Pediatric Center, The

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on August 29, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 an office review of the CASPER reports 153 and 155 and proficiency testing 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 -- provider reports, the laboratory failed to achieve 80% or more in two consecutive events for Hematology for the analyte Hematocrit (HCT) with the American Proficiency Institute (API). Cross refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 the CASPER 155 report and graded results from American Proficiency Institute (API). The laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Hematology for the analyte Hemoatocrit (HCT) resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 40% for HCT in event 1-2025. b) The laboratory scored 40% for HCT in event 2-2025. 2. A review of API graded results confirmed the laboratory failed two consecutive Proficiency Testing (PT) events. 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 review of the CASPER 155 report and graded results from American Proficiency Institute (API). The Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from American Proficiency Institute (API), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for two consecutive PT events for the analyte Hematocrit (HCT), resulting in initial unsuccessful performance. Cross refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 surveyor review of the Proficiency Testing (PT) records and interview with Testing Personnel 1 (TP1) as listed on the CMS 209 form, the laboratory director (LD) failed to sign attestation statements for Hematology Proficiency Testing (PT) events provided by American Proficiency Institute (API) from 1/1/23 to 12/11/24. The finding includes: 1. Review of PT records revealed the LD did not sign the attestation statements for all three Hematology PT events in 2023 and the 2nd event of 2024. 2. TP1 confirmed on 12/11/24 at 11:35 am the LD did not sign the attestation statements for the above mentioned PT events. 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 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of patient work records, review of the Manufacture Operator Manual (OM) and interview with the General Supervior (GS), the laboratory failed to follow the OM for Hematology testing performed on the Cell-Dyn Emerald from 6/8/21 to the date of survey. The findings include: 1. The OM stated patient results with S flags ""Check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results. Redraw and retest the specimen as required." 2. 3 out of 5 patient work records had "S" flags. But the laboratory did not follow the OM. 3. The GS confirmed on 1/19/23 at 1:40 pm the laboratory failed to follow the OM. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, 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 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration (CAL) records, Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Abbott Cell-Dyn Emerald analyzer from November 2020 to the date of survey. The findings include: 1. A review of Cal records revealed that the laboratory performed Cal once in the calendar year 2020 and 2022. 2. A review of Cal records revealed that the laboratory did not perform Cal in the calendar year 2021. 3. The GS confirmed on 1/19/23 at 1:32 pm that the laboratory failed to perform and document Cal once every six months. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Nurse Manager (NM), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the American Proficiency Institute for the first event in the calendar year 2020. The findings include: 1. The laboratory received an 80% for Platelet Count 2. There was no documented evidence that the laboratory investigated the failure. 3. The NM confirmed on 6/8/21 at 10:10 am that the laboratory did not review and document an evaluation of unacceptable PT results. 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 surveyor review of the Performance Specification (PS) records and interview with the Nurse Manager (NM), the laboratory failed to ensure that all PS 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 -- procedures were performed for Hematology testing on the Cell-Dyn Emerald from March 2021 to the date of survey. The finding includes: 1. There was no documented evidence that a Method Comparison was performed. 2. The NM confirmed on 6/8/21 at 11:15 am that not all PS were performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration Verification (CV) records and interview with the Nurse Manager (NM), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Cell-Dyn analyzer in the calendar year 2020. The finding includes: 1. A review of 2020 CV records revealed that CV was performed once on 11/9/2020. 2. The NM confirmed on 6/8/21 at 10:30 am CV was not performed every six months. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on nine out of nine TP in the calendar years 2016 and 2017. The finding include: 1. The laboratory did not document what records were reviewed and when they were reviewed. 2. The laboratory used tools incorrectly as follows: a. Direct observation of maintenance was used as a CA tool for specimen collection, following test procedure, recording and resulting of test results, documentation of quality control and Proficiency Test (PT) records, test performance, and reporting results. b. Assessment of test performance through PT testing and blind sampling tool was as a CA tool for the following test procedure, recording and resulting of test results, documentation of quality control, recognizes system failures, instrument maintenance and function checks, test performance, and reporting results 2. The TP #4 listed on CMS form 209 confirmed on 5/1/18 at 12:50 pm that CA was not performed correctly. 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 surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for flagging of Hematology results run on the Cell Dyn Emerald from 3/21/16 to the date of the survey. The finding includes: 1. The PM stated flagged results will be re-run, the re- run documented and reviewed with the Physician for acceptance or denial but a review of seven out of seven samples with flagged results revealed the above procedure was not followed. 2. The TP #4 listed on CMS form 209 confirmed on 5/2 /18 at 1:20 pm the PM was not followed. -- 2 of 2 --