SURVEYOR Volume 2024 | No. 2 Quality Review Edition
Volume 2024 | No. 2
SURVEYOR
TABLE OF CONTENTS
BOARD OF COMMISSIONERS Brock Slabach, MPH, FACHE I Chair CHIEF OPERATIONS OFFICER, NATIONAL RURAL HEALTH ASSOCIATION Maria (Sallie) Poepsel, PhD, MSN, CRNA, APRN Vice Chair OWNER AND CHIEF EXECUTIVE OFFICER, MSMP ANESTHESIA SERVICES, LLC Mark S. Defrancesco, MD, MBA, FACOG I Secretary PAST PRESIDENT, AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS Leonard S. Holman, Jr., RPh I Treasurer HEALTHCARE EXECUTIVE AND CONSULTANT Roy G. Chew, PhD I Immediate Past Chair PAST PRESIDENT, KETTERING HEALTH NETWORK John Barrett, MBA I Board Member-at-Large SENIOR CONSULTANT, QUALITY SYSTEMS ENGINEERING Gregory Bentley, Esq. PRINCIPAL, THE BENTLEY WASHINGTON LAW FIRM Jennifer Burch, PharmD PHARMACIST/OWNER, CENTRAL PHARMACY, CENTRAL COMPOUNDING CENTERS José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER, ACCREDITATION COMMISSION FOR HEALTH CARE Richard A. Feifer, MD, MPH, FACP CHIEF MEDICAL OFFICER, INNOVAGE Denise Leard, Esq. ATTORNEY, BROWN & FORTUNATO Marshelle Thobaben, RN, MS, PHN, APNP, FNP PROFESSOR, HUMBOLDT STATE UNIVERSITY
03 CORNER VIEW
04 FROM THE PROGRAM DIRECTOR
06 FREQUENT DEFICIENCIES IN COMPOUNDING PHARMACIES (PCAB PROGRAM) 23 FREQUENT DEFICIENCIES IN PHARMACIES 36 FREQUENT DEFICIENCIES IN HOME INFUSION THERAPY
LEADERSHIP TEAM
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER Patrick Horine, MHHA VICE PRESIDENT, ACUTE CARE SERVICES Matt Hughes VICE PRESIDENT, CORPORATE STRATEGY Barbara Sylvester, RN, BBA, MSOLQ DIRECTOR, REGULATORY AFFAIRS AND QUALITY
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Volume 2024 | No. 2
SURVEYOR
Welcome to the 2024 Surveyor Quality Review. Each year, program-focused editions of this CORNER VIEW publication analyze compliance with ACHC standards over 12 months of surveys. This year’s data span initial and renewal surveys conducted between June 1, 2023, and May 31, 2024. ACHC-accredited organizations use the data to benchmark their performance by comparing these frequently-cited standards against their own survey report. There is value for non-accredited organizations, too. Because ACHC standards are closely aligned with CMS requirements, the information is relevant regardless of how your organization achieves its Medicare certification. For programs outside the Medicare regulations, the value remains. ACHC standards represent an important risk management/quality improvement framework. Reviewing the kinds of issues that arise in your peer organizations is an opportunity to act preemptively to manage your own risks. This is a critical business function in all healthcare settings. We know that some standards consistently present more compliance challenges than others. Frankly, if we offered only a list of frequent deficiencies, this publication wouldn’t vary much from year to year. Instead, Surveyor Quality Review gives insight into trends by quoting findings and offering practical tips to avoid citations. Some standards appear almost annually because of a large number of required elements. Perhaps a policy needs clarification, or staff members were not fully trained on a revision that impacts their work. Perhaps new or contract employees were not adequately oriented to a requirement for documentation, or employees made a change in their workspace that compromises fire safety. For a complex standard, any of these examples represents a potential deficiency and a risk to the organization, its staff, or its patients.
By sharing the observations of ACHC Surveyors, we offer an expert’s perspective on the most current issues impacting organizations. Trends by Program Internally, we use these data to guide the development of educational resources. Organizations seeking to renew their ACHC accreditation in 2024 were also surveyed in 2021. This year, our leaders are including comparative comments as they introduce their program findings. When we experience a large uptick in the number of initial surveys, as we have for several programs in this period, those difficult standards are likely to be prominent as new organizations confront them for the first time. However, we hope to see at least incremental improvement in standards that appeared as frequent deficiencies for this cohort of organizations three years ago. If we don’t see triennial improvements for some of the most frequently cited standards, it means we need to give more educational focus to these in the resources (webinars, workshops, tools) we offer. It is never ACHC’s intention to leave clients wondering about what is expected. To the contrary, our goal is to provide a range of resources that engage and enrich the experience of continuous quality improvement in the healthcare markets we serve. In this year’s first issue of Surveyor , I wrote about team collaboration and handoffs. Remember that ACHC serves as an extension of your team, ready to confer and coach. With Surveyor Quality Review , we are passing an evidence-based guidance tool to you. I hope you grasp it firmly and run with it!
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.
José Domingos President & CEO
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PCAB COMPOUNDING FROM THE PHARMACY TEAM
On the other hand, TCRX6-E was cited on 20% of surveys in 2021 and has increased to 48% in 2024. It’s this year’s most cited deficiency, and the findings center around calibration, cleaning, and overall maintenance of the equipment used during compounding. Surveyors often assess compliance through direct observation of
Deficiencies for HIT5-1A and HIT5-7A have increased in frequency since 2021. Both standards were previously under 15%. HIT5-1A identifies required data for the client/patient record. HIT5-7A covers the organization’s discharge and transfer processes. In both cases, a lack of documentation was the primary issue, although surveyors did encounter some organizations without any discharge/transfer process in place. While there has been significant improvement since 86% frequency in 2021, HIT5-3C remains the most cited at a 44% rate of noncompliance in 2024. Many findings resulted from an incomplete plan of care (e.g., no safety measures, functional limitations, dose, rate, frequency, etc.). However, more concerning is the persistent lack of documentation of physician involvement. MD orders are essential to Medicare reimbursement for home infusion services. ACHC has deep expertise in pharmacy and our team will continue to partner with organizations of all sizes and interests. Our team is dedicated to helping you to achieve compliance, ensure patient safety, and satisfy payor requirements.
The role of the pharmacy is expanding and ACHC offerings reflect that growth. ACHC pharmacy standards are designed to accommodate a wide range of business models. PCAB Trends The past few years have been an interesting time for compounders. USP introduced General Chapter <800>, prompting changes to both <795> and <797>. ACHC responded with new accreditation standards for both sterile and nonsterile compounding, as well as a new HD service for those who wish to add accreditation for hazardous drug handling. Many of our customers found themselves caught in the middle of this flurry of change and asked us how to navigate the middle ground between “old” and “new.” Our answer? Flexibility. For approximately six months, pharmacies could opt for one of two sets of standards, based on their individual progress towards new USP requirements. Now that ACHC’s compliance date for the new standards has passed, one set of ACHC standards is in place for each service. However, we will continue to propose thoughtful, intentional solutions whenever possible. This year’s report highlights TCRX3-B as an impressive improvement, cited on 85% of surveys conducted in 2021 and down to 31% in 2024. This standard is for sterile compounding only, and the decrease in frequency reflects an increase of awareness surrounding competencies, training, and documentation. While we would love to see this percentage decrease further, it’s still a positive trend in the right direction.
compounding staff at work. Other Pharmacy Results
ACHC accredits many types of pharmacies in addition to those in the compounding space. For organizations in this group, the 2021 report cited ten standards above a 15% threshold. The 2024 report cites only four standards above a 15% threshold, reflecting a determined effort from pharmacies to reduce error, improve education, and institute quality controls. DRX5-2C wins the award for “most improved,” having decreased from 30% frequency in 2021 to 15% in 2024. Based on questions we receive during surveys, workshops, and conferences, we included three extra standards at 12%. While a frequency of 12% is certainly a very low threshold, our goal is to address common concerns and provide educational support. Home Infusion Therapy Results In 2021, four standards appears as deficiencies on more than 20% of surveys. This year five standards reached that threshold. As in 2021, these frequently cited standards all come from Section 5: Provision of Care and Record Management .
Jeffrey Reses, R.Ph., HDDP Senior Clinical Pharmacy Liaison
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PCAB COMPOUNDING CLINICAL LABORATORY
SECTION 3: PERSONNEL TRAINING AND COMPETENCY TCRX3-B Overview of the requirement: Note: This standard applies to sterile compounding only.
PCAB is a brand of ACHC focused on accreditation of compounding pharmacies subject to the regulations of the United States Pharmacopeia Convention (USP). PCAB accreditation recognizes these pharmacies for quality and consistency in producing sterile and nonsterile compounded medications.
Policies and procedures require both sterile compounding personnel to complete training/education prior to being assigned work independently. Required competencies are documented annually and/or semiannually, in areas consistent with the risk level of the compounding. Compliance is evaluated through review of policies, procedures, the competency assessment program and associated logs, and response to interviews. Most deficiencies noted inadequate competency assessments and missing documentation.
Comment on deficiencies:
PCAB ACCREDITATION
Frequency of citation:
31%
Services Non-Sterile Compounding Hazardous Drug Handling (Ref. USP <800>)
Examples of surveyor findings:
n The forms used in the pharmacy’s software did not allow for the documentation of the temperature of the incubator at the time the media fill was pl aced In the incubator and did not include the incubation range requirements, so it could not be determined from the records how the media was incubated. n The pharmacy lacked documentation of a competency assessment for cleaning and disinfecting procedures for all appropriate personnel. n The media fill process did not include the most challenging or stressful conditions the compounder may encounter. n The media fill result form is missing: Expiration date, lot #, and manufacturer. Documentation of growth or no growth during the time of incubation. Documentation of the date when test units were moved from one incubator to the other. n The technique used for performing gloved fingertip/thumb sampling (GFT) was touching the plate instead of rolling the fingertips over the plate. n Personnel files lacked: Initial GFT competencies resulting in zero colony forming units from both hands following three separate and complete evaluations in a row. Annual didactic training on hand hygiene and garbing. Evidence of initial didactic & written training/competency assessments prior to personnel performing or overseeing sterile compounding.
Sterile Compounding Hazardous Drug Handling (Ref. USP <800>)
FREQUENT DEFICIENCIES IN COMPOUNDING PHARMACIES
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
TCRX3-B TCRX4-A.01 TCRX5-D TCRX5-F TCRX5-G TCRX6-C TCRX6-E TCRX6-G
TCRX6-I
TCRX6-L
Personnel Training and Competency
Provision of Care and Record Management
Quality Outcomes/Performance Improvement
Patient Communications
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SECTION 4: PATIENT COMMUNICATIONS TCRX4-A.01
Tips for complianc e:
n Ensure pharmacy software and manual forms capture all required information. n Tailor competencies and skills assessment so they are specific to the risk level of the compounding, the employee’s role, and job responsibilities. .Ensure all personnel who compound and oversee compounding receive annual didactic training on cleaning and disinfecting procedures and competency assessment according to USP <797>, the organization’s policies and procedures, the category of compounding, and the employee’s job responsibilities. n Document the media fill process in detail in a policy and procedure to create a consistent and reproducible procedure. n Use gloved fingertip/thumb sampling (GFT) tests to validate garbing and gloving techniques. .Conduct Initial GFT tests on three separate occasions, performing complete hand hygiene, garbing, and gloving each time. The three samples may be completed on the same day as long as the personnel goes through the entire hand hygiene, gowning, and gloving sequence from beginning to end with zero CFUs for both hands for three successful completions in succession. Testing must be done in the current facility when the compounding environment Is not laid out the same, compounding equipment Is different, or the facility policies and procedures are not exactly the same as the facility where the testing was conducted because compounding practices can vary In different locations within the same organization. .Clearly document the sampling plan for the GFT program. Include when to read plates based on the initial placement into the incubator, the appropriate temperature range and duration in which plates are incubated, and the initial 3 post-gowning GFT results at 0 CFUs on both hands prior to new personnel entering the buffer room unsupervised.
Overview of the requirement:
Policies and procedures define the content of an accurate record for each patient. Compliance is assessed through review of policies and procedures and patient/ client records. Most deficiencies noted incomplete drug utilization review (DUR) and missing documentation of patient refusal.
Comment on deficiencies:
Frequency of citation:
30%
Examples of surveyor findings:
n Patient information was not collected to complete a thorough drug utilization review (DUR) for: Treatment diagnosis and other health conditions. Height and weight. .Medical/health conditions. .Other patient medications (both prescription and non-prescription). n The pharmacy does not have a form/template or a designated location within the pharmacy computer software to collect this pertinent information. n There was no documentation in the patient record when the patient refused to provide the pertinent patient information. n The pharmacy’s SOPs did not address collecting information regarding the diagnosis for the prescription, other prescription and non-prescription medications, and other medical/health conditions. n Develop a process to routinely collect the required information for the patient chart. Create an intake form or an assessment template within the pharmacy’s computer software and use it for new and existing patients. ٝ Educate staff to fill out the form or where to document the information correctly with the pharmacy computer software. Have the pharmacist review the patient information for completeness as part of performing the final check of a prescription, prior to release. Document patient refusals. Implement a process to audit patient records to verify ongoing compliance. n Audit the pharmacy’s SOPs to ensure required elements are included.
Tips for compliance:
Media fill testing must simulate the most complex sterile compounds prepared by the pharmacy and address the most challenging or stressful conditions the compounder may encounter.
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TCRX5-F
SECTION 5: QUALITY OUTCOMES/PERFORMANCE IMPROVEMENT TCRX5-D
Overview of the requirement:
Incidents, accidents, and complaints/grievances are tracked and trended at least quarterly as performance improvement activities. This includes data on infections and communicable diseases. This standard is evaluated using quarterly PI reports and incident/variance reports. In many cases, deficiencies were noted when patient and staff infections and illness were not reported or monitored for risk. Data is not consistently trended across time to look for patterns and improvement opportunities.
Overview of the requirement:
The PI Program includes activities with a goal and description of who, what, when, and how for each. Surveyors review documentation of performance improvement activities to evaluate compliance. Most deficiencies were cited for missing elements, particularly goals/thresholds, and plans of correction.
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
26%
Frequency of citation:
25%
Examples of surveyor findings:
n The pharmacy lacks evidence of a written, effective, ongoing Performance Improvement (PI) Program. n Although the pharmacy had a Performance Improvement Program, it did not include: ٝ . Who is responsible for conducting PI activities? .A description of how data is gathered and organized. .Goals/thresholds or proposed plans of correction when goals/thresholds are not met. .Evidence of an activity/study as a component n The pharmacy lacks formal documentation of PI activities. Data is available but not analyzed and trended effectively. n Create a formal PI Program that includes the required activities, frequency of activities, who is responsible for conducting the activities, method of data collection, and who will receive the reports. n Add acceptable goals/thresholds to PI activity logs and create a standardized evaluation form to be used whenever an aspect of the PI Program fails to meet the goal/threshold. n Ensure each activity/study includes each of the required items, which can be done by using a template with clear places to add each of these items. A PI Program can be instrumental in an organization’s success. Don’t just include leadership; ask if any other personnel would be interested in participating with the PI Program. Staff members work daily in the organization’s environment and can bring valuable insight into the issues that arise and may have great suggestions on how to approach problem solving.
Examples of surveyor findings:
n Quarterly and annual PI reports were not in evidence. n The quarterly reports lack summarizing trends, patterns, and actions to decrease recurrence. n The pharmacy does not include data concerning reports of patient and staff infections as part of the overall Performance Improvement (PI) Plan. n Compare incident reports with quarterly reports to verify the monitoring of trends over time. n Include a component of infection prevention in your PI Program and quarterly/ annual reports. n Integrate an element of ongoing monitoring of processes that involve risks, such as an employee illness log. Document if personnel are following the infection control policy upon return to work. Monitor and report any patient and staff infections as part of the overall PI plan. Develop a method of voluntary self-reporting for employees. Individuals must report and be evaluated by the designated person(s) as to whether they have a personal risk of potentially contaminating the compounding environment and compounded preparations. The designated person(s) is responsible for evaluating whether to exclude these individuals from working in the compounding area before their condition has resolved.
Tips for compliance:
Tips for compliance:
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SECTION 6: PROVISION OF CARE AND RECORD MANAGEMENT TCRX6-C
TCRX5-G Overview of the requirement:
Written policies and procedures are established and implemented regarding continuous quality control for finished preparations. Compliance is evaluated through review of policies, observation, and response to interviews. Most deficiencies resulted from incomplete policies and procedures for testing, as well as a lack of follow through when testing does not meet the requirements.
Overview of the requirement:
Policies and procedures are written to support safe storage, labeling, handling, and disposal of pharmaceutical components and preparations. Compliance is assessed through direct observation, interviews, and review of policies and logs. Deficiencies noted improper storage, insufficient cleaning practices, and incomplete documentation of environmental controls.
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
28%
Frequency of citation:
44%
Examples of surveyor findings:
n The pharmacy’s policy on testing lacks: The acceptable limits of the test.
Examples of surveyor findings:
n Storage: ٝ . Written policies and procedures were not established and implemented relating to the storage of pharmaceuticals, components (including APIs, excipients, ingredients, and devices) and compounded preparations. .The expiration date was extended in the compounding software when products were expiring before the assigned BUD for the compounded preparation when the product was needed to complete a compounded preparation. There was no process in place that required compounding personnel to verify a product’s labeled expiration date to ensure its accuracy in the compounding software system and that it was not altered. ٝ .Active and inactive ingredients being stored on the floor along with corrugated cardboard boxes being permanently stored in the compounding area. .Hazardous APIs and antineoplastic hazardous medications that required further manipulation were not stored separately from other non- hazardous items. .The date of transfer was missing on the label of smaller storage containers when used to transfer ingredients from larger containers. n Cleaning and disinfection: ٝ . Reusable containers (e.g., glassware, speed mixer jars) are cleaned and washed in the dishwasher, but there is no disinfection (or sanitization) step. ٝ . Cleaning agents used are not listed on the cleaning logs and the logs are also consistently missing dates and signatures. .A nonsterile HD room was observed being mopped using a reusable household sponge mop using a ready-to-use solution that was randomly diluted when no further dilution was needed. .A negative pressure C-SEC was observed to have extensive amounts of dust and cobwebs. n Temperature and humidity are not monitored and/or documented daily on days the facility Is opened or via a continuous recording device in all drug storage areas, including will-call area and each room of a cleanroom suite.
ٝ .Specific actions required when a preparation does not meet the test. .How quality control information is incorporated into the pharmacy’s PI Program. .Frequency of required testing for sterile and nonsterile preparations. n The compounder’s finished preparations are not tested for potency in each of the dosage forms they prepare: solutions, suspensions, capsules, tablets, suppositories, creams/ointments, and lozenges. n The pharmacy makes some preparations on a weight/weight basis and dispenses using a volumetric device. The pharmacy did not have evidence that the device is accurately dispensing the stated mg amount. n Quality control (QC) testing is not being used to improve the performance of staff. Several potency tests for formulas made by the compounding staff have not been thoroughly investigated as quality related events (QREs). n Implement a testing or quality control program to verify the quality of preparations and the competency of personnel. Include: ٝ . When to test preparations. .What test(s) should be performed. .How to interpret the test and acceptable limits. ٝ .Specific actions required when a compounded preparation does not meet the test. .How quality control information is used to improve the performance of personnel. .How quality control data is incorporated into the PI Program. n Develop an SOP governing QREs and adhere to the process of investigation and resolution. Document any out of specification results and actions taken. n Test the dispensing devices to assure accuracy of dispensing for formulas made as mg/gram and dispensed as an mL dose. Evaluate the bases used and concentrations of added ingredients. n Document potency testing of the compounder’s finished preparations in every dosage form they prepare.
Tips for compliance:
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TCRX6-E Overview of the requirement:
Policies and procedures describe the use, calibration, cleaning, and disinfection or sterilization of equipment used throughout the compounding and delivery process. Compliance is assessed through review of policies and procedures, review of manufacturer’s instructions, response to interviews, and direct observation. Deficiencies were focused on calibration, environmental controls, and cleaning/ disinfection procedures. Surveyors noted several issues specific to the use of balances for compounding.
Comment on deficiencies:
Frequency of citation:
48%
Examples of surveyor findings:
n Calibration: ٝ .Magnehelic pressure gauges, pH meter(s), and the filter integrity gauge are not being checked for accuracy and calibrated as specified by the manufacturer. .The ACD (Repeater Pump) is calibrated each day prior to use but is not being documented. .A hot plate was required to be set at 70 degrees, but there was no calibration mark for that temperature. ٝ .Issues specific to balances: о The balance is missing one of the leveling feet. о The calibration weights being used by the pharmacy are not certified or assessed for accuracy.
Tips for compliance:
n Storage: ٝ . Make sure policies and procedures reflect pharmacy practices and vice versa. .Materials, supplies, chemicals, or components used in compounding must not be stored on the floor. .Remove all corrugated cardboard boxes from the compounding area(s). .Label storage containers with the name, strength, lot number, expiration date, transfer date, manufacturer, and appropriate warning labels. .Regularly audit the entire inventory to remove expired and outdated chemicals, preparations, and components. о Do not rely on just the pharmacy software, do this manually. о Any product left in inventory must have sufficient time left before expiration so that the product does not limit the BUD of the finished compound. ٝ . Store hazardous medications separately from other non-hazardous items. n Cleaning and disinfection: .Document the cleaning and disinfecting agent(s) used on the cleaning logs. .Use cleaning agents per the manufacturer’s directions. .Mop heads for the HD rooms should be disposable and discarded after each cleaning. Mops handles must be made of cleanable material (e.g., handles should not be made of wood or any other porous material) and must be cleaned and disinfected before and after each use. .Appropriately clean and sanitize/disinfect reusable containers.
о The minimum weighable accurate quantity (MWAQ) for the balances is not posted, and compounding personnel were not able to verbalize the correct MWAQ for the balance. о A balance was repeatedly moved while cleaning the hood and was not releveled and recalibrated after being moved. о A balance had not been moved for an extended period of time, as evidenced by an extensive amounts of powder under the balance.
n Temperature, humidity, and pressure differential:
The temperature/humidity devices are not appropriate for pharmacy use. The pharmacy does not verify the accuracy of its temperature and humidity sensing devices in a manner that complies with NIST standards and within the last 12 months. An ISO 8 pre-sterilization area was not being monitored for pressure differentials. n Issues specific to the powder containment hood: Operating the hood with the sash in the utmost position.
n Temperature and humidity:
ٝ . Document correct actions when temperature excursions occur. .Monitor temperatures and humidity for all applicable areas of the pharmacy at least once per day on days the facility is open or via a continuous recording device.
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Visible residue and white powder on surfaces Inside and outside the hood. Cracks along the outer edge and in the panel or missing panels. n The balances and hot plate/stirrers are very stained and have visible residue. n Of the four ointment mills, one had a torn cover, three had visible residue, and all four had a wool pad underneath that was not cleanable.
TCRX6-G
Overview of the requirement:
Policies and procedures define the contents of the Master Formulation Record (MFR) for every nonsterile and all nonsterile to sterile (“high risk”) compounded preparation or sterile compounded preparations prepared for more than one patient. The MFR requires a minimum of 13 elements. Compliance is assessed through review of the policies and procedures, direct observation of compounding, and response to interviews. Most deficiencies cited incomplete quality control procedures, incorrect compounding instructions, and inconsistencies with BUD assignment.
Comment on deficiencies:
Tips for compliance:
n Calibration:
Maintain daily written or electronic documentation demonstrating compliance with equipment calibration, verification, accuracy measurements, and maintenance requirements. Ensure that the calibration log states the expected frequency for calibration. ٝ .Calibrate equipment periodically as specified by the manufacturer, or annually, as appropriate. .Educate, train, and assess the competency of staff on the process of calibrating equipment. n Temperature, humidity, and pressure differentials: .Ensure temperature sensing devices used to monitor temperature in drug storage areas are all within the appropriate calibration date.
Frequency of citation:
38%
Examples of surveyor findings:
n Master formulation records lack critical detail for someone unfamiliar with the compounding process to produce the compound from start to finish and with the same consistent quality each time. n MFR Issues: .BUDs being assigned inconsistently with USP standards, what was stated on the MFR was not what was stated on the label, and the justification for the BUD Is not accurate for the compounded preparation. .Equipment was not all listed or the instructions lacked calibration of the equipment. .The instructions for compounding the preparation: о Lacked instructions to measure the ingredients. о The instructions did not match the process used to compound the preparation. о Instructions stated to use a specific piece of equipment, and a different piece of equipment was used.
ٝ .Use NIST-certified thermometers and hygrometers to record temperatures and humidity in the buffer and anterooms.
n Cleaning, disinfection/sterilization:
.The pharmacy should ensure that all surfaces of the hood are deactivated, decontaminated, cleaned, and disinfected/sanitized, as appropriate per USP <795>, <797>, and <800> standards. .Operate all hoods with the sash at the proper level, as reported in your certification report. All compounding personnel must know the operational limitations of the equipment used, especially their balances. Ensure that the balances are properly positioned. All of the feet should be in contact with the surface of the direct compounding area. Check to ensure the balance is level prior to each compound, especially if it was moved for cleaning. Know the MAWQ of your balances; refer to USP <1176>. When performing final checks of compounded preparations, ensure the appropriate balance was used based on the MAWQ of the balance.
n Quality control procedures.
The expected quality control Indicators (e.g., color, odor, texture, consistency) were not always stated on the MFR. ٝ .The expected result of the filter integrity test was not stated. ٝ .Lacked verification of the actuation of a dosing dispensing container when dosed by clicks. .No theoretical weight was stated on the MFR for the compounder to compare to when performing weight variation testing. .Particulate visual inspection was not included. .MFR states the quality control testing (e.g., USP <51> test to be conducted but it is not performed. n Observed a pharmacy technician revising an existing MFR instead of making a new MFR which is then reviewed by a pharmacist prior to compounding. There is currently no policy, nor training documented on this procedure.
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Examples of surveyor findings:
n The policy governing nonsterile compounding lacks:
Tips for compliance:
n Verify ongoing compliance with the MFR requirements by auditing a certain number of formulas at a certain frequency. n Mark the MFR with a revision date to easily identify that it has been updated and complies with the 2023 chapters of USP <795> and <797>. n List the quality control tests to be performed and the expected results on the MFR. n Ensure that all BUDs referenced on the MFR are accurate, complete, and reflect the new USP <795> and <797> standards. n Train staff when they identify any variances in the compounding process compared to the MFR to report it to a pharmacist to ensure the appropriate revisions are made. n MFRs must include what container/closure system is to be used to package and dispense the compounded medication. n Develop a process, training, and competency assessments for pharmacy technicians who will be allowed to modify MFRs. n All instructions contained on MFRs should be detailed enough to allow someone unfamiliar with the compounding process to produce the compound from start to finish and with the same expected quality each time. n Create a process to ensure MFRs are created and reviewed by at least one other pharmacist prior to finalization and use. n Review and update MFRs to include accurate ingredient weights/quantities and mixing instructions with equipment settings, if appropriate. n Ensure that all BUD reference studies are appropriate. Even small variances in process and materials can invalidate a BUD study conducted with a specific base because there is no standard formulation for bases and they can vary in water content, pH of the aqueous environment, surfactants and emulsifiers used and many other variables that can affect the ultimate physical and chemical stability of the formulation.
Checks and rechecks for each procedure at each stage of the process. Personal hygiene, hand washing, gowning, and gloving for non- hazardous nonsterile compounding. Documentation of deviations that occur during compounding.
n Additional observations:
The compounder was observed not routinely capturing and recording all balance tares, thereby obviating the ability to perform in-process checks for each stage of compounding the preparation. Cross-contamination issues: о A disposable lab coat was not removed and properly discarded after being visibly contaminated on the sleeves with an API. о One compounder was compounding capsules using loose powders on the countertop at the same time as another technician was weighing and mixing loose powder outside the containment ventilated enclosure (CVE) on the same countertop in very close proximity to the other compounder. Neither compounder compounded within the containment ventilated enclosure (CVE). о There was visible residue on the Hobart mixer, powder hoods, electronic balances, and the hot plate/stirrers. Compounders being repeatedly interrupted during critical compounding processes for issues unrelated to the compounded preparation being compounded at the time. The pharmacy did not clean compounding equipment between compounds with different ingredients. Several stock formulations made did not contain the electronic notation of the pharmacist’s initials; to illustrate, a final check of the preparation was performed, and which pharmacist performed it.
n The pharmacy uses an unsanitary cart to transport chemicals. The cart had visible powder residue on each shelf. There was rust present on the cartwheels and castors.
TCRX6-I Overview of the requirement:
Note: This standard applies to nonsterile compounding only. Policies and procedures define techniques for how nonsterile compounding is performed. Compliance is assessed through review of the policies and procedures, direct observation of compounding, and response to interviews. Most deficiencies resulted from errors observed during compounding procedures, particularly those related to cross-contamination and quality control. Cleaning and sanitizing procedures were also cited.
Tips for compliance:
n Ensure policies and procedures address appropriate hygiene, garbing, and gloving. Gloves and the appropriate garb (mask, gown, beard cover) that must be worn when handling compounded preparations. Use compounding garb that adequately prevents the potential for cross- contamination, including, but not limited to, disposable sleeve covers.
Comment on deficiencies:
Frequency of citation:
39%
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PCAB COMPOUNDING
Examples of surveyor findings:
n During the observation of compounding, the technician used a stock solution and entered an incorrect lot number on the compounding record. After using the vial, it was discarded in the trash. It was stated that there is no “in-process” check currently being performed. No volumes were being double-checked. n During the observation of the media fill the following was noted: A rubber stopper was dropped on the deck very near the front opening of the vertical flow hood and was used. Rubber stoppers were opened from autoclave bags and poured out in a pile on the deck and not laid out appropriately for first air. ٝ A preparation was not sterilized in the final dispensing container, and the tip of the tubing used to fill the dispensing containers was not kept sterile and in direct first air. Gowns were not fully zipped and closed. Sterile gloves were not regularly disinfected with sIPA during the compounding process. n Handwashing technique: Nails were not cleaned using a nail pick/cleaner under warm running water. Upon rinsing, water drained from the elbows back down to the hands, potentially contaminating the hands with contaminated water from the upper forearms. n The compounder was observed removing their hands from inside the PEC (LAFW) to remove waste and bring in supplies. The hands were not re-sanitized with sterile isopropyl alcohol (sIPA) 70% before returning to work inside the PEC. The moving of hands from outside and inside the PEC was not kept to a minimum. n The technician’s head entered the hood during compounding and cleaning. During Category 3, compounding skin was showing, and a nonsterile respirator was worn. n The particulate matter inspection was not performed using a black/white background box prior to labeling. n An appropriate smoke test was not performed to determine if there was any ingress of air from the HD buffer room to the pre-sterilization area. There is a large pass-through and it does not have its own source of HEPA-filtered air. n The pharmacy lacks a process to validate that bulk bottles of medications are reconstituted appropriately before they are used to make CSPs. n First air principles: First air was blocked in the vertical and horizontal laminar hoods during the filling of vials. ٝ When disinfecting gloves or filling vials, the placement of supplies caused the technician to block first air to the tops of vials and the critical site on syringes.
n Implement policies and procedures regarding measuring, weighing, and mixing loose powders. Develop a process for powder containment. Keep supplies such as weigh boats and spatulas outside of the powder hood due to the potential for cross-contamination. n Create a thorough training and competency process for all compounders and pharmacists who oversee the compounders and provide final checks of the compounded preparations. n Educate technicians that compounding directions should be followed as described, including order and method of mixing components. Direct staff that any deviations should be documented. Review common deviations to determine if compounding records and master formulation records should be adjusted. The compounding record should be a complete and reproducible record of the compounding process. n Ensure that all personnel remain uninterrupted while performing critical tasks Verify cleaning and sanitizing processes comply with USP standards. Appropriately clean compounding work surfaces and equipment after use. Change to all disposable equipment if cleaning procedures are not able to effectively remove all drug residue. Examine each piece of equipment prior to use for any wear and tear or damage that requires repair prior to use.
Conduct an annual observation competency assessment of compounders to ensure they comply with the compounding process as stated in the MFR and CR.
TCRX6-L Overview of the requirement:
Note: This standard applies to sterile compounding only. Policies and procedures define techniques for how sterile compounding is performed. Compliance is assessed through review of policies and procedures, direct observation of compounding and response to interviews. Most deficiencies cited errors in hand hygiene and garbing, aseptic technique, and principles of first air.
Comment on deficiencies:
Frequency of citation:
33%
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SURVEYOR
PCAB COMPOUNDING
Tips for compliance:
n Train and critically observe all personnel performing hand washing, gowning, and gloving. Ensure that the sterility of the hands and gloves is uncompromised throughout the compounding process. Avoid placing the gloved hands in or on the waste receptacle. n All personnel should know how to appropriately stage supplies into the compounding area so as not to impede the compounding process or block first air, including wiping them with sIPA or an EPA-registered disinfectant agent whenever they are transferred from a less sterile ISO environment to a more sterile ISO environment and when introducing them into the direct compounding area. n Educate staff on aseptic technique and proper hand placement for the various types of hoods (e.g., vertical, horizontal) used in the pharmacy to ensure first air is not blocked. n Ensure all compounding stages have checks and rechecks. n All personnel must understand how to use equipment, even something as fundamental as a syringe. n Clean in a manner that does not potentially introduce contamination from outside of the LAFW into the compounding area of the LAFW. n A sterile cleaning and disinfecting agent(s) must be used when cleaning inside the PEC. n Establish a process to ensure bulk vials of medications are reconstituted appropriately before their use in CSPs. It may be helpful to ask the hood certifier to make a second recording of the dynamic airflow smoke study, but on the second recording, intentionally interrupt the first air in the horizontal and vertical hood so the technician can visualize the impact of first air interruption.
PHARMACY ACCREDITATION
Services
Distinctions
Ambulatory Infusion Center Community Retail Infusion Nursing Infusion Pharmacy Long-Term Care Pharmacy
Infectious Disease Specific to HIV Nutrition Support Oncology Rare Diseases and Orphan Drugs Telehealth
Mail Order Pharmacy Specialty Pharmacy Specialty Pharmacy without DMEPOS
FREQUENT DEFICIENCIES IN PHARMACIES
60%
50%
40%
30%
20%
10%
0%
DRX1-4A DRX2-4C
DRX4-7A
DRX5-1A
DRX5-2B
DRX5-2C
DRX7-5B
DRX7-9A
DRX7-9B
Organization and Administration
Provision of Care and Record Management
Program/Service Operations
Human Resource Management
Risk Management: Infection and Safety Control
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PHARMACY
SECTION 1: ORGANIZATION AND ADMINISTRATION DRX1-4A
SECTION 2: PROGRAM/SERVICE OPERATIONS DRX2-4C
Overview of the requirement:
There is an individual who is designated as the manager/leader responsible for the overall operation and services of the organization. Another individual is authorized, in writing, to act as the manager/leader in the absence of the manager/leader. Ambulatory Infusion, Community Retail, Infusion Nursing, Infusion Pharmacy with or without Sterile Compounding, Mail Order Pharmacy, Specialty Pharmacy with or without DME Compliance is evaluated through direct observation and review of personnel files. Most deficiencies were related to the appointment and job description of the temporary/alternate leader.
Overview of the requirement:
At the time of admission, patients are provided with written information regarding how to contact the organization, relevant state agencies, and ACHC with grievances/complaints about the care/services they receive. Ambulatory Infusion, Community Retail, Infusion Nursing, Infusion Pharmacy with or without Sterile Compounding, Mail Order Pharmacy, Specialty Pharmacy with or without DME Admission packet and patient record reviews are used to validate compliance. Deficiencies noted a lack of documentation of patient/client receipt as well as missing content from the admission packet itself. In several cases, information for the state BOP was not listed.
Applicable services:
Applicable services:
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
12%
Frequency of citation:
13%
Examples of surveyor findings:
n A temporary leader has not been appointed to act in the absence of the leader. n The duties of the temporary leader were not included in the job description. n There was a statement in the job description for the PIC, but the duties of the PIC as the temporary leader were not included in the appropriate job description. n Although the job description addendum for a temporary leader was available, the form was not filled out including the name of the temporary leader and the required signature. n There was no application or resume of the alternate manager/leader verifying the education and experience required for the position. n Authorize, in writing, an individual to act as the temporary leader. n Add the duties of the temporary leader to the appropriate job description or create a job description specific to the temporary leader and have it reviewed by the appropriate individual. n Designate, in writing, an onsite alternate administrator with the responsibility and authority for the daily operation of the agency during absence of the administrator. n Document evidence to support that the alternate manager/leader is qualified for the position.
Examples of surveyor findings:
n The organization’s new patient packet did not contain:
ٝ . The name or position of a contact person to reach out to voice a grievance or complaint. ACHC’s telephone number (once accredited). .The organization’s process for receiving, investigating, and resolving grievances/complaints about its care/service. The appropriate state regulatory body’s hotline telephone number. о Site is dispensing to Georgia residents, but the Georgia BOP contact info is not provided. о The contact information for the NY Board of Pharmacy is missing. о There was no evidence that the patient was provided information required by Florida AHCA regulations. о The telephone number of the Louisiana Board of Pharmacy (BOP) was not included.
Tips for compliance:
n Patient/client records did not have documentation of receipt of: New patient welcome packet.
.Information about the organization’s process for receiving, investigating and resolving grievances/complaints about its care/service.
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SURVEYOR
PHARMACY
Tips for compliance:
n Update the policy concerning the patient complaint and grievance process to ensure it includes all contents required by ACHC standards. n Once accredited, add ACHC’s phone number to written documentation in the event the client/patient does not have access to the website or requests a written copy. n Audit state regulations for required language and current agency/pharmacy board contact information. Reeducate personnel on the contents of the new patient packet and how they are to document providing this information to the client/patient at the start of care. Implement a consistent process for documenting proof of receipt by the client/patient of the new patient packet (e.g., include it on delivery tickets as a start of care line item).
n The personnel records lacked documentation of an initial competency assessment upon hire, annually, and prior to personnel performing a new task. n Personnel files reviewed did not contain documentation of training and competency assessments for infusion pumps. n Current competency assessments for pharmacists and technicians were identical and did not include a specific focus on the pharmacist’s role in educating patients on specialty drugs. n Personnel records reviewed showed competency assessments completed solely using self-assessments. n Complete and maintain documentation of a competency assessment completed upon hire, annually, and prior to personnel performing a new task. n Develop a process that encompasses all required elements, including frequency and methods. Note that self-assessment alone is not acceptable. Peer review of clinical personnel competency by like disciplines is acceptable if defined by the organization. n Ensure that the assessment of skills is specific to the employee’s role and job responsibilities: Address the unique responsibilities of pharmacists, including educating patients on specialty drugs. Distinguish these responsibilities from non- clinical staff. Conduct assessments for all ambulatory infusion nurses to ensure they are proficient in the essential topics and procedures. Consider utilizing a course to assess pharmacists’ knowledge of disease states pertinent to the pharmacy’s specialties. Ensure comprehensive coverage of the nurse’s role in providing infusion therapies. Your nursing competency form should include essential topics such as various line care and maintenance, infusion procedures, administration of various infusion drugs, drug education, and counseling for patients based on different therapy types.
Tips for compliance:
SECTION 4: HUMAN RESOURCE MANAGEMENT DRX4-7A
Overview of the requirement:
The organization must design a mandatory Competency Assessment Program for all personnel who set up, train, clean, test, repair, and/or educate on the use of medications, equipment, and/or supplies. n For pharmacies that receive ACHC Community Retail Accreditation, this standard only applies to personnel who provide Community Retail-accredited product codes. n Organizations accredited for Infusion Pharmacy with Sterile Compounding should refer to DRX4-7C for competency assessment requirements. Ambulatory Infusion, Community Retail, Infusion Nursing, Mail Order Pharmacy, Specialty Pharmacy with or without DME Compliance is evaluated through review of policies and procedures and documentation of ongoing competency assessments. Most deficiencies resulted from missing documentation of required competencies in individual personnel files. Assessment of skills must be specific to the employee’s role and responsibilities.
Applicable services:
Comment on deficiencies:
Frequency of citation:
15%
Examples of surveyor findings:
n Written policies and procedures did not address competency assessments that ensure personnel educating patients on the use of medications are competent to provide quality care related to the medications and disease states managed by the organization. n Written policies did not address the procedures required for the organization to design a Competency Assessment Program, which ensures that personnel educating patients on the use of medications are competent to provide quality care.
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