Baptist Health Medical Center-Stuttgart

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: Baseds upon a review of the CMS 209 form, records of testing personnel competency assessment, lack of documentation and interview with laboratory staff, the laboratory failed to assess testing personnel competency utilizing the six procedures required by CFR 493.1413(b)(8) for 2 of sixteen testing personnel included on the form CMS 209. Findings follow: A) Review of the authorizations to perform testing signed by the laboratory director, testing personnel (numbers 10 -11 on form CMS 209) are authorized to perform moderately complex testing in chemistry, hematology, coagulation, and urinalysis specialties. B) Review of the competency assessment records for testing personnel (numbers 10 and 11 on the form 209) dated January 2023, January 2024, and January 2025 revealed that the personnel were evaluated as competent to perform patient testing on the Alinity chemistry analyzer, the Sysmex 1000/XN hematology analyzer, the Sysmex CA-600 coagulation analyzer, and the Clinitek Advantus urinalysis analyzers but the competency evaluations did not indicate the procedures used to evaluate the personnel competencies. C) Upon request, the laboratory could not provide documentation that the competencies of testing personnel (numbers 10 and 11 on the form CMS 209) were evaluated using the six procdures required by CFR 493.1413(b)(8). D) In an interview on 7/22/25 at 11:05 a. m., the laboratory staff member (number 2 on the form CMS 209) confirmed that the testing personnel (numbers 10 and 11 on the form CMS 209) performed moderately complex patient testing and the competencies were not evaluated using the six required procedures. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based upon a review of the Dade application sheet for on-board stability for innovin reagent for the Sysmex CA 600 analyzer, observations made during a tour of the laboratory, and interview with a laboratory staff member, the laboratory failed to document the expiration date and time of the innovin reagent used for prothrombin time (PT) testing on the Sysmex CA-600 coagulation analyzer. Findings follow: A) Review of the application sheet for on-board stability of innovin reagent on the Sysmex CA 600 coagulation analyzer revealed an on-board stability of 24 hours. B) During a tour of the laboratory at 08:40 a.m. on 7/24/25, the container of innovin in use on-board the Sysmex CA-600 analyzer was observed, labeled with the word "innovin" on the container, and no other labeling as to date/time placed into use or expiration date/time. C) When asked when the innovin was placed into use, the laboratory staff member ( number 1 on the form CMS 209) stated "at 12:00 a.m. on 7 /24/25" and explained the laboratory staff replaces the innovin at midnight with fresh innovin which is placed in a container labeled "innovin". D) When asked if it was possible that the laboratory staff on duty at 12:00 a.m. could possibly forget to change the innovin reagent the laboratory staff member ( number 1 on the form CMS 209) confirmed that it was a possibility. E) When asked if there was documentation which would allow laboratory staffing during the day hours to determine if the time/date of the last innovin change, the laboratory staff member ( number 1 on the form CMS 209) responded that there was not such documentation available. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based upon the review of the Individualized Quality Control Plans (IQCP) for High Sensitivity Troponin (TNI) performed on the I-Stat instrument, Naturetic Peptide Tests (BNP) on I-Stat instrument, and microbiological assays performed by Polymerase Chain Reaction (PCR) procedures on the Cepheid GeneXpert instrument the laboratory failed to specifiy the external quality control (QC) material employed in the IQCP of three of three plans reviewed. Finding follow: A) Review of the IQCP for -- 2 of 3 -- TNI assays performed on the I-Stat instrument revealed that external QC will be performed monthly and when a new lot number and shipment of reagents are received. The identity of the control material used was not specified. B) Review of the IQCP for BNP assays performed on the I-Stat instrument revealed that external QC will be performed monthly and when a new lot number and shipment of reagents are received. The identity of the control material used was not specified. C) Review of the IQCP for PCR assays performed on the Cepheid GeneXpert instrumentrevealed that external QC will be performed monthly and when a new lot number and shipment of reagents are received. The identity of the control material used was not specified. D) In an interview on 7/24/25 at 11:45 a.m., the laboratory staff member (number 2 on the form CMS 209) confirmed that the IQCP's identified above did not specify the identity of the external control materials used in the QC process. D5783

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . 1. Through a review of policy and procedure manual, quality control (QC) records for 2021, patient medical records, lack of documentation as well as interviews with staff, it was determined the laboratory reported patients when results of Chemistry Quality Control (QC) failed to meet the laboratory's criteria for acceptability. Survey findings follow: A. A review of the policy and procedure manual revealed the protocol for Chemistry QC: "Two levels of quality control will be run each day of patient testing. Patients will not be report until QC is acceptable." B. A review of Chemistry QC results for June and September of 2021 (two of nine months), revealed on 6/4/2021 Chemistry Control Level 2 was out of range for Alanine Aminotransferase (ALT). C. A review of Chemistry QC results for June and September of 2021 (two of nine months), revealed on 6/4/2021 and 6/7/2021 Chemistry Control Level I and Level 2 was outside of the laboratory's acceptable range for Creatine Kinase. D. A review of medical records revealed on 6/04/2021 the laboratory reported thirteen patients for ALT with only one Level of QC in range of laboratory's criteria for acceptability. E. A review of medical records revealed on 6/4 /2021 the laboratory reported seven patients for CK and on 6/7/2021, the laboratory reported four patients for CK without documentation of acceptable QC. D. In an interview on 11/18/2021 at 10:00, technical consultant confirmed that patients were reported when the quality control results were outside of the laboratory's acceptable range. 2. The laboratory failed to evaluate patient results back to the last acceptable quality control result when quality control for ALT and CK failed to meet the laboratory's criteria for acceptability. Survey Findings follow: A. Review of the 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 -- "Daily QC Review - Abbott Architect" policy and procedure revealed that quality control is unacceptable if either or both of the normal and/or abnormal controls fall outside of plus or minus 2 standard deviation range and if the control(s) are not acceptable after one repeat and a second repeat with fresh QC material

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature in one of five separate rooms in which supplies with storage temperature requirements were stored . Findings follow: A. In an initial tour of the laboratory on 2/20/19 at approximately 10:00 AM, five separate rooms were observed in which reagents and/or supplies with storage temperature requirements were stored namely; the main laboratory, microbiology laboratory, blood bank, supply storage room, and glass wash room. B. In a tour of the Laboratory on 2/22/19 at approximately 10:30 AM, eight boxes of BD Veritor Flu A&B test kits lot # 8149422 expiration date 2021/03/15 and storage temperature requirement of 0 degrees C. to 30 degrees C., and four boxes of BD Veritor RSV test kits lot # 8204377 expiration date 2021-5-09 and storage temperature requirement of 0 degrees C. to 30 degrees C. were observed in the glass wash room separated from the laboratory by a closable door. C. Upon request, the laboratory was unable to provide documentation of temperature records for the glass wash room identified above. D. In an interview on 2/22/19 at approximately 10:10 AM, the technical supervisor identified as number eight on the CMS 209 form confirmed that the temperature had not been monitored in the glass wash room identified above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5783