Kickapoo Community Health Center

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Siemens EXL 200 analyzer's monthly maintenance records from July 2024 to May 2025, and staff interview, the laboratory failed to have documentation of performing complete monthly maintenance for 5 of 11 months. The findings included: 1. A review of the laboratory's Siemens EXL 200 analyzer's monthly maintenance records from July 2024 to May 2025 identified the following 7 maintenance procedures to be performed monthly: Replace IMT pump tubing Clean IMT system Clean clot check drain Replace/clean air filters Stylet HM wash probes Replace HM pump head Reagent drain cleaning 2. Further review of the records identified the following months with missing documentation of maintenance being performed: a) July 2024 Missing: Replace/clean air filters Replace HM pump head Reagent drain cleaning b) November 2024 Replace IMT pump tubing Clean IMT system c) December 2024 Stylet HM wash probes Replace HM pump head Reagent drain cleaning d) March 2025 Replace HM pump head e) May 2025 Replace IMT pump tubing Clean IMT system Clean clot check drain Replace/clean air filters Replace HM pump head Reagent drain cleaning 3. Testing personnel number 1 (as listed on Form CMS 209) confirmed the findings after her review of the record on 09 /30/2025 at 1100 hours in the office. D5783

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, review of the laboratory's policies, and staff interview, it was revealed the laboratory failed to have documentation of a policy for or of performing a competency assessment on 1 of 1 technical consultants. The findings include: 1. A review of the laboratory's submitted Form CMS 209 (signed by the laboratory director on 9/1/2023) revealed the laboratory identified 1 technical consultant. 2. A review of the personnel records for the technical consultant revealed the laboratory failed to have documentation of a competency being performed. 3. A review of the laboratory's policies revealed the laboratory failed to have documentation of a policy which addressed competency assessments of the technical consultant and the required frequency. 4. An interview with testing personnel number 1 (as listed on Form CMS 209) on 09/05/2023 at 1405 in the conference room confirmed the findings. 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 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 -- 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 Individualized Quality Control Plan for the BioFire analyzer, review of the laboratory's verification records, and staff interview, it was revealed the laboratory failed to have documentation of developing Individualized Quality Control Plans when current instrumentation was replaced for 2 of 2 analyzers. The findings include: 1. A review of the laboratory's Individualized Quality Control Plan for the BioFire analyzer revealed the plan was developed for the analyzer with the serial number 2FA0502 in 2021. 2. A review of the laboratory's verification studies for the BioFire analyzer revealed the laboratory replaced the analyzer in use twice since the initial Individualized Quality Control Plan was developed. Serial number 2FA07850 In use: 07/2022 to 05/2023 Serial number FA2252 In use: 05/2023 to 8/2023 3. The laboratory was asked to provide documentation of developing a new Individualized Quality Control Plan for each of the new analyzers. No documentation was provided. 4. An interview with testing personnel number 1 (as listed on Form CMS 209) on 09/05/2023 at 15000 hours in the conference room revealed the facility was not aware new Individualized Quality Control Plans needed to be developed with each new analyzer. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant Moderate Complexity Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the