Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 08/28/2018 with the laboratory staff. The survey process was discussed. An opportunity for questions and comments was given. Based on the onsite survey conducted on 08/28/2018, this facility was found NOT to be in compliance with the CLIA regulations found at: 42 CFR 493.1250 Analytic Systems 42 CFR 493.1403 Laboratory Director, (moderate complexity) The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. 23-day termination process recommended. The laboratory voluntarily suspended all Thyroid Stimulating Hormone testing as of 08/28/2018. An exit conference was held 08/28/2018 with the laboratory staff. The process for submitting the corrections was explained. An opportunity for questions and comments was provided. The laboratory has voluntarily ceased Thyroid Stimulating Hormone (TSH) testing. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the submitted CMS-209, the laboratory's procedure manual, review of the laboratory's personnel files and staff interview, it was revealed that the laboratory failed to ensure policies and procedures were established and followed to access the competency of 2 of 2 Technical Consultants. Findings included: 1. A review of the submitted CMS-209 revealed the laboratory identified two Technical Consultants. 2. A review of the laboratory's personnel files for 2017 and 2018 competency assessments for Technical Consultant #1 and Technical Consultant #2 revealed the following: a. The competency assessment for Technical Consultant #1 was assessed by Technical Consultant #2. b. The competency assessment for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Technical Consultant #2 was assessed by Technical Consultant #1. 3. A review of the laboratory's procedures revealed the facility do not have a procedure for assessing the competency of the Technical Consultants. 4. During an interview on 08/28/2018 at 11: 10 AM, Technical Consultant #1 confirmed the laboratory did not establish written policies and procedures for competency assessment of Technical Consultants. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2016, review of laboratory procedures and staff interview, it was revealed that the laboratory failed to have documentation of grading proficiency testing results returned by the proficiency testing agency as "not graded." Finding included: 1. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2016 (Event 3) revealed the following results returned to the facility as "not graded" by the proficiency testing agency: TSH CH-13 2. The laboratory procedure titled "Proficiency Testing (PT) Assessment Policy stated, "Any 100% score that is notated with a code should be self-graded and investigated for