Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the dates and times specimens were received in their laboratory management systems for eight (PT#1-PT#8) out of 11 patients reviewed. Findings Included: 1.) Review of Patient Records revealed the following: a. PT#1 specimen was collected on 4/5/2021 at 10:38 a.m. and was resulted for bilirubin on 4/5/2021 at 10: 38 a.m. b. PT#2 specimen was collected on 6/16/2021 at 10:38 a.m. and was resulted for bilirubin on 6/16/2021 at 10: 38 a.m. c. PT#3 specimen was collected on 11/10/2022 at 2:57 p.m. and was resulted for bilirubin on 11/10/2022 at 2:57p.m. d. PT#4 specimen was collected on 12 /5/2022 at 1:57 p.m. and was resulted for bilirubin on 12/5/2022 at 1: 57p.m. e. PT#5 specimen was collected on 4/8/2021 at 10:14 a.m. and was resulted for complete blood count on 4/8/2021 at 10:14 a.m. f. PT#6 specimen was collected on 2/2/2022 at 9:21 a.m. and was resulted for complete blood count on 2/2/2022 at 9:21 a.m. g. PT#7 specimen was collected on 6/14/2021 at 2:57 p.m. and was resulted for complete blood count on 6/14/2021 at 2:57 p.m. h. PT#8 specimen was collected on 12/6/2022 at 8:33 a.m. and was resulted for complete blood count on 12/6/2022 at 8:33 a.m. The result time matched the collection time and there was no unique specimen received time and date for the patient reports. 2. Review of Policy and Procedure: Specimen Collection/Rejection, signed 7/12/2017 by laboratory director, stated "specimens on registered patients are labeled with the following information (usually using computer generated label): a. Patient Name b. Patient medical record or date of birth c. date and time of collection d. initials of person collection [SIC] specimen." Policy did not indicate if the collection time was the same as specimen received or test resulted time. 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 -- 3.During interview on 4:16 p.m. at 12/14/2022, Sp-1 (Pediatric Manager) and SP-2 (Adult Manager) confirmed the laboratory management system could not identify when specimens were received with date and time. -- 2 of 2 --