Summary:
Summary Statement of Deficiencies D0000 06/11/2018 - 06/12/2018 Based on an unannounced revisit survey conducted on June 11, 2018 and June 12, 2018, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493. Specifically, the following Conditions we're not met: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; The laboratory resumed patient testing in February 2018. ****************************** 11/28/2017 Based on an unannounced revisit survey conducted on November 28, 2017, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493. Specifically, the following Conditions we're not met: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; The current laboratory director is also the technical consultant and had not been on-site 2 days per week until compliance was met as required by the CMS Regional Office Directed