Childersburg Primary Care

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the Laboratory Director failed to sign the attestation statements for three of three events in 2022. The findings include: 1. A review of the API PT records revealed the no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2022 Hematology 1st Event. b) 2022 Hematology 2nd Event. c) 2022 Hematology 3rd Event. 2. During an interview on March 1, 2023, at 9:55 AM, Testing Personnel #1 confirmed the above findings. 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 acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. 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 a review of the Hematology calibration records, the Medonic User Manual, and an interview with Testing Personnel #1, the Laboratory failed to perform calibrations on the Medonic Hematology analyzer every six months as per the manufacturer's instructions. The laboratory failed to perform two of two calibrations due in 2022. The findings include: 1. A review of the Hematology calibration records revealed the Medonic was last calibrated 12/21/2021. There was no documentation of calibrations performed in 2022. 2. A further review of the Medonic User Manual revealed on page 59, "It is recommended to calibrate the instrument every six months." 3. During an interview on March 1, 2023, at 10:05 AM, Testing Personnel #1 confirmed the two calibrations due in 2022 were not performed. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155) and a review of AAB (American Association of Bioanalysts) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Hematocrit (Hematology) for Event #3, 2019 and Event #1, 2020. The laboratory scored zero percent (0 %) for Hematocrit (HCT) for Event #3, 2019 and sixty percent for HCT, Event #1, 2020. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The 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 -- findings include: 1. A review of the CASPER reports revealed the laboratory failed HCT testing for Event # 3, 2019 (scored 0 %) and Event #1, 2020 (scored 60 %). 2. A review of the AAB proficiency testing evaluations confirmed these findings. 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 a review of the CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155) and a review of AAB (American Association of Bioanalysts) proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for two consecutive testing events, Hematocrit (Hematology) for Event #3, 2019 and Event #1, 2020. The laboratory scored zero percent (0 %) for Hematocrit (HCT) for Event #3, 2019 and sixty percent for HCT, Event #1, 2020. These consecutive failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A review of the CASPER reports revealed the laboratory failed HCT testing for Event # 3, 2019 (scored 0 %) and Event #1, 2020 (scored 60 %). 2. A review of the AAB proficiency testing evaluations confirmed these findings. -- 2 of 2 --

Summary Statement of Deficiencies D5779