Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Francis A. Caban MD PA DBA Caban Skin Institute on 6/3/25. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 493.1250 Condition: Analytic Systems D6076 493.1441 Condition: Laboratory Director High Complexity Testing D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory failed to ensure the defined cryostat temperature was monitored for the Histopathology testing performed by the laboratory for two (10/2023 and 3/2025) months of three (10/2023, 6/2024, and 3 /2025) months reviewed (See D5413); the Laboratory failed to document the Hematoxylin and Eosin (H&E) Histopathology staining materials for intended reactivity for three (10/2023, 6/2024, and 3/2025) of three months reviewed (See D5473); the Laboratory failed to document