Summary:
Summary Statement of Deficiencies D0000 An unannounced investigation of complaint TX00328642 and a recertification survey was conducted on site. An entrance conference was held 01/07/2020 with the laboratory assistant. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 01/07/2020, this facility was found NOT to be compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1441 Laboratory Director High Complexity 493.1487 Testing Personnel High Complexity Complaint TX00328642 was substantiated. An exit conference was held on 01/07/2020 with the laboratory assistant. The exit conference attendee was advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. 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: This STANDARD was not met as evidenced by: Based on review of laboratory records and interview the laboratory failed to verify the accuracy of Dermatologic pathology and Mohs micrographic analyses twice annually to ensure accurate and reliable results in 2018 and 2019. The findings were: 1) Based on review of the laboratory's Proficiency QA records the last peer review assessment for accuracy in Dermatology pathology analysis was performed on 12/4/2017. The last peer review assessment for accuracy in Mohs surgery analysis was performed on 1/15/2017. 2) Proficiency QA records for 2018 and 2019 were requested at 1052 hours 1/7/2020. 3) Based on interview with the laboratory assistant at 1320 hours the proficiencies (peer reviews) were unable to be found. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of patient test requisitions, patient test reports, and in interview with staff, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in preanalytic systems. Findings included: 1. Random review of patient test requisitions with their corresponding patient test reports were requested and included the following: Patient #CS17-08115; collected 11/07/2017; received 11/07/2017; report date 11/08/2017 included documented grossing results without initials of the person who performed the grossing. Patient #CS17-08111; collected 11/07/2017; received 11/07/2017; report date 11/08/2017 included documented grossing results without initials of the person who performed the grossing. The grossing results did not include initials of the testing person or of Testing Person -2 (TP-2), who was the only testing person that qualified to perform grossing. During an interview on 01/07/2020 at 4:20 pm, the laboratory assistants were asked who documented the above grossing results, one of the laboratory assistants stated, he may have written the grossing results from a previous requisition and the one documented on was the corrected requisition. He stated the previous requisitions may have been submitted with errors such as the "wrong site" (of the specimen) and that requisition with errors was shredded. He reviewed and confirmed it was his handwriting for the above documented grossing results (Patients CS17-08115 and CS17-08111). 2. During an interview on 01/07/2020 at 4:20 pm, the laboratory assistants were asked for documentation of