Suncoast Pathology Rialto Laboratory

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologists (CAP) proficiency testing records for the subspecialties for Histology(human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PGR) for two out of two years (1st and 2nd Events for 2016, and 1st and 2nd Events for 2017) the laboratory failed to verify the accuracy of Histology for proficiency testing that was not scored by the proficiency testing program. Findings included: During the record review of CAP proficiency testing records it was found that for two out of two years (1st and 2nd Events 2016 and 1st and 2nd Event 2017) HER2, and ER/PGR proficiency testing results that were not evaluated or scored by the proficiency testing had not been graded by the laboratory. The following were the ungraded results and the corresponding codes: HER2-A 2016 Event - Specimen # Core 08 HER2-41, Code 21 ( Specimen problem), Specimen # Core 03 HER2-02 , Code 27 (Lack of participant or referee consensus), and Specimen # Core 07 HER2-02, Code 27 HER2- B 2016 Event - Specimen# Core 10 HER2--03, Code 27 HER2-A 2017 Event - Specimen# HER2-01, Code 27 PM2-A ER/PGR 2016 Event - Method/Specimen# Core ER Core 2 - % Staining PM2-01, Code 26 (Educational Challenge), Method /Specimen # ER Core 2 - Intensity PM2 - 01, Code 26, Code 26, Method/Specimen # ER Core 4 - Intensity PM2-01, Code 26, Method/Specimen # ER Core 6 - Intensity PM2-01, Code 26, Method/Specimen # ER Core 8 - Intensity PM2-01, Code 26, Method/Specimen # ER Core 9 - Intensity PM2-01, Code 26, Method/Specimen # ER Core 1-Intensity PM2-02, Code 26, Method/Specimen# ER Core 4 - Intensity PM2- 02, Code 26, Method/Specimen# ER Core 5 - Intensity, Code 26, Method/Specimen # Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- ER Core 6 - Intensity, Code 26, Method/Specimen# ER Core 8 - Intensity PM2-02, Method/Specimen# ER Core 9 - Intensity, Code 26, Method/Specimen# ER Core 10 - Intensity, Code 26, Method/Specimen # PGR Core - 1% Staining - PM2-03, Code 27, Method/ Specimen # PGR Core 1 - Intensity, Code 26, Method/Specimen# PGR Core 2 - Intensity, Code 26, Method/Specimen# PGR Core 5 - Intensity, Code 26, Method /Specimen# PGR Core 7 - Intensity, Code 26, Method/Specimen# PGR Core 8 - Intensity, Code 26, Method/Specimen# PGR Core 9 - Intensity, Code 26, Method /Specimen# PGR Core 10 - Intensity, Code 26, Method/Specimen # PGR Core 1 - Intensity, Code 26, Method/Specimen# PGR Core 2 - Intensity, Code 26, Method /Specimen# PGR Core 3 - % Staining, Code 27, Method/Specimen # PGR Core 3 - Intensity, Code 26, Method/Specimen # PGR Core 4 - Intensity, Code 26, Method /Specimen# PGR Core 5 - Intensity, Code 26, Method/Specimen# PGR Core 7- Intensity, Code 26, Method/Specimen# PGR Core 8 - Intensity, Code 26, and Method /Specimen# PGR Core 10 - Intensity, Code 26. PM2-B 2016 ER/PGR Event Method /Specimen # ER Core 1 - Intensity, Code 26, Method/Specimen # ER Core 3 - Intensity PM2-05, Code 26, Method/Specimen # ER Core 4 - Intensity PM2-05, Code 26, Method/Specimen # ER Core 5 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 7 - Intensity PM2-05, Code 26, Method/Specimen # ER Core 8 - Intensity PM2-05, Method/Specimen # ER Core 9- Intensity PM2-05, Code 26, Method /Specimen # ER Core 10 - Intensity -PM2-05, Code 26, Method/Specimen # ER Core 2 - Intensity PM2 -06, Method/Specimen # ER Core 3 - Intensity, Code 26, Method /Specimen # ER Core 4 - Intensity PM2-06, Code 26, Method/Specimen # ER Core 5 - Intensity PM2-06, Code 26, Method/Specimen # ER Core 7 PM2-06, Method /Specimen # ER Core 8 - Intensity PM2-06, Code 26, Method/Specimen # ER Core 9 - Intensity PM2-06, Code 26, Method/Specimen# ER Core 10 - Intensity PM2-06, Code 26, Method/Specimen # PGR Core 1 - Intensity PM2-07, Code 26, Method /Specimen # PGR Core 4 - Intensity PM2-07, Method/Specimen # PGR Core 5 - Intensity PM2-07, Method/Specimen # PGR Core 6 - Intensity PM2-07, Method /Specimen # PGR Core 8 - Intensity PM2-07, Method/Specimen # PGR Core 9 - Intensity PM2-07, Method/Specimen # PGR Core 10 - % Staining PM2-07, Code 21, Method/Specimen# PGR Core 2 - Intensity PM2-08, Code 26, Method/Specimen # PGR Core 3 - Intensity,PM2-08, Code 26, Method/Specimen # PGR Core 5 - Intensity, PM2-08, Code 26, Method/Specimen # PGR Core 6 - % Staining, PM2-08, Code 21, Method/Specimen # PGR Core 6-Intensity PM2-08, Code 26,, Method /Specimen # PGR Core 8 - Intensity PM2-08, Code 26, Method/Specimen # PGR Core 9 - Intensity PM2-08, Code 26, and Method/Specimen # PGR Core 10 - Intensity PM2-08, Code 26. PM2- A 2017 ER/PGR 2017 Event Method/Specimen # ER Core 1- % Staining PM2-01, Code 21, ER Core 2 Intensity PM2-01, Code 26, Method /Specimen# ER Core - 4 Intensity, Code 26, Method/Specimen# ER Core 7 - Intensity, PM2-01, Code 26, ER Core 8 - Intensity PM2-01, Code 26, ER Core -9 Intensity PM2-01, Code 26, Method/Specimen# ER Core 10 - Intensity, PM2-01, Code 26, Method/Specimen# ER Core 1 - Intensity PM2-02, Code 26, Method /Specimen# ER Core 2 - Intensity PM2-02, Code 26, Method/Specimen# ER Core 5 - Intensity PM2-02, Code 26, Method/Specimen# ER Core 6 - Intensity PM2-02, Code 26, Method/Specimen# ER Core 7 - Intensity PM2-02, Code 26, Method /Specimen#ER Core 8 - Intensity PM2-02, Code 26, Method/Specimen# ER Core 9 - Intensity PM2-02, Code 26, Method/Specimen# ER Core 10 - Intensity PM2-02, Code 26, Method/Specimen# PgR Core 3-% Staining PM2-03, Code 27, Method /Specimen# PgR Core 3 - Intensity PM2-03,Code 26, Method/Specimen# PgR Core 4 - Intensity PM2-03, Code 26, Method/Specimen# PgR Core 5 - Intensity PM2-03, Code 26, Method/Specimen# PgR Core 6 - Intensity PM2-03, Code 26, Method /Specimen# PgR Core 7 - Intensity PM2-03, Code 26, Method/Specimen# PgR Core 8 - Intensity PM2-03, Code 26, Method/Specimen# PgR Core 9 - Intensity PM2-03, -- 2 of 6 -- Code 26, Method/Specimen# PgR Core 10 - Intensity PM2-03, Code 26, Method /Specimen# PgR Core 4 - Intensity PM2-04, Code 26, Method/Specimen# PgR Core 5 - Intensity PM2-04, Code 26, Method/Specimen# PgR Core 6 - Intensity PM2-04, Code 26, Method/Specimen# PgR Core 7 - Intensity PM2-04,Code 26, Method /Specimen# PgR Core 8 - Intensity PM2-04, Code 26, Method/Specimen# PgR Core 9 - % Staining PM2-04, Code 21, Method/Specimen# PgR Core 9 - Intensity PM2-04 Code 26, and Method/Specimen# PgR Core 10 - Intensity PM2-04, Code 26. PM2-B 2017 Event Method/Specimen# ER Core 1 - Intensity PM2-05, Code 26, Method /Specimen# ER Core 2 - % Staining PM2-05, Code 21, Method/Specimen# ER Core 4 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 5 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 6 - Intensity PM2-05, Code 26, Method /Specimen# ER Core 9 - Intensity PM2-05,Code 26, Method/Specimen# ER Core 10 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 2 - Intensity PM2-06, Code 26, Method/Specimen# ER Core 3 - Intensity PM2-06, Code 26, Method/Specimen# ER Core 4 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 5 - Intensity PM2 - 06, Code 26, Method/Specimen# ER Core 7 - Intensity PM2-065,Code 26, Method/Specimen# ER Core 8 - Intensity PM2-05, Code 26, Method/Specimen# ER Core 9 - Intensity PM2-06, Code 26, Method/Specimen# PgR Core 1 - Intensity PM2- 07, Code 26, Method/Specimen# PgR Core 2 - Intensity PM2 - 07, Method /Specimen# PgR Core 3 - Intensity PM2 -07 Code 26, Method/Specimen#PgR Core 1 - % Staining PM2-08, Code 27, Method/Specimen# PgR Core 1 - Intensity PM2 - 08, Code 26, Method/Specimen# PgR Core 2 - Intensity PM2 - 08, Code 26, Method /Specimen# PgR Core 3 - Intensity PM2 - 08, Code 26, Method/Specimen# PgR Core 4 - Intensity PM2 - 08, Code 26, Method/Specimen# PgR Core 5 - % Staining PM2 - 08, Code 42, Method/Specimen# PgR Core 5 - Intensity PM2 - 08, Code 26, Method /Specimen# PgR Core 6 - Intensity PM2 - 08, Code 26, Method/Specimen# PgR Core7 - Intensity PM2 - 08, Code 26, and Method/Specimen# PgR Core 10 - Intensity PM2 -08, Code 26. During an interview on 04/30/2018 at 11:00, the Business Manager said the laboratory was checking results but not documenting the evaluation. 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 College of American Pathologists (CAP) proficiency testing records for General Immunology and Histology two out of two years (2016 A and B Events and 2017 A and B Events) and interview with the Histotechnologist Supervisor and the Histology Technical Supervisor, the Laboratory failed to document