Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of Proficiency testing/ Quality Assurance records and interview with Office Manager (OM) and the histotechnician, there was no evidence of evaluation of the peer comparison slide activities. Findings include: 1. The laboratory did not have documentation demonstrating the laboratory director evaluated the peer comparison slides for 2017 and 2018. 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 observation and chemical inventory record review, the laboratory was not properly labeling and documenting histopathology chemicals. Findings include: 1. During a tour of the laboratory on 8/15/2018, it was observed that chemicals were not labeled with receipt and open dates. 2. The laboratory had a chemical inventory logbook that was discontinued on 6/8/2018. The forms had headings that included: date received, chemical name, lot number, expiration date, and tech initials. 3. On 8/15 /18 at approximately 2:45PM, the histopathology technician stated that he knew 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 -- chemicals should be labeled properly but with busy schedules this was something that was overlooked. He recognized from other histopathology positions that labeling reagents is routine laboratory practice D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require