Birmingham Internal Medicine Associates Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Quality Assurance Manager, the laboratory failed to retain the PT review page documentation for one of four events reviewed in 2022. The findings include: 1. A review of the API PT records revealed no documentation of a review from the Laboratory Director for the Hematology 3rd Event in 2022. 2. During an interview on 6/27/24, at 11:13 AM, the Quality Assurance Manager confirmed the above findings. 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: Based on a review of the environmental records and an interview with the Quality Assurance Manager, the Laboratory failed to ensure the room temperature for 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 3 -- Quidel Triage analyzer was within the manufacturer's acceptable limits. The room temperature was noted out of acceptable ranges for 135 days from 2022 to 2024. The findings include: 1. A review of the environmental records revealed the room temperature was out of the manufacturer's acceptable parameters (20-24 degrees Celsius) for a total of 135 days as follows: A) July, October, November and December 2022; 14 days; B) January through September, November and December 2023; 96 days C) January through April 2024; 25 days 2. During an interview on 6/27/24, at 1: 30 PM, the Quality Assurance Manager confirmed the above findings. -------- Based on a review of the environmental records and an interview with the Quality Assurance Manager, the Laboratory failed to ensure the room temperature for the Quidel Triage analyzer was within the manufacturer's acceptable limits. The room temperature was noted out of acceptable ranges for 135 days from the date of the last survey, 6/15 /2022, to the date of the current survey, 6/27/2024. The findings include: 1. A review of the environmental records revealed the room temperature was out of the manufacturer's acceptable parameters (20-24 degrees Celsius) for a total of 135 days as follows: A) July, October, November and December 2022; 14 days; B) January through September, November and December 2023; 96 days C) January through April 2024; 25 days 2. During an interview on 6/27/24, at 1:30 PM, the Quality Assurance Manager confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration records and an interview with the Quality Assurance Manager, the Laboratory failed to perform calibrations on the Sysmex XP-300 Hematology analyzer every six months. This was noted for two of four possible calibrations in 2022 through 2023. The findings include: 1. A review of the Hematology calibration records revealed the Sysmex XP-300 was calibrated 4/6 /22 and then almost nine months later on 1/29/2023. There was no evidence of documentation to review for the second half of 2022. 2. During an interview on 6/27 /24, at 12:15 PM, the Quality Assurance Manager confirmed the calibration due in October 2022 was not performed due to lapse in contract. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the Personnel records, a review of the Laboratory Personnel Report (CMS-209), and an interview with the Quality Assurance Coordinator, the Technical Consultant failed to conduct direct observation of routine patient specimens while assessing competency. This was noted for two out of two Testing Personnel. The findings include: 1. A review of the Personnel records revealed timely competency assessments for Testing Personnel #1 and Testing Personnel #2. All reviewed competency assessments documented the Phlebotomist Supervisor as the observer. The Phlebotomist Supervisor is not listed on the CMS-209 and does not meet the qualifications of Technical Consultant. 2. A review of the CMS-209 revealed the Laboratory Director to be the Technical Consultant. 3. During an interview on 6/27 /2024 at 10:37 AM, The Quality Assurance Coordinator confirmed the above findings. -- 3 of 3 --

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 a review of the Quidel Triage Meter Quality Control (QC) records, a lack of QC manufacturer's assay sheets, and an interview with the Laboratory Manager, the laboratory failed to retain the manufacturer's assay information sheets for control materials for two and a half years from the last survey (01/03/2020) to the current survey (06/15/2022). The findings include: 1. A review of Quidel Triage Meter QC records revealed a log sheet documenting the following for Cardiac Panel [CK-MB (Creatine Kinase - MB) , Myoglobin, and Troponin I] and D-Dimer: a) QC lot number b) QC expiration date c) Cartridge lot number d) QC result value The QC records did not include the manufacturer's assay sheets or documentation of acceptable ranges for each QC lot number. 2. During an interview on 06/15/2022 at 11:30 AM, the Laboratory Manager confirmed the laboratory had not retained the manufacturer's assay sheets with acceptable QC ranges. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Quidel Triage Meter Quality Control (QC) records, patient logs, and an interview with the Laboratory Consultant, the laboratory failed to perform controls each day of patient testing or implement an Individualized Quality Control Plan (IQCP) for the Triage Meter. This was noted from 06/24/2021 (when patient testing started) to 10/20/2021. The findings include: 1. A review of the Triage Meter QC records revealed the laboratory performed only monthly QC from 07/20 /2021 to 09/29/2021 on the D-Dimer and Cardiac Panel cartridges; however the laboratory failed to implement an IQCP (to allow for reduced frequency of QC performance) until 10/20/2021. 2. A review of patient testing on the Triage Meter revealed 39 patient Cardiac Panels and 26 patient D-Dimers were performed from 06 /24/2021 to 09/30/2021, with no record of QC each day of patient testing. 3. During an interview on 06/15/2022 at 11:15 AM, the Laboratory Consultant confirmed the IQCP for the Triage Meter was not signed and implemented until 10/20/2021. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records, a review of the Policy and Procedure Manual, and an interview with the Laboratory Consultant, the Technical Consultant failed to evaluate the performance of testing personnel at least semiannually during the first year of moderate-complexity patient testing. This was noted on one out of three testing personnel. The findings include: 1. A review of the testing personnel records revealed the initial training for Testing Personnel #3 was on 09/15/2021, however there was no documentation of the semiannual competency evaluation due in March 2022. 2. A review of the Policy and Procedure Manual under "Competency Evaluation for Personnel Performing Clinical Testing" revealed the following: "... Newly hired personnel or a current staff member who is learning a procedure for the first time must demonstrate competency in accordance with the following schedule: Initial training...Six months following the initial...Twelve months following the initial...". 3. During an interview on 06/15/2022 at 11:30 AM, the Laboratory Consultant confirmed there was no semiannual competency evaluation documented for Testing Personnel #3. -- 2 of 2 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the Biosite Triage records, a review of testing specialties on the current and previous Form CMS-116, and an interview with Testing Personnel #2, the surveyor determined the Laboratory Director: (1) failed to ensure the laboratory validated the manufacturer's performance specifications for the Biosite Triage analyzer, before patient testing began, and (2) failed to ensure the laboratory notified the CLIA State Agency within three months of testing to include the Specialty of Chemistry on the Certificate of Compliance. The findings include: 1. During the initial tour of the laboratory with TP #2 on 1/3/2020 at approximately 10:15 AM, the surveyor confirmed the only non-waived specialties in which the laboratory tested was Hematology. TP#2 stated the laboratory had not added any new tests or analyzers since the previous survey. [Note: Hematology was the only specialty on the Form CMS-116 for the 2017 survey, and the 1/3/2020 survey.] 2. A review of laboratory records revealed quality control testing on the Triage Meter for Cardiac Profile (Troponin, Myoglobin and and the isoenzyme CK-MB) from 7/2 - 12/5/2019, and D- dimer from 8/1 - 12/16/2019. A review of the Procedure manual revealed a small manufacturer's booklet with a hand-written note signed by TP #1, "Biosite Triage taken out of use 12/31/19". 3. During an interview on 1/3/2020 from 3:00 to 3:15 PM with TP #2 (who was speaking to TP #1 via her cell phone), the surveyor asked if 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 -- laboratory had validated the manufacturer's performance specifications before the analyzer was used for patient testing. TP #2 provided the validation data, and stated they had begun using the analyzer in July 2019. 4. A review of the validation records revealed the laboratory had performed reportable range (linearity) studies on the Cardiac and D-dimer cartridges using the 5-level Triage Total 5 kit on 11/19/2019. The Laboratory Director reviewed and approved the validation on the same date. The surveyor stated the data validated the instrument's accuracy and reportable range, however there was no evidence precision was checked. 5. As the interview continued on 1/3/2020 the surveyor asked if the CLIA State Agency had been notified within three months of testing to include the Specialty of Chemistry on the Certificate of Compliance. TP #2 stated, "No." The surveyor then asked how many patient tests were performed on the Triage in 2019; the laboratory agreed to forward the information to the CLIA Office. 6. On 1/3/2020 at 4:45 PM, TP #1 forwarded an e- mail to the surveyor with the following patient test statistics: A) July 2019: 10 D- Dimers; 7 CK-MB; 5 Myoglobin; 6 Troponin B) August 2019: 17 D-Dimers; 6 CK- MB; 5 Myoglobin; 5 Troponin C) September 2019: 18 D-Dimers; 13 CK-MB; 10 Myoglobin; 14 Troponin D) October 2019: 13 D-Dimers; 18 CK-MB; 10 Myoglobin; 18 Troponin E) November 2019: 9 D-Dimers; 10 CK-MB; 5 Myoglobin; 10 Troponin F) December 2019: 10 D-Dimers; 6 CK-MB; 2 Myoglobin; 6 Troponin SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --