Birmingham Internal Medicine Associates Llc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 Technical Consultant (TC), the Laboratory failed to ensure humidity in the room in which the Sysmex XP 300 Hematology analyzer was operated was within the manufacturer's acceptable limits. Humidity was noted below acceptable ranges for 55 days from 2021 to 2023. The findings include: 1. A review of the Sysmex XP 300 Hematology temperature records revealed Humidity was outside the manufacturer's acceptable parameters (30-80%) for a total of 59 days as follows: A) January through April 2024; 30 days B) January through April and December 2025; 29 days 2. During an interview on 1/7/2026, at 12:34 PM, the Technical Consultant confirmed the above findings and stated for best laboratory practice the laboratory door being closed will correct the humidity. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual 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 -- tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to evaluate semi-annual competencies for Testing Personnel (TP) performing moderate complexity testing. This was noted for one of four new TP listed on the CMS-209 (Laboratory Personnel Report) in 2024. The findings include: 1. A review of the personnel records revealed no evidence of evaluation by the TC for the semi-annual competencies of TP# 1 for November 2024. 2. During an interview on 5/1/2024, at 11:03 AM, Testing Personnel #8 confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to ensure all testing personnel had documentation of annual competency assessments. The surveyor noted no documentation of the 2024 annual competency assessment for one of four testing personnel listed on the CMS- 209 (Laboratory Personnel Report). The findings include: 1. A review of the personnel records revealed Testing Personnel #4 annual competency evaluations performed on 5/12/2025. There was no documentation of a 2024 annual competency assessment. 2. During an interview on 1/7/2026, at 1:32 PM, the TC confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 Personnel records and an interview the Technical Consultant, the Technical Consultant failed to assess competency at least semi annually in the first year of patient testing. This was noted for one out of three new Testing Personnel since the date of the last survey, January 27, 2022, to the date of the current survey, October 11, 2023. The findings include: 1. A review of Personnel records revealed Testing Personnel #1 to have an intial training date of 10/5/22 and an annual competency date of 9/18/2023. No evidence of a six month competency assessment was available for review. 2. During an interview on 10/11/2023 at 10:00 AM, the Technical Consultant confirmed the above findings. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the Technical Consultant, the Technical Consultant failed to assess competency of Testing Personnel at least annually. This was noted for one out of two Testing Personnel 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 -- previously qualified from the date of the last survey, January 27, 2022, to the date of the current survey, October 11, 2023. The findings include: 1. A review of Personnel records revealed the Testing Personnel #4 to have one annual competency dated November 2021. No evidence of an annual competency assessment for 2022 or 2023 was available for review. 2. During an interview on 10/11/2023 at 11:00 AM, the Technical Consultant confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #3, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on three out of three Hematology surveys reviewed for 2020. The findings include: 1. A review of API attestation statements revealed Testing Personnel #3 had performed all three events in 2020 for Hematology - Complete Blood Count. 2. During an interview on 01/27/2022 at 10:05 AM, Testing Personnel #3 stated she performed PT because testing personnel were so new and couldn't do PT. The surveyor asked if the testing personnel could perform patient testing, and Testing Personnel #3 confirmed yes they could performed patient testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology Sysmex XP-300 maintenance records, a review 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 -- of the Sysmex XP-300 Instructions For Use, and an interview with the Laboratory Consultant, the laboratory failed to document quarterly maintenance. This was noted from 2020 -2021. The findings include: 1. A review of the Hematology maintenance records revealed a place to document quarterly (every 3 months) maintenance on the Sysmex XP-300 Maintenance Log and it was documented the following times: May 2020, July 2020, December 2020, February 2021, September 2021, and October 2021. No documentation of quarterly maintenance during these gaps Jan 2020 - March 2020, August 2020 - November 2020, and March 2021 - August 2021. 2. A review of the Sysmex XP-300 Instructions For Use revealed in section 12 page 12-12 under Clean SRV "When the main power switch is turned ON, and if either the counter value exceeds 4,500, or if 3 months have passed since the last maintenance, a message will appear prompting the operator to perform periodic maintenance (SRV cleaning)..." 3. During an interview on 01/27/2022 at 3:25 PM, the Laboratory Consultant confirmed the above findings and agreed quarterly maintenance was not documented at least every 3 months. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records for the Triage meter (Troponin I), the patient logs, and an interview with the Laboratory Consultant, the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 30 days of patient testing as per the IQCP. This was noted for two month from January 2020 to December 2021. The findings include: 1. A review of the IQCP for the Triage meter (Troponin I) revealed a QC Plan which specified two levels of QC should be performed and documented every 30 days of patient testing, and with each new lot number. 2. A review of the January 2020 to December 2021 Triage meter QC data log revealed QC had been performed most months (except July 2021 and August 2021), however the QC testing exceeded the 30 day frequency specified in the IQCP during those months. QC was performed on 06/09/2021, and the next QC run was on 09/15/2021; during this period, 13 patient tests were performed. 3. During an interview on 01/27/2022 at 2:50 PM, the Laboratory Consultant confirmed the laboratory failed to follow the IQCP between 07/09/2021 to 09/15/2021 and 13 patient tests were performed during this time period. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the Hematology quality control (QC) reports, patient logs, and an interview with the Laboratory Consultant , the laboratory failed to ensure at least two levels of quality control was performed and acceptable prior to performing patient testing. This was noted one day out of 8 months reviewed by the surveyor. This is a repeat citation. The findings include: 1. A review of the Levey-Jennings for the Sysmex XP-300 revealed only the Low QC was performed on 4/20/2021; there was no documentation of the Normal and High QC on this date. 2. A review of the patient logs revealed 3 patient Complete Blood Counts (CBCs) were run on 04/20/2021. 3. During an interview on 01/27/2022 at 2:50 PM, the Laboratory Consultant confirmed only one level of QC was run on 04/20/2021 and three patients were performed on this day. D5781

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on reviews of the records for the two Biosite Triage analyzers (used for D- Dimer and Cardiac Profile testing), patient records, and an interview with the previous Technical Consultant, the surveyor determined the laboratory failed to ensure a complete validation of the manufacturer's performance specifications for precision was performed before patient testing began. The findings include: 1. A review of the installation procedures for the two Biosite Triage analyzers (Serial Numbers [SN] 78143 and 80897) revealed accuracy and reportable range were verified by running five samples from the Alere Total 5 Calibration Verification (C-V) kits on the D- Dimer and Cardiac Profile cartridges on each instrument on 8/29/2018. 2. A review of quality control (QC) records revealed two levels of QC for the above tests were run on 8/14/2019 on Triage SN78143, and on 8/29/2019 on Triage SN80897. Since the QC and C-V samples were only run once for each level, the surveyor was unable to determine how the laboratory verified the manufacturer's performance specifications for precision (reproducibility). 3. During an interview on 8/15/2019 from 11:10 to 11: 20 AM, the previous Technical Consultant (listed on the "Laboratory Personnel Report" - Form CMS-209 for the 2017 recertification survey) reviewed the 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 2 -- records, and confirmed the laboratory had failed to verify precision for the Triages. The surveyor then asked when patient testing began; the Consultant answered "9/7 /2018". Thus, the above findings were confirmed. . 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: Based on reviews of the Hematology quality control (QC) reports and the patient records, and an interview with the previous Technical Consultant, the laboratory failed to ensure at least two levels of quality control were performed and acceptable, prior to analyzing patient specimens and reporting the results on two days in 2018. The findings include: 1. A review of the Sysmex Insight Report with the daily control values for the Sysmex XP-300 Hematology analyzer revealed no QC results for 3/30 /2018 or 4/10/2018. 2. During an interview on 8/15/2019 at 1:18 PM, the previous Technical Consultant (listed on the "Laboratory Personnel Report"-Form CMS-209 for the 2017 recertification survey) reviewed the Hematology records and confirmed the testing personnel had failed to perform QC on the above dates. The surveyor then asked if patient CBC's (Complete Blood Counts) were run; the Consultant stated 10 patient CBCs were run on 3/30/2018, and 21 CBC's on 4/10/2018. Thus, the above findings were confirmed. SURVEYOR ID #32558 Licensure & Certification Surveyor -- 2 of 2 --