Introduction
The pharmacy space in the United States is governed by rigorous standards designed to ensure patient safety, medication efficacy, and overall care quality. Among these standards, those set by the United States Pharmacopeia (USP) play a critical role in guiding hospitals on the proper handling, compounding, and storage of medications. USP standards are essential for maintaining the integrity of pharmaceuticals and protecting patients from potential harm. However, compliance with these standards is not merely a matter of best practice but a regulatory requirement that hospitals must adhere to maintain their accreditation.
Accreditation bodies such as The Joint Commission (JCO) and the Accreditation Commission for Health Care (ACHC) are tasked with evaluating hospitals’ compliance with CMS standards, which includes adherence to USP requirements. These organizations conduct thorough surveys to assess whether hospitals meet the requirements, focusing on critical areas such as sterile compounding, handling hazardous drugs, and environmental controls. The surveys conducted by JCO and ACHC are pivotal in ensuring that hospitals maintain high standards of care and continuously improve their practices.
This document provides an in-depth exploration of how JCO and ACHC survey hospitals against these standards within the pharmacy, highlighting their methodologies, areas of focus, and the challenges hospitals face in achieving compliance.
USP Standards Overview
The United States Pharmacopeia (USP) is a scientific, non-governmental organization that sets quality standards for medicines, food ingredients, and dietary supplements. In the context of hospital settings, three primary USP chapters are particularly relevant and regulated: USP 795, USP 797, and USP 800. There are other chapters that may be cited, but as a pharmacist I have a general awareness without spending time reading that content. Yet.
- USP 795: This chapter provides guidelines for non-sterile compounding, which involves the preparation of medications in a form that does not require sterility, but does include proper cleaning. It covers aspects such as the quality of ingredients, compounding processes, documentation, and facility requirements.
- USP 797: USP 797 is concerned with sterile compounding, which involves the preparation of medications that must be free from microbial contamination. This chapter outlines stringent requirements for cleanroom environments, personnel training, and quality assurance processes to ensure that compounded sterile preparations (CSPs) are safe for patient use.
- USP 800: USP 800 addresses the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment. It includes guidelines on facility design, engineering controls, personal protective equipment (PPE), and work practices. This chapter is retaining the content required to maintain sterility from USP 797.
Joint Commission (JCO) Survey Process
Introduction to JCO
The Joint Commission (JCO) is an independent, non-profit organization that accredits and certifies healthcare organizations and programs in the United States. JCO’s mission is to continuously improve healthcare for the public by evaluating healthcare organizations and inspiring them to excel in providing safe and effective care. Accreditation by JCO is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting specific performance standards.
Survey Preparation
Hospitals must be well-prepared for a JCO survey, which typically involves several months of preparation. This preparation includes conducting internal audits, maintenance, and training staff on the latest USP standards, and ensuring that all documentation is up-to-date and readily accessible. Hospitals often form committees or task forces to oversee the preparation process and address any areas of concern before the survey begins. Pharmacy usually participates in these preparations, in conjunction with hospital or health system quality leadership. I have observed the evolution of engagement with JCO surveyors that started superficially in my early years, with increasing time spent interviewing those involved in sterile compounding.
Survey Process
The JCO survey process is thorough and multifaceted, designed to assess every aspect of a hospital’s operations in relation to USP standards.
- Initial Assessment: The survey begins with an initial assessment, where JCO evaluators review the hospital’s policies, procedures, and previous compliance records. This assessment helps JCO determine the areas that will require the most focus during the on-site survey.
- On-Site Survey: During the on-site survey, JCO surveyors visit the hospital to conduct a comprehensive evaluation. This process includes interviews with staff, facility tours, and an in-depth review of documentation. Surveyors pay close attention to how the hospital handles compounding, especially sterile compounding, to ensure compliance with USP 797 and USP 800 standards.
- Key Areas of Focus: JCO surveyors focus on several key areas during their evaluation:
- Compounding Practices: The surveyors assess whether the hospital’s compounding practices align with USP standards. This includes evaluating the cleanroom environment, staff competency, and quality assurance protocols. Having the correct documentation in a timely manner becomes essential.
- Hazardous Drug Handling: Compliance with USP 800 is critical for patients AND employees, and JCO surveyors meticulously review how the hospital handles hazardous drugs, from receiving and storing to compounding and administering.
- Environmental Controls: The environmental controls within the compounding areas are scrutinized to ensure that they meet the necessary standards for air quality, pressure differentials, and temperature control.
- Tracer Methodology: One of the unique aspects of the JCO survey is the use of tracer methodology. This approach involves following the care process for specific patients from the point of entry to the hospital through to discharge. Pharmacy team members can be pulled into any CMS standard to review standards and how clinicians contribute to positive patient outcomes.
Surveyors may review USP standards from questions arising from a patient tracer, or direct review of how policies and procedures align with observed practices and interviewing staff.
Survey Outcome
At the conclusion of the survey, JCO provides the hospital with a detailed report outlining their findings. This report includes any citations for non-compliance, recommendations for improvement, and, if necessary, a timeline for addressing deficiencies. Hospitals are required to submit a plan of correction to JCO, detailing how they will resolve any issues identified during the survey. JCO may also conduct follow-up surveys to ensure that corrective actions have been implemented effectively.
I would add that in my time working around these surveys, my JCO surveyors have increased their awareness of the USP standards from my early pharmacy career, and the amount of time spent in the pharmacy overall. There may still be a “surveyor roulette” related to the depth of experience in pharmacy-related topics, but the integration of USP standards continues to expand.
If you have only worked in hospital systems, you may not be familiar with the next group below who have an increased focus on home health, hospice and ambulatory programs. As health systems have increased ambulatory offerings JCO has also expanded their “conditions of participation” to include more content geared towards specialty pharmacies, and home infusion elements being published in July 2019.
ACHC Survey Process
Introduction to ACHC
The Accreditation Commission for Health Care (ACHC) is a non-profit organization that provides accreditation services to a variety of healthcare providers, including hospitals. In my experience ACHC has not been as common with hospital accreditation in the western states I have practiced in and an increased focus on home health, hospice and other ambulatory programs that benefit from accreditation. ACHC’s mission is to promote excellence in patient care and operational efficiency through a collaborative and consultative approach to accreditation. ACHC accreditation is recognized as a mark of quality and commitment to compliance with industry standards, including those set by USP. In fact, in my background with ACHC surveyors in the home infusion setting, I quickly found their surveys (all before the 2019 and 2023 updated standards) were far more detailed in content and review of our pharmacy practices.
Survey Preparation
Preparation for an ACHC survey is similar to that for a JCO survey, with hospitals conducting internal reviews, training staff, and ensuring that their policies and procedures are aligned with USP standards. ACHC offers resources and support to hospitals during the preparation phase, helping them understand the accreditation process and the specific requirements they will be evaluated against.
Survey Process
The ACHC survey process is designed to be thorough yet collaborative, with a focus on helping hospitals improve their compliance and patient care practices.
- Pre-Survey Preparation: ACHC’s approach to surveying is highly customized, taking into account the specific needs and challenges of the hospital/home infusion teams. Before the on-site survey, ACHC surveyors work with the hospital to understand its unique circumstances and to identify areas where the survey will focus.
- On-Site Survey: During the on-site survey, ACHC surveyors conduct a comprehensive evaluation of the hospital’s facilities, processes, and documentation. This includes interviews with staff, facility tours, and a detailed review of how the hospital complies with USP standards. ACHC places a strong emphasis on collaboration, often working with hospital staff to identify practical solutions to compliance challenges.
- Key Areas of Focus: Similar to JCO, ACHC surveyors focus on key areas related to USP compliance:
- Compounding Practices: ACHC evaluates the hospital’s compounding practices, ensuring that they meet the standards outlined in USP 795, USP 797, and USP 800. Surveyors assess the physical environment, staff competencies, and quality assurance measures.
- Hazardous Drug Handling: Compliance with USP 800 is a significant focus, with ACHC surveyors reviewing how the hospital manages hazardous drugs throughout their lifecycle.
- Risk Assessment: ACHC places a particular emphasis on risk management, encouraging hospitals to proactively identify and mitigate risks associated with compounding and handling hazardous drugs.
Survey Outcome
ACHC’s survey process culminates in a comprehensive report that outlines the findings of the on-site evaluation. This report includes any areas of non-compliance, along with recommendations for improvement. ACHC adopts a consultative approach, often working with hospitals to develop practical strategies for addressing deficiencies. Accredited facilities are required to submit a plan of correction, and ACHC may conduct follow-up surveys to ensure that improvements have been made.
Comparative Analysis: JCO vs. ACHC Surveys
Both JCO and ACHC are respected accreditation bodies that survey hospitals against USP standards, but they approach the process in slightly different ways. While JCO’s survey process is rigorous and focuses heavily on compliance through the use of tracer methodology, ACHC’s approach is more collaborative, with a strong emphasis on risk management and continuous improvement. I again want to emphasize their approaches may feel similar from afar, but it is clear that compounding standards are increasingly gathering attention during the surveys I have participated in. Despite these differences, both organizations share the common goal of ensuring that hospitals adhere to USP standards to protect patient safety and improve care quality.
Challenges in USP Compliance
Compliance with USP standards presents several challenges for hospitals, including:
- Common Deficiencies: Hospitals often struggle with maintaining environmental controls in compounding areas, ensuring consistent staff training, and managing the complexities of hazardous drug handling. Recently the increased workloads of testing have contributed to a documentation workload, pharmacy leaders are feeling it.
- Regulatory Changes: The USP standards are periodically updated, and hospitals must stay abreast of these changes to remain compliant. Recent revisions to USP 797 and USP 800 have introduced new requirements that hospitals are still adapting to and timelines from issuing the updates vs implementation of the standards reward early adopters come survey time.
- Resource Constraints: Many hospitals face challenges related to staffing, financial resources, and technology, all of which can impact their ability to fully comply with USP standards. The financial burden for all facilities juggling high pharmacy turnover, onboarding to new skill sets, and trying to offset varying beyond use dates (BUDs) vs outsourcing can prove frustrating. Drug shortages always influence the daily decisions of pharmacy team members.
Strategies for Success
To overcome these challenges, hospitals can adopt several strategies:
- Best Practices for Compliance: Hospitals should implement best practices in compounding, hazardous drug handling, and environmental controls. This includes regular staff training, routine internal audits, and the use of advanced technologies to track, monitor, and maintain compliance. As updates are issued, work to address them early to avoid being caught trying to implement after your survey window hits. There may be grace from a surveyor, but dragging your feet will not be a survivable strategy.
- Staff Training and Education: Ongoing training and education are critical to ensuring that staff are knowledgeable about USP standards and competent in their application. Pharmacy teams are finding traditional hospital education platforms difficult to update, and bringing them in-house to a pharmacy-managed platform is becoming more common.
- Continuous Quality Improvement: Hospitals should adopt a culture of continuous quality improvement, regularly reviewing and refining their processes to enhance compliance and patient safety. It is essential to have the right checklists in place to ensure risk is minimized, but also cloud-based solutions that provide redundant methods for reporting allowing deeper and more meaningful improvements to be implemented. Find a platform that can be adjusted with your improvement timelines.
Conclusion
Adhering to USP standards is essential for hospitals to ensure patient safety, medication efficacy, and regulatory compliance. The Joint Commission (JCO) and the Accreditation Commission for Health Care (ACHC) play pivotal roles in assessing and accrediting hospitals based on their adherence to these standards. While their approaches may differ, both organizations share a commitment to promoting excellence in healthcare. Hospitals that prioritize compliance with USP standards through rigorous preparation, staff education, and continuous improvement are better positioned to deliver safe and effective care to their patients.
Paper checklists are an early phase to enabling success during these audits, it is highly recommended you find a cloud-based Single Sign On (SSO) compatible platform to help manage your education, task definitions, and reporting features to remove barriers to a safe and compliant program. By cleanly defining expectations, enabling real time and role based tasks firing in an automated cadence, you can make this easier on your front line team members. When your team has confidence in their routine, being interviewed by a surveyor is less intimidating.
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