CMS Final Changes The Hospital Improvement Rule

CMS Final Changes The Hospital Improvement Rule

Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP, CCMSP
AD, BA, BSN, MSN, JD President of Patient Safety and Education 5447 Fawnbrook Lane Dublin, Ohio 43017 (Call with questions, No s) questions to CMS 2 2

Introduction

Introduction First, CMS published the proposed changes in the Federal Register on June 16, 2016 Second, CMS was to publish the final rules before June 1, 2019 The statute says all laws must be passed within three years of being published CMS gets a one year extension until June 16, 2020

Introduction Third, CMS published the final regulations on September 30, 2019 with an effective date of November 29, 2019 Regulations are effective 60 days after publication in the Federal Register with two exceptions for CAH on QAPI and ASP Fourth, CMS will come along and publish interpretive guidelines and survey procedures to match the revised regulations so the surveyors and the hospitals will know what it means Monitor the survey memo website Fifth, CMS reserves the right to tinker with the language when the survey memo is issued

Hospital Improvement New Law
and 393 Pages

PDF Version of New Law

Introduction Sixth, CMS will publish it in a transmittal and then that day CMS will update the CMS hospital CoP manual Hospitals will then need to review and implement the requirements Hospitals can do a gap analysis where they go through it line by line and document how they meet compliance Hospitals can get a complaint survey, validation survey or certification survey In 2019, CMS announced will do observations of the 4 AO surveys instead of the traditional validation survey If out of compliance CMS may issue a statement of deficiency and will have to do a plan of correction

Final Hospital Improvement Rule
For questions on the revised regulation, the name and phone number of people to answer questions is at the beginning and under each section Captain Scott Cooper, , Mary Collins, Alpha-Banu Wilson Kianna Banks Later, can questions to or

For the most part, CMS implemented most of the proposed rules in the final rules There are some exceptions and these will be discussed This was very different from the discharge planning standards that were published the same day Many of the proposed changes were NOT finalized in the final discharge planning standards Both of these affected all hospitals including critical access hospitals (CAH)

The full name of the law is Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care This law also combine the transparency law which has a section on H&Ps It also contains a third law that updates fire safety standards for End Stage Renal Disease Facilities This law applies to all hospitals, including critical access hospitals (CAHs) that accept Medicare or Medicaid reimbursement In ASC rules, do not need transfer agreements with hospitals anymore

Introduction Note that there is a lot of information in the proposed and final rules that talked about what is currently a problematic standard Clarifies some important sections that are already in the current CoP requirements This information is very helpful to hospitals on what they can do now to reduce deficiencies and ensure compliance Sometimes they have reworded a CoP to make sure that hospitals are clear as to what CMS is looking for

Hospitals Do Not Want One of These

The Conditions of Participation (CoPs)
CoP manual is updated more frequently How can hospitals keep up the changes? Hospitals should check the CMS survey memo website once a month and consider having one person who is responsible to do this Monitor for the new changes Have one person sign up to get the Federal Register (FR) for free to monitor CMS new regulations Have one person check to see if the manual has been updated

Subscribe to the Federal Register

CMS Survey and Certification Website

CMS Survey Memos

Email questions hospitalscg@cms.hhs.gov

Also Called the State Operation Manual
questions

CAH SOM or CoP Manual Email questions to cahscg@cms.hhs.gov
questions to

CMS Transmittals

CMS Final Hospital CoP Changes

Hospital Improvement Rule Introduction
Again, the following is the name given by CMS to the final rule published effective December 1, 2019 Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care It makes changes to the following CoP sections: Nursing, Infection Control, Patient Rights, Medical Records, QAPI, Lab, emergency preparedness, and Dietary (CAH) It addresses restraints, implementation of an antibiotic stewardship program, care plans, and LIPs

Hospital Improvement Introduction
The final rules affect all hospitals and critical access hospitals (CAHs) They are intended to ensure hospitals are following standards of practice There are other sections that impact other healthcare facilities like ASCs, transplant centers, home health agencies, community mental health etc. They are intended to improve the quality of care to patients and reduce barriers to care The regulation is 393 pages long

Table of Contents is Long

Hospital Improvement Introduction
CMS says benefits of this law includes; Reduce inappropriate antibiotic use Prevent discrimination Improve use of quality data Implement an antibiotic stewardship program to reduce inappropriate antibiotic and resistance Reduce hospital-acquired conditions (HACs) such as CAUTI, vascular catheter infection, surgical site infection after a CABG, DVT or PE after TKA or THA

Why Revise the CoPs? Improve outcomes and quality of care
Reduce unnecessary readmissions Reduce HACs Improve antibiotic use at reduced costs Reduce healthcare associated infections (HAIs) Mentions these changes are consistent with the National Quality Strategy Published in March 2011 by AHRQ on behalf of HHS Set focus on QI with three aims to provide better and more affordable care and 6 priorities

CMS Hospital Acquired Conditions or HACs

QAPI Program

QAPI Current CoPs require hospitals to examine the quality of its services and implement specific improvement projects on an ongoing basis This has resulted in hospitals making progress in delivering safer, high quality care CMS made a minor change to the program data requirements for hospitals under Appendix A But major changes for CAHs under Appendix W Currently hospitals must incorporate patient care data into their QAPI such as data submitted to or from the QIO

QAPI Will require that the hospital QAPI program to incorporate quality indicator data, including patient care data, submitted to or received from Medicare quality reporting and quality performance programs This would include data on readmissions and hospital acquired conditions (HACs) Hospitals are already collecting and reporting on a lot of this data so efficient to include some of this data in the QAPI program Like HAC Reduction Program, Hospital VBP Program, Inpatient and Outpatient Quality Reporting Program

CMS Hospital Acquired Conditions

Hospitals in Systems CMS has finalized you can have system wide QAPI
It is called “unified and integrated QAPI for multi-hospital systems” Must be part of a hospital system Under a board that is responsible for 2 or more hospitals Not required but an option for hospitals in systems Must be consistent with your state law Note will update the QAPI worksheet

Hospitals in Systems The board is responsible for making sure that each of the hospitals meet all the QAPI requirements Each hospital must show that the QAPI program is established in a manner that takes into account each hospital’s unique circumstances and any significant differences in patient population or services offered Example a children’s hospital verses a psychiatric hospital or an acute care hospital Services such as one hospital has a burn unit or a cardiovascular unit and does lots of open hearts or cardiac procedures

Hospitals in Systems Each must have P&Ps to ensure the needs and concerns of each hospital is addressed Regardless of practice or location To make sure that issues localized to a particular hospitals are considered CMS said such a model would incorporate each individual hospital’s QAPI program But the new model would enable increased efficiencies, innovations, and flexibility and allow for dissemination of best practices

CAHs The regulatory changes are effective 60 days after the Federal Register is published unless otherwise specified Since published September 30, 2019 the effective date would be November 29, 2019 However, CMS gave CAHs 18 months to comply with the QAPI requirements So must be implemented by March 30, 2021 The board is also responsible for make sure that QAPI standards are met

CAH QAPI Program Basically CMS is implementing the QAPI standards under Appendix A for CAH CAH QAPI had not been updated since 1993 and did not reflect current standards These replace the existing reactive annual evaluation and quality assurance requirements with a proactive approach of a QAPI program The section on evaluation of the diagnosis and treatment provided by physicians and non-physicians has been relocated to a new section under “staffing and staff responsibilities”

CAH QAPI Program CAHs are encouraged to use the technical assistance and services available through the state Flex Programs This includes the Medicare Beneficiary QA Project supported by HRSA’s Office of Rural Health Policy

CAH Checklist & Quality Network

CAH QAPI Program CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven QAPI program Program has to be appropriate for the size and what the CAH does Must involve all departments Must use objective measures to evaluate services Must be ongoing and comprehensive Board is responsible for QAPI program Use objective measures to evaluate processes Has a definition of medical error and adverse event (AE)

CAH QAPI Program Must address outcome indicators related to improved outcomes And the prevention of medical errors and AEs Such as the medication error rate, adverse drug reactions, delay or misdiagnosis, retained surgical items, burns, etc. Including the transition of care including readmissions CMS rewrote all the discharge planning requirements effective November 29, 2019 Use measures to track performance Such as falls rate, The board is responsible for the QAPI program

CAH QAPI Program Address priorities to improve care and patient safety
Communicate clear expectations for safety Evaluate all improvement actions and go back to the drawing board if not working Determine the number of distinct projects Implement P&P on what staff should do to prevent and report unsafe patient care practices, medical errors, and adverse events Lists program activities such as measures to track and analyze

CAH QAPI Program Look at high-volume, high-risk services, or problem-prone areas Document QAPI projects Use data to monitor the effectiveness and safety of services provided and quality of care Identify opportunities for improvement Basically, CMS is adopting the similar QAPI standards found in Appendix A which is the manual for larger hospitals

Psychiatric Hospitals

Medical Records for Psych Hospitals
Progress notes must be recorded by physicians, psychologists and other LIPs responsible for the patient’s care Remember LIP changed to LP Nurses, social workers, and others may be involved in treatment modalities Clarified the scope of non-physicians to document in the progress notes Others such as nurse practitioners, psychologist, CNS, and physician assistants can document in the progress notes

Medical Records for Psych Hospitals
Must be within scope of practice and allowed by the hospital so need a policy How often you document in the progress notes is determined by the condition of the patient However, at a minimum must document at least weakly for the first 2 months After that it must be at least once a month Documentation must contact recommendations for revisions to the treatment plan It must include an assessment of the patient’s progress with the treatment plan

Patient Rights and Non-Discrimination

Non-Discrimination To participate in Medicare hospitals must agree to follow the civil rights requirements of Title VI of the Civil Rights Act of 1964 Implemented by various other federal laws such as the Rehab Act of 1973 Age Discrimination Act of 1975 OCR Section 1557 of the Patient Protection and Affordable Care Act This prohibits discrimination based on race, color, national origin, disability, age, and sex. etc

Non-Discrimination NOT Implemented
CMS noted there were no prohibitions in the CMS CoPs on gender identities which can be a barrier to seeking care by patients who fear discrimination Numerous studies show the impact or perceived discrimination when seeking medical care The IOM report in 2011 found that many lesbian, gay, bisexual, and transgender people refrain from disclosing sexual orientation or gender to their health care provider The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding

The IOM Report of LGBT

TJC Resource

Non-Discrimination So CMS is was proposing to make rules regarding nondiscrimination as required by OCR Section 1557 of the ACA which is already a federal law that many hospitals have not heard of Many hospitals opposed having this federal law in two different places In the final rules, CMS decided not to do this CMS surveyors can still punt OCR 1557 violations directly to the OCR Hospitals still need to make sure they are in compliance

Non-Discrimination OCR 1557
So hospital would need a policy that the hospital cannot discriminate Staff must be educated Patients and/or support persons must be informed that they have these rights so amend the patient rights There are 2 signs required Must be notified in language they can understand and most states must have a sign in 15 different languages Sign the hospital will not discriminate Must tell them how to file a complaint if they encounter discrimination

OCR has Sample Notice in English

List 15 Top Language Spoken in Every State

PAs Ordering Restraint and Seclusion

PA Ordering Restraints
Use to say that physicians and licensed independent practitioners (LIPs) could order restraints PAs are sometimes not LIPs but licensed practitioners (LPs) or licensed dependent practitioners depending on the state law Therefore many hospitals would not let a PA order restraints So changed the language to say LPs instead of LIPs

Changed LIP to LP This way there is no problem to have PAs order restraints As long as allowed by state law and the hospital So as hospitals are updating policies, Medical Staff bylaws, Rules and Regulations, and other documents be sure to change LIP to LP CMS has 50 pages of restraint standards Restraints are a problematic standard for hospitals CMS discusses many of the requirements that are already present but changed LIP to LP

A patient in restraints who is violent and or self destructive must have an evaluation and a new order in 24 hours by a physician or LP By one who is responsible for the care of the patient Must also be authorized to order restraints by the hospital Must be consistent with state law Condition of patient must be monitored by a physician, LP, or other licensed practitioner or trained staff

Restraint and Seclusion
Basically CMS is talking about the one hour face to face exam that must be done by a patient who is violent and self destructive CMS is specific about what must be assesses no matter who is doing the exam Hospitals should have a form that includes these requirements such as: The patient's reaction to the intervention The patient's medical and behavioral condition The need to continue or terminate the restraint or seclusion

Document One Hour Include in evaluation, physical and behavioral assessment (Tag 179) Include a review of systems, behavioral assessment, as well as patient’s history Include 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 Train staff in these requirements (Tag 196)

PA will have to be trained on the policy as required by physicians or NPs who order restraints A trained nurse or other person qualified to do the one hour face to face exam must notify the physician or LP as soon as possible This can include the PA Change made at the request of the American Academy of Physician Assistants So would need to change your R&S policy to reflect these changes

Emergency Preparedness

Emergency preparedness (EP) plan must be reviewed and updated every two years instead of annually In a disaster, must cooperate and collaborate with the state or federal EP officials Remember, emergency preparedness is now under Appendix Z, but can only be accessed under the survey memo website Three changes were made on February 1, 2019

Need EP P&P on based on the emergency plan Need a communication plan based on the plan Must be updated at least every two years Has a list of what must be in the communication plan The policies must be reviewed and updated at least every two years Training and testing program must be reviewed and updated every two years Must be based on the emergency plan

Must train staff every two years Must conduct exercises at least twice a year Must participate in an annual full scale exercise that is community based If not available then an individual facility based functional exercise If the hospital experiences a natural or man made emergency, and the EP was activated, the hospital is exempt from the next full scale community based drill

Conduct an additional exercise opposite the full-scale exercise This can be a mock drill It can be a table top exercise It could be a second full scale exercise either individual or community based Analyze and document the hospital’s response Maintain documentation of all the drills and revise the plan as needed

H&P for Healthy Outpatients

History and Physicals Previously, required that all patients undergoing survey or certain procedures had to have a H&P done It had to be done within 24 hours if the patient was admitted If a family doctor did the H&P of a patient going to surgery, it could not be older than 30 days It must be updated the day of surgery before the patient went to surgery The H&P needed to be on the chart

Final Changes to H&Ps CMS proposed to make changes to the hospital H&Ps in the Medicare and Medicaid Programs: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction: Proposed Rule The transparency rule was one of three laws that were published together The effective date is November 29, 2019 Remember the interpretive guidelines will be published Would change H&P requirements for healthy outpatients in hospitals and in ASCs

History and Physicals The medical history and physical must be documented within the 30 day rule and 24 after admission or registration But prior to surgery or a procedure requiring anesthesia Unless it meets the exception The H&P must completed and documented by a physician, oral and maxillofacial surgeon, or other qualified licensed individual As allowed by state law and hospital policy

H&P Hospital Final Changes
Allows hospitals flexibility to have a pre-surgery or pre-procedure assessment instead of a H&P in selected surgeries and procedures Must have a Medical Staff policy to allow Applies to outpatient surgery and procedures only The pre-procedure or pre-surgery assessment would still need to be documented in the chart For example appropriate minor things like cataract surgery, YAG laser, or capsulotomy which involves minor sedation or is done under a local Not required but an option for hospitals

H&P Hospital Changes The hospital policy would have to consider the following things: Age and diagnosis Type and number of surgeries and procedures to be scheduled Co-morbidities Level of anesthesia required National guidelines Standards of practice for assessment of specific types of patients Any applicable state laws

Data shows 28.6 million ambulatory surgeries performed in hospitals and ASCs 25.7 million or 53% of these were performed in hospitals Found the most frequently performed included endoscopy of both small and large intestine, extraction of lens, insertion of prosthetic lens, and spinal injection So CMS decided to have a less burdensome option for assessment of these outpatients

Would require that the assessment be completed and documented after registration, but prior to the surgery or procedure So if assessment done before registration, would need to be updated before the outpatient surgery or procedure These would be the ones the MS have decided do not need a H&P and need a policy on this Policy would need to indicate consideration of age, dx, comorbidities, level of anesthesia etc as discussed previously Even if procedure on the list can still decide to do a H&P

H&P Hospital Changes In ASCs says some subgroups of patients may benefit from a H&P such as patients who cannot lie supine, have chest pain, SOB, pacemakers, recent MI, on dialysis or take insulin The assessment would have to be done by the physician or other qualified licensed individual Would NOT implement the 30 day rule change as for ASCs The assessment would could be older than 30 days if the ASC has a policy and approved by the Medical Staff

MS By-Laws and Rules & Regulations
Note that the hospitals would need to amend their Medical Staff bylaws and rules and regulations These would need to be consistent with the hospital policy if the hospital elects to allow the assessments instead of a H&P in health outpatients Remember, this is an option and not required Some hospitals may elect to still require a H&P for all patients

Medical Record and Medical Staff Sections
The H&P changes will appear in the medical record chapter It is also rewritten and will be repeated in the Medical Staff section It is also rewritten and appears in the surgery section CMS has always had five different tag numbers regarding H&Ps

LAB Look Back Program

Look Back Program Over a period of 12 weeks
Timeframe for patients or donors tested after February 20, 2008 If the blood collecting agency, such as the Red Cross, notifies the hospital that it received potentially infectious blood Such as one contaminated with HIV or Hepatitis The hospital has to make a reasonable attempt to give notification Over a period of 12 weeks This is in here because in the CoP it previously said this provision would expire

Look Back Program So the look back provision continues
And if unable to locate patient this must be documented in the medical record For example difficulty locating a homeless patients We generally made at least 3 attempts then documented and closed the file Usually the hospital notifies the patient’s physician who notifies the patient to come in and get tested If exceeds 12 weeks document the extenuating circumstances beyond the hospital’s control Every hospital should have a look back policy

Nursing Services

Nursing Services CMS felt that some of requirements were confusing due to unnecessary distinctions between inpatient and outpatient services Felt confusion on how hospitals meet their nursing staffing requirements Previously stated that there must be supervisory and staff personnel for each nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient Deleted “bedside” which implies that it applies to inpatients only

Nursing Services So if a patient puts their light on and says they are having an allergic reaction to the unit of packed cells A nurse needs to get to the bedside timely If the patient’s nurse is tied up or off the unit, then another RN, or the charge nurse, or nursing supervisor must assess the patient timely This one tag number is about 25% of the nursing deficiencies It doesn’t matter if the patient is on the medical unit or in the emergency department

Nursing Services The hospital must have an adequate number of RNs, LPNs, and other staff to provide nursing care to all patients as needed Having a plan of care is a frequent deficiency in nursing If there is an interdisciplinary plan of care, if nursing can get everything in there that they need You don’t need to do a separate plan of care Note in discharge planning regulations you need to assess goals and preferences

Nursing Plan of Care Clarified that a plan of care is required for every inpatient and it should reflect the needs of the patient Patient goals should be part of care plan Care plan should include: Physiological and psychosocial factors Physical and behavioral health comorbidities Patient discharge planning Should be consistent with medical care

Nursing Plan of Care In the preamble, mentions that a plan of care is generally for inpatients However, CMS encourages hospitals to review their P&Ps to determine if there are some outpatients where a plan of care would be appropriate For example, a patient receiving care in the outpatient department who was a post multiple trauma patient Is getting care to the burn wounds and dressing changes Had multiple fractures and getting PT and other care

Nursing Services P&P All nurses must adhere to the nursing policies and procedures Removed the section that said non-employee nurses must follow to emphasis that all nurses must follow The CNO must provide for adequate supervision and evaluation of all nursing personnel of clinical activities This would include licensed nurses, including agency nurses, and non-licensed such as nurse aides, orderlies, and other support staff

CNO Evaluating All Nurses
Some CNOs did not know you had to do an annual evaluation of non-employee nurses such as agency or traveling nurses or contract staff Even if the agency does an evaluation still need to do in the hospital This doesn’t mean the CNO has to actually do the annual evaluation but to make sure it is done May be done by the evening or night supervisor for nurses that work nights or department managers Non-licensed staff must be supervised by a licensed nurse

Nursing Services Outpatient RN
Patient must have ongoing assessments Must be sufficient numbers, and types of supervisory and staff nursing personnel to respond to the appropriate nursing needs and care of the patients Hospitals must have a policy to state which outpatient departments would be required to have an RN present Such as outpatient ambulatory surgery recovery unit Maybe not needed at outpatient MRI

Nursing Services Outpatient
Policy must be approved by the CNO Changed from MS to CNO Must be reviewed by the CNO at least every three years Must establish an alternative staffing plan Policy to take into account factors such as: The types of services delivered The acuity of patients typically served by the facility and The established standards of practice for such services

Outpatient RN It must also reflect the care given and be kept current
Such as dressing changes, foley insertions, wound irrigations, administration of chemotherapy, etc. Must be started and implemented in a timely manner

Clarifications Drug & Biologicals
The following is applicable to all patients, and not just Medicare patients, in the hospital Previous manual said it applied to Medicare patients only All drugs and biologicals must be prepared and administered in accordance with Federal and State laws Need an order of the practitioner or practitioners responsible for the patient’s care Hospitals determines who can write these orders Consistent with state law, scope of practice and P&P Must be written in accordance with accepted standards of practice

Clarifications Flu and Pneumococcal Vaccine
Need order for all medications Exception is flu and pneumovac Must have physician-approved hospital policy such as approval of MEC Then assess for any contraindications Nurse can write the order Pharmacy sends up No one is required to sign the order

Clarification Verbal Orders
If verbal orders are used, they are to be used infrequently Must only be accepted by persons who are authorized to do so by hospital P&P Verbal orders have been a problematic standard for hospitals for years CMS has tag numbers; 407, 408, and 454 Make sure they are signed off as soon as possible Make sure staff are aware of the hospital policy

Medical Records None of These Were Adopted

Medical Records Outpatient
The CoPs apply to inpatients and outpatients However, some of the language makes it sound like it applies only to inpatients Terms such as admission, discharge, or hospitalization Wanted to clarify the distinction between inpatient and outpatients The content of the MR must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services Note, this is a current requirement

Medical Records This sentence may not capture the documentation needed for outpatients such as a progress note So wanted to add an extra sentence at the end to read as follows: Document all inpatient stays and outpatient visits to reflect all services provided to the patient Wanted to add under the requirement to document an admitting diagnosis and must document all diagnoses specific to each inpatient stay and outpatient visit Not adopted but hospitals should still recognize the concern we are not documenting well enough for outpatients

Medical Records NOT Adopted
Proposed to require language that the MR contain documentation of complications, hospital-acquired conditions (HACs), healthcare-associated infections (HAI), and adverse reactions (AE) to drugs and anesthesia Which is already a requirement in the hospital CoPs Making changes to ensure there is documentation for both inpatients and outpatients to reflect all services that were provided to the patient But for medical and legal reasons still need to document information to monitor the patient must be documented in addition to care provided

Medical Records Change would require that the medical record would include documentation of discharge summary and transfer summaries With outcomes of all hospitalization, Disposition of cases and all follow up for inpatient or outpatient CMS wanted to emphasis the importance of the discharge summary and transfer summary (or continuity sheet) Wanted to change the final diagnosis with completion of MR in outpatients to 7 days None of these were finalized in a separate rule but the discharge planning standards were and contains these requirements

Medical Staff: Autopsies

Autopsies Previous tag 364 said that the Medical Staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest The mechanism for documenting permission to perform an autopsy must be defined and there must be a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed Now CMS has removed the requirement the above requirement

Autopsies CMS is deferring to state law regarding such medical-legal requirements Still would need to get consent to do the autopsy An exception is if it is a coroner’s case This does not prohibit hospitals from performing autopsies CMS said removing this section should not be construed as a diminution of their support for hospitals to continue to perform autopsies

4 Swing Bed Changes

Swing Bed Changes There were four changes for swing beds
This includes CAH and any small and rural hospital that has them The swing bed regulations were completely rewritten on October 12, 2018 One change was that Appendix A and W swing bed were only the regulations Hospitals needed to go to Appendix PP, the LTC manual, to find the corresponding sections which had the interpretive guidelines & survey procedure

Swing Bed Changes Dental services Activity Program
Previously said facility must assist residents in obtaining routine and 24-hour emergency dental care Hospitals are addressing emergent dental need under the existing CoPs and hospitals have P&P already Has deleted this section since duplicative CAH tag 404 Activity Program Deleted the section that said the facility provide an ongoing activity program based on the resident's comprehensive assessment and care plan directed by a type of qualified professional specified in the regulation

Swing Bed Changes Activity Program (continued):
Previously said the facility must provide an ongoing program to support the resident in their choice of activities This was based on their comprehensive assessment and care plan Deleted since swing bed patients are not long term residents and only receive services for a short time However, if the hospital has a patient for an extended period of time them expected to do this

Swing Bed Changes Social worker
Previously had a section that said if you had 120 beds or more you had to have a full time social worker This just confused everyone since CAH cannot have more than 25 beds and rural hospitals not more than100 beds So this section has been removed Many wondered why this section was not removed a long time ago

Swing Bed Changes Resident performing services
The CoPs had a section that said that patient had the right to choose or refuse to perform services and can’t require it Document need or desire to work Is it voluntary or paid and if so must have prevailing rate and have in plan of care In a LTC maybe the resident who was a chef made special pastries on Sunday or a resident helped fold towels for physical therapy

Swing Bed Changes Resident performing services (continued)
Doesn’t make sense since shorter LOS so it was REMOVED CAH tag number 361 Hospitals can elect to still do this if they want If they allow residents to perform services then must have a policy and procedure Can never require a patient or resident to do work

CDC Guide to Infection Prevention for Outpatient Settings

CDC Guide Infection Control Outpatients
Didn’t create any new requirements This document reflects existing evidence-based guidelines produced by the CDC However, wants hospitals to look at the CDC two documents on Guide to Prevention for Outpatient Settings Updated periodically and in September 2016 44 pages long CMS can cite hospitals if they are not following the standard of care

CDC Guide Infection Control Outpatients

CDC Outpatient Assessment Tool

Infection Control and Antibiotic Stewardship

Introduction ASP CMS says these changes are consistent with the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) Developed by the interagency Task Force for Combating Antibiotic-Resistant Bacteria in response to th President’s Executive Order 13676 Outlined the steps for implementing this Action plan to improve antibiotic use by prescribing practices across all settings Wants all hospitals to have an antimicrobial stewardship program by 2020

Presidential Document CARB

National Action Plan CARB

National Action Plan CARB
Plan to be followed so we knew it would be end up in the hospital CoPs CDC says 23,000 patients die a year from drug resistant bacteria Causes 2 million illnesses each year It also threatens the health of animals This is a roadmap to guide the nation to prevent antibiotic resistance Money was budgeted for this

Introduction HHS Action Plan on HAI
CMS discusses that there are 722,000 patient infections a year and 75,000 deaths CMS is concerned about the growing threat to patient safety posed by organisms resistant to antibiotic or MDROs HHS published the HHS action plan to prevent HAIs in response and hospital can use this as resource to identify HAIs Says 1 in 20 patients has a HAI HAI cost between $28 to 33 billion per year

National Action Plan to Prevent HAI

Evidenced Based and Best Practices
New requirement to ensure hospitals follow nationally recognized infection prevention and control guidelines and best practices Flexibility for hospitals as opposed to any specific guide for IC and ASP such as SHEA or IDSA guidelines Hospital need to update P&P as guidelines change Note: CMS deleted the log requirement because most hospitals have electronic surveillance and can analyze data from application of medical informatics and computer science technologies

Antibiotic Stewardship Program
CMS wanted to clarify existing provisions CMS updates current practices which includes a requirement for hospitals to have an ASP or antibiotic stewardship program This can help antibiotic prescribing practices It can also help to reduce C-diff infections An individual must be appointed by the board to be the leader of the ASP Must be recommended by the Medical Staff Must be qualified by training and education

Hospitals must have an active hospital-wide program for surveillance, prevention, and control of HAI and other infectious diseases Infection prevention and control problems and antibiotic use issues identified must by: Addressed in the QAPI program The infection preventionist or IP must be qualified through education, training, experience, or certification in infection prevention and control

The Infection Preventionist
Hospital (board) has to appoint the infection preventionist (IP) Would require MS (MEC) and nursing leadership (CNO) to approve or recommend IP If more than one preventionist must work together as a team Certification is not required but good way to show IP is qualified As a CIC from APIC or training and education from APIC, AORN, IDSA, or SHEA

Control Within and Between Hospital
P&P are required and must employ methods to prevent and control infections within the hospital and between the hospital and other settings and institutions such as LTC Adjusting scope of hospital program in a broader sense to include prevent infections between patients, staff, and visitors as well as between other healthcare organizations Patients or residents can carry infection with them between facilities This is why CMS did the draft changes of the infection control worksheet

Control Within and Between Hospital
CMS initially surveyed 40 hospitals and LTC facilities when transferring patients back and forth For example, you don’t want a nursing home resident with MRSA sharing it with other hospital patients You don’t want a patient getting C-diff and sharing it with other LTC residents Noted some IC issues and the CDC came out with some excellent resources This includes for LTC and for hospitals

Excellent Resource IP Training
The CDC excellent resource that is free It is nursing home infection preventionist training Many of the same issues apply to hospitals It has 23 modules Include water management, linen management, TB prevention, infection surveillance, injection safety, infection control plan, point of care testing, hand hygiene, cough etiquette, outbreak management and more Training is free and flexible You can earn CNE

Excellent Resource IP Training

CDC Infection Control Training
The CDC/STRIVE curriculum was developed by Ips by the Health Research & Education Trust These courses can be taken in any order There is no cost Great for new employee training, periodic training, and annual infection control training Includes many such as environmental cleaning, personal protective equipment, competency based audits and feedback, hand hygiene, strategies to prevent HAIs, patient and family engagement etc.

CDC Free Training Modules

CMS Infection Control Pilot

Active Antibiotic Stewardship Program
Training must be in infectious diseases An active ASP must include the following; Coordination with others such as the IP, Medical staff, nursing, pharmacy and the QAPI program Document the evidence based antibiotics in all departments and services Document sustained improvements in proper antibiotic use, reduction in C-diff and antibiotic resistance Must follow evidenced based guidelines and best practices An example would be the CDC core elements of a ASP

Antibiotic Stewardship Program ASP
Changing title of chapter to Infection prevention and control and antibiotic stewardship program Added the word prevention to promote cultural change Added ASP to emphasis the importance Added the paragraph to require that the hospital infection control and ASP be active and hospital wide Would need to do surveillance, prevention and control of HAI and infectious diseases

Infection Control This includes maintaining a clean and sanitary environment No blood on the floor or ceiling ES cleans rooms appropriately after patient is discharged This is to avoid sources and transmission of infection Repeats some of the pre-existing provisions IP responsible for documentation of the IC program

Hospital Acquired-Conditions (HACs)
Adding requirement to clarify hospitals must develop IC program to reflect their scope and complexity If offers surgical surgery have a plan for surgery patients If care for many cancer patients what is in the IC plan or program CMS says hospitals should find it helpful to refer to the list of HACs

CMS Hospital Acquired Conditions

Surveillance and CDC Net
Surveillance is redefined to include infection detection, data collection, analysis, monitoring, and evaluation of preventative interventions Surveillance activities must be documented Must be conducted with recognized standards such as the CDC National Healthcare Safety Network Got to implement interventions to address issues identified in detection Example; discovered 3 patients got a SSI after their TKA or 6 patients in the ICU had diarrhea and diagnosed as Norovirus

Must have a hospital wide ASP The board appoints a qualified person to be in charge of the ASP Must have education in infectious diseases or antibiotic stewardship Most have an infectious disease physician to be the head Must be recommended by both medical staff leadership and pharmacy leadership

Responsibilities of the Leader of the ASP
The development and implementation of a hospital-wide antibiotic stewardship program, Based on nationally recognized guidelines And to monitor and improve the use of antibiotics Responsible to document all the ASP activities Communicate and work with nursing, MS. Pharmacy leadership, QAPI program and IC program Competency based training to staff and MS Include P&P and practical application of the ASP

Must coordinate with those responsible for antibiotic use including MS, nursing, QAPI program, pharmacy services and infection prevention program Document the evidenced-base use of antibiotic in all departments and services Documents any improvements, including sustained improvements, in proper antibiotic use

Leadership Responsibilities in ASP
Board must ensure the following: Systems are in place for the tracking of all infection surveillance, prevention, and control, and antibiotic use activities All HAIs and other infectious diseases identified by the infection prevention and control program as well as antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with hospital QAPI leadership P&P must follow national guidelines

Responsibilities of the IP
Lists a number of responsibilities for the IP so consider placing in their job description IP has a direct role in the competency based training of all staff including MS and LIPs IP must develop and implement the P&P Again must be evidenced based so cite the authority in the reference section Policy need to hospital wide infection surveillance, prevention, and control

Responsibilities of the IP
IP must communicate and collaborate with the QAPI program in all IC issues Note there is a section on QAPI in both the QAPI worksheet and the IC worksheet IP must audit compliance with the IC P&Ps IP must collaborate with the ASP The hospital should be familiar with the CDC core elements of an ASP There are three: outpatient, hospital, and CAH

CDC Toolkit Core Elements

CDC Core Elements of Hospital ASP

CDC Outpatient Core Elements

Core Elements Small and CAHs
CDC, AHA, Office of Rural Health and Pew Charitable Trusts came out with practical strategies to implement ASP This is for small and critical access hospitals Implementation strategies include: Leadership commitment and accountability Pharmacist leader with drug expertise Evidenced based actions Tracking such as days of therapy and use the CDC Net Reporting and education,

ASP CAH & Small Hospitals Core Elements

Check List of Core Elements

System Wide Infection Control and ASP
For the first time, a hospital in a system can have system wide IC and ASP Called unified and integrated IP and control and ASP Board of 2 or more hospitals can elect to do Must make sure is consistent with state law The board is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section

Each hospital in the system must show: It is set up in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital For example, the hospital has a pediatric hospital and a psychiatric hospital in its system Need P&P to make sure each hospital is given due consideration

Each hospital in the system must show (continued): A qualified person with expertise in ASP is communicating with the IC program and implements and maintains the P&P A qualified person must also provide education to staff on the ASP and IC program This person must be designated by the board to do these things

TJC Antibiotic Stewardship Program
Standards effective January 1, 2017 and these are in here for reference only and to help understand what CMS is looking for Added Medication Management standard MM was developed after the White House Forum on Antibiotic Stewardship which occurred June 2, 2015 TJC shows a commitment to slow the emergence of antibiotic resistance bacteria, detect resistant strains, and prevent the spread of resistant infections CDC says 20-50% of all antibiotics in the US are unnecessary

Standard: The hospital has an antimicrobial stewardship program based on evidence-based national guidelines Has 8 elements of performance EP1 Leaders establish antimicrobial stewardship as a priority for the hospital Accountability for leadership can be evidenced by the IC plan, PI plan, strategic plans, budgeting resources, using the EHR to collect data, accountability documents

EP2 Educate staff and LIPs involved in a ordering antibiotics, dispensing, administrating, and monitoring for antimicrobial resistance and antimicrobial stewardship practices Education occurs upon hire or granting of privileges and periodically after that as needed EP3 Educate patients, and their families regarding the appropriate use of antimicrobial medications, including antibiotics, as needed (Deleted 2018) An example of an article you can use is the CDC’s Get Smart document, “Viruses or Bacteria-What’s got you sick?

EP 4 The hospital has an antimicrobial stewardship multidisciplinary team that includes the following: Pharmacist, Infection disease physician, and Infection preventionist, Part-time or consultant staff are acceptable EP 5 The hospital's antimicrobial stewardship program includes the following core elements: Leadership commitment-having dedicated people, and financial and IT resources

Accountability-single leader responsible for outcomes and experience with successful programs show a physician leader is effective Drug expertise-appoint a single pharmacist leader responsible for improving antibiotic use Action-implement recommended action such as systematic review of ongoing treatment need after a certain period like antibiotic time out after 48 hours CDC amends this one in 2019 Tracking-monitor the program which may include information on antibiotic prescribing and resistance patterns

Reporting-regularly report information on the program to MD/DOs, nurses, and staff which may include information on use and resistance patterns Education- educate staff, practitioners, and patients on the program which may include information about resistance and optimal prescribing Mentions the CDC core elements TJC recommends that hospitals use this document when designing their program Choosing wisely also has 24 organizations that have recommendations on prescribing antibiotics

EP 6 The hospital's program uses hospital approved multidisciplinary protocols such as policies Examples of protocols are as follows: Antibiotic Formulary Restriction Plan for Parenteral to Oral Antibiotic Conversion Guidelines for Antimicrobial Use in Adults Guidelines for Antimicrobial Use in Pediatrics Care of the patient with C-diff Preauthorization Requirements for Specific Antimicrobials Use of prophylactic antibiotics

Assessment of Appropriateness of Antibiotics for Community Acquired Pneumonia, skin and soft tissue infection, and UTI EP 7 The hospital collects and analyzes data on its antimicrobial stewardship program, including antimicrobial prescribing and resistance patterns EP 8 The hospital takes action on improvement opportunities identified in its antimicrobial stewardship program

Survey Guide The TJC survey guide discusses how the ASP will be surveyed Will use 6 different tracer sessions to ensure compliance so more complex than originally thought Includes individual patient tracers, competence assessment session, MS session, data management system tracers, MM tracers, and LD During MS may ask about what education has been provided but will not look in MS files for now

TJC Survey ASP During MM will explore 4 related documents-CDC Core elements, protocols/order sets that have been developed, data, and improvement reports During the last day leadership session, will discuss how ABS is a hospital priority During the individual tracer will look to see how education was provided to the ED patients, ambulatory and clinic patients Will include those patients admitted who were prescribed antibiotics

TJC Survey Activity Guide

CDC Has Many Resources

Antimicrobial Stewardship Toolkits

SHEA Toolkit

SHEA IDSA Guidelines for ASP
hwww.ahaphysicianforum.org/resources/appropriate-use/antimicrobial/content%20files%20pdf/Guidelines-Institutional-Program.pdf

ASHP Practice Guidelines

CMS Infection Control Proposed Changes to the Work Sheet Infection Control Interpretive Guidelines

Infection Control Pilot
CMS published proposed changes in the infection control worksheet as a pilot program The infection control worksheet was drafted to be used in long term care (LTC) However, proposed changes were made to the hospital infection control worksheet The plan was to use the draft worksheets and to do 40 hospitals to be paired with the LTC one CMS has provided copies of the draft infection control worksheets

The survey memo is 64 pages long All surveys during the pilot will be educational No citations will be issued These are being conducted by a national contractor and not CMS surveyors 40 hospital surveys were paired with surveys of LTC This is being done to assess infection prevention during the transition of care Reflects what is in the Hospital Improvement Rule

In the first year of the pilot, in 2016, the draft infection control worksheet was developed for LTC The hospital infection control worksheet was also revised In the second year of the pilot project, in 2017, is to assess the continuum of infection prevention efforts between hospitals and nursing homes In 2018 did more surveys of LTC facilities The LTC regulations have been finalized and will be phased in over three years

Draft Hospital Infection Control Worksheet

CAH Infection Control and ASP, Staffing and More

CAH Staffing and C&P CAH stands for Critical Access Hospital
These are generally 25 beds or less although can have a 10 bed rehab or behavioral health unit Located in rural areas and generally 35 miles from the closest hospital unless in mountainous terrain Most of the changes were the same as discussed previously for hospitals with a few additions Emergency preparedness is the same as previously discussed

CAH Staffing and C&P The quality and appropriateness of the diagnosis and treatment provide by the physicians is evaluated by one of the following; One hospital that is a member of the network Quality Improvement Organization (QIO) or equivalent entity Other appropriate and qualified entity identified in the State rural health care plan With telemedicine contract, the distal site hospital can reevaluate their distant site physician

CAH Final Changes The quality and appropriateness of the diagnosis and treatment provide by the midlevel providers are evaluated by the physicians (MD/DO) Such as NP, PS, or CNS Swing bed four changes discussed above Deleted the requirement for CAHs to disclose the names of people with a financial interest in the CAH since already a requirement in the provider agreement Same if CAH is in a system Can have system wide infection control or QAPI

Provision of Services Dietary
Must make sure nutritional needs of patients are being met Must have an order for all diets Must be ordered by the practitioner responsible for the patient’s care Can C&P dietician to order diet if allowed by state law Changed to included swing bed patients Diet includes therapeutic diet, supplemental feedings and TPN and any necessary lab tests

Critical Access Hospital Changes
Board determines full legal responsibility for implementing and monitoring all policies Need a policy and procedure committee Now can update policies every two years instead of an annual basis Need to periodically review clinical privileges and performance Same requirements as discussed above in infection control and the antibiotic stewardship program (ASP)

Infection Prevention & Control and ASP
Must have a program facility wide to prevent and control HAIs To do surveillance Must follow nationally recognized standards Must follow best practices for improving antibiotic use Any issues must be addressed in QAPI program IP must be qualified

Infection Prevention & Control and ASP
IP appointed by board and approved by MS and nursing leadership P&P to controlling infections within the CAH and between the CAH and other healthcare settings IP addresses any issue identified by public health Must maintain a clean and sanitary environment Same requirements as previously discussed for the antibiotic stewardship program So not repeated again

QAPI Program This was discussed previously so will not be repeated
CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven QAPI program Has a definition of medical error and ADE Program has to be appropriate for the size and what the CAH does Must involve all departments Must use objective measures to evaluate services Board is responsible for QAPI program

QAPI Program Address priorities to improve care and patient safety
Communicate clear expectations for safety Evaluate all improvement actions and go back to the drawing board if not working Determine the number of distinct projects Implement P&P on what staff should do to prevent and report unsafe patient care practices, medical errors, and adverse events Lists program activities such as measures to track and analyze

QAPI Program Look at high-volume, high-risk services, or problem-prone areas Document QAPI projects Use data to monitor the effectiveness and safety of services provided and quality of care Identify opportunities for improvement Basically, CMS is adopting the similar QAPI standards found in Appendix A which is the manual for larger hospitals

The End! Questions? Sue Dill Calloway RN, Esq. CPHRM, CCMSCP, CCMSP
AD, BA, BSN, MSN, JD President of Patient Safety and Education 5447 Fawnbrook Lane Dublin, Ohio 43017 (Call with questions, No s) 202 202

Nothing in the Final Rules
In the proposed rules, CMS talked about the difference between a patient release and an authorization form Many hospitals were not in compliance with the OCR rules on this They reminded hospitals to the OCR changes They discussed the importance of making sure patients had access to their records OCR is now fining hospitals if this does not occur and first hospital fined $85,000 Nothing in the final rules for hospitals so this is provided as a resource but it was included in the discharge planning final rules

Patient Access to Medical Records

Current provisions in the hospital CoPs did not take into account that medical records may be maintained electronically Or that the patient had the right to get them electronically Note the federal HIPAA law, which is enforced by the Office of Civil Rights (OCR) does do this already CMS said the patient should be able to access medical records in an electronic format when records are maintained this way Can’t frustrate patient efforts to get their records

CMS is therefore clarifying the following: The patient has the right to access their medical records, including current medical records, upon an oral or written request, in the form and format requested by the individual (paper or electronic) Must be within a reasonable time 30 days or if stored off site then 60 days If the patient does get not their records in this timeframe he can file a complaint with OCR At

Can File a Complaint with OCR

OCR Rights of Individual Patients
CMS mentions that OCR has a document on patient rights under HIPAA to access their health information so make sure staff are aware So this is also already a current law and many hospitals are not aware of it Patients have a right of access to their information Includes right to inspect medical records Can allow to make requests or fax Would need to verify the identity of the patient Can not require a person to come in person to request records Can’t require patient to mail you the authorization

HIPAA Resources www.hhs.gov/hipaa

OCR Resources

OCR Rights of Individual Patients
Patient can request a paper or electronic copy Must send to patient within 30 days of request A 30 day extension is available if archived offsite and not readily accessible Can charge for records but no retrieval fee Discusses the reasons when a hospital may deny the request Can request copies of x-rays Can’t refuse to give copies because hospital bill not paid

www. hhs. gov/hipaa/for-professionals/privacy/guidance/access/index

Second FAQ Feb 2016

New Clarification in 2017 on Costs

AHIMA Model Release Form

https://engage. ahima. org/HigherLogic/System/DownloadDocumentFile

HIPAA Access versus Authorization
Based on the OIG Access Guidance to clarify a misunderstanding on the patient’s right to access Access request- the hospital may require a written, signed request by the patient under the access rule It must identify the designated person and where to send the PHI HHS says you cannot require them to sign an authorization form when the access rule applies The fee limitation applies Time frame applies such as 30 days with exception Disclosures under the access rule are mandatory

Access request- Key message in guidance is that if a patient directs a hospital or entity to send their records to another person or entity an authorization is not required In fact, requiring the patient to sign an authorization when the patient directs the records to sent to a third party could run afoul of HIPAA All that is required is that the request be in writing, signed by the patient, and clearly identify who and where to send the records Other elements, such as purpose, etc. is not required for a valid access request. Don’t want unnecessary obstacles.

OCR Access Guidance

Authorization- can reject a request without an authorization but be careful when sending form letters to patients denying requests if there is a valid access request Disclosures under the authorization rule are not subject to the fee restrictions Are not subject to the response timeframe of the access rule Want a HIPAA compliant authorization form for this as opposed to a patient access request form

Not always easy to tell if the request from the patient falls under the access right or a request by a third party based on an authorization If unclear you can clarify with the patient if request was a direction or a request from a third party If patient requests copy then can charge for labor to copy, supplies such as paper or flash drive, and postage and no retrieval fee Can do actual cost, average costs, or flat fee for EHR

Confidentiality of Alcohol and Drug Records
Effective March 21, 2017 and February 3, 2018 Needed to update and modernize law since last change was 1987 To assist with electronic sharing of substance abuse disorder information especially with new modes of integrated care Wanted to make the law more understandable Written summary can be given electronically Will have to update signed consent forms Holders of PHI need security P&P

Final Rule Substance Use Disorder Pt Record

Final Law PDF Version 76 Pages

Payment and Healthcare Operations (HCO)
Final Rule February 3, 2018 New rules maintain the core protections in the 2017 rule The 2018 rule expands the way the protected health records (PHI) on substance use disorder patients can be shared Payment and Healthcare Operations (HCO) When the patient consents in writing to the information to be disclosed for payment and healthcare operations then the recipient listed in the consent form can then share the information with their contractors, sub-contractors and legal representatives (not for treatment or diagnosis)

CMS Final Changes The Hospital Improvement Rule

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CMS Final Changes The Hospital Improvement Rule

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