Risky Business – the Next Generation

By Dr. Joel Goodman, PhD, FCACB (Ret)

Risk Management is part of every business organization’s plan for survival. Businesses that do not have a robust risk management strategy stand a good chance of failing because of some unplanned event that “we just never thought of”. While laboratory technicians and technologists are always cognisant of patient safety, risk management goes far beyond what we normally think needs to be done to ensure patient safety. Risk management protects patients from pre-analytical, testing, and post-analytical lab errors, from privacy breaches, from exposure to pathogens during their physical encounters with the laboratory, and from other safety issues as well (e.g. falling down the steps at the entrance to a specimen collection centre). Of course protection of our lab employees and the environment is also paramount in any risk management plan.

Many people and organizations have pontificated about the wisdom of planning and being prepared. The motto of the United States Coast Guard is “semper paratus”, latin for “always prepared”. The motto of Scouting (boy scouts, girl guides, girl scouts), “Be Prepared”, has been with them for over a hundred years. Benjamin Franklin is quoted as saying “By failing to prepare you are preparing to fail”. Richard Cushing, the American prelate of the Roman Catholic Church said, “Always plan ahead. It wasn’t raining when Noah built the ark”. And, as the Oracle of Omaha, Warren Buffet, advised, “Someone is sitting in the shade today because someone planted a tree a long time ago”.

Sounds obvious, doesn’t it? And yet most medical laboratories are seriously unprepared for eventualities that are very real, but to many seem only remotely possible. So they find it unnecessary to prepare for these eventualities. And yet fires do happen in laboratories. So do serious injuries. So does SARS and COVID-19.

Have you checked your fire extinguisher lately?

When looked at superficially, a fire in the lab means everyone scrambles outside while the fire is put out by the local fire department or by laboratory staff. Ask yourself how many of your laboratory employees or colleagues even know where the fire extinguishers are kept? Are they checked annually to be certain they are fully operational? Are those checks documented (remember, “if it isn’t documented, it didn’t happen”). Do staff members know how to use them? Are laboratories aware that if the fire department is called to put out a fire it will most likely take upwards of three months for all of the safety and environmental checks to be completed, hazardous material to be cleaned up and disposed of, and for laboratory managers to be allowed to even enter the lab? Has your laboratory examined all the risks for fire? Are you aware of the dangers lurking within the lithium batteries that provide battery backup for most laboratory instruments and computers?  

Are you testing your instruments “open”?

Most laboratories use a single vendor to supply their testing instruments and the reagents for these instruments in specific areas of the lab (e.g. Beckman Coulter or Sysmex for hematology, Roche or Abbott for biochemistry, etc.). If that vendor has a problem with their ability to supply reagents or parts for their instruments, does the laboratory have a plan for how to continue to test? Back-up instruments provide little help when you can’t get reagents to run them. Are your testing instruments “open”, that is can they run with reagents from other manufacturers? Will your hospital be able to adequately serve its patients without a fully-functioning medical laboratory? And who will take responsibility for having shut down all or part of the laboratory?  

Does the person on call know what to do on a Sunday at 3 am?

While most labs have backed up their electrical needs with diesel or gas generators, are these generators checked routinely? Will there be a power loss in your laboratory and you find there is only minimal diesel fuel in the generator’s storage tanks? Will you find that only certain power outlets in the lab are hooked up to the generator’s grid? Do your refrigerators and freezers have alarms that are activated when temperatures rise or fall beyond set parameters? Does the person “on call” for a freezer alarm know what to do on a Sunday at 3:00AM? Will the individual or corporation that ultimately responds to these alarms so well at 3:00PM also do so at 3:00AM? Has this been tested? How often? Is it documented? A meltdown in a freezer could ruin ten years of someone’s research in less than 2 hours.  

Do you know the danger each of your employees’ face?

Safety of lab employees does not end with an adequate supply of face shields, gloves and masks. Is your laboratory staff protected from dangerous trespassers coming into the lab? Can a disgruntled spouse or business associate walk through the lab door and harass or even assault one of your employees? In most hospitals, anyone from the street can waltz right into the lab, if they know where the lab is. And are lab employees adequately protected when they walk from the lab to the cafeteria or even to a seminar room? How do they call for help from a washroom?  

How often do you check for pollutants, scents, bacteria and viruses?

What about the air we breathe in our laboratories? Do we routinely check for pollutants, scents, bacteria and viruses? Do we check this in real time or only once a year? Do we even have a protocol in place to do this? Are there adequate filtration devices cleaning the air as it is returned to the lab? How often are these filters cleaned or replaced? We talk a lot about aerosols but are we dealing with them adequately? Many labs still allow capped specimens to be opened within the operating laboratory and have not yet mandated that every specimen must be opened under a properly functioning and regularly-tested fume hood.  

Where do all chemicals and viruses go?

Does your laboratory protect the environment? Where do the effluents from your instruments end up? Does the mercury, the azides, the other hazardous chemicals (and there are many) go straight down the drains? Does the lab do an assessment of effluents when a new reagent is introduced or even during an evaluation of a new test? Does the lab monitor what chemicals and biomaterials are going up the fume hood and into the air above the building? And where do these chemicals and viruses that go up the fume hood end up? Do they end up in the air or on the grass around the hospital? Has anyone checked? What risk to employee and patient safety does this pose? Are the ventilation systems (HVAC) routinely checked for bacteria (Legionnaires Disease) and fungal contamination (Aspergillus, Stachybotrys, etc.)?  

Who owns the top risks and is responsible for results?

A proper risk management plan must take all of this into account. Because of the magnitude of the risks in a medical laboratory, some think it is better to have different risk plans for different sections of the lab. Clearly this is not a job that can be carried out by a few employees during their lunch hour. It requires input from all sections of the lab, and requires the full cooperation and support of management. From Chief Operating Officers, Vice Presidents, Laboratory Directors, and technical managers to front line staff throughout the lab, input is vital. Adequate funding for risk management must also be in place or a great plan can quickly deteriorate into an exercise in futility.  

Are you shopping locally?

The days of “just-in-time” inventory control as a way of saving space and dollars no longer works. For most laboratories, the supply chain is just too weak, as we have all seen during the global COVID-19 pandemic. We cannot rely solely on suppliers from other countries (even if we have backup suppliers from those or even other countries) any longer, and must therefore try to support local producers of the goods and services we need to operate our laboratories. Building up local suppliers is not only good for the country’s economy, by providing high-paying jobs, but also builds expertise locally and safeguards the supply chain, thereby reducing risk. Governments are doing this now but how many lives have been lost due to the unavailability of personal protective equipment in long-term care homes in North America and Europe?  

Are you rethinking the inspection by accrediting agencies?

Inspections by accrediting agencies are woefully inadequate when it comes to risk management. But this is changing. COVID-19 will change this very quickly. The requirements of the newly released ISO 22367; 2020 will no doubt soon become part of the accreditation checklists of the College of American Pathologists (CAP), the Ontario Laboratory Accreditation (OLA) Program, and other medical laboratory accrediting agencies in North America and around the world. However, satisfying the requirements of these accrediting bodies will prove to be the least of the problems for the laboratories. The lawsuits, secondary inspections, fines, and management dismissals that can result from failing to manage risk can be overwhelming for many organizations.  

Is your staff competency and compliance training robust enough?

One area that will certainly be looked at by these accrediting agencies is maintenance of competency and staff training; especially for the front line staff. A small amount of training or a single course attended in one specific area of the laboratory really does very little for staff that must rotate through many areas of the laboratory. Managers who are asked to sign off annually on staff competency based on a simple 5 question quiz is laughable, and no doubt makes their confidence in the ability of the staff to perform adequately inherently shaky. Managers need time and stimulating protocols to adequately assess the competency of the people they trust to operate their labs. And the front line staff need clear direction on what is required of them in order to maintain their competency. Part of a proper risk management plan will have to include protocols ensuring that all staff are truly adequately trained, motivated to learn more, and are competent to perform that tasks they are asked to do. This will be especially important for new staff or when a new test category (e.g. molecular genetics) is introduced to the laboratory. Lack of adequate training for laboratory staff is probably the single greatest risk for laboratory errors of all types. Laboratory staff needs to be trained not only on “how we do things around here” but offered the opportunity for education in order to understand exactly why we do things this way. This education will motivate staff to do things correctly and also encourage them to question old ways of doing things and thereby recommend (“cascade up”) ways to improve efficiency, reduce the risk of errors, and provide a safer work environment. This will dramatically improve morale and give staff more pride in their work they do with the knowledge that someone actually cares about their work experience and about the experience of the patients they serve.  

Are you prepared for an unexpected surprise?

At this point, I believe it is important to caution Laboratory Directors that they bear the ultimate responsibility for the safety of their laboratory employees and contractors, just as they bear responsibility for the accuracy of the results of the tests performed in their labs. If a cleaner slips on a wet lab floor, who will bear the responsibility for this employee being in pain and possibly out of work for a while. And who will this employee’s lawyer instruct her/him to sue? The hospital – certainly; the CEO of the hospital – probably; the Laboratory Director – usually. Lawyers cleverly direct their efforts to where the money is. To manage risks, Laboratory Directors must step up to the plate, win the support of upper management, and rally their troops around a well-developed and thorough risk management program. If this is neglected, well, “see you in court”.

To all of the laboratory management team and the front line staff I say (in legalese), when it comes to risk management, “govern yourselves accordingly”. And as that old Fram oil filter commercial so poignantly stated “You can pay me now (by changing the oil filter) or pay me later (by replacing the engine)".

 

About the author:

Dr. Joel Goodman, PhD, FCACB (Ret)

Joel Goodman graduated from The University of Toronto with BSc, MSc, and PhD degrees in the late 1970’s. His education included a year of post-MSc research under the supervision of Nobel Prize-winning scientist Sir Hans Krebs. After a short post-doctoral appointment at St. Michael’s Hospital in Toronto, he operated a commercial medical laboratory, before enrolling in the Diploma Program in Clinical Chemistry at the University of Toronto. After owning and operating several other medical laboratories, he joined Dynacare as their Chief Science Officer and Laboratory Director. Dr. Goodman has served on many scientific committees including the Ontario Laboratory Accreditation Advisory Board (chairperson), the Management Committee of the Institute for Quality Management in Healthcare, the Ontario Association of Medical Laboratories Quality Assurance Committee, and the Fecal Occult Blood Testing (FOBT) Quality Assurance Committee (chairperson). Since retiring from Dynacare in 2018, Joel occupies his time as a review editor for Clinical Biochemistry, a medical laboratory/molecular genetics consultant, and a very mediocre gardener.