Childrens Medicine Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 19, 2024. 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: 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 the laboratory tour, review of temperature logs and hematology reagents storage manufacturer's recommendations, the laboratory failed to monitor temperatures for the hematology reagents storage room in 2023 thru the date of survey, 12/19/2024. Findings: 1. A review of the Sysmex CellPack reagent reference #CPK-310A package labelling, revealed the required storage at +1*C - +30*C. The reagent was found stored in a storage room in which the temperature was not being monitored to assure proper storage in 2023 thru the date of survey. 2. An interview with the technical consultant (TC)(TP#5 CMS 209) and (TP#3 CMS 209) in the break room at approximately 12:30 PM on 12/19/2024 confirmed the above findings. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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 -- 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 personnel records review and staff interviews, the laboratory director failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory in 2023 thru the date of survey as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Personnel documents review revealed the lab director had no proof that annual competencies were performed on the technical consultant (TC) (TP # 5 CMS 209) in 2023 thru the date of survey, 12/19/2024. 2. An interview with the laboratory's (TC) (TP#5 CMS 209) and (TP#3 CMS 209) in the lab break room on 12/19/2024, at approximately 12:45 PM, confirmed the lab director failed to ensure proper oversight of the laboratory in 2023 thru the date of survey. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 29, 2022. 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: D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on patient final lab reports review in 2021, 2022 and interviews with the office manager and laboratory's Technical Consultant(TC), the laboratory failed to provide the units of measure and reference ranges for CBC results from the Cell-Dyn Emerald Hematology analyzer. Findings: 1. Review of patient final reports in 2021 and 2022 revealed reports did not have the units of measure and reference ranges for each analyte and differential of the Complete Blood Count (CBC) from the Cell-Dyn Emerald Hematology Analyzer. 2. Interviews with the office manager, (TS), and (TPs #3 and #6 CMS 209) on 12/29/2022, at approximately 12:00 PM, in the break room, confirmed that the units of measure and the reference ranges for each analyte and differential were not on the final reports that were randomly selected for review in 2021 and 2022 from the Cell-Dyn Emerald Hematology Analyzer. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 8, 2018. 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: D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on testing personnel (TP) competency and staff interview, the laboratory director failed to delegate employee competency responsibilities to qualified personnel as required. Findings include: 1. TP competency document review revealed the initial competency for Staff #4 (CMS 209) was performed by unqualified TP. 2. TP competency document review revealed the annual competencies for 2017 and 2018 were performed by unqualified TP for the following TP on CMS 209: Staff #3, Staff #5, Staff #6, and Staff #7. 3. An interview with the clinic manager on 8/8/18 in athe breakroom at approximately 1 p.m. confirmed the aforementioned TP competencies were performed by unqualified TP. 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 -- 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 competency document review and staff interview, the laboratory director (LD) failed to ensure all personnel receive appropriate training for the type and complexity of the services offered. Findings include: 1. Laboratory personnel document review revealed an initial training competency has not been performed for the technical consultant (TC) in the specialty of hematology in 2018 thus far . 2. An interview with the clinic manager on 8/8/2018 in the breakroom at approximately 1:00 p.m. confirmed an initial training competency has not been performed for the TC in 2018 thus far. -- 2 of 2 --