Johnson County Hospital

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 review of the laboratory's MedTox individualized quality control plan (IQCP), review of MedTox manufacturer's instructions, review of MedTox quality control results, and interview with the technical consultant the laboratory established and performed quality control procedures that are less stringent than those specified by the manufacturer from 1/24/2024 - 4/3/2024. 1. Review of the laboratory's MedTox IQCP state "one external positive and one external negative control will be performed per lot or shipment. 2. MedTox manufacturer's instructions state "run external controls routinely or as needed for any of the following reasons: (1) to practice the test with a known control, (2) when you open a new lot of test devices, (3) once a week..." 3. Review of MedTox quality control results from 1/24/2024 - 4/3 /2024 revealed the laboratory performed quality control on 2/12/2024. 4. Interview with the technical consultant on 4/3/2024, at 1:52PM, confirmed the laboratory established and performed quality control procedures that are less stringent than those specified by the manufacturer. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the technical consultant, the laboratory failed to document blood bank competency assessment (CA) in 2022 and 2023, for four out of four testing personnel (TP) performing high complexity blood bank testing. 1. Review of CMS 209 form revealed four testing personnel performing high complexity testing. 2. Interview on 4/3/2024, at 11:15 AM, with technical consultant confirmed the four testing personnel perform high complexity blood bank testing. 3. No documentation of blood bank CA was found on the four TP performing high complexity blood bank testing. 4. Interview with the technical consultant on 4/3 /2024, at 11:15 AM, confirmed blood bank CA was not documented in 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory policy, "General Policies for Coagulation", lack of documentation, and interview with the technical consultant and laboratory manager, the laboratory failed to follow manufacturer's instructions and laboratory policy for coagulation. Findings are: 1. Based on the laboratory's policy "General Policies for Coagulation" "with every new lot number of reagents, 20 normal patients will be run to validate the normal range." 2. The laboratory changed innovin lot number and had no documentation of validation of the normal range. 3. Interview with the technical consultant and lab manager on 5/19/2022 at 1pm confirmed the laboratory had changed innovin lot number and had not validated the normal range. 4. The laboratory tested 156 patients since the laboratory changed innovin lot number. 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 --