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By: Georgette Samaritan, RN, MAG Mutual Risk and Patient Safety Department - Senior Risk Consultant
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The emerging shift to outpatient surgery in ambulatory surgery centers (ASCs) continues to be reinforced by Medicare and other third party payers. The advantages for patients who opt to visit an ASC are numerous – No overnight stay; usually lower complication rates and procedures are less expensive than in a hospital. However, as the numbers of ASCs increase, the potential for errors and medical malpractice claims also rise. In 2007 MAG Mutual Insurance Company directed its Risk Management consultants to provide special support to its insured ASCs.
According to Dan Wright, VP Risk Management Services for MAG Mutual , “Protecting patients, protecting physicians and staff, and protecting the owner/operator of the practice are central to Ambulatory Surgical Center insurance and risk management issues.” Wright also cautions ASC owner/operators to be proactive. “Historically, these organizations have enjoyed good loss ratios and claims histories, and therefore are competitive for purchasing medical malpractice insurance. However, unless owners/operators of these centers prepare for the risks, they can easily find themselves compromised.”
Many ASCs do not have a designated, trained risk manager or specific person in charge of patient safety. Regardless, every ASC that MAG Mutual insures is offered an opportunity to have a risk assessment conducted by an experienced consultant, and provided with a list of resources including: policy and procedure manuals, standards directories, and credentialing resources, all as part of a value-added service.
Regardless of the ASC model, open, closed, and /or specialty-specific, there are key systems & processes which should be well-established and operating. Our ASC policyholders are encouraged to work with us and your state and accreditation organizations for assistance in evaluating existing systems, and suggestions and guidelines for implementing additional ones.
Special attention is given to the following areas:
- Patient selection/Pre-operative assessment
- Patient & Staff orientation and education
- Physician credentialing. Every surgeon or anesthesia provider needs to have their own list of approved procedures
- Communication, informed consent and documentation
- Discharge planning
- Patient Follow-up
ASCs should have well-established, well-defined and well written protocols. ASC operators should have a tight control on the type and number of procedures being performed at their facilities on an ongoing basis. ASCs are also strongly encouraged to seek out and maintain the appropriate facility accreditations.
Establishing a proactive risk assessment program applies to the redesign of existing processes and the design of new processes. For example, if surgeons at a surgery center plan to use a new laser, the organization should evaluate the safety implications and/or risks of using the new device. Make sure you have the proper environment and support, including appropriately trained physicians and staff.
Take the following steps to create and implement a proactive risk assessment program:
- Determine the high-risk process to be analyzed (such as medication administration or use of new medical equipment).
- Describe the chosen process.
- Identify the ways in which steps in the process could break down (the failure modes).
- Identify the possible effects of the failure modes on patients and the seriousness of the possible effects.
- Prioritize the failure modes for analysis and action.
- Determine why the priority failure modes could occur. This may include performing a hypothetical root cause analysis (RCA).
- Redesign the process and/or underlying systems to minimize the risk of the failures or to protect patients from their effects.
- Test and implement the redesigned process.
- Monitor the effectiveness of the redesigned process.
- Maintain the effectiveness of the redesigned process over time.
One way to determine processes to analyze is to use information published periodically in the Joint Commission on the Accreditation of Healthcare Organization’s Sentinel Event Alert. Some sentinel events that might occur at ASCs include wrong-site surgery, medication errors, medical gas mix-ups, and transfusion errors, as well as anesthesia-related and medical equipment–related events.
MAG Mutual’s Risk Management consultants advise that the ASC chief administrative officer play a key role in helping to select high-risk, problem-prone processes to be analyzed for proactive risk assessment. Mr.Wright elaborated on the importance of ‘buy-in’ at all levels.“Because ambulatory care organizations tend to have fewer staff members than other health care organizations, it’s likely that organization leaders would serve on the team conducting the annual analysis. If not, they should take an active role by being informed of the results and recommendations from the assessment and provide feedback and support to the team.”
When critical test results arrive, the ASC should have a policy in place to ensure they reach the correct person who can act on the information.
Develop polices to:
- Identify which of your providers should receive the various test results.
- Determine the communication and notification system that works best for your providers.
- Identify who the results should go to when the provider who ordered the tests is not available.
- Educate providers about the policy.
Regardless of inpatient or outpatient care, the patient who undergoes a surgical procedure will have the same expectation of the level of care they will receive. Treatment complications and bad results appear as the most frequent allegations in ASC malpractice claims, followed by infections, product or equipment malfunction or failure, and incorrect type of treatment. Here are two examples of how a minor outpatient surgical procedure could become a major legal headache.
The patient was a healthy 38 year-old male with a history of a knee strain three months earlier. Conservative care had not yielded improvement and an MRI revealed a torn medial meniscus. The surgeon presented the patient with the option to have a knee arthroscopy either at the local hospital or an ASC.
The patient chose the ASC as it would be more convenient for him. The day of surgery the patient and his wife arrived on time. He met briefly with the anesthetist for the first time. The anesthetist found the patient was a good candidate for surgery and a low risk for complications. An IV was started and the patient prepped for surgery. The surgery proceeded without incident. The patient was taken to the recovery area.
While in the recovery area the patient vomited before his gag reflux had returned. The recovery nurse went to clear his airway by using the bedside suction machine. The machine failed to work. It took the nurses 10 minutes to find a machine that did work. In the meanwhile the patient suffered oxygen deprivation and subsequent brain damage.
During discovery it came to light the owners of the ASC had purchased the suction machine from a local hospital and it was outdated. In addition to being used by the ASC, the ASC could provide no evidence that the machine had ever had routine maintenance or inspections. The malpractice lawsuit was settled prior to going to trial for an undisclosed amount.
The patient was to have arthroscopic knee surgery on her left knee however the surgery was incorrectly performed on the right knee despite black markings on the patient's left knee to indicate the correct surgery site. The patient filed a malpractice lawsuit based on claims that personnel in the room failed to follow an internal time-out policy to verify the correct body part and side of the body before surgery.
Although the patient reached confidential settlements with the surgeon who performed the incorrect surgery and the ambulatory surgery center (ASC), she proceeded to trial against the anesthesiology practice, arguing that the time-out policy applied to all surgical staff, including the anesthesia personnel. A jury awarded the patient $175,000 against the anesthesiology practice.
