Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2017, 2018, and 2019 WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing records and interview with TP (testing personnel) 3/21 /19, the laboratory failed to retain all proficiency testing records for at least two years. Findings: 1. The laboratory failed to retain attestation statements signed by the laboratory director and TP for the 2017 SP Micro B2 event, the 2018 SP Micro B2 event, and the 2018 SP Micro B3 event. 2. The laboratory failed to retain the report form used to record responses for the 2018 SP Micro B1, B2, and B3 events. 3. The laboratory failed to retain the graded results for the 2017 SP Micro B2 event and the 2018 SP Micro B3 event. During interview at approximately 10:45 a.m., TP #1 confirmed the records were not retained. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2017, 2018, and 2019 pathology verification records, and interview with TP (testing personnel) 3 /21/19, the laboratory failed to verify the accuracy of the Mohs histopathology and dermatopathology slides at least twice a year during 2017 and 2018. The laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- "QUALITY ASSESSMENT PLAN" states "... 4. Proficiency Testing: Mohs lab will participate in the American Society for Mohs Surgery Proficiency Testing Program as needed for Maintenance of Fellow Membership. Records will be maintained in 'ASMS Proficiency' section of Procedure Manual. Histopathology lab will participate in a peer review of twelve cases per year, as well as, consultation/corroboration of dermatopathology with..." Review of 2017, 2018, and 2019 pathology verification records revealed: 1. The laboratory participated in a peer review for 1 case through ASMS (American Society for Mohs Surgery) during 2017 and submitted 12 dermatopathology cases for review by an outside laboratory in May 2017. 2. During 2018, the laboratory submitted 1 case to ASMS for peer review, but the case was unacceptable. There was no documentation of resubmission. During interview at approximately 1:35 p.m., TP #1 confirmed that the laboratory did not resubmit the 2018 peer review case. He stated they attended the ASMS annual meeting instead. He verified they had not performed any other activities to verify the accuracy of the Mohs histopathology and dermatopathology testing during 2017 and 2018. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with TP (testing personnel) 3/21/19, the laboratory failed to discard supplies that exceeded their expiration dates. Findings: During a tour of the laboratory approximately 12:30 - 12:50 p.m., the surveyor observed the following expired supplies available for use: Mohs Laboratory 1. 1 partial bottle of Gill 2 Hematoxylin (lot #045416, expiration date 9/2017); 2. 1 partial bottle of Eosin - Y Alcoholic 0.25% (lot #046743, expiration date 6/2018); 3. 1 box of Polarstat Plus Frozen Embedding Medium (lot #044033, expiration date 2/2018); 4. 1 box of Dermatophyte Test Medium (lot #1803805, expiration date 2/7/2019). Dermpath Laboratory 1. 1 box of fungus control slides (lot #56547 H, expiration date 1/2019); 2. 3 cubes of 10% Neutral Buffered Formalin (lot #31377, expiration date 7 /2016). During interview at approximately 1:50 p.m., TP #1 stated the formalin was there when he started but it had not been used. D5819 TEST REPORT CFR(s): 493.1291(j) All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility. This STANDARD is not met as evidenced by: Based on review of 2017, 2018, and 2019 DTM (dermatophyte test medium) fungal culture logs and interview with TP (testing personnel) 3/21/19, the laboratory failed to ensure that all DTM test reports were entered in the EMR (electronic medical records system) to ensure timely accesibility. Review of patient DTM fungal culture logs revealed that 19 patient DTM fungal cultures were performed from 12/1/17 - 2/18/19. During interview at approximately 12:05 p.m., TP #1 stated they recently realized that none of the DTM fungal culture results had been entered in patient charts (EMR) -- 2 of 4 -- since December 2017. He stated they are currently in the process of entering them in the EMR. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved