Tools, Technologies and Training for Healthcare Laboratories

Blowing the Whistle

In the aftermath of the 2004-2005 Maryland General Scandal, the hospital laboratory in question was back in compliance. Regulations were changed. Standards were toughened. But is everything well now in the laboratory?

Blowing the Whistle on the Tip of the Iceberg

January 2005
with Sten Westgard

Mixed metaphors suggest some rather funny situations. You can picture someone in trouble standing on tippy-toe on the top of an iceberg, whistling for help. An unlikely situation, yet one that might indeed represent the state of the laboratory today. Some other people might prefer the metaphor “blowing the whistle on a few bad apples,” which seems to be the public perspective put forth by government agencies, accreditation organizations, and professional associations. In private, if you can get them off the record, they’re actually quite concerned and rightfully so.

All’s Well that Ends Well?

The Maryland General Hospital laboratory is back in compliance with all regulations and requirements, according to an August 20th, 2004 letter sent to the hospital by the Centers for Medicare & Medicaid Services (CMS).[1]

Part of the solution to the laboratory problems involved Park City Solutions, a laboratory consulting firm. This company was retained to run the laboratory and hire more lab workers.

In the wake of the scandal, nearly every agency, organization and body involved with laboratory regulation has proposed or promised reforms to help insure there will be no repeat of Maryland General:

  • Congressman Elijah E. Cummings of Baltimore is seeking an investigation by the Government Accountability Office (GAO) into the effectiveness of the inspections by “deemed providers” such as CAP and JCAHO. Cummings has also introduced legislation (HR 5311, the Clinical Laboratory Compliance Improvement Act) that would require unannounced inspections for all Medicare labs and would grant whistle-blower protections to lab personnel.
  • JCAHO has begun a switch from focusing on paper documentation to interviews with lab workers. They will also conduct only unannounced inspections starting in 2006. [2]
  • CAP has established a toll-free complaint number for possible whistle-blowers, requires all accredited labs to post this number, and has “put laboratories on notice” that any action taken against whistle-blowers will have severe consequences. It also is “diligently working to internally to improve its accreditation process and externally to strengthen communication among federal and state authorities and private-sector organizations.”[3]
  • Maryland State Senator Paula C. Hollinger has proposed state-level legislation that would strengthen medical laboratory oversight and give whistle-blower protections.

So the hearings have been held, the reforms have been proposed, the committees have met, and the promises have been made, and the stories have now been written by the major industry press[4]. So we can all breathe easier, right?

What’s the Matter with Maryland?

As it happens, we’re finding more problems, not less. Even as the case on MGH was closed, problems with other labs were being discovered:

On June 30th, 2004, the state of Maryland suspended the license of Reference Pathology Services in Rosedale, Maryland after finding so many violations of regulations that, in the words of a federal official, the lab posed “an immediate jeopardy to the health of its patients and that of the general public.” The violations began in October 2002 and continued until at least April 2004 and included:

  • In approximately 6,000 cases, the lab reused filters in cervical cancer test kits, when those filters should have been thrown out.
  • The lab did not conduct required controlled testing on equipment and materials to certify that they worked properly.
  • The lab did not report sexually transmitted disease cases to local health departments, nor report cervical cancer cases to a state registry. [5]

Inspectors had visited the lab in May and June 2004 after a whistle-blower alerted the state authorities and CAP. CAP withdrew its accreditation from the lab in May 2004.

[As with the Maryland General case, CAP had inspected and accredited the lab (in January 2003) during the time when violations were occurring.] Over 3,000 patients were offered retesting for sexually transmitted diseases. The lab was finally shut down on September 5th, 2004 and put up for sale.

But that wasn’t the end of it, either.

Two more Baltimore Hospital labs – Good Samaritan Hospital and Union Memorial Hospital - were inspected in September 2004 and found to have numerous violations. CMS determined on November 15th that the violations were serious enough to put them at risk for losing Medicare funding. In some cases, the labs had not even followed up on problems that they knew existed.

The Good Samaritan Hospital lab and Union Memorial Hospital lab, both part of the same system of hospitals, were cited for various problems: failure to follow up on specimen-labeling problems; not completing competency checks of employees; not reviewing the records of transfusion reactions in a timely manner; not having a system to document and remedy problems reported to the lab, not documenting continuing education for their pathologists and cytotechnologists, not providing proper documentation of quality control tests, and had flawed electronic systems for assessing lab quality and reporting problems.

On September 16th, both CAP and Maryland state officials inspected Union Memorial, with state officials returning later for further inspection. CAP had inspected Good Samaritan in June 2004, while the state inspection took place on September 20th. [6]

[It should be noted that the problems at Good Samaritan and Union Memorial are not even remotely on the same scale as those of Maryland General or Reference Pathology Services. Both hospitals acted quickly to bring their labs back into compliance. As of 2005, both labs are back in the good graces of CMS and the state of Maryland. We have received some anonymous communication that some of the violations cited may in fact have been "false positives," that is, inspectors finding flaws where there were none. However, the hospitals in question appear to have adopted a code of silence, so the truth may never be known.]

After this string of laboratory problems, the Baltimore Sun weighed in, with an editorial titled, “Iceberg revealed”. They stated, “there is a clear need for tightened government standards…What was particularly alarming is that the state inspectors discovered these errors after they were missed by the private inspection agency [CAP] that had accredited both hospitals. That’s also what happened in the case of faulty test results sent out by Maryland General.”[7]

So is there something in the water in Maryland? Of course not. What’s happening in Maryland is that after the first scandal, the state inspectors have taken a closer look at other CAP-accredited labs. And the publicity from Maryland General may have inspired other whistle-blowers to come forward. As scrutiny increases, more problems are being detected.

What’s the matter with the accrediting organizations?

Having racked up a record of 0 for 4 in these incidents, one might be tempted to blame CAP for the problems. But is it fair to blame accrediting organizations, such as CAP and JCAHO, that are forced to comply with the government regulations in order to gain approval as a “deemed provider”? They are attempting to do a job that has been defined by a government committee, whose real interests and conflicts of interests are largely unknown. That’s hard work. And just because it’s hard doesn’t mean the work has been done well. In the world of quality, reliance on inspection to assure quality is known to be unreliable!

Dr. Ronald Lepoff, MD, FACP, the Chair of CAP’s Commission on Laboratory Accreditation has said, “Even in retrospect, I’m not completely sure myself what happened [at Maryland General Hospital], and I’ve read all the reports that the federal government and the state issued after they investigated, and all of our own reports.” [8]

Regarding the Reference Pathology case, Dr. Lepoff noted that the sheer volume of records in any medical office made it impossible to turn up “every possible deficiency….’You can’t look at every record, and if they tried, the inspections would’ve taken months…It’s just not practical.’”[9]

Elissa Passiment, executive director of the ASCLS, told a similar story to the Baltimore Sun. She said that CAP’s standards are high, but “there is no way to ensure that inspectors in every case spend as much time as necessary and are strict enough in their reviews of a lab’s internal controls and recordkeeping.” [10]

Dr. Lepoff has further stated, “There is no quality system alive that will ensure people won’t act with malice or dishonestly”[11]

Dr. Mary Kass, MD, FCAP, president of CAP, stated in her congressional testimony “we have concluded that neither our inspection process nor any other would have detected these problems without the benefit of the whistleblower complaint information.”[12]

In testimony before the Maryland State Senate, Dr. Kass has also noted that “CMS recognizes the inherent variability of inspections and permits a disparity rate of up to 20 percent before questioning the deemed status of any accrediting organization. In the past five years, the percentage of variability between CAP inspection results and federal validation surveys has ranged from a low of 1 percent to a high of 9 percent. The College’s most recent disparity rate was 7 percent, in 2003. It is not unusual for federal and state validation surveys to yield results that vary from those of the original inspection.”[13]

The Government Accountability Office recently noted similar problems with JCAHO inspections. GAO found that, in a sample of hospital accreditations from 2000 to 2002, JCAHO often missed problems that state validation surveys found. Specifically, JCAHO missed 78% of the hospitals in the sample that had deficiencies in Medicare requirements. And of that same sample, JCAHO did not identify 69% of the deficiencies that state agencies found. [14]

So, in the words of the inspectors, and as the facts themselves prove, inspections really can’t be expected to find all the problems that inspections should find, whether or not they are surprise or announced. As we have noted in an earlier essay, inspections are always inherently inadequate and belated.

What’s the matter with the proposed remedies?

Of all the reforms and proposed rule changes, there are few that can actually address the real problem. The economic pressures and incentives today still put cost reduction ahead of quality control. The proposed remedies actually do nothing to improve production processes, which is the real basis for improving quality. They only address improvements for the inspection process, which wouldn’t even be necessary if the production processes were okay! Unfortunately, you can’t inspect quality into a process. You can put the fear of God into people, but fear usually doesn’t work to improve quality either; it only leads to further cover-ups.

Unannounced inspections may catch a few laboratories off guard, but these are only slightly more likely to uncover deficiencies. In any laboratory where workers are intimidated by management, whether or not an inspection is a surprise is of little relevance. Maryland General workers were intimidated into silenced by their boss not only during inspections, but every day.

Improved communication between state, federal, and private agencies will undoubtedly help. Frankly, it’s shocking that these groups haven’t been talking to one another all along. This is akin to the 2004 JCAHO goal to stop operating on the wrong limbs of patients - it's basic stuff that we should have been doing in the first place. But again, if the lab workers are silenced and the records are faked, it won’t matter that all the agencies are communicating effectively. They’ll just all be looking at the same lies.

Whistle-blower protections hold out more hope. The whistle-blowers in Maryland are the ones who helped uncover the worst labs. But remember that laboratory workers are already overworked and underpaid. Even under the horrible conditions at Maryland General, only a handful stepped forward and spoke out – and ultimately only two of them testified. It’s rather cruel to expect workers to do the heavy lifting for quality in addition to everything else. It’s as if we are no longer holding the managers, the CEOs, the regulators, or the inspectors responsible for doing their job – we’re asking the lab worker to do all that work for us.

Your New Year’s Resolution – Speak up for Quality!

There are many of you who know of the problems in labs across the country or in your own particular lab. It’s time to step forward and speak out! Silence does not speak well for the laboratory profession. Remember what Rumsfeld said, “the absence of evidence is not the same as evidence of absence.” Silence does not mean everything is fine, but it may be misinterpreted that way by supervisors, managers, directors, inspectors, and agency officials.

We need to start talking about quality in a serious way if we are to have any hope of assuring the quality of laboratory testing for patients, ourselves, and our families.


  1. “Maryland General Hospital in Compliance” September 28th, 2004.
  2. Julie Bell, “Reforms sought in U.S. Lab oversight” September 6th, 2004, Baltimore Sun.
  3. "CAP Emphasizes Communication, Whistleblower Protections at Maryland Hearing", CAP Statline November 12, 2004, Volume 20, Number 22.
  4. “Learning from Maryland General’s Mistakes” Clinical Lab Strategies, July 2004. “When a ‘good’ lab goes ‘bad’: Where do we go from here?”, MLO December 2004.
  5. Julie Bell, “Testing violations shut down health lab” Baltimore Sun, August 27th, 2004.
  6. Julie Bell, “Hospital labs critized for flaws, errors” Baltimore Sun, December 9th, 2004.
  7. “Iceberg revealed”, Baltimore Sun, December 10th, 2004.
  8. “Learning from Maryland General’s Mistakes” Clinical Lab Strategies, July 2004.
  9. Julie Bell, “Testing violations shut down health lab” Baltimore Sun, August 27th, 2004.
  10. Julie Bell, “Stricter oversight of labs sought”, Baltimore Sun, August 28th, 2004
  11. Julie Bell, “Reforms sought in U.S. Lab oversight” September 6th, 2004, Baltimore Sun.
  12. Kass Congressional testimony, July 7th, 2004.
  13. Kass Maryland Senate testimony, November 9th, 2004.
  14. Government Accountability Office Report GAO-04-850, July 2004.