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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