Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, and review of 2021, 2022, and 2023 temperature logs 12/6/23, the laboratory failed to define an acceptable range for refrigerator temperature that was consistent with manufacturer's instructions. Findings: During a tour of the laboratory at approximately 10:25 a.m., the surveyor observed the following items in the laboratory refrigerator, available for use: a. 1 open bottle of Renoir Red diluent b. 1 open bottle and 1 unopened bottle of Mach 4 HRP polymer c. 1 open bottle of Mach 4 Mouse Probe d. 1 open bottle of Background Punisher Review of manufacturer's instructions revealed the reagents stored in the refrigerator require storage at 2-8 degrees Celsius. For example, manufacturer's instructions for the Renoir Red diluent state "... Storage and Stability Store at 2C to 8C. The product is stable to the expiration date printed on the vial label, when stored under these conditions. ... Storage under any condition other than those specified must be verified. ..." Review of 2021, 2022, and 2023 temperature logs revealed an acceptable refrigerator temperature range of 0 degrees Celsius to 8 degrees Celsius which was not consistent with manufacturer's instructions. D5475 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of manufacturer's instructions, and interview with TP (testing personnel) 12/6/23, the laboratory failed to check the IHC (immunohistochemical) Helicobacter pylori stains for negative reactivity each time of use. The laboratory's "Immunohistochemistry Policy" states "... Controls All cases are run with a tested known positive control to determine the accuracy of the IHC staining results. ... The IHC performed ... uses biotin-free, polymer base, multimer detection systems. The CAP Anatomic Pathology checklist item, ANP.22570 includes the following statement: 'Immunohistochemical tests using polymer-based detection systems (biotin-free) are sufficiently free of background reactivity to obviate the need for a negative reagent control and such controls may be omitted at the discretion of the laboratory director.' The laboratory director and manager have approved the elimination of IHC negative reagent controls. ..." Review of manufacturer's instructions for the reagents used in the Helicobacter pylori stain revealed requirements for quality control. For example, the Renoir Red Diluent product insert states "... Quality Control: ... Positive Tissue Control: ... One positive external tissue control for each set of test conditions should be included in each staining run. The tissues used for the external positive control materials should be selected from patient specimens with well-characterized low levels of the positive target activity that gives weak positive staining. ... Negative Tissue Control: Use a negative tissue control fixed, processed, and embedded in a manner identical to the patient sample(s) with each staining run to verify the specificity of the IHC primary antibody for demonstration of the target antigen, and to provide an indication of specific background staining (false positive staining). Also, the variety of different cell types present in most tissue sections can be used by the laboratorian as internal negative control sites to verify the IHC ' s performance specifications. ... Nonspecific Negative Reagent Control: Use a nonspecific negative reagent control in place of the primary antibody with a section of each patient specimen to evaluate nonspecific staining and allow better interpretation of specific staining at the antigen site. ..." During interview at approximately 12:30 p.m., TP #1 and the laboratory director confirmed that they do not run a negative control with the IHC Helicobacter pylori stain. D5785