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 surveyor review of the Procedure Manual (PM) and interview with Testing Personnel (TP), the laboratory failed to follow the procedure for "Media or Stain Receipt Log" from 7/29/21 to the date of survey. The findings include: 1. The procedure form for "Media or Stain Receipt Log" was not used. 2. The TP #1 confirmed on 8/16/23 at 10:45 am that the laboratory failed to follow the above mentioned procedure. 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 surveyor observation of the Flammable Cabinet and interview with the Testing Personnel (TP), the laboratory failed to appropriately label reagents used for Histopathology testing from 7/29/21 to the date of the survey. The findings include: 1. 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 -- One reagent was observed to only have a preparation date. 2. The reagent did not have an expiration date, identity or other pertinent information required for proper use. 3. The TP #1 as listed on CMS form 209 confirmed on 8/16/23 at 10:30 am that the reagent was not labeled appropriately. -- 2 of 2 --