Ahvi Cath Lab/Asc

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 competency records, review of policies and procedures, and an interview with the Cath Lab Director (RN1), the laboratory failed to evaluate the competency for five (5) of twelve (12) personnel hired since May 2025. The findings include: 1. Review of the Competency Assessment for Clinical Laboratory Personnel records revealed four (4) of eleven (11) personnel did not have completed competency records. a. Two (2) of four (4) staff (TP2 and TP3) hired since May 2025 did not have documentation of completed competency assessment. b. Two (2) of four (4) competency assessments reviewed (TP1 and TP4) did not have the six procedures of competency assessed. Competency assessments did not include "Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples". c. Two (2) of four (4) staff (TP1 and TP4) did not have a competency assessment twice in the first year. 2. A request was made for competency assessments for one (1) of one (1) technical consultant but none was available. 3. A review of policies and procedures showed the laboratory has a policy for performing routine competency assessment for testing personnel but was not being followed and there was no policy for performing competency assessment for the technical consultant. 4. An interview with RN1 on 7/1/2026 at 10:00 AM confirmed the competency assessments were not completed and no assessment was performed for the technical consultant. 5. The laboratory reports performing 485 tests annually. D5403 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of Quality Control Procedures, the Oxicom Individualized Quality Control Plan (IQCP), the Oxicom quality control (QC) log sheets, and an interview with the technical consultant, the laboratory did not follow their written procedure and IQCP to perform two levels of liquid controls weekly for six (6) of thirty-four (34) weeks in 2022. Findings: 1. Policy #1203, Quality Control Measures for Laboratory Services, states "The Oxicom 3000 will be checked weekly with the Liquid Control samples. All liquid readings will be recorded on the Oxicom QC worksheet." 2. The Oxicom 3000/O2Sats IQCP states External Liquid Quality Controls will be performed weekly. 3. The Oxicom QC logsheets were missing QC documentation for the weeks 1 /7/22, 01/31/2022, 02/14/2022, 03/07/2022, 04/18/2022, 07/04/2022. 4. The technical consultant confirmed these findings by interview on 8/22/22 at 15:00. 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 --