Bh Services Southeast 1, Pc

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (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. This requirement is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and interview with the lead testing personnel, the laboratory failed to notify the state agency of the change in specialties within 6 months of the change in 2019. The findings include: 1. Observation of the laboratory on January 9, 2020 at 12:30 p.m. revealed the Cell-Dyn 1700 on the counter. The instrument was not being used for patient complete blood count testing. 2. Review of the laboratory maintenance log for May 2019 revealed the instrument was removed from use on May 15, 2019. 3. Interview with the lead testing personnel on January 9, 2020 at 2:30 p.m. confirmed the laboratory stopped patient testing for complete blood count on May 15, 2019 and did not notify the state agency within 6 months of the change. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's proficiency testing records, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), and interview with the lead testing personnel, the laboratory failed to ensure proficiency testing samples were tested by personnel who routinely perform patient testing in 2018 and 2019. The findings include: 1. Review of the laboratory's proficiency testing records revealed attestation statements that were signed by the lead testing personnel for five of five testing events (2018 events two and three, 2019 events one, two and three). 2. Review of the CMS-209 revealed three testing personnel who perform patient testing. 3. Interview with the lead testing personnel on January 9, 2020 at 2:30 p.m. confirmed the laboratory failed to ensure all testing personnel participated in proficiency testing in 2018 and 2019. Only one of three testing personnel performed proficiency testing for the last five testing events. -- 2 of 2 --

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: The laboratory failed to maintain satisfactory participation in two out of three events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 PT records, the laboratory failed to maintain satisfactory performance for the WBC differential analyte, resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory scores: 2018 event two WBC differential = 53% 2018 event three WBC differential = 67% 2) Review of the laboratory's 2018 PT records revealed the following: 2018 event two: Granulocytes % sample numbers HEM-06, HEM-07, HEM-08, HEM-10 scored as unacceptable; Lymphocytes % sample numbers HEM-06, HEM-07, HEM-10 scored as unacceptable, resulting in an overall WBC differential score of 53%. 2018 event three: Granulocytes % sample numbers HEM-11, HEM-13 scored as unacceptable; Lymphocytes % sample numbers HEM-11, HEM-13, HEM-14 scored as unacceptable, resulting in an overall WBC differential score of 67%. -- 2 of 2 --