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Summary Statement of Deficiencies D0000 A Recertification survey was performed at The Pediatric Clinic, CLIA ID 19D1086156 on April 17, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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, review of the laboratory's performance specification studies, and interview with personnel, the laboratory failed to verify complete performance specifications for C-Reactive Protein (CRP) testing on the Piccolo analyzer. Findings: 1. Observation by surveyor during the laboratory tour on April 17, 2025 at 12:40 p.m. revealed the laboratory utilized the Metlyte Plus CRP reagent disk on a Piccolo Express for CRP patient testing. 2. Review of the Federad Drug Administration (FDA) categorization database revealed the Metlyte Plus CRP reagent disk for Piccolo Express categorized as moderate complexity testing. 3. Review of the laboratory policy and procedure manual and Piccolo records revealed the laboratory did not verify performance specification for moderate complexity to include accuracy, complete precision, reportable range and reference range. 4. Review of patient test records from calendar year 2024 revealed the laboratory performed ten (10) patient test on the Metlyte Plus CRP. Further review of the 5. In interview on April 17, 2025 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 -- at 1:53 p.m., the Technical Consultant, Testing personnel and clinic manager confirmed the laboratory was not aware the CRP disk was not waived and confirmed the test was not set up as a moderate complexity test to include verification of performance specifications. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on observation by surveyor, review of Food and Drug Administration (FDA) website, laboratory test menu, Piccolo records and interview with personnel, the Laboratory Director failed to verify complete performance specifications for C- Reactive Protein (CRP) testing on the Piccolo analyzer. Refer to D6007. D6039 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(1) (b) The technical consultant is responsible for-- (b)(1) Selection of test methodology appropriate for the clinical use of the test results; This STANDARD is not met as evidenced by: Based on observation by surveyor, review of Food and Drug Administration (FDA) website, laboratory test menu, Piccolo records and interview with personnel, the Technical failed to verify complete performance specifications for C-Reactive Protein (CRP) as moderate complexity testing on the Piccolo analyzer. Refer to D6007. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review was performed on September 29, 2024 at The Pediatric Center, CLIA ID #19D1086156. The following condition level deficiencies were identified: 493.803: Successful Participation 493.1403: 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 review of proficiency testing results from the CMS-153, CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for White Blood Cell Differential in three of four testing events resulting in non-initial, unsuccesful performance. Refer to D2130 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing results from the CMS-153D and CMS-155D reports, the laboratory failed to achieve a score of at least 80% for White Blood Cell Differential (WBC Diff) in three out of four events in 2023-2024, resulting in a non- initial unsuccessful performance. Findings: 1. Review of proficiency testing records from the CMS-153D and CMS 155D reports revealed the laboratory received a score of less than 80% for the following analytes for three (3) of four (4) events resulting in non-initial unsuccessful performance: a. 2023 Event 1: Score of 0% for Cell ID or WBC Diff (instrument) c. 2023 Event 3: Score of 67% for Cell ID or WBC Diff (instrument) d. 2024 Event 1: Score of 67% for Cell ID or WBC Diff (instrument) 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for White Blood Cell Differential (WBC Diff) in three out of four events in 2023-2024, resulting in an non-initial unsuccessful performance. Refer to D2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 10, 2024 at Th Pediatric Center, CLIA ID #19D1086156. The following condition level deficiencies were identified: 493.801: Successful Participation 493.1403: 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 review of proficiency testing results from the CMS-153D, CMS-155D and American Proficiency Institute (API) and interview with laboratory personnel, 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 3 -- laboratory failed to achieve a score of at least 80% for White Blood Cell Differential (WBC Diff) in two out of three events for 2023, resulting in an initial unsuccessful performance. Refer to D2130 D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the CMS-155D report and American Proficiency Institute (API) proficiency testing results, the laboratory failed to submit results to API prior to the event cutoff for Event 1 in Hematology resulting in a score of 0. Findings: 1. Review of the API results and CMS-155 for individual laboratory PT data revealed Event 1 of 2023 score of 0* for all Hematology analytes. 2. In interviewat 11:45am, testing personnel stated that the laboratory did not have a testing personnel during this time and did not submit results to API. Testing personnel confirmed the laboratory did not participate in Event 1 of 2023. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing results from the CMS-153D and CMS-155D reports, the laboratory failed to achieve a score of at least 80% for White Blood Cell Differential (WBC Diff) in two out of three events for 2023, resulting in an initial unsuccessful performance. Findings: 1. Review of proficiency testing records from the CMS-153D and CMS 155D reports revealed the laboratory received a score of less than 80% for the following analytes for two (2) of three (3) events resulting in initial unsuccessful performance: a. 2023 Event 1: Score of 0% for Cell ID or WBC Diff (instrument) b. 2023 Event 3: Score of 67% for Cell ID or WBC Diff (instrument) 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for White Blood Cell Differential (WBC Diff) in two out of three events for 2023, resulting in an initial unsuccessful performance. Refer to D2130 2. The laboratory failed to submit results to API prior to the event cutoff for Event 1 in Hematology resulting in a score of 0. Refer to D2127 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 17, 2021 at The Pediatric Center, CLIA ID # 19D1086156. 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 observation by surveyor, review of manufacturer's instructions and test menu, as well as interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for Emergency Use Authorization (EUA) SARS COV- 2 testing. Findings: 1. Observation during laboratory tour on June 17, 2021 at 1:29 pm revealed the laboratory performs SARS COV-2 testing utilizing the Abbott BinaxNow test kit.. 2. Review of the manufacturer's instructions for use under "Conditions of Authorization of the Laboratory" section 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. In interview on June 17, 2021 at 1:40 pm, Testing Personnel confirmed the laboratory was not aware of and does not provide the "fact sheets" for the COVID test to patients. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 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 -- 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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Based on observation by surveyor, review of manufacturer's temperature requirements, and interview with personnel, the laboratory failed to monitor the room temperature where supplies are stored per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on June 17, 2021 at 1:04 pm revealed the laboratory did not monitor the room temperature of the office area where the following extra test kits were stored: a) Consult Diagnostics Strep A test kit b) Abbott BinaxNow RSV Card c) Abbott BinaxNow Covid-19 test kit d) Immunocard State Flu A&B test kit e) OSOM Mono test kit 2. Review of the manufacturer's storage requirements for the above supplies revealed the following: 2 - 30 degrees celsius. 3. In interview on June 17, 2021 at 2:08 pm, Testing Personnel confirmed the laboratory did not monitor the room temperature of the office area where extra test kits were stored. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (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 were performing test methods as required. Refer to D5413. -- 2 of 2 --