Browsing articles in "Practice Issues"

Contact Lens Prescriptions- Patient Forms

To assist your practice with patient requests for contact lens prescriptions, the following sample-patient forms are offered below. We include a template for a Contact Lens Agreement that would reflect your practice’s policy regarding contact lens prescriptions. See the FTC Contact Lens Rule, effective 10/16/2020, for compliance requirements for contact lens prescribers: FTC CL Rule

If you have questions, please contact OMIC’s Risk Management group. Email us at riskmanagement@omic.com or call us at 1-800-652-6642, enter 4 for Risk Management.

Contact Lens Request – Denied Follow Up Care Needed

Contact-Lens-Prescription COPY Requested

Sample CL Prescription Received-Patient Signature

Sample CL Agreement- New FTC CL Rule effective 10-16-2020

Medical Record Request Includes Expired Contact Lens Prescription

 

Improving the Accuracy of Electronic Health Records

Anne M. Menke, RN, PhD, OMIC Risk Manager

As the discussion of the two closed claims involving EHR in the lead article shows, records can become unreliable if steps are not taken to confirm the accuracy of the information. In a study that evaluated changes in the medical record of an ophthalmology practice when an EHR was adopted, the authors found that the length of the record increased due to copy-and-paste, copy-and-forward, and all-normal functionalities.1 They raised concerns that the increased volume of EHR records would make it difficult to distinguish the critical findings from the background data and adversely impact the eye surgeon’s ability to effectively diagnose and treat the patient. An editorial in Ophthalmology described the type of errors that EHRs can introduce, noting that they have created serious and unintended consequences that need to be identified and addressed immediately to ensure the integrity of the EHR.2 Risk reduction strategies from these articles and other sources are discussed here.

Q What principles should guide the use of EHR?

A A basic principle is to “document what you do and only what you do.”2 Experts stress the importance of unique documentation for each patient encounter and warn that functions such as carry forward can lead to documentation of findings that were not actually seen.1 This has implications for billing, as noted later.

Q Given the risk of erroneous documentation, may I use functions such as copy forward? If so, what are considered “best practices” for copying and pasting or carrying forward prior entries?

A Yes. Most articles reviewed for this issue of the Digest acknowledge the need for these tools, especially since adoption of EHRs has been shown, at least initially, to negatively impact the physician’s productivity and decrease the number of patients seen in a day. Some documentation guidelines make a very useful distinction between historical data that is unlikely to change (what I will call “stable data”) and information that is expected to change(what I will call “variable data”). Variable data can “only be presumed to be correct at the time the health care team member obtained it.”3 Examples include the chief complaint, review of systems, physical examination, assessment, and plan, all of which will usually be different for each encounter. One organization allows each physician to copy forward his/her own variable data elements, but requires in its EHR policy that the physician edit the data to make them current. Furthermore, the organization prohibits physicians from copying variable data from the note of another physician. Other groups ban any use of the copy-forward function for variable data. Stable data elements include allergies, historical procedures and surgeries, previous medical history, previous developmental history, immunizations, family history, previous social history, and prior reports (pathology, cytology, radiology, procedures, etc.). One institution allows all EHR “authors” to copy stable data elements from prior entries whether or not the current physician obtained the information. It does caution that reports that are not new should be labeled as copies and that current reports should be prominently displayed.

Q Are there other risks besides inaccuracy if information is copied and pasted?

A The authors of the editorial in Ophthalmology noted not only the possibility of documentation errors, but also the risk of billing fraud. Indeed, the Office of the Inspector General of Health and Human Services (HHS) warned that some providers may be using the technology to game the system. For example, notes from office visits in EHR tend to be much longer and more detailed. Some computer programs incorporate the additional data elements into their billing algorithm and may inadvertently code the visit as more comprehensive than it actually was, leading to possible allegations of false claims and billing fraud. In malpractice lawsuits, plaintiff attorneys have also questioned how a physician could have obtained all the information recorded in a visit note in such a short time. Concerned about such billing and documentation issues, one organization asked its software vendor to program the EHR so that all copied data must be reviewed and verified by clicking on a button. If the information is not pertinent to the current visit, the policy states that the physician should not carry it forward into the current record. Physicians who use EHR systems without such a review button can use the free-text feature to indicate in their note that they have confirmed the accuracy of the data that has been carried forward.

1. Sanders DS, Lattin DK, Read-Brown S, Tu DC, Wilson DJ, Hwang TS, Morrison JC, Yackel TH, Chiang MFl. “Electronic Health Record Systems in Ophthalmology: Impact on Clinical Documentation.” Ophthalmology. 2013;120(9):1745-1755.

2. Silverstone DE, Lim MC. “Ensuring Information Integrity in the Electronic Health Record: The Crisis and the Challenge.” Ophthalmology. 2014;121(2):435-436.

3. University of Illinois Medical Center at Chicago Documentation Guideline. Key Content Expert: David Sarne, MD, EMR Documentation Committee, http://chicago.medicine.uic.edu/compliance/comp_ppg/.

 

Documentation Issues in Paper & Electronic Records

OMIC Digest-No-2-FINAL-7-14-14 revAnne M. Menke, RN, PhD, OMIC Risk Manager

When lawsuits against policyholders are resolved and the claim is closed, OMIC asks insured ophthalmologists about 1) risk management issues that were brought to their attention by the claim and 2) the steps they have since taken to reduce exposure to this type of claim in the future. In our most recent surveys covering the latter half of 2013, fully half of the answers to the first question and a third of the responses to the second were about documentation problems that had impacted the claim. To better understand the precise type of documentation issues that influenced the outcome of recent cases, I reviewed OMIC lawsuits that closed in 2012 and 2013. This article will address the most common deficiencies, in decreasing order of frequency.

Operative report

Not surprising for a surgical specialty, operative reports are carefully scrutinized in ophthalmic surgery lawsuits. In many claims, the operative report failed to mention complications that led to poorer than anticipated outcomes and unhappy patients. The majority of OMIC claims relate to cataract surgery, and the main documentation deficiency in the cataract claims reviewed for this article was the absence of discussion of capsule rupture. This is a known complication and if it is documented, disclosed to the patient, and managed well, the defense attorney would argue that the outcome was a maloccurrence rather than malpractice.

In one such case, a patient alleged persistent glare, halos, corneal edema, and extreme light sensitivity caused by an irregular iris following cataract surgery. The defense expert reviewing the case explained that he could not determine if the standard of care was met or not based upon the operative report as it did not mention that the surgeon had performed an anterior vitrectomy, removed the entire capsular bag, and somehow injured the iris. The defense expert surmised that the ophthalmologist encountered floppy iris syndrome but noted that the only action documented in the medical record to address it was to administer Atropine. The insured ophthalmologist consented to settle and OMIC paid $200,000.

Other operative note deficiencies include failing to document an adverse event (see Closed Claim Study); operative notes that were pre-dictated but not amended to address complications; lack of any operative note at all (a LASIK surgeon explained that if the surgery had no complications, he did not dictate a report; see the discussion of this case under “Telephone care”); and two operative notes, dictated one day apart, offering different accounts of the surgery (the plaintiff dismissed the case before the reason for the two forms could be explored; defense counsel felt they would have posed problems for a successful defense).

Preoperative decision-making

Complications arising from surgical care would not have happened if the surgery had never taken place. Attorneys representing patients thus review the preoperative decision-making process carefully to determine if the surgery was indicated. In one case, a patient who experienced irregular astigmatism after implantation of a premium toric intraocular lens filed a claim. The defense expert felt that the surgery was indicated and had no concerns about the intra- or postoperative care, but questioned why the preoperative evaluation did not include keratometry, topography, or refractions from the patient’s recent preoperative visits, which would have helped assess the amount and type of astigmatism prior to surgery. The patient did not pursue the claim and it closed without payment.

In another case, a patient sued after developing diplopia and excessive scarring when a lid lesion was removed. One defense expert felt that the scarring could not have been anticipated and that the patient had experienced a rare, idiosyncratic immune response. Another defense expert, who sees many patients with the same type of benign lesion, questioned the need to remove it. He also criticized the lack of documentation about why the surgeon decided to excise it, as the record did not contain any patient complaints about problems the lesion was causing. With the consent of the insured ophthalmologist, the case settled for $95,000.

Informed consent

The adequacy of the informed consent discussion is often challenged in lawsuits. It is more difficult to obtain informed consent when the patient has limited English proficiency. In one of the cases reviewed, a Spanish-speaking patient had cataract surgery complicated by posterior capsule rupture and anterior vitrectomy. He sued after losing all vision following a postoperative retinal detachment. The only consent form found in his medical record was for a clinical trial in which he was not a subject, and there was no documentation about the use of a translator during the informed consent discussion with the non-Spanish-speaking surgeon. While there was support for the care, the poor outcome and lack of evidence of consent convinced the ophthalmologist to settle the case, for which OMIC paid $200,000. Documentation of consent for limited-English-proficiency patients should include the language in which the discussion took place and the name and relationship of any translators. OMIC has recommendations on the use of interpreters for both limited-English-speaking and deaf patients on our website.

Examinations and tests

A number of lawsuits would have been defensible if key exam elements had been documented. The most frequent problem stemmed from failure to document dilated retinal exams in patients who were later diagnosed with retinal detachments. In one such case, the ophthalmologist recalled dilating the eye but worried that the jury might not believe him, as he lived in an area where juries tended to side with the plaintiff. He decided to settle and OMIC paid $100,000.

Another surgeon also reported performing a dilated retinal exam. At his deposition, he was questioned because his documentation was in two different colors. He testified that the documentation about the dilated exam might have been added after he learned that another ophthalmologist had diagnosed a retinal detachment. His case settled for $320,000.

Another case involved a physician who was asked to quickly examine a patient for a colleague. She confirmed that the patient had a retinal detachment in the periphery and accordingly advised the patient to return to his retinal surgeon for the necessary operation. The physician considered this to be a “curbside consultation” and so did not document the encounter. The lack of documentation presented problems when she was later named as one of the defendants in a lawsuit. Regardless of her limited involvement with the patient, by examining him, she had established a physician-patient relationship for which a record was required. Fortunately for this physician, the plaintiff agreed to dismiss her from the lawsuit.

Telephone care

Ophthalmologists take after-hours calls from their own patients and those of their call partners as well as from emergency rooms when they are on-call. OMIC has regularly had to settle cases when the call has not been documented by the ophthalmologist, and his or her recall differs from the patient’s account or what the emergency room physician documented. In one case, a patient called her ophthalmologist after LASIK surgery to report red, irritated eyes and was told to continue to take the drops prescribed to alleviate dryness. She called again while out of town to report worsening vision. She testified that the only advice she was given was to continue taking her drops. The physician recalls urging her to go the local emergency room but did not document either call. The patient developed an infection and corneal ulcer that left her with halos and night driving problems. The defense was complicated by the absence of documentation of the two phone calls as well as the lack of an operative note. As mentioned under “Operative report,” this surgeon felt there was no need for an operative report for uncomplicated refractive surgery. The case settled for $50,000. Our website has contact forms for after-hours calls.

Contradictory records

Before the advent of electronic health records (EHRs), documentation deficiencies were predictable, stemming from illegible handwriting, missing pages, untimely entries, and questionable accuracy.1 Problems also routinely surfaced with pre-dictated operative reports that, as noted previously, were not amended to address intraoperative complications. EHRs have successfully addressed the handwriting issues and have been credited with preventing some types of harm, such as medication errors stemming from wrong doses, routes, allergies, or drug-drug interactions. Nonetheless, EHRs have also created unintended consequences, including new sources of error and harm, as two OMIC cases illustrate.

In one case, a child presented to the emergency room, where the ER physician noted a dilated, non-reactive pupil with a shallow laceration in the lower lid conjunctiva. He diagnosed traumatic hyphema and contacted the on-call ophthalmologist, who asked that the patient see him in his office the next day. The ophthalmologist’s EHR record from that outpatient visit indicated essentially normal findings of a round, reactive pupil without afferent pupillary defect (APD), and a white and quiet conjunctiva. The only abnormal finding was cell and flare in the anterior chamber, which led to a diagnosis of traumatic iritis. Before the recommended return visit, the patient lost vision and was seen by a physician covering for the ophthalmologist’s practice. After eliciting a history of sickle cell disease from the mother, the second ophthalmologist asked her to bring the child right in. The vision was NLP, the pupil was fixed and dilated, IOP was 46, and there was a 4+ APD. Despite treatment, the child ended up with HM vision and the parents sued. The ophthalmologist who initially saw the child reviewed his note and realized with dismay that the EHR had populated it with many normal findings. He fully intended to change the note later in the day but forgot to do so when his clinic got busy; indeed, it had never been signed as complete. There was no documented IOP, but the physician clearly remembered that he checked it himself when the staff member needed to leave the room to avoid becoming sick when the child vomited. The documentation problems, combined with criticism of his decision to treat the child over the phone instead of going to the ER, led OMIC to settle the case with his permission for $380,000.

Similar problems surfaced in another case with EHR in which the plaintiff alleged a delay in diagnosis of a retinal detachment. On several visits, the exam findings contradicted the physician’s assessment. Once, the findings showed cell and flare, yet the ophthalmologist discontinued the steroid drops and gave the patient a long follow-up period. The defendant physician explained he would never have stopped the steroids if the inflammation had continued and attributed the discrepancy in the records to use of the “carry forward” function, which automatically populated the record with the previous exam’s findings. On another key visit, the findings showed normal retina vessels and clear vitreous, yet the assessment was retinal vasculitis, which had prompted the ophthalmologist to refer the patient to a retina specialist. Plaintiff experts and the subsequent treating physician felt that the retinal detachment had been present for some time yet was not detected by the ophthalmologist. Problems with the records helped convince the ophthalmologist to settle for $290,000.

Risk management documentation strategies

In the event of a malpractice claim, the medical record often becomes the most important evidence used to determine whether or not the physician met the standard of care. While ophthalmologists have the opportunity to testify about documentation deficiencies, the plaintiff’s attorney will use the discrepancies to challenge the ophthalmologist’s credibility and diligence. This review of ophthalmic lawsuits shows that ophthalmologists need to pay particular attention to noting in the operative report any complications and how they were managed; the decision-making process when determining a diagnosis and course of treatment; informed consent discussions about risks, benefits, and alternatives of the proposed treatment; key pertinent positive and negative findings; and telephone conversations with the patient and other physicians.

Electronic health records introduce new sources of error and confusion. A growing body of literature warns of the risks that certain features of electronic health records pose to the integrity of the medical record. An Institute of Medicine (IOM) report addressed what it terms “e-Iatrogenesis,” defined as “patient harm caused at least in part by the application of health information technology (HIT).”2 The IOM report, which analyzed events in hospitals, found many problems associated with the implementation of HIT, including inaccurate and missing data, but a low level of harm caused by it. OMIC’s claims experience similarly shows that—so far—EHRs have mostly impacted the defensibility of the care. Please see the Hotline article for advice on how to ensure that EHRs produce accurate, reliable accounts of care.

1. Boyd D. “The Risks of Electronic Medical Records: Defending the Record.” ASHRM Forum. 2013;Q3:4-5.
2. IOM. “Roadmap for Provision of Safer Healthcare Information Systems: Preventing e-Iatrogenesis.”

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.

 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.

 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?

 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.

 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?

 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?

 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.

 

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