Paul F Rockley Md

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/10/2022 found the PAUL F ROCKLEY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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, record review and staff interview, the laboratory failed to document the making of the 95 percentage (%) alcohol solution used on the SAKURA TISSUE TEK Vacuum Infiltration Processor (VIP) from 09/01/2020 to 05/10/2022. Findings include: -Examination of the SAKURA TISSUE TEK VIP on 05/10/2022 at 01:45 PM, showed the processor had the following reagents: Alcohol 100 %, Alcohol 95 %, Formalin 10%, Pro-Par Clearant and Paraffin. -Review of the reagent log from 09/01/2020 to 05/10/2022 revealed that the laboratory used alcohol 100 % during the period of reference. - Review of the procedure manual policy "Alcohol Dilutions Procedure for Tissue Processor" revealed the following: "The histology technician will maintain a log documenting the production of a new mixture set. This log will state the date the mixture was made, the percentage of the dilution, the expiration date of the alcohol 100 % used and the lot number of the 100 % alcohol." -The laboratory had no documentation for the preparation of the 95 % alcohol solution from 09/01 /2020 to 05/10/2022. During an interview on 05/10/2022 at 2:00 PM, the laboratory consultant confirmed that the laboratory failed to keep record of the 95 % alcohol preparation used on the SAKURA TISSUE TEK VIP for the period of reference. 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 D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the open dates for reagents used in their Hematoxylin & Eosin (H & E) stains. Findings include: Record review of the laboratory's logs titled "Reagent Log", "Tissue Processor Maintenance Log" and "Hematoxylin and Eosin Staining Maintenance Log" showed that the laboratory failed to record when the reagents where opened from 6/14 /16 to 6/14/18. During an interview on 6/14/18 at 3:08 PM, Testing Personnel B stated she didn't know they needed to record the open date for their reagents. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment (QA) plan failed to monitor, access and correct problems identified to ensure the accuracy of patient reports. Findings include: Review of the laboratory's monthly QA checklist documentation showed that the laboratory did not do any random monthly review of patient requisitions to the final surgical reports to ensure accuracy from 6/14/16 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 -- through 6/14/18. During an interview on 6/14/18 at 4:12 PM, Testing Personnel B stated they did not do monthly random checks of patient requisitions to the final surgical reports to ensure accuracy. -- 2 of 2 --