Midwest Medical Group, Pllc

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: 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 proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of three consecutive testing events for TSH (Thyroid Stimulating Hormone), resulting in unsuccessful performance. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance in the subspecialty of Endrocrinology for the analyte TSH (Thyroid Stimulating Hormone) for two of three consecutive testing events in 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for TSH; (a) First 2025 Event - 40% (b) Third 2025 Event - 40% (2) A review of the proficiency testing scores from API for 2025 confirmed the above findings. 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 proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte TSH (Thyroid Stimulating Hormone) in two of three consecutive testing events in 2025. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/28,29/2022 The findings were reviewed with the laboratory manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for two of five patient specimens. Findings include: (1) On 03/28/2022 at 10:30 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument: (i) BD Veritor System - qualitative detection of SARS-CoV-2 nucleocapsid antigens from direct nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "BD Veritor System". Under the section titled, "Specimen Transport and Storage" which stated, "Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. It is essential that correct specimen collection and preparation methods be followed."; (3) The surveyor reviewed five test reports for patients tested on 03/14/2022 and 03/15/2022 and identified the following: (a) Patient Report #4 - Although the specimen result date and time were documented (03/14/2022 at 11:29 am), the collection date and time were not on the patient report; (b) Patient Report #5 - Although the specimen result date and time were documented (03/15/2022 at 12:06 pm), the collection date and time were not on the patient report; (4) The surveyor was not able to determine if the results had been interpreted within 1 hour after inoculation since the specimen 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 -- collection date and time were not on the patient report; (5) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/28/2022 at 02:45 pm the laboratory could not prove the results had been interpreted within one hour after inoculation as indicated above. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of 13 proficiency testing events reviewed. Findings include: (1) On 03/28/2022, the surveyor reviewed 2020 and 2021 proficiency testing records. The following was identified for one of 13 testing events: (a) Third 2020 Hematology Event for Urine Sediment - one of two result had not been graded by the proficiency testing program: (i) For the result (US-06), the following was identified: (aa) US-06 - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) The surveyor reviewed the record with the laboratory manager who stated on 03/28/2022 at 11:05 am, the laboratory had not evaluated the result that was not graded by the proficiency testing program. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for Aspartate Aminotransferase and CO2 testing for two of two lot numbers. Findings include: (1) On 03/28/2022 at 10:20 am, the laboratory manager stated the following to the surveyor: (a) AST (Aspartate Aminotransferase) and CO2 testing were performed on the Alfa Wassereman ACE Axcel analyzer; (b) Two levels of Alfa Wasserman Chemistry QC (quality control) -- 2 of 3 -- materials (level 1 and level 2) were performed each day of patient testing; (c) Established ranges were used for determining acceptability of QC results. (2) The surveyor reviewed the Alfa Wasserman QC package insert instructions which stated, "The value and expected range for each constituent are derived from intralaboratory data. The expected range includes instrument, reagent and environmental variations. The mean of several determinations may not duplicate that value printed on the package insert but should fall within the expected range. Each laboratory should establish its own mean and precision parameters." (3) The surveyor reviewed QC records which included documentation of establishing QC ranges, Levey-Jennings graphs, and cumulative data for level 1 lot #1501UNCM and level 2 lot #1166UECM used during the review period of January 07, 2022 through the first day of the survey (03/28/2022). The documentation showed the ranges that had been utilized by the laboratory to determine acceptability of QC results for level 1 and level 2 were wider than the established QC ranges as follows: (a) AST (i) Level 1 - On 03/04/2022, the laboratory had changed the established mean and standard deviation (SD) to a mean of 49 and SD of 6.2 (range of 38.2 - 59.8), which was wider than the manufacturer's package insert range (range of 42.4 - 55.6). (b) CO2 (i) Level 1 - On 03/04/2022, the laboratory had changed the established mean and standard deviation (SD) to a mean of 13.6 and SD of 1.04 (range of 11.54 - 15.68), which was wider than the manufacturer's package insert range (range of 12.92 - 16.88); (ii) Level 2 - On 03/04 /2022, the laboratory had changed the established mean and standard deviation (SD) to a mean of 26.0 and SD of 2.61 (range of 21.68 - 32.12), which was wider than the manufacturer's package insert range (range of 26.44 - 34.56). (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/29/2022 at 11:20 am, ranges wider than the manufacture's package insert range, as shown above, had been used to evaluate QC results. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the laboratory manager, the laboratory failed to provide normal reference intervals for one of one wet prep patient test report. Findings include: (1) On 03/28/2022 at 10:10 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed wet prep testing. (2) The surveyor reviewed one test report for a patient tested on 03/28/2022 at 10:23 am. The report did not include a normal reference range; (3) The report was reviewed with the laboratory manager, who stated on 03/28/2022 at 02:30 pm the patient report did not include a normal reference range. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The survey was performed on 03/22,23/18. The surveyor reviewed the findings with the laboratory supervisor at the conclusion of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2016 and 2017 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) 2017 Hematology - First Event (i) MPV (Mean Corpuscular Volume) (aa) 1 of 5 HEM-02 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non- graded result; (3) The surveyor asked the laboratory supervisor if the result had been documented as evaluated. The laboratory supervisor reviewed the records and stated the non-graded result had not been documented as reviewed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of written policies and procedures and interview with the laboratory supervisor, the laboratory failed to ensure policies and procedures had been approved, signed, and dated by the current laboratory director. Findings include: PROCEDURE MANUAL (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor CBC (Complete Blood Count) testing was performed using the Cell-Dyn Emerald analyzer; (2) The surveyor reviewed the procedure manual for the above testing. It had not been approved, signed, and dated by the current laboratory director; (3) The surveyor reviewed the procedure manual with the laboratory supervisor, who stated it had not been approved, signed, and dated by the current laboratory director. INDIVIDUALIZED QUALITY CONTROL PLAN (1) The laboratory supervisor stated the following to the surveyor: (a) The laboratory performed TSH (Thyroid Stimulating Hormone), FT4 (Free Thyroxine) and PSA (Prostate Specific Antigen) testing on the Qualigen FastPack analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP and identified the QCP (Quality Control Plan) portion had not been approved, signed, and dated by the current laboratory director; (3) The surveyor reviewed the records with the laboratory supervisor who stated the QCP had not been approved, signed, and dated by the current laboratory director. 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 a review of records and interview with the laboratory supervisor, the laboratory failed to demonstrate performance specifications prior to patient testing. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor the laboratory performed TSH (Thyroid Stimulating Hormone), FT4 (Free Thyroxine) and PSA (Prostate Specific Antigen) testing on the Qualigen FastPack analyzer; (2) Later during the survey, the laboratory supervisor stated the following to the surveyor: (a) The analyzer was removed from service on 08/20/16; (b) The manufacturer sent a new analyzer back to the laboratory and it was put into service on 08/24/16. (3) The surveyor asked to review the performance specification records for the replacement analyzer. The laboratory supervisor stated that accuracy, precision, reportable ranges had not been demonstrated and reference ranges had not been verified on the new Qualigen FastPack analyzer. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies -- 2 of 5 -- and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's quality control instructions. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated the following to the surveyor: (a) The Ace Alera analyzer was used to perform Albumin, Total Bilirubin, Direct Bilirubin, Calcium, CO2, Chloride, Creatinine, Glucose, ALP (Alkaline Phosphatase), Potassium, Total Protein, Sodium, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Triglycerides and BUN (Blood Urea Nitrogen); (b) Two levels of Alfa Wassermann Chemistry quality control (QC) materials were performed each day of patient testing. (2) Later on the first day, the surveyor reviewed the manufacturer's instructions for the QC materials which stated, "The value and expected range for each constituent are derived from intralaboratory data. The expected range includes instrument, reagent and environmental variations. The mean of several determinations may not duplicate the value printed on the package insert but should fall within the expected range. Each laboratory should establish its own mean and precision parameters."; (3) The surveyor reviewed records for testing performed from 03/01/18 through the first day of the survey. For each analyte (listed above), it was identified the laboratory had used the package insert ranges instead of laboratory established ranges for level 1(lot# 1213UNCM) and level 2 (lot# 937UECM) used during the review period; (4) The surveyor reviewed the findings with laboratory supervisor who stated the laboratory had used the package insert ranges instead of laboratory established ranges for determining acceptability of QC results. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to follow their policy for monitoring the effectiveness of their IQCP. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated the following to the surveyor: (a) The laboratory performed TSH (Thyroid Stimulating Hormone), FT4 (Free Thyroxine) and PSA (Prostate Specific Antigen) testing on the Qualigen FastPack analyzer; (b) IQCP's (Individualized Quality Control Plans) had been developed for the test systems. (2) The surveyor reviewed the IQCP (dated as effective 10/07/16). The surveyor then reviewed records for the testing. There was no evidence of QA reviews for the IQCP's between the effective date of 10 /07/16 and 03/28/18; (4) The surveyor reviewed the records with the director of laboratory services and asked if QA reviews had been performed in 2016, 2017 and 2018. The director of laboratory services stated QA reviews had not been performed. D5807 TEST REPORT CFR(s): 493.1291(d) -- 3 of 5 -- Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor CBC (Complete Blood Count) testing was performed using Cell - Dyn Emerald analyzer; (2) On the second day of the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 03/22/18 at 10:08 am; the second report was for an adult male patient with the testing performed on 03/22/18 at 10:02 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit, which were: (a) RBC - 4.20 - 6.30 10^6/L (b) Hemoglobin - 12.0 - 18.0 g/dL (c) Hematocrit - 37 -51% (3) The surveyor viewed the findings with the laboratory supervisor who stated the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require