Chattanooga Diagnostic Associates Llc

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance (Rev.140, Issued: 5/29/15, Effective: 5/29/15, Implementation: 5/29/15) (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. Based on review of testing menu during on-site survey 7/31/18 and interview with Practice Manager, determined the laboratory had failed to notify HHS within 6 months of deletion of 5 of 7 specialties in November of 2017 as issued under their Certificate of Compliance. The findings include: 1. Review of test menu during on-site survey 7/31/18 disclosed deletion of Mycology, Parasitology, Urinalysis, Endocrinology and Hematology testing as of November 2017. 2. The laboratory failed to notify HHS within a 6 month period upon deletion of 5 specialties in November of 2017. 3. Interview at approximately 4:30 p.m. July 31, 2018 with the Practice Manager confirmed the laboratory had failed to notify HHS of deletion of 5 of 7 specialties in November of 2017 as issued under their Certificate of Compliance. ========================================= D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: =================================== Based on review of 2017 and 2018 Proficiency Testing (PT) attestation sheets and interview with the 2 blood gas testing personnel, determined the PT samples were not tested by all 4 of 4 testing personnel and 3 attestation sheets were not signed by director. The findings include: 1. Review of the 2017 and 2018 PT attestation sheets revealed only 1 of 4 testing personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- attested to performing all events of proficiency testing. 2. Review of 2017 and 2018 PT attestation sheets revealed 3 of 8 (AQ-A2018, AQ-B and SO-B 2017) attestation sheets were not signed by director. 2. Interview with the 2 blood gas testing personnel at approximately 4:00 p.m. July 31, 2018 confirmed only 1 of 4 testing personnel had performed PT testing for all events in 2017 and 2018 and 3 of 8 attestation sheets were not signed by director. ===================================== D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: ____________________________________ Based on a desk review of the Centers for Medicare and Medicaid CASPER Report 0155D and the laboratory's 2017 Proficiency Testing (PT) results, determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology for event's one and three of 2017, resulting in the 1st unsuccessful performance for Hematology (Reference D2123). ____________________________________ D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: _____________________________________ Based on desk review of the Centers for Medicare and Medicaid (CMS) CASPER Report 0155D and the laboratory's 2017 Proficiency Testing (PT) program results for Hematology, determined the laboratory failed to participate in testing events one and three of 2017, resulting in the 1st unsuccessful participation for Hematology. The findings include: 1. Desk review of the CMS CASPER Report 0155D showed 0% unsatisfactory performance for testing events one and three of 2017 for Hematology. 2. Laboratory's PT program results for testing events one and three of 2017 for Hematology showed "Failure to Participate" resulting in 0% scores and the 1st unsuccessful participation for Hematology. ______________________________________ -- 2 of 2 --