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February 26, 2021 9 Min Read

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A look at last year's non-pandemic regulatory changes and where 2021 is headed

In the past year, hospitals faced considerable challenges keeping up with regulatory changes outside of immediate priorities posed by the coronavirus. Yet, as organizations move well into 2021, it’s critical to pause and understand regulatory changes that will undoubtedly impact compliance requirements. The year’s close saw key revisions to the CMS Conditions of Participation (CoPs) along with significant changes from The Joint Commission (TJC) hospital standards. Additional regulatory modifications took effect in January. A summary of these changes provides a quick reference to guide organizations for optimum preparedness and sustainable compliance.

Significant Revisions to the Medicare Conditions of Participation

  • Restraint requirements were revised to enable hospital policy flexibility.
  • The annual review of Emergency Preparedness changed to every two years with an expanded definition of the exercises/drills that may be accepted. TJC Emergency Management (EM) requirements were also revised to align with the new CMS timeframe.
  • Quality Assessment and Performance Improvement (QAPI) language was updated.
  • The rule that “the medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and education interest” was removed, deferring instead to state law.
  • CMS now allows medical staff to preclude certain patients/procedures from the requirement for a pre-procedural history and physical examination and update in ambulatory environments. To align with these CMS regulations, TJC revised two provisions related to presurgical risk assessments.
  • Nursing standard changes clarified CNO’s responsibilities.
  • The Infection Control CoP was re-titled Infection Prevention and Control and Antibiotic Stewardship Programs and now incorporates antibiotic stewardship program requirements. TJC added and revised the Medication Management (MM) requirements related to antimicrobial stewardship programs.
  • The Discharge Planning CoP was replaced entirely.
  • Regulations for psychiatric hospitals were moved, and the type of practitioners who may write progress notes was expanded.
  • Ambulatory Surgical Centers no longer need a transfer agreement with a hospital.
  • Transplant center language was updated, and outcome requirements were removed.
  • Swing bed requirements were changed.

Changes in Joint Commission Requirements and Processes

TJC issued several requirement changes to the hospital standards. These include changes to documentation requirements for rapidly titrated medications, including block charting guidelines and titration medication parameters in critical care/procedural settings. Clarification was provided on the minimum components of a medication order and requirements for processes related to similarly acting agents. No new National Patient Safety Goals were issued. However, there were minor editorial revisions, and some requirements moved to the standards.

In the behavioral health area, several changes were made that warrant a thorough review of current policies. Critical Access Hospitals must now comply with requirements to reduce the risk of suicide, and requirements for behavioral health care and human services organizations were added and revised. Over 90 requirements related to child welfare services were added to the accreditation program manual, which was renamed the Comprehensive Accreditation Manual for Behavioral Health Care and Human Services.

The Life Safety Code (LSC) surveyor duties for on-site surveys at hospitals were expanded to include the physical environment and all off-site emergency department and hospital-based ambulatory surgery locations. For all other off-site locations, clinical surveyors will continue to evaluate the physical environment and LSC requirements, with an enhanced focus on LSC’s business occupancy requirements.

New standards effective January 2021

New perinatal safety standards were put in place to reduce the harm related to maternal hemorrhage in perinatal care and maternal severe hypertension/preeclampsia in hospitals. It is important to note that if a hospital does not provide obstetrical services but can receive patients who may be pregnant in the Emergency Department, organizations are now responsible for meeting elements of both maternal hypertension and hemorrhage requirements.

  • Revision of the Sentinel Events (SE) chapter to help staff understand if a fall should be reviewed as a sentinel event for all programs
  • Guidelines changed annual influenza vaccination goals
  • Standards for fluoroscopy services were also revised

Open the PDF for detailed information on each of these revisions, along with updates on significant changes occurring throughout 2021.

About Our Authors

Lisa Eddy
Lisa Eddy, MSN, MHA, RN, CPHQ

Vice President - Clinical Compliance & High Reliability Practice

Lisa has more than 25 years of experience in CMS certification and accrediting agency regulatory compliance. First-hand knowledge at the executive nursing level, hospital operations, quality and risk management and critical care nursing, are all embedded in the guidance she provides to organizations to help them achieve and maintain regulatory approval.

Bud Pate
Bud Pate, REHS

Director of Content Learning – Clinical Compliance & High Reliability Practice

With more than four decades of experience, Bud Pate is a nationally recognized expert in CMS and Joint Commission compliance, process simplification, clinical quality, and patient safety. He works with healthcare organizations across the country to achieve sustainable, common sense solutions that promote efficiency, protect patients and comply with external regulatory requirements.

Ann Smedley
Ann Smedley, BSN, RN-BC

Consultant - Clinical Compliance & High Reliability Practice

Ann brings over 20 years of mental health, psychiatric nursing and nursing leadership to help behavioral health units and facilities manage psychiatric improvement projects. Her experience in geriatric, adult, adolescent and child psychiatric nursing and operational patient care services facilitates successful accrediting agency and CMS regulatory compliance.

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