Volume 2024 | No. 2
SURVEYOR
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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