Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 19, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of profiency test (PT) records and staff interview, the laboratory failed to maintain copies of all PT documents. Findings include: 1. Review of PT records revealed the lack of documents for 2019 event #3 and 2020 event #2. 2. An interview with lead histotechnologist in the breakroom on 1/19/2021 at approximately 10:30 a.m confirmed the lack of documents for the aforementioned events. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or 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 -- procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory failed to verify at least twice annually the accuracy of any test or procedure performed. Findings include: 1. TP document review revealed there were no twice annually peer reviews performed for Histopathology (MOHS) testing in 2020. 2. An interview with lead histotechnologist in the breakroom on 1/19/2021 at approximately 09:15 a.m. confirmed the lack of Pathology peer reviews for the aforementioned year. 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 (SOP) review and staff interview, the laboratory director (LD) failed to ensure an approved Potassium Hydroxide (KOH) Quality Control (QC) procedure was available as required. Findings include: 1. SOP review revealed the LD did not ensure an approved KOH QC procedure was available in the SOP for mycology slides. 2. An interview with the lead histotechnologist at the facility on 01 /19/2021 at 10:00 AM in the breakroom, confirmed the control procedure is not available for KOH slides. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to perform and document QC on potassium hydroxide (KOH) slides. Findings include: 1. No QC documents were available to review on KOH slides at the time of survey for 2019 or 2020. 2. An interview with the lead histotechnologist at the facility on 01/19/2021 at 10:00 AM in the breakroom, confirmed controls were not performed on KOH slides . D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 4 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing (PT) records and staff interview, the laboratory director (LD) failed to ensure PT results were returned to the PT agency by the event due date. Findings include: 1. Review of PT records for 2019 and 2020 revealed the laboratory received a score of 0% or "no results received" on 2019 Events 2 and 3; and Events 1,2, and 3 of 2020. 2. Interview with the lead histotechnologist on 1/19/2021 at 11:00 am in the breakroom confirmed results were not reported to the PT agency in time to be evaluated which resulted in a score of 0% or "no results received". D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require