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.
Nerd Apprentices (audit for excellence)
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