The CMS has fined the Cleveland Clinic's Marymount Hospital in Garfield Heights, Ohio, more than $600,000 for six serious violations in its blood laboratories.
The hospital has less than a month to fix the problems or risk having its right to perform laboratory testing withdrawn, the federal agency said in an e-mail.
In a more than 330-page report issued to the hospital this spring, federal surveyors found that the lab was out of compliance with policies and procedures related to documentation and personnel training and for hematology and immunohematology testing.
Marymount was also cited for not conducting proficiency testing. Federal regulations require the testing of unknown samples sent to the lab by a CMS-approved program. This helps the agency to evaluate how accurately the facility performs its tests.
The oversights posed a risk to the accuracy and reliability of patient test results, thus elevating the violation to “immediate jeopardy,” the CMS' most serious complaint, which can result in a healthcare facility losing its government funding.
On June 30, the CMS imposed a $10,000 fine per day for non-compliance, but by the end of August, the Marymount lab had addressed only three of the six violations cited in the report. On Sept. 3, the lab was closed, the fine dropped to $2,500 and the lab's “immediate jeopardy” status was removed, but the hospital remains in noncompliance.
The CMS regulates all U.S. lab testing performed on patients through regulations called the Clinical Laboratory Improvement Amendments (CLIA). That program aims to ensure quality at approximately 251,000 labs nationwide.
All facilities that perform even one test on bodily fluids derived from patients for diagnosis, prevention or treatment purposes require a CLIA certificate. Facilities that run tests for forensic purposes are exempt.
If Marymount Hospital is not back in compliance with the CLIA conditions by Oct. 5, “its certificate may be revoked,” the CMS said.