Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide a written procedure manual that is signed and dated by the Laboratory Director (LD) before patient testing is performed. Findings include: 1. Record review on 03/14/2022 of the antibody validation binder revealed seven antibody (S100, S0X10, M5TF, HPV Low, HPV High, CK 116, Ki67) validations that were not signed and dated by the approval pathologist, 2 (HPV Low, HPV High) of which were already in use for patient testing. 2. Record review on 03/14/2022 of the laboratory procedure manual revealed no written procedure for the newly validated antibodies for the Immunohistochemistry antibody staining. 3. Staff interview on 03/14/2022 at 12:20 PM with the Laboratory Manager confirmed the above findings. 4. The laboratory performs 7,360 IHC tests annually in the specialty of pathology. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review, surveyor observation and staff interview, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- failed to provide an updated written procedure manual that is signed and dated by the Laboratory Director (LD) before use. Findings include: 1. Record review on 03/14 /2022 of the 'H&E Staining Sakura Prisma-G2 Combo' Version 002 procedure with a publish date of October 2020 revealed the approval date of the procedure manual by the LD to be 02/16/2021. 2. Surveyor observation on 03/14/2022 of the H&E staining Sakura Prisma-G2 combo instrument revealed the laboratory staining program, however it was not documented in the procedure manual. 3. Staff interview on 03/14 /2022 at 12:30 PM with the Laboratory Manager confirmed that the laboratory updated the procedure manual to include the staining program, but never had the LD sign and date the updated procedure manual. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow manufacturer's recommended temperature storage criteria in the specialty of pathology for the period of January 2020 through December 2020. Findings include: 1. Record review on 03/14/2022 of the 'Refrigerator Temperature Maintenance Log' for the period of January 2020 through December 2020 revealed the following: a. Acceptable temperature range for refrigerator 5850 in 2020 was 3 to 10 Degrees Celsius. b. Based on the package insert of the reagents stored in that refrigerator, the recommended storage temperature is between 2 to 8 degrees Celsius. c.