Wpm Pathology Laboratory, Chartered

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 laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to assess the competency of four of four Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for four of four Technical Supervisors in 2019, 2020 and to the date of the survey in 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C -Technical Supervisor D 3. During an interview on August 16, 2021 at 2:25 PM, the Laboratory Director/Technical Supervisor A confirmed these findings. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an absence of microscope maintenance records and interview with Testing Personnel (TP) #5, the laboratory failed to define a function check protocol for the microscopes. Findings were: 1. No documentation was available for the maintenance of microscopes for a 12 month period. 2. Interview with TP#5 on February 25, 2020 at 10:45 AM confirmed the laboratory failed to define a function check protocol that ensures the microscopes are performing accurately in the 12 month period of 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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)