Don’t Be Afraid to Say You’re Sorry
By Paul Weber, JD,
OMIC’s vice-president of risk management
Digest, Spring 2001
Poor patient outcomes will occur during the career of even the most careful and skilled ophthalmologist. A long-standing debate in medicine concerns whether an overt statement of regret by a physician for a poor medical or surgical outcome could be perceived as an admission of guilt and catalyze a malpractice claim by the patient or be used in court as evidence of liability. But several studies and surveys show that a physician who sympathetically communicates and responds to a patient who has a poor outcome may actually minimize the risk of the patient filing a lawsuit.
Q Is an apology or expression of regret appropriate if a patient experiences a “known risk” of a procedure?
A One study found that more than 50% of malpractice lawsuits are precipitated by the physician’s unwillingness to spend time with the patient and failure to communicate effectively with the patient.1 An expression of regret is not an admission of fault or liability. A statement such as “I regret things didn’t end up the way we had hoped” or “I’m sorry things didn’t come out the way we had planned” conveys disappointment with the outcome but not the treatment itself. Avoid confessional or self-incriminating statements such as “I guess we blew it,” which focuses on the physician’s concerns about his or her performance and not on the patient’s concerns about the injury or loss.
Q What else can I do to minimize my risk of a claim when a patient has an adverse outcome?
A Four common complaints were identified in deposition transcripts of patients who sued their physician following a poor outcome: the physician deserted the patient, delivered information poorly, devalued the patient’s views, or failed to understand from the patient’s perspective.2 Following a poor outcome, set aside ample time to meet with the patient and family. Even though the outcome may be a known complication or side effect that was discussed before the procedure or treatment, assume the patient has only a vague understanding or recollection of the information provided at that time. Come prepared to review the same information now in small, easily understandable chunks. Do not delegate this responsibility as this gives the impression that you are avoiding or are indifferent to the patient’s concerns. Making time for the patient is probably the most effective way to show your concern.
Q How should I document these conversations?
A After explaining the nature of the poor outcome and the steps to remedy it or to help the patient adjust to a permanent loss, it is important to document that the patient appeared to understand and had all questions answered. If you spend a significant amount of time with a patient, document how much (“spent 20 minutes with patient’s family reviewing clinical outcome of surgery”). Recollections often fade as the amount of time actually spent counseling a patient if it is not in the record. Using the patient record to convey and document opinions that a poor outcome was the result of an error or omission by another provider will not help the patient and may reflect poorly on the person placing the blame. Contact OMIC to discuss how to keep confidential, privileged record of the chronology of events.
Q Should I waive my fee or refund money to a patient with a poor outcome?
A This issue has been addressed in previous risk management articles that can be accessed on OMIC’s website, www.omic.com.3,4 Contact Paul Weber at (800) 562-6642, ext. 603 or pweber@omic.com to discuss your options.
Q Can an apology or statement of regret be used as evidence in court?
A In most states, any discussion with a patient, including expressions of sympathy, can be used as evidence in court. Only a few states, such as California, have ruled it inadmissible to bring into evidence a benevolent gesture or expression of sympathy relating to the pain or suffering of a person involved in an “accident,” including medical incidents. No two situations or patients are alike so there will never be one foolproof approach to communicating with a patient who has has a poor outcome. That said, most patients want an ophthalmologist to recognize and respond to them not only as a patient with a clinical problem but also as a human being with emotions related to that problem.
Notes
- J. Kelley Avery, MD, “How the Medical ‘Lawsuit Pie’ is Cut – Lawyers Tell What Turns Some Patients Litigious,” Medical Malpractice Prevention, July/August 1986.
- Howard B. Beckman, et al., “The Doctor-Patient Relationship and Malpractice – Lessons from Plaintiff Depositions,” Archives of Internal Medicine, June 27, 1994, v.154.
- Paul Weber, JD, “When to Report ‘Free Servicing’ of Patients to Data Bank,” Argus, July 1995.
- Byron H. Demorest, MD, “Waiving Your Bill May Avert a Claim Following a Poor Clinical Outcome,” Argus, November 1992, (see “Waiving Your Bill May Avert a Claim Following a Poor Clinical Outcome,”)
Bridging Language Barriers
By Paul Weber, JD
OMIC’s vice-president of risk management
Digest, Winter 2001
In August 2000, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) published guidelines for compliance with Title VI of the 1964 Civil Rights Act as it applies to persons who speak little English, or have limited English proficiency (LEP). Title VI assures that no person shall be discriminated against on the basis of color, race or national origin under any program that receives federal monies, including Medicare and Medicaid. The OCR guidelines mandate the policies and procedures for identifying individuals with limited English proficiency and the steps for providing “effective communication” in the form of language assistance and interpreter services.
Q How do I determine whether my practice is in compliance with federal guidelines?
A First, assess the number of LEP patients your practice treats on a regular basis and all the primary languages spoken by these patients. Involve all front and back office staff in the assessment process to ensure that you include the complete range of languages spoken by patients in your practice. Even if your practice cares for a large number of Spanish speaking patients, don’t assume Spanish is the only language for which you might have to provide assistance. In many areas of the country, there is no one dominant foreign language spoken. Document this assessment process.
Q How will my practice comply with federal guidelines if my patients speak many different foreign languages?
A Among other factors, the OCR takes into account the size of the practice and the frequency with which other languages and LEP patients are encountered. The OCR emphasizes flexibility, focusing on the “end result” and whether the practice has taken steps to ensure that LEP patients have access to the physician’s services. If 30% or more of the patients seen in your practice are Spanish speaking, clearly you will want to ensure that the practice has an ample number of Spanish speaking staff and physicians and/or interpreter services available. It’s also important to provide written information, such as informed consent documents, in a patient’s spoken language. If you do not treat many patients who speak a particular foreign language, you may be able to arrange with a community organization to have an interpreter available in person or by phone during patient consultations. Document these arrangements and whether there are delays or other service-related problems with respect to LEP patients.
Q Can a patient’s family member or friend be used as an interpreter?
A The OCR requires the provider to first inform the LEP patient of the right to receive free interpreter services and permits the use of family and friends only after such offer of assistance has been declined and documented. This is to protect the privacy of patients who might not want to reveal personal health information in the presence of family members or friends and to ensure that the interpreter is sufficiently proficient in both languages. Since inaccurate or incomplete interpretation of an ophthalmic problem could cause serious harm, do not rely exclusively upon a patient’s family member or friend to serve as an interpreter.
Q Does the OCR provide specific guidance on this matter?
A Given the diversity of patient populations and ophthalmic practices, problems and ambiguities are inevitable. OCR provides technical assistance to health care providers to ensure that LEP persons can access their services. OCR will help identify successful practices and strategies used by other providers as well as sources of federal reimbursement for translation services.
Q Who is responsible for paying for interpreter services?
A In certain instances, the physician may be forced to pay for interpreter services. The AMA has been joined by nearly 40 state and specialty medical societies (including the American Academy of Ophthalmology) in objecting to shifting this cost burden to the physician.
Q What if it is determined that my practice is not in compliance with federal guidelines?
A OCR will investigate whenever it receives a complaint or report that alleges possible noncompliance with Title VI. If noncompliance is found, OCR will send a letter of findings to the practice setting out the areas of noncompliance and the steps that must be taken to correct them. OCR must attempt to secure voluntary compliance through informal means. If the matter cannot be resolved informally, OCR must secure compliance through (a) termination of federal assistance after the practice has been given an administrative hearing, (b) referral to the Department of Justice for injunctive relief or other enforcement proceedings, or (c) any other means authorized by law.
For more information about Title VI guidelines, visit the HHS OCR web site at
http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/index.html
http://www.cvrc.state.nm.us/NM%20Electronic%20Materials/LEP%20Guidance.pdf
Disclosure of Risks, Complications, and Adverse Outcomes
By Anne M. Menke, RN, PhD OMIC Risk Manager
Allegation
Loss of vision following cataract surgery.
Disposition
Defense verdict on behalf of insured oph- thalmologist.
Case Summary
A 77-year-old female presented to the insured ophthalmologist with com- plaints of being unable to read, drive, or watch television and vision in the left eye of light and dark sensation only. Visual acuity was 20/25 OD and 20/80 with refraction OS. Past ocular history included peripheral iridectomies OU for intermittent angle closure glaucoma and pseudophakia OD. Medical history was significant for atrial fibrillation treated with aspirin, COPD, and hypertension. The patient had a dense cataract, grade 3-4+. The ophthal- mologist recommended phacoemulsification with IOL placement under topical anesthesia and a clear corneal incision. After removing the extremely dense cataract, the insured detected a large rent in the posterior capsule and per- formed an anterior vitrectomy with removal of the remaining cortex. He attempted to place the IOL in the sulcus but resorted to anterior chamber placement due to instability. No bleeding was noted.
The patient’s postoperative course was com- plicated by the development of a full eight-ball hyphema with loss of vision on day 3; treat- ment consisted of bed rest in a recliner at 30 degrees and 1% ophthalmic Atropine. The ophthalmologist later testified that he recom- mended but the patient refused hospitalization; he did not document this or any pre- or postop discussions regarding the possible effects of the patient’s aspirin therapy. IOP, slightly elevated at 28 on postop day 1 and treated with topical agents, rose to 62 on day 4 when the patient experienced a rebleed, prompting an anterior chamber paracentesis and hospitalization. An anterior chamber washout was needed the next day to control the pressures. Blood staining of the cornea and IOP of 30 was noted on day 13. The retina specialist to whom the patient was referred performed another anterior chamber paracentesis and found no posterior bleeding on B scan. The patient requested a second opin- ion; the consultant explained the treatment options but told the patient there was little chance for visual improvement.
Analysis
The plaintiff’s expert was critical of the insured on several accounts. First, the insured should have considered the impact of aspirin therapy on the development of the hyphema or rebleed and advised the patient to discontinue taking aspirin once bleeding developed. Second, the insured did not recognize the early readings as falsely low in the face of edema and hyphema. Third, had systemic agents been used to control the patient’s elevated pressure, optic nerve damage and the resulting loss of vision might have been prevented. Fourth, the hyphema should have been washed out earlier with care taken to remove the clot.
While noting the insured’s lack of documen- tation regarding aspirin and recommended hospitalization, defense experts supported the accuracy of the IOP measurement and felt he had appropriately recognized and managed the intraoperative and postoperative complica- tions. The jury returned a verdict in favor of the insured ophthalmologist.
Risk Management Principles
The ophthalmologist disclosed the potential complications to the patient and responded each time to the patient’s complaints by promptly examining her, even on Christmas. This responsive care no doubt contributed to the jury’s defense verdict. Like many patients, the plaintiff was angry about experiencing two rare complications and about learning the permanent nature of her vision loss from a con- sultant she herself had asked to see. Had the ophthalmologist explained that she had two risk factors that might lead to rupture of the posterior capsule (the dense cataract and the fragile condition of the capsule), the patient might have been better prepared to deal with her poor outcome.
When anticoagulants are medically neces- sary for surgical patients, the surgeon should explain the need and risks to the patient and choose the most appropriate anesthesia and operative technique. Instructions to stop medications, especially anticoagulants, and recommendations for hospitalization must be documented. When there is significant loss of vision, the patient should be kept informed of treatment options and prognosis for recovery. If a poor outcome is final, the patient should be assisted in adapting to a low vision status.
ROP Case Defines Legal Duty of Care to Patients
By Anne M. Menke, RN, PhD, and Paul Weber, JD
Anne Menke is OMIC’s Risk Manager. Paul Weber is OMIC’s Vice President of Risk Management/Legal.
Digest, Summer 2005
“When does a physician’s duty to a patient end?” It is a question frequently asked by the medical profession and debated by the legal profession. In a retinopathy of prematurity case involving blind twins that initially resulted in a $15 million plaintiff verdict against an OMIC-insured pediatric ophthalmologist, two pediatricians, and one of the pediatricians’ practice group, OMIC learned just how difficult it can be to answer that question. This article provides an overview of the facts of this case and the many legal hurdles faced by the OMIC defense team before an appellate court reversed the plaintiff verdict and made a final determination that the ophthalmologist had no duty to the patient.
In December 1996, twins were born at 30 weeks gestational age in a hospital with a well-established protocol for screening and treating retinopathy of prematurity (ROP). In early February 1997, the hospital’s neonatal intensive care unit (NICU) nurse met with the twins’ mother and told her to schedule an outpatient ophthalmic appointment for both babies. A few days later, before the babies’ discharge, the neonatologist determined that Twin B met the in-hospital screening criteria and asked the OMIC-insured pediatric ophthalmologist to examine the baby. The insured determined that the baby’s retinas were not fully vascularized and noted the presence of Stage I ROP, for which no treatment was indicated. He wrote a follow-up order for a repeat evaluation by a screening ophthalmologist in two weeks to monitor for the development of threshold ROP. The NICU nurse and neonatologist met with the mother at different times to inform her of the results of the ROP examination and to explain the importance of follow-up evaluations; the mother was given a copy of the hospital’s letter to parents explaining ROP (“Dear Parent” letter).
As part of the hospital’s discharge process, the neonatologist contacted the twins’ pediatrician and told him he was referring two premature infants for outpatient care. At the time of the pediatrician’s first outpatient visit with the mother and infants, he addressed the babies’ numerous medical problems and reviewed the neonatologist’s referral letter with the mother. This letter indicated that the mother had made an appointment with an ophthalmologist.
Soon thereafter, on February 16, 1997, the day before the ophthalmic appointment, the mother contacted the pediatrician’s office and requested insurance authorizations for a circumcision, hernia repair, and tongue clipping. When she came to pick up the authorizations the next day, she asked, for the first time, for an insurance authorization for the ophthalmologist. The pediatrician’s office staff informed her that they could not process her request that day. The authorization form was never sent to the OMIC-insured ophthalmologist. In any event, the mother did not bring the children to the appointment; in her deposition, she claimed that she was told by the insured’s staff that the twins could not be seen without an authorization. The insured denied this.
The mother scheduled another appointment with the insured ophthalmologist for February 28, 1997 but again did not show up, this time because the babies were hospitalized for other health problems under the care of another physician. The twins were scheduled to return to the pediatrician for follow-up after discharge, but were never brought in. Instead, the mother sought treatment from a second pediatrician and told this doctor that there were no concerns about the babies’ eyes. When this pediatrician reviewed the first pediatrician’s records, she noted the concern about ROP and the absence of ophthalmic follow-up; she referred the twins to a different ophthalmologist, not the insured. By that time, June 1997, both babies were blind.
Gaps in the Process of Care
The insured ophthalmologist had only seen Twin B once in the hospital. He had never been asked to see Twin B again in the hospital or in his office and was initially bewildered when he was served with a lawsuit in March 1999 alleging negligent care of twins with ROP whose name he did not recognize. Only after reviewing the complaint did he realize that the plaintiff was the mother of Twin B and that she had scheduled an outpatient appointment with him for both twins in mid-February under a different last name. He checked his appointment records and found that his office had placed a reminder call before the appointment but that the mother did not bring the twins to that appointment or to one that she rescheduled for the end of February. Per office policy, his staff did not follow-up with new, self-referred patients who did not keep appointments, assuming they had decided to seek care elsewhere. The first pediatrician noted that appointments had been made for follow-up of the ROP during the initial visit, but he did not have a system in place to ensure that he received consultant reports. The second pediatrician was given falsely reassuring information by the parents and only later learned of the ROP after asking for and reading the medical records of the first pediatrician.
The Trial and Verdict
Efforts to dismiss the OMIC insured from the case were successful for Twin A since the insured had never examined that infant. OMIC’s Claims Committee and expert witnesses believed the insured had met the standard of care in his treatment of Twin B, and they challenged the existence of an ongoing physician-patient relationship. OMIC and the insured ophthalmologist accordingly decided to take the case to trial. After a five-week trial, the jury awarded the plaintiffs $15 million (plus prejudgment interest) according to the breakdown of fault in the chart on page 5.
The jury assumed that the insured’s relationship with Twin B did not end after his consult in the hospital but followed him after Twin B was discharged. The percentage of fault the jury assigned to the parents ignored the undisputed evidence and the following facts:
• The mother played a significant role in the delay in diagnosis and treatment of ROP by not informing the ophthalmologist of the twins’ name change, not keeping the outpatient appointments with him, and not providing accurate information to the second pediatrician when asked about the condition of the babies’ eyes.
• Her noncompliance occurred despite conscientious efforts to educate her: she was counseled about ROP by the neonatologist and NICU nurse; she received a letter from the hospital about ROP; and she spoke to the first pediatrician about the babies’ health problems. During her testimony, however, she denied understanding the significance of the problem, and her lawsuit blamed the care providers for inadequate follow-up.
Both OMIC and the trial counsel for the insured strongly believed that there was no legally sufficient evidence to support the jury’s finding that an ongoing physician-patient relationship existed between the insured and Twin B. Additionally, when polled after the verdict, the jury cited concern for the infants as the primary factor in its decision-making process. This presented a very compelling case to appeal.
Standard of Review for Appealing a Case
Typically, under a “no evidence” review, the court of appeals (or supreme court) must adhere to what the jury found unless there is no more than a scintilla of proof to establish a particular issue, “scintilla” being shorthand for that virtually indefinable quantum of proof that makes the reviewing court comfortable enough to say, “there is sufficient evidence to support the jury’s verdict.”
In the OMIC insured’s case, the defense argued primarily that there was no legally sufficient evidence – no more than a scintilla – to establish that the insured had an ongoing physician-patient relationship with Twin B. If no physician-patient relationship existed, there could be no duty, and therefore no malpractice, regardless of how badly the patient may have suffered.
Specifically, the insured argued, and the state court of appeals accepted, that the various pieces of evidence – the “Dear Parent” letter, the missed appointments, the participation in the twin’s health plan, the alleged referral from the first pediatrician – did not constitute legally sufficient evidence that the insured had an ongoing physician-patient relationship with Twin B. The plaintiffs argued the opposite interpretation of that same evidence.
Rendered in February 2004, the opinion of the majority of the state court of appeals explained: “We believe, however, that none of these facts, either individually or combined, are evidence of the actual continuation of the physician- patient relationship.” The appellate court was concerned about expanding the duty of continued care and stated: “If we were to expand the duty of continued care to all patients who are seen at hospitals by consulting physicians beyond the hospital setting based solely upon the fact that they were seen by the physician in the hospital, there would be no end to the physician- patient relationship.”
Supreme Court’s Final Review
The case was by no means over after the appellate court’s opinion. Over the following eighteen months, the plaintiffs petitioned for an en banc rehearing, in which the full eight members of the court of appeals would review the case, but their petition was denied. They appealed the rehearing denial to the state supreme court, arguing that the court of appeals did not apply the appropriate standard of review in a “no evidence or legal sufficiency” case. The state supreme court denied a rehearing. OMIC was delighted with this decision in the ophthalmologist’s favor and felt that the $730,000 it cost to defend this insured’s care was money well spent.
This case illustrates both the complexity of providing medical care to premature infants and the intricacies of the legal process. The appellate court’s decision was based on the particular facts of this case and may not apply generally to ophthalmology consultants. Additionally, this case was state specific and may or may not be used as precedent for other states. The detailed risk management recommendations for hospital- and outpatient-based ROP care that OMIC developed in response to this case, however, have proved generally useful to pediatric ophthalmologists and retina specialists. This sample protocol better protects physicians and premature infants by standardizing the nonclinical aspects of care and assigning responsibility for all steps in the treatment process. This document, “ROP: Creating a Safety Net,” can be found in the Risk Management Recommendations section of www.omic.com.
New Safety Rules for Outpatient Surgery
By John W. Shore, MD, Anne M. Menke, RN, PhD, and Betsy Kelley
Dr. Shore is an OMIC Director and a member of the Risk Management and Underwriting Committees.
Anne Menke is OMIC’s Risk Manager. Betsy Kelley is OMIC’s Product Executive.
Digest, Fall 2005
When outpatient surgical facilities (OSFs) first opened, physicians frustrated with the heavily regulated world of hospitals opted to perform low-risk procedures there or in their offices. Partly in response to encouragement from health care insurers, the volume, scope, and complexity of procedures performed outside of hospitals grew, and many physicians became owners and directors of ambulatory surgery centers (ASCs). Just as in hospitals, adverse outcomes inevitably occurred in outpatient settings, and states and regulatory agencies predictably responded by introducing laws and regulations to oversee them. Many states now require freestanding ASCs to be licensed. Texas and California permit only certain types of procedures to be performed in office settings, and Florida suspended all office surgery for a period of 90 days in order to evaluate the safety risks.
OMIC’s exposure to malpractice claims at outpatient facilities has increased over the years, a result both of the shift toward expanded and riskier outpatient care and of insuring a larger number of such facilities. Whereas there were 27 OSFs insured by OMIC in 2000, today there are more than 130. After paying out on several large claims, OMIC’s Board set a goal of improving patient safety in OSFs and asked the authors of this article to initiate a study to determine steps facilities should take to reduce the number and severity of future claims. The follow- ing case study highlights the risks of outpatient surgery and illustrates the main concerns the study identified: patient selection, sedation, and perioperative monitoring.
An 81-year-old female presented for upper eyelid functional blepharoplasty for bilateral ptosis at an ASC. She had a history of systemic and pulmonary hypertension, COPD, coronary artery disease, stent placement x 2, carotid artery disease, and peripheral vascular disease, and was on beta-blockers, ace-inhibitors, statin drugs, calcium, and aspirin. As instructed, she took her antihypertensive medications the morning of surgery. The planned local anesthesia was to be administered by the ophthalmologist, with minimal sedation given by a registered nurse. Preoperatively, the patient’s O2 saturation was 99% but blood pressure was elevated at 168/92, so she was given two doses of oral Valium and sublingual Procardia (nifedipine). The surgery was uneventful and, after a 30-minute stay in the recovery room, the patient was discharged home with a BP of 109/59 and an O2 saturation of 94%. She later became incontinent of urine, experienced a right-side facial droop, difficulty swallowing, and inability to ambulate without assistance. By the time her family called the surgeon, the patient was sluggish and hard to arouse. She was diagnosed in the emergency room with a cerebrovascular accident, or stroke. Subsequent strokes left her paralyzed on the right side, unable to speak, and in need of a wheelchair, feeding tube, and nursing home care.
The lawsuit alleged negligent prescription and administration of Procardia, negligent choice of anesthesia, negligent monitoring during sedation and in the recovery room, and negligent discharge. Expert witnesses for both the plaintiff and the defendant physician raised concerns about the dosage of Valium in an elderly patient and the administration of Procardia, which carried a “black box” warning that it should not be used sublingually to control blood pressure because of reports of strokes. Given the patient’s complex medical comorbidities, it was hard to support the choice of a registered nurse to provide the sedation and monitor the patient. Similar criticisms emerged about the response to the drop in blood pressure, especially the decision to discharge the patient before the pressure returned to pre-procedure levels. Although defense experts felt the stroke was due to the patient’s known, severe, cardiovascular disease and not the Procardia, the insureds and OMIC agreed to settle the case because of the numerous concerns about her care. The $750,000 indemnity payment was split equally between the ophthalmologist and the ASC.
The defense attorney for the ophthalmologist and the ASC readily acknowledged that this surgeon was highly respected and that the ASC was by far the best he had ever seen. As this case shows, even the most competent and caring providers are at times involved in medical errors. The physician and nurse in this case deeply regretted the patient’s poor outcome and were determined to evaluate the entire care process to ensure that similar problems did not recur. OMIC worked with them to help revise protocols and later incorporated the lessons learned from this case into the new requirements for patient selection, sedation, monitoring, and emergency response that apply to outpatient surgical facilities. These “Outpatient Surgery Facility Risk Management Requirements” are included in OMIC’s new application for coverage and also can be found in the Risk Management Recommendations section of www.omic.com.
Facilities Affected by New Rules
There is no change in the facilities that must comply with the requirements, as insured ophthalmologists who operate ambulatory surgery centers or refractive surgery centers and those whose in-office surgical suites allow “outside utilizers” already must apply for coverage by submitting a surgery center application. These OSFs have liability exposure for activities such as credentialing, quality assurance, and peer review, and for the care provided by their staff. Policyholders will complete the simpler “Outpatient Surgical Facility Application” (OSFA) and be expected to comply with the listed underwriting and risk management requirements by their 2006 renewal date.
OMIC-insured physicians who do surgery in their own offices and do not allow “outside utilizers” need not complete the OSF application, since they do not have the peer review exposure and their policy provides coverage for them, their staff, and their practice or entity. (If the ophthalmologist does not want to share the limits of his or her coverage with the entity, an additional premium is charged.) While they are not bound by these risk management requirements, policyholders who per- form office-based surgery nonetheless face the same clinical risks. To assist them in promoting patient safety, OMIC has developed voluntary guidelines, “Office-Based Surgery for Adults,” which can be found in the Risk Management Recommendations section of www.omic.com. OMIC is developing guidelines for pediatric office-based care.
Patient Selection
Unlike hospitals, OSFs do not usually have critical care specialists available to respond to emergencies. The case discussed earlier and our analysis of all outpatient surgery claims convinced us that proactive steps must be taken to ensure that patients selected for outpatient procedures can be safely cared for if adverse events develop. The surgeon must carefully evaluate the patient’s overall condition and risk and be satisfied that the procedure is within the facility’s capabilities and scope of practice and competency of the health care providers who work there. The American Society of Anesthesiologists established a physical status (PS) classification system to help assess the patient’s risk during operative procedures. We combined the patient’s PS classification and age in order to determine which patients can be selected for surgery at OMIC-insured outpatient surgical facilities:
• Adults (age 15 and older) who are healthy (PS 1), have mild systemic disease (PS 2), or severe systemic disease that is not a constant threat to life (PS 3) are, as a rule, appropriate candidates for outpatient procedures. Patients with systemic disease that is a constant threat to life, or who are moribund, not expected to survive the procedure, or declared brain-dead (ASA PS 4, 5, and 6) may not have surgical procedures performed at OMIC-insured outpatient facilities.
• Neonates (0 to 30 days), infants under 6 months of age, and ASA PS 3 pediatric patients of any age should receive care only in centers that are specifically designed for patients of this age or complexity and that have equipment and qualified providers immediately available to handle all possible complications.
• Infants aged 6 months to 1 year and children age 1 to 14 years with PS 1 or 2 status can, as a gen- eral rule, be provided safe care at OSFs. Those in these age groups with PS 3, 4, 5, or 6 must be referred to centers that specialize in complex pediatric care.
Sedation Administered by Non-anesthesia Personnel
Sedation can pose significant risks for the ophthalmic patient because, in general, eye patients tend to be older than other surgical patients and may have comorbid diseases that complicate their anesthesia care. That risk is amplified when non-anesthesia personnel (i.e., ophthalmologists, registered nurses, and physician’s assistants) administer and monitor moderate (“conscious”) sedation to adults, or when any sedation is provided to pediatric patients (children under 15).
Patients receiving moderate sedation and all children can slip into deeper levels of sedation that approach general anesthesia and compromise their protective reflexes. To ensure that patients can be rescued from deeper levels of sedation, non- anesthesia providers who prescribe, administer, or monitor the effects of moderate sedation (including any pediatric sedation) must demonstrate an understanding of the pharmaco- logical agents/reversal agents and recognize the associated complica- tions of each, be able to rescue patients who enter a state of deep sedation, be capable of establishing an airway and/or providing positive pressure ventilation, and have advanced age-specific cardiopulmonary resuscitation skills (ACLS or PALS).
Monitoring Post-procedure Care
Ophthalmic personnel are highly skilled in the technical aspects of patient care. Many, however, do not have the licensure, training, or expertise needed to administer sedation, monitor and manage patients, and effectively respond to complications during the perioperative period. To protect patients, at least two staff members, one of whom must be a licensed health care provider with ACLS/PALS certification (e.g., the surgeon or a registered nurse), must be present until all patients have been dis- charged from the surgical facility.
If moderate or deep sedation or general anesthesia are adminis- tered, at least two staff members with ACLS/PALS certification must be present at all times until the patient is ready for discharge. If anesthesia other than straight local or peripheral nerve block is used, the patient must be monitored after the procedure/ anesthesia and up until discharge by a registered nurse or other licensed health care provider whose scope of practice includes post-anesthesia care for that age group.
The patient must meet all written, age-appropriate discharge criteria prior to discontinuation of monitoring and discharge. The decision to dis- charge a patient may be made only by the surgeon, the anesthesiologist/ CRNA, or the post-anesthesia care registered nurse and should be based upon established and pre-written discharge criteria. Prior to discharge, the patient and the responsible caregiver (if applicable) must be educated about postoperative care and given a copy of the discharge instructions. The instructions must address pain relief, activity restrictions, special diet requirements (if any), and wound and follow-up care, including the name of the physician providing follow-up care and the date of the appointment. The instructions also must clearly explain the symptoms of complications and instruct the patient when and how to contact the physician if any noted symptoms arise.
Support Available for OMIC-insured Facilities
OSFs presently licensed and/or accredited may already meet or exceed these requirements. We anticipate, however, that some OSFs may not yet meet all of the requirements and may need additional time or assistance to implement them. If your OSF will need more time to comply, please contact your under- writer to request an extension. As always, OMIC’s risk manager is avail- able for confidential advice and assistance, and resources to help with implementation are included at the end of the OSFA. While we recognize that change can be difficult, we are convinced that the practices we are requiring will reduce the liability risk of our policyholders and ultimately result in better, and safer, care of patients.
