Monday, August 30, 2010

Culture is the Key

At nearly every company I have ever been employed, Human Resources (HR) was considered a four-letter word. Nobody wanted to have any interaction with HR. You didn’t want phone calls from them, you didn’t want any e-mails from them, you just wanted to stay off their radar. Typically, when people were contacted by the HR department they weren’t receiving good news.

I believe that most people view HR as a part of the organization that only looks for personnel that are breaking the rules. We all know that part of their job is to ensure that employees are compliant with the rules and regulations of the organization. However, I think in most companies more emphasis can and needs to be placed on some of the more enriching aspects of human resources.

HR should be the primary entity that focuses on the establishment and cultivation of company culture. This extends far beyond a thorough discussion on values during new employee training and orientation. Culture is ongoing and I believe that the responsibility for building a solid culture is often left up to the employees to execute on their own without much encouragement from anyone. The values of the organization serve as a guide for each individual and determine how they conduct themselves in regard to customers and other employees in the organization. HR executives should create programs that bring the values to life on a daily basis. That first starts with the leadership team, who should be modeling these behaviors each day.

I can’t tell you how many times I went to one boring corporate meeting after another only to watch the big wig executives “grand stand” on a stage about how important company values were. But if you asked any of the employees the majority would say that they didn’t feel valued at all and they didn’t feel like the company was representing its values well either. Most hadn’t received merit increases in over a few years. That wasn’t due to poor performance, it was due to the company’s lofty goals that were unrealistic for the economic environment we were all up against. It was just another meeting where we all pretended that we felt “empowered and valued” or whatever the new catch phrase was, but those qualities rarely described the environment we worked in on a daily basis.

HR should be constantly working to create a company culture that truly embodies the values that the organization seeks to represent. If that isn’t possible then either the leadership or the values themselves need to change. People don’t like working in environments that breed a culture of “say one thing and do another.” It’s dishonest, and I like to believe that most people are honest, they want to do what’s right and they want to work for people that also want to do what’s right.

Tuesday, July 13, 2010

A Quality Issue That Deserves Some Attention

For the summer I’m working as an intern at a medical device management company called Access MediQuip. My project for the summer is to create a well-researched report outlining the trends of the implantable medical device industry. Throughout my research I’ve come across some pretty interesting information.

I was completely unaware of how many products are recalled by device companies (or the FDA) in a given year. Already in 2010 there have been 23 recalls posted on the FDA’s website (2010). Comparing the list of recalls in recent years to that of 2001 to 2005, it appears that the number is growing and not declining. A Supreme Court ruling in 2008 could be the reason why.

In 2007 about 235,000 people were affected by the recall of MedTronic’s Sprint Fidelis. This is an accessory device called a lead that wires a defibrillator to the patient’s heart. In 2005, Guidant Corporation, had a similar recall due to defective defibrillators. At the time, both companies were facing a barrage of lawsuits from angry patients that had been affected by the potentially faulty devices. Because the devices had been approved by the FDA, going through the pre-market approval process, the Supreme Court ruled in 2008 that manufacturers are protected from lawsuits pertaining to malfunctioning devices. This is provided the company was not already aware that the products were unsafe.

So the injustice begins. Not only are there several thousand individuals still implanted with the Sprint Fidelis and other potentially faulty devices, but these people will not be entitled any recompense for the trouble and stress. It gets better. Patients that need to have the device removed because of its potential hazard are not guaranteed any reward by the manufacturer to help pay for corrective surgery costs. History reveals that manufacturers are not at all generous when it comes to financing what they’ve screwed up. Some will only pay for the actual device, not the cost to have the procedure done and many have refused even that. That leaves someone else to foot the bill. Sometimes it’s the private insurer, sometimes it’s the patient, and many times it’s the taxpayers. The implantable device demographic is largely an elderly population, meaning that most will qualify for Medicare.

I’m very surprised that this issue hasn’t garnered more attention. Not only does it unnecessarily increase healthcare costs, but it poses a huge quality problem for the patients. Judging from the increasing list of recalls from the FDA, it doesn’t appear that the quality issue will improve any time soon. Maybe that’s because device manufacturer’s have the protection of the Supreme Court on their side. What real incentive do they have to improve quality if there are no real consequences for the lack thereof? You would think that declining sales would provide enough motivation, but in the research I’ve seen manufacturer’s still manage to make huge profits even in the midst of recalls. I’m not saying that devices need to be perfect, because every product purchased is subject to some level of malfunctioning. However, device makers need to get some more skin in the game. The government needs to raise the stakes on companies by creating penalties for a certain percentage of faulty products and requiring device makers to pay for their mistakes instead of shifting the cost to taxpayers, patients, and private insurers.


References

(2010). List of Device Recalls. Retrieved July 13, 2010 from http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm

Tuesday, June 22, 2010

Who Says It's An Adverse Event?

In determining whether or not an adverse event has occurred in the healthcare setting I believe that both the patient’s perspective and the physician’s perspective are very important. It’s difficult, if not impossible to choose only one perspective in evaluating these events.

If I take the definition of The Healthcare Book, the credo for patient safety is “freedom from accidental injury.” I like this definition because it’s pretty straightforward. If the patient is injured accidentally, regardless of the good intentions of the doctors and the risk involved with the procedure—unintentional injury to the patient in any form is an adverse event. Even if the procedure was performed correctly and everything possible was done in good faith to preserve the health of the patient, if an injury occurred or the patient was harmed, I believe that qualifies as an adverse event. I think that it’s important to acknowledge the harm in patients even when procedures are correctly performed and injury is perhaps unpreventable. To not acknowledge the injury to the patient is to accept the issues surrounding the treatment as status quo and there is little incentive to improve healthcare quality.

In determining whether or not an adverse event has actually occurred, it is important to consider the patient and the practitioner’s perspective. Some patients may perceive that they have been the victim of an adverse event when one hasn’t actually happened. If we go back to the definition in The Healthcare Quality Book, I think it’s safe to say that if the patient was not accidentally injured in some way, it’s not an adverse event. A patient might have an emotional scare (i.e. being read the wrong lab results), but if the individual is not actually physically harmed the event should not be reported as adverse. Still, healthcare organizations can learn a lot from slip ups like reading the patient the wrong lab results. Patient complaints of issues in a healthcare facility shouldn’t be ignored, but they also shouldn’t be the final word.

Doctor perspective also should not be the only determining factor on whether or not an adverse event has occurred. Doctors and medical staff typically do not report events at the rate that they occur. Quite the contrary, the number of events reported is far lower than the actual events that happen. This is mostly because health care organizations have not created a “safe” culture for providers to report these issues without fear of disciplinary action. Therefore, physicians and healthcare staff may be more likely to keep adverse events quite to protect themselves.

In order to truly determine if a patient did not receive appropriate care or was accidentally injured, there will likely need to be an investigation by the organization and in some cases state or federal authorities. In any event, the word of the patient and health care provider should be weighed carefully, but the verdict would need to be delivered after a pretty through evaluation of what actually happened. This protects both the patient and the provider.

Tuesday, June 8, 2010

I Know It When I See It

One of the most interesting aspects of working for a healthcare organization and learning in the HSA program is the ability to gauge whether or not my company actual subscribes to the principals discussed in my classes. It’s actually quite funny that many of the philosophies regarding healthcare quality and strategy are simply ignored by my organization. I would give them the benefit of the doubt and say they don’t know any better, but they’re one of the largest pharmaceutical companies in the world—yet even they have neglected some of the core principles of what not to do when you’re trying to create a high quality organization.

I like Guaspari’s little short story called, I Know It When I See It. It was funny that the “product” of choice was actually punctuation, but I got the gist of the story. What I’ve observed in my company and other large pharmaceutical organizations is exemplified in The Boss’s initial reaction to the success of Process Inc.: “Try harder. Do better.” As ridiculous as it is to read in the story, I’ve actually encountered that attitude first hand from management within my company and I’ve heard similar stories from other reps. The reality is that pharma is a dying industry and most companies were not prepared for the rapid decline of profits (due to patent expiration and generic competition). Rather than take a look at the flaws within the system as a whole, it must be easier to simply tell employees to try harder and do better. Just like Guaspari’s short story, that “direction” from management leads to decreased morality and productivity and exacerbates already existing problems within the company.

After The Boss realizes that “Try harder, do better” adds no value to the organization, he comes up with a plan to implement more inspection within the organization. Ironically enough, my company did the same thing. They’re idea was to mandate more activity—indirectly, this is a way of inspecting the quality of the sales rep’s work ethic and therefore profitability of the organization. How many calls per day were made, how many dinner programs and lunches were set up with doctors. These ridiculous mandates not only ticked off our physicians at times, but they were a waste of energy because people couldn’t focus on what would actually make a difference in the business. The job of a pharma rep represents a non-traditional view of healthcare quality, however it can still be judged as an aspect of quality in relation to the organization. Doctors measure quality not just by the characteristics of the products that reps sell, but the overall interaction with them as well as the pharmaceutical organization.

Eventually, The Boss at Punctuation, Inc. figured out that the problem with his company was within the system. It’s smarter to take an approach of prevention rather than putting out fires. He was eventually able to return his organization to a profitable powerhouse. I do believe that the pharmaceutical industry is attempting to restructure itself due to the fact that it’s a very broken system and profits (at least for my company) have not been reaching projections. They’ll probably eventually get it right, but they’ve wasted a lot of time and money in the process. It just proves the point that quality issues are not necessarily attributable to one source—they typically result from problems within the entire system.

Tuesday, May 25, 2010

How Should We Define Quality in Healthcare?

If I had to define what quality means in the most general sense, it would be how well something satisfies my expectations. When I go grocery shopping at Whole Foods (my favorite grocery store) I expect the quality of the produce as well as the selection to be at a certain level—superior to what I might find in a Wal-Mart or Target produce section. My guess is that my expectation of Whole Foods is derived from my experiences there and fact that the groceries are more expensive—but that’s just the price of eating organic.

Even though my previous definition of quality is a suitable measure for Whole Foods and other retailers or businesses, it doesn’t work so well when it’s applied to healthcare. Measuring health care quality against patient satisfaction alone is very short-sighted. The problem is that when it comes to the science of medicine, patients don’t really know what to expect. They know that a receptionist should be kind and courteous and that they shouldn’t have to wait two hours to see the doctor, but they don’t necessarily know what medications or therapeutic approaches would be best for their condition. They’re trusting the doctor who went to medical school to tell them that. Doctors are brilliant people, but they’re still human and capable of making errors that can result in reduced quality for the patient.

I like the Institute of Medicine’s (IOM) definition of quality: “Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (Ransom, 2008). That sums up the definition of quality nicely, I think. If the doctor is practicing evidence-based medicine by following the protocol of current research, then regardless of the outcome the patient is getting the best quality of care that the medical community knows how to give.

The IOM definition is appropriate in terms of simply defining quality, but the six dimensions of quality as illustrated in Crossing the Quality Chasm reveal more insight on how to actually measure it. The six characteristics of quality answer this question: Is the healthcare delivery safe, effective, efficient, timely, patient centered, and equitable? If the answer is yes then it’s probably safe to say that the care the patient received was of high quality (Ransom, 2008).

In the wake of the healthcare reform, many Americans are wondering how the new legislation will affect healthcare quality. I’m actually wondering the same thing. As a pharmaceutical rep, I interact with primary care physicians every day. Many of them are already struggling under a demanding patient load and reimbursement cuts make it financially difficult for these doctors to see fewer patients. I think that the quality of care is already suffering in these offices due to time constraints, and it makes me wonder what will happen to healthcare quality overall once the whole bill is in effect.

Another interesting aspect of healthcare quality is the integration of new technology, a service feature that the U.S. health system is never short on. Lighter and McLaughlin make important points in The Rationale for Quality Improvement in Healthcare. They discuss the conundrum that the health care system is in regarding the demand for new technology by the consumer and the cost-containment pressures that come from several different sources. Culturally, I think that Americans are conditioned to believe that more is better. There seems to be this preconceived notion that if something costs more then that inherently makes it better quality than a comparable, but less expensive product or service. This mentality might have filtered into the healthcare system as well.

Even though state of the art technologies are in demand from consumers, the reality is that we can’t afford it as a nation. The pressure to get costs under control has resulted in a managed care system that is sometimes a bit too restrictive for the provider’s taste. Lighter and McLaughlin state, “Observing the effects of cost containment on patient utilization patters, providers often express concern that payers sacrifice quality for reduced cost.” There seems to be a very fine line between ensuring quality and controlling overall costs. What’s even more complicated is the fact that healthcare is still a business and organizations are focused on the bottom line which isn’t always in the best interest of the patient.

The U.S. definitely needs a better system of “checks and balances” so that more patients receive higher quality of care. The question is, how do we create that system and what does it look like? Hopefully, I’ll have a better understanding once I complete this summer semester.

References

Ransom, E., Joshi, M., Nash, D., & Ransom, S. (2008). The Healthcare Quality Book (2nd Ed.). Chicago: Health Administration Press.

Lighter, D., McLaughlin, C. The Rationale for Quality Improvement in Healthcare.

Saturday, May 22, 2010

Test post.