Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies, surveyor observations, patient final reports, and confirmed in interview, the laboratory failed to follow its policy and properly label patient specimens for CBC (complete blood count) patient testing on the ABX Pentra hematology analyzer. Findings were: 1. Review of the laboratory policy Specimen Collection Handling and Transportation revealed "date and time of collection and techs initials must be recorded on the specimen container...Label specimen with 2 identifiers of the phi [patient health information]." 2. A tour of the laboratory on 8/24/18 at 1050 hours revealed 5 of 13 CBC specimens with only 1 identifier (patient first and last name) on the specimen rack next to the ABX Pentra hematology analyzer. 250918 75580 244028 251071 252686 3. Review of the patient final reports of the 5 specimens revealed the laboratory performed CBC testing for the 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 -- above specimens. 4. An interview with the technical consultant on 8/24/18 at 1100 hours confirmed the above findings. She acknowledged the laboratory personnel should have at least 2 identifiers and note the date and time on the specimen tube. -- 2 of 2 --