Joint Commission Deletes 94 More Hospital Requirements on Restraint and Seclusion

The Joint Commission, as part of the first phase of Project REFRESH, has announced the deletion of 94 duplicative restraint and seclusion requirements under its Hospital Accreditation Program (HAP).

The accrediting organization previously announced the deletion of 131 hospital requirements as a component of the Project REFRESH initiative to streamline standards and elements of performance (EPs). Project REFRESH is a series of interrelated process improvement projects currently underway at The Joint Commission.

The deleted restraint and seclusion standards, under the Provision of Care, Treatment, and Services (PC) chapter, were only applicable to

Joint Commission Revises Plan of Care Requirements

The Joint Commission has released a Revision to Deemed Program Requirements for Psychiatric Hospitals for Plan of Care, Treatment, and Services (PC) standard PC.01.03.01 – The hospital plans the patient’s care.

The revision is intended to more clearly address the Centers for Medicare & Medicaid Services (CMS) Condition of Participation (CoP) for psychiatric hospitals related to the inclusion of treatment modalities in patient treatment plans (§482.61(c)(1)(iii)).

The update adds a new

CMS Releases Comprehensive Update to Organ Transplant Requirements, SOM Appendix X

The Centers for Medicare & Medicaid Services (CMS) has released an advanced copy of a comprehensive update to its Organ Transplant Interpretive Guidelines for Conditions of Participation (CoPs) at 42 CFR §§ 482.68 through 482.104. CMS Survey & Certification Memorandum S&C: 16-10-Transplant, published on March 11, 2016, updates the Organ Transplant Interpretive Guidelines to incorporate previously-published changes, clarifies certain areas, and addresses feedback received based on previously-released drafts. CMS indicates that the updated Interpretive Guidelines will be published in a new Appendix X of the State Operations Manual (SOM).

These updated Interpretive Guidelines supersede all previous versions, including the version released in CMS Survey & Certification Memorandum S&C-08-25 on June 13, 2008. In S&C-08-25, CMS also identified the Interpretive Guidelines would be formalized in a new Appendix X of the SOM, though almost nine years later no formal Appendix has been published. Regardless, the Interpretive Guidelines in the S&C Memorandum are considered official interpretations for the Organ Transplant Program CoPs.

The Interpretive Guidelines have additions, substantial clarifications and deletions in several areas, including but not limited to the following:

HFAP Revises Pharmacy and Nursing Standards for Hospitals

In response to recent regulatory changes established by the Centers for Medicare & Medicaid Services (CMS), the Healthcare Facilities Accreditation Program (HFAP) has revised 11 standards in its Acute Care Hospital manual. The revisions address the new and revised CMS interpretive guidelines for Pharmacy Services, and one requirement that impacts Nursing Services.

The HFAP is providing these ‘pre-publication’ requirements to allow HFAP accredited facilities the time necessary to begin implementation strategies while the standards undergo the final approval process. Information that is new or revised is provided in BOLD print.

HFAP anticipates its new requirements will be finalized in April or May 2016. Upon final approval, an electronic message will be sent to clients to announce the effective date of the changes.

Summary of Revisions:

Standard 25.00.00 Condition of Participation: The expectations to demonstrate compliance for this Condition-level requirement have been expanded. The pharmacy services must include either a pharmacy that is directed by a pharmacist, or, when appropriate, a drug storage area that is competently supervised.

Standard 25.00.04 Pharmacy Management & Administration: Pharmacy services must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications throughout the inpatient and outpatient services using accepted professional principles, such as the USP/NF.

Several policies and procedures that minimize drug errors are identified and required including: Weight-based dosing for pediatric populations, Monitoring drug alerts and/or recalls, and standardization of communication practices.

Standard 25.00.05 Management: This requirement clarifies the expectations and job description of the pharmacy director.

Standard 25.01.01 Medication Control & Distribution: Policies and practices relating to the safe dispensing of medications must be in accordance with accepted standards of practice; specific policy requirements are identified.

Standard 25.01.02 Supervision of Pharmacy Activities: The hospital must adopt and implement written policies and procedures to ensure all medications are prepared by authorized personnel. This regulation identifies extensive and specific requirements for COMPOUNDED PREPARATIONS.

Standard 25.01.03 Security of Medications: CFR reference information is provided regarding the self-administration of medications.

Standard 25.01.07 Inventory Management System: This regulation introduces the concept of “Beyond-use-date” (BUD) relating to outdated drugs. The hospital must maintain and implement policies and procedures that provide clear and consistent direction to pharmacy staff regarding how to determine the BUD information, even if this information is not available from the manufacturer.

Standard 25.01.09 Automatic Stop Medication Orders: This standard recognizes that hospitals with an electronic health records may have time and dose parameters automatically built into the CPOE screens.

Standard 25.01.12 Informational Resources: Through this regulation, the pharmacy is responsible to serve as a resource for medication-related information to the healthcare practitioners in order to minimize adverse drug events. Specific requirements are identified.

Standard 25.01.31 Pharmacy Services: This standard will be scored to cite shortcomings in the Pharmacy that are serious, yet, do not rise to a CMS Condition-level deficiency.

Standard 16.01.01 Preparation and Administration of Drugs: This Nursing Service requirement has been expanded to ensure staff adherence to accepted standards of practice to prevent healthcare-associated infections related to medication preparation and/or administration.  Standards of practice related to compounded sterile preparations (CSPs) are required. Also, the concept of “Beyond-Use-Date” (BUD) is introduced with several requirements established.

Background

For more information on the new and revised CMS interpretive guidelines for Pharmacy Services, see CMS Revises Interpretive Guidelines for Hospital Pharmacy Services, Expands Guidance Related to Compounding of Medications

CMS Revises Requirements for Hospital Pharmacy Services, Compounding of Medications

On November 20, 2015, the Centers for Medicare & Medicaid Services (CMS) issued Transmittal 151 (R151SOMA), revising interpretive guidelines for hospital pharmaceutical services and expanding guidance on compounding of medications in its State Operations Manual (SOM), Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.

A CMS Survey & Certification Memorandum – Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications (S&C 16-01-Hospital) – was previously published on October 30, 2015.

These are not new or revised Conditions of Participation (CoPs), but clarifications to the interpretation of existing requirements and the guidance CMS provides to surveyors in Appendix A for regulations in 42 CFR Part 482, concerning preparation and administration of drugs as well as pharmacy requirements and accepted standards of practice for drug compounding. However, the organization is required to comply with the requirements of these interpretations. The revised interpretive guidelines are effective November 20, 2015.

The revised interpretive guidelines include:

Pharmaceutical Services:

CMS revised portions of interpretive guidelines the pharmaceutical services CoP to bring them into alignment with current accepted standards of practice. To improve clarity, the revised guidance addresses:

• accepted professional pharmacy principles, including United States Pharmacopeia (USP) standards;
• compounding of medications, particularly compounded sterile preparations (CSPs);
• determining beyond-use dates (BUDs);
• safe and appropriate storage and use of medications; and,
• policies and procedures related to high-alert medications and minimizing drug errors.

New ASPEN Tag:

CMS added a new standard-level tag to allow surveyors to cite to the regulatory language found in the condition stem statement at either the standard- or condition-level, as appropriate, in the Automated Survey Processing Environment (ASPEN).

Preparing CSPs Outside of the Pharmacy:

CMS updated its guidance for the nursing service regulatory requirements concerning medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those limited instances when compounded sterile preparations (CSPs) may be prepared outside of the pharmacy.

New & Revised Interpretive Guideline Chapter/Section/Subsection/Title [Status]

• Appendix A/A-0405/§482.23(c) Standard: Preparation and Administration of Drugs [Revised]
• Appendix A/A-0489/§482.25 Condition of Participation: Pharmaceutical Services [New]
• Appendix A/A-0490/§482.25 Standard level tag for Condition for Coverage: Pharmaceutical Services [Revised]
• Appendix A/A-0491/§482.25(a) Standard: Pharmacy Management and Administration [Revised]
• Appendix A/A-0492/§482.25…The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision…& §482.25(a)(1)- A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. [Revised]
• Appendix A/A-0500/§482.25(b) Standard: Delivery of Services [Revised]
• Appendix A/A-0501/§482.25(b)(1) – All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist [Revised]
• Appendix A/A-0502/§482.25(b)(2)(i)- All drugs and biologicals must be kept in a secure area, and locked when appropriate. [Revised]
• Appendix A/A-0505/§482.25(b)(3) – Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. [Revised]
• Appendix A/A0507/§482.25(b)(5) – Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. [Revised]
• Appendix A/A0510/§482.25(b)(8) – Information relating to drug interactions and information [Revised]

The revised interpretive guidance will be published in a future update to the CMS State Operations Manual (SOM) Appendix A.

AHA, AMA at Odds Over ‘Surprise’ CMS Final Rule

The American Hospital Association (AHA) and the American Medical Association (AMA) are at odds over two provisions in a final Medicare rule that gives physicians more influence over hospital decisions. And each organization stated its case with heated language in letters to the Centers for Medicare & Medicaid Services (CMS).

The AHA likened the new rule to a “surprise switcheroo,” while the AMA says that if the AHA, using “very troubling” logic, got its way, “patients would be astonished and appalled to learn” of rules excluding medical staff members from service on the governing body.

The Final Rule, which specifies how hospitals must meet “Conditions of Participation” in the Medicare program, requires:

• That a hospital or healthcare system can not have a single integrated medical staff serving more than one hospital, but that each hospital must have its own medical staff.
• That every hospital’s governing board include a member of that hospital’s medical staff.

The AHA’s June 5 letter says these two new provisions weren’t in the Oct. 24 proposed rule. When they were incorporated in the final May 16 rule, it “surprised and greatly concern hospitals and other interested stakeholders.” The final rule thus violates the Administrative Practice Act because stakeholders didn’t have a chance to object when the proposed rule was open for comments, the AHA says.

Read the complete article on the HealthLeaders Media website.

To learn more about the two CMS Final Rules published in the May 16, 2012 Federal Register (CMS-3244-F, ‘Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation’ and CMS-9070-F, ‘Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction’), as well as the Proposed Rules published in the October 24, 2011 Federal Register, see CMS Publishes Final Rules Revising Hospital and CAHs Conditions of Participation; Eliminates Duplicative and Outdated Requirements to Promote Efficiency and Transparency for Hospitals, ASCs, ESRDs, Other Programs.

CMS Publishes Final Rules Revising Hospital and CAHs Conditions of Participation; Eliminates Duplicative and Outdated Requirements to Promote Efficiency and Transparency for Hospitals, ASCs, ESRDs, Other Programs

On May 9, 2012, the Centers for Medicare and Medicaid Services (CMS) released pre-publication copies of two Final Rules designed to reduce the regulatory burdens related to the provision of healthcare and to “reflect the Centers for Medicare and Medicaid Services’ (CMS) commitment to the general principles of the President’s Executive Order 13563, released January 18, 2011, entitled “Improving Regulation and Regulatory Review.”

The first Final Rule (CMS-3244-F, Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation) intends to eliminate certain “burdensome” Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAH).

The second Final Rule (CMS-9070-F, Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction) seeks to “eliminate duplicative, overlapping, outdated, and conflicting regulatory requirements for health care providers and suppliers, including hospitals, ambulatory surgical centers, end-stage renal disease facilities, durable medical equipment suppliers.” This Final Rule eliminates “outmoded” infection control and emergency equipment requirements previously applicable to ambulatory surgical centers (ASC) and National Fire Protection Association (NFPA) Life Safety Code requirements for all but high risk end stage renal disease (ESRD) facilities.

Both Final Rules where published in the May 16, 2012 Federal Register. CMS-3244-F, Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation, is available here. CMS-9070-F, Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction, is available here.

Both original Proposed Rules were published in the October 24, 2o11 Federal Register. CMS-3244-P, Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation, is available here.  CMS-9070-P, Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction, is available here.

Summary of Changes in the CMS Final Rule(s)

Governing Body Requirements

CMS proposed to allow a single governing body for hospitals in multi-hospital systems. In the Final Rule, CMS approved this revision and also added an additional requirement that at least one member of a hospital’s medical staff serve as a member of the multi-hospital system governing body in order to ensure communication and coordination between the system’s governing body and the medical staffs of the individual hospitals.

Patient’s Rights Requirements

CMS proposed to modify the reporting requirements when a patient death involves only the use of two-point wrist restraints and no use of seclusion. CMS finalized this proposed rule with minimal change, clarifying that hospitals need only to record in an internal log or other system soft wrist restraint-related deaths, and need not submit the information in the log to CMS or otherwise publicly release the information.

Medical Staff

CMS proposed to clarify that a hospital may grant privileges to both physicians and non-physicians to practice within their state scope of practice, regardless of whether they are also appointed to the medical staff. In the Final Rule, CMS removed the proposed concept of physicians and other clinicians being privileged to practice without appointment to the medical staff. Under the Final Rule, the medical staff may include other categories of non-physician clinicians. While the Final Rule falls short of requiring hospitals to place APRNs and other clinicians on the medical staff, the rule and its accompanying narrative does signal that CMS is supportive of APRNs, PAs, and other clinicians practicing to the full extent of their scope under state law.

Nursing Care Plan

CMS proposed to integrate the nursing care plan into the overall interdisciplinary care plan in those hospitals that use an interdisciplinary plan of care. The Final Rule permits either a stand-alone nursing care plan or one integrated into an interdisciplinary care plan.

Administration of Medications

The Final Rule allows hospitals to have an optional program for patients and support persons for self-administration of appropriate medications. The program must address the safe and accurate administration of specified medications, ensure a process for medication security, address self-administration training and supervision, and document medication self-administration.

Administration of blood transfusions and intravenous medications

The Final Rule eliminates the requirement for non-physician personnel to have special training in administering blood transfusions and intravenous medications. CMS also revised the requirement to clarify that those who administer blood transfusions and intravenous medications do so in accordance with state law and approved medical staff policies and procedures.

Orders by Other Practitioners

CMS proposed to allow all clinicians acting in accordance with state law and hospital privileges to provide orders for drugs and biologicals. The Final Rule allows for drugs and biologicals to be prepared and administered on the orders of non-physician practitioners provided such practitioners are acting pursuant to state law, hospital policy, and medical staff bylaws, rules and regulations. The non-physician practitioners may also document and sign these orders pursuant to state law and hospital policy.

Standing Orders

The Final Rule allows hospitals flexibility to use standing orders but adds a requirement for medical staff, nursing and pharmacy to approve written and electronic standing orders, order sets, and protocols. The rule also requires that orders and protocols be based on nationally recognized and evidence-based guidelines and recommendations.

Verbal Orders

The Final Rule eliminates the requirement for authentication of verbal orders within 48 hours and instead defers to applicable state law for authentication timeframes.

Infection Control Log

The Final Rule eliminates the obsolete requirement for a hospital to maintain an infection control log. Hospitals are already required to monitor infections and do so through various surveillance methods including electronic systems.

Outpatient Services Director

The Final Rule removes the requirement for a single director of outpatient services position, as many hospitals already have separate directors for individual outpatient departments and the single, overall director position may be duplicative and unnecessary.

Transplant Center Process Requirements

The Final Rule eliminates a duplicative requirement for an organ recovery team that is working for the transplant center to conduct a blood type and other vital data verification before organ recovery when the recipient is known, as the verification will continue to be completed at two other times in the transplant process.