Aguilar Pediatrics

Summary Statement of Deficiencies 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 the proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the PT samples were routinely performed by the testing personnel (TP) who performed hematology testing. Findings: 1. The "Laboratory Personnel Report (CLIA)" (CMS-209 form) listed five TP. Five of the five TP listed were performing moderate complexity hematology testing. 2. The hematology PT records from 2022 and 2023 included five events which were reviewed. One of the five TP listed on the CMS-209 performed the PT testing for three of the five events and another TP performed the testing for two of the five events. During the survey the TC confirmed that the other three TP had been trained and were performing hematology testing in the lab for at least three to six months. 3. During the survey on 09/18/2023 at 12:15 PM, the TC confirmed that the PT testing system failed to include rotation of the PT specimens among the five TP listed on the CMS-209. 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 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 -- 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 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 record review and interview with the technical consultant at 2:00 pm on the day of survey, the laboratory did not have the attestation statement for the 2020 MLE event 3 proficiency testing challenge. Findings: 1. The laboratory performs proficiency testing for hematology 3 times a year and with each event, sent to the laboratory) the proficiency test provider includes a written statement that the director and testing staff sign stating testing be performed in the same manner as patient testing; 2. Review of proficiency test records for MLE 3 in 2020 shows that the attestation statement was not included in the laboratory records; and 3. This was confirmed during interview with the technical consultant during the survey. 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 record review and interview with the technical consultant at 2:00 pm on the day of survey, the laboratory director did not ensure that the competency of the technical consultant was assessed annually. Findings: 1. The laboratory director 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 -- reviewed a quiz that that the technical consultant took to assess knowledge; 2. The laboratory director signed two competency check quizzes for the technical consultant for 2021, but did not sign one for 2020, as the competency review is to be performed annually; and 3. This was confirmed during interview with the technical consultant during the survey. 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)