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Volume 2025 | No. 2
Quality Review Edition THE Accreditation Resource for Data Nerds SURVEYOR
Volume 2025 | No. 2
SURVEYOR
TABLE OF CONTENTS
03 Corner View
04 From the Program Director
06 Frequent Deficiencies in Compounding Pharmacies
30 Frequent Deficiencies in Pharmacies
42 Frequent Deficiencies in Infusion Pharmacies
56 Frequent Deficiencies
in Home Infusion Therapy
BOARD OF COMMISSIONERS
LEADERSHIP TEAM
Brock Slabach, MPH, FACHE Chair CHIEF OPERATIONS OFFICER, NATIONAL RURAL HEALTH ASSOCIATION Maria (Sallie) Poepsel, PhD, MSN, CRNA, APRN Vice Chair OWNER AND CEO, MSMP ANESTHESIA SERVICES, LLC
Leonard S. Holman, Jr., RPh Treasurer HEALTHCARE EXECUTIVE AND CONSULTANT
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER, ACCREDITATION COMMISSION FOR HEALTH CARE Richard A. Feifer, MD, MPH, FACP CHIEF MEDICAL OFFICER, INNOVAGE
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER Patrick Horine, MHHA VICE PRESIDENT, ACUTE CARE SERVICES
John Barrett, MBA Officer-at-Large SENIOR CONSULTANT, QUALITY SYSTEMS ENGINEERING Gregory Bentley, Esq. PRINCIPAL, THE BENTLEY WASHINGTON LAW FIRM
Matt Hughes VICE PRESIDENT, COMMUNITY CARE SERVICES Jonathan Kennedy, CPA, MBA VICE PRESIDENT, FINANCE AND CORPORATE SERVICES
Denise Leard, Esq. ATTORNEY, BROWN & FORTUNATO
Mark S. Defrancesco, MD, MBA, FACOG Secretary WOMEN’S HEALTH CONNECTI CUT/PHYSICIANS FOR WOMEN’S HEALTH (RETIRED)
Marshelle Thobaben, RN, MS, PHN, APNP, FNP PROFESSOR, HUMBOLDT STATE UNIVERSITY
Jennifer Burch, PharmD OWNER, CENTRAL PHARMACY, CENTRAL COMPOUNDING CENTERS
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Volume 2025 | No. 2
SURVEYOR
CORNER VIEW WITH PRESIDENT & CEO, JOS É DOMINGOS
You made a great decision when choosing ACHC to accredit your pharmacy. Whether you are new or have years of experience with us, I am confident that you have already felt first-hand our intense focus on customer service. Real support that builds your team ACHC doesn’t engage in “accreditation theatre” through complex scoring rubrics or punitive surveys that give an illusion of rigor without adding any true value for your organization. Instead, we focus on real support designed to close any gaps between your current state and full standards compliance. We are known as Accreditation Nerds for our genuine belief in— and passion for—the efficacy of accreditation to enhance quality and safety in healthcare organizations. But we know it works best when those organizations understand and embrace continuous performance improvement. The Quality Review edition of Surveyor is an excellent place to start. This publication is a resource, demonstrating how ACHC program teams work to help you develop individual expertise within your organization, while recognizing that your staff may have varying levels of experience and current knowledge of accreditation standards. The standards covered are the most frequently cited on recent surveys and the compliance tips provided are divided into categories to make them useful for individuals across a range of roles and experience. “Accreditation Nerd Newbies” are just that: individuals new to the process of compliance with accreditation standards. ACHC uses a Plan- Do-Study-Act framework to organize standards.
Even a "simple" standard may include multiple elements for full compliance. Under Compliance tips for Nerd Newbies, we offer a clear summary of the expectations for each standard. “Accreditation Nerd Apprentices” understand the concepts of meeting and maintaining standards. Compliance tips for Nerd Apprentices focus on using data on hand to continuously assess how well your organization is performing. Finally, “Accreditation Nerd Trailblazers” are those individuals who are passionate about maximizing their agency's capacity for excellence. They are enthusiasts who eagerly share their knowledge with colleagues to create a path forward. Nerd Trailblazers thrive on the goal of continuous improvement. Compliance tips for Nerd Trailblazers cover best practices designed to level up your organization. These tongue-in-cheek categories are our way of saying that it’s possible to approach accreditation seriously without being humorless. When we say that we want to help you develop your staff into a team of Accreditation Nerds, you immediately understand our goal. Partnership you can rely on Once your organization is ACHC-accredited, we become your partner, dedicated to meeting your needs. ACHC’s staff of Accreditation Nerds— account advisors, surveyors, clinical educators, quality and regulatory, and other experts— thrive on being helpful. Review the information on the pages that follow confident that we’re ready to dig in to answer questions, provide feedback, offer suggestions, and direct you to any additional resources you need.
MISSION STATEMENT
Accreditation Commission for Health Care (ACHC) is dedicated to delivering the best possible experience and to partnering with organizations and healthcare professionals that seek accreditation and related services.
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Volume 2025 | No. 2
SURVEYOR
FROM THE PROGRAM DIRECTOR
A survey with no findings—no identification of non-compliance—is exceedingly rare, and that knowledge can be daunting. The important takeaway when exploring deficiency data is growth and improvement. This Quality Review edition of Surveyor identifies and analyzes the most challenging standards. This year’s data span initial and renewal surveys conducted between June 1, 2024, and May 31, 2025. This publication covers three ACHC accreditation programs: PCAB (Compounding Pharmacy), Pharmacy, and Home Infusion Therapy.
TCRX6-D tells a similar story of vast improvement, but with room to grow. In 2022, compounding pharmacies were at a rate of 63% non-compliance with this standard. This year’s data shows us that organizations have a much better grasp of shipping system validations with a reduction to 37% non- compliance. This number is still high, and we encourage compounding pharmacies to take a hard look at training and competencies for all staff who are involved with shipping compounded preparations. Detailed instructions, consistency of packaging, and ongoing education will go a long way to improve compliance. Pharmacy Results The first chart in this section covers deficiencies cited in infusion centers, community retail, mail order, and specialty pharmacies. Six standards were noted on 15% of the surveys conducted. This represents a significant improvement from the level of compliance three years ago when this cohort of pharmacies was last surveyed. At that time, we used a threshold of 20% and there were 13 standards that were identified as noncompliant on at least that percentage of surveys. The three most frequently cited ( DRX5-2B, DRX5-2C, DRX7-9A ) remain the most challenging standards this year, but the remaining 10 from 2022 all dipped below this year's 15% threshold. Three new standards appeared as frequent deficiencies ( DRX4-8A, DRX5-4A, DRX7-1D ) in 2025. It is notable that DRX7-1D focuses on monitoring
HIT5-1A was cited on 43% of surveys. The standard requires that the organization's policy for client/ patient records include specific items. ACHC Surveyors noted that policies were not adequately implemented. Documentation did not include the detail needed to support excellent patient care. HIT5-3C was a finding on 71% of surveys in 2022 and for only 26% this year. This requirement for the plan of care includes specific data points but previous deficiencies focused on the absence of a physician signature. This year, very few plans of care lacked evidence of physician oversight but some were missing other required elements. HIT5-8B was noted on 21% of surveys. This standard, which focuses on regular review of patient medications by a licensed, skilled professional, improved for this cohort of providers by 12.5% over 2022 results. Summary I am excited to begin my journey leading ACHC Pharmacy Accreditation programs by presenting this publication. I look forward to your feedback and insight on how my team can better support your success. Please reach out at any time.
This is my first Surveyor since joining ACHC to lead the pharmacy team. I have found it to be a valuable resource. For me, it offers insight into where we may need to provide additional training to ensure that pharmacies have a full understanding of what compliance looks like in practice. For customers, it offers actionable tips to improve your pharmacy practice. PCAB (Compounding Pharmacy) Trends When USP <800> became mandatory, we developed the service of Hazardous Drug Handling PCAB, which includes new standards ( TCRX7A-7N ). Effective June 1, 2024, we discontinued the Distinction in Hazardous Drug Handling. Hazardous Drug Handling PCAB is now the service option for organizations seeking accreditation for compounding with hazardous drugs. Ten standards were cited as non-compliant on more than 25% of surveys for PCAB (Compounding Pharmacy) Accreditation. Four of these standards are in Chapter 6, which covers provision of care and record management. TCRX6-C was the most frequently cited; 41% of surveyed compounding surveys have difficulty meeting requirements for safe storage, labeling, handling, and disposal of pharmaceutical components and preparations. However, three years ago, 69% of compounding pharmacies struggled with this standard. While we’re pleased with the improvement, we’d like to see organizations invest even more time in ongoing audits for compliance.
infection rates in patients and is only applicable to pharmacies that provide infusion-related services (ambulatory infusion suites/centers, infusion nursing, and infusion pharmacies). The fact that the dataset used to graph the frequency with which a standard is cited also includes mail order and specialty pharmacies means that it's likely that this standard is noncompliant for a higher percentage of the organizations to which it applies than is reflected in this graph. This year we have the first 12 months of data since USP <797> updates from November 2023 were incorporated within ACHC Standards. To share specific detail of the challenges that infusion pharmacies encounter in establishing sterile compounding compliance, we are discussing deficiencies for this pharmacy service in a separate chart on pages 42-55. Most standards in the first section also apply to infusion, so be sure not to overlook that content. Home Infusion Therapy Results This year, we focus on standards that were cited for non-compliance on at least 20% of the surveys performed. Three years ago, when this cohort of providers was last surveyed, three standards were noted at this level. This year, three standards again reached that frequency, but a new standard emerged as the most challenging.
Caroline Girardeau PharmD, MBA, PMP, BCPS Program Director
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PCAB (COMPOUNDING PHARMACY)
SECTION 1: ORGANIZATION AND ADMINISTRATION TCRX1-D Frequency of the citation: 31%
Overview of the requirement: The organization’s leadership is required to identify a designated person (DP) or persons as responsible and accountable for preparing, storing, packaging, and transporting compounded preparations (sterile and/or non-sterile). The designated person(s) must receive documented training specific to the role. Comment on deficiencies: Compliance is evaluated through review of written policies, procedures, and personnel files. Surveyors noted that many organizations had not identified a designated person (DP) and were missing both job descriptions and policies. Examples of ACHC Surveyor findings: ■ No employee has been formally identified as the designated person. No written policies and procedures outline the DP’s job. ■ PIC was verbally identified as the designated person, but the responsibilities for this role were not defined in a job description. ■ The job description for the DP is missing: ٝ Mandate that the designated person determines whether a Compounded Sterile Preparation (CSP) is expected to retain its integrity and quality when temperature excursions occur when compared to USP <659>. ٝ Stipulation that this person ensures there is a designated area for non-sterile compounding. ٝ The requirement to include the responsibilities associated with ensuring a QA/QC Program is both in place and reviewed annually. The DP must review policies and procedures annually as well.
PCAB (COMPOUNDING PHARMACY) ACCREDITATION Services Non-Sterile Pharmacy Compounding Sterile Pharmacy Compounding Hazardous Drug Handling PCAB
FREQUENT DEFICIENCIES IN COMPOUNDING PHARMACIES
60%
50%
40%
30%
20%
10%
0% TCRX1-D TCRX3-B TCRX4-A.01 TCRX5-F TCRX5-G TCRX6-C TCRX6-D TCRX6-E
TCRX6-H TCRX7-B
Organization and Administration
Patient Communications
Quality Outcomes/ Performance Improvement
Provision of Care and Record Management
Hazardous Drug Handling PCAB
Personnel Training and Competency
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PCAB (COMPOUNDING PHARMACY)
SECTION 3: PERSONNEL TRAINING AND COMPETENCY TCRX3-B Frequency of the citation: 28%
Compliance tips for: Nerd Newbies
A designated person (DP) must be identified and have a written job description. The DP maintains oversight over the pharmacy’s compounding processes and personnel. The standard outlines specific responsibilities that vary depending on whether the pharmacy conducts sterile or non-sterile compounding (or both). Examples include: ■ Overseeing a training program (or delegating the training program to an assigned trainer). ■ Taking immediate corrective action if deficient compounding practices are observed. ■ Reviewing and approving all policies and procedures initially and every 12 months. ■ Ensuring compounding areas meet all standards and requirements. ■ Evaluating and documenting the QA and QC programs at least every 12 months. ■ Determining the integrity and quality of compounded preparations when temperature excursions occur. ■ Establish and implement written policies and procedures to identify a designated person or persons and clearly define the responsibilities of leadership and all compounding personnel. ■ Audit personnel files to ensure that the DP’s job description includes all associated responsibilities. ■ Develop a checklist for auditing personnel files and include the requirement for the DP job description. ■ Take the checklist a step further by including each DP responsibility and requiring verification that specific elements are present.
(understand the requirement)
Overview of the requirement: Sterile compounding personnel are required to complete training/education prior to being assigned work independently. Policies and procedures require competencies, documented semiannually (Category 1 and 2) and quarterly (Category 3), in areas consistent with the risk level of the compounding. Note: This standard applies to sterile compounding only. Comment on deficiencies: Compliance is evaluated through review of policies and procedures, competency assessments, and personnel files. Surveyors may also conduct staff interviews. Most deficiencies were related to missing elements for personnel with direct sterile compounding oversight, particularly documentation of aseptic technique validation, including gloved fingertip/thumb sampling, and media fill testing. Examples of ACHC Surveyor findings: ■ The pharmacy has developed a training for the USP <797> core skills, but this is not documented. ■ Personnel records reviewed for those with direct sterile compounding oversight were missing: ٝ Sterile compounding trainings. ٝ Gloved fingertip/thumb (GFT) samplings (including initial). ٝ Media fills and post-media fill GFT samplings. ٝ DCA surface samplings. ■ The pharmacy makes Category 3 compounded sterile preparations (CSPs). The media fill process is being performed every 6 months but should be performed every 3 months for Category 3 compounding for people actively compounding. In contrast, people with direct oversight require GFT, media fill, and surface sampling of the DCA at least every 12 months.. ■ The aseptic technique validation process does not: ٝ Have enough units being made to meet USP <797> guidelines. ٝ Replicate the most strenuous process. ٝ Include surface sampling of the DCA after completion. ٝ Visual observation of nail cleaning, hand cleansing, and use of an alcohol hand rub. ■ One pharmacist has the training and ongoing documentation to oversee sterile compounding and provide direct oversight. No additional personnel have been trained to cover when the pharmacist is not available (e.g., out sick, on vacation) and when pharmacists are assigned on-call responsibilities.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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PCAB (COMPOUNDING PHARMACY)
SECTION 4: PATIENT COMMUNICATIONS TCRX4-A.01 Frequency of the citation: 28%
■ There was no documented evidence of the required training and assessments before non- compounding staff are allowed entry into the classified area(s). Non-compounding staff include third-party cleanroom certification professionals, maintenance technicians, personnel responsible for restocking and cleaning, inspectors, etc.).
Compliance tips for:
This standard requires training and competencies for sterile compounding personnel. Didactic training is conducted initially and every 12 months. For staff who are actively compounding, aseptic technique validation is conducted every six months for Category 1 & 2, and every three months for Category 3. Staff with direct oversight are evaluated for compliance with USP <797>, including: ■ Hand hygiene and garbing. ■ GFT sampling post-hand hygiene and garbing, and post-media fill. ■ Aseptic technique manipulation including visual observation, media fill testing, and DCA surface sampling. ■ Review personnel files and confirm the inclusion of all aspects of compounding training and testing as required by the updated USP <797> and state board of pharmacy regulations. (For example, include written information documenting the GFT and media fill incubation times and temperatures.) ■ Audit policies and procedures for the required initial and ongoing competency assessments for compounding personnel and personnel with direct oversight. These team members must demonstrate knowledge and competency in: ٝ Post-hand hygiene, garbing, and gloving. ٝ Aseptic technique visual observation. ٝ Media fill testing, post-media fill GFT sampling, and DCA surface sampling. ■ Ensure training and competencies are conducted at the correct cadence for the category of CSPs compounded. ■ Pay close attention to media fill testing and verify the presence of all required components. Designate alternate employees to assist the designated person with conducting training and assist with competency assessments.
Overview of the requirement: Policies and procedures define the content of an accurate record for each patient.
Nerd Newbies (understand the requirement)
Comment on deficiencies: Surveyors assess compliance through review of policies and procedures and patient/client records. Most deficiencies noted incomplete documentation of pertinent patient information. Examples of ACHC Surveyor findings: ■ No policy was found addressing the content of the client/patient record. ■ The frequency and parameters for updating patient/client information are not specified in the policy. ■ The pharmacy does not attempt to obtain the following: ٝ Documented drug/environmental allergies. ٝ Other patient medications, both prescription and nonprescription. ٝ Patient health conditions/disease states. ٝ Treatment diagnosis. ٝ Other relevant information such as height and weight. ■ There was no documentation that client/patient refused to provide client/patient-specific information when requested.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
A reasonable effort must be made to record the following in the client/patient record: ■ Identification data ■ Communication information ■ Date of birth ■ Gender ■ Name of prescriber ■ Prescribed drug(s) ■ Treatment diagnosis ■ Other patient medications, prescription and nonprescription ■ Other patient health conditions ■ Other relevant information, e.g., height and weight when applicable to the course of treatment ■ Allergies and /or sensitivities to drugs and/or relevant non-drug substances which may include: ٝ Peanuts. ٝ Soy. ٝ Latex. ٝ Shellfish. ٝ Adhesive/tapes. ٝ Disinfectants. ■ Audit intake forms and confirm they contain: ٝ Each element of the standard. ٝ The option to select “None” or “N/A.” ■ Implement a process to document clearly that a client/patient has declined/ refused to provide the information. ■ Develop a process within your pharmacy’s clinical/dispensing platform that: ٝ Highlights the key missing elements of the client/patient record. ٝ Alerts personnel that the information is missing and needs to be obtained. ■ Educate staff on the importance of addressing any highlighted missing items when communicating with the client/patient. ■ Create a process and timeline for follow-up when clients/patients do not provide the required information.
SECTION 5: QUALITY OUTCOMES/PERFORMANCE IMPROVEMENT TCRX5-F Frequency of the citation: 27% Overview of the requirement: Risks, including infections, communicable diseases, and all variances (incidents, accidents, and complaints/grievances), are tracked and trended at least quarterly as performance improvement (PI) activities. An action plan is created to decrease occurrences. Comment on deficiencies: This standard is evaluated using PI reports and incident/variance reports. In many cases, pieces of data were collected but not incorporated into a formal PI Program. Most deficiencies related to the frequency of PI reports, lack of corrective action plans, and insufficient data analysis.
Nerd Newbies (understand the requirement)
Examples of ACHC Surveyor findings:
■ The pharmacy lacks a formal PI plan. ■ The pharmacy lacked evidence of ongoing monitoring of processes that involve risks, including infections and communicable diseases for patients and staff. ■ The data is being collected, but: ٝ It is not placed in a PI report for an official trending or pattern. ٝ It is not reported monthly or annually.
ٝ No threshold or written plan of correction exists for ongoing studies. ٝ There was no quarterly PI report or communication of findings.
Nerd Apprentices (audit for excellence)
Compliance tips for:
■ PI data alone is not sufficient. Tracking, trending, analysis, and a plan of correction are required for a full assessment. ■ This standard applies to gathering and assessing data on a quarterly basis. Data are related to infections and communicable diseases, as well as a review of variances, including but not limited to:
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
ٝ Incidents. ٝ Accidents. ٝ Complaints/grievances.
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PCAB (COMPOUNDING PHARMACY)
Compliance tips continued:
TCRX5-G Frequency of the citation: 33%
■ Audit the pharmacy’s PI Program to ensure all components of this standard are included. ■ Create a PI scorecard for data collection and/or meeting minute template. ■ Review data collected quarterly to identify any trends and implement a corrective action plan for items not meeting the goal/threshold. ■ Create a system for gathering and organizing data to convert trends into a quarterly meeting template. ■ Develop and implement a PI meeting template with all the required reporting activities for recording each quarter's meeting minutes. ■ Put your template in a format that allows you to have all necessary information at the end of the fourth quarter. This will greatly help you with trending for the annual PI report.
Nerd Apprentices (audit for excellence)
Overview of the requirement: Written policies and procedures are established and implemented regarding continuous quality control (QC) for finished preparations. This applies to sterile and non-sterile compounding. Comment on deficiencies: Compliance is evaluated through observation, response to interviews, and review of policies and procedures. Surveyors noted that policies and procedures did not incorporate the most recent USP changes related to quality control processes for finished preparations (e.g. monitoring weight, variation, and potency). Examples of ACHC Surveyor findings: ■ Written policies were not found that define the ongoing continuous quality control program for non-sterile compounding. ■ The pharmacy does not conduct USP <1163> testing of preparations in accordance with its policies and procedures. ■ The SOP governing quality programs refers to USP <1075>. This is an obsolete chapter which has been replaced by USP <1163>. ■ Policies and procedures lack specificity about the QC processes to be performed on compounded sterile preparations (CSPs) and compounded non-sterile preparations (CNSPs). Weight variation and potency testing are not addressed and/or specifically defined. ٝ Volumetric dispensing devices (for example, Topi-clicks) are not addressed. ٝ Formulas for capsules, suppositories, and troches are not being assessed for weight variation. ٝ Formulas of creams made as weight/weight (mg/gram) and dosed as weight/volume (mg/ml) are not assessed for accuracy. ٝ Potency testing is not regularly performed on each compound type; only topical creams are tested. ■ Upon interview, staff were unable to describe: ٝ Steps to conduct final preparation testing and why it was being done. ٝ The procedure to follow if/when a test result falls out of specification. ■ The potency testing of finished preparations each compounder produces is not documented in a manner that tracks each individual's performance. ■ Non-sterile to sterile Category 2 preparations had BUDs assigned beyond guidelines, with no sterility testing.
Nerd Trailblazers (prepare the path for others)
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PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
SECTION 6: PROVISION OF CARE AND RECORD MANAGEMENT TCRX6-C Frequency of the citation: 41% Overview of the requirement: Policies and procedures are written to support safe storage, labeling, handling, and disposal of pharmaceutical components and preparations. Comment on deficiencies: Compliance is assessed through direct observation, interviews, and review of policies and temperature/ cleaning logs. Most deficiencies noted improper handling of cleaning/sanitizing agents and insufficient monitoring of the temperature of storage areas.
This standard represents the implementation of an ongoing QC process designed to assess finished preparations. Requirements for CNSPs differ from CSPs, but policies and procedures must contain these core elements regardless: ■ When to test preparations and what tests should be performed. ■ Appropriate methods and equipment. ■ How to interpret the test and limits of the test. ■ Specific actions required when a preparation does not meet the test. ■ How QC information is used to improve the performance of personnel and incorporated into the PI Program. ■ Each role involved in delivering care to an individual understands the full scope of that client/patient’s goals for care. ■ If care is not documented, there is no evidence that it occurred. Ensure policies and procedures governing QC address: ■ Compliance with USP <1163>. ■ A program of weight variation assessment. ■ Various bases used, and testing of high and low concentrations of added ingredients. ■ Potency testing is conducted according to your policies and procedures: ٝ At required intervals. ٝ For non-sterile to sterile preparations. ■ Accuracy of dosing. ■ Systematic processes to address test results that fall out of required specifications. ■ Frequency of quality control testing is performed at a minimum every 12 months on all compounded products, or at a shorter interval according to your organization’s policies. ■ Conduct master formulation record and compounding record audits. ■ Observe the various compounding processes to ensure QC activities are being conducted according to the facility’s policies and procedures and USP <1163>. ■ Interview staff on the QC activities. For example, ask how they record the results for pH meter, weight variation, and/or bubble point integrity testing. ■ Perform QC testing every six months on all compounded products, and incorporate this interval into organizational policies.
Nerd Newbies (understand the requirement)
Examples of ACHC Surveyor findings: ■ Cleaning practices:
Nerd Apprentices (audit for excellence)
ٝ The agent used for cleaning is not listed on the log. ٝ Cleaning is performed using 70% Isopropyl Alcohol (IPA). IPA is a disinfecting agent, not a cleaning agent. Use a cleaning agent, followed by IPA, or an EPA-registered one-step cleaning- disinfecting agent. ٝ The pharmacy does not clean and disinfect reusable storage containers and spray bottles prior to refilling for reuse. ٝ There was a week when cleaning was not documented. It was unclear if the weekly cleaning took place and documentation was overlooked, or if the week was skipped accidentally. ٝ Chemicals are transferred from larger containers, and the label on the smaller container is missing the date of transfer and the ingredient name. ■ Temperature and humidity: ٝ Temperature sensing devices were not calibrated to National Institute of Standards and Technology (NIST) or manufacturer standards. ٝ Room temperature storage areas are not monitored for appropriate temperature and humidity conditions as described in USP <659>. ٝ The freezer where ice bricks were stored was not monitored continuously with a calibrated device. ٝ Drug storage is monitored only on weekdays. The pharmacy is not open on weekends or holidays; staff cannot effectively determine if an excursion has occurred when the pharmacy is closed.
Nerd Trailblazers (prepare the path for others)
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PCAB (COMPOUNDING PHARMACY)
■ Storage areas: ٝ There was no designated area for recalled medications. ٝ Several boxes of components are stored on the floor. ٝ There was no evidence of regular inspections for expired pharmaceuticals, components, and compounded preparations.
■ Ensure all electronic/paper cleaning forms/logs list all areas to be cleaned (e.g., non-sterile compounding areas, SCA, SECs, and PECs) and the frequency they are required to be cleaned (e.g., daily, weekly, or monthly). ٝ Review each log monthly to verify: о All required cleaning has taken place. о Cleaning and disinfection agents are listed with appropriate details. ٝ Sign the log to verify completed tasks have been reviewed. ■ Regularly audit inventory with a specific focus in mind, such as: ٝ Confirming labels on repackaged containers reflect all required elements. ٝ Separating expired, recalled, and quarantine items. ■ Routinely check temperature-sensing devices as well as any other equipment used to monitor the environment. ٝ Are they properly calibrated? Are the manufacturers’ guidelines easy to find? ٝ Is third-party certifier’s equipment certified and calibrated? ٝ If using duplicate thermometers, do you use two different models or brands? ٝ Have you calibrated thermometers using, for example, NIST standards? ■ Review policies and procedures to ensure compliance with the most recent USP updates. ■ Select any required log related to this standard and hold an in-service for staff. Discuss common errors using data from your PI Program. Develop checklists for any items that are routinely missed. ■ Educate staff on processes for transferring cleaning agents and chemicals from a larger container to a smaller container. Include these tasks in competency assessments. ■ Develop a clear process for handling recalled, expired, quarantined, or adulterated products. Educate, implement, and include the process in the organization’s policies and procedures.
Nerd Apprentices (audit for excellence)
Compliance tips for:
■ Temperature monitoring applies to all pharmaceuticals, components, and compounded preparation storage areas. ■ Maintaining compliant storage requires attention to: ٝ The manufacturers’ requirements for devices used to assess and maintain the correct temperature. ٝ Whether the storage is refrigerated, frozen, or room temperature. ٝ USP <659> requirements for every scenario. ٝ The alert and reporting capabilities. ■ Storage areas also require established processes for: ٝ Regular inspections to remove and dispose of expired pharmaceuticals, components, and compounded preparations. ٝ Quarantine areas for expired, recalled, and quarantined products waiting for test results or DSCSA resolution. ٝ Contingency plans when storage conditions fall outside of established ranges. ٝ Hazardous vs non-hazardous drugs. ٝ Labeling. ٝ Cleaning and disinfection.
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
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SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-D Frequency of the citation: 37%
■ A validated shipping system ensures the integrity of pharmaceuticals and compounded preparations is maintained during transit. These pharmaceuticals are often delivered by a third-party shipping service, but the standard also applies to nurses who transport medications to patients in the home. Distance, climate, geography, time of year, and the size/quality of the container are just some of the factors that may compromise or reduce the efficacy of a drug. ■ Organizations must define testing methods, test regularly, and document the results. Shipping validation is conducted internally or by a third party and addresses: ٝ Sanitation, light, and temperatures (room temperature, refrigerated, frozen) experienced during transit.
Nerd Newbies (understand the requirement)
Overview of the requirement: The organization’s shipping system must be validated to ensure pharmaceuticals and compounded preparations are maintained under appropriate conditions of sanitation, light, and temperature. Third- party or internal studies are conducted with consideration of environmental extremes encountered during transportation. Comment on deficiencies: Surveyors evaluate compliance through observation and staff interviews. Most deficiencies result from inadequate testing methods and a lack of training. Examples of ACHC Surveyor findings: ■ The organization does not have a validated shipping system to ensure pharmaceuticals are maintained under appropriate conditions. ■ Shipping testing methods are not conducted according to the storage conditions outlined in USP <659>: ٝ A reliable data tracker is not used to monitor temperature throughout the shipment. ٝ There is no documentation capturing the details of what was shipped, how it was packed, and the length of time of the shipment ■ Shipping studies were not performed during the hottest and coldest months. ■ Products labeled for frozen storage conditions are being shipped with testing applicable to refrigeration. ■ Upon interview, shipping personnel were not aware of: ٝ How shipping pack-outs were tested to ensure the medication arrives at the patient at the correct temperature. ٝ The number of ice packs and their placement in the package for each package configuration. ■ Pharmacy did not complete shipping validation testing for all types of packaging. They use boxes of different sizes and various sizes of kangaroo pouches.
ٝ Delivery containers, phase change material, insulation. ٝ Patient education on home storage requirements. ٝ Payload size/weight.
■ Ensure that shipping and courier containers are tested for each of the varying packing sizes. ■ Gather the appropriate data needed to conduct the mean kinetic temperature (MKT) when an excursion occurs to aid in determining the viability of the medication. ■ Develop and enforce a schedule for your pharmacy to conduct testing under extreme temperatures. Pay close attention to seasonal changes for all destinations and routes. ■ Audit shipping practices to confirm there have been no changes in cold chain products. If so, revalidate to ensure shipping temperatures are maintained. ■ Create a pack-out/shipping diagram to help personnel replicate the shipping and packing experience. ■ Evaluate the effectiveness of current training for shipping personnel. Update and educate as needed. ■ Conduct mock survey interviews with pharmacy staff responsible for packaging. Ask how pack-outs are done for different temperatures, how they determine when seasonal pack-outs need to change, and how shipping methods are tested. ■ Assess the competency of packaging personnel when conducting ship validation testing.
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Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-E Frequency of the citation: 33%
■ Comprehensive understanding of equipment operating parameters is critical to the compounding process. Compounding personnel must maintain daily written or electronic documentation demonstrating compliance with equipment, calibration, verification, accuracy measurements, and maintenance requirements on the days the equipment is used. ■ Policies and procedures address, at a minimum: ٝ Manufacturer’s recommendations.
Nerd Newbies (understand the requirement)
Overview of the requirement: The pharmacy follows established policies and procedures outlining the use, calibration, cleaning, and disinfection/sterilization of equipment used throughout the compounding process. Comment on deficiencies: Compliance is assessed through direct observation, response to interviews, and review of policies, procedures, and manufacturers’ instructions. Many deficiencies were specific to balances used for weighing ingredients. Surveyors also noted a lack of consistency with device testing and equipment calibration.
ٝ Storage minimizing the risk of contamination. ٝ Calibration that states frequency and findings.
ٝ Cleaning, disinfection, and/or sterilization procedures and schedules. ٝ Use, calibration, maintenance, and accuracy testing of ACDs (applies to sterile compounding only). ٝ Monitoring devices (e.g., temperature, humidity, pressure) verified for accuracy at least every 12 months or as required by the manufacturer, whichever is more frequent. ■ Confirm compliance with manufacturers’ manuals and guidelines for all applicable equipment. ■ Check humidity measuring devices, pressure gauges, and temperature devices for accuracy. Document results with actual numbers/figures and not simply a pass/fail. Implement corrective actions when out of range. ■ Record repeater pump calibration in the compounding record or on a log identifying the repeater pump by the serial number used. ■ Use checklists, calendar reminders, and logs to ensure consistency. ■ Institute a schedule of frequent observation of all personnel to ensure that they are working within the operational parameters of their equipment. ■ Focus on training and competencies related to balances, as they are the foundation of the compounding process. ٝ Confirm weights used for calibration are certified. ٝ Educate staff that MAWQ is addressed in USP <1176> and how to calculate the MAWQ for the balances in the pharmacy. ٝ Label each balance with the MAWQ. ٝ Modify MFRs and CRs to include the calibration of the equipment to be used and the results of the calibration.
Examples of ACHC Surveyor findings: ■ Equipment not calibrated within the required time frames:
ٝ Devices used to monitor and record temperature and humidity. ٝ Bubble point integrity test pressure gauges. ٝ Compounding equipment, such as mixers, balances, and pH meters.
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ٝ Automatic Compounding Device (ACD) (e.g., TPN compounders, repeater pumps). ■ Deficiencies related to balances and minimum accurate weighable quantity (MAWQ): ٝ During observation of compounding, the balance was not leveled. All four legs were not touching the deck/worksurface. ٝ Upon interview, compounding personnel did not know the minimum accurate weighable quantity (MAWQ) for their balances. ٝ The pharmacy did not have an MAWQ assigned to the balances used to weigh ingredients. ٝ The pharmacy uses a MAWQ that is not compliant with USP <1176>. ٝ Calibration of balances is performed using weights that have not been certified. ■ Hot plates and stirrers are tested annually for temperature, but there is no threshold for passing or failing. There is no requirement to follow up when they repeatedly do not perform as expected.
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Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-H Frequency of the citation: 27%
■ The pharmacy must maintain a CR for every compounded preparation. The CR documents the ingredients, the compounder, and the approval of the pharmacist—but it doesn’t stop there. ■ A complete CR also includes: ٝ Name, strength or activity, and dosage form. ٝ Date and time of preparation. ٝ Assigned internal identification number (e.g., prescription number, order, or lot number). ٝ Method to identify both the individuals involved in the compounding process and those who verify the final compounded preparation. ٝ Total quantity compounded. ٝ Final yield. ٝ Assigned BUD. ٝ Storage requirements. ٝ Results of QC procedures. ٝ MFR reference, when applicable. ٝ Physical description of the final CNSP, when applicable.
Nerd Newbies (understand the requirement)
Overview of the requirement: Written policies and procedures are established and implemented that outline the contents of the compounding record (CR) for each preparation. Comment on deficiencies: Compliance is evaluated through observation, interviews, and review of policies and procedures. Surveyors cited deficiencies related to incomplete CRs due to missing results of quality control (QC) procedures. CRs were often found to be missing the final yield and physical description. Examples of ACHC Surveyor findings: ■ The pharmacist was observed performing QC procedures, but the results were not documented on the compounding record. ■ The results of QC checks were inaccurate or incomplete. For example: ٝ A paste and capsules were noted as "clear and particulate-free." ٝ Formulas for creams did not have an assessment for the results of expected color and lack of grittiness. ٝ Formulas for suspensions do not contain the results of an assessment or suspendability. ■ The compounding records do not contain a physical description of the final compounded preparation. ■ The sterile CRs do not clearly state the yield as the volume per dispensing unit and the number of dispensing units made. The yield was reported as the total volume in mLs compounded. ■ Troche and suppository dosage forms did not have a quality check done to ensure the weights were within an acceptable variance. ■ The CRs were missing: ٝ The source, lot number, and expiration of ingredients.
ٝ Pertinent calculations. ٝ For each component: о Name.
о Vendor, lot number, and expiration date when CSP is prepared for more than one patient or prepared from nonsterile ingredient(s), and for each CNSP. о Weight, volume, or measurement. о Strength or activity.
ٝ Specification of the supplies needed (syringes, needles, empty sterile bags). ٝ Specification of BUD assignment and rationale (e.g., Mfg for 24 hours). ٝ Calculations of amounts to be added to achieve the final volume. ٝ Specification of which hood is used. ٝ The sterilizing filter in the ingredient list. ٝ Documentation of the container closure system.
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Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips continued:
Examples of ACHC Surveyor findings: ■ The organization has no documentation that employees are fit-tested for respiratory protection appropriate to their assigned duties. ■ There is no evidence that personnel who handle hazardous drugs have received training on: ٝ How to read and interpret a Safety Data Sheet (SDS). ٝ HD spill prevention and management (including use of spill kits). ٝ Use of eyewashes when suspected HD exposure may occur. ■ Training was completed but there was no evidence of competency assessments for personnel who handle HDs. ■ Personnel files did not contain confirmation in writing that they understand the risks of handling HD medications.
■ Audit all CRs for sterile and non-sterile compounded preparations to ensure they contain the information required by the current versions of USP <795> and <797>. Pay close attention to these commonly missed elements: ٝ Results of QC tests. ٝ Physical description of the final compounded preparation. ٝ Source, lot number, expiration of ingredients. ٝ Yield. ٝ Names of compounders and pharmacists involved with the preparation. ■ Compare policies and procedures to current USP guidelines. Update CR processes as necessary and share knowledge with staff. ■ Revise the MFR so that the CRs will prompt the missing elements to be recorded. ■ Develop and implement a checklist for elements of the CR to be use every time. ■ Lead an in-service focused on required QC procedures and documentation practices in the CR. ■ Add successful completion of a CR to required competencies.
Nerd Apprentices (audit for excellence)
Compliance tips for:
Nerd Trailblazers (prepare the path for others)
■ Personnel who handle HDs are trained and competent in the identification, receipt, storage, compounding, repackaging, dispensing, and disposal of HDs, as applicable to their job duties. ■ At a minimum, training and competency assessments include: ٝ Proper use of PPE, including respiratory protection. ٝ The pharmacy’s list of HDs and their risks. ٝ How to read HD labels and SDSs. ٝ Knowledge of the pharmacy’s policies and procedures related to handling HDs. ٝ Proper use of equipment and devices (e.g., engineering controls). ٝ Techniques for compounding with HDs. ٝ Response to HD exposure. ٝ Spill prevention and management. ٝ Proper disposal of HDs and trace-contaminated materials. ■ Update the list of HDs used onsite at least every 12 months and create an assessment of risk for each medication that will not follow USP <800> containment requirements. ■ Audit personnel files and ensure applicable employees have: ٝ Signed an attestation that they understand the risks of handling HDs. ٝ Documentation of training and competencies for handling HD products.
Nerd Newbies (understand the requirement)
SECTION 7: HAZARDOUS DRUG HANDLING PCAB TCRX7-B Frequency of the citation: 31%
Overview of the requirement: Personnel who work with hazardous drugs (HDs) must receive training and demonstrate competency in identification, receipt, storage, compounding, repackaging, dispensing, and disposing of HDs. Note : This standard only applies to compounding pharmacies seeking accreditation for Hazardous Drug Handling PCAB. Comment on deficiencies: Surveyors evaluate compliance by interviewing personnel and reviewing policies, procedures, personnel files, and training logs. Most deficiencies were cited for improper use of PPE, specifically respiratory protection. Surveyors also noted a lack of training documentation and competency assessments.
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Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
NOTES
Compliance tips continued:
■ Develop a program that both ensures and documents fit-testing for respiratory protection. ■ Implement a process for reassessing when fit-testing needs to be reperformed (e.g. significant weight gain or loss or facial surgery affecting mask performance). ■ Evaluate HD competency assessments. Do they include all required elements of the standard? Assess the need for checklists and additional education. ■ Train all staff who handle HDs based on their job functions (receipt, storage, compounding, repackaging, dispensing, and disposal) on the correct process for spill prevention and management (including use of spill kits) and response to known or suspected HD exposure (including the use of eyewashes). ■ Simulate a HD spill, and ensure the spill kit has everything you need to contain and clean up the spill without having to secure additional components. Does your kit have the right supplies (e.g., glove sizes, gowns, wipes, etc.)?
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Volume 2025 | No. 2
SURVEYOR
PHARMACY
SECTION 4: HUMAN RESOURCE MANAGEMENT DRX4-8 A Applicable services: Ambulatory Infusion, Community Retail, Infusion Nursing, Infusion Pharmacy with or without Sterile Compounding, Specialty Pharmacy with or without DME
PHARMACY SERVICES AND DISTINCTIONS
Frequency of the citation: 16%
Services
Distinctions
Overview of the requirement: A written education plan is developed and implemented that defines the content and frequency of evaluations. The plan includes training provided during orientation as well as ongoing in-service training for each classification of personnel. Note: For pharmacies that receive ACHC Community Retail Accreditation, this standard only applies to personnel who provide Community Retail-accredited DMEPOS product codes. Comment on deficiencies: Compliance is evaluated through staff interviews and review of policies, procedures, and training/in- service logs. Deficiencies resulted from gaps in education documentation. The most common issue was lack of ongoing, annual training. Examples of ACHC Surveyor findings: ■ Personnel files did not contain evidence of completion of the following required annual training: ٝ Client/patient rights and responsibilities. ٝ Communication barriers. ٝ How to handle grievances/complaints. ٝ Ethics training. ٝ Infection control training. ٝ Emergency/disaster training. ■ Employees did not have evidence of completion of any annual training. There was evidence that
Ambulatory Infusion Center/Suite Community Retail Hazardous Drug Handling* Infusion Nursing Infusion Pharmacy Infusion Pharmacy without Sterile Compounding
Long-Term Care Pharmacy Mail Order Pharmacy Specialty Pharmacy Specialty Pharmacy without DMEPOS
Infectious Disease Specific to HIV Nutrition Support Oncology Rare Diseases and Orphan Drugs
*Not a stand-alone service. Available for pharmacies seeking or renewing Infusion Pharmacy Accreditation.
FREQUENT DEFICIENCIES IN PHARMACIES
60%
50%
40%
30%
the training was conducted, but a list of employees in attendance was not available. ■ Required topics are only addressed in orientation training, not annual training.
20%
10%
0%
DRX4-8A
DRX5-2B
DRX5-2C
DRX5-4A
DRX7-1D
DRX7-9A
Provision of Care and Record Management
Human Resource Management
Risk Management: Infection and Safety Control
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