Prime Pediatrics Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 02, 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: 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 Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) profiency test (PT) records and interview with the offfice manager , the laboratory failed to rotate PT samples with all testing personnel who routinely perform the testing in the laboratory. Findings include: 1. Review of API hematology 2021 PT testing events 1, 2, 3, and 2022 testing event 1, the same staff [#6 and #7 (CMS 209)] ran all 20 specimens of the 4 PT testing events per the attestation statements available. 2. Review of API bacteriology 2021 PT testing events 1, 2, 3 the same staff [#6 and #7 (CMS 209)] ran all 15 specimens of the 3 PT testing events per the attestation statements available. 3. Interview with the practice manager in the breakroom on 09/29/22 at approximately 12:03 P.M, confirmed the aforementioned statements. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) profiency test (PT) records and interview with the office manager, the laboratory testing personnel (TP) and lab director failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Reveiw of API PT records revealed the lab failed to have the attestation statements signed by the TP and lab director for hematology 2022 event 2; and 2022 events 1 and 2 for bacteriology. 2. Interview with the practice manager in the breakroom on 09/29/22 at approximately 12:03 P.M, confirmed the aforementioned statement. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Test (PT) documents and staff interview, the lab failed to test samples the same number of times that it routinely tests patient samples. Findings include: 1. Review of API

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 2, 2022. 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 and 3rd event of 2021), resulting 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 -- in the first unsuccessful occurrence for Hematology # 760 including: red blood cell count (RBC) #775. 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 3rd events of 2021), resulting in the first unsuccessful occurrence for RBC, analyte #775. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #775 RBC on event 1of 2021 with a score of 60% and event 3 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed RBC on events 1 and 3 of 2021 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 proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2021), resulting in the first unsuccessful occurrence for RBC #775 Findings include: Refer to D 6016 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 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 director failed to ensure the laboratory -- 2 of 3 -- maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2021), resulting in the first unsuccessful occurrence for RBC #775. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #775 RBC on event 1 of 2021 with a score of 60% and event 3 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed RBC on Events 1 and 3 of 2021, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 15, 2020. 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: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 3, 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 American Proficiency Institute (API) proficiency testing proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive 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 -- events (Event 2 of 2018 and Event 1 of 2019), resulting in the first unsuccessful occurrence for red blood cell count (RBC) #0775, hematocrit (HCT) #0785, hemoglobin (HGB) #0795, and Hematology #0760. Findings include: Refer to D2130 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (2nd Event of 2018 & Event 1 of 2019), resulting in the first unsuccessful occurrence for Hematology #0760, red blood cell count (RBC) #0775, hematocrit (HCT) #0785, and hemoglobin (HGB) #0795. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology #0760, red blood cell count (RBC) #0775, hematocrit (HCT) #0785, and hemoglobin (HGB) #0795 on Event 2 of 2018 with a score of 0% and Event 1 of 2019 with a score of 0%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 2. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed Hematology on Event 2 of 2018 and Event 1 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 (2nd Event of 2018 and 1st Event of 2019), resulting in the first unsuccessful occurrence for Hematology #760, red blood cell count (RBC) #0775, hematocrit (HCT) #0785, and hemoglobin (HGB) #0795. The findings include: Refer to D 6016 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 -- 2 of 3 -- required under Subpart H of this part; 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 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 (3rd event of 2018 and 1st event of 2019), resulting in the first unsuccessful occurrence for Hematology #760, red blood cell count (RBC) #0775, hematocrit (HCT) #0785, and hemoglobin (HGB) #0795. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology #0760, red blood cell count (RBC) #0775, hematocrit (HCT) #0785, and hemoglobin (HGB) #0795 on Event 2 of 2018 with a score of 0% and Event 1 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 Hematology on event 2 of 2018 and event 1 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --