Woodlands Skin Surgery Center, Pa,The

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 11/29/2023. The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor's observations and staff interview, the laboratory failed to label 14 of 14 secondary containers with reagents used for Hematoxylin and Eosin (H&E) staining of Mohs surgery tissue. Findings included: 1. Surveyor's observations on 11 /29/2023 at 0905 hours in the laboratory revealed an automated stainer with 14 containers filled with various unidentified solutions/reagents. A legend listing the reagents for the H&E stain was posted above the stainer, but individual receptacles were not labeled to indicate what solutions each contained. 2. In an interview on 11/29 /2023 at 0910 hours in the laboratory, facility's Histotechnologist (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the 2018 and 2019 personnel records, laboratory policies, and confirmed in interview, the laboratory failed to establish policy and procedures to assess competency for 1 of 2 technical supervisors. Findings were: 1. Review of the laboratory records available revealed no documentation of a policy and procedure to assess competency for 1 of 2 technical supervisor (TS#2). 2. An interview with the laboratory director on 11/6/19 at 1035 hours in the break room confirmed the above findings. 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 --