Summary:
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 the lack of daily checks records of temperature's and interview with the laboratory director on June 13, 2024 at 12:43 PM; it was determined that the laboratory fail to monitor and document the temperature of the transport cooler used for the storage of patient samples referred from other laboratories. The laboratory transport from other laboratories 11,984 patient samples in the year 2023 and 8,674 from January to June 2024. The findings include: a. On June 13, 2024 at 10:56 AM; the daily checks of the cooler temperature was requested and it was not available. b. On June 13, 2024 at 12:43 PM; the laboratory director confirmed that the laboratory fail to monitor and document the transport cooler temperature where the patient samples were transported to HRP LABS-Laboratorio Clinico (year 2023 and 2024). The laboratory transport from other laboratories 11,984 patient samples in the year 2023 and 8,674 from January to June 2024. 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 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 -- 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)