Test Management System is Key to Prompt Diagnosis
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2013
The OMIC claims database includes cases where ophthalmologists needed to take prompt, decisive action but failed to do so. At times, physicians did not appreciate the emergent nature of the patient’s condition. Other times, physicians appeared to be on the right track but did not pursue the diagnostic process to completion by obtaining, reviewing, communicating, and following up on the results of diagnostic tests. This article will review the role other members of the health care team can play in helping maintain a robust test management system.
Q What is the best way to ensure that test results on hospitalized patients are reported to me promptly?
A Do not assume that the laboratory technician or nurse knows which tests need to be done urgently or which results you consider to be clinically significant. Give adequate information on the test order to guide the lab or imaging department, and provide ways to reach you both during and after office hours. Inform the nurse caring for the patient of your diagnosis, its consequences, and planned studies. Instruct the nurse to contact you as soon as the results are available. Include in your written order any symptoms that should be reported to you as well. “Mr. Avery has had more bleeding than expected. I am ordering a CT to check for intraocular bleeding. I will be performing surgery on another patient, but please contact me as soon as the results are in, and please watch the patient for any signs of increased bleeding, such as….” If the hospital has an electronic health record, be sure the alert system is on and you respond to any alerts that appear. Ask the circulating nurse in the OR to watch for these alerts if you are performing surgery.
Q I have a small practice and we do not have an electronic health record (EHR). How can my staff help track tests?
A Offices without EHR have created an effective tracking system using a simple Excel spreadsheet. Ask your front office staff to review your exam record or super bill for any tests and to enter each one into the Excel spreadsheet. Assign a staff member to check the tracking sheet daily and weekly and to contact the laboratory or consulting physician if results are not received in the expected time. If the patient did not present for the test or consultation, ask staff to contact the patient to determine why and report back to you for follow-up instructions.
Q May my staff member review the results?
A Your staff member may help by conducting an initial review and sorting the results, but you are expected to review and sign all reports and to arrange for another ophthalmologist to conduct the review when you are out-of-town. Normal results may be placed in a folder for you to sign and review at the end of the day; a copy of the results can be mailed to the patient and the original filed in the medical record with the notation “mailed to patient on [date].” The Excel spreadsheet can be updated to indicate “normal results, patient notified, no follow up.” It is helpful to send a document explaining the reason for the test and the meaning of the results. Abnormal results need careful handling. Staff should receive training and be provided with a written protocol on how to manage them. The protocol should identify test values that need a prompt response, such as those the laboratories have identified as critical or those you have determined to be clinically significant. Thank staff each time you are notified of such results to encourage them to interrupt you for these important messages.
Q How can I be sure that patients are notified of results?
A There are two methods that work well, especially when used together. While busy practices might prefer to only notify patients of abnormal results, patient safety experts agree that it is best to inform them of all results. One method is to inform patients of tests to be completed and ask them to address an envelope to be used to send them their results. Patients then know to watch for the results and have provided their most current contact information. Patients are asked to call the practice if they have not received the self-addressed envelope within a specified period of time. Another method, which ensures that test results are incorporated into the treatment plan, is to instruct staff to schedule a follow-up appointment for any patient referred out for testing or consultation so the results can be shared. Insist that the appointment be scheduled before the patient leaves the office so the patient is part of the appointment tracking system. When pulling records for the next day, ask staff to confirm that results from tests and consultations have been received. If not, have staff call to obtain them.
Release of Medical Records
Anne M. Menke, RN, PhD, OMIC Risk Manager
The HIPAA Omnibus Final Rule introduced new regulations for ophthalmologists and their staff to understand and implement. The need to update policies and procedures to address these changes provides a good opportunity to review some of the key federal regulations governing patient privacy and confidentiality that have been in effect since 2003. This Hotline article will address the release of medical records, and clarify when a patient’s authorization is needed and when the federal “minimum necessary rule” applies.
Q My patient is on anticoagulants. I need the latest results for the INR test done to monitor her levels. My technician called the patient’s primary care provider and was told we need a patient authorization to obtain this information. Is that correct?
A No. HIPAA anticipated that physicians would need quick access to information in patient records in order for healthcare to be delivered without delay. For that reason, the regulations make clear that a covered entity (healthcare provider, health plan, or clearinghouse) does not need to obtain an authorization if the information requested relates to treatment, payment, or healthcare operations (often labeled “TPO”). Diagnosing and treating conditions is the primary aim of care, so there are the least restrictions related to it. If a physician is part of the patient’s current treatment team, he or she should be provided any information requested, including a copy of the entire medical record. (Please note that certain types of records, such as psychotherapy notes, drug or alcohol treatment records, etc., have special protection under federal and state law and may need a specific authorization before being released. Ophthalmologists are unlikely to have copies of these records.) Ophthalmologists may release records for treatment to other healthcare providers, such as hospitals, ambulatory surgery centers, and pharmacies. The covered entities’ right to access and share this information is explained to the patient in the Notice of Privacy Practices.
Q My patient is unhappy with his premium IOL and has instructed his credit card company to stop payment. May I respond to the letter from the company? Do I need the patient’s authorization?
A You may respond to the letter from the credit card company without the patient’s authorization, as the query relates to payment for healthcare. Unlike requests for medical information for treatment purposes, however, you are required to limit the information you provide to the company to “the minimum necessary.” You could thus provide documents related to the patient’s choice of the particular intraocular lens, such as a copy of the consent discussion and consent form, for example, but not information related to other eye or medical conditions. It would be unusual to release the patient’s entire medical record to resolve a payment issue. The same need to limit information to the minimum necessary applies to the third part of TPO, healthcare operations. Operation activities include those that the healthcare provider asks other outside companies and individuals to perform on its behalf. The work OMIC performs for its policyholders falls into this category. Disclosures mandated by law, such as reporting communicable diseases, faulty medical devices, or child abuse or neglect, may also be made without an authorization. While the minimum necessary rule applies to disclosures for operations, you may at times need to provide more information, including the entire record. The main point to remember is that you need to evaluate what information is needed to accomplish the specific objective.
Q When do I need to obtain the patient’s authorization?
A You should assume that you need an authorization any time the request does not involve treatment, payment, or operations. Such an authorization is needed when the patient wants the records. Under HIPAA, the patient has the right to request a copy of his or her records, or to ask that the records be sent to someone else. If the patient is the one requesting records, then it is the patient who decides what information is released. As a general rule, unless the patient specifically asks that only some of the records be sent, you should release the entire record, including billing statements, correspondence and records from other providers, advanced beneficiary notices, etc. If you are not sure whether a document is part of the medical record, please contact OMIC’s confidential Risk Management Hotline for assistance by calling 800.562.6642, option 4, or by emailing riskmanagement@omic.com.
Reduce the Risk of Compounded Drugs
Anne Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2012
State and federal legislatures are reviewing changes in law to increase the safety of compounded drugs. Even before new laws and regulations go into effect, ophthalmologists can take action to reduce the risk of administering compounded drugs.
Q Am I required to use FDA-approved drugs instead of compounded ones?
A No. OMIC is not aware of any law that prevents physicians from choosing the drug or device they feel is in the best interest of their patient. Physicians should certainly be aware of whether there are FDA-approved medications available to treat the condition, and document the decision-making process that led to choosing one drug over another. Bear in mind that compounded drugs do not undergo the same premarket review for safety and efficacy as FDA-approved manufactured drugs.
Q What do I need to do to credential a compounding pharmacy?
A You need to perform due diligence by evaluating the compounding pharmacy’s licensure, accreditation, and compliance with laws and regulations. First, check with the board of pharmacy in your state. Ask the pharmacy board to send you your state laws governing compounding pharmacies; this will help you determine if state law requires the pharmacy to be licensed in your state, and whether a patient-specific prescription is needed before ordering drugs. Ask the pharmacy board if it is aware of any concerns about the particular company. Second, determine whether the pharmacy has achieved voluntary accreditation by the Pharmacy Compounding Accreditation Board (PCAB), an organization composed of eight of the nation’s leading pharmacy organizations. Third, gather information about the compounding process. The IACP has created The Compounding Pharmacy Assessment Questionnaire (“CPAQ”), a comprehensive tool to help the medical community assess and select a compounding pharmacy. It is available online at www.iacprx.org. Ask the pharmacy if it complies with the United States Pharmacopeia Convention (a scientific nonprofit standard setting organization) 797 standards for the compounding, transportation, and storage of compounded sterile products.[1] Go in and actually meet the pharmacists and inspect the facility. Determine where the compounding pharmacy’s raw products are obtained, if they are pharmaceutical grade for humans, and how batches are sorted and tested.[2] Ask what sample size the pharmacists use and whether they have sterility tests performed independently at an unaffiliated lab. Although price shopping is tempting, do not base your choice of pharmacy on cost alone.
Q What steps can my practice take?
A When ordering products, ask the compounding pharmacy to prepare the medication specifically for ophthalmic use, confirm the dose and sterility, identify the syringe suitable for the medication, provide storage and beyond-use instructions, and include a copy of the sterility tests with each order. Follow the storage and beyond-use instructions provided by the compounding pharmacy. Keep a log of medications that were compounded, and document the lot number in the patient’s medical record so that you can easily contact affected patients in the event of a recall. Follow current clinical guidelines on the proper aseptic technique during the preparation and administration of injections. Report any suspected adverse events following use of compounded products to the FDA’s MedWatch program at www.fda.gov/medwatch. For help with adverse events, recalls, and patient communications OMIC insureds are encouraged to contact OMIC’s confidential Risk Management Hotline by calling (800) 562-6642, option 4.
Q Am I required to obtain informed consent to administer or use compounded drugs?
A Informed consent is generally required for procedures or treatments whose risks exceed those that a lay person with average knowledge of medical issues would understand. The standard is not what a physician feels a patient should know, but what a prudent layperson would want to know. Informed consent is thus not required for a simple x-ray, but would be for fluorescein angiogram since the dye can cause fatal, allergic reactions. In the case of medications, physicians are expected to obtain informed consent from patients by explaining the condition, the expected benefit from the medication, known complications, and available alternatives. If the drug is being used off-label, that information should be part of the consent process. Prior to the highly publicized meningitis cases discussed in the lead article, it is unlikely that ophthalmologists explained to patients where they obtained their drugs. In the current environment, some patients may ask, and most patients would probably want to know. While it is not necessary to obtain the patient’s informed consent to use compounded drugs, be prepared to answer any questions patients may have about the issue. Practices and ambulatory surgery centers who use many compounded drugs may want to prepare an information sheet that explains what compounding is, and the steps the practice has taken to credential the compounding pharmacy.
1. Welcome to USP797.org, http://usp797.org.
2. Sellers S, Utian WH. “Pharmacy compounding primer for physicians: prescriber beware.” Drugs 2012 Nov 12;72(16):2043-50.
When Patients Won’t Pay for Care
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Winter 2013
Some patients who opt for high-deductible health insurance plans or go without insurance altogether decide to postpone or refuse recommended care. Some of these patients are perfectly willing to receive the care, but not to pay for it. When patients base their healthcare decisions primarily on financial considerations, they put their physicians in a difficult position. OMIC’s risk management team has received a number of calls from policyholders trying to balance their professional liability risk with their practice’s financial well-being. The following discussion assumes that the patient has some financial resources and provides general principles for dealing with this situation. In the case of indigent patients who have no financial resources, ophthalmologists may decide to provide care at little or no cost and/or help the patient find alternative sources of care. OMIC believes this is not only compassionate but also helps minimize the risk of a claim. Please call our confidential risk management hotline at 800.562.6642, option 4, for specific advice.
Q. My patient presented with a macula-on retinal detachment. I recommended that surgical repair take place within several days. When my surgery scheduler informed the patient of the price, the patient said he was not willing to pay and refused to sign a financial agreement form. Do I have to provide the surgery free-of-charge now that I have established a physician-patient relationship?
A. No. OMIC is not aware of any law or regulation related to outpatient, non-emergent care that requires a physician to provide free care. To our knowledge, the only situation in which patients have the legal right to obtain care without payment being an issue is in an emergency room. The law governing this care is the Emergency Medical Treatment and Active Labor Act, or EMTALA, and applies only to care provided in the ER, and only until a physician determines that the patient does not have an emergency medical condition (EMC), or that the emergency medical condition has been stabilized. If no EMC exists, or it has been stabilized, the hospital may then ask about the patient’s insurance status, and may then either provide further care with payment provided by insurance or on a fee-for-service basis. Hospitals provide patients who choose not to pay for non-emergent care information on where such care may be obtained outside the hospital. Ophthalmologists may also choose to refer patients who are not willing to pay for care to other possible sources of care.
Q. If I refuse to provide the care I am recommending unless the patient pays, am I “abandoning” the patient?
A. If you offer to treat the patient, you have not abandoned him. Clarify to the patient that you are available to provide the treatment, but that you expect to be paid for your care. Explain when the care is needed, what the consequences of not getting the care are, and where else the patient may go for care. Document the conversation, and provide the patient with a list of resources as well as a written discussion of the consequences of not getting treatment. Consider discharging the patient (see http://www.omic.com/terminating-the-physician-patient-relationship/ for a sample form).
Q. Should I provide emergent care even if my patient won’t sign a financial agreement?
A. While we are not aware of a law or regulation that requires physicians to provide any care for free except as discussed above in the context of EMTALA, we feel that the risk to the patient and physician alike is too great to refuse to provide emergent care when you have established a physician-patient relationship. Our risk management recommendation, therefore, is to provide the emergent care, and then address the patient’s financial obligations. If the patient continues to refuse to pay for care after the emergent condition has been treated, consider terminating the relationship.
Q. My patient showed up for an appointment for a non-emergent condition, but won’t pay her copay or deductible. May I reschedule the appointment?
A. Yes. As long as you are confident in the screening process your staff use to determine the appointment category, you may ask patients to come back when they are prepared to meet their financial obligations. See “Telephone Screening of Ophthalmic Problems”.
Ophthalmologists should consider developing a “Patient Financial Responsibility” policy and statement that clarifies what options are available for payment, and what consequences the patient might face if he does not meet his financial responsibility. Many sample statements are available on the internet.
Managing Medical Emergencies in the Office
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer 2012
Ophthalmologists and staff who work in an ambulatory surgery center or hospital operating room know that patients may have life-threatening cardiac or respiratory problems during a procedure. In these settings, emergency equipment and personnel with advanced training in the management of medical emergencies are on hand. Office-based eye surgeons and staff rarely have to confront such situations and may find themselves unprepared to provide safe patient care in the event of a life-threatening emergency. OMIC has had several cases related to death in the office setting. Lessons learned from these cases may provide assistance to our policyholders.
Q We perform fluorescein angiography (FA) in our office. I know that, in rare cases, patients have died from anaphylactic reactions. What should we have on hand when performing FA?
A FA is arguably the riskiest office-based procedure in ophthalmology. Based upon a review of expert witness testimony in related claims, it is clear that there is no need for a full “crash cart.” Ophthalmologists do not have the current competency to use most of the drugs and equipment found in crash carts, which are usually located in emergency rooms, intensive care units, and hospital wards. Moreover, few eye surgeons maintain Advanced Cardiac Life Support (ACLS) certification, and so should not attempt intubation or IV administration of emergency drugs. Both plaintiff and defense expert witnesses have opined that an “emergency kit” containing key drugs, such as Benadryl and epinephrine, along with oxygen and equipment to assist breathing (e.g., Ambubag and age-appropriate airways tubing), were adequate. They also recommended maintaining IV access until after the procedure was completed. There was disagreement about the need for an AED as these are only effective in treating arrhythmias.
Q What were the main criticisms?
A Rather than focusing on equipment, concerns centered on the lack of preparedness for a medical emergency. In two separate cases, family members were present and later testified that staff seemed harried and confused. They did not know where the oxygen tank and emergency kit were located and lost valuable time. In one case, there was disagreement about protocol and whether to call the anesthesia practice in the building, the code team from the adjacent hospital, or 911. When the anesthesia practice did not respond, they called 911, only to learn that only one of the building’s three elevators was large enough to accommodate a stretcher to the 10th floor, leading to a longer delay in getting emergency treatment. Neither practice kept the drug kit and oxygen in the room where the FAs were performed. And, clearly, neither had conducted emergency drills.
Q What is the best way to prepare a protocol for an ophthalmic office?
A Evaluate your patient population to determine the most likely and riskiest type of emergency situations, and review the types of procedures performed and anesthesia administered in the office. Offices that administer moderate sedation or perform procedures with a high risk of bleeding need more medications and equipment (see “Office-Based Surgery for Adults” at www.omic.com). Take into consideration the skill level of the physician and staff, the distance to the nearest emergency room, and 911 response time. This evaluation will help determine the materials needed in an “emergency kit.” Offices that do not offer FAs, moderate sedation, or higher risk procedures mainly need to know and recognize the signs and symptoms of medical problems common in adult patients, such as heart and lung conditions that put patients at risk for heart attacks and strokes. All physicians and staff members should have current certification in basic life support (BLS) for health care providers, which will allow them to do CPR if needed while awaiting the ambulance. Diabetic patients may also have hypoglycemic conditions, so a form of glucose should be available. Two persons, including a physician, should be available at all times when patients are in the office.
Q What is an emergency protocol?
A This is a document that describes the roles of the physician and staff members in the event of an emergency. Here are some common elements. One staff member should stay with the patient while another goes to notify the physician so that the patient’s condition may be evaluated. The physician should quickly determine if 911 needs to be called. The caller should give precise information about the patient’s condition and location and watch for the arrival of the ambulance. The physician should ask one person to document the patient’s condition and the exact sequence of steps taken to treat it (have a form available in the emergency kit). Family members, if present, may be able to assist by providing comfort to the patient. If not present, they should be notified as soon as possible. The protocol should also provide for a staff “debriefing” to collect information and provide support, as well as a plan for staying in contact with the patient and family.
