Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with the laboratory staff and the technical supervisor (TS), the laboratory did not ensure that an eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory, it was observed that there was no eye wash station available in the laboratory where laboratory testing is performed. During an interview at 10:35 AM on the day of the survey, laboratory staff stated that the eye wash station was down the hall in a patient room. 2. During an interview on 11/19/2021 at 1:00 PM, the TS confirmed that the eye wash station was not located in the room where laboratory testing is performed. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on procedure manual and record review and interview with the technical supervisor (TS), the laboratory failed to establish and follow written policies and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedures to assess employee and, if applicable, consultant competency. Findings: 1. The laboratory director delegated the responsibilities for the positions of clinical consultant (CC), general supervisor (GS), and TS to the testing person (TP) who performs histopathology testing in the laboratory. 2. During an interview on 11/19 /2021 at 1:00 PM the TP stated that they began work at the laboratory in November, 2020. 3. Procedure manual review showed that the laboratory did not have a written procedure for how to assess the competency of the TP in their role as the TP or in their duties as CC, GS, and TS. 4. Record review showed that there was no documentation that the laboratory had performed competency assessments on the TP to evaluate their performance as TP, CC, GS, and TS. This was confirmed by the TS during the exit interview. 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 procedure manual and quality assurance (QA) review and interview with the technical supervisor (TS), the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The laboratory's PT procedure states that twice a year the laboratory will send 3 patient cases to another pathologist for review. 2. A review of QA records showed that there was no documentation that PT slides had been sent out in 2020. 3. During an interview on 11/19/2021 at 1:00 PM, the TS confirmed that PT slides were not sent out in 2020. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review and interview with the technical supervisor (TS), the laboratory did not follow written procedures for performing QA in the laboratory. Findings: 1. The "Mohs Quality Assurance Manual" was reviewed. "Section III. Post-Analytical" states, "Twice a year the Histotechnician, Director of Laboratory Operations, or the Mohs surgeon will review cases previously done. This process will include pulling the patient charts, the Mohs log, and slides. They will be checked to make sure that the operative report, map, Mohs log, and slides are accurate. If there are any discrepancies, it will be noted on the QA form and