Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed on March 29, 2021 at Martin & Marshall Dermpath, LLC, CLIA ID # 19D0955011. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance policy, records, and interview with personnel, the laboratory failed to document microscope maintenance per laboratory policy. Findings: 1. Review of the laboratory's "Microscope Maintenance" policy revealed the following procedures: a) "For each day of use: - Clean the eyepieces - Clean the condenser - Clean the filter -Clean the stage (If used for bio hazardous specimens, disinfect stage and knobs after each use with disinfectant spray)." b) "For each week of use and/or as needed: - Clean the objectives - Wipe off body" c) "As needed: - Replace bulb - Center light" d) "Annually: - Complete PM" 2. Review of the laboratory's records for 2020 and 2021 revealed the laboratory did not have documentation of microscope daily, weekly, and as needed maintenance. 3. In interview on March 29, 2021 at 11:22 am, the Director of Anatomic Pathology for the pathology group stated the doctor did not have a quality 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 -- control sheet to document microscope maintenance. The Director of Anatomic Pathology for the pathology group confirmed the laboratory did not document the daily, weekly, and as needed, microscope maintenance in 2020 and 2021. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure required maintenance was performed to ensure acceptable levels of performance. Refer to D5433. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to include written duties and responsibilities of personnel involved in all phases of testing. Findings: 1. Review of the laboratory's policies, procedures, and personnel records revealed job descriptions related to the duties of the Testing Personnel were not included. 2. In interview on March 29, 2021 at 10:30 am, the Director of Anatomic Pathology for the pathology group confirmed a written description of duties and responsibilities of the Testing Personnel were not included. -- 2 of 2 --