Beaumont Internal Medicine & Geriatric Associates

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on March 26, 2025. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of laboratory instrument specifications, laboratory humidity records, and confirmed in interview, the laboratory failed to ensure the operating environment for the Roche Cobas Pure Chemistry Analyzer was within manufacturer specifications before patient testing for 15 of 40 days reviewed in January and February 2025. The findings included: 1. Review of the manufacturers "Cobas Pure" instructions for use, section "Specifications", subsection, "Environmental conditions during operation" included the following condition: "Ambient humidity: 30-85% (without condensation)" 2. Review of the laboratory temperature and humidity records included the following days in January and February 2025 where the humidity was below the operation specifications for the Roche Cobas Pure chemistry analyzer: January 2025: 13 Days 1/02/2025 - 27% 1/06/2025 - 25% 1/07/2025 - 25% 1/08/2025 - 'Lo' 1/09/2025 - 'Lo' 1/10/2025 - 'Lo' 1/14/2025 - 23 1/15/2025 - 23 1/16/2025 - 23 1 /17/2025 - 'Lo' 1/20/2025 - 'Lo' 1/23/2025 - 'Lo' 1/24/2025 - 'Lo' February 2025: 2 days 2/20/2025 - 23% 2/21/2025 - 'Lo' Surveyor asked if laboratory operations were paused until the humidity could reach the appropriate operating specifications, and testing personnel (TP) 1 stated they did not. 3. In an interview on 3/26/2025 at 14:05, in the laboratory, TP1 confirmed that the humidity was out of the Roche Cobas Pure chemistry analyzer on the above days where patients were tested. 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 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 review of laboratory verification documents, laboratory data, and confirmed in interview, the laboratory failed to ensure that the normal reference intervals for 14 of 37 analytes, tested on the Roche Cobas Pure chemistry analyzer, were appropriate for the laboratory's patient population before it was put into use in December 2024. The findings included: 1. Review of the laboratory verification procedures for the Roche Cobas Pure chemistry analyzer, approved by the laboratory director on 12/20 /2024, included the following instructions found on the "Verification of Reference Interval; Report Interpretation Guide": "A reference interval is typically established from a study which calculates the central 95% of results measured on specimens from healthy persons (minimum 120 persons). In contrast, the verification study hypothesizes that the proposed range is correct for the lab's population. It then test a much smaller number (minimum 20) of specimens to see if there is sufficient evidence to REFUTE the hypothesis. Specifically, the verification study tests whether more than 10% of the results are outside the proposed reference interval. If so, the verification fails. Otherwise it passes." 2. Review of the "Verification of Reference Interval Summary" included the following 14 chemistry analytes on the Cobas Pure that had greater than 10% of the results outside the proposed reference range, subsequently failing the verification of the proposed reference interval (ref int): Analyte [Ref Int] %outside: Passes Amy [23-85] 25%: No BUN [8-21] 20%: No Chol [50-200]30%: No CO2 [23-32] 30%: No Glu [70-105] 15%: No Iron [37-145] 15%: No Trig [35-160] 20%: No UIBC [111-343] 15%: No UA [3.4-7.0] 20%: No Ferritin [13-150] 25%: No FSH-Male [1.5-12.4] 20%: No Testost-F [8-48] 60%: No Vit B12 [232-1245] 15%: No Vit D [30-100] 50%: No Surveyor asked if any additional studies had been performed to verify the 14 that had failed and testing personnel (TP) 1 stated the laboratory had plans to submit additional patient information, but that they had not performed the additional studies yet. 3. In an interview on 3/26/2025 at 10:25 hours, in the conference room, testing personnel (TP)1 confirmed that the 14 analytes above failed to verify the proposed reference intervals by the manufacturer before the Cobas Pure was put into use for patient testing. Key: Amy - Amylase BUN - Blood Urea Nitrogen Chol - Cholesterol CO2 - carbon dioxide Glu - glucose Trig - triglycerides UIBC - Unsaturated Iron Binding Capacity UA - uric acid FSH-Male - follicle stimulating hormone - Male Testost-F - Testosterone - Female Vit B12 - Vitamin B12 Vit D - Vitamin D -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observations, review of policies and procedures and interview of facility personnel found the laboratory did not have a written procedure for testing patient specimens using the Alcor miniised erythrocyte sedimentation analyzer. The laboratory had tested 7839 patient specimens using the miniised erythrocyte sedimentation analyzer in 2022. The findings included: 1. Observations made during the inspection found the laboratory was currently using the Alcor miniised sedimentation analyzer (serial number 00165) to test patient specimens. 2. Review of policies and procedures found no written procedure for the use of the miniised erythrocyte sedimentation analyzer. During interview of testing person one conducted May 1, 2023 at 10:58 AM confirmed the laboratory did not have a written procedure for performing sedimentation rates using the miniised sedimentation analyzer and did not hove the manufacturer's instructions. 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) 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 -- 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 observations, review of verification studies, patient test records and interview of facility personnel, the laboratory failed to verify the reportable range of the erythrocyte sedimentation rate using the Alcor miniiSED erythrocyte sedimentation analyzer prior to testing 7839 patient specimens. The findings included: 1. Observations made during the inspection found the laboratory was using the miniiSED erythrocyte sedimentation analyzer (serial number 00165) to test patient specimens for sedimentation rates. 2. Review of the verification study provided by the laboratory found no documentation of the laboratory verifying the accuracy, precision and reportable range for the miniiSED erythrocyte sedimentation analyzer, or verify the reference range was acceptable for it's patient population. The laboratory offered a comparison study as the verification of the analyzer 3. During interview of testing person one on May 1, 2023 at 10:58 AM, she confirmed that the laboratory had not verified the accuracy, precision and reportable range for the miniiSED erythrocyte sedimentation analyzer, or verify the reference range was acceptable for it's patient population. 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 observations, review of verification studies, patient test records and interview of facility personnel, the laboratory director failed to ensure verification procedures were adequate to verify the accuracy, precision, reportable range and suitability of reference ranges for the Alcor miniiSED erythrocyte sedimentation analyzer prior to testing 7839 patient specimens. (see D 5421) D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: The laboratory director failed to ensure that an approved written procedure for -- 2 of 3 -- sedimentation rate testing was available to all testing personnel outlining the step by step performance when using the Alcor miniised sedimentation analyzer. (see D 5401) -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on March 23, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the American Proficiency Institute (API) testing records, the facility failed to achieve successful performance for 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 -- two of two consecutive proficiency testing events for the analyte TSH, resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records for 2022 and 2023, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive proficiency testing (PT) events for the analyte TSH. Two out of two consecutive testing event scores of unsatisfactory performance result in unsuccessful PT performance. Findings were: 1. A review of the CASPER Report 155 lists the following unsatisfactory scores for the analyte TSH in 2022 and 2023: 2022 - Event 3 - TSH - 0% 2023 - Event 1 - TSH - 60% 2. A proficiency desk review of American Proficiency Institute (API) proficiency testing (PT) records from 2022 and 2023 confirmed that the laboratory received the following unsatisfactory scores for TSH: 2022 - Event 3 - TSH - 0% 2023 - Event 1 - TSH - 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for TSH. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Proficiency Institute -- 2 of 3 -- (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for TSH for two of two consecutive events in 2022 to 2023. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on November 4, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2086 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Proficiency Institute (API) records, the laboratory failed to achieve satisfactory performance in two 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 -- consecutive testing events in 2022 for Triiodothyronine, resulting in unsuccessful performance (refer to D2107), and failed to achieve an overall satisfactory performance for the subspecialty Endocrinology for two consecutive testing events in 2022 (refer to D2108). D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) testing records from 2022, the laboratory failed to achieve a testing event score of satisfactory performance (80% or greater) for two consecutive testing events for the analyte Triiodothyronine in the subspecialty in Endocrinology. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Report 155 listed the following scores in 2022: 2022 Event 2: Triiodothyronine - 0% 2022 Event 3: Triiodothyronine - 40% 2. A proficiency desk review of API proficiency testing records from 2022 confirmed that the laboratory received the following scores the Triiodothyronine in the subspecialty Endocrinology: 2022 Event 2: Triiodothyronine - 0% 2022 Event 3: Triiodothyronine - 40% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records from 2022, the laboratory failed to achieve an overall testing even score of satisfactory performance (80% or greater) for two consecutive testing events in the subspecialty Endocrinology resulting in unsuccessful performance. The findings include: 1. A desk review of the CASPER Report 155 listed the following scores for the subspecialty Endocrinology in 2022: 2022 Event 2: Endocrinology - 75% 2022 Event 3: Endocrinology - 60% 2. A proficiency desk review of API proficiency testing records from 2022 had the following analyte scores resulting in unsuccessful overall performance (80% or greater) in the subspecialty Endocrinology: 2022 Event 2: Triiodothyronine: 0% 2022 Event 3: Thyroid Stimulating Hormone: 0% Triiodothyronine: 40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for the Subspecialty Endocrinology, and the analytes Triiodothyronine and Thyroid Stimulating Hormone. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the subspecialty Endocrinology for two consecutive events in 2022 (refer to D2108), and failed to achieve satisfactory performance for the analyte Triiodothyronine for two consecutive events in 2022 (refer to D2107). -- 3 of 3 --

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 review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017, 2018 and 2019, confirmed by staff interview, the laboratory director failed to attest to the routine integration of samples into the patient workload using the laboratory's routine methods. Findings: 1. Review of API PT documentation revealed that attestation statements for the following testing events were signed by testing person 1: Hematology/Coagulation 1st event 2018 Chemistry-Core 2nd event 2018 Chemistry-Core 3rd event 2018 2. Review of education and training documentation showed that testing person 1 did not meet the regulatory requirements for delegation of signatory authority by the laboratory director in this case. 3. In an interview at the site on 06-14-2019, testing person 1 stated she was not aware of the education and training requirements for performing this function. It should be noted that the laboratory director did sign Performance Review forms for the events listed. . 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 --