HPC chart completeness-an internal audit

Abstract

Background & Aim According to FACT standards, the cell processing facility should perform internal audits on a regular basis. In CTMF, HPC chart completeness is defined as one of the yearly key audit topics. This study is an example of the HPC chart completeness internal audit, in which selected parameters of the HPC chart were audited and analyzed, to indicate trend and help process improvement. Methods, Results & Conclusion Methods The HPC cryopreservation processes occurred in CTMF from 06/01/2018 to 07/15/2018. Total 5 autologous patients chart, 11 processes were audited. Goal: Compliance 95% at the time of audit, 100% after corrections made. Auditor is the laboratory supervisor, who has the knowledge of the processes, and did not participate in the processes being audited, and therefore independent. Results 1. 59 missing / incomplete entries identified at the time of audit, total 604 pages, 2543 entries audited, approximately 97.7% compliance (entries completed out of all audited entries). After correction, 100% compliance. 2. Incomplete Entry Analysis-per Incomplete Type: (1) Sampling Record and Coulter/Flow print-out contributed to a big portion (20%) of all incomplete entries. Major examples are Sampling and Testing Record cover sheet) missing review, or not initialed and dated. (2) Batch Record: label control took up 1/7 of all entries missed in the batch record. All 18 “Batch Record, Others” missing items were from the last day of patient “D”’s last day of the 4-day collection. (3) 45% (5 out of 11) CryoMed print-out did not have initial and / or date. (4) Chain of Custody, Storage Record, Release Criteria were other weak areas affecting the completion rate. See Figure 1. 3. Incomplete Entry Analysis-per timing Min number of collection/process was 1, max 4. 3 patients had 2 days collections. The 4-day collection had the highest incomplete entries per processing day (7.3). Out of the 59 incomplete entries, 43 (73%) were from Processing Days, 16 (27%) were from After Processing Days (post thaw, infusion). 4. Incomplete Entry Analysis-per staff, Incomplete Rate. Figure 2. 5. Incomplete Entry Analysis-as Performer/as Reviewer. Out of the 59 incomplete entries, 47 (80%) were from performers, 12 (20%) were from reviewers. 6. Incomplete Entry Analysis-per staff as Paperwork Manager. Figure 3. Conclusion Audit result is acceptable. Recommendation is to enhance good documentation practice, enhance Paperwork Magager and facility director review in a timely fashion, especially for multiple days collections.