Summary:
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 CLSM Specimen Processing Procedure Manual, observation of the CBC testing procedure in the lab testing area on 3/30/23 at 10:30 a. m., and interview with the lab manager/TP (testing personnel) #1, TP #2 and the quality manager/TP#3 as listed on the Centers for Medicare & Medicaid Services (CMS) 209 form at 10:30 a. m. on 3/30/2023, the laboratory did not follow the facility's specimen processing procedure for identification of specimens and paperwork from the time they are received into the laboratory until the time a final report is released. Findings include: 1. The Specimen Processing Procedure Manual states: "A specimen may be considered acceptable for processing and analytical testing if the following criteria are met, and all correlating information is accurate: * Primary specimen container has two patient identifiers * Requisition form or electronic requisition has two patient identifiers * Billing information is given * Sample volume is adequate to meet all requested testing requirements * At least one (1) diagnostic code on the requisition * Physician requesting testing should be listed on the requisition if the account has multiple physicians * An affirmative order for analytical testing is clearly marked on the requisition form * The collection date is within stated stability" 2. The Specimen Processing Procedure Manual; Sample Requirements #2. under Sample Identity states "All clinical sample containers must be labeled with 2 unique identifiers that match the paperwork sent with the sample (e.g. test requisition, demo sheet (manifest), insurance information) or electronic requisition. Laboratory personnel are responsible for verifying the information." 3. 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 -- Observation of 8 of 8 CBC (complete blood count) specimens and the corresponding patient manifest worksheets on 3/30/2023 at 10:30 a. m. in the lab testing area revealed the manifest worksheets included only accession numbers with no patient names or other identifier. a. The specimen bar code on the sample was used to enter patient information into the Sysmex XN 530 hematology analyzer for CBC testing. b. 2 of 8 CBC specimens on the day of survey had to be repeated. On repeat testing, the testing personnel prints the results from the Sysmex hematology analyzer for both the initial and repeat run. The CBC results printed from the analyzer contain only the patient's accession number for identification. 3. TP#1, TP#2 and TP#3 confirmed in an interview at 10:30 a.m. on 3/30/2023 that the specimens are processed (requisition checked and accession numbers assigned) on their main campus laboratory and transported to this location for CBC testing. They confirmed the CBC specimens which are labeled with the name, date of birth, accession number and barcode are accompanied by the demo/manifest (requisition) worksheet which only includes the accession number. 4. The laboratory is not following their written Specimen Processing Procedure Manual which requires the patient specimens obtained from the main lab for testing to match the paperwork sent with the sample and the manifest paperwork to contain two patient identifiers. -- 2 of 2 --