Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on April 4, 2022. J Matthew Knight MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the open dates for reagents used in their Hematoxylin & Eosin (H & E) stains from 10/26/2021 to 04/04/2022. Findings: Review of the laboratory's "Chemical Log" showed in the "Date Opened" column listed "N/A" for the dates the following reagents were opened: 100% Reagent Alcohol lot numbers 092323 and 133489, Vintage Bluing lot number 130229, Focus 1% Acid Alcohol lot number 127906, Xylene Substitute (XS-3) lot number 128724, and 95% Reagent Alcohol lot number 130608. During an interview on 04/04/2011 at 10:30 PM, the Administrator acknowledged not all the dates the reagents were opened were recorded on the log. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide all required information for the Mohs surgical reports for three of three sampled patients, (#1, #2, #3). Findings: On 04/04/2022 at 10:40 AM, the laboratory provided a copy of the Visit Note for the Mohs surgical procedures to patients if requested. Review of Visit Notes showed the name of the laboratory as it appeared on the CLIA (Clinical Laboratory Improvement Amendments) certificate was missing from the report. On 04 /04/2022 at 10:58 AM, the Administrator said they gave a copy of the Visit Note to patients if they requested it, and the name of the laboratory as it appeared on the CLIA certificate was not on the Visit Notes. -- 2 of 2 --