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 23, 2024. The following standard-level deficiencies were cited: 493.1251 Procedure Manual 493.1407 Laboratory director responsibilities 493.1413 Technical consultant responsibilities . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure one of two non-waived testing procedures included all required elements. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 07/23/24. 2. An American Optical 150 microscope was observed as present and available for use during the tour: The laboratory performed Urine Sediment microscopic examinations (USed) using this instrument. 3. USed reporting criteria and reference ranges for microscopic elements were not established in the Urinalysis Procedure found in the Laboratory Procedure Manual. 4. In an interview at 1:00 p.m. on 07/23/24, TP1 confirmed the above finding. . D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director failed to ensure two of six testing personnel (TP) were assessed semi- annually and annually through testing previously analyzed specimens, blind samples, or proficiency testing (PT) samples for one of two tests performed in 2022 and 2023. Findings are as follows: 1. The laboratory was cited for non-performance of blind sample assessment during the previous survey conducted on 07/19/22. 2. Blind sample assessment for Urine Sediment microscopic examinations was not found on date of current survey, 07/23/24, for two of six testing personnel in 2022 and 2023 laboratory records. See D6051. 3. In an interview on 07/23/24 at 11:50 a.m., Testing Personnel 1 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 observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure competency assessments were completed by qualified personnel in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 07/23/24. 2. The following instruments were observed as present and available for use during the tour: Hematology -Sysmex XP-300 (used for complete blood counts) Chemistry -American Optical 150 microscope (used for Urine Sediment microscopic examination) 3. Performance of competency assessments was required by the Technical Consultant as established in the Laboratory Personnel Competency Testing Policy found in the Laboratory Procedure Manual. 4. 2022, 2023. and 2024 competency assessment documents reviewed for six of six testing personnel were performed by personnel who did not meet the Technical Consultant education requirements at 42 CFR 493.1411. 5. In an interview at 11:50 a.m. on 07/23/24, TP1 confirmed the above finding. . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) -- 2 of 3 -- 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 observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure two of six testing personnel (TP) were assessed semi-annually and annually through testing previously analyzed specimens, blind samples, or proficiency testing (PT) samples for one of two moderate complexity tests performed in 2022 and 2023. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 07/23/24. 2. An American Optical 150 microscope was observed as present and available for use during the tour: The laboratory performed Urine Sediment microscopic examinations (USed) using this instrument. 3. Assessment of test performance using external proficiency samples was required at least annually for all TP as established in the Proficiency Testing procedure found in the Laboratory Procedure Manual. 4. Testing Personnel 3 (TP3) did not participate in USed PT in 2022 and 2023 for annual competency assessment and Testing Personnel 6 (TP6) did not participate in USed PT in 2023 for semi-annual assessment as indicated on American Proficiency Institute Attestation Statements reviewed on date of survey. 5. The laboratory was unable to provide alternative blind sample evaluation documentation completed in 2022 and 2023 for TP3 and TP6 upon request. 6. In an interview at 11:50 a.m. on 07/23/24, TP1 confirmed the above finding. *This finding was previously cited during the 07/19/22 survey* . -- 3 of 3 --

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, 493.1253, 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 perform a complete performance verification of the Hematology analyzer prior to putting it into production in May 2022. See D5421 3. 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 4. The laboratory failed to ensure

Summary Statement of Deficiencies 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure one of five reportable ranges obtained during performance verification activities completed in 2022 were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a. m. on 07/19/22. 2. A Sysmex XP-300 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification (PV) activities on the XP-300 for Red Blood Cells, White Blood Cells, Hemoglobin, Hematocrit, and Platelets were completed in May 2022 as indicated in laboratory records. 4. The upper limit of the reportable range for Hemoglobin (HGB) in the Sysmex XP-300 Automated Hematology Analyzer procedure found in the Laboratory Procedure Manual did not reflect the actual reportable range value obtained by the laboratory during the PV. The values listed in the procedure were the manufacturer's stated reportable ranges. See below. Analyte PV Procedure HGB 0-22.4 0.1-24.0 5. The laboratory was given five business days to provide documentation showing the HGB reportable range in the XP-300 analyzer software had been updated to reflect the laboratory's PV values. 6. In an interview at 1:25 p.m. on 07/19/22, TP1 and the Operations Manager (OM) confirmed the above finding. 7. In an email received at 8: 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 -- 37 a.m. on 07/25/22, the OM provided documentation from the manufacturer indicating the reportable range study performed at implementation was a verification study and the results were within manufacturer guidelines. The manufacturer did not indicate the analyzer software had been updated to reflect the laboratory's HGB PV values. . 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 four of five testing personnel were assessed at least annually in 2021 through testing Microbiology, Chemistry,and Hematology previously analyzed specimens, blind samples, or proficiency testing samples. Findings are as follows: 1. The laboratory performed moderate complexity Urine Cultures (UC), Urine Sediment (US), and Hematology (CBC) testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 07/19/22. 2. Laboratory records indicated five of five testing personnel (TP) performed the above moderate complexity tests in 2021. Proficiency testing or blind sample competency assessments were not found for four of five TP in 2021 laboratory records as indicated below. TP Missing assessments TP1 UC, US, CBC TP3 US TP4 CBC TP5 US, CBC 3. The laboratory was unable to provide the missing blind sample evaluation documents upon request. 4. In an interview at 12:00 p.m. on 07/19/22, TP1 confirmed the above finding. -- 2 of 2 --

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 Bacteriology, Urinalysis, and Hematology proficiency testing samples were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Bacteriology, Urinalysis, and Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30/20. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) proficiency provider. 3. An untitled document located in the PT manual indicated all PT samples would not be performed by one employee. 4. The attestation statements for all API PT events from the third events of 2018 through the second events of 2020 indicated multiple testing personnel completed testing on each PT sample. 5. In an interview at 12:15 p.m., TP1 confirmed the above finding and indicated the PT samples were tested by two employees in an effort to verify test result. . 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). 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2019 proficiency testing (PT) score when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed manual microscopic analysis of urine sediment testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30/20. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One urine sediment result from the first 2019 Hematology PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte US- 02 Urine Sediment 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above analyte was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. In an interview at 12:20 p.m. on 09/30/20, TP1 confirmed the above finding. . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to follow an established policy to verify the accuracy of test results manually entered into the electronic medical record. Findings are as follows: 1. The laboratory performed Bacteriology, Urinalysis, and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30/20. TP1 indicated the test results were entered manually into NextGen, the electronic medical record. 2. A requirement for review of 10 manual entries per quarter was established in the Test Result Reporting Review procedure located in the CLIA Manual. 3. Documentation of manual test result entry review from the second quarter of 2018 through date of survey was not found in laboratory records. The laboratory was unable to provide the missing documentation for this time period upon request. 4. In an interview at 11:15 a.m. on 09/30/20, TP1 confirmed the above finding. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure training for 1 of 1 new testing personnel was performed and documented in 2018. Findings are as follows: 1. The laboratory performed Bacteriology, Urinalysis, and Hematology testing as confirmed by Testing Personnel -- 2 of 3 -- 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30/20. 2. Testing Personnel 5 (TP5) was hired on 09/18/18 as indicated on the competency assessment form completed in September 2019. 3. Initial training documents for TP5 were not found during review of laboratory's records. 4. The laboratory was unable to provide the missing documents upon request. 5. In an interview at 11:10 a.m., TP1 confirmed the above finding and indicated TP5 began patient testing soon after hire in 2018. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant failed to ensure competency was assessed at least semiannually during the first year of patient specimen testing for 1 of 1 testing personnel hired in 2018. Findings are as follows: 1. The laboratory performed Bacteriology, Urinalysis, and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30/20. 2. The Personnel Competency Testing Policy procedure located in the CLIA manual indicated personnel were evaluated semi- annually during the first year of employment and annually thereafter. 3. Testing Personnel 5 (TP5) was hired on 09/18/18 as indicated on the competency assessment form completed in September 2019. Initial training documents from 2018 were not found during review of laboratory records. See D6045. 4. A semiannual competency assessment for TP5 was not found in laboratory records. 5. The laboratory was unable to provide the missing semi-annual competency documents upon request. 6. In an interview at 11:10 a.m. on 09/02/20, TP1 confirmed the above finding and indicated TP5 began patient testing soon after hire in 2018. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure a comprehensive annual competency assessment was performed for 2 of 4 testing personnel in 2018. Findings are as follows: 1. The laboratory performed Bacteriology, Urinalysis, and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m. on 09/30 /20. 2. The Personnel Competency Testing Policy procedure located in the CLIA manual indicated personnel were evaluated semi-annually during the first year of employment and annually thereafter. 3. The 2018 annual competency assessments for Testing Personnel 2 and Testing Personnel 3 did not include an evaluation of Throat Cultures, Urine Cultures, and Hematology testing. 4. The laboratory was unable to provide the missing annual competency assessments upon request. 5. In an interview at 11:13 a.m. on 09/30/20, TP1 confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing 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 retain proficiency testing records for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology, Urinalysis, and Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 5/17/18 at 9:05 a.m. 2. The laboratory performed Proficiency Testing (PT) using American Proficiency Institute (API) as the provider. 3. The API PT results were missing the Attestation Statements for the following PT Events: 2017 Microbiology 1st Event 2017 Hematology / Coagulation 2nd Event 2018 Hematology / Coagulation 1st Event 4. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 11:00 a.m. on 5/17/18, the GS confirmed the above findings. . 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 --