Waco Mclennan Co Public Hlth Dist Lab

Summary Statement of Deficiencies D0000 An onsite survey conducted November 29, 2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, proficiency testing records from 2021, and interview with the Laboratory Manager, the laboratory failed to assess the accuracy of wet mount and potassium hydroxide (KOH) microscopic procedures twice annually for one of one year in 2021. Findings included: 1. A review of the laboratory's policy "Proficiency Testing Review" stated "Proficiency testing must be performed for all tests of moderate complexity". 2. A review of the laboratory's proficiency testing records from 2021 found the laboratory was not enrolled in PT (proficiency testing) or a twice annual verification program for Wet Mount or KOH preparations. 3. In an interview on 11/29/2022 at 12:15 PM, the Laboratory Manager confirmed the laboratory was neither enrolled in a proficiency testing program nor did the laboratory have a method in place to verify the accuracy of the test results at least twice a year. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 the laboratory's policies and procedures, competency assessment records, and interview with the Laboratory Manager, the Technical Consultant failed to assess competency for one of one testing personnel performing wet mount and potassium hydroxide (KOH) microscopic procedures for 2021. The findings included: 1. The laboratory's policy titled "Testing Personnel Competency Procedure" stated "Competency evaluations of laboratory testing personnel should occur at least semiannually during the first 12 months the individual tests client specimens. Thereafter, competency evaluations must be performed at least annually." 2. Based on review of competency assessment records, the Technical Consultant did not document annual competency for wet mount and KOH procedures for the Laboratory Manager, who served as the primary testing personnel for these tests in 2021. The annual volume for these tests was listed as 20 tests on the survey paperwork. 3. In an interview on 11/29/2022 at 12:15 PM, the Laboratory Manager confirmed the Technical Consultant had not performed a competency assessment for wet mount and KOH preparations in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Review of proficiency testing records, patient test records and interview of facility personnel found the laboratory failed to test proficiency testing specimens in the same manner as it tests patient specimens that produce a reactive Rapid Plasma Reagin (RPR) result in six of six testing events in 2019 and 2020. The findings included: 1. Review of the Medical Laboratory Evaluation (MLE) proficiency testing records for 2019 and 2020 found no responses or graded results for quantitative RPR results in six of six testing events. 2. Review of patient test records for 2021 found the laboratory performed quantitative RPR testing on patient samples producing a reactive RPR result, and would report this titered result to the provider. 3. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted on March 2, 2021 at 09:59 AM confirmed that the laboratory did not perform quantitative procedures on proficiency testing specimens as they do on patient specimens. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Review of the laboratory policy titled RPR control procedure, quality control logs and interview of facility personnel, found the laboratory failed to follow their own procedure for verifying the volume delivered by the dispensing needle ( used for delivery of the Rapid Plasma Reagin (RPR) antigen) met their own requirements. The findings included : 1. Review of the RPR Control procedure found on page 1 "The dispensing needle for the antigen is to be tested weekly by the following method: a. Attach the hub of the needle to the tip of a 1 ml pipette. b. Fill the pipette and count the number of drops delivered in 0.5 ml. There should be 30 +/- 1 drop per 0.5 ml. c. Record results on the RPR Quality Control Log to be maintained in the laboratory at all times." 2. Review of the RPR Quality Control Logs found the column for needle volume dispensing to be pre-filled with a value of "60" each day. 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on March 2, 2021 at 10:55 AM found the laboratory does not check the antigen needle volume delivery weekly as defined in their own procedure. -- 2 of 2 --