Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have a written or electronic request for patient testing from an authorized person for the routine chemistry testing for four (#1-#4) of 4 patient charts audited. Findings include: 1. On May 1, 2018 at approximately 12:45 PM, record review revealed for four of four patient charts audited the laboratory did not have a written or electronic request for the routine chemistry urinalysis testing by an authorized person. 2. During the interview on May 1, 2018 at approximately 12:45 PM, technical consultant #2 as listed on the CMS-209 confirmed there was no written or electronic orders for the patient testing. 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 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)