Texas Medical Liability Trust

2013 Volume 6

Do you know your cyber liability risks?

IN THIS ISSUE:

TMLT the Reporter

theREPORTER PROUDLY SERVINGTexas physicians and policyholders since 1979 with quality coverage and responsible pricing.

T

(Continued on page 2)

by John Southrey, CIC, CRM

CYBER LIABILITY AT TMLT

MLT has received more than 100 cyber liability claims

from policyholders since adding cyber liability coverage to all policies in Decem-ber 2011. The majority of these claims involved breaches of electronic protected health information (ePHI) stored on unencrypted computers and mobile devices that were either stolen or lost. These incidents were all possible violations of HIPAA privacy laws.

A CYBER EXTORTION CLAIMAmong the more sinister cyber claims reported to TMLT was a cyber extortion claim involving more than 6,000 electronically stored patient records.

A physician arrived at his practice and was unable to access his electronic patient records. A cyber criminal had hacked the practice’s servers and installed “ransom-ware” to encrypt the medical records and deny access to them. The hacker left a message demanding several thousand dollars before he would decrypt the files and permit access to the records.

1Do you know your cyber liability risks?

6CME Activity: Avoiding seven common malpractice pitfalls

28Prescription Access in Texas database (PAT)

S P E C I A L I S SU E : includes 2.5-hour CME activity

2 TMLT the Reporter

The physician immediately notified the FBI Cyber Crime Division and local police about the data breach. He contacted the TMLT claim department to initiate coverage under his cyber liability policy. The physician also hired an attorney to assist with reporting the breach to the U.S. Department of Health and Human Services (HHS).

HHS enforces the breach notice provi-sions of the HITECH Act. Under HITECH, health care providers are required to report a breach of unsecured PHI to HHS if the breach involved the “impermissible use or disclosure of” PHI of more than 500 individuals. Notifi-cation is to include the affected patients and local media. HHS also places a press release about the breach on its website. Providers are required to report the breach to HHS within 60 days after its discovery.

The physician’s attorney hired a forensic computer specialist to recover the inaccessi-ble patient records. A media release vendor and a fraud detection/credit monitoring vendor were hired. The physician incurred expenses for a call center to answer patients’ questions. These direct costs did not include the potential damage to the physician’s rep-utation resulting from the media reports and patient notifications.

The physician received a letter from the Office for Civil Rights (OCR) notifying him of their investigation of the breach. (OCR is responsible for enforcing federal privacy laws.)

“Please be advised that the U.S. Depart-ment of Health and Human Services (HHS), Office for Civil Rights (OCR) received your breach notification report on …, 2013, pur-suant to the HITECH Breach Notification Rule, 45 C.F.R. § 164.408 and § 164.414.

Per the notification, you reported to OCR that … [the clinic] might not be in compliance with the Federal Standards for Privacy of Individually Identifiable Health Information and/or the Security Standards for the Protection of Electronic Protected Health Information (45 C.F.R Parts 160 and l64, Subparts A, C, D, and E, the Privacy and Security Rules). Specif-ically, you reported a breach of approxi-mately 6,300 patients’ protected health information by a hacker that infected your network and encrypted your medical re-cords. The hacker then demanded money in return for allowing access into your medical records. These allegations could

reflect violations of 45 C.F.R. §§164.502(a), 164.530(c), 164.404, 164.406, 164.308(a)(1)(ii)(A), 164.308(a)(1)(ii)(B), 164.308(a)(5)(ii)(B), 164 308(a)(6)(ii), 164.308(a)(7)(ii)(A), 164.308(a)(7)(ii)(B), 164.312(a)(1), and 164.312(c)(1), respectively. …

Covered entities must cooperate with OCR during a complaint investigation (45 C.F.R §160.310(b)) and permit OCR access to its facilities, records and other informa-tion during normal business hours or at any time, without notice, if exigent circum-stances exist (45 C.F.R. §160.310(c)). …

If we are unable to resolve this matter voluntarily, and if OCR’s investigation results in a finding that [the clinic] is not complying with the Privacy and Security Rules, HHS may initiate formal enforce-ment action, which may result in the impo-sition of civil money penalties. . . We have enclosed a separate fact sheet explaining the penalty provisions under the Privacy and Security Rules. The fact sheet also ex-plains that certain violations of the Privacy and Security Rules may be subject to crimi-nal penalties, which the U.S. Department of Justice is responsible for enforcing.

Under the Freedom of Information Act, we may be required to release this letter and other information about this case upon request by the public.”

Also attached to this letter was a “data request” consisting of a three-page matrix of checklists that cited numerous potential compliance failures. The physician had only 14 days from the date of the letter to provide the requested information, including docu-mentation of his “internal investigation and corrective action regarding the incident” and proof that a HIPAA Security Rule risk analy-sis was done.

The physician is still dealing with this matter and will be for quite some time. It is not clear what corrective actions the OCR will require of the physician’s practice. In the inter-im, he has retained new IT staff and imple-mented new privacy and security protections.

The ransom demand was never paid and the forensic computer specialists were unable to re-store all of the medical records from the original server. The physician paid and incurred expens-es for this claim that exceeded the $50,000 limit of his TMLT cyber liability coverage.

A cyber criminal

had hacked the

practice’s servers and

installed “ransom-

ware” to encrypt the

medical records

and deny access to

them.

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FINES AND PENALTIES CAN BE SERIOUSAs of September 23, 2013, all health care providers were required to comply (there are a few exceptions) with the expanded privacy protections mandated in the HIPAA Omnibus Final Rule. The Omnibus Rule is a comprehen-sive update of the regulations enacted under the HIPAA Privacy and Security Rules that expanded the rights of patients and tightened federal breach notification requirements. The Privacy Rule applies to all forms of PHI (oral or recorded in any form or medium) and the Security Rule applies only to ePHI.

Under the Security Rule, covered entities are required to implement suitable administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of patients’ ePHI. They must also conduct an analysis of the risks and vulnerabilities of their ePHI. The OCR expects organizations to have reasonable and appropriate safeguards in place to protect patients’ ePHI — especially if that information is accessible over the Internet.

Providers are becoming increasingly exposed to unauthorized access, acquisition, use, and disclosures of unsecured PHI/ePHI that could result in costly violations. Breach vulnerabilities are abundant in health care. A workforce that is untrained about privacy and security protocols;4 storage of unencrypted ePHI especially on portable devices; ongoing hacking and virus attacks; and privacy breach-es by disgruntled employees represent several possible exposures. It is widely recognized that health care IT lags other industries in employ-ing adequate privacy and security practices.

In 2012, OCR Director Leon Rodriguez stat-ed that health care providers need to get their HIPAA policies and procedures in working or-der or they will face more audits and increased civil monetary fines.

Two recent data breach examples involving ePHI are representative of the OCR’s call-to-action.

1. In 2012, Phoenix Cardiac Surgery of Phoenix and Prescott, Arizona agreed to pay HHS a $100,000 settlement and take corrective action to employ pol-icies and procedures to safeguard the PHI of its patients.

The OCR’s investigation found the practice was posting clinical and surgical appointments for its patients on an In-ternet-based calendar that was publicly

accessible. The OCR also found Phoenix Cardiac Surgery had implemented few policies and procedures to comply with HIPAA Privacy and Security Rules and had only limited safeguards in place to protect their patients’ ePHI.

Mr. Rodriguez highlighted this case as a warning. “We hope that health care providers pay careful attention to this resolution agreement and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compliance no matter the size of a covered entity.”

2. For the first time, the OCR pursued a HIPAA breach of less than 500 patient re-cords. The Hospice of North Idaho (HONI) reported to HHS that an unencrypted laptop computer containing the ePHI of 441 patients had been stolen in June 2010.

In 2012, HONI agreed to pay a $50,000 settlement to HHS because HONI did not conduct a security risk analysis to safeguard the ePHI of their patients and they did not have policies or procedures in place to address mo-bile device security, as required by the HIPAA Security Rule.

Once again, Mr. Rodriquez used this case to admonish the health care community. “This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information. Encryption is an easy method for making lost information un-usable, unreadable and undecipherable.”

With penalties and random audits expected to escalate, it is imperative for health care providers to carefully identify their risks and vulnerabilities to a data breach and to employ privacy and security policies and procedures to safeguard all PHI.

On September 1, 2012, Texas House Bill 300 (HB 300) became effective and it significantly revised the Texas Medical Records Privacy Act for covered entities who store PHI. HB 300 in-creased a provider’s cyber liability exposure by adding more stringent safeguards than those found in HIPAA and HITECH.

TMLT has received more than 100 cyber liability claims from poli-cyholders since adding cyber liability coverage to all policies in December 2011.

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THE MESSAGE IS CLEAR Providers must dedicate sufficient attention, resources, staff training, and systems to comply with state and federal laws to minimize their risk of violations and reputational harm. It appears assertive enforcement of data breach-es by the OCR will fall hard, particularly on health care providers who have clearly failed to address and remedy privacy and security issues. The liabilities and potential assessment of civil penalties associated with such failures can inflict heavy time and financial burdens.

All covered entities should review their HIPAA policies and procedures, conduct a risk assessment, update their Notice of Privacy Practices, and generally ensure they are in compliance. Specifically, physicians should:

· update their HIPAA notice of privacy practices;

· conduct a HIPAA security risk analysis;

· revise HIPAA employee training to comply with the 2013 changes required by the Omnibus Rule, HB 300, and by Senate Bills 1609 and 1610;

· revise Business Associate Agreements to include the language required under the HIPAA Omnibus Rule and HB 300 to obtain written assurances that your Business Asso- ciates will similarly protect patients’ PHI;

· implement technical safeguards such as encryption to all ePHI stored on portable devices or that is electronically trans-mitted; and

· develop breach notification policies and procedures and a response plan for staff.

CYBER LIABILITY COVERAGEHealth care providers can transfer some of their cyber-related risks by purchasing cyber liabil-ity insurance. TMLT includes cyber liability coverage limits of $50,000 per claim subject to a $50,000 aggregate per policy period, with the option to purchase increased limits up to $1 mil-lion. As illustrated by the cyber extortion claim, the base policy limits may be inadequate and the purchase of higher limits is often recommended.

TMLT’s cyber liability coverage includes:

· privacy regulatory defense and penalty coverage;

· security and privacy liability coverage;

· multimedia liability coverage;

· network asset protection coverage (in-cluding business interruption);

· privacy breach response costs, patient notification expenses, and patient support and credit monitoring expenses coverage;

· cyber extortion coverage; and

· cyber terrorism coverage (including business interruption).

PRIVACY AND SECURITY RESOURCESKeeping up with the changes to privacy and security laws and the latest cyber threats can be overwhelming. TMLT offers fee-based tools for physicians to update their privacy and security policies and procedures and to mini-mize the risk of violations. These tools include the following.

· TMLT’s Privacy and Security Toolkit is designed to educate physicians about applicable federal and state medical privacy and security laws, including the changes mandated by the Texas Medical Records Privacy Act.

· TMLT’s HIPAA Privacy and Security Risk Analysis is designed to review HIPAA Privacy and Security Rule standards on protecting patients’ personal health information. TMLT representatives use the National Institute of Standards and Technology 800-66 Tool to conduct a comprehensive risk analysis. This service also includes a review of Texas privacy and security laws and requirements.

TMLT staff is also available to assist physi-cians with other practice-based concerns, such as:

· post-implementation EHR assessment to improve EHR/EMR use; and

· training employees on policies and proce-dures related to federal and state privacy and security regulatory requirements.

These direct

costs did not include the potential

damage to the

physician’s reputation

resulting from the

media re-ports and

patient no-tifications.

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For more information, contact Stephanie Downing at stephanie-downing@tmlt.org or 800-580-8658 x4884.

RESOURCES1. htpp://www.hhs.gov/ocr/privacy (for

HHS Guidance)

2. http://www.csrc.nist.gov (for National Institute of Standards and Technologies information)

3. Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information www.HealthIT.gov/mobiledevices

4. Understanding your Cyber Liability Cov-erage http://resources.tmlt.org/PDFs/cyber-liability-brochure-2013.pdf

5. U.S. Department of Health and Human Services. Breaches affecting 500 or more individuals. Available at http://www.hhsgov/ocr/privacy/hipaa/administra-tive/breachnotificationrule/breachtool.html

6. American Medical Association. The Health Insurance Portability and Ac-countability Act (HIPAA) omnibus final rule summary. Available at http://www.ama-assn.org/resources/doc/washing-ton/hipaa-omnibus-final-rule-summa-ry.pdf

7. HHS’ Office for Civil Rights (OCR) has developed an array of tools to educate consumers and health care providers about the HIPAA Privacy and Securi-ty Rules, including a video titled The HIPAA Security Rule for small providers to help them establish basic safeguards and to comply with the Security Rule’s requirements. The videos are available at http://www.youtube.com/user/USGov-HHSOCR

8. The OCR has also developed three mod-ules for providers about compliance that is available at Medscape.org:

· Patient Privacy: A Guide for Providershttp://www.medscape.org/viewarti-cle/781892?src=ocr

· HIPAA and You: Building a Culture of Compliancehttp://www.medscape.org/viewarti-cle/762170?src=ocr

· Examining Compliance with the HIPAA Privacy Rulehttp://www.medscape.org/viewarti-cle/763251?src=ocr

John Southrey can be reached at john-southrey @tmlt.org.

Health care providers can trans-fer some of their cyber- related risks by purchasing cyber liability insurance.

6 TMLT the Reporter

OBJECTIVES

On completion of this course, the physician should be able to describe ways of avoid-ing these seven common pitfalls that contribute to malpractice claims and hinder the physician’s defense:

1. failure to communi-cate with patients;

2. maintaining illegible or incomplete documenta-tion;

3. inappropriate actions by office staff;

4. failure to or-der or follow up on test results;

5. failure to refer, to track referrals, and to commu-nicate with the referring physician;

6. prescribing medications inappropri-ately; and

7. failure to obtain and document informed consent.

Avoiding seven common MALPRACTICE

PITFALLS

CMEActivity

COURSE AUTHORJames Schutte, PhD is a writer and editor who specializes in medical risk manage-ment issues. He received his PhD from Southern Methodist University in human physical growth and development, and completed postdoctoral research fellow-ships in cardiology and pulmonary medi-cine at the University of Texas Southwest-ern Medical Center.

Dr. Schutte is the author of the textbook, Preventing Medical Malpractice Suits: A handbook for doctors and those who work with them (Hogrefe & Huber, 1995), and has written several popular risk management courses for TMLT.

DISCLOSUREDr. Schutte has no commercial affiliations/interests to disclose related to this activity.

TARGET AUDIENCEThis 2.5-hour activity is intended for physi-cians of all specialties who are interested in practical ways to reduce the potential for medical liability.

CME CREDIT STATEMENTPhysicians are required to complete and pass a test to earn CME credit. A passing score of 70% or better earns the physician 2.5 CME credits.

TMLT is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. TMLT designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credits.TM Physi-cians should claim only the credit commen-surate with the extent of their participation in the activity.

ETHICS STATEMENTThis course has been designated by TMLT for 1 credit in medical ethics and/or profes-sional responsibility.

PRICINGThe following fee will be charged when accessing this CME course online at www.tmlt.org/cme.

Policyholders: $25 Non-policyholders: $100

CME DISCOUNTTMLT policyholders who complete this program will earn a 3% discount (maximum $1,000) that will be applied to their next eligible policy period.

INSTRUCTIONSthe Reporter CME test and evaluation forms must now be completed online. After reading the article, go to www.tmlt.org/cme. Log on with your myTMLT user name and password to access the course. Follow the online in-structions to complete the forms and down-load your certificate.

If you do not have a myTMLT account, please call customer service at 800-580-8658 ext. 5050.

Questions about the CME course? Please call 877-880-1335.

ESTIMATED TIME TO COMPLETE ACTIVITYIt should take approximately 2.5 hours to read this article and complete the questions and evaluation form.

RELEASE/REVIEW DATEThis activity is released on November 15, 2013, and will expire on November 15, 2016.

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1To address this problem, TMLT has iden-

tified seven avoidable pitfalls they frequently encounter while examining malpractice claims. These pitfalls both contribute to the circumstances that may have led to the pa-tient’s injury and hinder TMLT’s ability to ef-fectively defend the doctor. Note that there is a great deal of overlap between these pitfalls because they mostly involve similar types of errors committed in different situations. It is important to address them separately be-cause each requires a different solution.

To illustrate how these pitfalls give rise to malpractice claims, this article will use anec-dotes from actual Texas medical malpractice claims that were drawn from court records or the TMLT closed claim files. 1 Because malpractice claims typically involve multiple allegations and complex legal arguments, most of the anecdotes have been simplified to illustrate a single point. Thus, the anecdotes should be considered as “based on” the actual incidents. Also, when a claim is settled, the agreement usually contains a privacy clause that prevents divulging the dollar amount of the settlement.

One final note — this course is presented

for general educational purposes only. The author is not an attorney, and noth-ing herein should be construed as legal advice. If you have specific questions or concerns about professional liability issues, especially those involving events

that have already taken place, please contact the TMLT Risk Management Department at 800-580-8658.

1. FAILURE TO COMMUNICATE WITH PATIENTSNothing is more basic to a working therapeutic alliance, good clinical practice, and optimal risk management than effective physician- patient communication. Your communica-tion skills are also important to your patients’ satisfaction with your care and their percep-tions of your professionalism and competence. A 2009 survey of patients identified the top three physician characteristics that patients ranked as “important” or “very important.” The characteristics were “pays attention to my concerns” (90 percent); “is compassion-ate” (83 percent); and “speaks in terms I can understand” (83 percent). 2 Further, a review of studies published between 1949 and 2008 found that patients were significantly more compliant with medical care provided by physicians whom patients judged to be good communicators compared with those with poor communication skills. 3

INTRODUCTION

When a malpractice suit is filed against one of its policyholders, TMLT claim supervisors go to work evaluating the merits of the case. Too often, claims are settled due to faulty communication and doc-umentation practices.

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More to the point of this course, a physi-cian who communicates well with patients is less likely to be targeted by a malpractice suit. A study by pediatrician Gerald Hickson and colleagues at the Vanderbilt University Medical Center found that those physicians who were sued most frequently also generat-ed the most complaints about their interper-sonal skills, even by patients who had never filed a malpractice claim. 4 A well-informed patient is not only better able to comply with your instructions, but is your single best ally in preventing a malpractice suit.

An example is shown by a TMLT closed claim involving a 44-year-old man who was referred by his family physician to an inde-pendent imaging center after conservative therapy failed to alleviate his back pain.

The patient arrived on a Thursday after the center’s radiologists had left for the day, so technicians performed an MRI of his lumbar spine. The next day, the first radiologist re-viewed the films and developed a differential diagnosis that included tumor, hematoma, or osteomyelitis in the L4 – S1 region. In order to confirm this impression, he ordered a gadolinium study to be completed within 72 hours. Reasoning that his report would not be complete without the gadolinium study, the first radiologist did not dictate a preliminary report. He asked the center’s staff to contact the patient and schedule the study.

The first radiologist went home early, and was not aware that his staff attempted to call the patient using a nonworking telephone number provided by the patient’s family phy-sician. Though the patient’s intake form listed his correct telephone number and address, the staff did not review it. Neither the patient nor the family physician were advised of the need for the additional study.

Saturday morning, the patient came to a hospital emergency department (ED) com-plaining of back pain radiating down both legs. He informed the ED staff of his MRI on Thursday, and that he had not been contacted about the results. The ED staff then contact-ed the imaging center asking for the written report. The imaging center staff contacted the first radiologist at home, and he instructed them to have the radiologist on duty review the films and prepare a report.

Although the second radiologist would later claim that he prepared a hand-written report confirming the need for a gadolinium study and that he faxed it to the ED, the ED

did not receive it. The imaging center was un-able to produce the original report or verifica-tion that it had been faxed to the ED. The ED physician and staff reported receiving only an oral report of findings that included degener-ative disease and a mild diffuse posterior disc bulge, along with foraminal stenosis and a compression fracture.

Based on this report and his own evalua-tion, the ED physician diagnosed back pain and a herniated disc and discharged the patient. On Sunday the patient returned to the ED complaining of the inability to feel or move his legs. A second MRI revealed a spinal epidural hematoma, and a neurosurgeon promptly initiated decompressive surgery.

The patient was ultimately diagnosed with cauda equina syndrome and secondary incom-plete paraplegia. The patient subsequently sued, alleging in part that the first radiologist breached his duty by failing to communicate a possibly emergent condition to either the pa-tient or the referring family physician, a direct violation of the American College of Radiology reporting standards. The case was ultimately settled with a payment on behalf of both ra-diologists, the imaging center, and the hospital.

Although many physicians are reluctant to discuss the “worst case” scenario with their patients early on, had the patient in this case been informed that a potentially disabling di-agnosis was being entertained, he would have shared this information during his first visit to the ED. The likely outcome would have been an immediate surgical consult and treat-ment. Another issue is that, when a potential-ly urgent or emergent situation is involved, you should call the patient yourself, or at least confirm that your staff actually spoke with the patient and conveyed the information.

Begin by listening William Osler said it best: “Listen to your pa-tient, he is telling you the diagnosis.” The prob-lem is, a physician who’s overworked, running behind schedule and struggling to catch up too often cuts the patient off before gathering the information needed to make a correct diagnosis.

A study published in the Annals of Internal Medicine found that, on average, physicians interrupt the patient 18 seconds into the explanation for the visit. 5 This is important because the first symptom the patient lists may not be the most significant, and may not even be the main reason for the visit. This can lead to “premature closure” in which the phy-

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sician arrives at a presumptive but incorrect diagnosis because he or she failed to elicit all the symptoms and medical history that would point to the correct diagnosis.

Suppose, for example, your patient is a secretary in her early 30s who describes symp-toms of pain and numbness in her left wrist. If you immediately focus on a presumptive diagnosis of repetitive use syndrome, she may not have a chance to explain that the pain often radiates down from her shoulder, and that it’s sometimes accompanied by pain in her jaw, tightness in her chest, and profuse sweating.

One tactic for avoiding premature closure is to encourage patients to bring lists of their symptoms and complaints. While you may dread such lists, they can actually provide a very efficient way of prioritizing the visit. By scanning the list, you can quickly deter-mine which symptoms may be related, which should be addressed now, and which can be addressed during a later visit.

However, the most important step in avoiding premature closure is to listen to your patient without interrupting. Physicians of-ten interrupt out of fear that the patient will talk endlessly if allowed. However, repeated studies have found that patients who are not interrupted will rarely talk for more than two minutes. And allowing them those two min-utes is important — not just for establishing a diagnosis — but so patients know that you care enough to listen to their concerns, and not rush them through the medical equivalent of an assembly line.

Be aware that body language speaks louder than words. No matter how sincere your tone of voice, if you roll your eyes while saying “I feel really badly for you,” the patient will perceive the opposite. Likewise, drumming your fingers, checking your watch, or standing with one hand on the doorknob all convey the message “make it quick—I have better things to do.”

Sit down, make eye contact, lean slightly forward, and acknowledge what is being said by nodding or an occasional “I see.” Do not take notes as your patient is speaking, as this makes you appear distracted. Instead, pause the conversation. “You’ve given me some very important information. Let’s stop for a few seconds so I can write it down.”

After your patient has finished, summarize your understanding. “So you’ve been having a lot of abdominal pain lately, which you think is probably stress-related, but you want to make sure it’s not something more serious.

Have I covered everything?” If the patient disagrees, keep working until the patient is satisfied with your summary.

Ask your patients what they think may be causing their symptoms or if they have expe-rienced the symptoms in the past. The patient with abdominal pain may be aware that she was diagnosed with a gallstone years earlier, and did not receive treatment for it. Yet she may not volunteer that information unless you ask.

Finish with an open-ended question, such as “Is there anything else you’d like to tell me?” Patients with high anxiety levels may have trouble getting to the core reason for the visit, especially when it involves fears of cancer or other serious diagnoses. When you sense this, consider a little friendly prodding along the lines of “Something else seems to be worrying you. Why don’t you tell me about it?”

Show empathyYour patients want you to care about them as people. When they’re suffering, they want you to show that you relate to their pain and share their sorrow, even if there’s nothing you can do about it.

Too often, physicians try to distance them-selves from adverse developments, fearing that any expression of sorrow or regret will be equated with an admission of responsibility. Yet your patient will interpret a dismissive attitude of “Oh well, these things happen” as “I really don’t care.”

Showing empathy is as simple as talking to patients the way you would talk to your friends. Ask about how their illness or injury is affecting them and how they’re coping. Connect with their feelings, show respect for their efforts to cope, and offer reassurance. “I know this is terribly hard for you, and I feel badly for you. I think you’re handling the situation better than I could, and I admire that. Just know that I’m here for you, and I’ll do everything I can to help.”

If you talk to your patients like friends, that’s how they’ll perceive you. And people rarely sue their friends.

Speak in simple terms and verify with teach-backNo one wants to look foolish, and patients may nod and pretend to understand you, even though you might as well be speaking to them in a foreign language. For most patients —in-cluding many who are well educated — that’s exactly what medical terminology is.

Also, be aware that even patients who

10 TMLT the Reporter

understand the words you’re using may have trouble grasping the concept. For example, some patients think in very literal terms, such that the simple instruction “take one pill twice a day” will leave them befuddled as to how they’re supposed to take the same pill twice.

If you don’t know how to explain your pa-tient’s diagnosis or treatment on a basic level, the websites en.wikipedia.org and medscape.com provide patient-friendly explanations of most medical conditions and treatments. While it is okay to direct patients to such websites, you still have a duty to personally educate your patient. Where appropriate, illus-trate your explanations with models, pictures, diagrams, and sketches.

Finally, verify your patients’ understand-ing with teach-back. Have them repeat your instructions in their own words. At times, you will be astounded at how little they compre-hend, but this is the best way to clarify any misunderstandings. In the process, you will learn how to explain things more clearly.

Explain your rationaleAssume you’ve just diagnosed hypercholes-tremia in a patient and prescribed a statin. The patient comes back in a month, and his cholesterol is still too high. You prescribe a higher dose of the same drug. A month later, the patient returns and his cholesterol is still too high, so you prescribe a different statin. There’s a good chance your patient will think you’re just guessing and not a very good physi-cian, and may seek care elsewhere.

Now assume that you explain your rationale up front. “I’m going to start by prescribing the lowest dose of the drug that has the fewest side effects. Not all drugs work the same in every patient, and the dose may not be high enough to get your cholesterol down to normal. If not, we’ll try a higher dose of the same drug. And if it still doesn’t work, we’ll try a different drug. The one I’m prescribing today is a generic that you can get filled in most pharmacies for around $5 a month.”

Explore noncompliance While some patients ignore medical ad-vice out of simple apathy, you should never assume this to be the case because there are a host of other reasons that might be driving noncompliance. The patient may stop taking his calcium channel blocker because he’s no longer experiencing headaches. Or perhaps he was experiencing unpleasant side effects.

Then again, it may be that he had the mis-taken assumption that all antihypertensive medications cause impotence. Or he doesn’t get the prescription filled because he’s unin-sured, money is tight, and he doesn’t know how much it will cost.

One way to monitor compliance with medication orders is to have patients bring the bottles of all their current medications with them to every visit. For patients you see regularly, a quick check will allow you to see if all your prescriptions are being filled and whether the patient is taking them as directed. This is especially useful for elderly patients with fading memories, many of whom take multiple medications.

The best time to address noncompliance is when the treatment is prescribed. Ask a simple question, “Can you think of any prob-lems you might have in following my instruc-tions?” If your plan does not work for the patient, try to negotiate a mutually agreeable alternative on the spot.

If your patient does not comply with the agreed treatment plan, explore the reasons in a non-confrontational manner. “I’m con-cerned that you’re not taking your medication regularly. This could have serious conse-quences for your health. Tell me about the problems you’re having with the medication, and let’s see if we can find a solution that works better for you.” Be sure to document this conversation.

Keep your patients oriented to the flow of the visitMany patients dread medical exams, espe-cially those that involve pain or being touched in sensitive areas. You can help alleviate their anxiety by telling them what you’re doing and sharing your findings as you go.

Always answer three critical questionsSome patients may not be able to absorb and process all of the information you communi-cate to them. However, you should routinely use teach-back to ensure that every patient knows the answers to these three critical questions at the end of every visit:

· What is my main problem?· What do I need to do?· Why is it important for me to do this? 6

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22. MAINTAINING ILLEGIBLE OR INCOMPLETE CHARTSIllegible physician handwriting is a standing joke, but one you may not find so funny when a plaintiff ’s attorney shows the jury a blown-up copy of your indecipherable chart notes. Never forget that the purpose of the medical chart is to provide for continuity of patient care. The excuse of “But I can read them!” offers no defense if another caregiver cannot.

Further, medical records are legal doc-uments, which the Texas medical statutes require you to create and maintain. The failure to maintain adequate medical records is a frequent cause of disciplinary actions by the Texas Medical Board (TMB) and hospital peer review committees.

If you simply cannot write legibly, consider using a transcription service. Or better yet, a software program that allows you to dictate your notes into your computer or smart phone, making corrections as you go. If your practice uses electronic health records (EHRs), most systems allow you to download your dictated notes directly into the patient’s chart. While EHRs will eliminate legibility problems, given that all entries must be typed, they cannot compensate for failure to obtain and document the necessary information.

Yet another reason to improve your docu-mentation practices is that the new ICD-10 code sets — currently scheduled to go into effect October 1, 2014 — require a much great-er level of specificity. Whereas the current ICD-9 has under 18,000 code combinations, the ICD-10 has more than 160,000. If your claims are coded by an assistant or outside billing service, failure to provide complete and accurate documentation will result in a number of problems, not the least of which is a decrease in your income.

Document the medical historyYou were taught in training to take and docu-ment a complete medical history because that is the best way to reach an accurate diagnosis and avoid medical errors. You have probably adopted a few timesaving shortcuts since then. Just be aware that if these shortcuts dimin-ish the quality of care you deliver, and if they result in a malpractice suit, the benefits of any shortcuts will be dwarfed by the consequences.

Advances in genomic medicine have made family history more important than ever, espe-cially in screening patients for familial cancer risk. 7 Yet one study that reviewed the charts

of primary care physicians found that only 55 percent documented the patient’s family cancer history. Those that did rarely contained enough information to provide an adequate assessment of familial risk. 8

Where relevant, obtain prior medical re-cords from other providers, review them, and document your summary of how they affect your own diagnosis and treatment plan.

Document your own findings and actionsMany physicians are reluctant to document the differential diagnosis out of fear that it can be used against them if a patient sues over a wrong diagnosis. In reality, careful documen-tation showing that your diagnosis was reason-able and within the standard of care will be your best defense against a missed or delayed diagnosis claim.

Do not assume that test and consultation reports speak for themselves; document your impression of them. This is especially important when the report is inconsistent with your clinical impression or diagnosis. Also document your plan of care because this allows you to pick up where you left off during the last visit, and reminds you of what tests or consultations to order next.

Finally, document each scheduled appoint-ment, including no-shows. If a third-party asks for documentation of a visit, you won’t get paid if you don’t provide it. Creating doc-umentation after the fact from memory can cause many problems and should be avoided. Documenting no-shows is important because they are evidence of noncompliance.

Above all, never attempt to backdate new chart entries or alter existing ones. Altering a chart may undermine your defense. The TMLT closed claim files are overflowing with otherwise defensible claims that had to be settled because the physicians altered the medical record. Nothing you could hope to gain from altering the chart is worth the risk.

If you’re faced with even the threat of a malpractice claim, secure the chart in a safe place and call the TMLT Claim Department immediately. Follow their instructions and advice.

Document all conversations with patientsEvery communication with your patients, including phone calls and emails, should be documented. It is especially important to document conversations involving informed consent, and even more so when the patient

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3declines recommended treatment.

An example why is shown by a claim involving a 61-year-old man who came to his local ED complaining of chest pain, a burning sensation in his left chest and epigastric area, and shortness of breath. The patient had a long history of coronary artery disease, and experienced his first myocardial infarction (MI) at age 47.

The patient was transferred and admitted to another hospital by his regular cardiologist. Ten years earlier, while under the care of the same cardiologist, the patient had undergone cardiac catheterization that revealed severe to total blockage of all major coronary arter-ies. Despite undergoing angioplasty at the time, a repeat catheterization nine months later revealed little improvement. The patient elected to forego further procedures in favor of medical management. He had been doing well until the current admission.

The cardiologist performed an echocar-diogram and ECG, which revealed multiple abnormalities, including a septal infarction, marked S-T changes, and an ejection fraction of 26 percent. According to the cardiologist, the patient declined cardiac catheterization and elected to return home after three days in the hospital. However, this discussion was not documented in the chart.

The day after his discharge, the patient died of an myocardial infarction. His survivors filed suit against the cardiologist. During the trial the plaintiffs presented expert testimony that the cardiologist had been negligent in discharging the patient without offering him catheteriza-tion and further treatments, which would likely have saved his life. Defense experts countered that, in light of the patient’s medical history, it was entirely reasonable that he would refuse interventional treatment. The cardiologist was within the standard of care in accepting the patient’s decision to be discharged.

The problem was, the cardiologist had no documentation that this conversation ever took place. In situations like this, where the defense is largely based on the physician’s unsubstantiated recollections, juries may side with the plaintiffs.

Even in he said-she said situations in which the plaintiff also testifies from an uncorrob-orated memory, the jury may well find the plaintiff more believable because physicians talk with dozens of patients every day, and may not remember every conversation.

Yet another reason for documenting con-

versations is that, while you may share a warm and trusting relationship with a patient who would never dream of suing you, the family might not share those feelings. The good news is that your contemporaneous documentation of patient conversations will likely trump a plaintiff’s uncorroborated allegation of what was or was not discussed.

3. INAPPROPRIATE ACTIONS BY OFFICE STAFFNever forget that you can be held vicarious-ly liable for patient injuries resulting from actions by your staff or others you supervise. Even experienced, trusted employees with the best intentions will sometimes expose you to liability by overstepping their roles.

An example of this comes from a TMLT closed claim involving a one-year-old boy admitted to a community hospital for an ade-noidectomy and bilateral tympanostomy. The infant’s father signed a consent form speci-fying that anesthesia would be performed by the anesthesiologist “or his/her associates, all of whom are credentialed to provide anesthe-sia services at this health facility.”

The anesthesia was to be performed by a CRNA employed by the anesthesiologist’s professional association, along with a student in training to become a CRNA, for whom the anesthesiologist served as clinical instructor.

The anesthesiologist was not present in the hospital during the procedure. This was despite the American Association of Anes- thesiologists guidelines recommending that, when nurse anesthetists administer anesthesia, the supervising anesthesiologist remains “physically available for the imme-diate treatment of emergencies and provid-ing indicated postanesthesia care.” 9 Also, the un-credentialed student was allowed to administer anesthesia under supervision of the CRNA, in violation of the consent docu-ment and the Texas Occupation Code. 10

Anesthesia was induced at 7:20 a.m. and ended at 8:30 a.m. During the procedure, the records indicate that the infant was infused with 625 mL fluids and medications, but the urine output was not recorded. Upon extuba-tion by the student, the patient exhibited signs of a laryngospasm and his pO2 dropped to the 30s. The student applied a chin lift and gave oxygen by mask, and the laryngospasm ceased within one minute; however, the respirations remained shallow and the pO2 dropped when-ever the mask was removed.

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The patient arrived in the post anesthesia care unit (PACU) at 8:35 a.m. Initially pink in color, he quickly became cyanotic and was reintubated at 8:40 a.m. Although the patient had already received 625 mL of fluids, an IV of Ringer’s Lactate was started. Urine output in the PACU was recorded as 355 mL. A chest x-ray revealed diffuse density over both lung fields, consistent with fluid overload or possi-ble aspiration. The anesthesiologist was paged and arrived at 8:50 a.m. He ordered furosemide to treat the pulmonary edema and arranged transfer to a children’s hospital.

Arterial blood gases were drawn at 8:45 a.m. and 9:50 a.m.; both showed a pO2 in the 80s. A second x-ray taken at 9:35 a.m. showed improvements, but with new right upper lobe and perihilar infiltrates. On admission to the children’s hospital, the patient was sedated and placed on a ventilator. His pupils were 2 mm and reactive, but all four extremities were hypotonic. An x-ray taken at 1 p.m. showed the lungs were clear.

The patient self-extubated at 11 p.m. the same day, and the ICU physician on duty de-cided not to reintubate. At 8:25 the next morn-ing, the patient experienced acute decompen-sation requiring reintubation and stabilization of electrolytes. He subsequently developed pneumothorax and pneumomediastinum. Although he received immediate treatment for both conditions and ultimately survived, he sustained moderate to severe brain damage consistent with hypoxic-ischemic insult.

The parents sued the anesthesiologist and his professional association for negligent supervision, failure to obtain appropriate in-formed consent, and vicarious liability for the negligence of the CRNA and student. The case was settled.

Define staff duties in writingPractices are advised to have a printed manual that defines job descriptions for each position as well as practice policies and procedures. If you do not have such a manual, order a customizable template that conforms to Texas laws.

Each employee should be provided with a copy, and required to sign a statement that he or she reviewed the manual and agrees to abide by it as a condition of employment. This will be important to your defense should an employee who was fired for violating policies and proce-dures sue for wrongful termination.

Job descriptions must conform to licensing

requirements. Do not ask or allow an employee to perform a task that requires a license the employee does not possess. Also, make sure that all employee licenses are current and that they have met their continuing education requirements.

Only a licensed nurse, PA, or physician should triage patients who call in or present in person with potentially emergent symptoms. You are responsible for any medical advice given to patients by any non-physician you employ or supervise. Texas Senate Bill 406 — signed into law in June 2013 and effective on November 1, 2013 — expands the autonomy of physician assistants and advanced practice nurses. It allows the physician to delegate to them the authority to prescribe even Sched-ule II drugs. 11 All other office staff, including nurses, should document any medical advice they give in the patient’s chart, which should be reviewed by you the same day.

Patient privacy must be respected at all timesIf you treat Medicare patients, you are re-quired by the HIPAA Privacy Rule to appoint a privacy officer whose main duty is to ensure that everyone in the practice, including physi-cians, is kept current with ongoing updates to the Rule. Above all, everyone in the practice is required to be trained that patient privacy must be protected at all times whether at work or not.

Only providers involved in the patient’s care should be permitted access to the entire chart. All other medical staff should be permitted access only to the information they need to perform their specific duties.

For example, those involved in coding and submitting billing claims should only be permitted access to chart notes from unbilled visits. Even employees listed on a patient’s HIPAA form as someone with whom you are permitted to share health information should be instructed to not access that patient’s chart except for work-related purposes.

If your practice uses an EHR system, each employee who has reason to access patient charts should be provided with a unique pass-word and instructed to never share it with any-one. The password should limit the employees’ access to only those parts of the record needed to carry out their duties. The system should track who accesses what information, and you should review the tracking record periodically to guard against unauthorized browsing.

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44. FAILURE TO ORDER OR FOLLOW UP ON TEST REPORTSYou owe a duty to read and follow up on any tests you order; a rule that applies even in situations where a specialty over read has been ordered. The only exceptions are when another provider personally agrees or is contractually obligated to take over that duty. An example of the latter applies to physicians who do shift work in the ED, where contracts generally specify that the physician on duty is required to follow up on any test reports that arrive during his or her shift.

An example of the importance of tracking is provided by a closed claim in which a man, 75, was transported by ambulance to an ED. The patient had left-sided chest pain radiat-ing to his neck, pallor, and diaphoresis. The emergency medicine physician (EM) ordered two ECGs and monitored the patient for 85 minutes after the triage nurse’s assessment.

Although the triage nurse’s assessment list-ed the chief complaint as chest pain, the EM apparently did not review the nursing notes because that complaint did not appear in his own note. The EM diagnosed indigestion and prescribed metoclopramide. He discharged the patient without reviewing the ECGs.

The cardiologist who interpreted the ECGs the next morning called the EM and advised that the patient was suffering an acute MI. The EM then called the patient and instructed his wife to bring him back to the ED immedi-ately. The patient returned by ambulance, but died 50 minutes later. His wife filed a lawsuit against the EM and the hospital alleging failure to diagnose, failure to follow up on a diagnostic test, and failure to provide timely treatment.

Medical consultants who reviewed the claim were critical. The case was settled on behalf of both defendants.

Further complicating this case was the physician’s failure to read the triage nurse’s assessment. Reading the nursing notes is important because the patient, having already described his or her symptoms to the nurse, may assume that this information has already been brought to your attention and may make no further mention of it.

Ordering appropriate testsRemember that you are responsible for following up on test results. There have been several recent lawsuits involving situations in which physicians have been sued for failing

to follow up on abnormal findings that were incidental to the physician’s diagnosis or treatment.

A far better approach, not only from a legal perspective, but also that of utilization and patient safety, is to follow written, evidence- based diagnostic protocols published by the relevant medical specialty societies. To promote the use of the most current guide-lines, the Department of Health and Human Services maintains an online repository at www.guidelines.gov where you can search and download diagnostic and treatment protocols for most conditions.

In addition, the American Board of Internal Medicine has launched its Choosing Wisely initiative to reduce over-utilization by iden-tifying tests and procedures that should not be performed unless specifically indicated. So far, 26 medical and surgical specialty societies have contributed lists of the top five tests and procedures most over-utilized in their respec-tive specialties, along with advice on when and when not to order them.

Those lists can be downloaded from the Choosing Wisely website at www.choos-ingwisely.org. Also, most EHR systems have embedded protocols that will automatically suggest tests to order.

By leading you down the path that is most likely to be productive, the protocols eliminate waste by having you order only those tests that are clinically indicated. They also provide you with legal protection. A Harvard survey of malpractice plaintiffs and defense attorneys found that documented adherence to a recog-nized clinical guideline not only increased the odds of the physician winning a malpractice suit, but the failure to follow one significantly increased the odds of a plaintiff’s verdict. 12

The authors go on to point out that their findings under-estimate the true legal protec-tion of following protocols because, when the physician documents his or her adherence to practice guidelines, plaintiff’s attorneys are considerably less likely to file a claim in the first place.

Tracking test reportsA common source of malpractice claims is the failure to keep track of test and consultation reports. If you do not have a tracking system in place, a significant report will eventually slip through the cracks.

A difficult situation is created when pa-tients are told that they will only be contacted

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if their test results are abnormal. If a signifi-cant report is lost or misfiled, the patient is left to assume that “no news is good news.”

Here’s a common scenario: An abnormal report comes back, but since the patient is coming back in a day or two, the report is placed in the chart to be discussed during the visit. The patient is a no-show, and the chart gets re-filed. Not until the next visit, which may be months or even years later, does the physician become aware of the situation. By then the patient’s disease has advanced significantly, and the phy-sician may be sued for the delay in diagnosis.

Fortunately, a reliable tracking protocol is easy to implement, and should be printed and reviewed with everyone on the office staff. These are the steps to follow.

· Patients are instructed to expect a call back for each and every test ordered, even if normal, and to call in on their own by a specific date if they have not heard from your office. This step alone will catch most lost reports.

· All tests or consult reports should be logged as they are ordered. The log should include the date that the report is expected.

· When a report comes back, the date it arrives is entered into the log. The log is reviewed daily for overdue reports, and the lab or consultant is contacted to check on the report’s status.

· All reports are placed in a special file until reviewed by the physician. Staff are instructed to never place reports in the patients’ record until the report has been reviewed by the physician, who initials and dates it.

· Normal results may be reported back to the patient by office staff. The date and time of each attempt to contact the patient should be recorded. The date and time that the patient was actually notified of the report are then recorded in the log.

· Abnormal results are flagged and placed in a different file until someone (pref-erably you) contacts the patient. Again, the time and date of all attempts to reach the patient should be documented. If the patient does not respond to phone calls or other attempts at contact, send the pa-

tient two letters, one by regular mail and one by certified mail, with return receipt requested. In the letter, advise of the ur-gency of the situation and the importance of follow up. Even if the letter is returned unread, save it as evidence that you made every reasonable attempt to contact the patient. Abnormal reports are flagged as such in the log.

· When the patient is contacted, a fol-low-up visit is scheduled. The date and time the patient was informed of the abnormal report is entered into the log.

· The report is entered into the patient’s chart and the chart flagged with the date and time of the follow up visit. The flagged chart is not to be re-filed until after the visit.

· At the end of the day, patients with flagged charts who failed to show are contacted to remind them of the im-portance of follow up and rescheduled. Again, document all attempts at contact and send two letters if the patient does not respond.

· Only after the patient has been seen in follow up is the chart to be re-filed. The date and time of the visit is entered into the log.

Providing follow-upEven when you transfer care to another doc-tor, you do not transfer the duty of following up on test reports you ordered, unless that physician is informed of the existing or pend-ing report and specifically agrees to provide follow up. This is especially important to remember when you transfer a patient with pending test reports.

If you are a referral specialist who orders a test that shows an abnormal finding outside your specialty — such as a cardiologist who orders a chest x-ray that reveals a suspicious lung shadow— it is appropriate to call the referring primary care provider and reach an agreement as to which of you will follow up on the findings. Just be sure to document the oral agreement in a letter and forward it to the provider, along with a copy of the report.

Even if the other physician will be taking over followup, advise the patient directly of the potential seriousness of the situation.

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55. FAILURE TO REFER, TRACK REFERRALS, AND COMMUNICATE WITH THE REFERRING PHYSICIANAll physicians need to put patient safety first, know their own limitations, and when in doubt, refer out or seek a second opinion. But simply arranging for the patient to be seen by a specialist does not mean you have made an effective referral, as shown in the following closed claim.

A general internist became the primary care provider for a 56-year-old man. During the new patient history and physical, the internist reviewed the patient’s medical records, which included a calcified thoracic herniated nucleus pulposus (HNP) that had been diagnosed by a neurosurgeon four years earlier.

The neurosurgeon had recommended sur-gery, advising the patient of the possibility of acute deterioration resulting in paraplegia and incontinence. But after being advised of the risks of surgery, the patient opted against it. A routine physical examination was performed and the neurological findings were normal.

The patient saw the internist regularly over the next 18 months and did not complain of back pain. Seven months after his last visit, the patient returned with complaints of low back pain. Noting the prior diagnosis of a calcified disc, the internist advised the patient to take naproxen, stay off his feet, and avoid lifting anything. The patient was advised to return in a week or two if there was no improvement. The patient returned 15 days later with com-plaints of low back pain radiating down to the right heel and urinary retention. The internist also noted ataxia.

The patient was admitted to the hospital, and the internist ordered a consult with an or-thopedic surgeon. The internist did not advise the surgeon of the calcified HNP or provide the surgeon with the patient’s medical records. The surgeon conducted a thorough neurolog-ical exam in the internist’s presence, and all findings were normal. The surgeon ordered a lumbar MRI to be completed “ASAP.”

The following day the patient was again seen by the surgeon, and reported that his back was better. The patient’s neurological findings were normal. Suspecting that the urinary re-tention had a neurogenic etiology, the internist ordered a urology consult. Again, the internist did not inform the consultant about the calci-fied HNP or provide prior records.

The urological exam was normal, and the urologist concluded that the urinary retention

was caused by acute back pain and accentu-ated by narcotic pain relievers as well as the anticholinergic effect of the antidepressant the patient was taking.

Early the next morning, the internist and orthopedic surgeon were summoned to the hospital by nurses who informed them that the patient had lost sensation from the waist down, could not move his legs, and had lost reflexes. The MRI the orthopedic surgeon had ordered two days earlier had still not been per-formed. The orthopedic surgeon ordered one STAT. The MRI revealed an extremely large calcified HNP at T8-T9 causing severe cord depression.

The patient was transferred to another hos-pital where an emergency thoracotomy with anterior discectomy was performed. After a stay in a rehabilitation hospital and two years of outpatient physical therapy, the patient was able to walk with a cane but still had bowel and bladder incontinence. The patient subse-quently sued the internist and the orthopedic surgeon on a variety of allegations.

Defense experts were generally supportive of the care given. The internist had immedi-ately hospitalized the patient and called for appropriate consultations. The orthopedic surgeon had performed an examination ap-propriate for a patient with chronic low back problems that were not emergent in nature.

However, experts for both the defense and the plaintiff were critical of the internist’s failure to advise the surgeon of the patient’s known disc problems, finding that the failure to do so had led the surgeon to the wrong con-clusions. They were also critical of the surgeon for not ordering the MRI STAT. The case was settled on behalf of both doctors.

When you refer a patient, you should for-ward the medical records or at least a narra-tive summary of the salient information. The secondary lesson is, do not order tests “ASAP.” Any time there is a sense of urgency, either order the test “STAT” or specify the time by which you want the results to be available.

Ordering referralsToo often, a consultant is expected to diag-nose a patient after receiving nothing more than a referral slip stating “rule out [sus-pected diagnosis].” The referring physician may assume that the specialist will pick up on all the patient complaints and symptoms that triggered the referral. As the above case illustrates, making a timely and appropriate

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referral is not enough; if you don’t provide the specialist with all the relevant medical history that prompted the referral, you could be held responsible for the resulting missed or delayed diagnosis. Take the initiative and call the referring physician yourself to get the information you need.

Ideally, a referral should begin at the time of scheduling with a meeting or phone call during which the referring physician explains the background and reasons for the referral. Arrangements are also made to forward the relevant medical records and test reports. This personal exchange is important because it allows the specialist to probe for additional details or background that the referring physi-cian might not have considered significant.

Unless the specialist will be taking over care, the referring physician should ask for a written report and the approximate date to ex-pect it. Again, the specialist should be advised of any pending test reports, and an agreement should be made as to which physician will follow up on them. This conversation should be documented. Finally, your patient should be advised of the reason for the referral and the importance of keeping the appointment.

Tracking referralsReferrals should be logged and tracked in the same manner as test reports. If you are the referring physician, you should request to be notified by the referral practice if the patient fails to show, especially if a potentially seri-ous diagnosis is being considered.

Conversely, if you are the referral specialist, you should instruct your staff to notify the re-ferring physician when a patient fails to show. If a patient with a potentially catastrophic diagnosis has been referred to you through an ED, call the patient yourself or send two letters, as described earlier, explaining the potential seriousness of the situation. Document this conversation in the medical record.

Communicating with the referring physicianIf you are the referral specialist, you should call or meet with the referring physician as soon as the results are received to discuss your findings. This allows both of you the opportunity to have any remaining questions answered and ensure that all important in-formation has been exchanged. If additional tests or consultations are indicated, agree on who will order them. Document this exchange

in your written report, which should be pre-pared and sent promptly.

In one notable case from the TMLT closed claim files, a family physician referred a man, 45, with elevated prostate specific antigen and prostatic acid phosphatase to a urologist to rule out prostate cancer. Although the urolo-gist who examined the man would later insist that he was never informed of the elevated en-zyme levels by the family physician, the urol-ogist’s clinic notes contained the statement “prostate levels up.” The urologist diagnosed prostatitis and prescribed antibiotics.

The family physician received the report, but did not question the obvious failure of the urologist to address the elevated prostatic enzymes. The patient was diagnosed with prostate cancer three years later and under-went a radical prostatectomy. He survived and did well, but was rendered impotent at age 48. He sued the family physician, the urologist, and several other parties over the delayed diagnosis.

The defense experts who examined the claim were critical of the family physician for not challenging the failure of the urologist’s report to address the lab results, which were the reason for the referral in the first place. Ultimately, the claim was settled on behalf of the FP and other defendants.

The SBAR Communication ModelAn acronym for Situation, Background, As-sessment and Recommendation, the SBAR model was originally developed by Kaiser Permanente of Colorado as a structured way for nurses to communicate with physicians. 13 However, experience has found it to be a useful way of exchanging information both orally and in writing between providers on all levels. Assume you are a radiologist reporting your findings back to the primary care physi-cian who referred a patient to you. The SBAR model would work something like this:

Situation: “I’m reporting back to you on the mammogram and ultrasound results of your patient, Jane Smith, date of birth 10/27/1986, who you referred to rule out breast cancer on September 12.”

Background: “Ms. Smith is a 27-year-old woman with a positive family history for breast cancer who found a 2 cm mass on her left breast at 3 o’clock during a breast self-exam last July. We per-formed imaging studies on her on September 15.”

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Assessment: “The patient had no prior mam-mograms with which to compare our present findings. Our mammogram findings were not remarkable, but such findings are not partic-ularly reliable in younger patients, especially given the density of this patient’s breasts. Therefore, we also performed a breast ultra-sound. The ultrasound was suspicious but not definitive, and we cannot rule out cancer at this time.”

Recommendation: “In light of this and the patient’s family history, I would recommend either a surgical referral for biopsy or a repeat mammogram and ultrasound in two or three months.”

Thus, the SBAR model structures communi-cation in a way that promotes an efficient flow of essential information using fewer words.

6. PRESCRIBING MEDICATIONS INAPPROPRIATELYAt least 1.5 million patients are injured every year by medication errors, according to a study by the National Institute of Medicine. 14 The study conservatively estimated that in-patient medication errors alone added an additional $3.5 billion per year in medical ex-penses. That does not include the costs of lost wages and productivity, and there’s no way to measure human toll in pain and suffering. The problem is three times worse for pediat-ric patients, who suffer an 11 percent rate of inpatient medication errors. 15

Of the many types of medication errors, those that can be difficult to defend involve patients who suffer a catastrophic reaction to a drug to which there was a known allergy.

In another case from the TMLT closed claim files, an 86-year-old woman who suf-fered from a variety of age-related degenera-tive disorders, was seen by her family physi-cian for a urinary tract infection (UTI). The family physician had treated her for UTIs in the past with trimethoprim-sulfamethoxazole, but discontinued the drug after the patient suffered urticaria while taking it. He added sulfa to the drug allergy section at the top of her chart. The next time she presented with a UTI, the family physician treated her with other drugs.

More than two years after sulfa had been added to her drug allergy section, she again presented with symptoms of a UTI. After the woman’s family informed the family physician

that the patient had tolerated sulfa drugs well in the past, the family physician again pre-scribed trimethoprim-sulfamethoxazole, then crossed sulfa off of her drug allergy list and noted “per family has taken.”

Shortly after the visit, the patient developed skin lesions and was taken to an ED. Over the next few days the lesions became worse. She began to desquamate, and was transferred to a burn unit. The family physician’s assessment was that the patient had suffered an acute drug reaction and developed Stevens-Johnson syn-drome. During her hospital stay, she suffered severe pain as her condition deteriorated. She died 18 days later.

The family sued. Defense experts were critical of the family physician’s decision to prescribe a sulfa drug to a patient with a known allergy to it, particularly because there were many other drugs available to treat UTIs. The case was settled on behalf of the family physician.

Careful prescribing Prescribing decisions should be carefully considered. Known allergies aside, patients can suffer from unpredictable adverse drug reactions under a variety of circumstances. It is not uncommon today, due to the prevalence of pharmaceutical advertising, for patients to place considerable pressure on physicians to prescribe a certain drug. Advertising can be misleading as to the risk-benefit profile of drugs. Information continues to develop, even regarding medications that have been on the market for years.

FDA-approved drugs have approved label-ing describing indications, contraindications, and possible drug interactions. Labeling is updated based on new information about the drugs, but there is inevitable lag time in dis-seminating updated information. Sometimes medical articles are available that discuss clinical trials, drug data, and other informa-tion including data gleaned from physicians who have experience with the drugs. These resources may provide useful information to prescribers to help them select appropriate treatments for patients.

Once a drug is approved, physicians can prescribe it “off-label” for other purposes as well. Off-label prescribing is vital to medical progress because medical knowledge grows far faster than the FDA is able to verify and incor-porate into the label. For example, physicians had already figured out that early-stage Lyme

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disease could be effectively treated with inex-pensive generic antibiotics by the early 1980s. 16 However, the FDA did not begin the process of seeking an approved antimicrobial therapy for Lyme disease until 1998. 17

The terminology “off-label” can at times be misconstrued to mean “not legitimate,” which is clearly not the case. The standard of care for a drug’s use is defined by the health care community, not the FDA label. Often, off-label use is the best way to provide your patients with state-of-the-art therapy. Communication with your patient is important. If patients understand what is being prescribed as well as the benefits and risks, in most cases they will feel comfortable with the recommendation. Documenting these discussions in the pa-tient’s chart will reduce the likelihood of a later dispute regarding whether the discussion took place and the content of that discussion.

While physicians are allowed to freely discuss off-label drug use among themselves —including presentations at scientific meetings — pharmaceutical manufacturers are not. For a manufacturer to promote off-label use of a drug is called “misbranding” by the FDA, and it may subject the manufacturer and its repre-sentatives to federal fines and penalties.

Nevertheless, these activities have tak-en place. One example is the case in which GlaxoSmithKline pleaded guilty in July 2012 and paid $3 billion in criminal and civil penal-ties for misbranding antidepressants paroxe-tine and bupropion and the anti-diabetic drug rosiglitazone. 18

Further complicating the issue is the fact that in some cases, physicians have written fa-vorable articles regarding drugs manufactured by companies with whom they have a financial connection. Consider a 2010 article by re-searchers from the Mayo Clinic that reviewed 202 published articles on rosiglitazone. 19 The reviewers found that 29 of 31 authors (94 per-cent) who had written favorably about the drug had financial conflicts of interest, compared with 32 of 84 (38 percent) whose articles were judged neutral, and 18 of 64 (38 percent) whose assessments were unfavorable.

The authors concluded “there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies.”

Thus, even studies published in peer- reviewed journals may be tainted by financial conflicts of interest. Manufacturers of drugs

still under patent have financial incentives to find as many possible uses for their product as possible.

Another issue is that patented drugs are not always better than generics, although they are invariably more expensive. In her book, The Truth About Drug Companies: How They De-ceive Us and What To Do About It, pathologist and former editor-in-chief of the New England Journal of Medicine, Marcia Angell points out that that about 75 percent of new pharma-ceuticals approved by the FDA are “me-too” drugs, for which there are equally or even more effective — and far cheaper — generics readily available. 20

One advantage of generics is that their safety and incidence of side effects are better known, because it can take years to recognize the actual risks posed by drugs after they enter the market. For example, the significant cardiovascular risks of rosiglitazone were re-alized only after it was already on the market, causing the FDA to issue numerous restric-tions on its use.

Of course, you cannot be expected to scruti-nize the data behind every suggested off-label use for every drug you prescribe. But you can be wary, and not take every recommendation at face value.

Documentation of your reasons for off-label use and your discussion with the patient can be helpful later on, if your pre-scribing judgment is questioned. Awareness of FDA-mandated “black box warnings” of potentially serious or life-threatening side effects is also important in prescribing decisions and in communication with your patients. Closer monitoring of patients taking these drugs may be needed to determine whether the drug is effective and whether the benefits really do outweigh the risks.

Pain medicationsDrugs most frequently involved in medica-tion error claims are narcotic analgesics, accounting for more than 17 percent of such claims. 21 This is due, in part, to re-cent changes in physician attitudes toward prescribing opioid pain relievers (OPRs). Twenty years ago, fears of regulatory scru-tiny constrained the prescribing of OPRs by most physicians. These fears were not ungrounded. In 1992, a Kansas physician was convicted and imprisoned for second-degree murder and attempted second-degree murder of two terminally ill patients for providing

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them with life-shortening doses of narcotics to ease their intractable pain. 22 An appellate court later threw out the conviction and freed the physician in light of the AMA’s own standards in place at the time.

Those standards specifically stated, “the administration of a drug necessary to ease the pain of a patient who is terminally ill and suffering excruciating pain may be appropriate medical treatment even though the effect of the drug may shorten life.” 23 The physician was freed, but only after enduring time in pris-on and bankruptcy.

National news stories of the physician’s initial conviction made other physicians even more reluctant to prescribe narcotics. A JAMA article reported that many terminally ill pa-tients were living out their last days in mod-erate to severe pain. 24 The families of these patients fought back with a flurry of lawsuits alleging that physicians and institutions were allowing patients to suffer rather than pro-vide them with adequate pain relief. All these factors led the medical community, including the regulatory authorities, to rethink the issue. In 2001, the Joint Commission released new standards requiring hospitals, nursing homes, and other accredited facilities to assess patient pain levels and provide effective relief. 25

The result has been a surge in the use of opioid pain relievers. The Centers for Disease Control and Prevention (CDC) reports that OPR sales per 10,000 people quadrupled be-tween 1999 and 2010, from 1.75 kg per 10,000 population to more than 7 kg. 26 Clearly, some of this increase is appropriate and reflects a more humane approach to pain management, as well as an aging population with increasing and legitimate needs for pain relief. However, this is only part of the answer. During that same period, the CDC reported that OPR overdoses quadrupled. 27 The CDC report calculated that enough OPRs were prescribed in 2010 to provide every American adult with a 5-mg dose of hydrocodone every four hours for an entire month.

OPR overdose now accounts for 40 percent of all poisoning deaths, more than heroin and opium combined. 28 In 2011, non-medical phar-maceutical use was involved in 1.24 million ED visits, accounting for 51 percent of all ED visits, compared with 1 million visits involv-ing illicit street drugs. 29 Perhaps surprisingly, the most frequent patients to be treated for OPR overdose are middle-aged adults, who are disproportionately male, poor, and rural. 30

Three out of four individuals who use OPRs for non-medical purposes obtain them from someone with a legal prescription. 31 Most OPR prescriptions are written by dentists and primary care physicians. 32

Of particular importance, 80 percent of OPR prescriptions are written by just 20 per-cent of providers. 33, 34 Clearly, some of these drugs are being diverted for nontherapeutic use, and the authorities are taking action to stop it. In November 2012, the DEA and more than a dozen cooperating law enforcement agencies raided a dozen Texas medical offices and “pain clinics” that officials allege were little more than pill mills. 35

The TMB also joined the fray, suspending or restricting the licenses of 21 physicians who were arrested in the raid pending further investigation. 36 Yet inappropriate prescribing practices remain one of the most common causes of TMB disciplinary actions. Of 57 actions taken in June 2013, inappropriate pre-scribing was cited as a factor in 20. 37

The Texas Prescription Program monitors the drugs you prescribe as well as who is re-ceiving them and who is dispensing them. 38 If you prescribe an unusual volume of narcotics relative to your peers, or if you’re paid to be the “medical director” or other officer of a clinic that does, be aware that you’re most likely on someone’s radar already.

Also, be aware that the TMB defines a “pain clinic” as, “a publicly or privately owned facility for which a majority of patients are issued, on a monthly basis, a prescription for opioids, benzodiazepines, barbiturates, or carisoprodol, but not including suboxone.” 39 If this describes your practice, you must reg-ister with the TMB as a pain clinic and adhere to the relevant rules.

If you prescribe controlled substances for patients with chronic pain, it’s strongly recommended that you adhere to the TMB’s guidelines for pain management. 40 The TMB states that you are not required to follow those guidelines as long as your records document that your prescriptions are based on sound clinical judgment. However, doc-umented compliance with those guidelines is the best way of protecting patient safety while safeguarding yourself in case you are investigated.

While you should refer to the actual guide-lines, when forming a compliance plan, here is a brief synopsis of the important steps you should document in the patient’s chart.

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1. An evaluation of the patient’s pain, including intensity, likely causes, and indications for the use of a scheduled drug. Also include an assessment of the patient’s history or potential for sub-stance abuse.

2. A treatment plan that includes the objective of treatment and the physical psychosocial improvements that will be assessed to measure the plan’s success.

3. Informed consent, showing that the patient has been advised of the risks of adverse effects, including addiction and impairment of judgment and motor skills.

4. An agreement with the patient to the rules of treatment, including that the patient will not seek additional con-trolled substances from another doctor, will have all prescriptions filled at one pharmacy, will adhere to the medication schedule, and will submit to testing on request to ensure that therapeutic drug levels are maintained.

5. Periodic review of the treatment plan to ensure that goals are being met, and reassessment if they are not.

6. Consultation and referral as necessary, especially for patients at risk of sub-stance abuse or who exhibit possible signs of abuse.

AntibioticsThe overuse and misuse of antibiotics is an ongoing problem that contributes to over-utilization, antimicrobial resistance, and adverse drug reactions. Common examples include prescribing antibiotics for viral in-fections and using last-line antibiotics as the first drug of choice.

One CDC-sponsored study found that antibiotics were involved in one-fifth of all ED visits related to adverse reactions. 41 The study found that macrolides had the lowest incidence of serious adverse effects, with 5.1 incidents per 10,000 prescriptions; followed by cephalo-sporins (6.1 per 10,000); fluoroquinolones (9.2); penicillins (13); clindamycin (18.5); sulfon-amides (18.9); and vancomycin (24.1).

An example of just how pervasive the incor-rect prescribing of antibiotics can be is shown by a study that found that 99 percent of pre-

scriptions for fluoroquinolones in an academic medical center ED were prescribed incorrectly. 42 The study found that in 43 percent of cases studied, fluoroquinolones were inappropriate-ly used as a first-line agent; in 27 percent, the patients had no evidence of bacterial infection; and 11 percent had questionable need for such therapy. Fluoroquinolones should not have been prescribed in the first place in 81 percent of the patients. Even when the selected drug was actually indicated, only one percent of the patients in the study received both the correct dose and duration of therapy.

Even patients who have tolerated a drug well in the past can still have an adverse reaction. Allergies develop in response to prior exposure. Additionally the patient may now be taking another medication that interacts with your prescription. It is prudent to consider such risks before prescribing.

Safe prescribing practicesDrug allergies should be posted prominently on the chart and reviewed before prescribing. Also, keep a list of all medications a patient is taking. Encourage your patients to have all prescriptions filled at the same pharmacy, so that the pharmacist can alert you of potential drug interactions.

Be cautious in prescribing new drugs on the market, and don’t take information provided by manufacturer representatives and others as authoritative. Review the drug’s information in the PDR or other authoritative source, and determine whether it really is safer and more effective than generics. Even for drugs you pre-scribe frequently, a periodic review for updates and new warnings is a good idea. Advise your patients of known side effects and what to do if they experience them.

Computerized provider order entry (CPOE) systems can reduce many kinds of medical errors. Because the drug name and dose is typed, the problem with illegible prescriptions is eliminated. Also, assuming the patient’s entire drug regimen, known allergies, current medical history, and diagnosis is already in the system, potential interactions and contraindi-cations will be automatically flagged for review before prescribing.

A recent study found that CPOEs caught 48 percent of prescription errors, and had the potential to eliminate 1.7 million hospital med-ication errors annually. 42

If you’re still using hand-written prescrip-tions, here’s an abbreviated list of safe pre-scribing practices taken from the website of

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the Institute for Safe Medication Practices (ISMP) at www.ismp.org:

· Remember that many drugs have brand names that look and even sound very similar, such as Aldara and Alora, both of which are applied topically. To avoid con-fusion, print the drug name clearly, use the generic name, and state the diagnosis. Instead of Aldara, prescribe “imiquimod (for actinic keratosis).” This will allow the pharmacist to catch most errors.

· Do not abbreviate drug names — spell them out.

· Do not use non-English symbols: print “micro” instead of “μ.”

· Especially for Schedule II drugs, print dispensed amount using both numbers and letters (“thirty-30”) to prevent alteration.

· Use leading zeroes before decimals; “.5” may be misread as “5,” so print “0.5” instead.

· Do not use trailing zeroes; “5.0” may be misread as “50,” so print “5” instead.

· Avoid calculating doses, especially in pediatric patients. That’s because a single misplaced decimal alters the dose by a fac-tor of at least 10. Instead, the ISMP advises you stick to standardized doses, which have a broad therapeutic range. If you must cal-culate the dose, triple-check your math and include the formula and your calculation for the pharmacist to verify: “0.5 mg/kg/hr, weight 45 kg, dose=22.5 mg/hr.”

7. OBTAINING AND DOCUMENTING INFORMED CONSENTInformed consent is an extension of the doctrine of patient autonomy, which holds that the patient has the right to decide what is done to his or her body, including the right to refuse life-saving treatment. The essential assumptions of informed consent are:

· The patient (or guardian) is an adult of sound mind.

· The patient’s diagnosis has been ex-plained, along with the likely course of the disease if untreated.

· All viable treatment options have been explained, along with the likely benefits and potential risks of each. While the doctor may make recommendations, the patient has the freedom to choose his or her preferred course of treatment.

· No material misrepresentations have been made in obtaining informed consent.

The last item, “material misrepresentations,” deserves special discussion because it is typ-ically at the heart of claims alleging failure to obtain informed consent.

A representation is “material” if a reasonable person would want to consider it in making an informed decision to consent to treatment. Note that material representations can be im-plied as well as explicit. For example, when you offer to perform a procedure on a patient, you are making implied representations that: the procedure is medically indicated; it is generally accepted by your peers; you are fully trained and qualified to carry it out; there is a reasonable probability that the desired outcome will be achieved; and the facility in which the proce-dure is to be performed is fully equipped and appropriately staffed to carry it out safely.

If the procedure is experimental, if there is a question about whether the desired outcome can be achieved, or if any of the other implied representations are not true, this needs to be explained to your patient and spelled out in the informed consent documentation.

Above all, do not try to “sell” your patient by misrepresenting either the risks of going with-out treatment or the likelihood of a desirable outcome. To do so might void informed con-sent, and could create grounds for a separate action for fraud.

An example of that result is provided in a Texas case law decision involving a Laotian refugee who severed his right thumb and index finger and part of his middle finger in a work-related accident. 43 The surgeon who treated him saved the severed thumb bones and placed them in his groin for possible later use. The surgical team determined that the best treatment would be a Morrison procedure in which parts of the big toe are used to recon-struct a functional thumb. Because the patient spoke no English, the surgeons explained the procedure to the patient through an interpret-er. After receiving a thorough explanation of the procedure, the patient refused consent.

About a week later, the surgical team

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brought in another, more experienced inter-preter to again try to obtain consent. Although the surgeon would deny this during the subse-quent trial, the interpreter would testify that he was told to explain to the patient that he would never be able to return to work without a thumb, and described the surgery as involv-ing an incision, drainage and skin graft, which would result in a normal-looking thumb and big toe. Plaintiff’s experts would later testi-fy that, even when successful, the Morrison procedure does not result in a normal-looking thumb. The surgeon also failed to discuss the risks of infection and other complications.

The patient ultimately signed consent for what he understood to be “an incision, drain-age, and skin graft,” and woke up from the anesthesia to discover that part of his big toe had been grafted onto his thumb. He developed an infection and other sequelae, and was left with what his rehabilitation specialist charac-terized as a “grossly deformed” hand and foot, and was unable to walk without pain.

The patient filed suit for lack of informed consent and fraud. During the trial, the jury was allowed to inspect the patient’s hand and foot, and apparently agreed with the rehabil-itation specialist’s assessment. The patient was awarded just under $700,000 in damages, upheld on appeal.

This case illustrates an important point that many doctors overlook: signed consent does not establish informed consent. “Informed consent” is a legal concept rather than a medical one, and only the courts can determine wheth-er or not it actually existed—usually months or years after the events in question. A signed consent form is merely evidence of informed consent, and one of many types of evidence the courts may consider. In the present case, the jury found the testimony of the translator, who had no legal interests at stake, more convincing that either the signed consent document or the testimony of the surgical team.

Informed consent in TexasThe basic allegation of any informed con-sent claim is that “I’d never have undergone treatment if I’d known this could happen!” This allegation is frequently added to mal-practice claims as a fall-back strategy for a very simple reason: a patient who sues over a known complication that was listed on the consent form can only prevail in court by proving by a preponderance of evidence that the complication would not have occurred but

for your negligence. This is very hard to do. On the other hand, if the patient can convince a jury that you did not have consent to treat in the first place, you can be held liable for any untoward outcome, including the known and normal risks of the procedure.

A traditional problem with obtaining informed consent is knowing what risks need to be discussed without needlessly frightening the patient. A 1 percent risk of death would certainly warrant mentioning, but would a risk of 0.1, 0.01 or even 0.0001 percent? Where do you draw the line?

Unlike most states, Texas has largely sim-plified informed consent by streamlining the process and standardizing those risks that must be discussed for most common procedures. The Texas Medical Association (TMA) has prepared a plain language white paper on informed con-sent that explains the details of Texas law. What follows is a synopsis of that white paper.

Battery is the offensive touching of anoth-er person. In some states, a physician who treats a patient without consent may be sued for medical battery as well as lack of informed consent. If battery is proven, the physician can be held liable for a damage award even where there was no negligence and the patient sustained no injuries. Tex-as law, however, maintains that informed consent claims must be based on negli-gence, and does not recognize battery as a basis for a medical malpractice claim.

Written consent is legally required only for abortion and the treatment of minors. While the patient’s consent is still re-quired in other circumstances, it does not have to be written. However, even when written consent is not required, the ab-sence of it may lead to the legal presump-tion that the patient did not consent to treatment. Therefore it is to your advan-tage to obtain written consent whenever possible. Also, when written consent is ob-tained, the TMB requires that it be made a part of the medical record.

To facilitate a more standardized approach to the consent process, Texas passed legis-lation in 2003 that created the Texas Med-ical Disclosure Panel. The panel consists of six physicians and three attorneys, and was granted the power to identify which treatments required written disclosure

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(“List A”), and which do not require written disclosure (“List B”). 44

For List A procedures, the panel adopt-ed disclosure forms, in both English and Spanish, that physicians may use to inform a patient about the risks and hazards of a particular procedure. Additionally, the panel designed consent forms specifically for obtaining informed consent for radia-tion therapy, abortion, electroconvulsive therapy, hysterectomy, and anesthesia.

If a patient signs a consent form for a pro-cedure on List A after having been present-ed with the appropriate written disclosures, or if the procedure is on List B and does not require written disclosure, the law pre-sumes that the doctor has consent to treat.

While this legal presumption does not pre-vent the patient from arguing an informed consent claim, it places a burden of proof on the plaintiff. In the words of the TMA white paper this is, “extraordinarily diffi-cult to overcome.” On the other hand, if the physician fails to obtain written consent from the patient for a List A procedure, the legal presumption is that the physician was negligent in obtaining consent.

Some additional considerations for obtaining informed consent in Texas are:

· If the Panel has not assigned a procedure to either List A or List B, you have a duty to “dis-close all risks or hazards that could influence a reasonable person in making a decision to consent to the procedure.” One of the consent forms created by the panel is general in nature and can be assembled in a way that will satisfy the physician’s duty to disclose.

· The physician’s duty to educate the patient and obtain informed consent is nondele-gable, meaning that you are legally respon-sible for it and will be held liable for the consequences of treating without consent. While this does not prevent you from allow-ing a hospital worker or nurse to obtain consent for you, this does not relieve you of your own duty and serves merely to add ad-ditional parties who may also be held liable.

· The consent process for abortions is intentionally onerous and detailed. For

instructions and sample forms, visit the website of the Texas Department of State Health Services, at www.dshs.state.tx.us/hfp/hottopics.shtm.

· Emergencies generally create the pre-sumption of consent to treat, especially in life-threatening situations where the patient is unable to provide consent. In any case, juries tend to be very forgiving of well-intentioned physicians who step forward and try to act in the patient’s best interests. So if in doubt, treat.

· A Durable Power of Attorney does not give the holder permission to make medical decisions on behalf of the other person. In fact, Texas requires such documents to contain the legend “This Document Does Not Authorize Anyone To Make Medical and Other Health Care Decisions for You.” A separate Medical Power of Attorney is required for that purpose.

CONCLUSIONVery little of the information about TMLT’s “Seven Malpractice Pitfalls” and suggestions for avoiding them should come as a surprise to you. All of the pitfalls are lapses in what should be standard communication and documenta-tion practices in every medical practice.

As we have seen, good communication skills can actually save time while ensuring that es-sential information is passed along. Allowing pa-tients to explain the reason for the visit without interruption and encouraging them to bring lists of symptoms and concerns allows you to quickly assess the situation and prioritize the visit.

Following the Situation-Background-As-sessment-Recommendation model adds focus to communications with other providers so that more information can be exchanged in less time.

And the growing use of EHRs with embed-ded diagnostic and drug selection protocols will facilitate a more accurate diagnosis with less testing, and catch potential problems with prescriptions before the drug is even ordered.

As baby boomers age and decline in health, as more people obtain health insurance under the Affordable Care Act, and as documenta-tion standards tighten under the ICD-10, the demands on your time will only increase. Your best solution is to develop structured commu-nication and documentation practices that al-low you to use your time more efficiently while optimizing the quality of care you deliver.

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Sources1. The anecdotes from the TMLT closed

claim files were drawn from the TMLT publications of Case Closed: A collection of TMLT closed claim studies, Volumes 1-4, edited by Laura Brockway, et al.

2. Wiggins MN, Coker K, Hicks EK. Pa-tient perceptions of professionalism: implications for residency education. Med Educ. 2009;43:28-33.

3. Zolnierek KB, Dimatteo MR. Phy-sician communication and patient adherence to treatment: a meta-anal-ysis. Med Care. 2009;47:826-34.

4. Hickson GB, Clayton EW, Entman SS, et al. Obstetricians’ prior malpractice experience and patients’ satisfaction with care. JAMA. 1994;272:1583-7.

5. Beckman HB, Frankel RM. The effect of physician behavior on the collection of data. Ann Intern Med. 1984;101:692-6.

6. National Patient Safety Foundation. Ask Me 3. Available at http://www.npsf.org/for-healthcare-profession-als/programs/ask-me-3/ .

7. Guttmacher AE, Collins FS, Carmo-na RH. The family history — more important than ever. N Eng J Med. 2004;351:2333-6.

8. Sifri RD, Wender R, Paynter N. Can-cer risk assessment from family his-tory: gaps in primary care practice. J Fam Pract. 2002;51:856.

9. American Society of Anesthesiolo-gists. Recommended Scope of Practice of Nurse Anesthetists and Anesthesia Assistants. February 2007.

10. Texas Occupations Code, Chapter 157, Section 157.058, effective Sep-tember 1, 1999. Available at http://www.statutes.legis.state.tx.us/Docs/OC/htm/OC.157.htm.

11. Available at URL: http://www.hro.house.state.tx.us/pdf/ba83r/sb0406.pdf.

12. Hyams AL. Brandenburg JA, Lipsitz SR et al. Practice guidelines and mal-practice litigation: A two-way street. Ann Intern Med. 1995;15:450-5.

13. Kaiser Permanente of Colorado. Guidelines for Communicating with Physicians Using the SBAR Process. Available at http://ilemsc.org/PRRT/Kaiser_SBAR_Guidelines.pdf.

14. Aspen P, Wolcott J, Bootman L, Cronenwett, LR, eds. Preventing Medication Errors: Quality Chasm series. Washington DC: National Academies Press. 2007.

15. Kaushal R, Bates DW. Landrigan C, McKenna KJ, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285:2114-20.

16. Steere AC, Hutchinson GJ, Rahn DW, et al. Treatment of the early manifes-tations of Lyme disease. Ann Intern Med. 1983;99:22-6.

17. Food and Drug Administration. Lyme Disease-Developing Antimicrobi-al Drugs for Treatment. July 1998. Available at http://www.fda.gov/downloads/Drugs/GuidanceCompli-anceRegulatoryInformation/Guid-ances/ucm071166.pdf

18. Department of Justice. GlaxoSmith-Kline to plead guilty and pay $3 bil-lion to resolve fraud allegations and failure to report safety data (press release). July 2 2012. Available at http://www.justice.gov/opa/pr/2012/July/12-civ-842.html.

19. Wang AT, McCoy CP, Murad MH, Montori VM. Association between industry affiliation and position on cardiovascular risk with rosigli-tazone: cross sectional systematic review. Brit Med J. 2010;340:c 1344. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2841746/.

20. Angell M. The Truth About Drug Companies: How They Deceive Us and What To Do About It. New York: Random House. 2004.

21. The Doctors Company. Drug-re-lated adverse events on the rise: Protect yourself from claims. Mich Med. 2013;112(1):19. Available at http://www.thedoctors.com/Knowl-edgeCenter/PatientSafety/articles/CON_ID_005435

22. State v. Naramore, 965 P.2d 211.

23. Council on Ethical And Judicial Affairs. Council Report: Decisions near the end of life. JAMA 1992;267:2229-33.

24. SUPPORT Study Principal Investi-gators. A controlled trial to improve care for seriously ill hospital pa-tients. JAMA 1995;274:1591-8.

25. Lanser P, Gesell S. Pain management: The fifth vital sign. HealthcareBench-marks 2001;8(6):62, 68–70.

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26. Centers for Disease Control And Prevention. Vital signs: overdoses of prescription opioid pain reliev-ers—United States, 1999—2008. Morb Mortal Wkly Rep. 2011:60:1487-92. Available at www.cdc.gov/mmwr/pre-view/mmwrhtml/mm60e1101a1.htm.

27. Warner M, Chen L, Makuc D. In-crease in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. Hyattsville, MD: National Center for Health Statistics; 2009. Available at http://www.cdc.gov/nchs/data/data-briefs/db22.htm.

28. Substance Abuse and Mental Health Services Administration. Highlights of the 2009 Drug Abuse Warn-ing Network (DAWN) findings on drug-related emergency department visits. The DAWN Report. Rockville, MD. 2010. Available at URL: http://oas.samhsa.gov/2k10/dawn034/ed-highlights.htm.

29. Centers for Disease Control and Prevention. Prescription painkiller overdoses in the US. 2011. Available at http://www.cdc.gov/vitalsigns/Pain-killerOverdoses/index.html.

30. Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on Drug Use and Health: Volume 1: summary of national findings. Rock-ville, MD. 2011. Available at http://oas.samhsa.gov/NSDUH/2k10NS-DUH/2k10Results.htm#2.16.

31. Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SRB. Charac-teristics of opioid prescriptions in 2009. JAMA 2011;305(13):1299–1301.

32. Blumenschein K, Fink JL, Freeman PR, Kirsh KL, et al. Independent evaluation of the impact and effec-tiveness of the Kentucky All Sched-ule Prescription Electronic Report-ing Program (KASPER). Lexington (KY): Institute for Pharmaceutical Outcomes and Policy; 2010.

33. Swedlow A, Ireland J, Johnson G. Prescribing patterns of schedule II opioids in California Workers’ Com-pensation. Cal. Workers’ Compensa-tion Update. 2011 Mar:1–12. Available at http://www.cwci.org/research.html.

34. Horswell C. Dozens of health licenses surrendered in pill mill raids. Hous-ton Chronicle. November 5, 2012.

35. Texas Medical Board. Texas Medical Board suspends or restricts 21 licens-ees in pain clinic crackdown. Press release. 2012;(Dec. 18). Available at http://www.tmb.state.tx.us/news/press/2012/121218.php.

36. Texas Medical Board. Fifty-seven physicians disciplined by Texas Med-ical Board at June meeting. Press release. 2013;(Jun. 28). Available at http://www.tmb.state.tx.us/news/press/2013/2013-June-28-Press-Re-lease.pdf.

37. Information on the Texas Prescrip-tion Program available at https://www.txdps.state.tx.us/Regulato-ryServices/prescription_program/index.htm.

38. Texas Administrative Code, Title 22, Part 9, Chapter 195: Pain Man-agement Clinics. Available at http://www.tmb.state.tx.us/rules/rules/bdrules.php.

39. Texas Administrative Code, Title 22, Part 9, Chapter 170: Pain Manage-ment. Available at http://www.tmb.state.tx.us/rules/rules/bdrules.php.

40. Shehab N, Patel PR, Srinivasan A, Budnitz DS. Emergency depart-ment visits for antibiotic-associat-ed adverse events. Clin Infect Dis. 2008;47:435-43.

41. Lautenbach E, Larosa LA, Kasbekar N, Peng HP, et al. Fluoroquinolone utilization in the emergency depart-ments of academic medical centers: prevalence of, and risk factors for, inappropriate use. Arch Inter Med 2003;163:601–5.

42. Wasserman MR, Olsho LEW, Shoe-maker SJ, Spranca MD, et al. Reduc-tion in medication errors in hospitals due to adoption of computerized provider order entry systems. J Am Med Inform Assoc. 2013;20:470-6.

43. Melissinos v. Phamanivong, 823 S.W.2d 339.

44. Texas Civil Practice and Remedies Code. Section 74.102 Available at http://www.statutes.legis.state.tx.us/Docs/CP/htm/CP.74.htm.

Dr. Schutte can be reached at jameseschutte@aol.com.

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Hey, where are myCME test forms?

We are now offering all CME courses through TMLT’s online CME site, www.tmlt.org/cme. We no longer offer the option to complete

the Reporter CME in paper format. All CME completions will now be through the web site, which will provide 24-hour access to content, testing, receipts, and certificates.

To deliver courses through the CME site, we will now be charging a slight fee to cover the cost of the online catalog. Policyholder and non-policyholder pricing

will be in effect. Simply visit the site and log on with your myTMLT username and password to receive policyholder pricing.

They’re at www.tmlt.org/cme

If you do not have a myTMLT account, please call customer service at 800-580-8658, ext. 5050.

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TMLT the Reporter | 2 0 1 3 VOLUME 6

CHANGES MADE TO PRESCRIPTION MONITORING PROGRAMIn 2012, Texas physicians were granted online access to the Prescription Access in Texas database (PAT). The database gives physicians the real-time ability to query the prescription database and find out which con-trolled substances their patients have been prescribed by other practitioners.

As of September 1, 2013, an amendment to Texas law (S.B. 1643) has changed how the PAT program may be used. The law:

· now allows providers authorized to query the database to include the information gathered in the patient’s chart. This is a positive change for health care professionals since the law formerly did not allow inclusion of this information in the medical record;

· now allows pharmacy technicians and licensed nurses “acting under the direc-

tion of a practitioner” to be autho-rized users of the system. The initial law allowed a pharmacist, physician, dentist, veterinarian, podiatrist, advanced practice nurse, or a physi-cian’s assistant to access the program;

· allows three years’ worth of pre-scription data to be available for query (expanded from 1 year); and

· establishes an interagency work group to evaluate the effectiveness

of the prescription monitoring program. The work group “shall proactively engage stakeholders and solicit and take into account input from the public.”

Accessing the database can be helpful if a physician suspects a patient may be receiving prescriptions from other physicians without disclosing them or is exhibiting drug-seeking behaviors. We recommend that physicians consider querying the database regarding any new patient who is currently taking con-trolled substances, any existing patient who requests an early refill of a controlled sub-stance, or any patient who triggers concern about abuse of controlled substances.

For more information:· Please visit the Texas Prescription Program web site at http://www.txdps.state.tx.us/Regula-toryServices/prescription_program/index.htm

Texas Medical Liability Trust

theREPORTER

the Reporter is published by Texas Medical Liability Trust as an information and educational service to TMLT policyholders. The information and opinions in this publication should not be used or referred to as primary legal sources or con-strued as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the partic-ular facts and circumstances of each individual case and no generalizations can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. It is distributed with the understanding that neither Texas Medical Liability Trust nor its affiliates are engaged in rendering legal services. © Copyright 2013 TMLT

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