Summary:
Summary Statement of Deficiencies D0000 An unannounced revisit was performed on 8/9/18. The laboratory was found out of compliance with the CLIA Immediate jeopardy findings were abated. The laboratory voluntarily suspended testing on November 18, 201 in a letter from the laboratory director. No plans of corrections from the TX00248689 complaint investigation The laboratory was found to be closed. No instrumentation or laboratory supplies were available for patient te interview with the director of operations on 8/9/18 at 1100 hours in the laboratory confirmed that no patient t since 11/18/16. The conditions not corrected were: D5300 - 42 C.F.R. 493.1240 Condition: PreAnalytic Syst F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; m complexity D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant D6063 - 42 C.F.R. 493.1421 Con Laboratories performing moderate complexity testing; testing personnel; D6076 - 42 C.F.R. 493.1441 Condi Director; high complexity D6108 - 42 C.F.R. 493.1447 Condition: Technical Supervisor D6168 - 42 C.F.R. Condition: Laboratories performing high complexity testing; testing personnel; Noted deficiencies and plans discussed with the laboratory representative at the exit conference. The facility representative was given an o provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey e ________________________________________________________________________________________ 25846 Complaint investigation TX00248689. The laboratory was found out of compliance with the CLIA reg Immediate jeopardy findings were identified. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Con PreAnalytic Systems D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.140 Laboratory Director; moderate complexity D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant D6 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D6076 - 42 C. Condition: Laboratory Director; high complexity D6108 - 42 C.F.R. 493.1447 Condition: Technical Supervi R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; Noted deficienc correction were discussed with the laboratory representative at the exit conference. The facility representative opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided pr The laboratory voluntarily suspended testing on November 18, 2016 as documented in a letter from the labor Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain for entering the