dialogues in healthcare - the rozovsky group · patient’s underlying condition had changed such...

Dialogues in Healthcare © 2010 All Rights Reserved

Dialogues In HealthcareDialogues In Healthcare

STRATEGIES FOR EFFECTIVE COMMUNICATION

Volume 4, Number 7 July 2010

The Risk of Last Minute Consent Communications It happens in hospitals. It happens in office-based surgery practices and in ambulatory surgery centers. The paperwork is all there: the H&P, the consent form, everything. And then “it” happens: a last minute consent communication. Sometimes the “it” involves a change in status for the patient. In other circumstances, the patient has made a last minute decision to curtail the scope of the operation. Alternately, a patient may have had “second thoughts” and now agrees with the surgeon to an expanded intervention. And then there are cases in which the surgeon decides to modify the procedure. When the “it” occurs, does this signal a change in the consent process? Is it merely a matter of crossing out information on the consent form and initialing the change? Should the care provider add an addendum to the consent form and have the patient sign it? Does it matter if “it” occurs after the patient has received some pre-op medication or does not have his or her reading glasses or hearing aides? Is it just an administrative formality or is there more to the changes required by “it”? A few examples illustrate the challenges of last minute changes during the pre-op process. More than an inconvenience, last minute changes in the surgical plan pose important challenges for an effective consent process and potential liability risk exposure. Effective strategies can help reduce such risk exposure.

A Publication of The Rozovsky Group, Inc./RMS

Fay A. Rozovsky, JD, MPH Editor

POWERED BY ONEBEACON PROFESSIONAL INSURANCE


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Examples of Last Minute Changes in the Consent Process. There are numerous examples, but a few highlight the issues involved in last minute changes during the consent process: Change in Surgical Site or Laterality – In the pre-op area the surgeon discusses the surgical plan with the patient. The patient is scheduled for a left-knee arthroscopic procedure. However, the surgical plan and consent form indicate that the scheduled operation is on the patient’s right side. “Joan, something is wrong with the paperwork. I recall we were doing the right knee first. Is that correct?” the surgeon asks. The patient, Joan, nods her head up and down indicating yes. The surgeon quickly crosses out the word “left” on the consent form, writes in the word “right” next to it and initials the change. However, he does not do so on the surgical plan.

In the operating room the doctor is “challenged” by a surgical assistant during the time-out process. “Doctor, something is not right. The consent form says “right” but the surgical plan says “left.” We cannot proceed until the two documents are reconciled and there is confirmation of the surgical site.”

Listing the Wrong Procedure on the Consent Document or Surgical Plan - In the medical office surgery practice the medical tech was having a particularly difficult day. One staff member had called in sick and the receptionist was at lunch so the medical tech was handling multiple tasks. In the middle of the confusion, the medical tech was assembling the paperwork for the afternoon patients. While answering the phone, the medical tech mixed up the procedures to be done on two patients. A patient who was scheduled to have a minor plastic procedure on his right ear was listed as having a brow lift.

The patient was chatting with the nurse anesthetist scheduled for his case. He said, “I have a question. Why did the medical tech do all this work on my forehead? I am supposed to have an operation on my right ear.” The nurse anesthetist replied, “Really? The paperwork says you are scheduled for a brow lift. I will have to check on it.”

Listing the Wrong Diagnosis on the Consent Document or Surgical Plan – Mary Banes had undergone a screening colonoscopy when it was discovered she had a tumor that needed to be removed surgically. On



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both the surgical plan and the consent document her diagnosis was listed as LCIS (lobular carcinoma in situ) of the left breast.

“I am speechless. I do not know how anyone could have made this mistake. Ms. Bane’s here to remove that colon tumor. She does not have breast cancer,” said the surgeon. He continued, “I will just cross out the diagnosis and correct it on both forms and we shall be all set.” The nurse replied, “I am sorry doctor, but it is not that simple. We have to confirm the procedure and verify the consent process. The procedure will have to be delayed.” The surgeon shouted, “Are you crazy? What am I suppose to tell my patient?”

The Wrong Surgeon’s Name is on the Consent Document and Surgical Plan – In the surgeon’s office Mike Paho signed a consent document authorizing the surgeon for a procedure to relieve carpal tunnel syndrome of the right hand. The surgeon, Dr. Janeesh, co-signed the form and gave a copy to Mr. Paho. After Mr. Paho left the office, Dr. Janeesh completed the surgical plan using an on-screen form for this purpose. He entered his electronic signature in the “Surgeon’s Name” box of the form.

On the day of the operation, Dr. Janeesh said hello to the operating room supervisor and asked who was assisting him on the surgical procedure. The operating supervisor replied, “Paho? You must be mistaken Dr. Janeesh, I have your partner, Dr. Iglanti, listed as the surgeon. Look here at the print out.” Even though Dr. Janeesh insisted that he was the surgeon, the operating supervisor was adamant. “I am sorry doctor. There is nothing that I can do about it at this stage. Your patient has received pre-op medication and is in no condition to verify what you are telling me.”

The Consent has Expired per Institutional Policy and Procedure – The community hospital consent policy stated that surgical consents are valid for thirty days following the patient signing the document. An exception was included in the policy and procedure for situations in which the



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patient’s underlying condition had changed such that the surgery could not be performed in the absence of a new consent document. Barry Naughten signed a surgical consent on June 3, 2010 for a left foot bunionectomy. Mr. Naughten had postponed the procedure because his wife had to undergo an emergency cesarean section on June 18, 2010. The procedure was rescheduled for July 9, 2010. Mr. Naughten reported to the day-surgery unit at 9:00 AM on July 9th for the procedure scheduled at 11:00 AM. He had gotten all the way through the anesthesia provider administering a powerful pre-op medication when a nurse told the podiatric surgeon that she had a problem.

“Dr. Tetherington, your patient’s consent form is invalid. I have been getting all the paperwork ready for the procedure and I just noticed that the consent expired a few days ago. I wish I could do something about it, but the patient is out of it. The pre-op medication really looped him. Anesthesia says he cannot sign anything.”

The Risk Exposures in Last Minute Pre-Op Consent Communications. Each of these scenarios involves a common problem: a breakdown in the consent process. Each scenario demonstrates the importance of consent documentation in achieving effective communication in treatment authorizations. Indeed, when used effectively, consent documentation can identify risk-prone practices that can be stopped before culminating in adverse outcomes. What might be possible adverse outcomes in the case scenarios and other cases in which there are last minute consent communications? Consider the following: Medicare Billing and Coding Issues – Much of the National Coverage Determinations (NCDs) dealing with wrong site, wrong procedure, wrong patient revolve around procedures that are “not consistent with the correctly documented informed consent for that patient.’’1 The context for the NCDs can be found in the National Quality Forum (NQF) Serious Reportable Events.2 The outcome can have significant repercussions in terms of billing and coding since the NCD extends beyond acute care



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organizations and encompasses physicians who participate in Medicare Part B.3 As pointed out in another Medicare document the sweep of this “no payment” approach is interpreted to include:

All services provided in the operating room when an error occurs are considered related, and therefore, not covered.

All providers in the operating room when the error occurs, who could bill individually for their services, are not eligible for payment.

All related services provided during the same hospitalization in which the error occurred are not covered.4

The Effect on Private Payers – Health insurers and health plans may take a stance in their provider agreements that are similar to the NCDs from Medicare. The premise is that if Medicare will not pay for erroneous invasive and surgical procedures, they too will refrain from doing so. Litigation – Inaccurate or untimely consent documentation can be used as evidence of a breach of a standard of care in litigation. Claims might include breach of informed consent, negligent consent, and professional negligence on the part of physicians, nurses and other care providers. If a healthcare organization fails to intervene to prevent the wrong procedure or an operation on the wrong site, there could be liability, especially if it knew or ought to have known through the documentation and its employees that there was a problem. The same can be said with wrong patient procedures. Regulatory Scrutiny, Fines And Penalties – Situations have occurred in which healthcare facilities have been investigated and fined for the failure to follow regulatory framework with regard to the consent process and documentation requirements.5 Under many state healthcare professional licensure laws it is also possible that practices that ignore consent requirements could culminate in individual regulatory entanglements. Credentialing and Employment Issues – If there is a trend or pattern of non-compliance with consent requirements resulting in NCDs non-payment and private payer non-payment, there may be grounds for corrective action under applicable medical staff bylaws and employment requirements. The prospect of economic credentialing aside, the failure to follow consent and documentation requirements can jeopardize patient safety and the quality of care, factors that might motivate corrective action or employment sanctions.



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Financial Costs with Rescheduling – If scheduled elective procedures have to be postponed because of errant consent documentation, there can be a substantial financial cost to the organization and care provider. For patients, what might be perceived as an “inconvenience” by healthcare providers and institutions may mean significant logistical and financial costs. Adverse Publicity and Loss of Market Share – Highly publicized consent cases can have an adverse impact on the community’s trust of providers and organizations. Angry patients whose procedures have to be postponed because of inaccurate pre-op and consent “paperwork” may go to the press or vent their reaction on blogs, websites, and social media pages. The result may be loss of market share until confidence is restored in physicians, hospitals and other care facilities. Strategies for Managing Last Minute Consent Communications. There are a number of practical strategies to consider when controlling last minute consent communications. These strategies include:

1. Reinforce Consent Communication Fundamentals. Recognize that many of the scenarios described earlier can be avoided by following the basic tenets of the consent communication and documentation process as follows:

a. A person must be able to exercise his or her thought processes in order to make a treatment choice. The fact that the patient has received pre-op medication that may blur such abilities should raise a caution flag over any changes to the consent process or related documentation.

b. Consent is first and foremost a communications process that is recorded in documentation.

c. The consent process and documentation should reflect all the recognized elements of the decision-making process.

d. The consent process and documentation process at a minimum should meet the requirement of state law, and when applicable, Medicare Conditions of Participation.

e. A care provider should not cross-out, initial and date information on the consent document that has been signed and dated by the patient or surrogate. If information is inaccurate in the documentation, it may signal the need to revisit the consent communication process.



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f. The documentation of the completed consent process is a useful tool in furthering patient safety, quality outcomes and serves as important information for billing and coding and legal defense.

2. Emphasize the Patient’s Responsibility in the Consent Process.

Encourage care providers to reinforce individual responsibility with patients and surrogate decision-makers. Ask them to set reasonable expectations about what can happen on the day of a scheduled intervention should the patient present unprepared, without necessary medical clearance from a primary care provider, or a condition or illness that necessitates postponing a test or treatment. [See Sample Tool]

3. Encourage Demonstrated Competencies in the Consent Process. Think about orientation and in-service training on the consent process that challenges participants how to respond to scenarios like those described earlier. For those who provide responses inconsistent with applicable law or policy and procedure, take the time to provide one-to-one education.

4. Set Clear Expectations in Consent Policy and Procedure.

Eliminate any ambiguity about the core elements of, and individual role and responsibility for, completion of the consent process. Provide guidance on managing exceptions such as medical emergencies or a patient withdrawing consent to treatment.

5. Anticipate Consent Issues During the Pre-Op Process. Recognize that challenging consent issues may occur during the pre-op process that may necessitate postponing or cancelling an elective invasive test or procedure. Take into consideration such issues as:

a. A care provider’s decision to modify the surgical site after the patient has received pre-op medication and is unable to discuss such a change with the care provider.

b. Inaccuracies in consent documentation, including the patient’s diagnosis, diagnostic or surgical intervention or name of the care provider.

c. A patient’s request to modify the intervention. d. Expired consent documentation.

Provide in policy and procedure clear direction for staff to address

such consent issues, including use of chain of command protocols.



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6. Monitor and Address Anomalies in Consent Documentation.

Use risk management and performance improvement data to identify anomalies in consent documentation. Understand that such data may suggest the need for updated in-service education, changes in policies and procedures, and consent practices.

Conclusion. Last minute consent communications may signal an incomplete decision-making process. Although often done with the best of intentions, such last minute changes may have a ripple effect that goes well beyond the diagnostic or therapeutic authorization. Last minute change conversations do not contemplate the set up of the interventional or surgical suite or staffing requirements let alone possible changes in the anesthesia plan. Effective communication includes a “systems check” prior to the date of an elective diagnostic or therapeutic intervention. Such “systems check” measures include reminders about prep to be completed home, the importance of reporting any changes in medication or condition that may necessitate postponing the intervention, and reporting on time. Such brief discussions whether by phone documented by a nurse or medical tech or recorded electronically through a secure portal become part of the layers of communication documentation. It is an extended “speed bump” that can be recorded along with the pre-intervention “Time Out” process. Even though care providers might wish to accommodate a patient’s last minute wishes, the prudent approach is to stay the course and follow the agreed upon plan. To do otherwise could set off a cascade of unwelcome consequences. DDIALOGUES IN IALOGUES IN HHEALTHCAREEALTHCARE is a publication of The Rozovsky Group, Inc./RMS. This publication is

not intended to be and should not be used as a substitute for specific legal advice. Readers should obtain specific legal advice in managing discussions with patients and patient families. Contact Information: The Rozovsky Group, Inc./RMS, 272 Duncaster Road, Bloomfield, CT 06002. Tel: (860) 242-1302.



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1 Department of Health and Human Services, CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Transmittal 102 (hereinafter NCDs, Transmittal 102) (July 2, 2009). 2 National Quality Forum, ‘‘Serious Reportable Events in Healthcare: A Consensus Report,’’ (2002). NCDs, Transmittal 102 noted that the document had been updated to include 28 serious adverse events. See National Quality Forum, ‘‘Serious Reportable Events in Healthcare—2006 Update: A Consensus Report’’ (2007). 3 NCDs, supra note 1. 4 MLN Provider Inquiry Assistance, Job Aid 64505, July 8, 2009. 5 “Compliance Order and Deficiency Report,” R.I. Dept. of Health, November 3, 2009 at http://www.health.ri.gov/discipline/hospitals/RhodeIsland200911.pdf. See also, D. Suchetka, “C. C. Corrects Consent-Form Violations and Other Problems After Inspection, July 19, 2010, accessible at: http://www.cleveland.com/healthfit/index.ssf/2010/07/investigation_of_cleveland_cli.html.



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Sample

Pre Op Patient Education Tool

As part of the consent process, please make certain that the patient or surrogate receives the following information. It will help to set expectations about the need for possible postponement or cancellation of a scheduled elective diagnostic or therapeutic intervention. Further, from a patient safety perspective, it helps identify “change in condition” that merits further review before proceeding with the scheduled intervention. Finally, it reminds the patient or surrogate that last minute changes to the care plan to expand or modify the procedure are discouraged.

[In practices with paper consent documents, include a signed, dated and timed copy of this tool in the patient record. For those with electronic medical records, please complete the “sign in” drop down box on the EMR consent tools furnished to the patient.]

An Important Reminder

Approximately 48 to 72 hours prior to your scheduled procedure, expect to receive a telephone call from this office to confirm a number of details, including:

a. Type of procedure.

b. Pre-procedure preparation to be completed at home.

c. Recent changes in medication, including over-the-counter, non-prescription, herbal, or natural substances added by another physician, care provider or the patient. Please be ready to provide the names and amount of these preparations.

d. Recent changes in condition, including temperature, sore throat, asthma, infections.

e. Recent visits to other care providers or facilities for treatment including retail clinics, urgent care or walk-in clinics, dentists, optometrists or podiatrists. Please be ready to provide the names and contact information for these providers or facilities as it may be necessary to get further information prior to the scheduled procedure.



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CALL THIS OFFICE IMMEDIATELY

Up to the date of your scheduled procedure, please telephone the office if you have had any of the following:

A change in medications prescribed, ordered or recommended by any care provider, including physician assistants, nurse practitioners, podiatrists, dentists, or optometrists.

Diagnosis of new medical or dental conditions by other care providers.

Recent visits to urgent care, walk-in clinics, retail clinics, or emergency units or hospitals.

If you call after 4:30 PM, leave a message and someone will call you the next business day. We will use the information you provide to decide if it is necessary for you to come back to the office for a visit or to change the date for your scheduled procedure.

Please Understand:

A change in your condition may necessitate postponement of a scheduled elective procedure.

Unless you decide not to proceed with the scheduled procedure, our practice policy is to avoid last-minute changes to the planned diagnostic or therapeutic procedure.

Patient Name

Signature

Surrogate Name

Signature

Date Time

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