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 surveyor review of the Accession Log, Electronic Medical Records and interview with the Testing Personnel (TP), the laboratory failed to retain patient test records for Complete Blood Count tests on 7/30/18. The finding includes: 1. 23 out of 23 patient work records were not available for review. 2. The TP #2 listed on CMS form 209 confirmed on 3/26/19 at 11:30 pm all patient test records were not retained. 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 surveyor review of the Procedure Manual (PM), the lack of