Wyoming Valley Pathology Assoc

Summary Statement of Deficiencies D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment Policy, maintenance records and interview with Testing Personal (TP) #4 and #5 (CMS 209 form), the Technical Supervisor (TS) failed to perform and document the review of maintenance records from 12/15/2022 to date of survey 09/18/2024. Findings include: 1. According to the Quality assessment Policy," The Laboratory director's designee will review the laboratory records monthly for the following factors: Patient Test Management, Quality Control, Proficiency testing, Maintenance, Inventory, Communication, Complaints. 2. On the day of survey, 09/18/2024, the laboratory failed to provide documentation for 24 out of 24 monthly reviews by the Laboratory Director or designee for maintenance performed from 12/15/2022 to 9/18/2024 for the following: --- H & E Stain Quality Management Log -- IHC &Special Stain Quality Control Log -- Solution Change and Rotation for Automatic Stainer Log -- Solution Change and Rotation for Tissue Processor Log 3. Further review of temperature logs revealed that the laboratory failed to provide documentation for 24 of 24 monthly reviews by the Laboratory Director or designee for maintenance performed from 12/15/2022 to 9/18 /2024 for the following: --Room Temperature -- Tissue Processor -- Embedder -- Oven -- Refrigerators -- Humidity 4. TP #4 and TP #5 (CMS-209) confirmed above findings on 09/18/2024 at 1:38 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with testing personnel #5 (TP), the laboratory failed to document positive and negative reactivity every day of patient testing for the immunohistochemical (IHC) stains from 11/17/2020 to 12/15 /2022. Findings include: 1. On the day of survey 12/15/2022 at 10:30 a.m., review of stain QC records revealed, that a positive and negative control were not documented for the following immunohistochemical (IHC) stain from 11/17/2020 to 12/15/2022: - CD 3 - CD 5 - CD 10 - CD 20 - CD 23 - CD 34 - CD 138 - BCL-2 - BCL-6 - Cyclin D1 - Kappa - Lambda - Ki 67 - PAN CK - CK34B12 - P63 - CK7 - CK20 - PS04S - P53 - H. Pillory - LCA CD45 2. TP #5 confirmed the findings above on 12/15/2022 around 10:30 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of the laboratory procedure manuals and interview with testing personnel (TP) #5, the laboratory failed to establish a complete competency assessment policy to assess 3 of 4 clinical consultants (CC) and 1 of 2 technical supervisors (TS) for competency in 2018, 2019 and 2020. Findings include: 1. On the Laboratory personnel report (CLIA) Form CMS - 209, Personnel #3 and #4 are listed as a CC and personnel #2 is listed as a CC and TS. 2. On the day of survey, 11/17 /2020, the laboratory could not provide a complete competency assessment policy to assess consultants and supervisors for competency. 3. Personnel #2 performed the directors peer reviews in 2018, 2019 and 2020. 4. The laboratory could not provide competency assessments performed for 3 of 4 CC and 1 of 2 TS in 2018, 2019 and 2020. 5. TP #5 confirmed the findings above on 11/17/2020 around 10:00 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of service stickers on the Fisher brand thermometers and 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 -- interview with testing personnel (TP) # 5, the laboratory failed to perform service maintenance for 2 of 2 Fisher brand refrigerator thermometers and 1 of 1 Fisher scientific hygro room temperature thermometer in 2018 and 2019. Findings include: 1. On the day of survey, 11/17/2020, observation of the laboratory revealed, 2 of 2 Fisher brand refrigerator thermometers were due for maintenance on 06/19/2019. 2. Observation of 1 of 1 Fisher scientific hygro room temperature thermometer revealed, the thermometer did not state a maintenance date and the laboratory could not provide documentation of maintenance checks performed in 2018 and 2019. 3. The laboratory could not provide a maintenance policy for the maintenance of the refrigerator and room temperature thermometers. 4. The refrigerator stored stains and reagents used for the examination of histopathology slides. 5. TP #5 confirmed the findings above on 11/17/2020 around 10:15 am. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Hematoxylin and eosin (H&E) quality control (QC) records and interview with the testing personnel (TP) #5, the laboratory failed to document daily immunohistochemical (IHC) and specials stains QC for histopathology slides examined from 06/26/2018 to the day of survey. Findings include: 1. On the day of survey, 11/17/2020, review of the H&E QC records revealed, daily IHC and specials stains QC were not documented for histopathology slides examined from 06/26/2018 to 11/17/2020. 2. In 2018 - 122 specials stains and 947 IHC stains were used for histopathology slides examinations. 3. In 2019 - 2,569 specials stains and 218 IHC stains were used for histopathology slides examinations. 4. In 2020 (01/01/2020 to 11 /17/2020) - 1,537 specials stains and 188 IHC stains were used for histopathology slides examinations. 5. TP#5 confirmed the findings above on 11/17/2020 around 9:45 am. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manuals and interview with the laboratory director (LD), the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess Laboratories corrective Assessment in 2017 to the date of survey. Findings include: 1. On the day of survey, review of the laboratory's manuals, revealed that the laboratory failed to have a written policy to assess the quality of its laboratory systems in 2017 and 2018 (January 1st, 2018 to June 26th, 2018). 2. The LD confirmed the findings above on 06 /26/2018 around 9:30 am. D5785