To prepare for this Discussion, research the Good Samaritan Law for the state of Maryland. Find another jurisdiction with a different Good Samaritan Law. Consider how the two are divergent.

By Thursday October 20, 2016, post a 400 word comprehensive response to the following:

• What are the fundamental elements of the Good Samaritan Laws for the two jurisdictions you researched?

• How do they differ from one another? Be specific and provide examples?

• Do you think the law is clear and well written? Support your stance with examples.

• Are there any changes that you would like to see made to the law? What are those changes?

Support your work with proper APA citations from the Learning Resources and any other sources.

Judson, K., & Harrison, C. (2016). Law and ethics for the health professions. (7th ed. ). New York: McGraw- Hill.

Law&Et • cs FOR HEALTH PROFESSIONS

KAREN JUDSON CARLENE HARRISON

Medical Records and Informed Consent

LEARNING OUTCOMES After studying this chapter, you should be able to:

LO 7. I Explain the purpose of medical records and the importance of correct documentation.

LO 7.2 Identify ownership of medical records and determine

how long a medical record must be kept by the owners.

LO 7.3 Describe the purpose of obtaining a patient 's consent for release of medical information, and explain the

doctrine of informed consent.

LO 7.4 Describe the necessity for electronic medical records and the efforts being made to record all medical records electronically.

175

11 1

rF I

LO 7.1 Explain the purpose of medical records and the importance of correct documentation.

medical record A collection of data recorded when a patient seeks medical treatment .

-.._.,....,.,.~ ~

FROM THE PERSPECTIVE OF . .. -

SALLY, MICHAEL, AND TERESA handle requests for release of patients' medical records for a midwestern hospital serving a five-state area. They emphasize that they can release records only with signed authorization from the patient or on subpoena, and that they may then release photocopies, but never original medical records. When some- one visits the hospital to pick up copies of a patient's records, that per- son is asked to show identification.

Michael lets experience be his guide and checks out any request for release of records that "doesn't feel right." For example, if a hus- band brings an authorization form for release of medical records that he says his wife signed, her signature should be checked against the signature on hospital admission forms. It could be that a divorce is in progress in such a situation, and the husband or wife is seeking medi- cal records to prove the spouse an unfit parent.

"Never release medical records because the person making the request has intimidated you," adds Teresa. "The most officious person I've dealt with was an FBI agent who told me, 'I want this record. If you don't give it to me, I'll get it myself.' I said, 'Go for it.' Later the agent called and apologized to me."

Since the employing hospital is located in a city with an air force base, Sally, Michael, and Teresa often receive requests for medical records for active duty military personnel. "We have now been told that the mili- tary can get the records they request on any active duty person," adds Sally. "We still ask for an authorization, but it is not required, since the active duty person signs away that right when he or she signs up for the military. This applies to active duty personnel on duty or on leave, but it does not include dependents of the person in the military."

Michael, Teresa, and Sally know that medical records contain informa- tion that can be used in ways not intended when the health care data were collected. They also know that the hospital that employs them can be legally liable for improper release of medical records. Therefore, they are extremely careful about always obtaining proper consent before releasing records.

From the perspective of individuals seeking medical records for their own purposes, not related to health care or the welfare of patients, Michael, Teresa, and Sally are unrelenting obstacles. From the perspective of the patients whose confidential medical records are conscientiously protected, Michael, Teresa, and Sally are performing their jobs well. From the perspec- tive of their employer, Michael, Teresa and Sally are performing their jobs well and following the laws pertaining to the release of medical records.

Medical Records A medical record is a collection of data recorded when a patient seeks medical treatment. The medical record, as used in this chapter, refers to a patient's visits to one health care facility. The health record cov- ers all of a patient's health care issues, and covers all health care facili- ties the patient may have visited. The two terms are discussed in further detail in Chapter 8. Hospitals, surgical centers, clinics, physician

176 Part Two J Legal Issues for Working Health Care Prac titioners

offices, and other facilities providing health care services maintain patients' medical records. Medical records serve many purposes:

1. They are required by licensing authorities and provide a format for tracking, documenting, and maintaining a patient's communi- cation data, both inside and outside a health care facility.

2. They provide documentation of a patient's continuing health care, from birth to death.

3. They provide a foundation for managing a patient's health care.

4. They serve as legal documents in lawsuits.

5. They provide clinical data for education, research, statistical tracking, and assessing the quality of health care.

ENTRIES

As a legal document, a patient's medical record may be subpoenaed (via subpoena duces tecum) as evidence in court. When they are conscien- tiously compiled, medical records can prevail over a patient's recollection of events during a trial. When there is no entry in the record to the effect that something was done, there is a presumption that it was not done, and when there is an entry that something was done, the presumption is that it was done. Therefore, what is omitted from the record may be as important to the outcome of a lawsuit as what is included.

Records may be kept on paper, microfilm, or computer tapes or disks. For legal protection as well as continuity of care, the following information must be recorded in a patient's record:

• Contact and identifying information: the patient's full name, Social Security number, date of birth, and full address. If appli- cable, include e-mail address, horne and work telephone numbers, marital status, and name and address of employer.

• Insurance information: name of policy member and relationship to patient, details such as certificate and group numbers, telephone numbers, copy of insurance card, Medicaid or Medicare numbers if applicable, and secondary insurance.

• Driver's license information, state, and number.

• Person responsible for payment and billing address.

• Emergency contact information

• The patient's health history.

• The dates and times of the patient's arrival for appointments.

• A complete description of the patient's symptoms and reason for making an appointment.

• The examination performed by the physician.

• The physician's assessment, diagnosis, recommendations, treat- ment prescribed, progress notes, and instructions given to the patient, plus a notation of all new prescriptions the physician writes for the patient and of refills the physician authorizes.

• X-rays and all other test results.

• A notation for each time the patient telephoned the medical facil- ity or was telephoned by the facili ty, listing date, reason for the call, and resolution.

Chapter 71 Medical Records and Informed Consent 177

• A notation of copies made of the medical record, including date copied and the person to whom the copy was sent.

• Documentation of informed consent, when necessary.

• Name of the guardian or legal representative to be contacted if the patient is unable to give informed consent.

• Other documentation, such as complete written descriptions; photographs; samples of body fluids, foreign objects, and cloth- ing in cases involving criminal investigations; and so on. All items should be carefully labeled and preserved.

• Condition of the patient at the time of termination of treatment, when applicable, and reasons for termination, including docu- mentation if the physician-patient contract was terminated before completion of treatment.

Five Cs can be used to describe the necessary attributes of entries to patients' medical records. These entries must be:

1. Concise

2. Complete (and objective)

3. Clear (and legibly written)

4. Correct

5. Chronologically ordered

Medical records should never include inappropriate personal judg- ments or observations or attempts at humor.

PHOTOGRAPHS, VIDEOTAPING, AND OTHER METHODS OF PATIENT IMAGING

In today's health care environment, it has become increasingly com- mon to record patients' images through the use of photography, videotaping, digital imaging, and other visual recordings. For example, surgeons may photograph, videotape, or otherwise record procedures used during an operation for purposes of education or review. Cosmetic surgeons and physicians who treat accident victims may want to docu- ment visually the patient's condition "before" and "after" the incident. Such images then become part of the patient's medical record, subject to the same requirement for written release as the rest of the record.

Photographing or otherwise recording a patient's image without proper consent may be interpreted in a court of law as invasion of pri- vacy. Invasion of privacy charges are most often upheld in court if the patient's image was used for commercial purposes, but such claims have also been upheld under public disclosure of embarrassing pri- vate facts . For example, "before" and "after" photographs published by a cosmetic surgeon may cause embarrassment to the patient if he or she did not give consent for the photographs to be published.

If a health care facility routinely photographs patients to document care, a special consent form should be signed stating that:

• The patient understands that photographs, videotapes, and digital or other images may be taken to document care.

• The patient understands that ownership rights to the images will be retained by the health care facility, but that he or she will be allowed to view them or to obtain copies.

178 Part Two I Legal issues for Working Health Care Practitioners

• The images will be securely stored and kept for the time period prescribed by law or outlined in the health care facility's policy.

• Images of the patient will not be released and/or used outside the health care facility without written authorization from the patient or his or her legal representative.

If the images will be used for teaching or publicity, a separate con- sent form should be used.

CORRECTIONS

Errors made when making an entry in a medical record or errors dis!=overed later can be corrected, but corrections must be made in a specific manner, so that if the medical records are ever used in a medical malpractice lawsuit, it will not appear that they were falsified. Use these guidelines when correcting errors in a client's paper medical record:

• Draw a line through the error so that it is still legible. Do not black out the information or use correction fluid to cover it up.

• Write or type in the correct information above or below the orig- inal line or in the margin. If necessary, you may attach another sheet of paper or another document with the correction on it. In this case, note in the record "See attached document A" to indicate where the corrected information can be found.

• Note near the correction why it was made (for example, "error, wrong date," or "error, interrupted by a phone call"). You can place this note in the margin or, again, add an attachment. Do not make a change in the record without noting the reason for it.

• Enter the date and time, and initial the correction.

• If possible, ask another staff member or the physician to witness and initial the correction to the record when you make it.

Since the 1996 Health Insurance Portability and Accountability Act (HIPAA) mandated the conversion of medical records from paper to dig- ital form, most medical records are now hybrids, consisting of both elec- tronic and paper documentation. The federal mandate is for all medical records to be stored electronically by the end of 2014. Methods of correct- ing electronic records should be put in place within a medical practice to coincide with software health care providers choose to use, but all meth- ods must meet qualifications specified in federal and state law.

Rule number one in correcting an electronic medical record is that the original record must be maintained. Some software systems in use in medical practices may allow for a single strike-through line through incorrect information, or a system may use different colored type- face to indicate changed information. In any case, the original record should not be completely obscured.

Adding an addendum to correct or add to the original information is the correct method of correction. An addendum is a significant change or addition to the electronic medical record.

Health care providers should have in place a policy for creating addendums to patient medical records, but typically, an addendum to a patient's electronic medical record will include the following:

a. Patient name

b. Date of service

addendum A signif icant change or addition to t he electron ic health record (EHR).

Chapter 7 1 Medical Records and Informed Consent 179

I. Define medical record.

c. Account number

d. Medical record number

e. Original report to which the addendum is to be attached.

f. Date and time of the addendum and the electronic signature of the person creating the addendum.

Examples of documentation errors that are corrected by adden- dum include: wrong dates, wrong locations, duplicate documents, incomplete documents, or other errors. The amended version must be reviewed and signed by the provider.

2. List five purposes served by a patient 's medical record.

3. As the person responsible for charting in a medical office, would you record a patient 's statement that she often feels "woozy" and thinks she has "dropsy"? Why or why not?

4. If a reconstructive surgeon wants to publish "before" and "after" photographs of patients in a brochure left in the waiting room for distribution to prospective patients, what must she do?

5. If a patient makes critical remarks to you, a medical assistant, about your physician/employer, would you record the remarks in the patient's medical record? Why or why not?

6. You are charting after a patient's office visit and you are interrupted by a telephone call. The interruption causes you to incorrectly record results of the patient's blood tests. When you discover your mistake, can you correct it? If so, how?

7. Briefly explain how corrections made to an electronic medical record differ from corrections made to a paper record.

LO 7.2 Identify ownership of medical records and determine how long a medical record must be kept by the owners.

Medical Records Ownership, Retention, and Storage OWNERSHIP

Patients' medical records are considered the property of the owners of the facility where they were created. For example, a physician in private practice owns his or her records; records in a clinic are the property of the clinic. Hospital records are the property of the

COURT CASE Loss of Medical Records

A plaintiff brought a medical malpractice suit against a hos-

pital in Massachusetts. During discovery, the plaintiff learned

that the hospital had lost his medical records. An appeals

court entered a default judgment in favor of the plaintiff

as sanction for the hospital 's loss of the plaintiff's medical

records, and the state supreme court upheld the lower

court 's decision. The supreme court stated that the missing

records, which the defendant conceded were irreparably

180 Part Two I Legal issues for Work ing Health Care Practitioners

lost, contained the only documentation of the critical time

period during w hich the alleged malpractice event occurred,

making a determination based on the evidence impossible.

A default judgment was issued in favor of the plaintiff,

since the hospital's loss of medical records was such an

egregious error.

Keene v. Brigham & Women's Hasp., Inc., 439 Mass. 223 (2003).

admitting hospital. The facility where the medical records were cre- ated owns the documents, but the patient owns the information they contain. On signing a release, patients may usually obtain access to or copies of their medical records, depending on state law. However, under the doctrine of professional discretion, courts have held that in some cases, patients treated for mental or emotional conditions may be harmed by seeing their own records. Under HIPAA, patients who ask to see and/or copy their medical records must be accommodated, with a few exceptions. If patients need clarification, records may be reviewed in the presence of a trusted health care professional, but this is not a requirement for allowing patients to see their records.

When a physician in private practice examines a patient for a job- related physical, scheduled and paid for by the patient's employer or prospective employer, those records are still the physician's property, but the employer is entitled to a copy of the record that is pertinent to the job-related exam. Medical records should never be kept in an employer's general personnel files. The patient must obtain permis- sion from the employer to release information contained in the records.

Under HIPAA, patients are entitled to access any health care infor- mation a physician generates about them, with a few exceptions.

' cs"'' •

Check Your Progress

8. How long should medical records be retained?

9. Who owns a patient's medical record?

I 0. Define doctrine of professional discretion.

doctrine of professional discretion A principle under which a physician can exercise judgment as to whether to show patients who are being treated for mental or emotional conditions their records. Disclosure depends on whet her, in the physician's judgment, such patients would be harmed by viewing the records.

I I. Are you entitled to a copy of your own medical records on request? Explain your answer.

12. If medical records are lost prior to the filing of a medical malpractice lawsuit where the records are necessary, what might result?

RETENTION AND STORAGE

As a protection in the event of litigation, records should be kept until the applicable statute of limitations period has elapsed, which gen- erally ranges from two to seven years. In some cases, this involves keeping the medical records for minor patients for a specified length of time after they reach legal age. Some states have enacted statutes for the retention of medical records. However, most physicians retain records indefinitely, since, in addition to their value as documenta- tion in medical professional liability suits and for tax purposes, the patient's medical history may be vital in determining future treatment.

As illustrated in the court case on the previous page, "Loss of Medi- cal Records," medical malpractice is impossible to prove without med- ical records.

Confidentiality and Informed Consent Since medical office personnel have a duty to protect the privacy of the patient, medical records should not be released to a third party without written permission, signed by the patient or the patient's legal representative. Only the information requested should be released.

LO 7.3 Describe the purpose of obtaining a patient's consent for release of medical information, and explain the doctrine of informed consent.

Chapter 7 1 Medical Records and Informed Consent 181

fiduciary duty A physician's obligation to his or her patient, based on trust and confidence.

Requests for release of records may ask for records concerning a specific date or time span. Records may also be requested for a spe- cific diagnosis, symptom, or body system, or for results of certain diagnostic tests. Medical records personnel should not send unsolic- ited records. They should carefully review the signed release form to ensure that the correct records are sent.

When medical records are requested for use in a lawsuit, a signed consent for the release of the records must be obtained from the patient, unless a court subpoenas the records. In this case, the patient should be notified in writing that the records have been subpoenaed and released.

ROUTINE RELEASE OF INFORMATION

Medical information about a patient is often released for the following purposes:

Insurance Claims. The medical office supplies specific requested information, but does not usually send the patient's entire medical record. An authorization to release information, signed by the patient, is required before records may be released, but most health care providers incorporate the release into the patient registration form so that information can be provided in a timely manner.

Transfer to Another Physician. The physician may photocopy and send all records, or may send a summary. The patient must sign an authorization to release records.

Use in a Court of Law. When a subpoena duces tecum is issued for certain records (the subpoena commands a witness to appear in court and to bring certain medical records), the patient's written consent to release the records is waived.

The court case, "Not Guilty of Breach of Confidentiality," illustrates that physicians who produce patients' medical records for use in court, or those who testify in court as expert witnesses, are not liable for breach of confidentiality.

As illustrated in the chapter 's opening scenario, individuals respon- sible for releasing medical information must follow procedure to protect against unauthorized release, even in the previous situations where medical records are routinely requested.

The court case, "Breach of Confidentiality Declared-Damages Upheld," determined that damages were properly awarded to the plaintiff in a suit against a nurse who released confidential medical information without authorization.

COURT CASE Not Guilty of Breach of Confidentiality

A physician cannot be sued for breach of confidentiality

when required to produce a patient's medical records for

use in court testimony.

A patient (Cruz) sued a physician (Agelides) for breach

of fiduciary duty. (Fiduciary duty is a physician 's duty to his or her patient, based on trust and confidence.) In a pre-

vious malpractice action brought by Cruz against another

182 Part Two I Legal Issues for Working Health Care Practitione rs

physician, Agelides had given a sworn pretrial affidavit and

video deposition in favor of the defending physician. The

court held that Agel ides was immune from any civil liability

action as a result of his testimony as a w itness in the

previous trial.

Cruz v. Age/ides, 574 So 2d 278 (Fla. App. 3 Dist., 1991 ).

COURT CASE Breach of Confidentiality Declared- Damages Upheld

A 20-year-old unmarried woman who lived with her parents

decided to terminate her pregnancy at the Long Island

Surgi-Center. Because her parents strongly disapproved of

premarital sex and were implacably opposed to abortion,

she did not tell them of her decision. When she arranged

for the procedure, the woman provided her cell phone

number, but told the clinic never to call her at home.

Nevertheless, a day after the abortion one of the clinic's

nurses telephoned the young woman at home and spoke

with a person she knew to be the woman's mother. Because

blood test results had been received at the center that

morning, but had not been entered in the patient's medical

record, the nurse called the patient's home to determine

(I) information about the patient's blood type, and (2) if the

patient was experiencing vaginal bleeding. The nurse did

not explicitly tell the patient's mother that her daughter had

undergone an abortion, but the mother deduced the truth

from the nurse's questions. The patient's relationship with

her parents was irreparably damaged, and she sued the clinic,

charging breaches of confidentiality, privacy, and fiduciary

duty, and seeking compensatory and punitive damages. The

center conceded liability, and the matter proceeded to trial

on the question of damages. The jury awarded the plaintiff

$65,000 for past and future emotional distress and $300,000

in punitive damages. The Surgi-Center appealed the damages

awarded, but the appeals court upheld the awards.

Randi A. }. v. Long Is. Surgi-Ctr. , 2007 NY Slip Op 06953 ; 46 A.D. 3d 74.

While Michael, Sally, and Teresa, medical records employees, are explicitly aware of the dangers of releasing confidential medical informa- tion, all health care practitioners, like the nurse in the court case, "Breach of Confidentiality Declared-Damages Upheld," also need to be con- stantly aware of protecting confidentiality of patients' medical records.

Physicians receive subpoenas for patient medical records for a variety of reasons, including accidents involving patients, workers' compensation claims, and other nonmedical-liability reasons. When this occurs, the medical office sends a photocopy of the patient's medical records to the attorney who issued the subpoena.

When a physician is sued for medical malpractice, however, respon- sibility to comply with a subpoena to produce specified medical records in court may fall to the medical office employee in charge of medical records. In that case, the person in charge of medical records should follow these guidelines:

• Check the subpoena to be sure the name and phone number of the issuing attorney and the court docket number of the case are listed.

• If a copy of the subpoena is received, verify with the issuing attor- ney that it is the same as the original in every way.

• Verify that the patient named was a patient of the physician named.

• Verify the trial date and time as listed on the subpoena.

• Notify the physician that a subpoena was received, and then notify the physician's insurance company or attorney, if so directed.

• Check all subpoenaed records to be sure they are complete, but never alter them in any way.

• Document the number of pages in the record and itemize its con- tents. Make a photocopy of the original to be submitted, if permit- ted by state law and the court.

• Offer sworn testimony regarding the record, if so instructed by the court.

Chapter 7 1 Medical ecords and Informed Consent 183

Confidentiality of Alcohol and Drug Abuse, Patient Records A federal statute that protects patients with hist ories of substance abuse rega rd ing the release of information about treatment.

consent Permiss ion from a person, either expressed or implied, for something to be done by another.

doctrine of informed consent The legal basis for informed consent, usually outl ined in a state's med ical practice acts.

Some state laws specifically address the release of confidential medical information, especially as it pertains to treatment for mental or emotional health problems, HIV testing, and substance abuse. In addition, the fed- eral statute Confidentiality of Alcohol and Drug Abuse, Patient Records protects patients with histories of substance abuse regarding the release of information about treatment. Under no circumstances should information of this type be released without specific, written permission from the patient to do so. The patient also has the right to rescind (cancel) consent to release information, in which case the information should not be released.

The follow ing rules for authorizations for the release of medical records can serve as a general guide for medical assistants, health information technicians, and other health care practitioners:

• Authorizations should be in writing.

• Authorizations should include the patient's name, address, and date of birth.

• The patient should sign authorizations, unless he or she is not a legal, competent adult. In that case, parents or guardians should sign authorizations.

• Only the information specifically requested should be released.

• Requests for information coming into the medical office from insurance companies, physicians, or other sources should be wit- nessed and dated and include the complete name, address, and signature of the party requesting the information, as well as that of the party asked to release the information.

• Include a specific description of the information that is needed. List the purpose for which the data will be used and the date on which the consent expires.

CONSENT By giving consent, the patient gives permission, either expressed (orally or in writing) or implied, for the physician to examine him or her, to perform tests that aid in diagnosis, and/or to treat for a medical condi- tion. When the patient makes an appointment for an examination, that patient has given implied consent for the physician to perform the exam. Likewise, when he or she cooperates with various diagnostic testing procedures, implied consent for the tests has been given.

Informed Consent For surgery and for some other procedures, such as a test for HIV, implied consent is not enough. In these cases, it is important to ask the patient to sign a consent form, thereby docu- menting informed consent (see Figure 7-1).

The doctrine of informed consent is the legal basis for informed consent and is usually outlined in a state's medical practice acts. Informed consent implies that the patient understands

• Proposed modes of treatment.

• Why the treatment is necessary.

• Risks involved in the proposed treatment.

• Available alternative modes of treatment.

• Risks of alternative modes of treatment.

• Risks involved if treatment is refused.

184 Part Two I Legal Issues fo r W o rking Health Care Practitioners

~our Progress

13 . Name three reasons a med ical office might be requested to release a patient's medical records.

14. In which of the three situations named fo r question 13 might a patient's written consent to release

records be waived?

15. What is needed before the medical office can send a patient's medical record to the insurer?

16. If an insurance company submits a request for medical records pertaining to an enrolled patient's outpatient foot surgery and you are responsible for sending the records, should you send the patient's

entire file to be on the safe side? Why or why not?

17. As the person who reviews requests for patients' medical records, do you need to know the purpose

for which the data will be used? Explain your answer.

INFORMED CONSENT for SURGERY and PROCEDURES 1. I hereby authorize stall physicians and resident staff at -------,-,-,==="-"=='""------- to pertorm upon

(Name of Hospital or Facility) -------.c(Nc-am"'e-:

0 .-1 pcccat'ient) ----------- , such treatment, procedures and/or operations necessary to treat or diagnose the

condit ion(s) which appear indicated.

2. The operation(s) or procedure(s) necessary to treat and/or diagnose my cond ition and the risks, benefits/alternatives and options associated with them have been explained to me by ___________ .. _ _____ , and I understand the operation(s) or

(Name of Physician or provider)

procedure(s)to be: __________________ _

3. Different Provider: D Not Applicable I understand and approve that a different provider other than the physician named above may actual ly perform the procedure.

4. Operative Side: D Not Applicable D Lett D Right

5. Sedation & local Anesthetics: I authorize the administration of sedation and the use of local anesthetics, drugs and medicines as may be deemed appropriate_ If they witt be used, the risks and benefits/alternatives of sedation have been explained to me by the procedural physician.

6. Blood and Blood Products: D Not Applicable

I understand certain surgeries, procedures, or illnesses may result in loss ot blood. I authorize the administration of blood and/or blood components during the procedure as well as during the course ol my hospital stay. II blood will be used, the risks, benetits/alternatives have been explained to me by the physician. Patient Initials: _ ___ _

7. No Blood Products: o Not Appl icable I request that No blood derivative be administered to me. I hereby release the hospital , its personnel . the attending physician and its agents from any responsibility whatsoever for unfavorable reactions or any untoward results due to my refusal to permit the use of blood or its derivatives. The possible risks and consequences of such refusal on my part have been fully explained and I fully understand such risks and consequences may occur as a result of my refusal.

Signature ot PatienVResponsibte Person: __________ _ Relationship: _________ _

8. Unforeseen Conditions: It has been explained to me that during the course of the operation(s) or procedure(s) unforeseen conditions may be revealed that necessitate an extension of the original procedure(s) or different procedure(s) than those set forth above. I am aware that the practice of medicine is not an exact science and I acknowledge that no guarantees have been made to me concerning the result of the operation(s) or procedure(s).

9. Photography: I consent to the use of photography, closed circuit television recording and to use the photographs and other materials for study, educational and scientific purposes, in accordance with ordinary practices of the facility.

10. I consent to have my procedure/operat ion observed, for educational purposes, by individual(s) other than those assist ing the physician during the procedure/operat ion.

Physician or Provider Signature

Signature of Interpreter (if applicable)

Witness (Telephone consent) Date

Patient's Signature (if competent) Witness Date

Date Time

Time

Signature of Person Responsible Relationship Date

Second Physician or Provider Signature for Emergencies for incompetent patient and No family

Physician must initial faxed copy

Date

Time

FIGURE 7-1 A Sample Consent Form

Chapter 7 1 Medical Records and Informed Consent 185

- -

Informed consent involves the patient's right to receive all infor- mation relatiYe to his or her condition and then to make a decision regarding treatment based on that knowledge. Documents establish- ing that the patient gave informed consent prove that the patient was not coerced into treatment.

Adults of sound mind are usually able to give informed consent. Those individuals who cannot give informed consent include the following:

Minors, Persons under the Age of Majority. Exceptions include:

• Emancipated minors-those who are living away from home and responsible for their own support. A minor becomes "emancipated" through a court hearing where evidence is presented that the minor should be emancipated, and a judge makes a determination that the minor has met certain criteria. The minor is then declared "emancipated" and can consent to his or her health care treatment just as any adult of sound mind determines his or her health care treatment.

• Married minors

• Mature minors-those who, through the doctrine of mature minors, have been granted the right to seek birth control or care during pregnancy, treatment for reportable communicable diseases, or treatment for drug- or alcohol-related problems without first obtaining parental consent.

Persons Who Are Mentally Incompetent. Individuals judged by the court to be insane, senile, mentally challenged, or under the influence of drugs or alcohol cannot give informed consent. In these cases, a competent person may be designated by the court to act as the patient's agent.

Persons Who Speak Limited or No English. When a patient does not speak or understand English, an interpreter may be necessary to inform the patient and obtain his or her consent for treatment.

The rights of emancipated minors, married minors, and mature minors to consent to their own health care are discussed further in Chapter 11.

Other problems in obtaining informed consent may arise in situations such as when foster children need medical attention or a spouse seeks sterilization or an abortion. In each case, health care practitioners must determine who is legally able to give informed consent for treatment. When in doubt, seek legal advice.

Patient education is vital to the issue of informed consent. Stocking the medical office with brochures about various medical problems is not sufficient if the physician does not review the material with the patient. Patients who sue have successfully claimed lack of informed consent because they did not read the consent form they signed or did not read brochures handed to them. Health care personnel should be sure that patients understand all forms and all treatments/surgeries to be performed before signing.

Before proceeding with treatment, health care practitioners must determine whether or not patients are competent to give informed consent.

186 Part Two I Legal issues for Working Health Care Practitioners

LANDMARK COURT CASE Case Legalizes Abortion

In 1970 a single woman in Texas became pregnant. She had

difficulty finding work because of her pregnancy and feared

the stigma of an illegitimate birth. Under the fictitious name

"Jane Roe," the woman sued Henry Wade, the district attor-

ney in Dallas County, Texas, claiming that she had limited rights

to an abortion and sought an injunction against the Texas

statute prohibiting abortion except to save a woman's life.

It took three years for the case to reach the U.S.

Supreme Court, which struck down the Texas statute.

The ruling came too late for Jane Roe to have the abor-

tion she originally sought, of course, but it affected the

rights of all women w ho would seek abortions from that

time on. The Court held that the constitutional right to

privacy includes a woman's decision to terminate a preg-

nancy during the first trimester (three months) , but that

states could impose restrictions and regulate abortions

after that.

Roe v. Wade, 410 U.S. I 13, 144 "n 39" ( 1973).

Informed Consent and Abortion Law In Planned Parenthood v. Casey, U.S. 833 (1992), the U.S. Supreme Court upheld a 24-hour waiting period, an informed consent requirement, a parental consent provision for minors, and a record-keeping requirement for women seeking an abortion. At the same time, the Court struck down the spousal notice requirement of a Pennsylvania statute, in addition to other specific requirements. Casey and Webster v. Reproductive Health Services before it (1989) upheld Roe v. Wade, the 1973 Supreme Court decision that legal- ized abortion in the United States (see the above case, "Case Legalizes Abortion"), but allowed state regulation of abortion. A number of state legislatures took the cue and passed new abortion restrictions.

Among a long list of state-imposed abortion restrictions are laws that specify certain changes in informed consent. For example, some states require that a woman seeking an abortion be clearly informed of all alternatives to abortions and be told of all risks associated with such surgeries before she can give informed consent to the abortion. In addition, before a woman can consent to an abortion in many states, she must wait a certain length of time (usually 24 hours) before actu- ally signing a consent form.

Amore recent court case, "Case Allows State Regulation" on the next page, upheld Roe v. Wade, and also allowed a state to regulate abortion.

Technically, abortion is legal in all 50 states, but state legislatures have added many restrictions.

Since abortion law is constantly changing, health care practitioners must stay informed about current abortion laws in their respec- tive states. A good Web site for finding abortion laws in your state is statelaws.findlaw.com/family-laws/abortion.html.

HIV and Informed Consent State public health law varies for human immunodeficiency virus (HIV) testing, but, generally, health care practitioners must consider the following factors:

Can a minor (aged less than 18 in some states, 21 in others) consent to his or her own HIV test? Informed consent law for minors vary, but this determination may sometimes be made without regard to age, depending on the minor 's situation:

• Infants and young children do not have the capacity to consent, because they do not yet have the ability to make informed deci- sions. The person legally designated to make health care decisions

Chapter 71 Medical Records and Informed Consent 187

COURT CASE Case Allows State Regulation

The Pennsylvania legislature amended its abortion con-

trol law in 1988 and 1989. Among the new provisions,

the law required informed consent and a 24-hour waiting

period prior to the procedure. A minor seeking an abor-

tion required the consent of one parent (the law allowed

for a judicial bypass procedure) . A married woman seek-

ing an abortion had to indicate that she notified her hus-

band of her intention to abort the fetus. These provisions

were challenged by several abortion clinics and physicians.

A federal appeals court upheld all the provisions except

the husband notification requirement.

without violating their right to abortions as guaranteed by

Roe v. Wade? In a bitter 5-to-4 decision, the Court again reaffirmed Roe, but it upheld most of the Pennsylvania provisions. For the first time, the justices imposed a

new standard to determine the validity of laws restrict-

ing abortions. The new standard asks whether a state

abortion regulation has the purpose or effect of impos-

ing an "undue burden," which is defined as a "substan-

tial obstacle in the path of a woman seeking an abortion

before the fetus attains viability." Under this standard,

the only provision to fail the undue-burden test was the

husband notification requirement. The question in this case was, can a state require

women who want an abortion to obtain informed consent,

wait 24 hours, and, if minors, obtain parental consent Planned Parenthood v. Casey, 505 U.S. 833 ( 1992).

Good Samaritan acts State laws protecting physicians and sometimes other hea lth care practitioners and laypersons from charges of negligence or abandonment if they stop to help the victim of an accident or other emergency.

for the child has the right to decide whether the child should be tested for HIV.

• Married minors, emancipated minors, and minor parents may have the right to give consent for HN testing, depending on state law.

Can an HIV-infected minor consent to his or her treatment? Generally, parental or guardian consent is required for a physician to treat a minor for HN/AIDS, including treatment in school-based clinics. Married, emancipated, and mature minors can usually consent to their own care.

When Consent Is Unnecessary In emergency situations, when the patient is in immediate danger, the physician is not expected to obtain consent before proceeding with treatment.

All 50 states have passed Good Samaritan acts. These acts were intended to protect physicians and, in some states, other health care practitioners and laypersons from charges of negligence or abandon- ment if they stop to help the victim of an accident or other emergency, provided they:

• Give such care in good faith.

• Act within the scope of their training and knowledge.

• Use due care under the circumstances.

• Do not bill for their services. (If a physician treats a patient as a "Good Samaritan" and later bills the patient for services, he or she may be held as having established a physician-patient relation- ship and may not have the immunity from civil damages that a Good Samaritan law would otherwise provide.)

While some states offer immunity to Good Samaritans, sometimes the act of rescuing an accident victim can result in a legal claim of neg- ligent care if the injuries or illness were made worse by the volunteer's actions. Statutes typically don't exempt a Good Samaritan who acts in a wilful and wanton or reckless manner in providing emergency care, advice, or assistance. Furthermore, Good Samaritan laws usually don't apply to a person rendering emergency care, advice, or

188 Part Two I Legal Issues for Working Health Care Practitioners

assistance during the course of regular employment, such as services rendered by a health care provider to a patient in a health care facility.

Good Samaritan in legal terms refers to someone who renders aid in an emergency to an injured person on a voluntary basis. Usually, if a volunteer comes to the aid of an injured or ill person who is a stranger, the person giving the aid owes the stranger a duty of being reasonably careful. A person is not obligated by law to do first aid in most states, unless it's part of a job description. However, some states will consider it an act of negligence if a person doesn't at least call for help. Generally where an unconscious victim cannot respond, a Good Samaritan can help on the grounds of implied consent. However, if the victim is con- scious and can respond, a person should first ask permission to help.

If a person helps a victim in an emergency and is later sued, whether or not the defendant can use a state Good Samaritan law for his or her defense may depend on the court's definition of the state's law, as shown in the case, "Good Samaritans Can Be Liable for Damages to Person Injured during Rescue Attempt."

COURT CASE Good Samaritans Can Be Liable for Damages to Person Injured during Rescue Attempt

Good friends Alexandra Van Horn and Lisa Torti spent the

evening partying in a bar; then each woman left the bar in

her own car. Van Horn drove away first, and crashed into

a curb and streetlight standard at 45 mph. Torti, behind

Van Horn in the second car, saw the accident and , afraid

the wrecked car was about to "blow up," she removed

Van Horn. As a result, Van Horn was paralyzed.

Van Horn sued Torti. Torti 's defense was based on

California's Good Samaritan law, Health & Safety Code

section 1799. 102, which provides: "No person who in

good faith, and not for compensation, renders emergency

care at the scene of an emergency shall be liable for any

civil damages resulting from any act or omission. The scene

of an emergency shall not include emergency departments

and other places where medical care is usually offered."

Based on this statute, the trial court granted sum-

mary judgment for the defendant. The plaintiff appealed,

and the case eventual ly reached the California Supreme

Court, where justices interpreted the state's Good

Samaritan law to apply strictly to medical care, because the statute appears in the Health & Safety Code, in the

division entitled "Emergency Medical Services. " (A statute

providing broad immunity would li kely appear in the Civil

Code.) Torti did not render emergency medical care; she

merely pulled Van Horn from her crashed car, and, there-

fore, she was found potentially li able. This ruling meant

that Van Horn could take her case to a jury.

Common law principles applied were that the defendant's

broad interpretation of Health & Safety Code 1799. 102

would undermine establ ished common law regarding

liability for assisting others. There is no general duty to

give assistance, but under the common law, a person

who undertakes to help others has a duty to exercise

due care. Nothing in the statute overcomes the judi-

cial presumption that the legislature does not intend to

overru le established common law principles when it

enacts legislation. A broad inte rpretation, the court held,

would also render superfluous other California "Good

Samaritan" statutes, such as Govt C. 50086 (immunity for a person trained in first aid who is summoned by

authorities and renders emergency services) and Harb. &

Nav C. 656(b) (immunity for a person who assists at scene of vessel collision) (45 C 4th 333) .

As a result of the ruling, the California legislature

changed the state's Good Samaritan law. Health and

Safety Code section 1799.102 now reads in part: "No

person who in good faith, and not for compensation,

renders emergency medical or nonmedical care or assis-

tance at the scene of an emergency shal l be liable for civil

damages resulting from any act or omission other than an

act or omission constituting gross negligence or wi lful or

wanton misconduct."

Trial Court: Von Horn v. Watson (2008) 45 C 4th 322, 86 C.R. 3d 350, 197 P 3d 164. California Supreme Court: Alexandra Von Horn, Plaintiff and Appellant, v. Anthony Glen Watson et a/. , Defendants and Respondents; Anthony Glen Watson, Cross-complainant and Appellant, v. Lisa Torti, Cross-defendant and Respondent, Supreme Court of California, Dec. 18, 2008. Rehearing Denied Feb. I I, 2009.

Chapter 71 Medical Records and Informed Consent 189

Check Your Progress .··

18. Who may give informed consent?

19. Who may not give informed consent?

20. Must consent to perform routine medical care, such as a physical examination, always be in writing? Explain your answer.

21. In which health care situations is implied consent not sufficient?

22. What consequences generally ensue if a legally competent adult is treated without consent and an adverse event occurs?

LO 7.4 Describe the necessity for e lectronic medical records and the efforts being made to record al l medical records electronically.

health information technology (HIT) The applicat ion of information processi ng, invo lving both computer hardware and software, that deals with the storage, ret rieval, sharing, and use of health care information, data, and knowledge for communication and decision making.

Health Information Technology (HIT) According to the U.S. Department of Health and Human Services, health information technology (HIT) is "the application of informa- tion processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care infor- mation, data, and knowledge for communication and decision making." The broad category health information technology also includes telemedicine and use of the Internet for health information purposes. A central component of HIT is the patient's medical file, and as elec- tronic medical records become more widely adopted, confidentiality and privacy concerns must be addressed.

As of 2004, President George W. Bush had set a 10-year goal for the broad adoption of electronic medical records in the United States. President Barack Obama, who took office January 1, 2009, continued to urge health care providers to convert records to electronic form. In fact, under the Patient Protection and Affordable Care Act signed into law in 2010, physicians could receive up to $44,000 from the government to help with the cost of converting to electronic records.

Government-initiated steps toward broad adoption of electronic health information include the following:

1. The Health Insurance Portability and Accountability Act (HIPAA). Passed in 1996 and implemented in stages through 2005, HIPAA addresses privacy of health information and mandates certain pro- cedures and standards for the electronic transmission and storage of health care information.

2. Executive Orders. In April2004, President George W. Bush signed an executive order establishing the position of National Coordi- nator for Health Information Technology. The coordinator was charged with the development, maintenance, and oversight of a plan for nationwide adoption of health information technology.

In August 2006, a second executive order stated that all federal agencies would utilize, where available, health information technol- ogy systems and products meeting certain "recognized" standards. These HIT systems and products "shall be used for implement- ing, acquiring, or upgrading health information technology sys- tems used for the direct exchange of health information between agencies and with nonfederal entities." The order further stipu- lated that federal agencies shall require in contracts or agreements

190 Part Two I Legal Issues for Working Health Care Practitioners

with health care providers, health plans, or health insurance issuers that, where available, health information technology systems and products meeting recognized standards shall be used.

3. Adoption of the Health Information Standards Developed by Health and Human Services (HHS). As part of this effort, HHS has negotiated and licensed a comprehensive medical vocabulary and made it available to everyone in the United States at no cost. The results of these projects include standards for the following types of information:

• Transmitting X-Rays over the Internet: Today, a patient's chest X-ray can be sent electronically from a hospital or laboratory and read by the patient's doctor in his or her office.

• Electronic Laboratory Results: Laboratory results can be sent electronically to the physician for immediate analysis, diagnosis, and treatment, and could be automatically entered into the patient's electronic health record if one existed. For example, a doctor could retrieve this information for a hospitalized patient from his or her office, ensuring a prompt response and eliminating errors and duplicative testing due to lost laboratory reports.

• Electronic Prescriptions: Patients save time because prescriptions can be sent electronically to their pharmacists. By eliminating illegible handwritten prescriptions, and because the technology automatically checks for possible allergies and harmful interactions with other drugs, standardized electronic prescriptions help avoid serious medical errors.

4. Use of the Federal Government to Foster the Adoption of Health Information Technology. As one of the largest buyers of health care- in Medicare, Medicaid, the Affordable Care Act, the Com- munity Health Centers program, the Federal Health Benefits program, veterans' medical care, and programs in the Department of Defense- the federal government can create incentives and opportunities for health care providers to use electronic records.

The federal government maintains that the broad use of health information technology will improve individual patient care by:

• Improving health care quality

• Preventing medical errors

• Reducing health care costs

• Increasing administrative efficiency

• Decreasing paperwork

• Expanding access to affordable care

The previous benefits can be seen in the following examples:

• When arriving at a physician office, new patients do not have to enter their personal information, allergies, medications, or medi- cal history, since these facts are already available.

• A parent, who previously may have had to carry a large folder containing the child's medical records and X-rays by hand when seeing a new physician, can now keep the most important medical

Chapter 71 Medical Records and Informed Consent 191

;

. I

history on a keychain, or simply authorize the new physician to retrie\'e the information electronically from previous health care providers.

• Arriving at an emergency room, an elderly patient with a chronic illness and memory difficulties can authorize his or her physicians to access her medical information from a recent hospitalization at another hospital-thus avoiding a potentially fatal drug interaction between the planned treatment and the patient's current medications.

Public health benefits will include:

• Early detection of infectious outbreaks around the country. For example, three patients experience unusual sudden-onset fever and cough that would not individually be reported. They show up at separate emergency rooms, and through access to electronic health information, the trend is instantly reported to public health officials, who alert authorities of a possible disease outbreak or bioterror attack.

• Improved tracking of chronic disease management.

• Evaluation of health care based on comparisons of price and quality.

When Hurricane Katrina hit the Louisiana and Mississippi coasts on August 29, 2005, the destruction that resulted included the loss of countless paper medical records. As a result, many of the survivors couldn't remember the names of lost prescriptions, or when they had last been immunized against tetanus and other diseases. In addition, storm victims who reported to physicians had no medical records health care providers could use as a basis for treatment, and recon- struction, if even possible, would take valuable time.

By contrast, when Hurricane Sandy struck the East Coast on October 29, 2012, many health care providers had already converted paper files to digital files as part of HIPAA-mandated disaster plan- ning. In fact, for most of the providers who suffered through Sandy, the process of compliance began long before the storm. Those provid- ers that had disaster plans in place and had practiced them to be sure they worked were in the best position to ride out the storm without loss of critical data and services. And those providers who had dupli- cated all necessary electronic data at off-site data centers were also able to function during the storm or to restore function more quickly after the storm hit. For example, AtlantiCare, a health care system in New Jersey with a large regional medical center and 70 other locations throughout the state, made it through Sandy with few disruptions, thanks to advance disaster planning.

THE HIPAA DISASTER RECOVERY PLAN

A HIPAA disaster recovery plan for health care providers is a docu- ment that specifies the resources, actions, personnel and data that are required to protect and reinstate health care information in the event of a fire, vandalism, natural disaster or system failure.

A HIPAA-compliant disaster recovery plan must state how oper- ations will be conducted in an emergency and which workforce members are responsible for carrying out those operations. The plan

192 Port Two I Legal Issues for Working Health Care Practitioners

must explain how data will be moved without violating HIPAA standards for privacy and security. It must also explain how confi- dential data and safeguards for that data will be restored. Although HIPAA doesn't specify exactly how to do this, it does note that failure to adequately recover from a disaster could lead to noncompliance, exposing officers of the organization to fines or even jail time.

TECHNOLOGICAL THREATS TO CONFIDENTIALITY

Increasingly, as the federal government mandates and encourages health information technology, modern health care facilities rely on technology for creating, maintaining, and transporting patients' medical information. HIPAA imposes penalties for breaches of confidentiality regarding medical records that identify patients by name. The following guidelines can help ensure that confidentiality is not breached when employees use photocopiers, fax machines, com- puters, and printers to reproduce and send medical records.

Photocopiers

• Do not leave confidential papers anywhere on the copier where others can read the information.

• Do not discard copies in a shared trash container; shred them.

• If a paper jam occurs, be sure to remove from the machine the copy or partial copy that caused the jam.

Fax Machines

• Always verify the telephone number of the receiving location before faxing confidential material.

• Never fax confidential material to an unauthorized person.

• Do not fax confidential material if others in the room can observe the material.

• Do not leave confidential material unattended on a fax machine.

• Do not discard fax copies in a shared trash container; shred them.

• Use a fax cover sheet that states, "Confidential: To addressee only. Please return if received in error."

Progress

23. How does an electronic medical record differ from one kept on paper?

24. Define health information technology.

25. Name two measures the federal government has taken to speed the adoption of electronic medical

records.

26. According to the federal government, what are two ways the use of electronic records might improve patient care?

27. You are photocopying a patient's medical record and an employee from the clinic's accounting department is reading over your shoulder while he waits to use t he copier. What should you do?

Chapter 7 1 Medical ecords and Informed Consent 193

I ~

.....

Computers

• Locate the monitor in an area where others cannot see the screen.

• Do not leave a monitor unattended while confidential material is displayed on the screen.

• Because it is difficult to ensure the privacy of e-mail mes- sages, sending confidential patient information via e-mail is not recommended .

• When computers are sold or otherwise recycled, it's vital that hard drives be erased or removed and destroyed.

Printers

• Do not print confidential material on a printer shared by other departments or in an area where others can read the material.

• Do not leave a printer unattended while printing confidential material.

• Before leaving the printing area, check to be sure all computer disks containing confidential material and all printed material have been collected.

• Be certain that the print job is sent to the right printer location.

• Do not discard printouts in a shared trash container; shred them.

Since medical records are legal documents, and their confidentiality is protected by law, health care practitioners must take every precau- tion to properly enter information into medical records and to keep that information confidential.

194 Part Two I Legal Issues for Working Health Care Practitioners

Chapter Summary

Learning Outcome Summary

LO 7.1 Explain the purpose of medical records and t he importance of correct documentation.

What purposes do medical records serve?

They are required by licensing authorit ies and provide a format for tracki ng, documenting, and maintaining a patient's communication data, both inside and outside a health care facility.

They p rovide documentation of a pat ient's continuing hea lth care, from b irth to death.

• They provide a foundation for managing a patient's hea lth care.

• They serve as legal documents in lawsuits.

They provide clinical data for education, research, statistical tracking, and assessing the quality of health care.

What information is entered into a patient's medical record?

• Contact and identifying information.

• Insurance information

Driver's license information

• Person responsib le for payment and billi ng.

• Emergency contact information

• Patient's hea lth history

• Dates and t imes of appointments.

• Descriptions of patient's symptoms and reasons for appointments.

Examinations performed

Physician's assessment, diagnosis, recommendations, treatment, progress notes, prescriptions, and instructions to patient.

• X-rays and all test results.

• Notations for telephone ca lls.

• Notations of copies made.

Documentation of informed consent.

Names of guardians or legal representatives if patient unable to give informed consent.

• All other documentation

• Condition of patient at time of termination of treatment.

What are the five Cs of entries in medical records?

• Concise • Complete • Clear

Correct

• Chronolog ica lly ordered What is the accepted manner for correcting errors in a paper medical record?

• Draw a line through the error.

Write correct information above or below original line.

Note why correction was made.

• Enter the date, time, and initia l the correction .

• Ask a coworker to witness and intial the correction when it is made.

What is the accepted method of correcting an electron ic medica l record?

Follow policy for software used to create the electron ic medica l record.

If an addendum is added to record, be sure it includes:

Patient name

Date of service

Account number

Medica l record number

• Original report to which the addendum is to be attached.

• Date and time of the addendum and the electronic signature of the person creating the addendum.

Chapter 71 Medica. Records and Informed Consent 195

Learning Outcome Summary

LO 7.2 Identify ownership of medical records and determine how long a medi- cal record must be kept by the owners.

LO 7.3 Describe the purpose of obtain- ing a patient's consent for release of medical information, and explain the doctrine of informed consent.

LO 7.4 Describe the necessity for electronic medical records and the efforts being made to record all medical records electronically.

Who owns a person's medical record?

• The owners of the facil ity where the records were created.

How long should medical records be kept?

Until the applicable statute of limitations period has elapsed.

For w hat purposes is medical information routinely released?

Insurance claims

• Transfer of the patient to another physician.

Use in a court of law.

What information does the patient need to give informed consent?

Proposed modes of treatment.

• Why the treatment is necessary.

Risks involved

• Avai lable alternatives

Risks of alternatives

Risks involved if treatment is refused.

Who cannot g ive informed consent?

Minors

• Persons who are menta lly incompetent.

Persons who speak lim ited or no Engl ish .

W hen do Good Samaritan laws protect health care practitioners who stop to help in emergencies?

• When care is given in good fa ith.

• When caregivers act within the scope of their training and knowledge.

• When careg ivers use due care under the circumstances.

• When caregivers do not b ill for their services.

What benefits does the federal government ascribe to the adoption of health information t echnology, including the conversion to electronic records?

Improving hea lth care quality.

• Preventing medical errors

• Reducing health care costs.

Increasing administrative efficiency

Decreasing paperwork

Expanding access to affordable care.

What is the HIPAA Disaster Recovery Plan?

• A document that specifies t he resources, actions, personnel and data that are required to protect and rei nstate health care information in the event of a fire, va ndalism, natural disaster or system failure .

• disaster recovery p lan must state how operations will be conducted in an emergency and which workforce members are respons ible for carrying out those operations.

• must explain how data will be moved without violating HIPAA standards for p rivacy and security .

must explain how confidential data and safeguards for that data will be restored.

• failure to adequately recover from a disaster cou ld lead to noncompliance, exposing officers of the organization to fines or even jail time.

What machines requ ire special ca re in preventing technological threats to confidentiality?

• Photocopiers

Fax machines

• Computers

Printers

196 Part Two I Legal Issues for Working Health Care Practitioners

Ethics Issues Medical Records and Informed Consent

A basic tenet of medical law and ethics is that patients have the right of self-determination. That right, however, can be effectively exercised only if patients have enough information to make an intelligent, informed choice about medical treatment. Health care practitioners do not have the right to withhold infor- mation because full disclosure might prompt the patient to forgo needed therapy.

Dr. Carmen Paradis, a bioethicist with the Cleveland Clinic, says the following to health care practitioners regarding informed consent:

Make information relevant to how the patient thinks. For example, "3 percent" may mean nothing to a patient, where "3 out of 100" will. You may also want to say, "97 out of 100 will not have this problem."

Benefits must be weighed against risks for the patient. How risky is the treatment under consideration? Is the benefit marginal? In addition, make the information available ~wer time, so the patient is not over- whelmed with information all at once. And in addition to verbal explanations use alternative methods of giving information, such as videos, CDs, written material, and so on.

Medical providers at the Cleveland Clinic are fortunate, in that the clinic has an international center prac- titioners can call on for translations of medical documents into languages other than English, and for transla- tors who can relate to a patient's native culture and language.

Ethics ISSUE 1: A nurse working in a physician office is helping the physician explain a medical diagnosis and proposed treatment plan to a middle-aged woman who is a recent immigrant from Thailand. The woman speaks no English, and her daughter is attempting to translate the conversation. The woman has metastasized lung can- cer, and her prognosis is not good. The nurse notices a pronounced hesitation in the daughter's translation of this news to her mother, and she suspects the daughter has not relayed the information correctly, because the patient seems undisturbed by the news.

Discussion Questions

1. As the nurse or medical assistant helping the physician in this scenario, what would you do?

2. Assume that the nurse and the physician must obtain informed consent from the patient in the scenario. Should they rely solely on the daughter's ability to translate? Explain your answer.

Ethics ISSUE 2: You are an LPN in a reproductive services clinic, and a pregnant patient is suffering a medical condition wherein the pregnancy threatens her life. Her physician suggests that she undergo an abortion.

Discussion Questions

1. Will your personal values allow you to assist with the procedure? Explain your answer.

2. If your answer to question 1 is no, what are your alternatives?

Chapter 71 Medical Records and Informed Consent 197

Ethics ISSUE 3:

You have observed an LPN with whom you work in a hospital attempting to erase an entry she has made in a patient's paper medical record. She asks you not to tell that you saw her attempting to erase the entry.

Discussion Question

1. What will you do next?

Ethics ISSUE 4:

You have faxed a patient's medical record to another physician office and discover you have used the wrong fax number.

Discussion Question

1. What will you do next?

Chapter 7 Review

Enhance your learning by completing these exercises and more at http:/ /connect.mheducation.com!

Applying Knowledge

LO 7.1

a connect®

1. Assume you are in charge of recording medical information in a patient's record after the patient has seen his or her physician. What seven items will you be sure to record?

2. What are the five Cs for correctly entering information into a medical record?

3. After an entry in the medical record has been written or keyed and an error is discovered, what procedure should be followed to correct the error?

a. Use a pencil eraser to remove the entry on a written record; then write in the correction.

b. Use the delete or backspace key if the entry was keyed in; then key in the correction.

c. Draw a line through the error; then call the patient's physician.

d. None of these.

4. Which of the following comments should not be included in a patient's medical record?

a. "Patient complained of pain in her right index finger."

b. "Blood drawn for CBC."

198 Part Two I Legal Issues for Working Health Care Practitioners

c. "Patient requests no more Jell-0 ."

d. "Patient is big as a blimp."

LO 7.2

5. Dr. Wellness works as an employee of Anytown Medical Clinic. Who owns the records of his patients?

a. Dr. Wellness

b. Anytown Medical Clinic

c. Each of Dr. Wellness's patients

d. The state in which Dr. Wellness practices

6. Dr. Wellness also sees patients at Anytown General Hospital, where he maintains records of hospital stays, procedures, and emergency room visits. To whom do these records belong?

a. Dr. Wellness

b. Each of Dr. Wellness's patients

c. Anytown General Hospital

d. The American Hospital Association

7. Jan B. is a patient of Dr. Wellness, who practi.ces alone. She is moving and wants to transfer her medical records from Dr. Wellness to her new physician, Dr. Good, who works for the Good Samaritan Clinic. Does Jan have the right to obtain copies of her medical records?

a. Yes, but she must sign a consent form.

b. No

c. Only with a subpoena

d. None of these.

8. In the situation in question 7, who owns Jan's medical records before she moves?

a. Jan

b. Dr. Wellness

c. The state in which Dr. Wellness is licensed

d. None of these.

9. Who owns the medical records after Jan moves and begins to see Dr. Good?

a. Jan

b. Dr. Wellness

c. Dr. Good

d . The Good Samaritan Clinic

10. Which of the following is not necessary for Jan's medical records to be transferred to her new physician?

a. Jan must sign a form, requesting the transfer of her medical records and giving her consent.

b. Dr. Wellness must be informed that Jan is moving, and that her records will be transferred.

c. Dr. Wellness's office personnel must follow up after the records have been transferred, to be sure Dr. Good received them.

d . Jan's attorney must be present when she signs the request to transfer her records.

Chapter 71 Medical Records and Informed Consent 199

,.....- -,-

LO 7.3

11. In a court of law, which one of the follmving types of testimony will prevail?

a. A patient's recollection of events

b. A nurse's oral recollection of events

c. A physician's testimony

d. The written documentation in a medical record

12. Medical records are often subpoenaed in court because a patient's medical record is what kind of document?

a. Confidential document

b . Professional document

c. Error-free document

d. Legal document

13. Which of the following statements is not true of statute of limitations laws?

a. They vary with states.

b . They determine the period of time during which a lawsuit may be filed.

c. The most common time periods specified in such laws are two to seven years.

d . All specify that the time period for filing a medical malpractice lawsuit is two years.

14. Which of the following is not true of requests for medical records?

a. They should not be released to a third party without written permission.

b. A patient's legal representative can give written consent to release records.

c. Requests for release of records may ask for specific records.

d . A patient's complete medical record should always be released on request.

15. What is rule number one if you are correcting an entry in a patient's electronic medical record?

16. The copier malfunctions while you are photocopying a patient's medical records and prints too many copies of several pages. What will you do with the extra copies?

a. File them with the original copy of the patient's medical records.

b. Staple them to the photocopies, because you cannot destroy them.

c. Shred them in a paper shredder.

d. None of these.

17. Assume you are in charge of releasing medical records to a third party. Which of the following does not require the patient's written consent?

a. Release of the records to the patient's insurance company

b. Release of the records for use in a lawsuit, in response to a court's subpoena

c. Release of the records for research purposes

d. All of these require the patient's written consent.

18. Which of the following is not a threat to the confidentiality of a patient's medical record?

a. Written records are left open on a coder's desk when she takes her coffee break.

b. A medical transcriptionist allows a friend from another office to read over his shoulder while he transcribes a physician's dictation.

200 Part Two I Legal Issues fo r Working Health Care Prac titioners

c. A medical office employee inadYertently leaves pages from a patient's medical record in the fax machine tray.

d . A physician shows a patient's medical record to a consulting specialist.

19. Which of the following individuals may not be able to give informed consent for medical treatment?

a. A married woman who falls in her home

b. A child injured on a school playground

c. A pregnant teenager

d. A person who speaks a foreign language

LO 7.4

20. Health information technology (HIT) includes

a. Telemedicine

b. Use of the Internet

c. Digital versions of patients' medical files

d. All of these.

21. According to the federal government, which of the following is not a benefit of HIT with the wide adoption of technology?

a. Preventing medical errors

b. Reducin_g health care costs

c. Improving health care quality

d . Reducing discrimination in health care workplaces

Match each definition with the correct term by writing the letter in the space provided.

22. Addresses the electronic storage and transmission of health information.

23. Protects patients from being coerced into treatment.

24. Protects health care providers from lawsuits when providing care at an accident or emergency.

25. Provides for a continuum of medical care for patients.

26. Allows physicians to decide whether or not to show medical records to those patients treated for mental or emotional disorders.

27. A federal statute that protects the confidentiality of medical records of patients with histories of substance abuse.

Case Studies

a. Good Samaritan act

b. HIPAA

c. Uniform Anatomical Gift Act

d . Doctrine of informed consent

e. Confidentiality of Alcohol and Drug Abuse, Patient Records

f. Doctrine of professional discretion

g. Medical record

Use your critical thinking skills to answer the questions that follow each case study.

LO 7.3

A 10-year-old girl suffered from a rare malignancy in her brain and around her spinal cord. She had surgery, and most of the tumor mass was removed, but residual tumor remained in the brain and around the spi- nal cord. The girl's doctors informed her parents that chemotherapy and radiation were possible treatment

Chapter 7 J Medical Records and Informed Consent 201

options but could cause serious problems such as sepsis, a permanent loss of IQ and stature, and even death. The parents wished to proceed with the therapy.

While their child was undergoing aggressive chemotherapy and radiation, the parents did independent research and read of several drugs being administered for cancer in other states that were unapproved by the Federal Drug Administration (FDA) and were illegal in their home state but were touted by physicians using them as "miracle cures." The couple sued their child's physician for failure to disclose alternative treatments, thus depriving them of informed consent.

A court awarded summary judgment to the physician.

28. In your opinion, does the court's decision seem warranted? Why or why not?

29. Did the physician involved follow the law? Did he or she act ethically? Explain your answer.

30. Under the doctrine of informed consent, should a physician be responsible for informing patients of all treatment options, even if some of the treatments are illegal or not yet proven effective? Explain your answer.

When Ruth applied for health insurance, she listed a colonoscopy examination as part of her medical his- tory. The insurance company asked for more information. Ruth requested, in writing, that the clinic where she had been examined send only the colonoscopy records to her insurance company. In addition to the requested information on her colonoscopy, the clinic sent all of Ruth's medical records for the past five years, which included the diagnoses of fibrocystic breast disease and obesity. As a result, the insurance company issued Ruth a policy but attached riders stipulating that it would not pay for any illnesses arising from the fibrocys- tic breast disease or obesity.

Ruth complained to the clinic administrator, explaining that she had requested that only those records concerning her colonoscopy be forwarded to the insurance company. The administrator apologized and assured Ruth that the clinic's policy concerning release of medical records would be reviewed. He also told Ruth that should she ever incur medical expenses for those conditions excepted in her insurance policy, she should contact him.

31. Did the clinic err in sending all of Ruth's medical records to the insurance company? Why or why not?

32. In your opinion, did Ruth have a legal cause for action against the clinic? Explain.

33. What would you do, in the clinic administrator's place, to rectify the situation and make sure that similar problems did not arise in the future?

A patient asked her dermatologist for the name of an internist. She visited the recommended internist several times and then learned that, without informing her, he had sent the dermatologist two detailed reports on her condition and family medical history. Since her gastrointestinal condition had nothing to do with her dermatological complaint, she believed the internist had sent the records to show his appreciation for the referraL She told the internist that she felt her privacy had been violated.

202 Part Twa 1 Legal Issues for Working Health Care Practitione rs

34. Do you agree with the patient? \\by or why not?

Internet Activities LO 7.2 and LO 7.4

Complete the activities and answer the questions that follow.

35. Determine how long medical records must be kept in your state. Begin your search with the question: "How long are medical records kept in [fill in your state]"?

36. Search online for "health information technology occupations." What occupations are listed under HIT? List three advantages to pursuing an education in HIT. If your primary interest is in patient care, would a career in HIT interest you? Explain your answer.

37. Visit the Web site for the American Medical Informatics Association (AMIA) at http://www.amia.org/. Find the association's ethics philosophy under" About AMIA." Briefly describe the AMIA's stance on maintaining confidentiality of electronic records.

Resources

California's Good Samaritan Law:

Telephone interview November 5, 2007, with Dr. Carmen Paradis, Dept. of Bioethics, Cleveland Clinic.

www.portersimon.com/writ/writ-02-201l.pdf.

Content of medical records:

www.sh.lsuhsc.edu/policies/policy _manuals_ via_ms_ word/hospital_policy/h_6.5.0. pdf.

Informed consent:

www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/ informed-consent.shtml.

Sebelius quote:

Pear, Robert. "Standards Issued for Electronic Health Records." The New York Times, July 13, 2010, www.nytimes.com/2010/07/14/healthlpolicy/14health.html.

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