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CMS Infection Prevention and Control Regulations Update

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1 CMS Infection Prevention and Control Regulations Update
Intermountain APIC Karen Hoffmann RN MS CIC FSHEA FAPIC University of North Carolina School of Medicine-Chapel Hill

2 Consultant American Hospital Association (AHA)
Disclosures Contractor, Centers for Medicare and Medicaid (CMS) Quality, Safety and Oversight Group (QSOG) (formerly Survey and Certification Group (S&C) Consultant American Hospital Association (AHA)

3 The views and opinions expressed in this lecture are those of this speaker and do not reflect the official policy or position of any agency of the U.S. government. Disclaimer Important…

4 will take it to our editorial team for consideration and get back to her on their thoughts.
OBJECTIVES CMS and State Agency Structure and Accrediting organization(AOs) Describe Most common CMS/JC Hospital/ASC Infection Control Program (ICP) Citations List CMS IPC FAQs submitted to CMS Explain

5 Objective One Describe CMS and State Agency structure and Accrediting organization(AOs) relationship

6 CMS Survey and Certification Group (SCG) Structure
Federal CMS Headquarters -----Accrediting Orgs. 10 Regional Offices State Agencies

7 Organization of SCG Division of Acute Care Services (DACS)
Acute Care Hospitals, LTACs, CAHs, ASCs, Rehab, and Psychiatric Division of Nursing Homes (DNH) Nursing Homes Division of Continuing Care Providers (DCCP) Home Health and Hospice, ESRD, Psychiatric Residential Treatment Facilities Clinical Laboratory Improvement Amendments (CLIA) Important because each of these provider types

8 Where to Submit an Inquiry to CMS?
Division of Acute Care Services (DACS) Division of Nursing Homes (DNHs) ESRD Survey & Certification Group Find resources for compliance with the ESRD Conditions for Coverage here:   SCG General Information

9 CMS Conditions of Participation (CoPs) and Conditions for Coverage (CfCs)
CoPs - (Hospitals, CAHs, ASCs) CfCs - (ESRD, LTC/NH, ASCs) Minimum health and safety standards that providers and suppliers must meet in order to be Medicare and Medicaid certified and receive reimbursement. The Interpretive Guidelines (IGs)provide instructions to the surveyors on how to survey the CoP and CFC. cms.gov Health care organizations must meet Minimum health and safety standards in order to begin and continue participating in the Medicare and Medicaid programs.  CoPs and CfCs are Unique to each provider type. The Interpretive Guidelines (IGs)provide instructions to the surveyors on how to survey the CoP. “Should versus must is key

10 State Agency’s Role in Healthcare Patient Safety
Conducts inspections to certify for Medicare and Medicaid certified healthcare facilities compliance with minimal health & safety standards safeguards. - Investigates complaints made by individuals. - Validation surveys of Hospital AOs. The SAs are funded by CMS to carry out the survey process and ensure access to safe healthcare. The SAs are charged with evaluating compliance with minimal health and safety standards. This is different from the AO in that the AOs must ensure compliance with the CoP and CFC but may exceed the requirements for passing their surveys .

11 Surveyor Training on IPC
Training in professional discipline and work experience CMS Universal IPC Course CMS ASC IPC Course CMS Basic and Advanced Hospital Training CMS Basic Surveyor Training for Skilled/Nursing Facilities CDC Infection Control Webinars

12 Teamwork: Collaboration & Alignment
CDC - Interagency agreements (IA), surveyor and provider training, policy) FDA – Hand hygiene products AAMI – Standards for reprocessing medical devices APIC, SHEA, AORN, AMDA (stakeholders) - input and feedback) State Agencies (SAs) and Regional Offices (ROs) Accrediting Organizations (AOs) – Memorandum of Agreement CMS Teamwork with federal agencies and associations are frequent and ongoing and can happen in several ways. The CDC has funded a number of IA for supporting IC activities and assisted with the development of the ICWs surveyor training and policy formations Questions that come from surveyors, associations, or providers that need clarification. CMS has attended AAMI summits and often consults with their SME on issues or questions. It is understood the value of working with the IC associations to get feedback and that input often changes policy/ The closest group CMS and SCG works with is the SA and RO staff with a continuous line of communication And at high levels work with the AO through a MOA.

13 Accreditation organizations (AOs)
AOs (e.g. TJC,) are approved by CMS for enforcing standards that meet the CMS CoPs/CfCs. CMS grants AO "deeming" authority as meeting the CMS certification CMS conducts random validation surveys and complaint investigations of HCO with deemed status. AOs must provide CMS with a listing of documentation for HCO receiving conditional accreditation, preliminary, and non-accreditation. AOs provide CMS with accreditation decision reports for HCO involved in CMS validation surveys and any other survey report CMS requests. For 60 days after an AO survey, you are at risk for a full CMS validation survey? Let’s tall a little more about that between the AO and CMS. AOs can require more but must enforce the minimum COPs AOs (e.g. TJC,) are approved by CMS for enforcing standards that meet the CMS CoPs/CfCs. CMS grants AO "deeming" authority and "deem" each accredited HCO as meeting the CMS certification requirements…Result HCO not subject to routine Medicare survey and certification process. However, CMS still conducts random validation surveys and complaint investigations of HCO with deemed status. In addition, the AOs are obliged to provide CMS with a listing of documentation for HCO receiving conditional accreditation, preliminary , and non-accreditation. The AO also provide CMS with accreditation decision reports for HCO involved in CMS validation surveys and any other survey report CMS requests.

14 Posting AO Performance Data
CMS will post new information on the CMS.Gov website, including: Latest quality of care deficiency findings following complaint surveys at facilities accredited by AOs, list of providers determined by CMS to be currently out of compliance that also references the provider’s AO, and Overall performance data for the AOs themselves. certification/surveycertificationgeninfo/policy-and-memos-to- states-and-regions.html Memo released on August 20th for additional Reporting initiatives released…To increase transparency for consumers The list will include only hospitals at this time, however CMS hopes to be able to have the same publically available information for other providers and suppliers at a future time. Please see

15 QCOR National Deficiency Citations October 1, 2018 to May 2019
Provider Type Regulatory Tag Citation Rank Percent of Facilities Cited SNF/NF F Infection Prevention and Control 1 9.4% Hospitals A 0749 – Infection Control Program/Officer A0747 – Infection Control Condition of Participation 4 23 3.4% 1% CAHs C0278 – Infection Control 26.7% ASCs Q 0424 – Infection Control Program 3 15.9% ESRD V0113 – Gloves/Hand Hygiene V0122 – Clean, Disinfect V0147 – Staff Ed. Cath Care V0143 – Aseptic Technique V0115 – Gowns, Shields 2 7 9 10 17.8% 15.2% 9.7% 7.8% 6.9% Infection prevention and control continues to be a leading deficient practice identified in many health care entities

16 42CFR 482.42 CoP: Infection Control
The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. (a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases. (1) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. (b) Standard: Responsibilities of chief executive officer, medical staff, and director of nursing services. The chief executive officer, the medical staff, and the director of nursing services must (1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and (2)Be responsible for the implementation of successful corrective action plans in affected problem areas. CMS.gov

17 CMS Hospital IPC CoPs Infection Control Condition:
Sanitary environment to avoid sources and transmission of infections and communicable diseases Active program for prevention, control, and investigation of infections and communicable diseases

18 Standard: Organization & Policies 42CFR 482.42(a)
Person/persons must be designated as the infection control officer (IP). Delegation of authority in writing by leadership. Must have documentation of qualifications. Must develop and implement policies related to control of infections and communicable diseases. ICO (IP) must develop a system for identifying, reporting, investigating and controlling infections and communicable diseases- for patients, HCP, and visitors.

19 Infection Control Worksheet for Hospitals
Ultimate goal: a tool that promotes HAI prevention and patient safety in hospitals Consistency in survey process Address minimum health and safety standards for hospitals to meet the CMS CoP for Infection Control Tool is freely accessible on-line for hospitals Best practices self-assessment Proactive self-assessment in advance of a survey

20

21 Infection Prevention & Control Skilled/Nursing Facilities
The Overall Infection Prevention & Control Program (IPCP): A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases Based upon the facility assessment Follows accepted national standards

22 Infection Prevention & Control Skilled/Nursing Facilities
Written standards, policies, and procedures for the program must include: A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; When and to whom possible incidents of communicable disease or infections should be reported; Standard and transmission-based precautions to be followed to prevent spread of infections; When and how isolation should be used for a resident;

23 Infection Prevention & Control Skilled/Nursing Facilities
The Overall Infection Prevention & Control Program (IPCP): Include a system for recording incidents and the corrective actions taken by the facility Reviewed annually Update as necessary (New) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.

24 CMS Response: S&C Legionella Memo https://www. cms
CMS Response S&C Legionella memo released on June 2, 2017 with clarification on June 9th regarding provider types affected. - hospitals, - critical access hospitals (CAHS) - long term care (LTC) Facilities must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduces the risk of growth and spread of Legionella and OPPP.

25 Legionella S&C Memo Release
CDC Legionella Water Management Program Toolkit - Recognized problem with Legionella S&C rule to codify ASHRE-188 for acute and long-term care facilities on June 2, 2017. - Implement a WMP - Conduct a risk assessment - Specify testing protocols Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter pdf New CDC Vital Signs on HAI Legionella Disease cases released on June 6, 2017

26 CMS MLN Learning Network
New CMS Legionella Requirement for Hospitals, Critical Access Hospitals, and Nursing Homes Learn to control the growth and spread of Legionella and other waterborne pathogens; review information from the Centers for Disease Control and Prevention and the new surveyor Legionella training webinar. Act now to protect your patients and be in compliance with new CMS requirements. For More Information: Water management fact sheet Legionella fact sheet Frequently Asked Questions From Plumbing to Patients webpage Surveyor training video Partnership- -Archive-Items/ eNews.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending#_Toc

27 CMS Legionella Compliance
Conduct a facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g. Pseudomonas, Acinetobacter, Burkholderia, Stenotrophomonas, nontuberculous mycobacteria, and fungi) could grow and spread in the facility water system.  Implement a water management program that considers the ASHRAE industry standard and the CDC toolkit, and includes control measures such as physical controls, temperature management, disinfectant level control, visual inspections, and environmental testing for pathogens. Specify testing protocols and acceptable ranges for control measures, and document the results of testing and corrective actions taken when control limits are not maintained.

28 Objective Two. Most Common CMS and JC
Objective Two Most Common CMS and JC Hospital/ASC Infection Control IPC Citations

29 Most Frequent Hospital and Nursing Home Citation HH and Glove Use
Failure to clean hands before and after removing gloves Moving from patient to patient without cleaning hands and changing gloves Using ABHR on gloves rather than changing the gloves Thinking double gloving protects against puncture injury. Not having gloves accessible in locations where they are needed/used. OF course HH is a frequent area for citations For reasons of Failure to clean hands after removing gloves Moving from patient to patient without cleaning hands and changing gloves Using ABHR on gloves rather than changing the gloves Thinking double gloving protects against puncture injury. Not having gloves accessible in locations where they are needed/used.

30 Top 5 IC CMS Survey Citations
Failing to ensure designated “Infection Control Officer” was qualified through experience, ongoing education, and/or training to implement an effective ICP. ICP failed to identify, prevent, and control infection control issues and/or breaches by failing to implement an effective infection control risk assessment. 2018 Infection Control Consulting Services (ICCS)

31 Top 5 IC CMS Survey Citations
3. Hospital/ASC that chose to follow the AORN Guidelines for Perioperative Practice Failing to identify semi-restricted and restricted areas Personal undergarments extending beyond scrubs Keeping mask tied tightly Personnel cover head/facial hair, including sideburns and nape of the neck in semi and restricted areas Clean head cover that confines all hair. 2018 Infection Control Consulting Services

32 Top 5 IC CMS Survey Citations
4. Central processing failures: Inappropriate packaging of instruments, particularly peel pouches (more than one instrument when the instrument should be sterilized alone) Hinged instruments not opened wide enough Clean supplies stored in same room as sterile supplies Inadequate monitoring of the environment in the central processing department 2018 Infection Control Consulting Services

33 Top 5 IC CMS Survey Citations
5. Failure to adhere to standards for reprocessing of endoscopes Transport of endoscopes from the procedure room to the reprocessing area Monitoring of temperature and humidity in decontamination room Manual HLD practices via soaking (e.g. temperature of the soak solution) Use of personal protective equipment by employees in the decontamination room 2018 Infection Control Consulting Services

34 IC Top JC Citation The hospital reduces the risk of infections associated with medical equipment, devices and supplies — 72% In 2017, Only one standard cited more was The hospital provides and maintains systems for extinguishing fires — 86 percent

35 Most Cited JC IC Standards
IC  — The organization implements its infection prevention and control plan. Questions to help guide development of the plan include: What are the infection risks at the organization? What types of infection does the organization see most often? How do we communicate responsibilities for preventing and controlling infections to staff? Patients/residents? Visitors? What processes are in place for reducing infection risks with medical equipment, devices and supplies? Focus efforts on the infections identified by your surveillance, the infection risks in your community, and the care, treatment and services provided in your organization.

36 Most Cited JC IC Standards
IC facilities protect patients from infections caused by inadequately processed equipment. insufficient training in sterilization and HLD equipment. Lack of leadership oversight Recommended protocols are undermined by “shortcuts” No designated staff member assigned to sterilization and HLD Facility design or space issues prevent proper sterilization or HLD of equipment Joint Commission. Improperly sterilized or HLD equipment – a growing problem. Quick Safety 2018;33:  .

37 JC survey on Sterilization/HLD
How often do you assess for staff competency? How are managers/supervisors deemed competent? Where are documented competences kept? Show me the instructions for use of the sterilizer, the endoscope, or HLD. Show me the evidence-based guidelines for HLD and/or sterilization. Show me the documentation logs for HLD and/or sterilization. Are they complete? Are there gaps? Is there enough storage provided to store endoscopes? Are there enough surgical instruments to minimize the use of IUSS? Joint Commission. Improperly sterilized or HLD equipment – a growing problem. Quick Safety 2017;33: 

38 Objective 3 Questions submitted to the CMS

39 Hospital FAQ: Are skull caps CMS acceptable?
s: .  This includes adherence to nationally accepted standards of practice from expert organizations in infection prevention and control such as, but not limited to, the Centers for Disease Prevention and Control (CDC), the Association of peri-Operative Registered Nurses (AORN), and the Occupational Safety and Health Administration (OSHA).  Each of these organizations contain guidelines and recommendations related to surgical attire, including the covering of hair.  CMS does not support the American College of Surgeons statement on wearing skull caps in the OR as it is not a nationally accepted evidence based standard of practice.  The AORN standards regarding hair coverings are nationally recognized evidence based guidelines that also coincide with recommendations from the CDC, the World Health Organization (WHO) as well as the Association of Surgical Technologists (AST).

40 Regulations, Standards and Guidelines: Are Skull caps CMS acceptable?
Survey Procedures § That operating room attire is suitable for the kind of surgical case performed, that persons working in the operating suite must wear only clean surgical attire, that surgical attire is designed for maximum skin and hair coverage; The following agencies/organizations have adopted the requirement of full head covering for surgical personnel:        CDC - HICPAC Surgical Site Prevention guidelines (1999)(2018) OSHA – Prevention of Bloodborne Pathogens Final Rule WHO – Guidelines for Safe Surgery (2009) AST (Association of Surgical Technologists) – Standards of Practice (2007) AORN – 2019 Guidelines for Perioperative Practice

41 Can Radiology Use Power Injectors for Single Dose Vials?
All contrast agents are labeled SDV. CDC language would not allow for reuse of SDVs

42 Radiology and Power Injectors
FDA never approved reuse of bulk pharmaceuticals. Bulk packaging is not equivalent to a multi-dose vial FDA did approve manufacturer to fractionate using power injector. Alternative practice, can work with pharmacy to allow fractionating in ISO hood

43 Are cardboard boxes Ok for storage in kitchen areas?

44 Cardboard Boxes In Healthcare?
The problems with cardboard Collects moisture on floor and under the sink. Multi-layers with channels for vermin, insects, and pest Contamination on transport Can’t be washed or cleaned Mature Indian Wheat moth larvae pupating in corrugated cardboard

45 Cardboard Storage in the Kitchen
§482.41   Condition of participation: Physical environment. The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. (a) Standard: Buildings. The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well- being of patients are assured. These requirements are not limited to patient care areas and are also applicable in the kitchen and food storage areas, and any other hospital location that directly or indirectly impacts care provided to patients.    

46 Cardboard Storage Guidelines
Food Codes – None NFPA Standards - None AORN and AAMI ST: Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.

47 Cardboard Storage Guidelines
CDC – No guidance or recommendations. JC - Infection Prevention and Control: conduct a risk assessment per standard IC  to determine the appropriateness of having the container type used in a particular area. This could include where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. - policy, staff trained, and process implemented APIC - “Key principles of food storage: Remove all corrugated cardboard as soon as possible, because these boxes may deteriorate or damage the product, the product may leak, or water damage may be present; any moisture rots the boxes, and these conditions allow for pest infestations and possible damage to the product.”

48 Cardboard Storage in the Kitchen
CMS expects hospitals and nursing homes to follow State law, nationally accepted standards of practice, and if deemed for participation in Medicare the AOs. CMS Foodservice/ storage areas should only be cited if causing contamination in the kitchen or a part of unsanitary conditions

49 USEFUL CMS WEBSITES -Letters are organized by Federal fiscal years
SURVEY AND CERTIFICATION LETTERS -Letters are organized by Federal fiscal years Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and- Regions.html INTERPRETIVE GUIDELINES - Located in the Appendices to the State Operations Manual (SOM) ELECTRONIC CFR (e-CFR) - Electronic version of the Code of Federal Regulations (CFR).  The CFR is divided into “Titles”, with “Title 42 Public Health”, containing CMS regulations. 

50 My Why!

51 Hospital IC IUSS Breaches Immediately implemented mitigation strategy
Memo/letter to the Dept. of Surgery from leadership regarding premature release of implants through IUSS, specifying evidence-based indications for IUSS to include immediate discontinuation of premature release of implants. Face-to-face meeting with surgeons/medical staff on gravity of the premature release of implants through IUSS. Revised IUSS policy and procedure. Departmental huddles to include IUSS discussion. Focused surveillance of IUSS to include a detailed breakdown of frequency and indications of IUSS. CSP has discontinued all IUSS of implants. Increased instrument levels to minimize need for IUSS.

52 Hospital IC IUSS Breaches
Infection control breaches identified: 1. Premature release of implants through IUSS: One year look-back of records reviewed identified 18 patients who had IUSS of implants. There were 15 instances of premature release, prior to the biological indicator (BI) being read/finalized.  2. Nine of 15 premature release occurrences had a documented physician premature release form, leaving 6 without a physician release form. IUSS as indicated for emergent circumstances was not followed per organization policy. a. Lack of adherence to sterilization evidence based guidelines specific to IUSS. b. Lack of adherence to biological indicator (BI) manufacturer instructions for use. c. Lack of leadership oversight and accountability regarding evidenced-based IUSS indications and practices.

53 Hospital IC Endoscopy Breaches
HLD of one type of ENT scope was not performed between patient use as required by the MIFU.  Second type of ENT scope had unclear cleaning instructions that the organization had not clarified with the manufacturer to determine if the cleaning step was in fact being conducted appropriately. No evidence of monthly sterilizer maintenance as required by MIFU in the dental clinic. Lack of daily monitoring of reverse osmosis system feeding the sterile processing department.

54 Immediately Implemented Mitigation Strategy
Scopes will remain out of use, until staff education is completed Leadership change will occur immediately – interim leadership to be appointed today RCA and risk assessment will drive further mitigation processes Will speak with leadership for evidenced based guidelines and guidance IP’s to check patients to see what patients were affected Sterilizer – will have dedicated staff, risk assessment for all clinic sites, and team will ensure that quality checks per manufacturer will be completed – providing standardization for all clinic. Osmosis system is being cleaned immediately, log sheet to be audited by leadership.

55 ASC HLD/Sterilization Breaches
Reason for ITL:  Infection Control breaches identified in the high-level disinfection(HLD) process Sterilization of instruments Improper packaging of instruments for steam sterilization Not following adopted guidelines AAMI st79 Not following TASS guidelines for cleaning of eye Not following guidelines for disposing of sponges and syringes after each use Laryngeal Mask Airways (LMA’s) are reprocessed without specified manufacturer’s instructions immediate threat to life (ITL) 

56 ASC IC Breaches in Endoscopy
Endoscopes not wiped down at the Point of use Flushing scopes with effluent into solution used for pre-cleaning Not following instructions for use when performing leak testing Single use brushes reused No process for hang time of Endoscopes for reprocessing Enzymatic cleaner amount is estimated not measured Not following Instructions for Use when flushing endoscopes. Scopes not dried or stored properly Rapicide stored in the bottom of Scope cabinets Cabinets not vented per Instructions For Use

57 ASC IC Breaches in Endoscopy
Competency and training Lack of ongoing training for the Lead Endoscopy techs Competency for endoscopy was not comprehensive or validated Individual signing off on competencies had no training Current evidenced-based guidelines are not incorporated into competency and training No documentation of ongoing education and training related to IC, sterilization, HLD, TASS guidelines, & SSI

58 Shared Metered Dose Inhalers (MDIs) Among Multiple Patients
§482.23(c) Standard: Preparation and Administration of Drugs. Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. §482.42   Condition of participation: Infection control. The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. Question: Can common cannisters be shared among multiple patients?

59 Shared Metered Dose Inhalers (MDIs) Among Multiple Patients
CDC- No Guideline recommendation Institute for Safe Medication Practices (ISMP) commented on shared canister use in 2009, but did not offer definitive recommendations, suggesting only careful protocol development and stringent adherence to decontamination. Institute for Safe Medication practices. letters/acute care/articles/ APIC emphasized the importance of HH and disinfection to reduce sources of contact transmission when employing shared canisters and has addressed the dilemma of wasted medication due to partially used MDIs. APIC. Practice Guidelines Committee Report. June ports/June_2013/PGC_Board_Report_-_June_2013.pdf

60 Shared Metered Dose Inhalers (MDIs) Among Multiple Patients
10 studies - CC program safe if multidisciplinary- developed protocol was precisely followed at all times. (Neel et al. No outbreaks reported from the MDI-CC protocol. CMS says: ???

61 Shared Metered Dose Inhalers (MDIs) Among Multiple Patients
10 studies - CC program safe if multidisciplinary- developed protocol was precisely followed at all times. (Neel et al. No outbreaks reported from the MDI-CC protocol. CMS says: ??? Facilities must have policy that describes a protocol for HH and cannister disinfection to reduce sources of contact transmission.

62 Improper cleaning and disinfection of endoscopy equipment; and,
Improper cleaning and sterilization of surgical instruments

63 Some Closing Thoughts…
New hospital/CAH regulations on IPC pending and new revised IPPS quality measures revised. CMS and JC identifying IC breaches especially for HLD and sterilization. When you have an IC practice question consider sending to CMS for response. Division of Acute Care Services (DACS) and regulatory


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