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 laboratory's individualized quality control plan (IQCP) for the i-STAT chem 8+ and troponin I testing, i-STAT chem 8+ and troponin I quality control (QC) records, patient results and interview with the technical consultant (TC) #2, the laboratory failed to ensure that the IQCP for the i-STAT chem 8+ and troponin I testing was followed for one of eight months in 2025. Findings: 1. Review of the laboratory's IQCP for the i-STAT chem 8+ and troponin I states, "Two levels of liquid quality control (LQC) are performed with each new shipment of cartridges and at least monthly thereafter." 2. Review of the i-STAT chem 8+ and troponin I quality control (QC) records from January 2025 to August 2025 showed QC was not performed in July 2025. 3. Review of patient testing results showed the laboratory performed 142 chem 8+ patient tests and 44 troponin I patient tests in July 2025 when QC was not performed. 4. Interview with the TC #2 on September 17, 2025, at 9:00 AM confirmed the laboratory failed to ensure the i-STAT chem 8+ and troponin I IQCP was followed. D5813 TEST REPORT 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 -- CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of glucose i-STAT patient test report, lack of documentation of notifying individual responsible for test results, and interview with the technical consultant (TC) #1, the laboratory failed to immediately alert the individual responsible for using the test results when any test result indicates an imminently life- threatening condition, or panic values. Findings: 1. Review of glucose i-STAT patient test report showed a panic glucose value of 465 mg/dL on September 5, 2025 at 1:52 PM. 2. Lack of documentation showed the laboratory failed to immediately alert the individual responsible for using the panic glucose value. 3. Interview with the technical consultant (TC) #1 on September 17, 2025, at 10:00 AM confirmed the laboratory failed to immediately alert individuals responsible for glucose. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of performance evaluations and interview with the technical consultant (TC) #2, the technical consultant (TC) failed to evaluate and document the annual performance evaluation for nine of thirteen testing personnel (TP) in 2024. Findings: 1. Review of performance evaluations showed no annual performance evaluation for TP #5, TP #6, TP #13, TP #16, TP #17, TP #18, TP #19, TP #20, TP #21 in 2024. 2. Interview with the TC #2 on September 17, 2025, at 9:00 AM confirmed the technical consultant failed to evaluate and document the annual performance evaluation for all testing personnel in 2024. -- 2 of 2 --