Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: =================================== Based on review of three patient CBC (Complete Blood Count) reports manually entered in Electronic Medical Records (EMR) for 2018, lack of CBC instrument printouts and upon interview with the Nurse Manager, the laboratory failed to retain CBC instrument printouts for the last 2 years. The findings include: 1. Review of three patient CBC reports for January 26, 2018, April 10, 2018 and November 21, 2018 revealed manually entered results in the Electronic Medical Records. 2. CBC instrument printouts for manually entered CBC's into EMR for dates in January, April and November of 2018 were not retained. 3. Interview with Nurse Manager January 9th, 2019 at approximately 1:30 p.m. confirmed the laboratory was not able to retrieve CBC instrument printouts for the dates of review in 2018 and had not been retained since 2017. ==================================== 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. 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 -- (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)