Failure to Maintain Written Agreement for Laboratory Services
Penalty
Summary
The facility failed to maintain and provide a written agreement with a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory to ensure timely availability of required laboratory services when such services are not provided on-site. During document and policy review, surveyors were unable to identify any written agreement or contract verifying arrangements for laboratory services. In an interview, the Administrator reported being unable to locate the requested laboratory services contract at the time of survey, explaining that binders containing important documents had been relocated following a recent facility-wide evacuation. The facility ultimately could not produce documentation verifying how laboratory services are formally arranged and maintained in compliance with regulatory requirements. No specific residents, medical histories, or clinical conditions were described in the report in relation to this deficiency.
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