Summary:
Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, the laboratory's records, and an interview with the staff, the laboratory failed to ensure slides are maintained and stored under conditions that ensure proper preservation, affecting at least 2 patients' test slides. Findings: 1. On 02/20/2019 at 11:00 AM during a patient's chart, records, and slide review, the surveyor observed the following: a). From the laboratory's Mohs' patients' test log 4 patients were selected for map, slide and final report review. b). Of the 4 patients selected, 2 patients' slides could not be identified. c). The 2 patients' (Patient CX tested on 11/27/2018 and Patient TG - tested on 01/08/2019) slides were presented to surveyor stuck together with other slides. d). After much effort from the laboratory staff, the slides could not be separated; and e). After a further search through the slide box/drawer, the surveyor observed other slides that were clumped /stucked together and some showed evidence of breakage, due to the efforts to separate the slides. Being unable to separate the selected slides; Patient CX and TG slides could not be identified or retrieved from among the other patients' slides. 2. On an Initial survey conducted on 02/20/2019 at 11:50 AM, the staff confirmed the above findings and stated they had no idea why the slides were stuck so tightly together. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's manual, records, and an interview with the laboratory staff; the laboratory failed to establish written policies and procedures to assess employees performing Histopathology testing, affecting 5 out of 5 testing personnel (TP). Findings: 1. The laboratory contracts with a mobile testing service ("Got Mohs!") which provides equipment and temporary TP for the laboratory to perform Mohs procedures and slide production. The CMS 209 lists 5 temporary TP (from lines 2 thru line 6) who perform the grossing and tissue staining in the laboratory. 2. The personnel files revealed the following: a). The competency documents for the Temporary TP were from "Got Mohs!". b). The 'Got Mohs' competencies showed no evidence that they were conducted at the 1450 Busch Parkway, in Buffalo Grove location; and c). None of the 5 Temporary TP competencies had any visible evidence that their evaluations had been performed and signed by the technical supervisor (TS) or LD of the laboratory. 3. The patient logs and quality control worksheets show that 2 out of the 5 temporary TP listed on the CMS 209, has actually worked in the laboratory. No other documentation was presented as evidence that these 2 temporary TP, had not been assessed on-site by the TS or LD, prior to processing patients' tissues from Mohs surgery. 4. Review of the laboratory's manual revealed that it does not include an established competency policy or a step-by-step procedure for assessing TP performing grossing and tissue staining for the production of Histopathology slides. 5. On an Initial survey conducted on 02/20/2019 at 11:50 AM, the staff confirmed the above findings. -- 2 of 2 --