Christus St Michael Laboratory

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey completed on 1/8 /2025. The following conditions were not met: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory patient reports, and confirmed in interview, the laboratory failed to ensure access to patient test record on the Vitek 2 microbiology analyzer, used in the identification and susceptibilities of selected organisms, for records reviewed in February 2024. The findings included: 1. Review of the laboratory policy titled "Guidelines for Retention of Clinical Laboratory Records" stated the following: "For Laboratory Disciplines: Hematology, Coagulation, Urinalysis, Chemistry, Microbiology, Serology & Pathology. Item: Patient results, Log Books (w/ pt results), Test Requisitions, QC Records, Quality Management Records, Proficiency Testing Records, Associate Training and Competency Records. CAP Retention: 2 Years Christus Retention: 5 Years" 2. In an interview on 1/8/2025 at 14:45, in the supervisors' area, technical supervisor (TS) 3 stated the laboratory implemented a new Vitek 2 analyzer on June 24, 2024. Surveyor asked for the analytic record of the Vitek 2 susceptibility and or identification results for patient final reports reviewed in February 2024, on the previous analyzers software system, and none could be provided. 3. In an interview on 1/8/2025 at 16:15 hours, in the supervisor area, TS 3 confirmed the Vitek 2 patient analytic records for 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 -- the identification and susceptibility of bacteria isolated from patients could not be accessed on the computer back up system the laboratory had in place. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, manufacturer's instructions and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for verifying the dispense volume of the needle used for delivering the carbon antigen when testing 1423 patient samples for RPR (Rapid Plasma Reagin) between January 1, 2024 and September 30, 2024. The findings included: 1. During a mock demonstration of the RPR antigen needle check by testing person 7 conducted January 8, 2025 at 2:58 PM, she used deionized water to dispense 0.5 ml. She said she should get 30 + 1 drops to be acceptable for use. 2. Review of the laboratory's own written procedure (approved by the laboratory director 02/09/2024) found on page 1 under the heading QUALITY CONTROL: " The accuracy of the needle used to dispense RPR antigen must be verified monthly, when a new needle is used, when control patterns cannot be reproduced, or when the antigen drop does not fall cleanly from the tip. Remove the needle from the RPR antigen vial and place it on the end of a 1 ml syringe. Fill the syringe with distilled water. Hold the syringe in a vertical position over the sink and count the number of drops delivered in 0.5 ml. The needle is considered satisfactory if 30 + 1 drops is obtained in 0.5 ml." 3. Review of the Sure-Vue Rapid Plasma Reagin (RPR)instructions for use (Rev. 09-2021) found on page 1 under the heading HANDLING AND PROCEDURAL NOTES: "1. In order to obtain reliable and consistent results, the instructions in the package insert must be strictly followed. Do not modify the handling and storage conditions for reagents or samples. 4. The needle should deliver 60 + 2 drops of antigen suspension per milliliter when held in a vertical position. To perform accuracy check on the needle, attach the needle to a 1 or 3 ml syringe. Fill the syringe with the antigen suspension and, holding the syringe in a vertical position, count the number of drops delivered in 0.5 ml. The needle is considered satisfactory if 30 + 1 drops are obtained in 0.5 ml." 4. Review of patient test records found the laboratory tested and reported results for 1423 patients tested for RPR between January 1, 2024 and September 30, 2024 as follows: January 2024 - 165 February 2024 - 180 March 2024 - 164 April 2024 - 137 May 2024 - 139 June 2024 - 142 July 2024 - 166 August 2024 - 180 September 2024 - 150 5. During interview of testing person 7 conducted January 8, 2025 at 2:58 PM, she confirmed the laboratory did not follow the manufacturer's instructions for verifying the dispensed volume of carbon antigen from the needle. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, Food and Drug Administration (FDA) in-vitro diagnostic device database, quality control and patient records, and interview with laboratory personnel, the laboratory failed to ensure two levels of quality control materials were performed each day of patient testing for 18 patients tested between June 14, 2024, and September 25, 2024. The findings included: 1. Based on review of the laboratory policy "Verify Now: PRU (PRU) Test Procedure (Plavix)", under the section Reagent Quality Control, stated the following: "1. The manufacturer recommends a Level 1 and Level 2 Quality Control procedures be run once each time a new lot or a new shipment of Test kits is received. 2. Level 1 and Level 2 Quality Control Test Devices must also be performed at the frequency specified. Please refer to the Quality Control section below for additional instructions." Under the section Quality Control Procedures, the policy stated the following: "Wet Quality Control. The Wet Quality Control (WQC) procedure must be performed whenever a program is suspected with the temperature indicator of a newly received lot of Test Devices, whenever a problem is suspected with the VerifyNow System, and as part of the laboratory quality control program. CSMHS Laboratory Policy dictates that West Quality Control (WQC) levels I and II, will also be performed on a monthly basis, upon receipt of a new lot or a new shipment of test devices, and may also be used in correlation and competency assessments." 2. Based on a review of the Food and Drug Administration (FDA) in-vitro diagnostic device database on 1/8/2025 at 12:26 pm, (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm), the surveyor observed the VerifyNow PRU test has a moderate complexity rating for all assays except the VerifyNow Aspirin Assay, which is Waived complexity. 3. Based on a review of quality control and patient testing records from June 2024 to October 2024, the laboratory failed to run two levels of quality control material each day of patient testing on the following dates: June 2024 Two levels of quality control were performed on 6/6/2024. Patient testing on days without two levels of quality control: 6 /14/2024 - MRN 102411399 6/21/2024 - MRN 100418917 6/25/2024 - MRN 102219669 July 2024 Two levels of quality control were performed on 7/11/2024. Patient testing on days without two levels of quality control: 7/4/2024 - MRN 101317991 7/5/2024 - MRN 103101748 7/31/2024 - MRN 100416670 August 2024 Two levels of quality control were performed on 8/12/2024. Patient testing on days without two levels of quality control: 8/2/2024 - MRN 100416670 8/14/2024 - MRN 101171520 8/20/2024 - MRN 100947961 8/22/2024 - MRN 100717992 8/23/2024 - MRN 100922281 8/29/2024 - MRN 101804295 September 2024 Two levels of quality control were performed on 9/11/2024. Patient testing on days without two levels of quality control: 9/13/2024 - MRN 101968508 9/13/2024 - MRN 101699307 9 /13/2024 - MRN 101701400 9/22/2024 - MRN 100948209 9/25/2024 - MRN 100969222 9/25/2024 - MRN 100872938 4. In an interview at 13:56 hours on 01/08 /2025, the Hematology Supervisor stated the lab believed this test system to be waived complexity and had not established an individualized quality control plan to reduce quality control frequency. The Hematology Supervisor stated the laboratory ran quality control as described in the laboratory policy, which was monthly and each new lot or shipment. D5783