CEO SUMMARY: “It can’t happen here” is not good management. All clinical laboratories and pathology practices should anticipate the worst and develop their own internal controls to prevent the unthinkable and prepare for the unexpected. Rogue phlebotomists like the one at SmithKline Beecham Clinical Laboratories can appear anywhere, with similar destructive consequences.
WHAT’S HAPPENING TO Smith Kline Beecham Clinical Laboratories (SBCL) in Palo Alto, California can happen to any laboratory in any city or town.
One rogue phlebotomist at SBCL, making a bad decision on her own, created a situation which threatened the health of 3,600 patients!
Imagine if this was your phlebotomist and it was your laboratory in the daily headlines. Would you and your management team be ready to cope with this situation? More importantly, is your laboratory organized to prevent such a situation from occurring in the first place?
“Prevention is a superior management plan for handling crises caused when employees do things that they are not supposed to,” stated Richard Cooper, Partner with McDonald, Hopkins, Burke & Haber of Cleveland, Ohio. “Every lab should understand how suddenly it can find itself thrust into the public eye for the most unflattering situations.”
“The managed care setting presents a different set of management risks and legal exposure than the fee-for-service setting,” he said. “Quality of care issues become different. Most labs are familiar with the legal claim that the provider did not do everything that was appropriate for the patient. That is a common legal challenge in fee-for-service medicine.”
New Legal Challenges
“Managed care introduces a new legal challenge,” continued Cooper. “It stems from the risk that the provider assumes with capitated contracts. The laboratory could find itself facing legal claims that it reduced costs in a manner that exposed patients to risk or inferior care.
“Since employees are the source of a laboratory’s strength and its weakness, lab administrators should implement five safeguards to insure that their employees and staff follow procedures, obey laws and regulations, and deliver an acceptable level of healthcare,” he observed.
First on Cooper’s list is a rigorous background check on every new hire. “You should thoroughly research the past employment history of your prospective employees, subject to applicable employment laws” he said. “That way, you avoid hiring people with a known history of problems. You also help protect your lab should that employee later create a problem. You can demonstrate due diligence in hiring employees who provide reliable work histories.
Labs Have Liability On Several Grounds
Laboratories should understand their legal liability and exposure for damages extends across four basic areas.
1. PHYSICAL HARM
Did the laboratory cause a patient to suffer physically in any way?
2. PAIN & SUFFERING
Did the laboratory subject the patient to pain and suffering, whether physical harm was done or not?
3. PUNITIVE DAMAGES
How egregious and/or culpable was the laboratory and its employees in their actions?
4. REGULATORY & STATUTORY
Were regulations and laws violated by the laboratory?
“Second, continually review internal work rules and quality procedures to insure the lab’s full compliance with all laws, regulations, and standards of good practice,” Cooper said.
Notice that SmithKline’s responses to many issues in the Palo Alto crises refers back to existing SBCL policies which forbid the very things the phlebotomist did. SBCL understands the importance of detailed and complete operating guidelines and quality standards of care.
“Third, audit regularly. Verify and document that your laboratory staff is following policies and procedures,” he continued.
SBCL’s responses to newspaper reporters’ questions, consistently point out that their phlebotomy staff is regularly monitored by a group of managers. They want to make it clear that this one employee acted independently and hid her actions from those managers delegated to insure compliance.
“Fourth, when making decisions about reducing expenses and cutting costs, it is important for you to be sensitive to the quality of care your laboratory provides versus the cost of providing that care,” noted Cooper. “It is smart practice to document that your changes to the cost of providing services are designed to continue supporting services that are of appropriate quality.
“Fifth, when problems are identified, provide training to your staff to teach them how to avoid or prevent those problems from reoccurring,” he said. “This demonstrates your active and ongoing concern about quality and compliance. It provides further evidence that your laboratory is working to maintain a professional and fully compliant operation.”
It is interesting to compare Richard Cooper’s advice to laboratories with the actions of SmithKline Beecham in the Palo Alto phlebotomist episode. As a corporate entity, SmithKline is responding to each development with a consistent public face, based upon the same five principles elaborated above by Richard Cooper.
It this consistency holds up, then SmithKline may well survive this incident with a minimum amount of damage from civil litigation, regulatory sanctions, and possible criminal exposure.