Lufkin Pathology Associates

Summary Statement of Deficiencies 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 review of laboratory policies and procedures, lack of competency assessment records and interview with the Laboratory Director/Technical Supervisor, the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisor. The laboratory failed to assess the competency for one of one Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process to assess the competency of the Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for one of one Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisors include: - The Laboratory Director/Technical Supervisor 3. During an interview on January 8, 2024 at 3:30 PM these findings were confirmed by the Laboratory Director/Technical Supervisor. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step 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 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An onsite survey conducted 09/20/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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: Observations made during the tour of the facility, and review of manufacturer's instructions, found that the laboratory failed to ensure that 33 of 33 expired formalin vials were not available for use in patient testing. The findings included: 1. Observations made during the tour of the laboratory conducted October 25, 2021 at 1410 hours found expired formalin containers on the cabinet, and on the floor of the laboratory's grossing area. 2. Review of the manufacturer's instructions on the package labeling found the following Formalin solutions were expired: BioReference Laboratory Formalin container Lot 2105 expiration 05/20216; 9 vials. StatLab Medical Products Formalin Solution 10% Neutral Buffered pH 7.0, Lot 41700-00 expiration 02/2009; 24 vials. 3. During an interview of the Laboratory Director conducted on October 25, 2021 at 1450 hours in her office, it was stated, "They rarely give out formalin to offices that need some, but not those since they are expired." When asked where the non-expired formalin was kept it was stated that she didn't know. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency for the individuals responsible for high complexity testing in 2019 and 2020 for two of two testing personnel (TP) performing histopathology and cytology procedures. The findings included: 1. Review of personnel files found no records of competency assessment performed for TP2, and TP3 who were performing high complexity histopathology and cytology procedures during 2019 and 2020. 2. Interview of the Technical Supervisor conducted on October 25, 2021 at 1458 hours, confirmed there were no competency assessments available for review and that she 'was always told that MD's don't need to have one.'. Key: MD's - Medical Doctors -- 2 of 2 --