices Brief www.empsf.org

Insulin Pens

CMS Memo on Insulin Pens
Regurgitation of blood into the insulin cartridge after injection can occur creating a risk if used on more than one patient Hospital needs to have a policy and procedure Staff should be educated regarding the safe use of insulin pens More than 2,000 patients were notified in 2011 because an insulin pen was used on more than one patient CDC issues reminder on same and has free flier

CDC Reminder on Insulin Pens

CDC Has Flier for Hospitals on Insulin Pens

VA Alert on Insulin Pens
Pharmacist found several insulin pens not labeled for individual use Found used multi-dose pen injectors used on multiple patients instead of one patient use New requirement that can only be stored in pharmacy and never ward stocked Instituted new education for staff on use Part of annual competency of staff Instituted new policy of safe use of pen injectors

VA Issues Alert in 2013

VA Alert on Insulin Pens
Decided to prohibit multi-dose insulin pen injectors on all patient units except the following: Patients being educated prior to discharge to use a insulin pen injector Eligible patient is self medication program Patient needing treatment and no alternative formulation is available Patients participating in a research protocol requiring an insulin pen Pen injectors dispensed directly to patients as an outpatient prescription

FDA Issues An Alert in 2009

Insulin Pen Posters and Brochures Available

Brochure

All entries into a SDV for purposes of repackaging must be completed with 6 hours of the initial puncture in pharmacy following USP guidelines Only exception of when SDV can be used on multiple patients Otherwise using a single dose vial on multiple patients is a violation of CDC standards CMS will cite hospital under the hospital CoP infection control standards since must provide sanitary environment Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.

Single Dose June 15, 2012

Bottom line is you can not use a single dose vial on multiple patients CMS requires hospitals to follow nationally recognized standards of care like the CDC guidelines SDV typically lack an antimicrobial preservative Once the vial is entered the contents can support the growth of microorganisms The vials must have a beyond use date (BUD) and storage conditions on the label

Make sure pharmacist has a copy of this memo If medication is repackaged under an arrangement with an off site vendor or compounding facility ask for evidence they have adhered to 797 standards ASHP Foundation has a tool for assessing contractors who provide sterile products Go to Click on starting using sterile products outsourcing tool now

Safe Injection Practices www.empsf.org

Infection Control TJC has chapter on Infection Prevention and Control APIC and CMS now calls infection preventionists (IPs) Hospital must have sanitary environment to avoid sources and transmission of infection and communicable diseases (750) Active IC program for prevention, control, and investigation of infections and communicable diseases

Remember the Final Infection Control Worksheet

Infection Control (IC)
Standards apply to all departments of hospitals both on and off campus Infection prevention must include monitoring of housekeeping and maintenance including construction activities Areas to monitor include food storage preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, supply storage and equipment cleaning

Infection Control (IC) 747
Must all standards of care and practice (APIC (Association for Professionals in Infection Control and Epidemiology), CDC, SHEA (Society for Healthcare Epidemiology of America), OSHA, etc. Need to investigate infections and communicable diseases for inpatients and from personnel working in hospitals including volunteers Must have active surveillance program that includes specific measures for infection detection, data collection, analysis monitoring, and evaluations of preventive interventions

Infection Control Must have sampling or other mechanism in place to identify and monitor infections and communicable diseases Infection control must be integrated in PI Surveillance activities should be conducted in accordance with recognized surveillance practices such as those used by CDC NHSN (National Healthcare Safety Net) Requirement for hospitals to report central line infections to NHSN

IC Officer’s Responsibilities
Many have added these to their job descriptions Maintain sanitary hospital environment (ventilation and water controls, construction - make sure safe environment, safe air handling in areas of special ventilations such as the OR and isolation rooms, techniques for food sanitation, cleaning and disinfecting surfaces, carpeting and furniture, how is pest control done, and disposal of trash along with non-regulated waste)

IC Officer’s Responsibilities 2013
Develop and implement IC measures (hospital staff, contract workers, volunteers) Mitigation of risks associated with patient infections present upon admission and risks contributing to HAI Active surveillance Hospital must identify and track the following categories HAI selected by IC program targeted strategies based on national guidelines and periodic risk assessments Patients or staff with reportable communicable diseases

IC Officer’s Responsibilities 2013
Active surveillance (continued) Culture or patient colonized with MDRO Isolation patients Staff or patients with signs in which local, state, or feds request Staff or patients infected with significant pathogens Recommend use of automated surveillance technology (blue box advisory) or data mining Monitoring compliance with all P&Ps, protocols and other infection control program requirements

Blue Box Use Automated Surveillance

IC Officer’s Responsibilities
Program evaluation and revision of the program, when indicated Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism and outbreaks Complying with the reportable disease requirements of the local health authority Make sure IC program is integrated into hospital wide QAPI (now stands for quality assessment and performance improvement)

Infection Control (IC) 749
Long list of IC policies that hospitals must have Maintain a sanitary physical environment Hospital staff related measures (evaluate hospital staff immunization status for infectious diseases as per CDC and APIC, how you screen hospital staff for infections likely to cause significant infectious disease to others, policy on when staff are restricted from working)

IC Policies to Include:
New employees and what they need in orientation (including handwashing) P&P to mitigate risk when patient admitted with infection - must be consistent with the CDC isolation guidelines, staff knowledge of PPE Mitigate risk that cause or contribute to HAI such as SCIP measures, appropriate hair removal, timely antibiotics in OR, DC in 24 hours except 48 hours for cardiac patients, beta blockers during perioperative periods for select cardiac patients, proper sterilization of equipment, etc.

Immediate Use Steam Sterilization IUSS

Medical Equipment and Supplies Resources
Multi-Society Guidelines for Reprocessing Flexible Gastrointestinal Endoscopes by APIC at Disinfection of Healthcare Equipment Chapter in Guidelines for Disinfection and Sterilization in Healthcare Facilities Nov 2008 at Single Use Device Reprocessing at

IC Policies Isolation procedures for highly immuno-suppressed patients (HIV or chemo patients) Isolation procedures for trach care, respiratory care, burns, and other similar situations Other HAI risk mitigation includes promotion of hand hygiene, and measures to prevent organisms that are antibiotic resistant such as MRSA and VRE Things such as central line bundle, VAP bundle or sepsis bundle, prompt removal of foley catheter Disinfectants, antiseptics, and germicides must be used in accordance with manufacturers instructions

IC Policies Appropriate use of facility and medical equipment (hepa filters and negative pressure room, UV lights and other equipment to prevent the spread of infectious agents Patients, visitors, care givers, and staff must receive education on infection and communicable diseases There must be active surveillance system, method for getting data to determine if there is a problem Policy on getting cultures from patients, etc.

Policies and Organization
Need IC officer and IC committee IC officer must develop and implement policies on control of infection and communicable diseases Person must be designated in writing who is qualified through education and experience Lists the responsibilities of this person - consider putting into job description

Log of Incidents 750 7-16-2012 Deleted
Must NO longer maintain a log related to infections and communicable diseases, including HAI Use to require a log and it had to include information from patients and staff so need information from employee health nurse Included employees, contract staff such as agency nurses, and volunteers Included surgical site infections, patients or staff with MDRO, patients who meet isolation requirements Log use to be either a paper or electronic log, TJC IC requirement but will change to CMS

CEO, CNO, and MS The CEO, DON, and MS must ensure that there is hospital wide QAPI and training program that address problems identified by IC officer And implement a successful corrective action plan in affected problem areas Train staff in problems identified Problems must be reported to nursing, MS, and administration

Discharge Planning CMS issues 39 page memo on May 17, 2013
Revises discharge planning standards Includes advisory practices (blue boxes) to promote better patient outcomes Only suggestions and will not cite hospitals The discharge planning CoPs have been reorganized A number of tags were eliminated The prior 24 standards have been consolidated into 13

Discharge Planning Revisions

Transmittal July 19, 2013

2014 CMS Discharge Planning Worksheet

Discharge Planning The hospital must have a discharge planning (DP) process that applies to all patients (799) To determine if will need post hospital services like home health, LTC, assisted living, hospice etc. To determine what patient will need for safe transition to home Need to incorporate new research on care transitions Hospital needs adequate resources to prevent readmissions 1 in 5 patients readmitted within 30 days (20%) 1 in 3 patients readmitted within 60 days (34%) The hospital must have written DP P&Ps (799)

Discharge Planning (DP)
CMS later says DP applies to inpatients only However, recommends an abbreviated DP for certain categories of outpatients such as observation, ED, and same day surgery DP based on 4 stage DP process Screen all patients to determine if patient at risk such as screening questions by nursing admission assessment Evaluate post-discharge needs of patients Develop DP if indicated by the evaluation or requested by patient or physician Initiate discharge plan prior to discharge of inpatient

Discharge Planning Suggest input from MS, board, HH, LTC and others regarding the DP P&Ps Involve patient in the development of the plan of care (799) Standard: The hospital must identify at an early stage those patients who are likely to suffer adverse consequences if no DP is done (800) Recommend all inpatients have a DP If not must document criteria and screening process used to identify who is likely to need DP No national tool to do this

Discharge Planning Must do at least 48 hours in advance of discharge
If patient’s stay is less than 48 hours then must make sure DP is done before patient’s discharge Must make sure no evidence that patient’s discharge was delayed due to hospital’s failure to do DP (800) DP P&Ps must state how staff will become aware of any changes in the patient’s condition (800) If patient is transferred must still include information on post hospital needs (800)

Discharge Planning CMS instructs the surveyors to conduct discharge tracers on open and closed inpatient records Standard: The hospital must provide a DP evaluation to patients at risk, or requested by the patient or doctor (806) Must include the likelihood of needing post hospital services like home health, hospice, RT, rehab, nutritional consult, dialysis, supplies, meals on wheels, transport, housekeeping, or LTC Is the patient going to need any special equipment (walker, BS commode, etc.) or modifications to the home Must include an assessment if the patient can do self care or others can do the care

Discharge Planning Expected to have know about community resources
Must evaluate if patient can return to their home If from a LTC, hospice, assisted living then is the patient able to return (806) Hospitals are expected to have knowledge of capabilities of the LTC and Medicaid homes and services provided (806) May need to coordinate with insurers and Medicaid Discuss ability to pay out of pocket expenses Expected to have know about community resources Such as Aging and Disability Resources or Center for Independent Living

CMS DP Checklist for Patients

Discharge Planning Standard: A RN, SW, or other appropriately qualified person must develop or supervise the development of the DP evaluation (807) Written P&P must say who is qualified Standard: the DP evaluation must be completed timely to avoid unnecessary delays (810) Standard: The hospital must discuss the results of the DP evaluation with the patient (811) Standard: The DP evaluation must be in the medical record (812)

Discharge Planning Standard” RN, SW, or other qualified person must develop the discharge plan if the DP evaluation indicates it is needed (818) DP is part of the plan of care Standard: The physician may request a DP if hospital does not determine it is needed (819) Standard: The hospital must implement the DP plan (820) Standard: The hospital must reassess the discharge plan if factors affect the plan (821)

Discharge Planning Standard: If patient needs HH or LTC must provide patients a list (823) Standard: Hospital must transfer or refer patients to the appropriate facility or agency for follow up care (837) Standard: the hospital must reassess it DP process on an on-going basis and review the discharge plans to ensure they meet the patient’s needs (843) Must track readmissions Must review P&P to make sure DP is ongoing on at least a quarterly basis

Organ, Tissue, and Eye 884 Hospital must have written P&P to address its organ procurement Must have agreement with OPO Must timely notify OPO if death is imminent or patient has died OPO to determine medical suitability for organ donation Defines what must be in your written agreement (definitions, criteria for referral, access to your death record information) TJC has similar standards in TS or transplant safety chapter

OPO Agreements with Hospitals
CMS has a section in the hospital CoP on OPO or the organ procurement organizations Hospitals must have a written agreement with the OPO Must do the one call rule and notify the OPO if patient dies or death is imminent OPOs are not required to have an agreement with a hospital that does not have an OR or a ventilator OPO have to contract with hospitals that request it but limited to notification if no ventilator or OR

OPO Agreements with Hospitals

Organ, Tissue, and Eye Board must approve your organ procurement policy Must integrate into hospital’s PI program Surveyor will review written agreement with the OPO to make sure it has all the required information Check off the long list to ensure all elements are present

Tissue and Eye Bank Need an agreement with at least one tissue and eye bank OPO is gatekeeper and notifies the tissue or eye bank chosen by the hospital OPO determines medical suitability Don’t need separate agreement with tissue bank if agreement with OPO to provide tissue and eye procurement

Family Notification Once OPO has selected a potential donor, person’s family must be informed of the donor’s family’s option OPO and hospital will decide how and by whom the family will be approached Have to work cooperatively with the OPO and in educating staff OPO can review death records

Organ Donation Person to initiate request must be a designated requestor or organized representative of tissue or eye bank Designated requestor must have completed course approved by OPO Encourage discretion and sensitivity to the circumstances, views and beliefs of the families Surveyor will review complaint file for relevant complaints

Organ Donation Training
Patient care staff must be trained on organ donation issues Training program at a minimum should include: consent process, importance of discretion, role of designated requestor, transplantation and donation, QI, and role of OPO Train all new employees, when change in P&P, and when problems identified in QAPI process

Organ Donation Hospital must cooperate with OPO to review death records to improve id of potential donors Surveyor will verify P&P that hospital works with OPO Maintain potential donors while necessary testing and placement of donated organs take place Must have P&P to maintain viability of organs Ensure patient is declared dead within acceptable timeframe

Organ Transplantation
Hospital in which organ transplants are performed must be member of OPTN-Organ Procurement and Transplantation Network Must abide by its rules - 42 USC 274, section 372 of the Public Health Service Act Must provide data to OPTN, Scientific Registry and OPO (Organ Procurement Organization)

Surgical Services 940 If provide surgical services, service must be well organized If outpatient surgery, must be consistent in quality with inpatient care Must follow acceptable standards of practice, AMA, ACOS, APIC, AORN Must be integrated into hospital wide QAPI Will inspect all OR rooms Access to OR and PACU must be limited to authorized personnel

CMS Memo April 19, 2013 CMS issues memo related to the relative humidity (RH) AORN use to say temperature maintained between degrees and humidity between 30-60% in OR, PACU, cath lab, endoscopy rooms and instrument processing areas CMS says if no state law can write policy or procedure or process to implement the waiver Waiver allows RH between 20-60% In anesthetizing locations- see definition in memo

Humidity in Anesthetizing Areas

Surgical Services 940 Conform to aseptic and sterile technique
Appropriate cleaning between cases Room is suitable for kind of surgery performed Equipment available for rapid and routine sterilization And it is monitored, inspected and maintained by biomed program Temperature and humidity controlled ACS and AORN have P&P on many of these

Surgery 942 OR must be supervised by experienced RN or MD/DO
Must have specialized training in surgery and management of surgical service operation Will review job description LPN’s and OR techs can serve as scrub nurses under supervision of RN Qualified RN may perform circulating duties in OR - LPN or surg tech may assist in circulating duties - if allowed by state law

Surgical Privileges Surgical privileges must be delineated for all practitioners performing surgery, in accordance with competence of each practitioner Surgery service must maintain roster specifying the surgical privilege Privileges must be reviewed every two years Current list of surgeons suspended must also be retained Discussed in the earlier sections

Surgical Privileges MS bylaws must have criteria for determining privileges Surgical privileges are granted in accordance with the competence of each MS appraisal procedure must evaluate each practitioner’s training, education, experience, and demonstrated competence As established by the QAPI program, credentialing, adherence to hospital P&P, and laws

Surgical Privileges 945 Must specify for each practitioner that performs surgical tasks including MD, DO, dentists, oral surgeon, podiatrists RNFA, NP, surgical PA, surgical tech, et. al. Must be based on compliance with what they are allowed to do under state law If task requires it to be under supervision of MD/DO this means supervising doctor is present in the same room working with the patient

Surgery Policies 951 Aseptic and sterile surveillance and practice, including scrub technique Identify infected and non-infected cases Housekeeping requirements/procedures Patient care requirements pre-op work area patient consents and releases safety practices patient identification process and clinical procedures

Surgery Policies 951 Duties of scrub and circulating nurses
Safety practices Surgical counts Scheduling of patients for surgery Personnel policies in OR Resuscitative techniques DNR status Care of surgical specimens

Surgery Policies A-0951 Malignant hyperthermia
Protocols for all surgical procedures Sterilization and disinfection procedures Acceptable OR attire Handling infectious and biomedical waste Outpatient surgery post op planning

Preventing OR Fires 951 Read detailed section on use of alcohol based skin prep and how to prevent an OR fire AORN has very detailed policy on flammable prep in the OR and how to prevent fires Special precautions developed by NFPA and incorporated into NPSG by TJC ASA has good document on preventing fires in the OR Pa Patient Safety Authority has great recommendations

H&P 952 See prior sections on H&P
H&P must be on the chart before the patient goes to surgery Except in emergencies P&P specify what is an emergency

Consent 955 Informed consent is in three sections of the CoPs and each is different and not a repeat Third section in the surgery chapter Surgical services Consent must be in chart before surgery Exception for emergencies

Informed Consent Recommend anesthesia consent now (955)
Lists elements for well designed process, which are the optional elements Mandatory elements were under MR section Specifies what must be in the consent policy Who can obtain Which procedures need consent

Informed Consent Policy
When is surgery an emergency Content of consent form Process to obtain consent If consent obtained outside hospital how to get it into medical records Make sure it is on the chart before the patient goes to surgery

Informed Consent 955 Must disclose if residents, RNFA, Surgical PAs Cardiovascular Techs are doing important tasks Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices and placing invasive lines But requirement to have this in writing in under optional list or well designed list

Surgery Equipment 956 Call-in system Cardiac monitor Defibrillator
Aspirator (suction equipment) Trach set (cricothyroidotomy is not a substitute) TJC PC includes this plus ventilator, and manual breathing bags

PACU Standard: Must be adequate provisions for immediate post-op care Must be in accordance with acceptable standards of care, for all patients including same day surgery patients Such as following the ASPAN standards of care and practice Separate room with limited access P&P specify transfer requirements to and from PACU

2014 Changes to PACU Section

PACU PACU assessment includes level of activity, level of pain, respiration, BP, LOC, patient color, Aldrete If not sent to PACU then close observation of patient until has gained consciousness by a qualified RN Surveyor is instructed to observe care provided in the PACU to make sure they are monitored and assessed prior to transfer or discharge Will look to determine if hospital has system to monitor needs of post-op patient transferred from PACU to other areas of the hospital

Post-Operative Monitoring 2014
Hospitals are expected to have P&P on the minimum scope and frequency of monitoring in post-PACU setting Must be consistent with the standard of care Concerned about post-op patients receiving opioids Concern about risk for over-sedation and respiratory depression Once out of PACU not monitored as frequently Need appropriate assessment to prevent these complications (See Tag 405)

OR Register 958 Patient’s name, id number Date of surgery
Total time of surgery Name of surgeons, nursing personnel, anesthesiologist, and assistants Type of anesthesia Operative findings, pre-op and post-op diagnosis Age of patient See TJC RC which are now the same

Operative Report 959 Name and identity of patient
Date and time of surgery Name of surgeons, assistants Pre-op and post-op diagnosis Name of procedure Type of anesthesia

Operative Report 959 Complications and description of techniques and tissue removed Grafts, tissue, devises implanted Name and description of significant surgical tasks done by others (see list-opening, closing, harvesting grafts

Anesthesia A-1000 Must be provided in well organized manner under qualified doctor Optional service Must be integrated into hospital PI MS establish criteria for director’s qualifications Revised December 11, 2009, Feb 5, 2010, May 21, 2010 and February 14, 2011 Will review job description of director - see elements Wherever anesthesia is done - radiology, OB, OR, outpatient surgery areas State exemption process of MD supervision for CRNA

CMS Anesthesia Standards Changes
Hospitals are expected to have P&P on when medications that fall along the analgesia-anesthesia continuum are considered anesthesia P&P must be based on nationally recognized guidelines Must specify the qualifications of practitioners who can administer analgesia CMS further clarified pre-anesthesia and post-anesthesia evaluations CMS added FAQs which are very helpful Hospitals should review these as many changes and clarifications were made

Epidural or Spinal in OB
The administration of a regional (epidural or spinal) for the purpose of analgesia during labor and delivery Is not considered anesthesia Therefore, it is not subject to the supervision requirements for CRNA Unless subsequent administration of medication for operative delivery like a C-section then the anesthesia standards apply This section was removed even though this has always been CMS’s position

Anesthesia A-1000 If hospital provides any degree of anesthesia service must comply with all CoPs Anesthesia involves administration of medication to produce a blunting or loss of; pain perception (analgesia) Voluntary and involuntary movements Memory and or consciousness Analgesia is use of medication to provide pain relief thru blocking pain receptor in peripheral and or CNS where patient does not lose consciousness It is a continuum

Monitored Anesthesia Care (MAC)
Anesthesia care that includes monitoring of patient by an anesthesia professional (like anesthesiologist or CRNA) Include potential to convert to a general or regional anesthetic Deep sedation/analgesia is included in a MAC Deep sedation where drug induced depression of consciousness during which patient can not easily be aroused but responds purposefully following repeated or painful stimulus

Anesthesia Services Services not subject to anesthesia administration and supervision requirements Topical or local anesthesia ; application or injection of drug to stop a painful sensation Minimal sedation; drug induced state in which patient can respond to verbal commands such as oral medication to decrease anxiety for MRI Moderate or conscious sedation; in which patients respond purposely to verbal commands, either alone or by light tactile stimulation

Anesthesia Services 1000 Rescue capacity
Sedation is a continuum and not always possible to predict how patient will respond so need intervention by one with expertise in airway management Must have procedures in place to rescue patients whose sedation becomes deeper than initially intended Anesthesia services must be under one anesthesia services under direction of qualified physician no matter where performed Operating room, both inpatient and outpatient OB, radiology, clinics, ED, psychiatry, endoscopy etc.

Anesthesia Services 1000 There is no bright line between anesthesia and analgesia TJC has standards also on how to safely perform moderate or procedural sedation and anesthesia in the PC chapter Also references the need to follow nationally standards of practice such as ASA (American Society of Anesthesiologists), ACEP (American College of Emergency Physicians) and ASGE (American Society for GI Endoscopy), AGA etc.

Anesthesia Services 1000 Hospitals need to determine if sedation done in the ED or procedures rooms is anesthesia or analgesia This standard also sets forth the supervision requirements for staff who administer anesthesia P&Ps need to establish minimum qualifications and supervision requirements including moderate sedation MS credentialing standards and the nursing standards exist to make sure staff are qualified and competent Must have P&P to look at adverse events, medication errors and other safety and quality indicators

Anesthesia Services and Policies 1002
Anesthesia must be consistent with needs of patients and resources P&P must include delineation of pre-anesthesia and post-anesthesia responsibilities Policies include; Consent Infection Control measures Safety practices in all areas How hospital anesthesia service needs are met

Anesthesia Policies Required 1002
Policies required (continued); Protocols for life support function such as cardiac or respiratory emergencies Reporting requirements Documentation requirements Equipment requirements Monitoring, inspecting, testing and maintenance of anesthesia equipment Pre and post anesthesia responsibilities

Pre-Anesthesia Assessment 1003
Pre-anesthesia evaluation must be performed with 48 hours prior to the surgery Including inpatient and outpatient procedures For regional, general, and MAC Not required for moderate sedation but still need to do pre sedation assessment Preanesthesia assessment must be done by some one qualified person to administer anesthetic (non-delegable)

Organization and Staffing 1003
Pre-anesthesia assessment done by someone who can administer anesthesia such as; Qualified anesthesiologist or CRNA, Qualified doctor other than anesthesiologist Anesthesiology assistant (AA) under the supervision of anesthesiologist who is immediately available if needed Dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law CRNA may not require supervision if state got an exemption1 1 List of 16 state exemptions at Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota, Wisconsin, Montana, Colorado, and California.

Pre-anesthesia Evaluation 1003
Can not delegate the pre-anesthesia assessment to someone who is not qualified Must be done within 24hours Delivery of first dose of medication for inducing anesthesia marks end of 48 hour time frame However, some of the elements in the evaluation can be collected prior to the 48 hours time frame but it can never be more than 30 days o if you saw a patient on Friday for Monday surgery would need to show that on Monday there were no changes

Pre-Anesthetic Assessment 1003
Must include; Review of medical history, including anesthesia, drug, and allergy history (within 48 hours) Interview and exam the patient Within 48 hours and rest are updated in 48 hours but can be collected within 30 days Notation of anesthesia risk (such as ASA level) Potential anesthesia problems identification (including what could be complication or contraindication like difficult airway, ongoing infection, or limited intravascular access)

Pre-Anesthetic Assessment 1003
Pre-anesthetic Assessment to include (continued); Additional data or information in accordance with SOC Including information such as stress test or additional consults Develop plan of care including type of medication for induction, maintenance, and post-operative care Of the risks and benefits of the anesthesia

ASA Physical Status Classification System
ASA PS I – normal healthy patient ASA PS II – patient with mild systemic disease ASA PS III – patient with severe systemic disease ASA PS IV – patient with severe systemic disease that is a constant threat to life ASA PS V – moribund patient who is not expected to survive without the operation ASA PS VI – declared brain-dead patient whose organs are being removed for donor purposes

Survey Procedure Pre-anesthesia Evaluation
Surveyor to review sample of inpatient and outpatient records who had anesthesia Make sure pre-anesthesia evaluation done and by one qualified to deliver anesthesia Determine the pre-anesthesia evaluation had all the required elements Make sure done within 48 hours before first does of medication given for purposes of inducing anesthesia for the surgery or procedure ASA and AANA has pre-anesthesia standards

Pre-anesthesia ASA Guideline
Preanesthesia Evaluation 1 Patient interview to assess Medical history, Anesthetic history, Medication history Appropriate physical examination Review of objective diagnostic data (e.g., laboratory, ECG, X-ray) Assignment of ASA physical status Formulation of the anesthetic plan and discussion of the risks and benefits of the plan with the patient or the patient’s legal representative 1

Intra-operative Anesthesia Record 1004
Need policies related to the intra-operative anesthesia Need intra-operative anesthesia record for patients who have general, regional, or MAC Intra-operative Record must contain the following: Include name and hospital id number Name of practitioner who administer anesthesia Techniques used and patient position, including insertion of any intravascular or airway devices

Intra-operative Anesthesia Record
Intra-operative Record must contain the following (continued): Name, dosage, route and time of drugs Name and amount of IV fluids Blood/blood products Oxygenation and ventilation parameters Time based documentation of continuous vital signs Complications, adverse reactions, problems during anesthesia with symptom, VS, treatment rendered and response to treatment

Post-anesthesia Evaluation 1005
Post-anesthesia evaluation must be done by some one who is qualified to give anesthesia Must be done no later than 48 hours after the surgery or procedure requiring anesthesia services Must be completed as required by hospital policies and procedures Must be completed as required by any state specific laws P&Ps must be approved by the MS P&Ps must reflect current standards of care

Post Anesthesia Evaluation 1005
Document in chart within 48 hours for patients receiving anesthesia services (general, regional, MAC) For inpatients and outpatients now So may have to call some outpatients if not seen before they left the hospital Note different for CAH hospitals under their manual Does not have to be done by the same person who administered the anesthesia

Post Anesthesia Evaluation
Has to be done only by anesthesia person (CRNA, AA, anesthesiologist) or qualified doctor 48 hours starts at time patient moved into PACU or designated recovery area (SICU etc.) Evaluation can not generally be done at point of movement to the recovery area since patient not recovered from anesthesia Patient must be sufficiently recovered so as to participate in the evaluation e.g. answer questions, perform simple tasks etc.

Post Anesthesia Evaluation
For same day surgeries may be done after discharge if allowed by P&P and state law If the patient is still intubated and in the ICU still need to do within the 48 hours Would just document that the patient is unable to participate If patient requires long acting anesthesia that would last beyond the 48 hours would just document this and note that full recovery from regional anesthesia has not occurred

Post-Anesthesia Assessment 1005
Respiratory function with respiratory rate, airway patency and oxygen saturation CV function including pulse rate and BP Mental status, Temperature Pain Nausea and vomiting Post-operative hydration

Post-Anesthesia Survey Procedure
Surveyor is review medical records for patients having anesthesia and make sure post-anesthesia evaluation is in the chart Surveyor to make sure done by practitioner who is qualified to give anesthesia Surveyor to make sure all postanesthesia evaluations are done within 48 hours Surveyor to make sure all the required elements are documented for the postanesthesia evaluation

Post Anesthesia ASA Guidelines
Patient evaluation on admission and discharge from the postanesthesia care unit A time-based record of vital signs and level of consciousness A time-based record of drugs administered, their dosage and route of administration Type and amounts of intravenous fluids administered, including blood and blood products Any unusual events including postanesthesia or post procedural complications Postanesthesia visits

Six FAQs How can the same drugs be used in the OR for anesthesia but in the ED for a sedative? What nationally recognized guidelines are available for hospitals to use to develop their P&Ps? What is the appropriate training for a sedation nurse? Why is there a particular mention in the interpretive guidelines on ED sedation policies? Can hospital adopt a P&P that all anesthesia agents in lower doses can be used for sedation (NO!)

Services must meet needs of patients Optional service
Nuclear Medicine 1026 Services must meet needs of patients Optional service Radioactive material must be prepared, labeled, uses, transported, stored and disposed of in accordance with acceptable standards of practice Will not discuss but be sure to provide to your director if you do nuclear medicine

Nuclear Medicine Hospital must have written safety standards for radioactive material Handling of equipment and material Protection of patients and staff from radiation hazards Labeling of materials and waste Transportation of same Security of radioactive material Testing of equipment for radioactive hazards, et. al.

Equipment and Supplies
Must be appropriate for types of nuclear med services offered Must function in accordance with federal and state laws governing radiation safety - see 21 CFR Subpart J, Radiological Health See 10 CFR. Chapter 1, Part 20, US Nuclear Regulatory Commission Standards for Protection against Ionizing Radiation

Nuclear Med 1036 2015 Must be maintained in safe operating condition
Inspected, tested, and calibrated annually by qualified person Sign and date reports of nuclear interpretation, consults, and procedures Keep copies for five years of records Radiopharmaceuticals can be prepared on off hours without radiologist or pharmacist present Need P&P and follow guidelines like Society of NM and Molecular Imaging

SNMMI Website

NM Tech Scope of Practice

Nuclear Med Practitioner who interprets test must sign and date the test and be approved by MS to interpret Must maintain records of the receipt and distribution of radio pharmaceuticals Nuclear med studies must be ordered by practitioners who scope of federal or state licensure allow such referrals and who has staff privileges to perform

Nuclear Medicine Tests
Normal hepatobiliary scan (HIDA scan) used to detect gallbladder disease Normal pulmonary ventilation and perfusion V/Q scan

Outpatient Services Standard: Outpatient services must meet the needs of the patient Must be in accordance with standards of practice such as ACR, AMA, ACS, etc. Optional service but must comply with all CoPs Both on and off campus Outpatient services must be integrated into hospital QAPI Theme in rest of slides with being involved in PI, qualified director, follow SOCs, and met needs of patients

Outpatient Services 1077 Must be integrated with inpatient services
Medical records, radiology, lab, anesthesia, including pain management, diagnostic tests Hospital must coordinate the care of the patient Make sure pertinent information in medical record

Outpatient Services Have appropriate professional and nonprofessional personnel bases on scope and complexity of outpatient services Define in writing the qualifications and competencies necessary to direct the department Should include education, experience and training Will review P&P to determine person’s responsibility No longer a requirement to be sure that one person is overlooking all of ambulatory patients care and treatment (July 16, 2012)

Outpatient Tag The outpatient services department must be accountable one or more individuals responsible for the outpatient area No longer says it has to be single person responsible With appropriate personnel at each location where outpatient services are rendered Hospital has flexibility to determine how to organize their outpatient department Define in writing the qualifications and competencies of each of the outpatient directors

Outpatient Tag Survey Procedures (b) Ask the hospital how it has organized its outpatient services and to identify the individual(s) responsible for providing direction for outpatient services Review the organization’s policies and procedures to determine the person’s responsibility Will review the position description of the individuals responsible for outpatient services

Outpatient Orders 1080 2015 Orders can be made by practitioner who is;
Responsible for the care of the patient Licensed in state where he or she provides care to the patient Within state scope of practice Authorized by the MS, approved by the board, to order outpatient services under written P&P Whether C&P by the hospital or not Verify is licensed in state and within scope (NP, PA) Consider checking license, OIG excluded list of individuals, verify order is from practitioner etc.

OIG List of Excluded Individuals

Outpatient Services Standard: Outpatient Services must meet the needs of the patients in accordance with standards of practice Like AMA, ACR, ACS, etc. It is optional to have outpatient services but if provides must follow CoPs Services, equipment, staff, and facilities must be appropriate Orders for outpatients may be made by practitioner responsible for the care of the patient

Emergency Services 1100 Hospital must meet needs of patients Optional for Medicare Must follow acceptable standards of practice Must be integrated into hospital wide QAPI Need qualified MS director

Emergency Services Services must be integrated with other dept in hospital Surgery, lab, medical records, et al. Includes communications between departments Immediate availability of services, equipment, and resources of hospital Length of time to transport between departments is appropriate

Emergency Services Other departments must provide emergency patients the care within safe and appropriate times If offer urgent care on premises or in provider based clinics must follow these regulations Remember there is a separate COP on EMTALA Will review policies, including triage policy

Emergency Services Must have appropriate equipment
Periodic assessments of its needs Work with state and feds in emergency preparedness Surveyor will interview staff to see if knowledgeable about blood, IV fluid, parenteral administration of electrolytes, injuries to extremities, CNS and prevention of infection

Rehab Services Standard: If provides rehab, PT, OT, speech language pathology, audiology, must be staffed and organized to ensure safety of patients These staff must be qualified as specified by MS and state law Meet standards - American Physical Therapy Association, American Speech and Hearing Association, American Occupational Therapy Association, American College of Physicians, AMA Read what must be in the plan of care

Rehab Services Must be integrated into hospital wide QAPI
Must have proper equipment and personnel Scope of service should be defined in writing Review medical records to verify each person documents Director must be knowledgeable and experience and capable Will review job description Services must be furnished in accordance with written plan of care

Rehab Services Must be given in accordance with order of practitioner including outpatient orders No longer says physician only Orders must be incorporated in the medical record Orders by one authorized by the MS to order and by P&P Could be PA, CNS, NP as allowed per hospital P&P Document order (1133) Must be consistent with state scope of practice Plan of care must meet criteria such as based on assessment, measurable short and long term goals, updated as needed

Respiratory Services 1151 Must meet needs of patients
Acceptable standard of practice Appropriate equipment and number of qualified personnel Scope of service should be defined in writing Director who is doctor with experience to supervise service List of written policies you must have

Respiratory Policies Equipment assembly, operation, PM
Safety practices including IC for sterile supplies, biohaz waste, posting of signs and gas line id CPR Pulmonary function testing Procedures to follow in the advent of adverse reactions to treatments or interventions Therapeutic percussion and vibration Bronchopulmonary drainage

Respiratory Policies Mechanical ventilation
Aerosol, humidification, and therapeutic gas administration Storage, access and control of medications ABG procedure for analyzing CMS working on changes to respiratory and rehab section so stayed tuned Need order but can be from physician or LIP as allowed by state (scope of practice) and hospital and PA or NP credentialed by Medical Staff

Respiratory Services 1164 (Last CoP)
If blood gases or other clinical lab tests are performed in unit then the applicable lab standards must be met Need order of practitioner (1163, 2015) including outpatient orders One licensed and qualified and within scope of practice Such as NP, PA, CNS Will review medical records Will review to make sure all required policies and procedures are written

Statement of Deficiencies and Plan of corrections
Based on documentation of surveyor worksheet or notes and form CMS-2567

The End! Questions??? Sue Dill Calloway RN, Esq. CPHRM, CCMSCP
AD, BA, BSN, MSN, JD President of Patient Safety and Education Consulting Board Member Emergency Medicine Patient Safety Foundation (Call with questions, no s) 682 682

Websites Center for Disease Control CDC – www.cdc.gov
Food and Drug Administration - Association of periOperative Registered Nurses at AORN - American Institute of Architects AIA - Occupational Safety and Health Administration OSHA – National Institutes of Health NIH - United States Dept of Agriculture USDA - Emergency Nurses Association ENA -

Websites American College of Emergency Physicians ACEP - www.acep.org
Joint Commission Joint Commission - Centers for Medicare and Medicaid Services CMS - American Association for Respiratory Care AARC - American College of Surgeons ACS - American Nurses Association ANA - AHRQ is American Hospital Association AHA -

Websites U.S. Pharmacopeia (USP) www.usp.org
U.S. Food and Drug Administration MedWatch - Institute for Healthcare Improvement - AHRQ at Drug Enforcement Administration – (copy of controlled substance act) US Pharmacopeia - (USP 797 book for sale) National Patient Safety Foundation at the AMA - The Institute for Safe Medication Practices -

Websites CMS Life Safety Code page - American College of Radiology- Federal Emergency Management Agency (FEMA)- Sentinel event alerts at American Pharmaceutical Association - American Society of Heath-System Pharmacists -

Websites Enhancing Patient Safety and Errors in Healthcare - National Coordinating Council for Medication Error Reporting and Prevention - FDA's Recalls, Market Withdrawals and Safety Alerts Page: Association for Professionals in Infection Control and Epidemiology (APIC) infection control guidelines at Centers for Disease Control and Prevention - Occupational Health and Safety Administration (OSHA) at

Infection Control Websites
The National Institute for Occupational Safety and Health NIOSH at AORN at Society for Healthcare Epidemiology of America (SHEA) at

The End! Questions??? Sue Dill Calloway RN, Esq. CPHRM, CCMSCP
AD, BA, BSN, MSN, JD President of Patient Safety and Education Consulting Board Member Emergency Medicine Patient Safety Foundation 689 689

Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD

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Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD

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