Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient log book, slides, random patient sampling records, and interview with the office personnel, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. The findings included: a. Based on review of (patient #1): Laboratory's patient map records and patient's specimen slide indicated different specimen ID number comparing to the laboratory's log and accession number given. Mohs ordered, analyzed and reported on 1/8/2018. b. Based on review of (patient #2): Patient anatomical locations A. Left Abdomen, B. Left Plantar Flank. Laboratory's patient log book identified specimen locations as; A. Left P Flank, B. L Abdomen. Test ordered analyzed and reported 7/10/2018. c. The laboratory failed to establish, follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. d. The office personnel affirmed (8/8/2018, 12N), that the laboratory has no established or written policy and procedure to correct any problems that are identified. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --