Masochism, Medicine and Clinical IT: How Physicians Can Be Beaten Over and Over, and Still Come Back For More

At "Health Care Information Technology Vendors' Hold Harmless Clause - The Largest IT Industry Abuse Ever?" I pointed out that physicians and patients have become the unconsented experimental subjects of the IT industry.

Even worse, Tuskegee Study style, the risk is on the docs and patients, while the purveyors of the technology in question enjoy contractual freedom from liability and contractual protection from relevations of product risks and defects (see the remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278).

Could this situation get any worse?

It's worse.

Here is a tale about the companies that medicine will be dependent upon for EHR's and other clinical IT - now by force of government (financial at first, but I would not at all rule out punitive licensure and other measures as a possibility in the future for "EHR noncompliers"):

Chi-Town Daily News
Billing glitch led to mental health closures
Alex Parker / Staff Writer

April 07, 2009

The Chicago Department of Public Health lost more than $1 million in state funding by failing to fix computer problems with its [Cerner-developed] billing system, public records show, sparking a funding crisis and the scheduled closure of four South Side mental health centers today.

City officials have previously blamed the closures in large part on state budget cutbacks.

But a trail of official paperwork, obtained by the Daily News through the Freedom of Information Act, shows that the department’s new computerized billing system was so flawed that patient bills weren’t submitted to the state for six months in 2008.

Where have I seen the name of that company before regarding HIT difficulty? While not about billing per se, I saw the name in the UK House of Commons Public Account Committee's Conclusions and recommendations of The National Programme for IT in the NHS: Progress since 2006 :

The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner] Millennium system provided through BT. There are, however, considerable problems with existing deployments of [Cerner] Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

... The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

The problems with billing modules are not limited to one company. Yale had problems with another HIT billing vendor leading to a Justice Department investigation and a multimillion dollar fine, as did Drexel University with AllScripts and its subcontractor Medicomp, civil complaint in PDF here. I know about the former because I was there, I know about the latter only by circumstance even though I was there, reading about it at the HIT gossip site HisTalk.com from an anonymous commenter. Who knows how many other such situations exist, information flow censored by the aforementioned HIT vendor/purchaser nondisclosure clauses?

The Chicago article continues:

The city's current-year state payments are based on monthly reimbursements for service. When the state received no bills from the city for the last four months of the previous fiscal year, it amended the contract it had with the city to reflect the city's apparent lesser need for funds.

The city's public health chief, Terry Mason, declined to answer questions for this article. Carlo Govia, CDPH’s chief financial officer did not respond to a request to be interviewed. Nor did Cerner Corp., the Kansas City, Mo.-based company that developed the city's software.

The centers, which serve about 2,000 people, are scheduled to close today ... “These people are telling us in here that it don’t matter if we live or die,” says Helen Morley, a patient at the Beverly-Morgan Park facility.

Death by defective IT? It's not as if the problems were discovered suddenly:

The city first notified the Illinois Department of Human Services officials about the plan to switch from a state billing system to the Cerner system on Feb. 11, 2008 -- just over two weeks before the new system would be turned on. Shortly thereafter, the state warned that problems could arise if the city's system was unable to communicate with the state's computers.

“March 1st is right around the corner, and if the software is not programmed to work correctly with Springfield’s system, claims and service reporting will not be accepted,” says a Feb. 22 letter from Peggy Peterson, the chief DHS liaison to the city's public health department.

But the city began using the new system. [typical of asinine bureacratic edict - but could there also have been conflicts of interest, such as those with decision making authoirty being given financial stakes in this system's success? - ed.]

Problems ensued. On April 29, Peterson warned, “I can not stress enough the importance of continued and timely submission to DMH of all FY08 service reporting and billing via whatever software is functional.”

In the same email, she noted that the state began reducing monthly allocations based on billing in January, docking 10 percent of CDPH’s monthly service stipend, and would continue doing so if billing did not reach 100 percent. The city, she said, could risk more than $334,000 if it did not resolve its billing issues

In June, Peterson wrote that the state had received no billing since mid-March, shortly after the city began using the new system. A city official replied that the Department of Public Health and Cerner were working to fix the problems.

On June 9, Peterson again recommended that the city return to billing with the state system. She noted that the state had already docked the city $334,059 since February.

The next day, Mason wrote to DHS officials saying the transition to the Cerner system “to date, has been unsuccessful.” He said the city could not use the state system or manually submit bills because all of the city’s patient information resided in the new computer system.

... In August, the state wrote the city to say that it would withhold payment of $1.2 million that had been budgeted for Chicago mental health services. The funds were placed into a reserve fund, with no assurance the city would ever receive them.

A subsequent state letter advised the city that $99,000 of that cut was due to overall budget shortages affecting all mental health operators. The letter said $1,163,514 was due to the city's failure to submit bills to the state.

On Sept. 16, Peterson wrote a top city official to express “grave” concern about the city's inability to submit billing records since discontinuing its use of the state software in March.

Around the same time, records show that of the 14,261 claims submitted to the state, 95 percent were rejected for missing data.

Mason appealed the decision in late September, acknowledging in a letter to the state that billing had been a problem: "... Service reporting data and billing information has not been submitted for a period of six months."

He chalked the failure to file billing records up to the transition to the new computer system.

Mason's letter also said the state's decision to withhold money would "place the City of Chicago in an unfair position and result in the closure of multiple mental health facilities.”

Also in September, the city began using the state's billing system again. It was eventually able to submit records for about 90 percent of its outstanding bills from fiscal year 2008, but by that time the state had already decided not to allocate the money to the city.

On Oct. 31 the state wrote to say that the city's funding would not be restored.

DHS spokesman Tom Green says the decision to cut funding was based solely on the city's inability to provide billing data.

“The City did not provide adequate billing information to justify continuing to pay them the full amount," he says. "The Division of Mental Health chose not to allocate funding where it was not being spent effectively."

What a stunning and spectacular debacle. This, my friends, is the type of technology hospitals and physicians are now being pressured to adopt en masse by 2014.

Fortunately, in a surprise announcement, Chicago mayor Richard M. Daley said at a press conference that the plan to close four of Chicago’s city-run mental health clinics was put on hold for the moment, pending "investigation." All I can say is "amazing."

Can the dependence by physicians on HIT companies by government edict get any worse than this?

Indeed. It gets worse still:

Medical Economics
The problem with EHRs and coding
Apr 3, 2009
By: Deborah Grider, CPC, Robin Linker, CPC, Susan Thurston, CPC, Stephen Levinson, MD

... most physicians include among their highest priorities the goal of compliant evaluation and management (E/M) coding. Physicians believe they have a right to expect that these sophisticated and costly systems will ensure that they achieve compliant documentation and coding, thereby "making any E/M problems go away."

However, something has gone awry to create an environment that leaves well-intended physicians victimized when government audits reveal their software systems have allowed—even facilitated—submission of non-compliant and potentially fraudulent claims for E/M services. In the midst of increasing storm warnings of non-compliant designs, physicians are increasingly vulnerable to severe financial penalties.

This devastating storm has been developing for many years, often bolstered by an unintended lack of effective policies from several organizations that should have the best interests of physicians, patients, and the healthcare system at their core—organizations such as CMS, the Certification Commission for Healthcare Information Technology (CCHIT), and the U.S. Department of Health and Human Services (HHS), as well as EHR software vendors and physician training institutions (for more information).

With watchdogs like these, who needs enemies? Is this technology designed to help clinicians take care of their patients, or is this technology and its purveyors trying to kill people after driving clinicians to mental collapse - or to jail?

... Analyses of problems with EHR systems by physicians and their practice managers consistently reveal that the overwhelming preponderance of their challenges relate to the rarely discussed data-entry characteristics of the electronic history and physical (H&P), not to the heralded data-storage and retrieval features of their systems. One physician personally reported that "The software forces me to enter clinical information in a preloaded format; when I see a patient three weeks later, I cannot find any individualized details of the previous visit or understand why I did what I did."

Too often, these problems have proven insurmountable. At the Second HIT Summit in 2005, Mark McClellan, MD (then the administrator of CMS), reported "40 percent of attempted implementations fail." According to the April 1, 2006, issue of CIO Magazine, "The [Health and Human Services] department itself has acknowledged that the failure rate for EHR system implementation is 30 percent to 50 percent. Some healthcare network providers claim it is as high as 70 percent."

During the last several years, a significant number of articles have pointed out compliance problems intrinsic to the majority of current EHR systems. Chief among these relate to coding engines that fail to consider medical necessity, which CMS describes as "the overarching criterion for payment," and certain types of data-entry functionality that result in "cloned documentation," in which the records of every visit read almost word-for-word the same except for minor variations confined almost exclusively to the chief complaint.

The problem that physicians face is that most current EHR system designs have failed to incorporate protections to ensure the correct use of these shortcut tools. Without such "error proofing," it is not feasible for physicians, while concentrating on patient care, to differentiate the settings in which these various tools can be used compliantly from those circumstances in which their use could lead to pliant or even fraudulent documentation.

Guess who would be responsible for that?

("A computer is never put on trial.")

The Medical Economics authors are compliance experts who were called in to assist different physician groups during federal and state audits of those groups' EHRs, conducted either by individual Medicare Carriers, Recovery Audit Contractors (RACs), or the Office of the Inspector General of the HHS.

In each of the four cases, the audits revealed pliant E/M claims that were submitted as a consequence of physicians using their EHRs in accord with their particular designs for E/M documentation and coding. During audits the following was found:

• All of the systems had designs that failed to meet all of Current Procedural Terminology's and Documentation Guidelines for Evaluation and Management Services' published requirements for compliant documentation of medical history, physical examination, medical decision-making, and nature of the presenting problem(s) (which is the E/M system's measure of medical necessity)
• Each of the systems included three or more types of data-entry functionality that has been consistently identified as having the potential to promote non-compliant or even fraudulent documentation
• The E/M coding engines of all four systems failed to consider the three levels of risk in decision-making, failed to consider medical necessity in determining appropriate code levels, and failed to recognize the critical role of medical necessity in guiding medically indicated levels of care, documentation, and coding.

How, exactly, is such software supposed to help physicians?

This Medical Economics article concluded with a dire warning about a converging perfect storm, sounding similar to my own warnings at this blog. The article is worth reading in its entirety at this link. This all seems more like torture than the revolutionizing of healthcare via IT.

It seems physicians can be beaten over and over, not complain very much, and still come back for more. Being forced to use health IT may yet prove to be the most poster perfect example of physician learned helplessness and physician expected helplessness, ever.

Can it get worse than that?

Probably. See this post on government promoted, perhaps soon-to-be-government-mandated EHR computational alchemy, turning medical lead into gold, postmodern style.

-- SS

Are Health IT Designers, Testers and Purchasers Trying to Harm Patients? Part 2 of a Series

(Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here.)

At the (deliberately) provocatively-titled piece "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients? Part 1", I wrote that I would be presenting mockups showing the EHR deficiencies I am hearing about. These deficiencies in basic human computer interaction, biomedical information science, and presentation of information create a terrible user experience for clinicians.

The title of these posts are deliberately provocative because the stakes of the issues addressed are so high, not to mention a personal angle. My father died as a result of informational errors at a major hospital that could have been prevented with an effective EHR. They are dedicated to his memory.

These hellish user experiences are causing clinician cognitive overload, distracting and tiring them, and due to violations of fundamental good practices in information display, actually promoting error.

These violations are primarily due to lack of clinician input at design, sluggish vendor correction of reported critical deficits, programmer convenience, contractual gagging of a healthcare organization's ability to share these defects with other users and the public at large, and vendor immunity from liability on the basis of "learned intermediaries" (clinicians) between the defective IT and the patient.

Imagine if aviation worked this way. Imagine if the crash of the Continental Connection Flight 3407 had been due to defective instrumentation as suggested by the pilot's union.

I cannot present actual screen shots of vendor EHR defects, since the vendor contracts forbid that on the basis of intellectual property protection. However, I am drawing mockups to substantially illustrate the problems I am hearing about.

I am starting off with a relatively simple example. Many more will follow in future parts of this series.

This one can be called "Warning, no warnings" and reflects two problems I've heard about rolled into one:

(WARNING! No warnings! Click to enlarge)

This is a fictional representation of a screen from an actual major vendor EHR in use at many large hospitals in this country today.

Note the following:

• A warning that there are no warnings about abnormal results. "Please review all results carefully, there are no indicator flags" - in 2009?
• A results section that says "negative" and "results final." Most busy clinicians' eyes would stop there, especially in the wee hours as this report is from.
  
• An addendum to the report that the result is actually positive for MRSA, one of the most feared drug resistant pathogens today. In labs and diagnostic departments, a change from an initial impression or result happens. Unfortunately most EMR's do not support the old style method of erasure, or crossing out erroneous data with a pencil!
  
• No flag on that addendum of any kind, although at the lab at the point of data entry, a flag was requested and seen by the reporting technician!

The lack of a flag to signal an abnormal result saves a vendor the inclusion and interface of 1 binary bit of information (well, to be fair, 8 bits or one byte, practically speaking) in computers and networks that even at consumer grade can now pass millions of bits/second, and the contents of an entire encyclopedia in milliseconds.

This is sheer stupidity. (It reminds me of the Y2K issue.)

It's bad enough that the clinician is forced to hunt around every result for an indication of normalcy or abnormalcy.

Even worse, there is a disparity between what is seen at the lab - a flag calling attention to an abnormal addendum - and what is seen in the clinician view.

While a fictitious screen, this is not a fictitious example. This type of incident (I say 'type', as the specifics of the patient's condition were different) occurred to a patient whose treatment was in fact delayed until someone more than 24 hours later noticed the addendum. The patient's ultimate fate was not reported to me.

Even still, the leaders at the organization using this EHR are considering adding a report about this flaw to the regular queue of vendor fixes, rather than taking immediate, definitive "FIX THIS, NOW!" action.

This is despite the common sense view that if this happens again before a fix and a patient is harmed or dies, the hospital system will be held seriously accountable for the delays, and IT personnel will likely be on the stand. (The vendor, of course, gets held harmless.)

Imagine a jury's reaction: CIO - "uh, we didn't think the problem all that serious, and didn't have the resources to fix it right away, but we did call the vendor who said they'd attend to it one day real soon."

I can also put blame on the physicians for their physicians' learned helplessness - trying to muddle through their work with such a system, rather than refusing to use them in this condition. Or simply (in the manner of an old time surgeon I once rounded with in a summer NSF program for high school students) picking up the terminals and smashing them as the potentially dangerous junk they are.

One could blame the doctors for not reading below the "negative, results final" mark, but why should that be needed? Why is it the responsibility of the extremely busy physicians and other clinicians to provide their extra labor for the convenience of IT and IT vendors? Would a jury hold the clinicians accountable, seeing this display?

Would an aircraft manufacturer get away with blaming a pilot for an accident caused by horrible user interaction design of a plane's instrument displays, say, a hard to find stall warning that lacked flags or audible alerts?

It is unbelievable to me that a system like this could be put into production in a hospital. Simply unfathomable.

If I am involved as an expert witness in such cases, I will be sure to have the plaintiff attorneys ask the IT personnel about their clinical credentials.

This system was CCHIT "certified", I am told. Of what value is "certification" if it allows this type of design issue, and others to follow in future installments, on to the market?

More screens in part 3 of this series. It gets worse.

Far worse.

(Part 1 of this series is here and Part 3 is here).

-- SS

addendum:

Some have complained I am being "politically incorrect." At a time when our banks, major industries, investments, lifestyle and retirements have been seriously eroded by a combination of secrecy, incompetence, and criminal behavior on an unprecedented scale, I think such people need to get their priorities in order.

Physicians' Unexpected Un-Helplessness: Executives Invited To Leave Nashville-Based Healthcare System

At "Physicians' Expected Helplessness" I wrote that:

I am going to coin a new term to describe what I have observed as a corollary to physicians' learned helplessness: "Physicians' Expected Helplessness."

I observed that "Physician's learned helplessness", an adverse effect of dysfunctional medical training and culture described here, had perhaps led to societal expectations of physicians being weak in defense of their profession and its patient-protective values, and "having a target pasted to their backs."

In a case of human bites dog - or perhaps, more to the point, doctors bite dogs - a physician revolt has led to the ouster of unpopular and apparently ineffectual executives including the CEO, COO and Chief of HR at a large healthcare system based in Nashville.

Two more executives leave Saint Thomas Health Services

By Getahn Ward
THE TENNESSEAN

http://www.tennessean.com/article/20090212/BUSINESS01/902120346

Two more executives have left Saint Thomas Health Services, continuing changes after physician leaders recently cast votes of no confidence in the management team.

The position of Bev Weber, chief operating officer for the Nashville-based four-hospital health system, was eliminated, spokeswoman Rebecca Climer confirmed late Wednesday. Angelle Rosata, chief human resources officer, also has left, Climer said.

Their departures follow last week's resignation of Chief Executive Jim Houser, less than two weeks after the no-confidence votes by medical staff leaders at three of the system's hospitals — Saint Thomas and Baptist in Nashville and Middle Tennessee Medical Center in Murfreesboro.

Doctors were concerned about a review of operations that they expected to include budget cuts and more centralized management of the hospitals. [Translation: even more mission hostile, autocratic leadership by non clinical bureaucrats -ed.]

Patrick Madden, who ran a Pensacola, Fla., hospital system for Saint Thomas Health's Catholic-run owner Ascension Health, began his role as interim CEO of the Nashville-based health system Tuesday.

"The elimination of the system-level COO position will allow for greater communication and interaction between the hospital chief executive officers and our new interim CEO and his leadership team," Climer said in a statement.

Weber, who joined Saint Thomas Health in May 2006, was an intermediary [and probable obstructionist - ed.] between Houser and CEOs of the system's hospitals. Doctors feared the hospitals would lose much of their authority under a proposed structure they believed was being considered as part of the review.

Weber was a target along with Houser of the no-confidence votes.

The COO position was actually eliminated due to the position serving as an apparent bottleneck between CEO and the medical staff.

It should be remembered - and made clear to "management" by physicians and other clinicians - that clinicians are the enablers of healthcare, whereas executives and near everyone else are facilitators of healthcare.

As such, when push comes to shove the physicians "own" the hospital (and could in an emergency provide a lot of services even if the hospital burned to the ground). However, they only can protect their own interests if they stand up for themselves and for medicine's core values. That also means abandoning quaint notions of "political correctness" and "inclusiveness" as the sole means of interacting with those who do not share those values.

This is a phenomenon that hopefully may set an example for other medical staffs beleaguered with mission-hostile management.

-- SS

"Physicians' Expected Helplessness"

At "Physicians' Learned Helplessness", HC Renewal Blog described a term coined by a lawyer and presented in an article in Medscape General Medicine.

The lawyer suggested that physicians have developed a "learned helplessness" [Bond C. The training of the "helpless" physician. Medscape General Medicine 2007; 9(3):47].

This learned helplessness obstructs physicians from standing up for their profession, its faithful execution (faithful to science and to the Hippocratic oath, the ability to be faithful being interfered with by an increasing number of opportunistic non medical interlopers), and to their own livelihoods.

Two major points the lawyer described accounting for physicians' learned helplessness are:

Beyond the basics of medical economics, young physicians are generally not introduced to the regulatory and political environment in which they will have to practice.

and

Young physicians become so well trained in deferring gratification that many give up on ever getting any meaningful rewards for their sacrifices. With their resilience worn away, many just give up the fight.

These are keen observations by a lawyer. I am going to coin a new term to describe what I have observed as a corollary to physicians' learned helplessness:

"Physicians' expected helplessness"

In a comment to my post "Will the U.S. spend the Economic Recovery Act's $20 billion for Healthcare IT more wisely than the UK?", where I presented a government report on a true quagmire, the UK's national program for health IT, I received a comment that:

"... I believe that you have been a little too divisive in setting the business IT crowd up as an antagonist ... the rhetoric that you use has been at times abrasive and exclusionary... implying, whatever your intention, that there shouldn't be any role in health care implementations whatsoever for IT generalists."

Ignoring the hysterical conclusion that my "intention is that there should be no role whatsoever in HIT for IT generalists" [** see note below], this comment was not at all unique.

The comment reminded me of many other comments and pieces of feedback that I and like minded medical colleagues describing healthcare and health IT incompetence and malfeasance have received over the years: "be nice."

Here's the problem.

Why do people expect outspoken physicians and other clinicians to defend their professions and ultimately the patients to whom they are responsible in an "inclusionary" and genteel manner?

People want doctors to be their staunch defenders when they are sick. They want doctors to spare no language, make no compromise in getting them the very best treatment. They don't advice doctors to be "genteel" when helping them with an overbearing and unfair denial of life saving treatment by an insurer, for example - unless the patient is Darwinian extinction-level daft, that is.

But in defending their own occupation from invasion, for example by non medical IT leaders who believe their wisdom supercedes that of clinicians in development and deployment of medical tools (electronic health records, CPOE, decision support etc.) that happen to involve computers, people expect physicians to be - passive and polite?

The union leaders defending bus drivers I observed in my time as Medical Programs Manager in the Philadelphia regional transit authority would have laughed a person issuing such a comment right out of the room. In fact, I dare say nobody would be so bold as to even issue such a weak-kneed, emasculate comment in the presence of such personnel.

Why, then, to physicians?

Due to an expectation of physician helplessness, that is, "physicians' expected helplessness."

I call on my clinical colleagues to fight both physician's learned helplessness, and end others' expectations of physicians' helplessness, especially by those who count on it towards their own ends.

As one Transport Worker's Union leader said in discussing medical issues about busdrivers and other line personnel, while banging his fist on the table, "What the f*** are you idiots doing to my membership?" (I knew the union leader to be generally polite from my off hours encounters with him on the local commuter train.)

Such attitudes at crucial moments did help preserve his members' rights against edicts of senior management (who we reported to). Such directness would probably help protect physicians' rights as well, allowing them to better care for patients, and avoiding phenomena as recently described in the NY Times here: "When Doctors and Nurses Can’t Do the Right Thing."

Appeasement of non medical interlopers in medicine, who overstep their bounds and core competiencies, helps neither physicians nor patients.

It does help the career aspirations and incomes of those appeased, however.

-- SS

Note:

[**] I, in fact, teach such IT personnel at the graduate level to prepare them for facilitative roles in HIT. I am concerned, however, when such personnel are put in medical leadership roles, through either custom and tradition or managerial imperialism, that takes them outside their core competencies.

Pharma Union cowed into submission?

In various posts including this one, I've commented on the environment of cutbacks, quality issues, and fear that seems to permeate pharma.

Now a labor union leader at Merck has responded to the Philadelphia Inquirer article "FDA report shows problems at Merck vaccine plant." He writes in a letter to the editor:

Concerns at Merck

The article "FDA: Problems at Merck's vaccine plant" (Inquirer, April 24) indicated the concerns raised after an inspection at our facility, Merck's West Point site. We, the United Steelworkers Union members, are dedicated to the creation of quality products through all phases of the manufacturing process. We are committed to following FDA guidelines, industry standards, and the FDA's Good Manufacturing Practices, all of which are the foundation for a successful pharmaceutical and vaccine production plant.

The company has implemented new ideas on how to function at our site. The expectation placed on our members is that they are required to do more with less. This business philosophy is not unique to large corporations but it is new to the pharmaceutical industry. Our members have worked diligently to ensure that the demands that have been placed on them have been met. They also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.

Phil Hughes
Vice president
United Steelworkers Local 10-0086
North Wales (PA)

This somewhat cryptic letter can be interpreted in a number of ways. A clear message is that the union members are being asked to "do more with less", implying overwork. This seems an explanatory theme in the FDA 483 Inspection Report referenced in the Inquirer article, a copy of which I have obtained. There are, in fact, phrases in paragraphs of that FDA inspection report that do not belong in the same paragraph, such as:

5. SOP 1330, Headquarters Review of Lot Numbers for Product Quality Complaints (PQCs), dated 14 May 2007, states that all deaths and life threatening adverse experiences [with vaccines] require lot checks with batch record review. This is not always performed.

and

Rejects from the first pass through the inspection equipment are sent through the inspection equipment a second time and only those that are rejected a second time are discarded. [Four examples involving vials of Varivax, Zostavax and ProQuad follow.]

What is most concerning about the union leader's letter to the editor, however, is this:

They [our union member Merck employees] also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.

I ask why an article such as the one published in the Inquirer would raise concerns for Merck unionized workers about their "future" (i.e., jobs).

Is the union concerned about retaliation in the form of layoffs for the substandard report? Since it's unlikely Merck vaccine sales will be affected by easily correctable FDA inspection problems, and since it's also unlikely Merck Vaccine Division will go out of business, being touted as it is by Merck management as a significant source of company income (e.g., via the new Herpes vaccine), the fear of layoff retaliation appears possible.

I can only say that if the unions are so concerned and so milquetoast in their approach to employee overwork via mild-mannered letters to the editor, imagine what the non-unionized employees must be feeling.

Finally, I once worked as Medical Programs Manager for the regional transit authority in Philadelphia. The leader of its biggest union, Transport Workers Union local 234, would likely have had quite a different response in the Inquirer to the problems caused by his employees being made to "do more with less" in a life-critical operation.

When I first met Mr. Lombardo it was at a medical department meeting where he was banging his fists on the table, shouting at the doctors for f***ing around with his employees via workers comp denials, drug tests, etc. At the time I thought this behavior frightening and unprofessional, but now I see its value.

I wish I'd had a union leader will testicles representing me in my past few positions.

-- SS