Pediatric Physicians Pc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of the laboratory, procedure manual review and staff interview the laboratory failed to establish and follow policies for specimen labeling to include patient name or unique identifier for patient specimens collected for complete blood count (CBC) testing using the Sysmex XP 300 analyzer in 2021, 2022, and 2023. The findings include 1. Observation of the laboratory on 07/12/2023 at 9:00 am revealed the Sysmex XP 300 (Serial C2401) hematology analyzer in use for patient testing of CBC samples. 2. Review of the laboratory procedure manual revealed no policy or procedure for labeling of patient specimens collected for CBC testing. 3. Interview on 07/12/2023 at 9:15 am with testing person one revealed the following: Patient samples for CBC are collected in the patient room and brought to the laboratory for testing. Patient samples for CBC are not labeled with patient name and identifier after collection. 4. Interview on 07/12/2023 at 2:00 with testing person one confirmed the laboratory failed to establish and follow policies for specimen labeling when the laboratory's routine practice did not include labeling of specimens collected for CBC testing with patient name and identifier. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on observation of the laboratory, procedure manual review, patient test review, Department of Health and Human Services Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) review, and staff interview the laboratory failed to ensure the procedure used for the Sysmex XP 300 analyzer used for patient testing of CBC samples included requirements for patient preparation, specimen acceptability or rejection, step-by-step performance of the procedure including interpretation of results, calibration and calibration verification procedures, reportable ranges, control procedures, or

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, calibration and quality control (QC) records, patient data logs and patient test reports, and interview with the lead testing personnel, the laboratory failed to follow the quality control procedure in 2018 and 2019. The findings include: 1) Review of the laboratory procedure for Complete Blood Count (CBC) revealed that QC is to be performed "each time the equipment is calibrated or serviced." 2) Review of calibration and quality control records revealed that QC was not performed after calibration on the following dates: May 25, 2018, November 12, 2018 and April 17, 2019. 3) Review of patient data logs and patient final test reports revealed patient testing was performed and reported after calibration with no post-calibration quality control for patient number six on May 25, 2018, patient number seven on November 12, 2018 and patient number eight on April 17, 2019. 4) Interview with the lead testing personnel on January 22, 2020 at 11:50 a.m. confirmed the laboratory failed to follow the procedure for performing QC after calibration in 2018 and 2019 (three of four calibrations reviewed) with patient testing performed. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved