Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 8/15/2019 found that the Integrated Regional Laboratories Pathology clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and interview with staff, the laboratory failed to have annual competency assessment evaluation for 1 out of 2 Clinical Consultant staff (CC) (CC # B); 3 out of 3 testing personnel (TP) (TP# A, TP # B and TP # C) ; during the period of 2 out 2 years reviewed, and for 1 out of 2 General Supervisor (GS) (GS #B); during 1 out of 2 years reviewed. Findings include: Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director on 8/29/2019 revealed: a) 2 Clinical Consultant (CC) (CC # A was the laboratory Director and CC #B is a TP # C) b) 2 G S (GS # A is the LD and GS # B) c) 3 TP (TP # A, TP # B, TP # C). Review of employee documentation revealed the following: - No annual competency evaluation for CC # B; during the period of 2 out of 2 years reviewed. - TP # A; the forms provided to document the annual competency assessment did not correspond with this facility. 1)Form signed on 10/4/2018, Competency Assessment: RRL Histotechnician/ Histotechnologist with case IRLSS18: 11489. The date of the case was 9/12/2018, as per the patient log, no cases tested on the day of reference at the facility object of this survey. This competency assessment had a review for Cytology which is not listed in the 116 as specialty for this laboratory. 2)Form signed on 10/01 /2018, Employee annual training checklist document as the Facility: IRL Core Histology. -TP # B: The documentation provided did not meet requirements: a) 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 -- Competency Assessment for Histology Procedures performed by Histology technologist form, signed on 8/4/2017 and 8/29/2018, the evaluator was a TP # B. b) Form GEN 15A V1 03-13 Annual Competency signed on 12/5/2018, the evaluator listed for the assessment is not included in form 209. Tasks evaluated like patient accessioning, embedding, microtomy, staining, IHC (immunohistochemistry), are not performed at this facility. -TP # C: The documentation provided did not meet the requirements a) Pathologist Professional Practice Evaluation form of HCA Physician Services Group, is a company form provided as annual competency assessment, missing the 6 points required for the testing personnel. The 2017 signed on 3/12/2018 by a Chief Medical Officer not listed on the 209. b) The Initial Professional Practice Evaluation PS200bV2 0617 form signed by the LD on 8/13/2019, listed 3 cases for 2017 and 2 for 2018, no supporting documentation was provided to confirm that the cases reviewed are associated with this facility. -GS # B evaluation signed on 1/10 /2019 with a hiring date of 5/1/2018, states Core Histology manager and it is signed by Medical Director IRL, the signing person is not listed on the form CMS 209 as LD, a review of the ASPEN 116 web system, the signing person appears as the LD for laboratory with CLIA number for another facility. During a phone interview with Quality staff, on 08/15/2019 at 12:30 PM, she confirmed that this was the competency assessment they have for the personnel of above-reference. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on the review of patient reports and interview with testing personnel (TP) A at 9:30 AM; the information on the report was inaccurate for 1 out of 3 reports reviewed. Findings include: Review of final reports with case numbers SS18:11555, SS18: 13213 and SS18:14476; during the period of 2018, revealed that, report SS18:11555 failed to list the location for the frozen intra-operative consultation. During an interview on 8/15/2019 at 12:30 PM, with the TP, he confirmed that the report did not include the location where they performed the frozen section for the intra-operative consultation -- 2 of 2 --