Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Histology Technician, the laboratory failed to dispose of the Histo-Clear, Eosin Y Stain Solution, 1% w/v in Alcohol, Hematoxylin Stain Solution, Gill, 95% Reagent Alcohol and 100% Reagent Alcohol according to manufacturer's instructions for 2 out of 2 years (2016-2018). Findings included: Observation on 03/02/18 at 10:05 a.m. of the reagents in the flammable cabinet revealed instructions were found on the label that stated "Dispose of contents /containers in an approved waste disposal plant." for Histo - Clear (Lot# 05-17-04), Eosin Y Stain Solution, 1% w/v in Alcohol ( Lot# 1711013, expiration date 04/24/19), Hematoxylin Stain Solution Gill III ( Lot# 1713704, expiration date 05/18/19 ), 95% Reagent alcohol ( Lot# 1712806, expiration date 11/07/19 ), and the 100% Reagent Alcohol ( Lot# 1717114, expiration date 12/27/19).The label on the Histo-Clear also stated "Avoid release to environment". An interview on 03/02/18 at 10:20 a.m. with the Histology Technician confirmed that the laboratory was not following manufacturer's instructions for disposing of the Histo-Clear, Eosin Y Stain Solution, and 1% w/v in Alcohol. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where 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 -- the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based upon record review of patient reports and interview with the Laboratory Supervisor, the laboratory's patient test report failed to have the complete address of the testing laboratory for two out of two reports for the time period of 08/31/17 to 03 /02/18. Findings included: Review of two patient test reports dated 01/26/18 revealed the location of the testing laboratory was not a complete address. During the interview on 03/02/18 at 11:00 am, the Laboratory Supervisor confirmed the patient test report did not have the complete address. -- 2 of 2 --