Pediatric Center For Wellness

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 29, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the review of the Standard Operating Procedure(SOP) and staff interview, the laboratory failed to establish a safety procedure for an Eyewash. The Findings include: 1. SOP document review revealed that the laboratory failed to establish a safety procedure for the Eyewash in the laboratory. 2. During an interview with the Office Manager and the Administrative Lead, on March 29, 2023, in the breakroom, confirmed that the laboratory failed to establish a safety procedure for an Eyewash. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: 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 -- Based on the tour of laboratory and staff interview, the laboratory failed to ensure two identifier's were present on the urine specimens. Findings include: 1. During the laboratory tour, a urine specimen was observed with only one identifer, during the survey. 2. During an interview with the Office Manager and Administrative Lead on March 29, 2023 at 2:25 PM in the breakroom, confirmed the lack of two identifier's on the urine specimen. 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for 2022, Speciality- Hematology and staff interview, the laboratory failed to provide evaluation documentation. Findings: 1. A review of the API PT Hematology 2022 evaluation report for the 3rd event, the laboratory failed to provide

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 25, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) document review and staff interview, the laboratory failed to enroll in a PT program for the speciality of Hematology (0760). Findings include: 1. Review of PT documents provided and CMS CASPER Report 0096D, the lab failed to enroll in PT program for 2020 and 2021 Event #1. Lab director ceased patient testing upon discovery (April 2021). 2. Interview with staff #1 (CMS 209 form) on 5/25/21 at 11:00 AM in the breakroom confirmed the lab was not enrolled in PT for 2020 and 2021 Event #1. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) records and staff interview, the laboratory failed to follow the written policy for QA. Findings include: 1. Review of the laboratory's QA records reveals no documentation of preanalytic, analytic, or post analytic monitors being performed since 02/08/2019. 2. Interview with staff # 1 (CMS 209) on 05/25/21 at 12:30 pm in the breakroom, confirmed the laboratory has no documentation of QA review since 02/08/2019. 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 Temperature/ Humidity record review and staff interview, the lab failed to document room temperaturer as required by the manufacturer. Findings include: 1. Review of Temperature/ Humidity records reveals the lack of monitoring /documenting the room temperature for January 2020 through May 25, 2021. 2. Interview with staff #1(CMS 209 form) on 05/25/21 in the breakroom at approximately 1230 PM, confirmed the lack of room temperature documentation. 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 Horiba Micros 60+ document review and staff interview, the lab failed to perform and document maintenance per the maufacturer's manual. Findings include: 1. Maintenance document review revealed the lab did not have documented maintenance available at the time of the survey for 2020 or 2021 to date. 2. Interview with staff #1(CMS 209 form) on 05/25/21 in the breakroom at approximately 1230 PM, confirmed the lack of maintenance documents. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures -- 2 of 5 -- that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the lab failed to monitor over time the accuracy and precision of test performance. Findings include: 1. Review of QC records reveals the lab did not monitor QC overtime to detect shifts, trends, or any variance in the test system such as review of Levy-Jennings charts. 2. Interview with Staff #1 (CMS 209) in the breakroom on 05/25/21 at approximately 12: 30 p.m. confirmed the lab did not monitor QC over time for the accuracy and precision of test performance. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Quality Control (QC) record review and patient test report review, patient sample was processed on a day when QC was out of acceptable range. Findings include: 1. QC record review on 1/4/21 reveals low level lot # MX426 was out of range 6 runs without correcting and notation was documented by the lab director "No tests performed on 1/4/21". 2. Review of patient report Medical number # 13650 reveals the patient specimen was ran and reported at 12:29 PM. 3. Interview with staff #1 (CMS 209) on 5/25/21 at approximately 1:00 PM in the breakroom, confirmed the patient sample was ran without QC in acceptable limits. D5781

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 11, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event and 2nd event of 2019), 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 -- resulting in the first unsuccessful occurrence for Cell ID or WBC differential (DIFF) # 765. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (1st and 2nd events of 2019), resulting in the first unsuccessful occurrence for cell I.D. or WBC diff #0765. Th findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0765 cell I.D. or WBC diff on Event 1 of 2019 with a score of 7% and event 2 of 2019 with a score of 0%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed cell I.D. or WBC diff on events 1 and 2 of 2019 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 2nd events of 2019), resulting in the first unsuccessful occurrence for Cell I.D. or WBC Diff #765. The findings include: 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: -- 2 of 3 -- Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 2nd events of 2019), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Cell I.D./WBC Diff #0765 on Event 1 of 2019 with a score of 7% and Event 2 of 2019 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on events 1 and 2 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --