CEO SUMMARY: In the case of the Ohio State University Wexner Medical Center (OSUWMC) clinical lab, one attorney with long experience in CLIA regulatory matters says that the facts do not support the severe sanctions that CLIA officials may impose on a healthcare organization that is widely-respected nationally. While the lab did commit errors in its handling of PT specimens, the errors were inadvertent; it self-reported the errors; then instituted systemic changes to prevent recurrence of the same errors.
WOULD A REASONABLE PERSON agree that the Centers for Medicare & Medicaid Services (CMS) should impose Draconian sanctions for an inadvertent violation of the proficiency testing (PT) rules? This is the question being asked by one attorney with long experience in clinical laboratory legal issues.
It is the Ohio State University Wexner Medical Center (OSUWMC) laboratory, located in Columbus, Ohio, that faces the Draconian sanctions. The attorney raising this question is Jack R. Bierig, a partner with the law firm Sidley Austin LLP in Chicago, Illinois.
Bierig has worked on several cases involving PT violations under the Clinical Laboratory Improvement Amendments (CLIA). Given the facts as explained in the appeal letter sent to CLIA officials from OSUWMC Clinical Lab Director Amy Gewirtz, M.D., Bierig said that imposition of serious sanctions would be contrary to the intent of Congress.
“There is no way that a reasonable person could conclude that CMS should revoke the lab’s license or cite the laboratory director [Gewirtz] for failing to supervise the lab properly,” declared Bierig, who is not associated with this lab in any way. He saw the letter CMS sent to OSUWMC and the letter of appeal that the lab sent to CMS. “Assuming that the facts are as stated in that letter, the whole case is a travesty,” he commented.
‘A Very Minor Glitch’
“It would be very unfair to impose sanctions on the OSUWMC lab, given four important facts,” he said. “First, the laboratory runs 9,200 PT samples per year— nearly all without incident. Second, there was a very minor glitch with one PT specimen that hurt no one.
“Third, OSUWMC self-reported that PT issue to CMS,” continued Bierig. “Fourth, on its own initiative, OSUWMC’s lab then implemented a number of changes in its procedures to correct those problems promptly. “Even a cursory review of the facts shows that it wouldn’t be fair to impose these severe penalties against the OSUWMC lab. That would not be what Congress intended when it wrote the language of CLIA,” noted Bierig.
“The error was inadvertent, the lab self-reported the error, and the lab imposed systemic changes to prevent a recurrence,” he added. “Given these facts, it is ridiculous to impose sanctions against the OSUWMC lab and pull its CLIA license. The cure would be far worse than the disease. I hope that CMS reads the letter from Dr. Gewirtz and realizes how wrong that would be.
“Looking at the facts of this case, there are five specific issues that obviate the need to impose sanctions,” said Bierig. “First, the lab tried to do the right thing when it received the PT specimen but made a mistake that was completely inadvertent.
“Second, upon learning that it made the mistake, it did the responsible thing by self-reporting the error to CMS,” he stated. “That factor alone should count for something. Once the lab learned about the referral of the specimen to another lab, the letter shows that the lab acted completely responsibly.
“If CMS wants to encourage self- reporting, it shouldn’t throw the book at a lab that acts responsibly,” added Bierig. “Here’s a question for CMS: If a lab that self-reports an inadvertent PT referral gets severe sanctions in a case like this, why would any lab self-report?” he asked. “If you self-report and still get sanctions, CMS is removing the incentive for self-reporting.
“Third, after it determined that it had violated the PT specimen-handling procedures, the lab implemented appropriate systemic changes so that the same problem would not recur,” he added. “Dr. Gewirtz explains those changes in her letter to CLIA officials. Sure, the lab made a mistake, but, again, it did the right thing in response.
“Fourth, you have the patient care issue. If CMS shuts down this lab, it would have a significantly adverse impact on patient care,” emphasized Bierig. “Moreover, if they bar Dr. Gewirtz from directing a lab for two years, they punish an individual who has acted entirely responsibly and they deprive clinicians and patients of her expertise in directing a laboratory.”
Language Of The Statute
Bierig’s comments are rooted in common sense. “What should happen is that CMS should tell the lab, ‘Make sure this doesn’t happen again,’ and that should be the end of this matter,” he said. “I believe that CMS has this discretion. But if you ask CMS, the agency is likely to say they do not. If CMS were to take this position, it would be incorrect both as a matter of the language of the statute and its purpose.
“Were you to ask members of Congress about this PT issue, I believe they would all agree that deliberate efforts to subvert the PT process need to be addressed with severe sanctions,” noted Bierig. “But treating PT specimens as you would treat patient specimens is not a lab action that Congress intended to punish severely.
“Since the early 1990s, I have seen cases like this, and I called for changes in CMS enforcement positions back then,” Bierig offered. “I have been through a number of these PT cases. In most of them, the facts are strongly in favor of the lab and its director. Sometimes justice prevails and sometimes it doesn’t. It may depend on the region of CMS in which the issue arises. That’s why Congress needs to look into the issue unless CMS clearly indicates that it will not impose serious sanctions in a case involving inadvertent referrals which are promptly corrected.
“The regulations in this area are quite confusing,” noted Bierig. “Specifically, 42 C.F.R. section 493.801(b) provides that ‘(t)he laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens.’ At the same time, section 493.801(b)(4) recites that ‘(t)he laboratory must not send PT samples or portions of samples to any laboratory for analysis which it is certified to perform in its own laboratory.’ What is a lab to do that normally refers out a specific sort of specimen? By complying with the first provision, the lab violates the second.
“As far as I can tell, OSUWMC treated the PT sample in the same way that it treats patient samples, which was send it out,” he added. “That’s what they usually do. Should such conduct lead to harsh sanctions? I don’t think so, and I don’t believe Congress thinks so either.
“Next, Section 493.801(b)(4) provides that ‘(a)ny laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certification revoked for at least one year’,” noted Bierig. “In my view, the use of the word ‘intentionally’ bespeaks a congressional intent that, before certification is revoked, CMS must determine that the laboratory in question deliberately intended to subvert the PT process. I don’t see how, on the facts of this case, CMS could fairly come to such a conclusion.
“If I were representing OSUWMC and had any sort of serious sanction imposed by CMS against the laboratory or its director after final administrative action, I’d be in court the next day for a preliminary injunction to prevent CMS from implementing such sanction,” stated Bierig. “Based on the evidence, OSUWMC has a very strong case. Let’s hope that Congress becomes aware of this case and takes steps to do justice.”
Facts in OSUWMC Lab Case Create Opportunity For Congress to Change the Existing PT Law
IT MAY BE THAT AN UNUSUAL OPPORTUNITY EXISTS in the proficiency testing (PT) case of the Ohio State University Wexner Medical Center (OSUWMC) clinical lab, said Jack R. Bierig, a lawyer familiar with this matter.
“Given that OSU is a state institution, one would hope that members of Congress from Ohio would take an interest,” said Bierig. “These members should spearhead an effort by Congress to make it clear to CMS that severe sanctions should not be imposed for inadvertent PT referrals that are promptly corrected.”
In June, officials in the PT enforcement office in Chicago for the Centers for Medicare & Medicaid Services (CMS) sent a letter to the lab. In the letter, the CMS officials explained the alleged PT violations under the Clinical Laboratory Improvement Amendments (CLIA) and declared their intent to revoke the lab’s CLIA license, pending appeal.
“From the facts presented in the letters I’ve seen from CMS to the lab and from the lab to CMS, it looks like this situation is a major injustice under the CLIA rules,” he said. “The severity of the sanctions is contrary to what Congress intended when it passed CLIA.
“The PT referral provisions of the 1988 CLIA law are ripe for review,” noted Bierig. “CMS enforcement policy in this area needs to be consistent with what Congress intended when it drafted and passed the law in 1988. And, the fact that this case involves OSU’s Wexner Medical Center should have some influence because it’s a prestigious medical center in Columbus, Ohio, that serves hundreds of thousands of Ohio residents every year.
“If I were OSU, I would march into the office of my U.S. senator and my U.S. representative and say, ‘You need to change this law,’” he said. “No one is in favor of subverting the PT process. Everyone is opposed to that. But the way the law is currently written has caused enormous problems and costs.
“It has diverted money that these labs and hospital systems should be spending on patient care and causing all these legal and administrative fees for things that Congress never intended to be violations,” observed Bierig. “Over the years, CMS has taken an extremely harsh approach toward the application of the law in this area.
“Therefore, I believe the law needs to be changed,” he concluded. “CMS needs to under- stand that it should not be imposing serious sanctions in cases like this where there was no intent to subvert the PT process.”