Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA Initial Certification survey conducted at your facility on March 24, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a random audit of patient biopsy records from 2/14/2020 to 2/12/2021, and an interview with testing personnel #6 on the Centers for Medicare and Medicaid Services (CMS) 209 form, the laboratory failed to ensure that the quality of the stain reactivity was documented for the patient biopsy test performed. Findings include: A random audit of one of one patient biopsy test records from 2/14/2020 to 2/12/2021 revealed that on 8/13/2020 there was no documentation of the quality control of the stain reactivity for the biopsy performed. This finding was confirmed during an interview with testing personnel #6 on the CMS 209 form conducted on 3/24/21 at approximately 3:15 pm. The laboratory performs approximately 200 histopathology tests annually. D5805 TEST REPORT 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 -- 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 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 on a random audit of patient final test reports from 2/14/2020 to 2/12/2021, and an interview with testing personnel #6 on the CMS 209 form, the laboratory failed to ensure that the location of the laboratory in which the Mohs and biopsy slide reading was performed was specified on the final test report. Findings include: 1. A random audit of patient final test reports from 2/14/2020 to 2/12/2021 revealed that name and address of the laboratory where the Mohs test was performed was incorrect on one of ten reports reviewed. The final report indicated that the Mohs was completed at another laboratory location owned by the company. 2. A random audit of patient final test reports from 2/14/2020 to 2/12/2021 revealed that the location where the Biopsy slide reading was performed was not specific. The report identified two laboratories owned by the company and did not identify which of the two laboratories was the correct laboratory where the testing was performed. Th findings were confirmed during an interview with testing personnel #6 on the CMS 209 form conducted on 3/24 /21 at approximately 3:00 pm. The laboratory performs approximately 200 histopathology tests annually. -- 2 of 2 --