Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Cardiovascular Specialty Care Center of Covington, CLIA ID 19D2140476, on October 29, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's quality control records, and interview with personnel, the laboratory failed to retain the i-STAT cartridge lot number in use for patients tested for two (2) years. Findings: 1. Observation by surveyor during the laboratory tour on October 29, 2024 at 9:48 a.m. revealed the laboratory utilized two (2) i-STAT 300 instrument for Activated Clotting Time (ACT) testing. 2. Further observation during the laboratory tour revealed the laboratory had one i-STAT in each room (Cath Lab A and Cath Lab B) where testing was performed. 3. In interview on October 29, 2024 at 1:50 p.m., Personnel 3 stated the cartridge lot number in use in one room could differ from the cartridge lot number in use in the other room. 4. Review of the laboratory's quality control (QC) records revealed the laboratory documented the lot numbers of cartridges for monthly and new lot QC, but did not document the in use date of cartridges. 5. In interview on October 29, 2024 at 1:54 p. m., Personnel 3 stated the laboratory did not document when a lot was put into use. She further stated the laboratory did not utilize a printer with the i-STAT analyzer. The Technical Consultant stated the cartridge lot number utilized with each patient was retained in i-STAT analyzer but was unable to retrieve the lot information. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 policy and personnel records as well as interview with laboratory personnel, the laboratory failed to establish a written competency assessment policy for Technical Consultant. Findings: 1. Review of the laboratory's CMS-209 form revealed Personnel 2 served as Technical Consultant. 2. Review of the laboratory's policy "Performance Evaluations and Competency Assessments" revealed the laboratory did not include performance of competency assessment for Technical Consultant. 3. In interview on October 29, 2024 at 10:20 a.m., the Technical Consultant stated competency assessments for Technical Consultant were performed annually. 4. Review of personnel records for the Technical Consultant revealed a competency assessment was performed in 2022 and 2024 but not in 2023. 5. In interview on October 29, 2024 at 10:25 a.m., the Technical Consultant confirmed the laboratory's policy did not include competency assessment of the Technical Consultant. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions and maintenance records, as well as interview with personnel, the laboratory failed to perform the thermal probe check every six (6) months as required by the manufacturer in 2023 and 2024 for four (4) of four (4) checks reviewed. Findings: 1. Observation by surveyor during the laboratory tour on October 29, 2024 at 9:48 a.m. revealed the laboratory utilized the i- STAT 300 instrument for Activated Clotting Time (ACT) testing. 2. Review of the manufacturer's instruction manual for the i-STAT 300 section "Quality Control" revealed "Ensure the thermal probe check is performed every 6 months on each handheld reader." 3. Review of the laboratory's maintenance records revealed the laboratory did not have documentation of performance of thermal checks in 2023 and 2024. 4. In interview on October 29, 2024 at 1:32 p.m., the Technical Consultant confirmed the laboratory did not perform thermal probe checks as identified above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions and laboratory quality control logs, and interview with personnel, the laboratory failed to ensure the temperature of ISTAT cartridge shipments was satisfactory as required by the manufacturer. Findings: 1. Observation by surveyor during the laboratory tour on October 29, 2024 at 9:48 a.m. revealed the laboratory utilized the i-STAT Kaolin Activated Clotting Time (ACT) cartridge for ACT testing on the i-STAT 300 instrument. 2. Review of the i-STAT 300 user manual section "Quality Control" revealed "Check Temperature Strip for a New Shipment of Cartridges" and "Verify that the transit temperatures were satisfactory by reading the temperature strip included in each shipping container." 3. Review of the laboratory's quality control logs revealed the laboratory did not document temperature strip checks for shipments of cartridges. 4. In interview on October 29, 2024 at 1:40 p.m., Personnel 3 stated that the temperature strips were checked for acceptability but not documented. D5781