Metropolitan Pediatrics

Summary Statement of Deficiencies D0000 . The Metropolitan Pediatrics laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on July 8, 2025. The following standard-level deficiencies were cited: 493.1105 Retention requirements 493.1291 Test report . D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure annual competency assessment records were retained for at least two years in 2023 and 2024. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 10:04 a.m. on 7/8/25. 2. Previously qualified Testing Personnel 1, 2, and 3 (TP1, TP2. TP3) performed moderate complexity Chemistry and Hematology testing in 2023 and 2024 as indicated on the Laboratory Personal Report (CLIA) Form CMS-209 provided by the laboratory on the date of survey. 3. Annual 2023 competency assessment documents for TP1, TP2, and TP3 were not found during review of laboratory personnel records. The laboratory was unable to provide the missing documents upon request as confirmed by the LS in an email received at 11:55 a.m. on 7/11/25. . D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient 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 -- 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 document review and interview with laboratory personnel, the laboratory failed to ensure all test reports included the address of the laboratory in 2024 and 2025. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry and Hematology testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 10:04 a.m. on 7/8/25. 2. Three laboratory reports from 2024 and 2025 reviewed during the survey included the address of a different Metropolitan Pediatrics location. See below. Laboratory address: 1515 St Francis Ave, Suite 100, Shakopee, MN 55379 Address on patient reports: 3400 West 66th Street, Suite 450, Edina, MN 55435-2115 3. The laboratory performed 3190 tests annually as indicated on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form CMS-116 provided by the laboratory on the date of survey. 4. In an interview at 12:44 p.m. on 7/8/25, the Technical Consultant confirmed the above findings. . D5807 TEST REPORT CFR(s): 493.1291(d) (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 observation, document review, and interview with the laboratory personnel, the laboratory failed to ensure two of ten Urinalysis reference intervals reviewed were consistent between the procedure and a patient test report in 2024. Findings are as follows: 1. The laboratory performed Urinalysis testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 10:04 a.m. on 7/8 /25. 2. An Olympus CX31 microscope was observed as present and available for use for urine microscopic exams during the tour. 3. Urine microscopic exam reference intervals defined in the Urinalysis - Microscopic Evaluation procedure provided by the laboratory were not consistent with urine microscopic exam reference intervals included on a patient test report from 7/19/24. See below. Procedure Patient Report WBC Female 0-5/hpf WBC 0-0/hpf RBC Female 0-4/hpf RBC 0-0/hpf 4. The LS indicated the laboratory performed 529 urine microscopic examinations annually, and confirmed the above findings in an interview at 12:44 p.m. on 7/8/25. . -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to meet requirements for the specialty of Hematology as specified in 493.1251, 493.1256, and 493.1282 Findings are as follows: 1. The laboratory failed to establish written procedures for staff to follow when flagged values are obtained on patient testing. See D5403 2. The laboratory failed to verify criteria for quality control (QC) material prior to putting it into production for all QC lot changes since May 2022. See D5469 3. The laboratory failed to ensure

Summary Statement of Deficiencies 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure hematology proficiency testing (PT) samples were tested consistent with the number of times the laboratory routinely tested patient samples from one of six PT events in 2021, 2022, and 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 1:13 p.m. on May 25, 2023. TP1 confirmed the observed Sysmex XP-300 hematology analyzer replaced the Beckman Coulter ACT-Diff in May 2022. 2. The laboratory performed PT for Hematology using the American Proficiency Institute (API) PT provider. 3. PT test result printouts, generated by the Beckman Coulter ACT Diff analyzer, confirmed the five PT samples from the API 2021 Hematology/Coagulation 3rd Event were tested two times on November 22, 2021. See below for run times. Sample 1st run 2nd run 11-22-21 11-22- 21 HEM-11 15:29 15:31 HEM -12 15:46 15:50 HEM -13 15:51 15:55 HEM -14 15:58 16:02 HEM -15 16:03 16:07 4. In an interview at 2:37 p.m. on May 25, 2023, the Operations Manager and TP1 confirmed the above findings. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency 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 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain a copy of proficiency testing records from two of six proficiency testing (PT) events reviewed in 2021, 2022, and 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 1:13 p.m. on May 25, 2023. 2. The laboratory performed PT for Hematology using the American Proficiency Institute (API) PT provider. 3. The following elements of PT records could not be located during the survey: Year: 2022 PT Series Hematology/Coagulation Event: 1st Event Item(s): Proficiency Testing Performance Evaluation Year: 2021 PT Series Hematology /Coagulation Event: 3rd Event Item(s): Instrument printouts matching values submitted to API 4. The laboratory was unable to provide the missing documents at request the day of survey. 5. In interviews between 2:30 p.m. and 3:20 p.m. on May 25, 2023, TP1 and the Operations Manager confirmed the above finding. . 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

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to ensure microscopic examination proficiency testing (PT) was performed consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Pinworm and Urine Sediment microscopic examination testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m. on 05/07/19. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. Microscopic examination PT for Pinworms and Urine Sediment from the API 2017 Hematology/Coagulation 3rd event and the API 2018 Hematology/Coagulation 1st event were completed by multiple testing personnel as indicated on API Attestation Statements. See below. Event Testing personnel (TP) 2017-3 TP6, former TP C.P. 2018-1 TP3, former TP T.P. 4. In an interview at 12:30 p.m. on 05/07/19, the LS confirmed the PT had been performed by multiple testing personnel prior to the submission date and patient specimens would not routinely be handled in this manner. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, laboratory personnel failed to follow 1 of 1 Individual Quality Control Plans (IQCP) for Urine Culture quality control performance. Findings are as follows: 1. The laboratory performed Urine Culture testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m. on 05/07/19. 2. Urine Culture quality control (QC) frequency requirements were established as weekly and with new lots and shipments of media in the Metropolitan Pediatrics Individual Quality Control Plan. 3. Weekly QC was not performed or documented after 02/18/18 as indicated on the Quality Control for Urine Culture Plates forms revieweed on date of survey. 4. Thirty four patients received Urine Culture testing results which were reported without weekly QC performance in the timeframe reviewed; December 2018 through January 2019. The QC dates documented on the Quality Control for Urine Culture Plates form were 11/27/18, 01/10/19, and 02/14/19. Laboratory patient testing records indicated 20 patient specimens in December 2018 and 14 patient specimens in January 2019 received Urine Culture testing without weekly QC performance. 5. In an interview at 1:40 p.m. on 05/07/19, the LS confirmed the above finding and explained the laboratory changed their QC process but had not updated the IQCP. 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 observation, document review and interview with laboratory personnel, the laboratory failed to follow the Quality Assessment Plan (QAP) for 1 of 1 Individualized Quality Control Plans (IQCP) developed by the laboratory. Findings are as follows: 1. The laboratory performed Urine Culture testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m. on 05/07/19. 2. The laboratory implemented an IQCP on 11/01/16 to reduce quality control requirements for Urine Cultures. The QAP indicated the IQCP would be reviewed annually. 3. Annual IQCP review documentation was not present in laboratory records. The laboratory was unable to provide documentation of IQCP quality assessment review from 2017 and 2018 upon request. 4. In an interview at 2:05 p.m. on 05/07/19, the LS confirmed the above finding. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to evaluate 1 of 7 testing personnel for competency in moderate -- 2 of 4 -- complexity test procedures in 2018 and 2019 . Findings are as follows: 1. The laboratory performed Microbiology, Chemistry and Hematology testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m on 05/07 /19. 2. Personnel record review indicated the LS was evaluated for competency in 2018 and 2019 by Testing Personnel 1 (TP1). 3. TP1 was not qualified to perform the competency evaluation as her highest level of education was a high school diploma. The laboratory was unable to provide competency evaluation documents completed by a qualified TC in 2018 and 2019 upon request. 4. In an interview at 10:45 a.m. on 05/07/19, the LS confirmed the above finding. 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 document review and interview with laboratory personnel, the technical consultant failed to ensure 4 of 4 testing personnel were assessed through testing Microbiology, Chemistry,and Hematology previously analyzed specimens, blind samples, or proficiency testing samples at least annually in 2017 and 2018. Findings are as follows: 1. The laboratory performed Pinworm (PW) and Urine Sediment (US) microscopic examinations, Throat Cultures (TC), and Complete Blood Count (CBC) testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m on 05/07/19. 2. Proficiency testing (PT) results for were being used to evaluate testing personnel competency as established in the laboratory's Competency Assessment Policy. 3. Laboratory records indicated all testing personnel did not perform PT for each non-waived test in 2017 and 2018. The laboratory was unable to provide additional documented evaluations of blind sample testing upon request. See below where "x" indicates proficiency testing was not performed. 2017 Testing Personnel (TP) LS TP1 TP2 TP3 PW x x US x x x TC x x CBC x x x 2018 Testing Personnel LS TP1 TP2 TP3 PW x US x TC x CBC x x 4. In an interview at 2:10 p.m. on 05/07/19, the LS verified the testing personnel routinely performed the non-waived testing and confirmed PT for this testing was not completed by all staff in 2017 and 2018 as indicated above. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant failed to ensure 1 of 1 testing personnel received documented training when newly hired. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by the Laboratory Supervisor (LS) during a tour of the laboratory at 9:20 a.m on 05/07/19. 2. Testing personnel 7 (TP7), listed on the Laboratory Personnel Report (CLIA) Form CMS-209, began working in the laboratory on 10/15/18 as indicated in laboratory personnel -- 3 of 4 -- records. TP7 met the qualifications to perform moderate complexity testing at 493.1423(b)(4) based on a review of education documents. 3. Training documents for TP7 were not found during a review of laboratory records. The laboratory was unable to provide these documents upon request. 4. In an interview at 10:45 a.m. on 05/07 /19, the LS confirmed the above finding and stated training had been completed for TP7 but the training was not documented. -- 4 of 4 --