Summary:
Summary Statement of Deficiencies 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 observation and interview with the TC (technical consultant) and TP (testing personnel) #1 on 5/4/23, the laboratory failed to discard blood collection tubes that exceeded their expiration dates. During a tour of the laboratory approximately 11:55 a. m. - 12:15 p.m., surveyors observed the following expired supplies: 1. In a bin on the wall by the phlebotomy chair, available for use a. 2 tubes BD Vacutainer blue top Na (sodium) Citrate 3.2%, lot #2166978 with expiration date 3/31/23; b. 2 tubes BD Vacutainer red top serum, lot #1305730 with expiration date 3/31/23; c. 2 tubes BD Vacutainer green top Na Heparin lot #1319233 with expiration date 3/31/23. 2. In a cabinet, available for use a. approximately 50 BD Vacutainer blue top Na Citrate 3.2%, lot #2166978 with expiration date 3/31/23. 3. In a phlebotomy tray in a second cabinet, available for use a. 1 tube BD Vacutainer blue top Na Citrate 3.2%, lot 2166978 with expiration date 3/31/23; b. 1 tube BD Vacutainer red top serum, lot #1305730 with expiration date 3/31/23. During interview at approximately 11:55 a.m., the TC and TP #1 confirmed that the tubes were expired. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. 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 review of the laboratory's policies and procedures, observation, and interview with TP (testing personnel) #1 on 5/4/23, the TP failed to follow the laboratory's policy for specimen labeling. Review of the laboratory's "Specimen Collection and Processing" policy revealed "... V. Procedure A. Specimen Labeling: All specimens will be labeled appropriately regardless of type 1. Handwritten Labels a. After sample has been collected, and in the presence of the patient, print the patient's full name, date of birth, collector's corporate identification (ID), i.e., ABC123, date and time of collection on the container's label. ... c. Specimen type should be added if needed - example: plasma, serum, etc. ... 2. Electronic Labels - Dimensions/Laboratory Information System(LIS) (Reference Lab Included) a. After label is printed, verify all patient information is correct by comparing the label to the order, requisition, and asking the patient to state the information. b. Immediately following collection, and in the presence of the patient, place the pre-printed label on the specimen. c. Any information not included on the label , i.e., collector's corporate ID, patient's date of birth, date and time of collection should be written on the label. ..." During a tour of the laboratory approximately 11:55 a.m. - 12:15 p.m., the surveyor observed a urine specimen in a gray top urine transport tube without any patient identification information. During interview at approximately 12:00 p.m., TP #1 confirmed that she did not label the urine transport tube. -- 2 of 2 --