Informed Consent and Medical Accountability Legislation
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While we speak of access and cost of medical care reform, we speak little of quality and patient rights and autonomy. The following proposed legislation has been put to Peter DeFazio. Call him and let him know you want not only access 'n affordability but informed consent.
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Draft of Proposed Legislation Concerning
Informed Consent and Medical Accountability
Contents
I. Provide Take-Home-and-Keep Informed Consent Material
II. Provide to Persons (for Verification) All Their Medical Records Prior to Signing the Legal Consent
III. Provide Audio and Videotape (Truth In Surgery) Procedure Documentation Option
IV. Provide Take-Home Medical Records
V. Provide Typed Reports, Radiographic Pictures, Glass Tissue Slides, and Explants
VI. Assist Persons Impaired by Provider
I. Provide Take-Home-and-Keep Informed Consent Material
WHEREAS some people,
are anxious while obtaining personal medical information;
or must see and hear information more than once;
or have poor hearing, poor eyesight, or poor memories;
or need information in hand to discuss with loved ones;
BE IT RESOLVED THAT,
Take-home-and-keep informed consent and outcome material shall be given to involved persons 24 or more hours before their non-emergency medical or surgical procedure.
It shall be in writing and audio or videotape with no need to ask.
The informed consent shall be in the person's native language and shall include and not be limited to:
the name of the procedure in generally understood words;
a description of how the procedure is performed;
the reason or indications and contraindications for the procedure;
whether the procedure is diagnostic, therapeutic, preventative, or cosmetic;
expected outcome concerning pain, function, and sensation;
the procedure's probability success statistics in general, for this medical facility, for this practitioner, and for this person in particular;
expectations of the person compared to the expectations of the practitioner;
alternative procedures;
possible risks - physical, mental, psychological, emotional, and social;
possible complications, including infection rates and those documented on the Internet, Medline, MedNet, and HealthOnline;
expense;
average recuperation time.
LOGISTICS
Providers shall give involved persons Take-Home Informed Consent information upon which to make informed decisions.
Surgical Scheduling Departments shall mail Take-Home Informed Consent Material and the American Board specialty indications and contraindications for the proposed procedure and all alternative procedures to involved Persons at the time the surgery is scheduled.
Insurance carriers shall mail Take-Home Informed Consent material and the Quality Assurance Review Criteria to involved insured person the day the procedure is pre-certified.
CONSENT CONTENTS
The signed legal consent shall name each procedure in: 1. generally understood words and 2. by official name, description, and computer code number exactly as it appears in the Current Procedural Terminology book. The signed legal consent shall name each and every "incidental" procedure, including the creation of disfiguring scars by naming the incision, number, location, and size, i.e., "6-inch horizontal abdominal bikini incision (laparotomy) which will be closed with invisible stitches under the skin, or visible stitches, visible staples, or skin steri strip tape."
For each consented procedure there is to be a stated complaint or reason and a computer-coded diagnosis. The consent shall contain the official diagnosis as it appears in the International Classification of Diseases, including both the official name and computer code number.
Consent for "possible" procedures shall state the precise condition requiring the "possible" procedure. The Operative Report shall give clear, cogent, and indisputable photographic documentation of any unforeseen condition/s requiring the consented "possible" procedure/s. There shall be signed legal consent by the patient to either resuscitate or not to resuscitate, intubate or not to intubate, feeding by an abnormal route or not. Orders must be signed by the patient, if competent; or, if incompetent, by the family or the attorney.
Consent is not transferable from operating practitioner to another. The signed legal consent shall name the primary and all assistant operators by their full legal names and titles; shall clearly identify students/trainees, and whether they are observers or operators; and shall clearly identify procedures new to seasoned practitioners. Students participating in a course of professional instruction or clinical training program shall not perform a pelvic, breast, or rectal exams on any anesthetized or unconscious patient unless the patient gives informed consent to such examination. Students will inform conscious patients of their status prior to such intimate exams, and tell the patient if the intimate exam is medically indicated or merely for educational purposes. Students will not perform such intimate exams on minors under the age of 18 years of age unless such exam is necessary for diagnosis or treatment of such patient. The consent shall contain a statement of any special legal status that limits liability along with the practical consequences of that special status.
WHO CONSENTS and UNDER WHAT CIRCUMSTANCES
It shall be documented in writing who is to make the final consent decisions: the person, the person's designated relatives or friends, the practitioner, or the Person's Attorney. The autonomy of the person shall not be overridden by the provider requesting a court order to coerce testing or treatment, with the exception of paternity and AIDS testing that involves the need to know for the sake of a third party. The person has the right to end the provider relationship at any time for any reason.
Persons signing consent papers for non-emergency procedures shall be in an unaltered state of consciousness, shall not be in labor or in postpartum euphoria, and shall not be on mind- or emotion-altering drugs.
No one shall provide "consent" for otherwise competent Persons who ordinarily could give consent themselves but are rendered in an altered, semiconscious, or unconscious state by medication.
No one shall provide surrogate "consent" or involuntary "consent" for another person without a court order and the person's knowledge.
No spouse or relative shall be put in the position of being asked to give consent without prior written legal Temporary Power of Attorney for this one confinement and adequate medical information with which to make the decision.
In an emergency, the Provider takes full responsibility for performing only the necessary and least invasive procedures.
GENERAL
Persons consenting to diagnostic exploratory laparotomy (painful, disfiguring abdominal incision) shall be informed of their option to have video laparoscopy (mini video camera periscope used to look through an incision in the navel), abdominal CAT scan, or MRI scan.
Persons consenting to therapeutic large abdominal incision surgery of any kind shall be informed whether that procedure can be performed through band-aid incisions instead.
Persons consenting to implants permanently placed inside the body shall receive the package insert and full disclosure of the safety studies, FDA approval status, chemical components, device longevity, human body tolerance, implant manufacturer's/distributor's name, address, phone number, and contact person.
Persons consenting to exams or surgery on sex organs shall have the right to a person of their choice in attendance empowered to halt any procedure based on unauthorized touching, crude handling, cutting, or attempted removal of normal tissue. Persons undergoing pelvic, genital, or rectal exams shall be positioned and draped so the person can see the face and hands of the examiner at all times, or in the alternative, view a live real time CCTV monitor.
Persons consenting to amputations based on a pathology slide (eg. prostatectomy, mastectomy), shall be informed that the 3-day permanent section is more accurate than the 1-hour frozen section. The more accurate permanent section is reported in writing. The frozen section is verbally reported into the operating room by intercom, where misunderstandings have occurred. Persons shall also be told that there is a continuum from benign to malignant. A second opinion pathology reading may be negative for malignant cancer, though the first opinion was positive.
WOMEN
Women with abnormal bleeding shall be informed in writing of the hormone options to stop the abnormal bleeding.
Women with symptomatic fibroid shall be informed in writing of the hormone option that permanently shrinks the fibroid in one third of cases.
Women consenting to a D&C shall be informed in writing of one to two percent low incidence of a positive result.
Women shall be informed in writing of that "atypia" does not necessarily mean cancer and excessively bloody smears make the test of less value.
Women consenting to abdominal hysterectomy (womb/uterus removal) or women who are anemic shall be informed of the hormone option to stop uterine bleeding and to reduce uterine size for vaginal (no large abdominal scar) removal.
The consent for removal of normal ovaries shall state she clearly knows her ovaries are normal, and a clear, cogent reason for wanting her normal ovaries removed. The consent shall contain the word castration if both ovaries are to be removed. Consent to operate on ovaries and uterus shall state whether she wants only the abnormality or the whole ovary or uterus removed.
Women shall be informed
that ovaries produce multiple hormones that are not medically replaced;
that lifelong artificial hormones can lead to cancer;
of the significance of hemorrhagic cysts and adhesions;
that an ovary with a functional cyst is an otherwise normal ovary releasing its egg;
that the uterus is part of the immune system, produces sex hormones, and that uterine quivering is part of the orgasmic response.
Women shall be informed that any abdominal surgery on the reproductive organs can decrease sex drive and orgasmic fulfillment.
The use of a Weighted Speculum shall require signed legal consent along with documentation that the person handled both the weighted speculum and the appropriately sized duckbill speculum and made an informed choice.
The report of procedure shall include the size and weight of the speculum used along with the length of time it compromised the introitus.
Women shall be informed that any surgical manipulation of the external genitals can result in decreased sexual sensation and orgasmic fulfillment.
Women consenting to mastectomy (breast removal) shall be informed of the current statistics showing lumpectomy (lump only, not breast removal) to be equal in effectiveness.
Women facing mastectomy shall be informed in writing of the current statistics concerning the 30% disagreement rate among pathologists as to whether a pathology slide is cancerous; she shall be offered a second pathologist's opinion that shall be blind and independent.
The patient shall be given her pathology glass slide to take home and keep. Women shall be informed of research indicating that surgery can increase the growth rate of breast cancer, tests that can indicate the effectiveness of various ontological treatments, and information on the most promising alternatives in conjunction with available comparative (conventional, alternative, and non-treatment) survival charts extending to 20 years.
Women consenting to infertility treatment shall be given success statistics for each particular procedure both national and facility specific.
Women consenting to any female procedure shall be given take-home written American College of Gynecology surgical indications for her consented procedure and indications for all alternatives to her consented procedure.
Women consenting to hysterectomy for pelvic pain shall be given written information about all the possible causes of pelvic pain including bowel, and bladder pain causation. They shall be offered a diagnostic and therapeutic trial of bowel and bladder antispasmodic medication to rule out bowel and bladder as a cause of the pelvic pain. They shall also be offered a diagnostic pelvic MRI or CAT scan.
Expectant mothers shall be shown a videotape and informed of the 95% no-tear success statistics using midwife birthing techniques of perineal support and massage and 71% no-tear success statistics with under-water birth and no perineal support and massage.
Episiotomy (genital cutting and stitching to temporarily enlarge the birth opening) shall require signed legal consent, shall be written in generally understood words, and shall include the no episiotomy birthing option.
Expectant mothers shall be informed how each drug can alter her contractions, her pushing reflex, and her chances of needing a caesarian surgery.
Each drug that can alter the natural birth shall require signed legal consent.
Birth giving mothers shall be informed of their option to choose vertical birthing posture and freedom of movement: walking, standing, sitting, squatting, side lying, crawling, rocking, and in-water birthing positions, and shall assume any birthing position she chooses at any and all times during her birthing process.
Caesarean surgery consent shall be obtained without intimidation, coercion, or pharmacologic restraint.
PARENTS
Parents consenting to any procedure shall have the right to accompany their child to every and all places or in the alternative shall have the right to maintain audio and video contact at all times.
Parents consenting to circumcision shall be informed in writing that the surgery is done without the child's consent, permanently removes erogenous tissue, is painful during and after the surgery, is typically done without anesthesia, and may be objected to by the child, so that he may try to restore his foreskin as an adult.
Parents shall be offered in writing a teaching audio-videotape of the procedure in its entirety prior to signing the consent and shall be offered in writing an audio-videotape of their child's personal procedure in its entirety.
MEN
Men consenting to prostate procedures shall be informed of all their options and the effect of each procedure on function and sensation.
Men consenting to a radical prostatectomy shall be informed of all urine-controlling and potency-sparing procedures.
REMOVAL of a RIGHT or LEFT BODY PART
Persons consenting to amputation or removal of a right or left body part shall have the part to be amputated marked "cut" along with a dotted line in ink on the front, back, and sides of the body part.
The part is to be marked before signing the legal consent.
The consent shall contain documented reason for the amputation in the form of a final (not preliminary frozen section) pathology report and a picture.
Signed legal consents for amputation shall contain multiple signatures and shall contain the precise time the consent is signed.
The consent for amputation shall be signed by the person, a family member, the anesthesiologist, the surgeon, all assistant surgeons, and the persons positioning, scrubbing, and draping the involved part.
Persons requiring amputation procedures shall be awake until all the surgeons and operating room support staff enter the operating room itself (not somewhere else in the hospital) and verify the correct part to be amputated. The anesthesiologist may then put the person to sleep.
The person undergoing amputation shall be offered in writing the opportunity for a person of their choice to be in the operating room, or in the alternative, view CCTV to verify that the correct procedure is being performed on the correct part and if not, that person shall halt the procedure.
II. Provide to Persons (for Verification) All Their Medical Records Prior to Signing the Legal Consent
WHEREAS there can be a concern about,
the chief complaint;
the Practitioner's attitude toward and respect for the Person and the Person's medical issues;
what is to be done and why;
whether the procedure is diagnostic, therapeutic, preventative, or cosmetic;
the risks and benefits;
BE IT RESOLVED THAT,
All Persons be offered, as part of their informed consent, all their office and hospital medical records, including: history; physical; diagnosis; plan of action; risks and benefits to read, correct, question, and sign prior to signing the legal consent for surgery and medical treatments.
A written test shall document the comprehension of all informed consent material.
III. Provide Audio and Videotape (Truth in Surgery) Procedure Documentation Option
WHEREAS audio and videotape,
technology exists in many operating and treatment rooms to document diagnostic and treatment procedures including surgery;
is more authentic than typed reports;
is inexpensive and an emotional detaching and an emotional processing tool;
encourages technical skills refinement;
educates Providers and Consumers;
and many persons need to see, hear, and know what happened while unconscious;
BE IT RESOLVED THAT,
Persons about to undergo diagnostic or treatment procedures that would render them in an altered, semi-conscious, or unconscious state shall be informed of their option to receive an unedited audiotape or audio and videotape recording of their own personal procedure in its entirety.
If the Person furnishes the tape, there shall be no charge for the taping.
Signed documentation of the Person's orders shall become a permanent part of the medical record.
IV. Provide Take-Home Medical Records
WHEREAS,
Persons need to know their medical and surgical history;
Medical records can be inaccurate, inauthentic, eventually destroyed; & require costly, lengthy legal help to obtain or correct;
X-Rays, CAT scans, PET scans, MRI scans, and ultrasounds can be copied on film or on videotape;
BE IT RESOLVED THAT,
All Persons be informed of their right to receive a copy of their radiographs and their medical record in its entirety including all laboratory reports, routing slips, billing slips, and all computer entries upon completion of their procedure or confinement.
Involved persons can optionally request only a summary and can request at any time chosen by the person to immediately see any part of their medical record.
The medical record shall be written in words generally understood by the Person.
The Person shall have first right to read, question, correct, and sign approval of the record before it becomes a permanent, public, legal document, before authorizing the release of any information, or before assignment of benefits takes effect.
Persons shall be offered their original medical records when the record keeper converts to space-saving media.
The legal and other fees for any unresolved medical records disputes shall be paid by the Author of the record.
V. Provide Typed Reports, Radiographic Pictures, Glass Tissue Slides, and Explants
WHEREAS,
extracted implants and afflicted body tissue must be seen and touched for people to understand;
lab results are a great teaching tool to involved Persons and can be overlooked or misread by any one Practitioner;
BE IT RESOLVED THAT,
Persons shall have first right to receive, inspect, and keep removed implants, removed body tissue, and pathology glass slides.
Persons shall receive their typed lab reports along with a statement of normal ranges and reference material pertaining to their results.
Persons shall be offered a copy of their radiograph pictures.
VI. Assist Persons Impaired by Provider
WHEREAS,
Practitioners avoid assisting victims;
Practitioners may refuse to certify abuse and malpractice in victims.
BE IT RESOLVED THAT,
Victims of medical misrepresentation, fraud, abuse, incompetence, or negligence shall be treated or referred to affordable multidisciplinary physical, mental, emotional, social, financial, legal, and support group help.
It shall be a crime to aid or cover up malfeasance; misrepresent the federal, state, or hospital laws and bylaws; fail to halt, report, acknowledge and validate deviations from standards of care; obstruct justice; or refuse to treat, dismiss as "normal" or "mentally unstable"; or send victims back to the perpetrator.
The Attorney General and lawyers shall enforce state law and file suits. The perpetrator shall be summarily suspended until the victim obtains satisfactory redress.
VIOLATION,
of the Person's orders shall be redressed by a $200,000 fine for each violated order payable to the violated person within 10 working days of the written grievance and shall constitute a reportable misdemeanor. Patients suffering harm and/or unreimbersed after 10 working days may seek redress in civil courts. Violations that rise to the level of more serious criminal offenses, or result in harm to the patient must be reported to proper authorities.
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