Summary:
Summary Statement of Deficiencies 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 interview with testing personnel (TP) #2 as listed on the Centers For Medicaid & Medicare Services (CMS) 209 form, on day of survey 2/14/19 at 2:00 pm, lack of documentation of a specimen labeling procedure, review of 2 CBC (complete blood count) final results, and observation of 4 patient purple top specimens collected on 2/14/19, the laboratory failed to establish and follow written policies and procedures to ensure positive identification of the patient specimen from the time of collection through testing and reporting for CBC results. Findings include: 1) Observation of patient specimens revealed only a first initial and last name of the patient on the specimen tube. 2) Interview with TP #2 at 2:00 pm on 2/14/19 indicated that TP routinely entered the patient account number, patient's first initial and last name, and the TP's initals into the hematology analyzer. 3) The resulting CBC printout was then scanned into the LIS. 4) This process does not ensure positive identification of a patient's specimen from the time of collection through reporting of results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)