Center For Pediatric And Adolescent Medicine,The

Summary Statement of Deficiencies D0000 A Recertification survey was conducted February 4, 2025 at Center for Pediatric and Adolescent Medicine - CLIA ID # 19D0893300. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. 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 established and maintained. Refer to D6053. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 policies and personnel records as well as 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 -- interview with personnel, the Technical Consultant failed to perform a competency assessment semi-annually during the first year for one (1) testing personnel in 2023. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed "The technical consultant will orient, asses 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." 2. Review of personnel records for Testing Personnel 3 revealed she was licensed as a Laboratory Assistant in December 2022 and her semi- annual competency was due in June 2023; however, competency assessment was not performed until October 2023. 3. In interview on February 4, 2025 at 11:38 a.m., Testing Personnel 1 confirmed the laboratory did not have documentation of a semi- annual competency assessment as identified above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 30, 2023 at The Center for Pediatric and Adolescent Medicine, CLIA ID #19D0893300. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 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 surveyors, review of temperature logs, manufacturers' storage requirements, and interview with personnel, the laboratory failed to define room temperature limits that met manufacturer requirements for supplies. Findings: 1. Review of the laboratory's temperature log revealed the acceptable room temperature range was defined as 4-35 degrees Celsius. 2. Observation by surveyors during the laboratory tour on May 30, 2023 at 9:45 am and review of manufacturers' storage requirements revealed the following items were stored in the laboratory: a) BioMerieux BACT/ALERT PF Plus blood culture bottles: manufacturer's storage temperature requirements 15 - 30 degrees Celsius b) Vacuette blood collection tubes, Serum separator clot activator: manufacturer's storage temperature requirements 4 - 25 degrees Celsius 3. In interview on May 30, 2023 at 1:06 pm, the Technical Consultant confirmed the laboratory's defined acceptable room temperature range did not meet the manufacturers' storage requirements for the identified supplies. 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of maintenance records, and interview with laboratory personnel, the laboratory failed to ensure the weekly maintenance on the Sysmex XP-300 was performed as required by the manufacturer for two (2) of thirty (30) weeks reviewed. Findings: 1. Observation by surveyors during the laboratory tour May 30, 2023 at 9:45 a.m. revealed laboratory utilized a Sysmex XP- 300 analyzer for hematology testing. 2. Review of maintenance records for the XP- 300 revealed "Clean SRV Tray" as the weekly task. 3. Further review of Sysmex XP- 300 maintenance records revealed the laboratory did not perform weekly maintenance for the following two (2) weeks: November 28, 2022 January 30, 2023 4. In interview on May 30, 2023 at 12:30 p.m., the Technical Consultant confirmed the weekly maintenance identified above was not performed. D5781

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 12, 2021 at The Center for Pediatric and Adolescent Medicine, CLIA ID # 19D0893300. 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: I. Based on observation by surveyor, review of 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. Observation by surveyor during the laboratory tour on October 12, 2021 at 11:15 am revealed the laboratory utilizes the following SARS COV-2 tests: a) BD Veritor SARS COV-2 antigen b) Xpert Xpress COV-2/Flu/RSV c) 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. In interview on October 12, 2021 at 10:45 am the Technical Consultant stated the laboratory does not provide "fact sheets" for the COVID tests to patients. 4. Review of the laboratory's test menu revealed the laboratory performs 145 Quidel Quickvue, 308 BD Veritor, and 492 Xpert Xpress COV-2/Flu/RSV tests annually. II. Based on observation by surveyor, review of manufacturer's instructions, patient final test reports, test menu, and interview with personnel, the laboratory failed to include the Food and Drug Administration (FDA) Emergency Use Authorization statement on SARS COV-2 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 -- patient final reports. Findings: 1. Observation by surveyor during the laboratory tour on October 12, 2021 at 11:15 am revealed the laboratory utilizes the following SARS COV-2 tests: a) BD Veritor SARS COV-2 antigen b) Xpert Xpress COV-2/Flu/RSV c) Quidel Quickvue SARS COV-2 2. Review of the manufacturers' instructions revealed "This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories." 3. Review of the following random selection of patient final reports for SARS COV-2 revealed the laboratory did not include the identified Emergency Use Authorization statement on patient final reports: Patient 136130 Patient 53042 Patient 132715 Patient 20178 4. In interview on October 12, 2021 at 10: 54 am, the Technical Consultant confirmed the laboratory's patient final reports for SARS COV-2 did not include the identified statement. 5. Review of the laboratory's test menu revealed the laboratory performs 145 Quidel Quickvue, 308 BD Veritor, and 492 Xpert Xpress COV-2/Flu/RSV tests annually. 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 competency forms, personnel records, and interview with personnel, the laboratory failed to follow their established competency policy for two (2) of seven (7) testing personnel reviewed. Findings: 1. In interview on October 12, 2021 at 1:03 pm, the Technical Consultant stated the following two (2) personnel were hired as Testing Personnel in the beginning of 2021.: Testing Personnel 5 Testing Personnel 6 2. Review of the laboratory's "Training and Competency Assessment Form" revealed "Employee has successfully completed the necessary training that is required of them in all areas of the laboratory and they are ready to assume duties. Laboratory Director Review signature/date line." 3. Review of the "Initial Training and Competency Assessment Form" for Testing Personnel 5 and Testing Personnel 6 revealed the Laboratory Director did not approve/sign the identified two (2) personnel for testing. 4. In further interview on October 12, 2021 at 1:03 pm, the Technical Consultant confirmed the Laboratory Director did not approve /sign the identified testing personnel for testing. 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 procedures, test menu, and interview with personnel, the laboratory failed to establish complete policies for reporting SARS COV-2 results. Findings: 1. Review of the laboratory's test menu revealed the laboratory performs the following SARS COV-2 tests: a) BD Veritor SARS COV-2 -- 2 of 5 -- antigen b) Xpert Xpress COV-2/Flu/RSV c) Quidel Quickvue SARS COV-2 2. Review of the laboratory's policies revealed the laboratory did not have written procedures that included the following: a) Quidel Quickvue SARS COV-2 reporting of positive and negative results to state public health agency b) Process of reporting to include, who is responsible, frequency of reporting 3. In interview on October 12, 2021 a 10:26 am, the Technical Consultant confirmed the laboratory's policies did not include the identified information. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at The Center for Pediatric & Adolescent Medicine-CLIA ID # 19D0893300 on February 12, 2019. The Center for Pediatric & Adoloscent Medicine was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing; Testing Personnel 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 record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Clinical Consultant and Technical Consultants were complete. Findings: 1. Review of the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed the following personnel serve as Clinical Consultant and/or Technical Consultant: a) Clinical Consultant: Personnel 2 b) Technical Consultants: Personnel 2 and Personnel 3 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a policy related to competency assessment criteria or frequency for personnel serving as Clinical and Technical Consultants. 3. Review of personnel records revealed the laboratory did not perform competency assessments for the duties of Clinical Consultant or Technical Consultant. 4. In interview on February 12, 2019, Personnel 3 stated she did not have a competency assessment performed by the Laboratory Director for her duties as Technical Consultant. Personnel 3 stated she was hired January 2019 and in the facility's probationary period. Personnel 3 further stated the laboratory did not have a policy for competency assessment for personnel serving as Clinical and Technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Consultants. Personnel 3 confirmed the laboratory did not have documentation of performance of competency assessment for Personnel 2's duties as Clinical and Technical Consultant. 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 an assessment for unsatisfactory Hematology proficiency test (PT) results. Findings: 1. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT results revealed the laboratory received the following "unacceptable" results for three (3) events: 2017 3rd Event: Sample HEM-15 for Platelet Count, API grade: "unacceptable"-80% 2018 1st Event: Sample HEM-02 for RDW, API grade: "unacceptable"-80% 2018 2nd Event: Sample HEM-10 for RDW, API grade: "unacceptable"-80% 2. Review of the laboratory's PT records revealed the laboratory did not perform assessments for the "unacceptable" by API PT results. 3. In interview on February 12, 2019, Personnel 4 stated for the identified PT results she thought nothing further needed to be done since the scores were 80%. Personnel 4 further stated she was unaware any score below 100 % needed to be investigated. 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 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, record review, and interview with personnel, the laboratory failed to monitor the temperature of the closet where laboratory reagents are stored per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on February 12, 2019 revealed the following reagents were stored outside of the main laboratory in a closet without temperature monitoring: a) Cell Dyn Emerald Cleaner, Lot # 7746, Quantity: one (1) bottle b) Cell Dyn Emerald Diluent, Quantity: (1) box c) Cell Dyn, CN-Free Lyse, Lot #770, Quantity: one (1) bottle 2. Review of the manufacturer's requirements for the identified items revealed a temperature requirement of 4-35 degrees Celsius. 3. In interview on February 12, 2019 at 10:00 am, Personnel 4 stated the laboratory does not monitor the temperature of the storage closet where the identified items were stored. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 7 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to ensure reagents have not exceeded their expiration date. Findings: 1. Observation by surveyor during the laboratory tour on February 12, 2019 revealed the following expired items located in the laboratory's Kenmore refrigerator: a) Hemotrol Level 1, Lot #63165, Expiration date: 2018-04, Quantity: one (1) box b) Hemotrol Level 2, Lot # 63666, Expiration date: 2018-04, Quantity: one (1) box c) Hemotrol Level 3, Lot # 62067, Expiration date: 2018-01, Quantity: one (1) box 2. In interview on February 12, 2019 at 10:00 pm, Personnel 4 stated she was unaware the identified items had expired. Personnel 4 further stated the identified items were unused. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to establish their own means and ranges for Quality Control (QC) for Hematology testing as required by the manufacturer. Findings: 1. Observation by surveyor during laboratory tour on February 12, 2019 revealed the laboratory utilizes the Emerald Cell Dyn instrument with Cell-Dyn 18 Plus Controls for Complete Blood Count (CBC) testing. 2. Review of the Cell-Dyn 18 Plus Control package insert under "Performance Characteristics" section revealed the following: "The recovery ranges are intended to reflect inter-laboratory and inter-instrument variability; thus they are wider than the +/- 2 SD QC range for one instrument. Always perform quality control according to good laboratory practice, laboratory director's requirements, and any regulatory or accreditational requirements." 3. Review of the laboratory's "Quality Control Policy-Cell Dyn Emerald" revealed the following: Effective January 16, 2019: a) "Prior to implementation of a new lot of quality control, testing personnel will verify the accuracy of said lot and run it concurrently along with the current lot that is being used." b) "To prevent a quality control range that may be too narrow, our policy is to use the ranges as established by the manufacturer's package insert. The quality control will be closely monitored on a consistent basis as well as alongside a peer-review program to allow our laboratory to compare its performance with that of other laboratories." 4. Review of the laboratory's quality control records for December 2017, October 2018, and January 2019 revealed the laboratory utilized the -- 3 of 7 -- manufacturer's ranges of wider than 2 standard deviations (SD) for the following lot numbers put in use: a) Cell Dyn 18 Plus Low Control: Lot # L9014 b) Cell Dyn 18 Plus Normal Control: Lot # N9014 c) Cell Dyn 18 Plus High Control: Lot # H9014 5. In interview on February 12, 2019 at 10:20 am, Personnel 3 stated prior to January 2019, the laboratory established their own QC means and ranges. 6. In further interview on February 12, 2019 at 10:50 am, Personnel 3 and Personnel 4 stated the laboratory had issues with the established ranges being too tight with frequent repeats of QC material. Personnel 3 stated the Laboratory Director approved the laboratory utilizing the manufacturer's ranges and implemented a new quality control policy effective January 2019. 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 observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory personnel were performing test methods as required for accurate and reliable results. Refer to D6014. 2. The Laboratory Director failed to ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require