Joint Commission and <797> Compliance Update

February 2020 - Vol.17 No. 2 - Page #18

Q&A with Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP
Principal Consultant
Medication Management and Safety
Joint Commission Resources

Pharmacy Purchasing & Products: What are the top areas of noncompliance with USP <797>?

Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP: In 2018, The Joint Commission began surveying sterile compounding practices for compliance to USP <797>, and the results are enlightening (see TABLE 1 for the top areas of noncompliance under USP <797>).

More than four out of 10 hospitals scored noncompliant regarding staff competency assessment, which means that their competency assessments were incomplete, insufficient, or not performed as often as required (ie, every year). Note that some competency assessments must be observational while others should be didactic, followed by an exam. The passing exam score must be established, and the exam must be graded. Surveyors found that some organizations conducted exams but failed to grade them. Media-fill testing and gloved-fingertip testing also must occur at regular intervals. USP <797> is prescriptive in that it contains multiple required competency and training elements; hospitals can expect surveyors will request specific documents demonstrating training and competency compliance.

Over 30% of hospitals scored noncompliant for infection control practices (IC.02.01.01). These errors may result from a failure to use PPE correctly, incorrect aseptic practices, or poor hand hygiene. Also consider the performance of the HEPA filter in the cleanroom, which can impact infection control.

In addition, more than 30% of hospitals scored noncompliant with assuring an appropriate and safe environment, part of the Environment of Care standard, which includes correct design and functioning of the cleanroom.

Finally, note that almost 5% of hospitals scored noncompliant in correcting deficiencies identified in their certification reports (LD.01.02.01).

See SIDEBAR 1 for the most commonly cited Joint Commission standards over a decade. It appears that The Joint Commission’s decision to survey the requirements of USP <797> in 2018 has created a watershed moment for hospitals, who now recognize the urgency of achieving full compliance.

How have requirements for anticoagulation medications evolved?

Mansur: Effective July 1, 2019, anticoagulation protocols or guidelines should be in place for the following:

  • Updated requirements for policies and guidelines on use and monitoring of all anticoagulants, including direct-acting oral anticoagulants (DOACs)
  • Protocols for reversal of anticoagulation and management of bleeding episodes for patients on anticoagulation medications
  • Protocols on perioperative management of patients on oral anticoagulants
  • Policies that direct baseline and ongoing labs, and encompass DOACs
  • A process for reporting, responding to, and analyzing ADEs relating to anticoagulants and ADE outcomes

A process should be developed to segregate any ADEs relating to anticoagulation to permit specific review. As with all ADEs, The Joint Commission’s expectation is that the facility will identify any preventable factors that might have contributed to the ADE and then take steps to correct the process.

When the DOACs were first introduced, there was a sense that this class of anticoagulant would be easier to manage and require less monitoring than previous anticoagulants. However, with some reports of severe bleeding events in patients taking DOACs, it is clear that this category requires robust management and monitoring. Therefore, The Joint Commission has updated its National Patient Safety Goal (NPSG) to include new requirements for anticoagulants.

In December 2018, The Joint Commission published an R3 report for the changes being planned for the NPSG on anticoagulation safety.2 R3 reports are developed to explain the reasoning behind new requirements and to provide resources to assist hospitals in meeting them. See the RESOURCES BOX for tools to help hospitals construct policies and procedures for perioperative management of patients on oral anticoagulants.

PP&P: What should pharmacists be aware of regarding medications and the risk of suicide?

Mansur: As medication experts, pharmacists should recognize that certain medications may increase the risk of suicide. More than 125 medications include FDA language for suicidal ideation or behavior. Multiple categories are included: acid reflux (PPI, H2 antagonists), allergy medications, birth control and hormonal medications, antibiotics, anticonvulsants, beta blockers, ACE inhibitors, and benzodiazepines. However, it is important to also note that the role of medications in increasing the risk of suicide is controversial3; the data regarding this role are mixed. Interestingly, non-depressed patients may be at higher risk.3

Pharmacists have a responsibility to monitor patients and report adverse events related to medications and suicide to the FDA’s MedWatch system. Because the data are inconclusive regarding the role medications may play in suicide risk, pharmacists should adopt a cautious approach, and should watch and monitor patients carefully in order to collect as much data as possible.

PP&P: What does The Joint Commission offer in terms of specialty pharmacy accreditation?

Mansur: The Joint Commission now offers accreditation of licensed specialty pharmacies through its Home Care Accreditation program. This accreditation is offered as a separate, distinct business segment under the umbrella of the Home Care Accreditation Program. Organizations need not have a home care program to apply for accreditation. For those organizations that have home care programs, compliance with existing Home Care Pharmacy requirements, plus the following three new requirements, is mandatory as of July 1, 20194:

For Performance Improvement (PI) standard PI.01.01.01: The organization collects data to monitor its performance, the new EPs are:

  • EP 41 — For Specialty Pharmacies: The organization collects data on medication errors including the following:
    • Incorrect drug
    • Incorrect recipient
    • Incorrect strength of medication
    • Incorrect dosage form
    • Incorrect instructions
    • Incorrect quantity
    • Near misses
  • EP 42 — For Specialty Pharmacies: The organization collects data on the following:
    • Adherence rate
    • Turnaround time for patient delivery of medications and associated products supplied by the specialty pharmacy. (Note: The organization may choose to separate data for medications that require an intervention.)
    • Billing and coding errors

For Record of Care, Treatment, and Services (RC) standard RC.02.01.01: The patient record contains information that reflects the patient’s care, treatment, or services, the new EP is:

  • EP 8 — For Specialty Pharmacies: The record contains documentation of patient education on medication instructions and use of associated products.

PP&P: What is involved in a typical tracer in a specialty pharmacy survey?

Mansur: During a survey, The Joint Commission will focus on all of the requirements of the new Specialty Pharmacy section of the home care standards (a summary of each applicable standard and EP for specialty pharmacies is included in the back of the Home Care accreditation manual). These requirements encompass emergency management, infection control, provision of care, and more. If compounding is part of the scope of the specialty pharmacy, this will be reviewed as well.

A variety of tracers may be utilized as part of the specialty pharmacy survey. One that will likely occur is a tracer that focuses on how the data required by the standards is collected, analyzed, and what changes have been made as a result.

It is also likely that several patient tracers will be conducted to review the care received by the patient. These will focus on compliance with requirements such as a care plan, a home medication list, documentation of patient education, and so on.

PP&P: What should pharmacy directors focus on for upcoming specialty pharmacy surveys?

Mansur: Become familiar with the standards that pertain to specialty pharmacies within the Joint Commission Comprehensive Accreditation Manual for Home Care. Confirm consistent compliance with documentation of patient management requirements (eg, care plans should be individualized; should include goals with targeted dates for completion and ensure they are updated; document and update home medication lists and resolve discrepancies; and perform and document patient education, etc). Develop and implement a process for collecting and analyzing required data that is specific to specialty pharmacies. Using data to identify areas needing improvement and following up to streamline processes should be key objectives of data collection. 


  1. The Joint Commission. Facts About Hospital Accreditation. Accessed September 9, 2019.
  2. The Joint Commission. R3 Report: Requirement, Rationale, Reference. Issue 19, Dec. 7, 2018. National Patient Safety Goal for Anticoagulant Therapy. Accessed September 9, 2019.
  3. Lavigne JE. Suicidal ideation and behavior as adverse events of prescribed medications: An update for pharmacists. J Am Pharm Assoc (2003). 2016;56(2):203-206.
  4. The Joint Commission. New Home Care Accreditation EPs Added for Specialty Pharmacy. Accessed September 9, 2019.

Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP, is principal consultant for medication management and safety for Joint Commission Resources and Joint Commission International. She provides direction to hospital leaders on medication safety design, medication system optimization, and technology implementation to support patient safety and effectiveness. Jeannell received a BS in pharmacy from the University of Michigan and a doctor of pharmacy from Wayne State University in Detroit.


Developing P&Ps for Oral Anticoagulants

When developing policies and procedures for perioperative management of patients on oral anticoagulants, consider the following resources.


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