Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the Individualized Quality Control Plan (IQCP), Quality Control (QC) records, monthly QC data, Standard Operating Procedures (SOPs), as well as interview with the Laboratory Coordinator (LC), the laboratory failed to perform and document scheduled QC. FINDINGS: 1. Monthly QC performance from June 2023 to March 2025 exceeded specified due dates. 2. This is contrary to instructions indicated in the current, approved SOPs and IQCP which specify QC must be performed and documented monthly as well as for new lots, shipments, changes in storage conditions, and after preventative maintenance performance. 3. Thirty-five patients were tested during the respective period. 4. The LC confirmed the findings on June 5, 2025, at 12:00 P.M. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance 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 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the IQCP, QC records, monthly QC data, current, approved SOPs, as well as interview with the LC, the Laboratory Director (LD) failed to provide overall management for all phases of moderate complexity testing. Refer to D5445 and D6020. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's IQCP, SOPs, as well as interview the LC, the LD failed to comply with current, approved QA procedures including an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory system. Refer to D5445. -- 2 of 2 --