Baptist Memorial Medical Group Inc -Utim And Tmg

Summary Statement of Deficiencies D0000 During a recertification survey performed on 11/27/23, the laboratory was found out of compliance with the following condition: 493.1212 Condition: Endocrinology D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, PT attestation statements were not signed by the laboratory director and/or testing personnel for four of seventeen events reviewed from 2022 and 2023. The findings include: 1. Review of the laboratory's API PT records revealed the following: Attestation statement not signed by testing personnel for 2023 Hematology/Coagulation 1st Event. Attestation statements not signed by the lab director or designee for 2023 Hematology 1st Event, 2023 Immunology /Immunohematology 1st Event, 2023 Immunology/Immunohematology 2nd Event, and 2023 Chemistry Core 3rd Event. 2. Interview with technical consultant number two on 11/27/23 at 5:45 pm confirmed the laboratory failed to ensure attestation were signed by testing personnel for one of seventeen PT events reviewed and the lab director/designee for four of seventeen PT events reviewed. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 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 -- 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient test report, laboratory quality control (QC) records, staff interview and email communication, the laboratory failed to ensure manufacturer QC ranges for the testosterone analyte were verified before use. (Refer to D5469) D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of the laboratory's API proficiency testing records, and staff interview, the laboratory failed to follow its' own policy for review and evaluation of proficiency testing results for three of seventeen events reviewed from 2022 and 2023. The findings include: 1. Review of the laboratory policy #BMG:A001 titled "General Policies" revealed the following under the section titled "Proficiency Testing": "When the final results are obtained from the proficiency testing program, the laboratory will compare the results submitted with those of other participating laboratories. Results should be within the accepted range as set by the program if the survey is graded." "If for any reason an evaluation of the challenge was not performed, either due to lack of consensus or failure of the laboratory in the submission process, the results/lack of results for that challenge will be reviewed and dcoumented on the proficiency test result form and "Proficiency Testing Review and Competency" form." "Full documentation will be retained in the appropriate proficiency testing binder, including any

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, erythrocyte sedimentation rate (ESR) patient results, instrument printouts and stored data, the laboratory procedure manual, and interview with technical consultant number one, the laboratory failed to have a system in place to ensure the accuracy of patient test results from receipt through the reporting of patient test results. The findings include: 1. Observation of the laboratory on 10/18/21 at approximately 9:30 am revealed an Alcor Mini-Sed instrument in use for patient testing for ESR. 2. Review of patient number 12039270 revealed ESR reported as 15 mm/hr on 08/10/21. 3. Review of the ESR instrument printouts and stored instrument data revealed the source of the patient ESR results could not be determined. 4. Review of the laboratory's quality asessment plan revealed no policy regarding verification of the accuracy of patient test results from specimen receipt to reporting was included as part of the plan. 5. Interview with technical consultant number one on 10/19/21 at approximately 4 pm confirmed the laboratory does not have a process in place for ensuring the accuracy of patient test results from specimen receipt to final patient test report. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, proficiency testing (PT) records and staff interview, the laboratory failed to follow the policy for evaluation and investigation of proficiency testing results in 2020 and 2021. The findings include: 1. Review of the laboratory's policy titled "Quality Assessment Plan," revealed the following statements under the section titled "Proficiency Testing": "In the event that the PT performance indicates: 1. an unacceptable response for an analyte" "the Proficiency Testing Review and Competency Report must be completed by the lab manager and submitted to the Laboratory Director to review and sign all PT results." 2. Review of the laboratory's proficiency testing records revealed the following unacceptable and unsatisfactory scores with no

Summary Statement of Deficiencies 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 of the laboratory, review of the maintenance records for the Sysmex XN 2000 instrument, and interview with the laboratory supervisor, the laboratory failed to retain background counts for the Sysmex XN 2000 instrument for 2 years in 2016 and 2017. The findings include: 1. Observation of the laboratory on August 1, 2018 at 8:30 am revealed the Sysmex XN 2000 instrument in use for patient testing for performance of complete blood count (CBC). 2. Review of the maintenance records for the Sysmex XN 2000 instrument revealed that the background counts for the Sysmex XN 2000 instrument are stored in the instrument database. The last retrievable background count was for January 18, 2017. 3. Interview with the laboratory supervisor on August 1, 2018 at 4:30 pm confirmed the laboratory failed to retain background counts for two years for the Sysmex XN 2000 instrument in 2016 and 2017. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Citation #1 Based on review of the laboratory's policy titled "Quality Assurance Management Plan", the laboratory's 2016, 2017 and 2018 proficiency testing evaluation reports from the laboratory's proficiency testing provider-Medical Laboratory Evaluation (MLE), and interview with the laboratory supervisor, the laboratory failed to follow the Quality Assurance Management Plan for evaluation of proficiency testing in 2016, 2017, and 2018 for 7 of 7 proficiency testing events. The findings include: 1. Review of the laboratory's policy titled "Quality Assurance Management Plan" revealed the following statements under the section titled "Proficiency Testing": "We will carefully evaluate all results in a timely manner. Any unacceptable, unsatisfactory or unsuccessful grade will result in an investigation to determine cause and a