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 refrigerator and freezer temperature records, the Sysmex Eightchek 3WP Quality Control (QC) package insert, the Quidel Triage BNP (Brain natriuretic peptide) quick reference document, and an interview with the Technical Consultant, the Laboratory failed to ensure QC material and patient specimens were stored within the manufacturer's acceptable limits. Refrigerator #1 temperatures were outside acceptable ranges for 99 days and Refrigerator #2 temperatures were out 23 days all from 23 months reviewed in 2023 through 2025. Freezer #1 temperatures were outside acceptable ranges for 370 days and freezer #2 temperatures were out for 399 days all from 23 months reviewed in 2023 through 2025. The findings include: 1. A review of the temperature records revealed refrigerators #1 and #2 in which the Sysmex Eightchek 3WP Controls were stored were outside the manufacturer's acceptable limits for the following days: a) Refrigerator #1: i) 2023: 12 ii) 2024: 87 b) Refrigerator #2: i) 2023: 5 ii) 2024: 13 iii) 2025: 5 2. A review of the Sysmex Eightchek 3WP Control package insert revealed, "temperature limitation at 2-8 degrees Celsius." 3. A review of the freezer #1 and #2 temperature records revealed how many days each year freezer temperatures were outside acceptable limits: 1) Freezer #1: i) 2023: 103 ii) 2024: 206 iii) 2025: 61 2) Freezer #2: i) 2023: 103 ii) 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 -- 2024: 231 iii) 2025: 65 4. A review of the Quidel Triage BNP quick reference guide revealed, "store plasma at -20 degrees Celsius until tested." 5. During an interview on 7/16/2025, at 10:15 AM, the Technical Consultant confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of Proficiency Testing records and an interview with Testing Personnel #1, the Laboratory Director failed to sign the attestation statement provided by American Proficiency Institute (API). This was noted on four out of seven 2019 - 2021 Hematology Proficiency Testing Events. The findings include: 1. A review of Proficiency Testing records revealed the Hematology Event #1 2019, Event #2 2019, Event #3 2019, and Event #2 2020 attestation statements were not signed by the Laboratory Director/delegate. 2. During an interview on 08/18/2021 at 12:00 PM, Testing Personnel #1 confirmed the above attestations were not signed by the Laboratory Director/delegate. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records, the Proficiency Testing Procedure, and an interview with Testing Personnel #1, the Laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. This was noted on four out of seven 2019 - 2021 Hematology Proficiency Testing 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 -- Events. The findings include: 1. A review of Proficiency Testing records revealed the following: a) 2019 Hematology 1st Event - Samples 2, 3, and 5 had no critical values and were run twice. b) 2019 Hematology 2nd Event - Samples 6 and 7 had no critical values and were run twice. c) 2019 Hematology 3rd Event - Samples 11-15 were run 4 times over the span of 3 different days. d) 2020 Hematology 2nd Event - Sample 10 had no critical values and was run twice. 2. A review of the Proficiency Testing Procedure revealed the following, "...Do not test PT samples more than once unless it is regular documented laboratory procedure for testing patient samples. For example, if patient samples with abnormal results are retested, retest PT samples with abnormal results..." 3. During an interview on 08/18/2021 at 12:00 PM, Testing Personnel #1 confirmed the above PT samples were tested more than a routine patient sample. 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 maintenance records, a review of the Sysmex XP-300 User Manual, and an interview with Testing Personnel #1, the laboratory failed to retain documentation of daily, weekly, monthly, and quarterly maintenance. This was noted on 23 months out of 28 months reviewed by the surveyor. Also, the laboratory failed to documented weekly maintenance each week of patient testing on three out of five months reviewed. The findings include: 1. A review of the Hematology maintenance records revealed September to December 2020 (maintenance logs from April 2019 to August 2020 could not be located) and July 2021 (maintenance logs from Janurary 2021 to June 2021 could not be located) maintenance log completed. For October 2020 three out of four weekly maintenance documented, November 2020 two out of four weekly maintenance documented, and December 2020 three out of four weekly maintenance documented. 2. A review of the Sysmex XP-300 User Manual revealed daily weekly, monthly and quarterly maintenance is required on this analyzer. 3. During an interview on 08/18/2021 at 1: 40 PM, Testing Personnel #1 confirmed the documentation above could not be located during the onsite survey and the weekly maintenance was not documented weekly for 3 out of 5 months reviewed. Also, an email from Testing Personnel #1 on 08/19/2021 stated the maintenance logs were unable to be located. 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. This STANDARD is not met as evidenced by: Based on a review of the Hematology quality control (QC) records for the Sysmex XP- 300 and an interview with Testing Personnel #1, the laboratory failed to ensure at -- 2 of 7 -- least two levels of quality control were run and acceptable. This was noted nine days out of 10 months reviewed from April 2019 to July 2021 by the surveyor. The findings include: 1. A review of the QC records for the Sysmex XP-300 Hematology analyzer revealed the following: a) 09/16/2019 - No quality control run documented or documentation if patients were performed on this day. b) 04/17/2020 - No quality control run documented or documentation if patients were performed on this day. c) 04 /29/2020 - No quality control run documented or documentation if patients were performed on this day. d) 07/29/2020 - No quality control run documented or documentation if patients were performed on this day. e) 10/09/2020 - No quality control run documented or documentation if patients were performed on this day. f) 10 /28/2020 - No quality control run documented or documentation if patients were performed on this day. g) 04/05/2021 - No quality control run documented or documentation if patients were performed on this day. 2. During an interview on 08/18 /2021 at 1:20 PM, Testing Personnel #1 confirmed the documentation above could not be located during the onsite survey. Also, an email from Testing Personnel #1 on 08 /19/2021 stated the quality control for these days were unable to be located. 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. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include direct observations of routine patient testing in the evaluation of competency at least semiannually and annually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13 /20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP- 300 for this location and competencies were performed at a different location. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include monitoring the recording and reporting of test results in the evaluation of competency at least semiannually and -- 3 of 7 -- annually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of competency at least semiannually and annually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include direct observation of performance of instrument maintenance and function checks in the evaluation of -- 4 of 7 -- competency at least semiannually and annually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04 /12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples in the evaluation of competency at least semiannually and annually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30 /20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08 /18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to include assessment of problem solving skills in the evaluation of competency at least semiannually and annually during the first year of performing CBC's (Complete Blood Counts). This was noted -- 5 of 7 -- on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13 /20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP- 300 for this location and competencies were performed at a different location. 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 evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate the performance of personnel at least semiannually during the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for Sysmex 300 it had the following dates listed Initial Training Date 04/30 /20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08 /18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location on different instrumentation. 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 evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate the performance of personnel at least annually after the first year of performing CBC's (Complete Blood Counts). This was noted on one of three Testing Personnel (two of the three testing personnel performed initial training in June 2021 and August 2021). The findings include: 1. A review of personnel evaluation records revealed Testing Personnel #1 had a form on file that stated at the top "Tests qualified and trained to perform:" for -- 6 of 7 -- Sysmex 300 it had the following dates listed Initial Training Date 04/30/20, 6 Month Competency Date 10/13/20, and Annual Competency Date 04/12/20/21. There was supporting documentation for this form for other test performed at a different location, but no supporting documentation for the Sysmex XP-300 located at Birmingham Internal Medicine DBA STV at Springville. 2. During an interview on 08/18/2021 at 10:20 AM, Testing Personnel #1 confirmed there was no supporting documentation for the Sysmex XP-300 for this location and competencies were performed at a different location on different instrumentation. -- 7 of 7 --