- http://www.darkreport.com/dark/The-Dark-Report-8-6-2012.pdf
- http://www.darkdaily.com/clia-officials-propose-major-sanctions-against-prominent-academic-center-clinical-laboratory-due-to-inadvertent-referral-of-proficiency-test-referrals-813#axzz2H2Cs8lrw
- http://www.darkdaily.com/bill-to-fix-clia-proficiency-testing-language-for-clinical-laboratories-passes-in-the-house-awaits-senate’s-return-in-november-1019#axzz2H2Cs8lrw
- http://www.darkdaily.com/test-act-signed-by-president-obama-provides-regulators-discretion-when-clinical-laboratories-mistakenly-violate-clia-pt-requirements-121
Provide names of other journalists involved.
Joseph Burns, managing editor of The Dark Report, and Robert L. Michel, editor and publisher of The Dark Report
List date(s) this work was published or aired.
Aug. 6, 2012
Provide a brief synopsis of the story or stories, including any significant findings.
The Dark Report published an entire issue of the newsletter on Aug. 6 on efforts by CMS to issue severe sanctions against clinical laboratories for even minor and inadvertent errors in proficiency tests. The case CMS brought against the clinical laboratory at the Ohio State University Wexner Medical Center was the basis for our reporting. We explained that experts believed CMS’ enforcement efforts were severe, particularly given that the OSUWMC lab PT errors were inadvertent, the lab self-reported the errors, and no patients were harmed. Since then, Congress has passed and President Obama has signed the TEST Act to give CMS more latitude when enforcing PT rules, and the president of the American Clinical Laboratory Association has said our reporting on this case was significant in helping members of Congress to understand the issue.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
As the reporter on this story, I had a copy of the letter from CMS to OSUWMC in which CMS threatened severe sanctions against the lab. I requested copies of all correspondence between the clinical lab staff at OSUWMC and the CMS enforcement office in Chicago. CMS refused to provide any information to us except to answer questions through a spokesperson. We have since filed an FOIA request with CMS. We also wanted the response to the charges that OSU sent to CMS and sent several email requests (and made several phone calls) to the media relations staff asking for this response. After several requests, OSU media relations sent me the letter and other documents the clinical lab submitted to CMS in response to the threatened sanctions. The material totaled more than 100 pages, which became the basis for our reporting in this special issue.
Explain types of human sources used.
The types of human sources used included interviews with experts in PT violations, such as a lawyer who has defended clinical labs in similar cases, and a former lab director who is thoroughly familiar with CMS’ rules on PT violations. We also sought to interview sources at CMS but were refused. We have since filed an FOIA request that to date CMS has not fulfilled. We also requested interviews with the clinical lab staff at OSUWMC, but they refused our requests.
Results:
The results of our efforts were seven articles (a complete issue) published on Aug. 6. These articles included our reporting on the CMS charges against the lab and the lab’s response (more than 100 pages of documents). We also reported comments from experts in PT violations who helped our readers to understand how CMS proceeds when threatening sanctions against clinical labs for PT violations and how labs typically respond. This reporting included explanations of the difference between intentional and unintentional (or inadvertent) PT errors and how the Clinical Laboratory Improvement Amendments (the law CMS cites when threatening sanctions for PT violations) is vague and confusing. Our reporting was instrumental in helping members of Congress to understand the issues involved when CMS files sanctions against labs for PT violations and has been cited as a factor that lead to the passage of the TEST Act, which was signed into law in November.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
We have covered the issue of PT violations at other labs and the ongoing efforts of CMS to pursue the sanctions against the clinical lab at OSU. There have been no requests for corrections or challenges regarding our reporting.
Advice to other journalists planning a similar story or project.
We received the material OSU sent to CMS because we pressed for a response from OSU after an initial rejection and because we explained that CMS often alleges that PT violations are intentional (as is the case with OSU) when in fact PT violations are often unintentional and inadvertent and result in part from confusion due to the way the CLIA law is written. We believe our understanding of how unintentional errors are not uncommon caused the OSU media staff to release the lab’s response to us and not to other media outlets. Our advice to other journalists is not to take CMS documents at face value and not to take no for an answer but continue to explain the need to report on PT violations so that other clinical labs and officials at CMS will understand these issues fully.