Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
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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