Macomb Physicians Group Pllc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on November 5, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following Conditions: 493.803 Condition: Successful participation. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 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 review of the CMS database, American Proficiency Institute (API) and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) 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 -- proficiency testing reports, and interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the chemistry analyte, Total Cholesterol. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the CMS database, American Proficiency Institute (API) and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, and interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the chemistry analyte, Total Cholesterol, for two (2025 2nd and 3rd events) of two consecutive testing events in 2025. Findings include: 1. A review of the CMS database, American Proficiency Institute (API) proficiency testing reports, and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports revealed the laboratory obtained the following proficiency testing scores for Total Cholesterol: PT Event Total Cholesterol Score 2nd event 2025 0% 3rd event 2025 60% 2. A phone interview on 11/5/25 at 4:02 pm with the technical consultant confirmed the scores listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on review of the CMS database, American Proficiency Institute (API) and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, and interview with the technical consultant, the laboratory director failed to achieve satisfactory performance for the chemistry analyte, Total Cholesterol. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of the CMS database, American Proficiency Institute (API) and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) -- 2 of 3 -- proficiency testing reports, and interview with the technical consultant, the laboratory director failed to ensure the laboratory achieved satisfactory performance for the chemistry analyte, Total Cholesterol. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on August 20, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following Conditions: 493.803 Condition: Successful participation. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 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 review of the CMS database, American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, 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 2 -- interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the chemistry analyte, High-Density Lipoprotein (HDL) Cholesterol. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the CMS database, American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, and interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the chemistry analyte, High-Density Lipoprotein (HDL) Cholesterol, for two (2025 1st and 2nd events) of two consecutive testing events in 2025. Findings include: 1. A review of the CMS database and American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports revealed the laboratory obtained the following proficiency testing scores for High-Density Lipoprotein (HDL) Cholesterol: PT Event HDL Score 1st event 2025 60% 2nd event 2025 0% 2. A phone interview on 8/20/25 at 1:40 pm with the technical consultant confirmed the scores listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on review of the CMS database, American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, and interview with the technical consultant, the laboratory director failed to achieve satisfactory performance for the chemistry analyte, High-Density Lipoprotein (HDL) Cholesterol. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of the CMS database, American Association of Bioanalysis- Medical Laboratory Evaluation (AAB-MLE) proficiency testing reports, and interview with the technical consultant, the laboratory director failed to ensure the laboratory achieved satisfactory performance for the chemistry analyte, High-Density Lipoprotein (HDL) Cholesterol. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager, the laboratory failed to accurately document the test report date on patient test report for 2 (Patients 6 and 10) of 12 patient test reports reviewed. Findings include: 1. A review of the laboratory's patient test reports revealed the following: a. Patient 6's test report for their Prostate Specific Antigen testing indicated the test report date was 9/27/23. b. Patient 10's test report for their Thyroid Stimulating Hormone (TSH) and Lipid panel testing indicated the test report date was 10/24/23. 2. A review of the laboratory's testing logs revealed the following: a. Patient 6 had a lack of test results recorded on 9 /27/23 and had their testing recorded on 9/29/23. b. Patient 10 had a lack of test results recorded on 10/24/23 and had their testing recorded on 10/27/23. 3. An interview on 10/30/23 at 11:45 am with the Office Manager confirmed the patient test reports indicated above did not have the correct test report date. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do 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 -- following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager, the laboratory failed to issue corrected reports for 38 patients with inaccurate test reports. Findings include: 1. A review of the laboratory's "Macomb Physicians Group Patient Review" document revealed a total of 38 patients had inaccuracies in their test results reported. 2. A review of 4 (Patients 7, 8, 9, and 12) of the 38 patient test reports revealed a corrected test report had not been generated and issued to the authorized person or individual using the test results. 3. An interview on 10/30/23 at 10:06 am with the Practice Manager confirmed corrected reports for the 38 patients with inaccurate test reports did not have corrected reports generated and the information was attached as a note. -- 2 of 2 --

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 record review and interview with the Technical Supervisor, the laboratory failed to retain its documentation of quality control manufacturer instructions for 1 (Lot #40383) of 2 lots reviewed. Findings include: 1. A review of the laboratory's handwritten "Quality Control Chart" for its Prostate Specific Antigen testing revealed the high-end control range for lot #40383 revealed a range of 15.2 to >25.0 for testing dates between 12/4/20 and 5/5/23. 2. The surveyor requested the manufacturer's instructions for lot #40383 on 9/13/23 at 1:03 pm and they were not made available. 3. An interview on 9/13/23 at 1:03 pm with the Technical Supervisor confirmed documentation of quality control manufacturer instructions for lot #40383 was not available. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to ensure positive patient identification during the testing process for 2 patient results with no identifiers Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- documented in the NanoEnTek Frend analyzer (refer to D5203), failed to perform control procedures according to policy for its Prostate Specific Antigen (PSA) and Vitamin D patient testing (refer to D5445 B), and failed to ensure the results of control materials for Prostate Specific Antigen (PSA) testing had met manufacturer's criteria for acceptability before reporting patients (refer to D5481). 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 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to verify performance specifications of its Free Thyroxine (Free T4) testing (refer to D5421) and failed to perform control procedures each date of Free Thyroxine (Free T4) patient testing (refer to D5445 A). 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 record review and interview with the Technical Supervisor, the laboratory failed to ensure positive patient identification during the testing process for 2 patient results with no identifiers documented in the NanoEnTek Frend analyzer between June 2023 and August 2023. Findings include: 1. A review of the laboratory's NanoEnTek Frend analyzer's stored data revealed the following Prostate Specific Antigen (PSA) test results lacking any patient identifiers: a. Date: 6/29/23, Time: 22: 32:27, PSA: 2.46 ng/mL. b. Date: 8/25/23, Time: 02:21:46, PSA: 0.86 ng/mL. 2. A review of the laboratory's patient testing logs revealed Patient 3262 performed on 8/25 /23 had a PSA result of 0.86 and Patient 3035 performed on 6/30/23 had a PSA result of 2.46. 3. An interview on 9/13/23 at 1:10 pm with the Technical Supervisor confirmed the patients listed above did not have positive identification on the NanoEnTek Frend analyzer performing their testing. 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to verify performance specifications of its Free Thyroxine (Free T4) testing for 7 (March 2023 to September 2023) of 7 months since the test system was put into use. Findings include: 1. A review of the laboratory's quality control tapes revealed the laboratory started testing for Free T4 using the Frend analyzer on 3/3/23. 2. An interview on 9/13/23 at 12:55 pm with the Technical Supervisor revealed the laboratory had not verified the performance specifications of the Frend analyzer's Free T4 assay prior to testing patients. 3. A review of patient testing logs revealed a total of 120 patients were tested for Free T4 between March 2023 and September 2023. 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: . A. Based on record review and interview with the Technical Supervisor, the laboratory failed to perform control procedures each date of Free Thyroxine (Free T4) patient testing for 19 of 25 testing dates since testing began using the NanoEnTek began on 3/3/23. Findings include: 1. A review of the laboratory's patient and quality control testing logs revealed a lack of Free T4 quality control performance at least once each day patient specimens were assayed for the following dates: a. 9/8/23 b. 8 /25/23 c. 8/18/23 d. 8/11/23 e. 7/22/23 f. 7/14/23 g. 7/7/23 h. 6/30/23 i. 6/24/23 j. 6/16 /23 k. 6/9/23 l. 5/29/23 m. 5/24/23 n. 5/19/23 o. 5/12/23 p. 4/28/23 q. 4/21/23 r. 3/31 /23 s. 3/25/23 2. The surveyor requested an established Individual Quality Control Plan (IQCP) for its NanoEnTek Free T4 testing on 9/13/23 at 12:43 pm and it was not made available. 3. An interview on 9/13/23 at 2:03 pm with the Technical Supervisor confirmed the laboratory had not performed quality control testing at least each day of patient testing for the dates listed above. B. Based on record review and interview with the Technical Supervisor, the laboratory failed to perform control procedures according to policy for its Prostate Specific Antigen (PSA) and Vitamin D patient testing for 1 (July 2023) of 7 months reviewed. Findings include: 1. A review of the laboratory's Individual Quality Control Plan (IQCP) for PSA and Vitamin D revealed a section stating, "Testing with the CLINIQA Liquid Control Material is performed on two levels of external QC monthly, with each new lot of reagents, with each new shipment of reagents, when training new operators, whenever the lab conditions have changed significantly, or any time the accuracy of patient results is in question." 2. A review of the laboratory's quality control stored data on the NanoEnTek revealed a lack of quality control performed for PSA and Vitamin D assays between 6/2/23 and 8 /4/23. 3. A review of patient testing logs revealed five patients were tested for PSA -- 3 of 6 -- and one patient was tested for Vitamin D in July 2023. 4. An interview on 9/13/23 at 12:05 pm with the Technical Supervisor confirmed the laboratory had not established an IQCP and failed to perform PSA and Vitamin D controls in July 2023. 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 record review and interview with the Technical Supervisor, the laboratory failed to ensure the results of control materials for Prostate Specific Antigen (PSA) testing had met manufacturer's criteria for acceptability before reporting patients for 8 of 8 patients tested in January 2023. Findings include: 1. A review of the laboratory's Individual Quality Control Plan (IQCP) for PSA testing revealed a section stating, "Testing with the CLINIQA Liquid Control Material is performed on two levels of external QC monthly, with each new lot of reagents, with each new shipment of reagents, when training new operators, whenever the lab conditions have changed significantly, or any time the accuracy of patient results is in question." 2. A review of the laboratory's "Liquid QC Immunoassay Control" documentation showed the reference ranges for the NanoEnTek Frend analyzer PSA assay were as follows: a. Level 1- 0.98 to 2.42 ng/mL b. Level 2- 9.55- 20.35 ng/mL 2. A review of the laboratory's NanoEnTek Frend Analyzer quality control documentation revealed the quality control level 2 performed on 1/3/23 had a result of 2.50 ng/mL. 3. A total of eight patients were tested for PSA in January 2023 when quality control results were not acceptable. 4. An interview on 9/13/23 at 2:03 pm with the Technical Supervisor confirmed the laboratory had reported patient PSA testing when controls had not been acceptable. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to accurately document patient test results on the test report for 1 (Patient 3262) of 12 patient test record reviewed. Findings include: 1. A review of the laboratory's NanoEnTek Frend analyzer stored data revealed Patient 3262 had a Vitamin D result of 50.8 ng/mL on 8/25/23. 2. A review of the laboratory's handwritten patient testing logs revealed Patient 3262 had a Vitamin D result of 51.0 ng/mL on 8/25/23. 3. A review of Patient 3262's test report revealed a Vitamin D result of 51.0 ng/mL on 8/25 -- 4 of 6 -- /23. 4. An interview on 9/13/23 at 1:10 pm with the Technical Supervisor confirmed the patient's test result had not been accurately entered in the test report. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interviews, the Laboratory Director the failed to ensure verification of performance specifications for its Free Thyroxine (Free T4) testing were performed prior to patient testing (refer to D6085), failed to ensure control procedures were established for the laboratory's Free Thyroxine (Free T4) testing (refer to D6093 A), failed to ensure control procedures were maintained for the laboratory's Prostate Specific Antigen (PSA) and Vitamin D patient testing (refer to D6093 B), and failed to ensure

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Technical Consultant (TC) #1, the laboratory failed to verify the accuracy of the urine microscopic and the COVID-19 IgM and IgG testing at least twice annually for 1 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. A record review of the twice a year verification of accuracy documents revealed a lack of documentation as follows: a. urine microscopic - 2 events in 2021 b. COVID-19 IgM and IgG - 1 event 2021 2. An interview on 1/26/2022 at 12:30 and 2:10 pm, TC #1 confirmed there was no verification of accuracy performed for urine microscopic's in 2021 and for the 2 event in 2021 for COVID-19. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #1, the laboratory failed to include the patient's scanned final COVID-19 report into the electronic medical records (EMR) for 2 (#3 and #4) of 5 patient charts audited. Findings include: 1. Record review revealed for 2 (#3 and #4) of 5 patient charts audited the final COVID-19 report was not scanned into the patient's EMR file. 2. An interview on 1/26/2022 at 1:11 pm, TC #1 confirmed the final COVID-19 reports were not scanned into the EMR system. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Consultant #1, the laboratory failed to ensure Testing Personnel #2 performing the duties of a Technical Consultant, met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, -- 2 of 3 -- excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #1, the laboratory failed to ensure personnel performing the TC duty of performing personnel competency assessments was qualified for 6 (Testing Personnel (TP) #4 - #9) of 9 personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency records revealed TP #2 had performed competency assessments for the following testing personnel: a. TP #4 - performed on 10/28/2020 b. TP #5 - performed on 10/28/2020 c. TP #6 - performed on 10/28/2020 d. TP #7 - performed on 10/28/2020 e. TP #8 - performed on 10/28/2020 f. TP #9 - performed on 10/28/2020 2. A review of the qualifications for TP #2 revealed they did not meet the qualification requirements to perform Technical Consultant responsibilities. 3. An interview on 1/26/2022 at 10:05 am with TC #1 confirmed TP #2 did not meet the qualification requirements to be a Technical Consultant. -- 3 of 3 --

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #1 (TS1) and the Assistant Office Manager (AOM), the laboratory failed to retain the manual patient chemistry test requisition for 7 (#1-#6, #8, and #10 - #11) of 14 patient charts audited for 2 years. Findings include: 1. Record review of patient test results in the electronic medical record (EMR) revealed for 7 (#1-#6, #8, and #10 - #11) of 14 patient charts audited the manual patient chemistry test requisition with testing results was not scanned into or a part of the EMR system. 2. During the interview on 12/4/19 at approximately 2:20 pm, TS1 and the AOM acknowledged the manual chemistry test requisition was not consistently scanned into the EMR system or retained for 2 years. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: 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 -- . Based on record review and interview with Technical Supervisor #1 (TS1), the laboratory failed to maintain a record system that included the identity of the testing personnel (TP) performing the complete blood cell (CBC) count for 3 (#3, #7, and #13) of 14 patient charts audited. Findings include: 1. Record review for 3 (#3, #7, and #13) of 14 patient charts audited revealed the laboratory did not have a record system in place that included the identity of the testing personnel who performed and documented the CBC test results on the instrument printout. 2. During the interview on 12/4/19 at approximately 2:20 pm, the TS1 acknowledged that the TP inconsistently recorded their initials on the CBC instrument printouts. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . A. Based on record review and interview with Technical Supervisor #1 (TS1) and the Assistant Office Manager (AOM), the laboratory failed to 1) provide accurate and reliable patient test reports for 6 (#1-#4, #6, and #11) of 14 patient charts reviewed and 2) provide accurate and reliable manually resulted complete blood cell (CBC) counts for 6 (#2, #7, #9, and #12 - #14) of 14 patient charts audited. Findings include: 1. Record review of patient final test reports revealed the laboratory had reported CBC, hemoglobin A1C (A1C), glucose (Glu), cholesterol (Chol), triglycerides (Trig), high density lipoprotein (HDL), low density lipoprotein (LDL), thyroid stimulating hormones (TSH), bile acid (BA), thyroxine (FT4), vitamin B12, vitamin D, iron, % saturation, and total iron binding capacity (TIBC) with multiple results for the same test for the same patient on the same day of testing as follows: a. Patient #1 - collection date 12/20/17 1. Vitamin B12 - resulted 8 times 2. TSH, Trig, HDL, and LDL - resulted 6 times 3. A1C - resulted 5 times 4. Glu and FT4 - resulted 4 times 5. CBC - resulted 2 times b. Patient #2 - collection date 2/7/18 1. CBC, Trig, HDL, and LDL - resulted 4 times 2. TSH - resulted 3 times 3. Chol, FT4, and BA - resulted 2 times c. Patient #3 - collection date 4/18/18 1. Chol, Trig, HDL, and LDL - resulted 2 times d. Patient #4 - collection date 06/6/18 1. Chol and HDL - resulted 6 times 2. A1C and Trig - resulted 4 times 3. LDL - resulted 2 times e. Patient #6 - collection date 10/12/18 1. TSH - resulted 6 times 2. HDL - resulted 5 times 3. Iron, % saturation, TIBC, Chol, and Trig - resulted 4 times 4. LDL, Vitamin B12, and Vitamin D - resulted 2 times f. Patient #11 - collection date 7/23/19 1. Glu, iron, and % saturation - resulted 4 times 2. AIC and TIBC - resulted 2 times 2. Record review for 6 (#2, #8 #9, and #12 - #14) of 14 patient charts audited revealed the manually entered CBC test results in the EMR system were entered in duplicate. 3. During the interview on 12/4/19 at approximately 2:20 pm, TS1 and the AOM acknowledged multiple test results were available in the electronic medical record system for the same patient on the same day of testing. B. . Based on record review and interview with the Technical Supervisor #1 (TS1), the laboratory failed to provide accurate patient test results for 2 (#4 and #6) of 14 patient charts audited. Findings include: 1. Record review for 2 of -- 2 of 3 -- 14 patient charts audited revealed inaccurate patient test results entered into the electron medical record (EMR) system as follows: a. Patient #4 - Hemoglobin A1C entered incorrectly as 58%, should be 5.8% b. Patient #6 - Vitamin B12 entered incorrectly as 2000, should be >2000. 2. During the interview on 12/4/19 at approximately 2:20 pm, TS1 acknowledged the results were entered into the EMR system incorrectly. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #1 (TS1) and the Assistant Office Manager (AOM), the laboratory failed to maintain the patient's final test report as part of the patients' electronic medical record (EMR) for 4 (#5, #7, #8, and #10) of 14 patient charts audited. Findings include: 1. Record review revealed for 4 of 14 patient charts audited the following final patient test reports were not available in the EMR system for the surveyor on the day of the survey when requested as follows: a. Patient #5 - prostate specific antigen (PSA), written on patient log, no results in the EMR. b. Patient #7 - no manual complete blood cell (CBC) results in the patient's EMR system. c. Patient #8 - no thyroxine (FT4), Vitamin D, Vitamin B12, and folate results, written on the patient log no results in the EMR. d. Patient #10 - no PSA, iron, and total iron binding capacity results, written on the patient log no results in the EMR. 2. During the interview on 12/4/19 at approximately 2:20 pm, TS1 acknowledged results were not in the patient's EMR system for the 4 patient's listed above. -- 3 of 3 --