Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Bon Secours Surgical Dermatology on May 30, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, policy and procedures (P&P) review and interviews with the office manager and TP, the lab director failed to perform and document initial training and competency assessment for one (1) of 2 TP reviewed prior to testing patients. Dates of record review included 2018 and up to the date of survey on May 30, 2019. Findings include: 1. Review of the CLIA CMS-209 Form and an interview with TP A at approximately 10:45 AM revealed that TP A was new and began inking and grossing histology tissue samples on February 19, 2019. (See attached TP code sheet). 2. Review of available TP records revealed a lack of documentation of initial training and competency assessment prior to TP A inking and grossing histology tissue samples. The inspector requested to review the aforementioned documentation. The documentation was not available for review. 3. Review of P&P revealed the following statement: "Training and Information - Initial training will be done by a qualified Histology Technologist. Upon Completion, the training tech will be able to complete frozen sections and understand the Mohs 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 -- concept." 4. An interview with the office manager and TP at approximately 11:00 AM confirmed the findings. -- 2 of 2 --