Summary:
Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with the CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. 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 a review of laboratory policies and procedures, a direct observation of patient samples and an interview with the laboratory manager on 11/15/2024, the laboratory failed to label two patient blood tubes to include patient name or unique patient identification. The findings include: 1. The laboratory procedure, "Specimen Labeling and Transporting Procedure" established that specimens must be labeled with two patient identifiers, the collecting persons initials, the date and time of collection while with the patient. 2. A direct observation during the laboratory tour identified one K2 EDTA patient specimen tube and one Lithium Heparin patient specimen tube on the tube rocker that failed to have patient identifiers, date and time of collection and collectors initials. The laboratory failed to follow their policy and label the patient specimen blood tubes with two identifiers, collectors initials and date and time of collection. 3. An interview with the laboratory manager on 11/15/2022 at 2:28 pm confirmed that the laboratory failed to label specimens to ensure positive patient identification, following the laboratory's procedure. 4. The laboratory reports performing 766 tests annually. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a direct observation and an interview with the laboratory manger on 11/15 /2024, the laboratory failed to discontinue the use of eight expired specimen collection tubes. The findings include: 1. A direct observation of the phlebotomy draw trays on 11/15/2024 identified that the laboratory failed to discontinue the use of eight (8) BD buffered sodium citrate 3.2%, 2.7 ml tubes, lot 4011411, expiration 10/31/2024. 2. An interview with the laboratory manager on 11/15/2024 at 2:31 pm confirmed the above finding. 3. The laboratory reports performing 766 tests annually. -- 2 of 2 --