Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation for review and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency established by the laboratory. Findings include: 1. The laboratory began patient testing in the sub-specialty of Bacteriology on May 7, 2019, with an estimated annual test volume of 25,974. The laboratory utilizes the Life Technologies Quant Studio 3 to perform a lab-developed test (LDT) to test for 18 UTI Pathogens and 8 ABX Resistance Markers on urine samples. 2. It is the practice of the laboratory to perform weekly and daily QC. The laboratory's established policy for weekly QC states, "An analytical run begins with a weekly calibration plate containing: 1) One set of positive controls (each one containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control containing known amounts of DNA and RNA templates); 2) One set of no template controls (containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control, no template DNA or RNA is included). 3. No weekly QC documentation (as described above in #2) was provided for review during the survey conducted on June 30, 2021 to indicate the laboratory performed weekly QC procedures for the week of 8/4/2019 through 8/11/2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Approximately 13 patient samples were tested during this time period. 4. One patient report reviewed during the survey from testing that occurred on 8/06/2019 (Specimen# A19-260) and lack of the corresponding weekly QC records confirmed that the weekly QC was not performed during the week of 8/04/19 through 8/11/19. 5. The facility personnel confirmed that the laboratory failed to perform and document weekly QC during the time period indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) documentation, Quality Control (QC) records, and interview with the facility personnel, the laboratory failed to identify and correct problems associated with Quality Control performance. Findings include: 1. The laboratory began patient testing in the sub-specialty of Bacteriology on May 7,2019, with an estimated annual test volume of 25,974. The laboratory utilizes the Life Technologies Quant Studio 3 to perform a lab-developed test (LDT) to test for 18 UTI Pathogens and 8 ABX Resistance Markers on urine samples. 2. The laboratory's established QA policy states, "Quality Control results should be monitored daily for out-of-limits results by the person performing the assay. If any problem is noted, the Laboratory Director and/or qualified personnel must review it and