Thursday, November 24, 2016

Don't stop (Musings on government regulation as a TM disruptive force)

Updated: 25 Nov. 2016
November's blog was stimulated by a Dark Report about an Australian conference on medical laboratory professionals exploring disruptive forces in healthcare (Further Reading). 

This will be the first in a series exploring disruptive forces that have and still affect, or will affect, the practice of transfusion medicine (TM) and its diverse practitioners. Each blog will deal with one disruptive force and its related aftermaths.

What is this blog about and why might you want to read it? It requires more than the cursory scan you no doubt give most of the info overload you receive daily. But if you want to understand, truly 'dig' current transfusion realities, please consider giving it a read.

Executive version (over the long haul of all the blogs in the series):
  • At heart, the blogs are designed to combat 'BS baffles brains';
  • Because disruption affects all transfusion professionals, I hope you see its relevance to your practice;
  • Sub-aims include being able to 
    • Differentiate disruptive forces from normal progress;
    • Identify beneficial forces from those worth resisting;
    • Make the most of positive disruptive forces to improve patient care and safety.
In the 'management speak' ubiquitous in blood supplier annual reports, the last aim would be to leverage disruption and create a centre that drives not just leading or bleeding edge innovation but innovation that leads to transformative change.  

The blog's title derives from a 1977 ditty by the Brit-US rock band, Fleetwood Mac.

Disruption has been in the news a lot lately given the unexpected UK Brexit vote and Donald Trump's election as US President. A recent search of Google news stories for ''disruptive forces'' yielded 8,830 hits.

For decades now we've seen disruption in many aspects of our daily lives. A few examples, and I bet you can name even more:
  • Personal computers disrupt mainframes;
  • Apple's Macintosh WYSIWYG OS disrupts command-driven MS DOS; 
  • Internet disrupts everything;
  • Cable TV disrupts the networks;
  • Google disrupts libraries and the publishing industry;
  • Streaming services like Netflix disrupt DVD rental stores;
  • Apple's iPod disrupts music industry;
  • Uber disrupts taxis;
  • Airbnb disrupts hotels.
The list is endless. Disruption is big in the business world too, witness a new McKinsey Global Institute (management consulting firm) report, Ordinary Disruption: The Four Forces Breaking All the Trends: (Further Reading).

No doubt disruption is now established as the next big thing. But it's not new. Disruptive forces have affected clinical laboratories for decades. 

So what the heck are disruptive forces? The OED defines disruptive as 'innovative or ground-breaking'.

According to the UK consulting firm, Tomorrow Today Global:
A disruptive forces is not a force that results in incremental changes, improving products or services one step at a time. Rather disruptive forces result in a breakthrough or a step change that transforms society forever. Sometimes the disruption is complete and swift. 
The key here is a true disruptive force does not affect change in baby-steps but rather consists of a big step (innovation) that changes things forever. 

DISRUPTIVE FORCE #1: Tainted Blood Massive Screw-up
Being a medical laboratory technologist who became a transfusion science educator, I found it so tempting to begin with - you guessed it -  either laboratory automation or its latest iteration, molecular typing of red cell antigens and its kissin' cousin, personalized medicine. But I've resisted. 

The first blog will discuss the worldwide 'tainted blood' tragedy of the 1980s and '90s, which resulted in the related disruptive forces of 
  • Krever Inquiry (Royal Commission of Inquiry on the Blood System in Canada);
  • Vein-to-vein responsibility for blood transfusion;
  • Government regulation migrating from blood supplier to hospital transfusion services.
The focus will be on Canada because that's what I know best. But I suspect the transmogrification of blood suppliers and hospital transfusion services was similar in other countries, albeit some progressing faster, some slower than Canada. 

Note that I am an oldster (see 'Life as a blood eater' in Further Reading) and my recall is not perfect. If I inadvertently omit significant events or get things wrong, please comment below or e-mail me. My personal take on the highlights of these disruptive forces follows.

In Canada, the Krever Inquiry - 1993-1997 (Further Reading) -  resulting from the HIV and HCV 'tainted blood' scandals, had a huge impact on the blood supplier, the Canadian Red Cross Blood Transfusion Service (CRC-BTS). Krever was an earth-shaking disruptive force that eventually resulted in Canada creating two new blood suppliers in 1998

Goodbye CRC-BTS, hello CBS and H-Q!
Think about it. The blood supplier that had managed Canada's blood system from the get-go in the 1940s was to disappear under a cloud of suspicion. 

In exchange for not bringing the case of Canada's tainted blood scandal to trial, the Red Cross pleaded guilty to violating the Food and Drug Regulation Act by distributing a contaminated, drug (Factor VIII concentrate). The $5,000 fine was the maximum penalty for that charge under the Act. 

Other court cases proceeded against individuals but with no convictions:
In effect,the CRC-BTS was the fall guy (not its complicit government paymasters) for the entire tragedy. Two factors at work were the typical physician sin of paternalism and government secrecy. The panacea was to create new organizations at arms-length from government that would be more transparent. 

Only something NEW could restore the faith of Canadians in the blood system. 

The reality was that the new blood suppliers had many of the same transfusion professionals serving as leaders (medical directors), and the trench workers were the same, mainly medical lab technologists performing blood donor testing.  It's not like experienced, skilled personnel were hanging around like low-lying fruit waiting to be picked.

Regulatory Compliance Project
Meanwhile, in the mid-1990s the Canadian Red Cross initiated a Regulatory Compliance Project whereby standard operating procedures (SOPs) to encompass all operations were to be written and used in all CRC-BTS centres. To implement the SOPs and to maintain the system, a training component was included. SOPs were to comply with current Good Manufacturing Practices (cGMP). 

During this time I taught at University of Alberta, but after hours participated as an external consultant in developing training materials. 

It's worth noting that the transition to SOPs and training - a huge undertaking - happened on the 'disgraced' soon-to-disappear Canadian Red Cross's watch.  

Despite the long history of Quality Systemsthe first I became acutely aware of QSE (Further Reading) and their implications for hospital transfusion laboratories was at the CSTM 2000 annual conference in Quebec City. 

The Canadian province of Quebec had created transfusion safety officers (TSO), initially with both a medical technologist and nurse for 20 designated centres.  [Right click and select 'Translate to English']:
In 1999, following the report of the Krever Commission, a complete reorganization in transfusion medicine was initiated in the province of Quebec. To improve transfusion practice, roles and responsibilities were established for the professionals involved in the management of blood products from blood donor to recipient
Ontario, particularly at the McMaster University Medical Centre in Hamilton, had a few TSOs (CSTM blog - Gagliardi: Further Reading) who had become specialists in QSEs and writing standard operating procedures (SOP). 
And it was at this CSTM meeting I learned of the existence of the BC Provincial Blood Coordinating Office (PBCO), Canada's first PBCO, which had been created ~1998. 

A friend (CSTM blog - Chambers: Further Reading) introduced me to its then medical director as a 'geek' who could potentially manage and coordinate resources for its TraQ program (one of the luckiest days of my life).  

Soon I became aware of the extensive help the PBCO gave to transfusion services throughout BC to help with writing SOPs and training materials. The BC PBCO was ahead of the curve - way ahead of the curve. 
It's fair to say that these BC manuals served as templates for transfusion service SOPS written across Canada and perhaps beyond, particularly in developing nations since they were generously shared online.

Then in 2004 - a huge disruption - The Canadian Standards Association (CSA) published its Standards for “Blood and blood components” (also known as Z902-04). I wrote about it for the BC PBCO's Blood Matters newsletter:
It's worth noting that the UK's blood system, while not having a Krever-style commission until much later, was quite active and early in producing guidelines for transfusion services via the Red Book.

And the UK and Australia were leaders in creating transfusion safety officers: 
In the USA the AABB had its excellent Technical Standards but being AABB accredited was voluntary. Nonetheless, the AABB Standards served as best practice.

As in Canada, the government (FDA) regulated blood suppliers. I'm unaware about the U.S. situation, but in Canada, until the Krever Inquiry report on the tainted blood tragedy, inspections, if they occurred, lacked rigour. That's the politically correct way of saying government oversight of the blood supplier was a joke. For example, in my 13 years at CRC-BTS in Winnipeg, I cannot recall one inspection having happened. Maybe they did but I doubt it. These days, every staff member in a blood centre is ultra-aware when inspections and audits are to occur.

U.S. regulation and accreditation of blood transfusion labs is a quagmire of multiple bodies, e.g., AABB, FDA, CAP, CLIA, The Joint Commission, ISO 15189, COLA, and many others. Perhaps unfair but my best guess of the on-the-ground situation in U.S. hospital labs in the 20th C comes from graduates of the University of Alberta Med Lab Sci program, when so many went to work in the USA in the 1990s due to no jobs in Canada. 

First, U.S. employers loved them, probably because of their solid experience rotating in clinical labs, generally significantly more time than U.S. grads received. Second, I'll never forget their often humorous transfusion anecdotes. One example: 
  • 'My gawd, Pat they don't even label the test tubes for pretransfusion testing.' 
No doubt the situation is much improved today. Also worth noting is that the USA never had an inquiry into tainted blood scandals similar to Krever. And the U.S. was also late to adopt TSOs and hemovigilance.

First, be aware that before Krever even blood suppliers in Canada did not have SOPS or follow cGMPs. I worked for the CRC-BTS for 13 years as a bench technologist, supervisor, and clinical instructor and the methods used to test donated blood were unwritten. Methods used to crossmatch blood for patient transfusion were also unwritten. New staff learned as surgeons traditionally did: 
  • See one, do one, teach one (Further Reading)
  • Sidebar: After 6 months in Jamaica more or less goofing off, and longing for cooler climes, I wanted to return to CRC-Winnipeg but had to first substitute for a vacationing staff member in CRC-Calgary returning to her family in South America for an extended vacation. 
  • Spent one day watching a technologist perform pretransfusion testing (method was quite different than Winnipeg's) and was asked to do one. Afterwards the lab manager asked my supervisor if I could do the job and her reply was, 
    • 'She's good to go.' That was it. I was now the sole night technologist for CRC-Calgary.
The Winnipeg CRC-BTS also performed pretransfusion testing for all city hospitals (unique in Canada) and many rural ones in Manitoba and NW Ontario. 

Re-SOPs, once I became a clinical instructor for Winnipeg CRC-BTS I spent an entire summer holiday writing SOPs for the transfusion lab. None existed and it seemed a good thing to do, not only for staff but also for students during their clinical rotation in the one transfusion service lab in town. 

What follows focuses on the disruptive impact to hospital transfusion services due to vein-to-vein responsibility for transfusion safety.

SOPs and Competency Training - Med Lab Technologists
As noted post-Krever Canada's blood supplier underwent a tremendous disruptive transformation to cGMPs and training. To those who worked pre-Krever, post-Krever was a different universe. 

The disruptive requirement in transfusion services to have written SOPS and related competency training at first, at least in Canada, applied mainly to medical laboratory technologists. This spawned an entire industry, first via government-funded PBCOs and their equivalents and soon by the need for hospitals or health regions to hire TSOs to educate and train the 'trench workers', whether technologists or the nurses who administered blood transfusions.   

The cost to the public purse was huge (new PBCOs and TSOs), as was the disruption to the daily lives of affected professionals. But having SOPs and training was wonderful because 
  1. They standardized lab methods - learning no longer depended on who taught you.
  2. Your competency - knowledge and practical skills - were documented;
  3. The system became much safer.
Some, like the USA's talented Lucie Berte capitalized and built a successful career around QSEs and SOP development with diverse global clients.

SOPs and Competency Training - Nurses
Soon nurses - those who administer blood transfusion - were affected by the disruption of regulatory requirements. Indeed, hemovigilance programs (also a disruptive force) such as the UK's SHOT show that many errors continue to be clinically related due to human error failing to ensure 'right blood to right patient' at the bedside. 

Checklists and clinical audits of administering blood transfusions are now the norm in many locales. But SOPs and checklists only work if humans follow them.

SOPs and Competency Training - Physicians
The one profession seemingly least affected by the disruption of regulatory requirements are the clinicians (physicians) who prescribe blood transfusion. Blood supplier medical directors, and especially transfusion service medical directors, are affected because they are ultimately responsible for ensuring patient safety. 

Physicians continue to receive minimal education in transfusion medicine (typically a few hours as medical students). Ordering practices may be somewhat controlled and monitored by computerized test-order-entry systems requiring laboratory data to justify ordering blood products and hospital transfusion committees. But do physicians actually do this or do they often leave an order for ward staff to perform? 

In some jurisdictions, more rigorous monitoring of expensive blood products such as IVIg exists. 

But from all I know, despite such monitoring, if physicians want a blood product, they usually get it despite poor clinical indications, especially if they are 'grand poo-bahs' in their hospital. 

That said, blood education is ongoing and jurisdictions such as the NHSBT's Patient Blood Management program report good progress.

I've heard from colleagues that transfusion-related SOPS may have run amok in some locations. Specifically, they now include so many steps and documentation requirements that medical laboratory technologists can get lost in the trees and lose sight of the forest. It's complicated by centralized laboratories in which even staff in the main lab automatically default to asking the transfusion specialist to handle any problem, large or small. But that's a topic for another blog. 

Main point is that too much of a good thing can quickly go wrong.

In Canada the tainted blood scandal was a disruptive force that led to the Krever Inquiry and the creation of two new blood suppliers as well as the related disruptive force of government regulation, resulting in vein-to-vein monitoring of the entire blood system and the creation of SOPs and competency training for most involved in blood transfusion. 

I say for most because the one profession that's been least affected are the physicians who order blood components and products. They've been affected, more or less so, depending on their locale, but 'least' is the operative word. Correct me if I'm wrong. Why do physicians largely merit a get-out-of-jail-free pass on blood transfusion? 

Medical laboratory technologists and nurses receive SOP training and must show competency before they can perform tasks independently. Every aspect of their technical and clinical job performance is regularly audited. Physicians not so much...

Canadian Blood Services has a great resource, its Clinical Guide to Transfusion. The first chapter explains everyone's responsibilities:
The ordering clinician's first duty is 'To carefully assessing the clinical need for each order'. How effectively is this monitored, I wonder? 

Because of a tragedy that killed 1000s, life as transfusion professionals changed forever in the 1990s. In Canada, the Krever Inquiry led to government regulation requiring SOPs and competency training, which eventually extended to vein-to-vein monitoring of the blood system.

These disruptions were good for all concerned and promoted patient safety, because that's what it's ultimately all about. 

As always, comments are most welcome.

Couldn't resist this 1977 song by Fleetwood Mac, written by Christine McVie, which became the campaign song of Bill Clinton in the1992 US Presidential election. 
Don't stop, thinking about tomorrow,
Don't stop, it'll soon be here,
It'll be, better than before,
Yesterday's gone, yesterday's gone.
Don't you look back.


Dark Daily: In Sydney, Australia, Medical Laboratory Professionals Gather to Explore Disruptive Forces in Healthcare and How Labs Are Using Innovation and New Leadership Approaches to Successfully Transition to Value-Based Care

CSTM blogs - I will remember you:
Canada's Krever Inquiry

Life as a blood eater

Quality System Essentials (in brief)

Kotsis SV, Chung KC. Application of the "see one, do one, teach one" concept in surgical training. Plast Reconstr Surg. 2013 May;131(5):1194-201.