Center For Pediatric & Adolescent Medicine

Summary Statement of Deficiencies D0000 A Recertification survey was conducted at Children's Pediatrics - CLIA ID # 19D0906813 on September 10, 2025. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form (Laboratory Personnel Report), policies, and personnel records; as well as interview with personnel, the laboratory failed to follow their competency assessment policy for one (1) of two (2) personnel serving as Technical Consultants. Findings: 1. Review of the laboratory's CMS-209 form revealed the following personnel served as Technical Consultants: a) Personnel 1 b) Personnel 6 2. Review of the laboratory's form "Point of Care Coordinator Training and Competency Assessment" revealed the following frequency for competency assessment of the Technical Consultant: *"Initial" *"6-month" *"Annual" 3. Review of personnel records for Personnel 6 revealed a 2024 competency assessment performed by the Laboratory Director of a sister facility; however, the laboratory failed to provide documentation of a competency assessment performed by the Laboratory Director of this facility. 4. In interview on September 10, 2025 at 1:10 p.m., Testing Personnel 1 confirmed a competency assessment for Personnel 6 was not performed as identified above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on observation, review of the manufacturers' instructions and the laboratory's temperature records, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the laboratory. Findings: 1. Observation by surveyor during the laboratory tour on September 10, 2025 at 8:54 a.m. revealed the laboratory stored specimen collection supplies in the laboratory to include, but not limited to, the following: a) BBL Cultureswab Plus Collection and Transport System for Aerobes and Anaerobes - Manufacturer's storage requirements: 5-25 degrees Celsius b) BD Vacutainer C&S Transfer Straw Kit, C&S Preservative Plus Urine Tube - Manufacturer's storage requirements: 4-25 degrees Celsius c) Vacuette Tube 8 ml CAT Serum Sep Clot Activator - Manufacturer's storage requirements: 4-25 degrees Celsius 2. Review of the laboratory's temperature logs from April 2025 through September 2025 revealed the laboratory defined the acceptable room temperature limits as 18-27 degrees Celsius which exceeded the manufacturers' upper temperature limits. 3. In interview on September 10, 2025 at 8:59 a.m., Testing Personnel 1 confirmed the laboratory's acceptable room temperature upper limit exceeded the manufacturers' required limits as identified above. II. Based on observation, review of the manufacturers' instructions and the laboratory's temperature records, as well as interview with personnel, the laboratory failed to monitor the room temperature for eight (8) of eight (8) patient rooms where specimen collection supplies were stored. Findings: 1. Observation by surveyor during the laboratory tour on September 10, 2025 at 8:54 a.m. revealed the laboratory stored the following specimen collection supplies in patient rooms: a) BBL Cultureswab Plus Collection and Transport System for Aerobes and Anaerobes - Manufacturer's storage requirements: 5-25 degrees Celsius b) RAM Scientific EDTA K2 Safe-T Micro Capillary Blood Collection - Manufacturer's storage requirement "Store at room temperature." 2. Review of the laboratory's temperature logs from January 2025 through August 2025 revealed no documentation of room temperature monitoring in the patient rooms. 3. In interview on September 10, 2025 at 10:15 a.m., Testing Personnel 1 stated swabs and blood collection tubes were stored in patient rooms, but the rooms were not monitored for room temperature. She further stated the clinic had eight (8) patient rooms. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on observation, review of the manufacturer's instructions for use and the -- 2 of 4 -- laboratory's maintenance records, as well as interview with personnel, the laboratory failed to perform monthly maintenance on the Sysmex XP-300 as required by the manufacturer for two (2) of eight (8) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on September 10, 2025 at 8:54 a.m. revealed the laboratory utilized a Sysmex XP-300 for Hematology testing. 2. Review of the manufacturer's "Sysmex XP-300 Automated Hematology Analyzer Quick Guide" section "Maintenance" revealed the following: * "Monthly Maintenance/or Every 1,500 Samples" - "Clean Waste Chamber (Rinse Sequence)" - "Clean Transducer (Rinse Sequence" 3. Review of the laboratory's Sysmex XP-300 maintenance logs from January 2025 through August 2025 revealed the laboratory did not perform monthly maintenance in February 2025 and August 2025. 4. In interview on September 10, 2025 at 12:28 p.m., Testing Personnel 1 stated they perform monthly maintenance when the analyzer alerts them. She confirmed monthly maintenance was not performed as identified above. II. Based on observation, review of the manufacturer's instructions for use and the laboratory's maintenance records, as well as interview with personnel, the laboratory failed to perform quarterly maintenance on the Sysmex XP-300 as required by the manufacturer for two (2) of three (3) quarters reviewed. Findings: 1. Observation by surveyor during the laboratory tour on September 10, 2025 at 8:54 a.m. revealed the laboratory utilized a Sysmex XP-300 for Hematology testing. 2. Review of the manufacturer's "Sysmex XP-300 Automated Hematology Analyzer Quick Guide" section "Maintenance" revealed the following: * "3-Month Maintenance/or Every 4,500 Samples" - "Clean the SRV" 3. Review of the laboratory's Sysmex XP-300 maintenance logs from January 2025 through August 2025 revealed the laboratory performed quarterly maintenance in February 2025 but did not perform quarterly maintenance when due in May 2025 and August 2025. 4. In interview on September 10, 2025 at 12:28 p.m., Testing Personnel 1 stated they perform quarterly maintenance when the analyzer alerts them. She confirmed quarterly maintenance was not performed as identified above. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the laboratory. Refer to D5413 I. 2. The laboratory failed to monitor the room temperature for eight (8) of eight (8) patient rooms where specimen collection supplies were stored. Refer to D5413 II. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Findings: 1. The laboratory failed to perform monthly maintenance on the Sysmex XP- 300 as required by the manufacturer for two (2) of eight (8) months reviewed. Refer to D5429 I. 2. The laboratory failed to perform quarterly maintenance on the Sysmex XP- 300 as required by the manufacturer for two (2) of three (3) quarters reviewed. Refer to D5429 II. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D5209. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Technical Consultants failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the laboratory. Refer to D5413 I. 2. The laboratory failed to monitor the room temperature for eight (8) of eight (8) patient rooms where specimen collection supplies were stored. Refer to D5413 II. 3. The laboratory failed to perform monthly maintenance on the Sysmex XP-300 as required by the manufacturer for two (2) of eight (8) months reviewed. Refer to D5429 I. 4. The laboratory failed to perform quarterly maintenance on the Sysmex XP-300 as required by the manufacturer for two (2) of three (3) quarters reviewed. Refer to D5429 II. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 18, 2023 at Center for Pediatric & Adolescent Medicine, CLIA ID # 19D0906813. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and CMS 209 form (Laboratory Personnel Report) as well as interview with personnel, the Laboratory Director failed to ensure testing personnel had appropriate training documentation prior to patient testing. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed "The technical consultant will orient, assess and verify the competency of each testing personnel on each test method at least semi-annual {sic} during the first year and then on an annual basis thereafter." 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 9 listed as testing personnel. 3. Review of personnel records for Personnel 9 revealed a "Competency Assessment" form with "Initial" marked; however, the supporting documentation was testing responsibilities performed at the sister laboratory. 4. In interview on October 18, 2023 at 12 p.m., the Technical Consultant confirmed 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 -- Personnel 9 did not have records to support initial training performed at this laboratory. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. The Technical Consultant failed to evaluate the competency of two (2) of three (3) Testing Personnel in 2023. Refer to D6046. 2. The Technical Consultant failed to perform a competency assessment semi- annually during the first year for one testing personnel in 2023. Refer to D6053. 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 review of the laboratory's CMS 209 (Laboratory Personnel Report) form, policy and procedure manual, and personnel records; as well as interview with personnel, the Technical Consultant failed to evaluate the competency of two (2) of three (3) Testing Personnel in 2023. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 3 served as the Technical Consultant. 2. Review of the laboratory's "Competency Assessment" policy revealed "The technical consultant will orient, assess and verify the competency of each testing personnel on each test method at least semi-annual during the first year and then on an annual basis thereafter." 3. Review of personnel records for the following Testing Personnel revealed "Competency Assessment" forms with "Annual" marked; however, the supporting documentation was testing responsibilities performed at the sister laboratory: Personnel 4 Personnel 5 4. In interview on October 18, 2023 at 12 p. m., the Technical Consultant confirmed the annual competency assessments for the testing personnel identified were not performed at this laboratory. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 2 of 3 -- 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 review of the laboratory's CMS 209 form (Laboratory Personnel Report), policy and procedure manual, and personnel records; as well as interview with personnel, the Technical Consultant failed to perform a competency assessment semi- annually during the first year for one testing personnel in 2023. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 3 served as the Technical Consultant. 2. Review of the laboratory's "Competency Assessment" policy revealed "The technical consultant will orient, assess and verify the competency of each testing personnel on each test method at least semi-annual {sic} during the first year and then on an annual basis thereafter." 3. Review of personnel records for Personnel 8 revealed an initial training was performed in December 2022. 4. Further review of personnel records for Testing Personnel 8 revealed a "Competency Assessment" form with "6 month" marked; however, the supporting documentation was from a different laboratory. 4. In interview on October 18, 2023 at 12 p.m., the Technical Consultant confirmed the laboratory did not have documentation of a semi-annual competency assessment performed at this location for the testing personnel identified above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 23, 2022 at Center for Pediatric and Adolescent Medicine, CLIA ID # 19D0906813. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were 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 review of laboratory records, manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Review of the laboratory's test menu revealed the laboratory utilizes the following kits for SARS COV-2 testing: a) Cepheid Xpert Xpress SARS COV-2 b) Cepheid Xpert Xpress SARS COV-2/Flu/RSV Plus c) BD Veritor SARS COV-2 antigen d) GenBody COVID -19 antigen e) Quidel Quickvue SARS COV-2 2. Review of the manufacturers' instructions revealed "Authorized laboratories * using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. Review of the laboratory's records revealed the laboratory did not have a Fact Sheet for the Cepheid Xpert Xpress SARS COV-2 tests. 4. In interview on February 23, 2022 at 11:08 am the Technical Consultant confirmed the laboratory does not provide "fact sheets" to patients for the Cepheid Xpert Xpress SARS COV-2 tests. 5. Review of the laboratory's test menu revealed the laboratory performs 529 Cepheid SARS COV-2 tests annually. 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 -- 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 review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written policies and procedures that included the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run, as well as, operator variance), reportable and reference range studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on February 23, 2022 at 12:28 pm, the Technical Consultant confirmed the laboratory did not have a written policy for performance specification verification procedures. 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 by surveyor, review of validation studies, test menu, and interview with personnel, the laboratory failed to have complete accuracy studies for the Sysmex XP 300. Findings: 1. Observation by surveyor during the laboratory tour on February 23, 2022 at 10:30 am revealed the laboratory utilizes the Sysmex XP 300 for complete blood count (CBC) testing. 2. Review of the laboratory's validation records for the Sysmex XP 300 revealed the laboratory did not include acceptability criteria for the accuracy (correlation) studies. 3. In interview on February 23, 2022 at 12:31 pm the Technical Consultant stated the laboratory did not define the acceptability criteria for the correlation studies. 4. Review of the laboratory's test menu revealed the laboratory performs 6,474 CBC tests annually. D5785

Summary Statement of Deficiencies D0000 A Certification survey was conducted at Center for Pediatric and Adolescent Medicine-CLIA ID # 19D0906813 on September 12, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform and assessment for unsatisfactory Hematology proficiency test (PT) results. Findings: 1. Review of the laboratory's 2017, 2018, and 2019 American Proficiency Institute (API) PT results revealed the laboratory received the following "unacceptable" results: 2018 Hematology/Coagulation 2nd Event: Sample HEM-09 for Red Blood Cell Count, API grade: "unacceptable" 80% 2018 Hematology/Coagulation 3rd Event: Sample HEM-15 for Red Blood Cell Count, API grade: "unacceptable" 80% 2. Review of the laboratory's PT records revealed the laboratory did not perform assessments for the "Unacceptable" by API results identified above. 3. In interview on September 12, 2019, the Technical Consultant stated the laboratory did not perform assessments for the identified PT events. 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 2 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written policies and procedures that included: a) Complete Blood Counts (CBC) flags, to include manufacturer requirements for platelet flags b) Proficiency Testing, to include assessment of unacceptable results 2. In interview on September 12, 2019, the Technical Consultant confirmed the laboratory's policy and procedure manual did not include the identified policies. 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