Supervision Requirements - American Society of Anesthesiologists

Transcription

Supervision Requirements
Section Contents

DSA2 – Supervision of Nurse Anesthetists

DSA3 – Education/Training Differences Between Physician Anesthesiologists and Nurse
Anesthetists

2012 Michigan Association of Nurse Anesthetists Advocacy Handout

Michigan Society of Anesthesiologists SB 180 Talking Points

Michigan Society of Anesthesiologists Supervision Flyer

2001 ASA NEWSLETTER Article re Alabama Supervision Legislation

2013 Pennsylvania HB 1603 – Supervision Legislation

2013 ASA NEWSLETTER Article – Legal Success for Patients in New Jersey and Oklahoma

2000 Anesthesiology Article – Silber: Anesthesiologist Direction and Patient Outcomes
SUPERVISION OF NURSE ANESTHETISTS
Four states, by statute or regulation, authorize nurse anesthetists to practice outside the
relationship of a physician:
Hawaii
Montana
New Hampshire
Utah
Seventeen states have opted-out1 of the federal requirement for physician supervision of nurse
anesthetists:
Alaska
California
Colorado2
Idaho
Iowa
Kansas
Kentucky
Minnesota
Montana
Nebraska
New Hampshire
New Mexico
North Dakota
Oregon
South Dakota
Washington
Wisconsin
Forty-six states and the District of Columbia require physician supervision, collaboration,
direction, consultation, agreement, accountability, or discretion over nurse anesthetists
providing anesthesia services:
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of Columbia
Florida
Georgia
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Nebraska
Nevada
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Vermont3
Virginia
Washington
West Virginia
Wisconsin
Wyoming
The information provided in this document is based on states statute and/or regulation ASA is
aware of and should not be relied upon as legal advice. Updates to this document may be
offered to Erin Philp, M.A., J.D., State Affairs Associate, at [email protected]
1
On November 13, 2001, the Bush Administration published a final rule regarding the Medicare and Medicaid
anesthesia Conditions of Participation (COP) for hospitals, critical access hospitals (CAHs) and ambulatory surgical
centers (ASCs). The rule retains the current requirement for physician supervision of nurse anesthetists, but allows
state governors to opt out of this requirement under certain circumstances. ASA opposes gubernatorial opt-outs.
2
Limited to Critical Access Hospitals (CAHs) and specified rural hospitals.
3
Collaboration required during the first 12 months of an APRN’s licensure.
Last updated 7/30/2013
American Society of Anesthesiologists
DSA 2
PHYSICIAN ANESTHESIOLOGISTS AND NURSE ANESTHETISTS:
FOR THE HEALTH AND SAFETY OF PATIENTS, DIFFERENT TRAINING AND
EDUCATIONAL BACKGROUNDS SHOULD MEAN DIFFERENT LEVELS OF
RESPONSIBILITY
Patients should know the educational and training backgrounds of their health care
professionals and the important impact it could have on their health and safety. Consider
the vast difference between Physician Anesthesiologists (Physicians) and Nurse
Anesthetists (Nurses):
EDUCATION
PHYSICIAN
ANESTHESIOLOGISTS
(PHYSICIANS)
Bachelor’s degree
Nurse Anesthetists
(NURSES)
Doctoral or Graduate
Degree
Doctor of Medicine or
Osteopathic Medicine; 4
years
Graduate Nursing Degree: 2-3
years2
Post-Doctoral Internship
in General Medicine
1 year, required3
NONE REQUIRED
Post-Doctoral Residency
in Anesthesiology
Total hours of patient
care required during
training
3 years, required4
NONE REQUIRED
12,000 – 16,000 hours5,
including 3 months pain
management training (acute
& chronic), 4 months critical
care management, and at
least 2 months each in:
obstetric anesthesia,
pediatric anesthesia,
cardiothoracic anesthesia,
and neuroanesthesia6
~1,650 hours7
Initial Education
1
2
Associate degree in nursing, a
non-degree diploma from an
in-hospital nurse training
program, or a Bachelor of
Science in Nursing1
American Medical Association, “Nurse Anesthetists,” Scope of Practice Data Series, p. 21 (2009).
Id.
3
American Society of Anesthesiologists President Dr. Mark Warner, letter to Federal Trade Commission
Director Susan S. DeSanti, 19 Jan. 2011, p. 4 (Washington, DC).
4
Id.
American Medical Association, “Do you know your doctor?” p. 1 (2012).
6
Accreditation Council for Graduate Medical Education, “ACGME Program Requirements for Graduate Medical
Education in Anesthesiology,” p. 5 (2008).
7
“The results of an analysis of anesthesia hours reported by 2010 graduates show that nurse anesthesia students
receive a median of 1,651 hours of clinical experience.” American Association of Nurse Anesthetists,
5
DSA3
Clinical experience
required in pain
medicine
Anesthesiology residents
are required to treat no
fewer than 20 patients
evaluated for management
of acute, chronic, or cancerrelated pain disorders
during a specified 3-month
period, all while under the
direction of faculty
physicians with expertise in
pain medicine8
NONE REQUIRED
Subspecialty
accreditation available
in pediatric
anesthesiology, adult
cardiothoracic
anesthesiology, critical
care, obstetric
anesthesiology, hospice
and palliative medicine,
sleep medicine, and
pain medicine
These Board-certified
subspecialties each require
1-2 additional years of
training after an initial 4year residency in
anesthesiology9,10
NONE REQUIRED
Subspecialty
accreditation in pain
medicine
The Board-certified
subspecialty of pain
medicine requires 1-2
additional years of
training after an initial 4year residency in
anesthesiology11
NONE REQUIRED
While nurse anesthetists are valuable medical team members, their educational and
training backgrounds are significantly different from the comprehensive medical
education, training and clinical experience of physicians. In the interest of patient safety
and quality of care, the American Society of Anesthesiologists believes that the involvement
of a physician anesthesiologist in the perioperative care of every patient is optimal.
“Qualifications and Capabilities of the Certified Registered Nurse Anesthetist,” available at
http://www.aana.org/ceandeducation , accessed Feb. 21, 2013.
8
Warner, p. 4.
9
“Nurse Anesthetists,” p. 11.
10
ACGME website at http://www.acgme.org/acgmeweb/
11
“Nurse Anesthetists,” p. 32.
DSA3
Safety in the Operating Room—Putting Patients First
Opposing Senate Bill 180
AT ISSUE: Special interest groups working on behalf of nurse anesthetists are pushing legislation to
remove the requirement that a trained physician supervise the administering of anesthesia to a patient.
Senate Bill 180:
 Puts patient health and safety at risk.
 Will not increase patient access to surgical care.
 Will not reduce cost to patients and taxpayers.
BACKGROUND: Hollywood and advocates of independent CRNA practice make anesthesia appear
simple, but in reality it involves more than pushing a syringe and turning knobs. It carries significant
risks. Every anesthetic, from sedation to general anesthesia (actually a drug-induced coma) involves
administration of medications with potent respiratory and circulatory depressant effects to patients
with medical conditions of various kinds and degrees of severity. Anesthesia requires careful planning
and proper administration to see a patient safely through a physically stressful and painful procedure.
Unfortunately, some groups are placing their own interests ahead of patients receiving anesthetics.
They are advocating for changes in state law that would remove physician supervision of anesthesia care
in operating rooms across the state.
1: SENATE BILL 180 PUTS PATIENTS AT RISK.

Anesthetics, no matter how “simple” they seem, carry substantial risks, including the risk of brain
damage and death. Patients with significant medical problems (e.g., heart and lung disease,
obesity, diabetes) are at more risk for medical complications during surgery. Anesthesiologists
and other physicians are trained to diagnose and treat these events. Nurse anesthetists do not
have the same training.

Physician anesthesiologists have four years of medical school education and at least four years of
clinical anesthesiology training after their Bachelor’s degree; nurse anesthetists have 2-2.5 years
of training in giving anesthesia.

According to the Agency for Healthcare Research and Quality, physician anesthesiologists
prevent nearly six avoidable deaths for every 1,000 patients who encounter a complication.

“Studies” put forward by the special interests pushing Senate Bill 180 have been labeled “an
advocacy manifesto masquerading as science” and discredited for their flawed methods and
unscientific sample sizes.

Nurse anesthetists have no formal training to diagnose and treat patients with a spectrum of
chronic pain conditions or perform complicated, risky interventional pain procedures, including
injections very close to nerves and the spinal cord that carry substantial risks like the risk of
bleeding, infections, nerve damage, paralysis and even death.
Removing physician supervision threatens patients and could literally cost lives.
2: RURAL COMMUNITIES DESERVE QUALITY CARE, TOO.
Groups pushing Senate Bill 180 say the bill is needed to increase access to care in rural Michigan.
However, more access will not necessarily result from this legislation and it should not come at the
expense of patient health and safety.

While some rural hospitals claim they cannot recruit surgeons because of the surgeon’s added
responsibility to supervise nurse anesthetics, the facts are that there is no clearly established
added liability for surgeons related to supervision of anesthesia in Michigan.

At rural hospitals without physician anesthesiologists, the surgeon’s supervisory responsibility is
even more important to insure patients are medically prepared for surgery and assure patients
and families that a physician will lead the treatment of complications and emergencies.

Access issues are important and needed to be addressed, but not at the expense of
patient safety and quality care.
Families in rural Michigan deserve the same peace of mind as their urban and suburban neighbors in
knowing a physician is supervising the administration of anesthesia to their loved ones. Maintaining
physician supervision means better care for all Michigan residents, not just those who live in the “right”
place.
3: THERE ARE NO COST SAVINGS WITH SENATE BILL 180.
Medicare, Medicaid, and most third party payers pay the same fees regardless of who administers the
anesthetic. The fee for a physician-supervised anesthetic is the same as for a solo nurse anesthetic.
Statements that this legislation would save money are false. There are no cost savings to patients or
taxpayers as a result of Senate Bill 180.
THE BOTTOM LINE: Medical procedures are scary! When a patient or loved one needs surgery or
another procedure requiring anesthesia, they want to know a physician is in charge of their care and can
answer their questions.
Patients need and want certainty and accountability. Removing the physician supervision removes
certainty and it puts accountability into question. Any uncertainty at all in the operating room mean less
safety, less peace of mind and is not the best possible care.
Assuring the safety of a patient before, during and after anesthesia requires the broad understanding of
medical diagnosis and treatment acquired over many years of training and education. Michigan’s longheld policy of physician supervision achieves this; Senate Bill 180 undoes this.
Please oppose Senate Bill 180.
Your spouse.
Your parent.
Your child.
Serious surgery,
requiring deep sedation...
a drug induced coma.
No physician supervision?
No way.
Safety in the Operating Room —
Putting Patients First
While Hollywood has made anesthesia appear
simple on television and in the movies, in reality
it carries significant risks. Every anesthetic,
from “light sedation” (also often called twilight
anesthesia) through deeper levels of anesthesia
to general anesthesia (actually a drug-induced
coma) requires careful planning and proper
administration to see a patient safely through
what would otherwise be a painful procedure.
Unfortunately, some groups are placing their
own interests and profits ahead of patients
receiving anesthetics. They are advocating for
changes in state law that would remove
physician supervision of anesthesia care in
operating rooms across the state. This change
would eliminate the participation of physicians
from every anesthetic. Nurse anesthetists
(CRNA) would be solely responsible for the
entire plan and administration of anesthesia
care, including responding to serious problems
which may arise during a procedure or when a
patient is awakening from the drug induced
coma of anesthesia. Changes to the current
law would not improve the quality of health
care for Michiganders, nor would it reduce
costs or improve access to care.
Michigan Society of
Anesthesiologists
Threatening Patient Health & Safety
■
■
■
Many surgery patients have major medical
conditions that may become unstable during
the stress of surgery.
Anesthetics, no matter how “simple” they
seem, carry substantial risks, including brain
damage and death.
Procedures to treat chronic painful
conditions, often including injections very
close to nerves and the spinal cord, also
carry substantial risks, including bleeding,
infections, nerve damage, paralysis and
even death.
Physicians have well over a decade of education
and specialized training to evaluate patients
before they receive anesthesia or undergo
treatments for chronic pain. Physicians are
responsible for developing the plan for care
and are responsible for its safe delivery.
■
Physicians typically have at least 12 years of
education and medical training.
■
Nurse anesthetists have 4 years of
education and as little as 2 years of postgraduate training in giving anesthetics.
Physicians’ extensive training and experience
translates into improved health through better
and safer care.
According to a study done by the University of
Pennsylvania for the Agency for Healthcare
Research and Quality, anesthesiologists prevent
more than six avoidable deaths for every 1,000
patients who encounter a complication. Removing
physician supervision from operating rooms
threatens patients and could literally cost lives.
Raising Costs On Patients –
And Taxpayers
What’s more, eliminating physician supervision
from the anesthesia process would likely raise
costs for patients and taxpayers and make it
harder to attract physicians to underserved
areas. Under Medicare and Medicaid and
most insurance plans, the fees for CRNAprovided anesthesia and physician anesthesia
care are the same, eliminating any opportunity
for cost savings.
And because of the need for CRNAs to
frequently consult with additional physicians to
Michigan Society of
Anesthesiologists
adequately assess co-existing medical
conditions, costs could increase while driving
up insurance rates for everyone, making
Michigan a less attractive state for physicians
to start or expand a practice.
Highly trained physicians mean better
and safer patient care, better outcomes
and lower costs for taxpayers. Please
reject efforts to take doctors out of the
operating room and risk the health of
patients in Michigan!
www.mymsahq.org
120 N. Washington Sq. Suite 110 A • Lansing, MI 48933 • 517.346.5088
Patient Safety in the Operating Room vs Risking Lives, Raising Costs
Q Will removing physician supervision
of nurse anesthetists (CRNAs) in
hospital rooms and operating suites
have a negative impact on patient
health and safety?
FAQ’s
A YES. Physicians are trained to diagnose and treat medical issues
before, during and after medical procedures and anesthetics. Their
training and experience enable them to make split-second decisions
when needed to provide life-saving assistance, perform invasive
procedures, and treat catastrophic complications which may occur
during an anesthetic. CRNAs are not.
Assuring the safety of a patient before, during and after anesthesia
requires the broad understanding of medical diagnosis and treatment
acquired over many years of training and education. Less training and
less experience means less safety for patients when emergencies occur!
Q Are CRNAs in Michigan adequately
trained and qualified to provide
high-risk anesthesia care without
physician supervision?
Q Will taking physicians supervision
out of operating rooms save money
for taxpayers and patients?
A NO. While anesthesia may appear simple, these procedures carry
substantial patient risks up to and including the risk of death.
That’s why anesthesiologists have at least 12 years of education and
medical training before practicing anesthesia. Nurse anesthetists undergo
only 30 months of post-graduate training in anesthetics – not in the
diagnosis and treatment of medical conditions of the human body.
A NO. Under Medicare and Medicaid, the fees for CRNA-provided
anesthesia and physician anesthesia care are the same, eliminating any
opportunity for cost savings. What’s more, because of the need for
many CRNAs to consult with a physician to adequately assess coexisting medical conditions—a consultation not required by
anesthesiologists—costs could skyrocket, driving up insurance rates
for everyone and burning through tax dollars faster than ever.
Facilities needing after-hours coverage from CRNAs will experience
significantly greater costs as a result of overtime compensation as
well—costs they will pass on to patients and payers.
Q Is threatening patient safety the
best way to improve access to
anesthesia services?
Q Would changing Michigan law to
remove physician supervision from
high-risk anesthesia care have any
additional unintended consequences?
Q Does it matter to patients who is
responsible for their care?
A NO. The legislature can improve access to high-risk anesthesia care
in other ways without exposing patients to higher costs and risks to
health and safety.
A YES. Under the broad language of this special interest bill, CRNAs
without the specialized training of medical doctors would be
empowered to practice additional “sedation” and “pain management”
procedures outside of clinical settings—and to bill patients and taxpayers!
A YES. Surveys confirmed that 73% of Medicare recipients have
opposed changes to the physician supervision requirement
Michigan Society of
Anesthesiologists
www.mymsahq.org
120 N. Washington Sq. Suite 110 A • Lansing, MI 48933 • 517.346.5088
CONTENTS
Volume 65, Number 12
December 2001
FEATURES
Governmental Affairs: Progress in a Year of Turbulence
Governmental Affairs:
It’s A Team Sport!
4
Aside from the tragedies on September 11, the year 2001 will be
remembered as a banner year for
ASA. Annual Meeting attendance
was strong, ASAPAC giving was
unprecedented, and anesthesiology
and its patients scored a major victory in the Medicare supervision rule.
EDITORIAL BOARD
Editor
Mark J. Lema, M.D., Ph.D.
Associate Editors
Douglas R. Bacon, M.D.
Lawrence S. Berman, M.D.
David E. Byer, M.D.
Daniel F. Dedrick, M.D.
Norig Ellison, M.D.
Stephen H. Jackson, M.D.
Jessie A. Leak, M.D.
Jill Mhyre, M.D.
Paul J. Schaner, M.D.
Jeffrey H. Silverstein, M.D.
Ronald D. Smith, M.D.
R. Lawrence Sullivan, Jr., M.D.
Carlos O. Viesca, M.D.
Editorial Staff
Denise M. Jones
David A. Love
Roy A. Winkler
Karen L. Yetsky
The ASA NEWSLETTER (USPS
033-200) is published monthly for
ASA members by the American
Society of Anesthesiologists, 520
N. Northwest Highway, Park
Ridge, IL 60068-2573.
E-mail: [email protected]
Editor: [email protected]
Web site: http://www.ASAhq.org
Periodical postage paid at Park Ridge,
IL, and additional mailing offices.
POSTMASTER: Send address
changes to the ASA NEWSLETTER,
520 N. Northwest Highway, Park
Ridge, IL 60068-2573; (847) 825-5586.
Copyright ©2001 American Society of
Anesthesiologists. All rights reserved.
Contents may not be reproduced without
prior written permission of the publisher.
Oil painting by Ralph Canaday
John M. Zerwas, M.D.
2001: Not Shoes, Nor
Ships, Nor Sealing Wax
Member Generosity Places
ASAPAC on Political Map
12
Manuel E. Bonilla
5
Michael Scott, J.D.
Summary of 2001
State Legislative and
Regulatory Activities
16
S. Diane Turpin, J.D.
Changing Local Medicare
Policies: TEE and Endoscopy
9
Karin Bierstein, J.D.
ARTICLES
Toward Fair and
Reasonable Fees in
Obstetrical Anesthesia
21
2002 PBLD Program —
Open Call for Case
Submissions
28
Alexander A. Hannenberg, M.D.
Meg A. Rosenblatt, M.D.
Code ‘New’: Changes Improve
OB Coding and Billing
23
ASA Placement Services
Become Web-Based,
Expand Options
35
Update Your Member
Information and Pay
Dues Online
38
Information for Authors
42
Subspecialty News
36
James P. McMichael, M.D.
2001 Annual Meeting in New
Orleans Full of Surprises
25
Another Welcomed Surprise:
President George W. Bush
Addresses ASA House
26
DEPARTMENTS
Ventilations
1
Society for Ambulatory Anesthesia
Administrative Update
2
Glenn W. Johnson
Residents’ Review
Washington Report
ASAPAC …What Does That
Have to Do With Residents?
3
CMS’ Final Rule Retains Federal
Requirement for Supervision
What’s New in …
29
37
ASA News
38
Letters to the Editor
39
FAER Report
44
…Operating Room Management
Practice Management
Medicare Cuts Physician
Payments for 2002
31
Annual Meeting a Boon for
FAER Resident Scholars
The views expressed herein are those of the authors and do not necessarily represent or reflect
the views, policies or actions of the American Society of Anesthesiologists.
SUBSTANCE ABUSE HOTLINE
Contact the ASA Executive Office at (847) 825-5586 to obtain the addresses and telephone
numbers for state medical society programs and services that assist impaired physicians.
South Carolina – The South Carolina Board of Medical Examiners approved guidelines for office-based
surgery. The guidelines are the result of a task force
appointed last year.
The South Carolina Society of Anesthesiologists was
instrumental in the development of the task force and the
guidelines. The guidelines provide that anesthesia should
be administered or supervised only by a licensed, qualified
and competent practitioner. Supervision of the anesthesia
should be provided by a physician who is physically present, who is qualified to supervise the administration of the
anesthetic and who has accepted responsibility for supervision. The supervising physician should ensure that an
appropriate preanesthetic examination is performed, prescribe the anesthesia, ensure that qualified practitioners participate, be available for diagnosis, treatment and
management of anesthesia-related complications or emergencies and ensure the provision of postanesthesia care.
The guidelines divide office surgery into three levels
and set forth requirements for each related to training,
equipment and supplies, assistance of personnel, transfer
and emergency protocols and facility accreditation.
Legislation or regulations will be necessary to require
the reporting of adverse incidents and the accreditation of
level II and III offices.
Nurse Anesthetists’ Scope of Practice
Alabama – Legislation was signed into law requiring
nurse anesthetists to function “under the direction of a
physician licensed to practice medicine, or a dentist, who is
immediately available.” The Alabama Society of Anesthesiologists worked tirelessly to pass this bill.
Florida – S.B. 1024 would have permitted advanced
registered nurse practitioners, including nurse anesthetists,
to prescribe controlled substances under physician supervision. The session ended without passage of the bill.
Louisiana – H.B. 1765 would have repealed the
requirement that a nurse anesthetist be under the supervision of a physician or dentist when administering anesthesia. S.B. 726 would have allowed advanced practice
registered nurses (APRNs), including nurse anesthetists, to
write prescriptions. The Louisiana Society of Anesthesiologists was successful in defeating these bills. S.B. 731,
signed by the governor, allows an APRN to administer digDecember 2001
Volume 65
Number 12
ital blocks or pudendal blocks if the APRN has been
trained to administer such procedures and if the procedures
are listed in clinical practice guidelines.
Maryland – The Maryland Society of Anesthesiologists introduced H.B. 986 to codify a judicial interpretation
of the term “collaboration.” The legislation would have
clarified that the term “collaboration,” as used in the Maryland statutes, is synonymous with the terms “supervision”
and “direction.” The bill defined “collaborate” as “to
develop and implement an agreement for supervision and
direction of a nurse anesthetist by an anesthesiologist,
licensed physician or dentist. An anesthesiologist, licensed
physician or dentist shall be on site (defined as ‘physically
present in the facility in which the nurse anesthetist administers anesthesia’) and physically available to the nurse
anesthetist for consultation at all times during the administration of, and recovery from, anesthesia.” The Maryland
Association of Nurse Anesthetists introduced H.B. 1356 to
require the Board of Nursing to adopt and endorse regulations that conform to the intent of the federal Health Care
Financing Administration (now known as the Centers for
Medicare & Medicaid Services) regulations governing the
administration of anesthesia by nurse anesthetists in hospitals and ambulatory surgical centers. H.B. 1356 was
amended to require the Board of Nursing to adopt and
endorse regulations that govern the practice of anesthesia
as a nursing function in all practice settings where nurse
anesthetists are allowed to practice. Neither bill passed
before the session ended.
Michigan – H.B. 4591 was introduced to ensure that a
physician who delegates an act, task or function that
involves the administration of general anesthesia has privileges at the health facility and is physically available in the
health facility at the time the surgery is being performed.
The legislation seeks to close a loophole in existing law
that conceivably would allow a physician to supervise the
administration of anesthesia by telephone. The bill remains
in committee.
Mississippi – S.B. 2966 would have allowed licensed
nurse practitioners to perform acts of medical diagnosis
and treatment, prescription and operation in areas of the
state that have a critical need for primary medical care
without the direct supervision of a licensed physician.
19
PRINTER'S NO.
2205
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 1603
Session of
2013
INTRODUCED BY CHRISTIANA, CUTLER, HELM, AUMENT, MUSTIO, KILLION,
BURNS, D. COSTA, HARKINS, KOTIK, RAVENSTAHL, GIBBONS,
BENNINGHOFF, R. MILLER, SWANGER, O'BRIEN, HICKERNELL, MAHER,
HARHAI, GODSHALL, GILLEN, COHEN, MARSHALL, HACKETT, SABATINA,
BRIGGS, WATERS, MATZIE, DeLUCA, MULLERY, MENTZER, SCAVELLO,
SONNEY, SIMMONS, KORTZ, O'NEILL, GILLESPIE, GINGRICH,
DERMODY, TURZAI, HANNA, P. DALEY, ADOLPH, GROVE, STURLA,
J. HARRIS, KIRKLAND, BISHOP, KULA, M. DALEY, QUINN, MICOZZIE,
MILLARD, STEVENSON AND SCHLOSSBERG, JULY 1, 2013
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, JULY 1, 2013
AN ACT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Amending the act of December 20, 1985 (P.L.457, No.112),
entitled "An act relating to the right to practice medicine
and surgery and the right to practice medically related acts;
reestablishing the State Board of Medical Education and
Licensure as the State Board of Medicine and providing for
its composition, powers and duties; providing for the
issuance of licenses and certificates and the suspension and
revocation of licenses and certificates; providing penalties;
and making repeals," providing for the provision of
anesthesia care in certain settings; and conferring powers
and imposing duties on the Department of Health.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1.
Section 2 of the act of December 20, 1985
15
(P.L.457, No.112), known as the Medical Practice Act of 1985, is
16
amended by adding a definition to read:
17
Section 2.
18
19
Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
1
context clearly indicates otherwise:
2
* * *
3
"Anesthesiologist."
A physician who has successfully
4
completed an approved residency training program in the medical
5
specialty of anesthesiology.
6
* * *
7
Section 2.
8
Section 45.1.
9
10
(a)
The act is amended by adding a section to read:
Provision and supervision of anesthesia care.
General rule.--Anesthesia care in a hospital may be
provided only by any of the following:
11
(1)
An anesthesiologist.
12
(2)
A physician who is not an anesthesiologist and who
13
is privileged by a hospital to provide anesthesia care upon
14
finding that the physician can provide all of the following:
15
(i)
The services and procedures commonly employed to
16
render a patient insensible to pain for the performance
17
of surgical, obstetrical or other necessary clinical
18
procedures.
19
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(ii)
Support of life functions during the period of
anesthesia.
21
(iii)
22
(iv)
23
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Advanced cardiac life support.
Appropriate preanesthesia and postanesthesia
management for the patient.
(v)
Consultation regarding anesthesiology-related
25
patient care, such as inhalation therapy, emergency
26
cardiopulmonary resuscitation and special problems in
27
post-surgical pain relief, unless these responsibilities
28
are assigned to another physician who is judged by
29
medical staff peer evaluation to be specially well
30
qualified and who is willing and able to assume the
20130HB1603PN2205
- 2 -
1
responsibilities.
2
(3)
A physician enrolled in a residency program in
3
anesthesia or oral surgery.
4
(4)
A nurse anesthetist authorized by the State Board of
5
Nursing to provide anesthesia care and who is under the
6
supervision of either or the following:
7
(i)
8
immediately available when needed.
9
10
An individual under paragraph (1) or (2), who is
(ii)
(b)
The operating surgeon.
Students.--A student enrolled in an educational program
11
at a school accredited by the Council on Accreditation of
12
Educational Programs of Nurse Anesthetist of the American
13
Association of Nurse Anesthetist, as approved by the State Board
14
of Nursing, may provide supervised anesthesia care if the care
15
complies with regulations relating to patient safety promulgated
16
by the Department of Health.
17
(c)
Effect on unrestricted permits.--Nothing in this section
18
shall affect the ability of a dentist anesthetist or of an oral
19
surgeon who has received an unrestricted permit from the State
20
Board of Dentistry authorizing the dentist anesthetist or oral
21
surgeon to administer general anesthesia and deep sedation and
22
who is performing the surgery for which the anesthesia is being
23
provided to provide anesthesia care.
24
(d)
Delegation.--Nothing in this section shall restrict the
25
authority of a physician to delegate the performance of
26
anesthesia services, subject to the criteria and requirements as
27
under section 17 of this act, provided the provision of
28
anesthesia services is supervised by either of the following:
29
30
(1)
An individual under subsection (a)(1) or (2) who is
immediately available when needed.
20130HB1603PN2205
- 3 -
1
2
3
4
(2)
(e)
The operating surgeon.
Regulations.--The Department of Health shall promulgate
regulations to implement the provisions of this section.
Section 3.
20130HB1603PN2205
This act shall take effect in 60 days.
- 4 -
state beat
Legal Success for Patients in New Jersey and Oklahoma
Jason Hansen, M.S., J.D.
New Jersey
On
December
12,
the
Superior Court of New Jersey,
Appellate Division, upheld a
New Jersey Department of Health
(NJDOH) regulation requiring
anesthesiologists to supervise nurse
anesthetists when they administer
anesthesia in hospitals.
New Jersey Association of Nurse Anesthetists, Inc. v. New
Jersey Department of Health and Senior Services addressed the
validity of a regulation issued by the NJDOH that requires the
“physical presence of a collaborating anesthesiologist (CA)
during induction, emergence and critical change in status
when an Advanced Practice Nurse/Anesthesia (APN/A)
administers general or major regional anesthesia, conscious
sedation or minor regional blocks in a hospital.”
The New Jersey Association of Nurse Anesthetists
challenged the physical presence requirement, arguing among
other things that the NJDOH exceeded its authority. In ruling
against the New Jersey Association of Nurse Anesthetists,
the court referenced previous case law holding that the
“administration of anesthesia is, in fact, the ‘practice of
medicine’ since it is used in the treatment of ‘human ailment,
disease, pain, injury, [or] deformity.’” The court also drew a
special distinction between the nurses’ contention that this
rule regulated the nursing profession and explained that
the rule was “... regulating the practice of administering
anesthesia in a hospital setting.” Finally, the court highlighted
that it was within the Department of Health’s authority to
“recognize the differences in education, training and skill
of APN/As and anesthesiologists in establishing anesthesia
staffing regulations.”
The New Jersey State Society of Anesthesiologists filed
several briefs on the case and also presented arguments to the
court, providing an important perspective for its deliberations.
Oklahoma
On December 13, Oklahoma’s
Attorney General issued an
Attorney General Opinion (201221) with language favorable to
anesthesiology.
Written at the
request of the Oklahoma Board of
Nursing, the opinion addressed:
n The meaning of “timely onsite
consultation” with regard to the actual physical presence of
the supervising practitioner of a nurse anesthetist
n Whether the supervising practitioner of a nurse anesthetist
must be available for timely onsite consultation throughout
all stages of the administration of anesthesia
n Whether the Board of Nursing may distinguish between
analgesia and anesthesia as related to supervision of the
nurse anesthetist by the supervising practitioner
According to the opinion, what constitutes timely onsite
consultation “…is left to the sound medical judgment of the
supervising practitioner.” The opinion further provided that,
under Oklahoma law, the supervising practitioner need not
be onsite in all instances in order to be “available” for timely
onsite consultation. However, a supervising practitioner
of a nurse anesthetist must be available for timely onsite
consultation at all recognized stages of the administration of
anesthetic services.
Finally, the opinion determined the Oklahoma Board
of Nursing may not promulgate rules defining analgesia and
anesthesia in such a way so as to allow less supervision than is
required by statute.
The Oklahoma Society of Anesthesiologists submitted
written materials to the Oklahoma Attorney General’s office
and worked with its staff to ensure a thorough understanding
of anesthesia delivery and the practical implications of the
questions it was tasked with answering.
ASA applauds New Jersey and Oklahoma on these
important patient safety successes.
Jason Hansen, M.S., J.D. is
Director of State Affairs in
the Washington D.C. ofﬁce.
48
February 2013
n
Volume 77
n
Number 2
Anesthesiology
2000;93:152-63
Inc.
@2000AmericanSocietyof Anesthesiologists,
Wilkins,
&
Inc.
Williams
Lippincott
A nesthesiolo gistDirection and PatientOutcomes
JeffreyH. Silber,M.D., Ph.D,xSeanK. Kennedy,M.D., f Orit EvenM.5.,t WeiChen,M.S.,Sl-aurteF. Koziol,M.S.,\\
Shoshan,
M.D.**
AnnM. Showan,M.D.,# DavidE. Longnecker,
r52
Anesthesiolqgy
2UJO 93:152-63
O 20OOAmericm Striety of Ane$h6iologi$s,
Uppincon Willims & Wilkitu, Inc.
Inc
Anestlt esiolagist Direction and patient outcorte s
JeffreyH. silber,M-D.,P,h.e...s9gn
K. Kgn-edy,
M.D.,torit Even-sho.shan,
M.s.,+wei chen,M.s.,g
LaurieF. Koziol,M.S.,llAnn M. Showan,
M.D.,*David'E. Longnecker,
i.b.*
kckgroand:
Anesthesia senrlces for surglcal procedures may
or rury not be p€rsonally performed or medlcally dtrected by
anestheslologlsts.
Thls study compares the outcomes of surglcal
'Director, Center
for Outcomes Research,The Children,s Hospital
of Philadelphia. Associate professor, Departments of pediatrics and
Anesthesia,The University of pennsylvania School of Medicine, Department of Health Care Systems, The Wharton School and the Leonard
Davis Institute of Health Economics, The University of pennsylvania.
t Associate Professor, Department of Anesthesia, The University of
Pennsylvania School of Medicine.
+ Associate Director, Center for Outcomes Research,The Children,s
Hospital of Philadelphia.
g Director, Data Management and Computing, Center
for Outcomes
Research, The Children's Hospital of philadelphia.
ll Statistician, Center for Outcomes Research, The Children,s Hospi
ral of Philadelphia.
# Assistant Professor, Department of Anesthesia, The University
of
Pennsylvania School of Medicine.
" Robert Dunning Dripps professor and Chair, Department ofAnes_
thesia, The University of pennsylvania School of Medicine.
Received from the Center for Outcomes Research,the Department
of Anesthesiology and Critical Care Medicine, The Children,s Hospital
of Philadelphia; the Departments of Anesthesia and pediatrics, The
University of Pennsylvania School of Medicine; the Department of
Health Care Systems, The Wharton School and The lronard Davis
Institute of Health Economics, The University of pennsylvania, phila_
delphia, Pennsylvania. Submitted for publication February 17, ZOOO.
Accepted for publication May t2, ZOOO.
This work was predominantlv
self-funded. The development of the merhodology ,*j
ir, ,hi, p"p.,
was partially supponed from two external sources: Two grants from
The Agency for Healthcare Research and
eualiry (AHRe), HM56O and
H$9460, and a grant from the American Board of Anesthesiology
(ABA), Raleigh, North C-arolina, conceming the effect of
board certif,cation on outcome. The speci.6c questions regarding anesthesiologist
direction status explored in this paper were not directly funded bv
either rhe AIIRQ or ABA, and this paper does nor necessari.lyreflecr rhe
views of the AHRe or the ABA on this subject. We thank paul
R.
Rosebaum, Ph.D., The Wharton School, and WilliamJ. Greeley, M.D.,
The Children's Hospital of philadelphia, for their helpful comments
and suggestions. The authors are solely responsible for any errors or
omissions.
Adress reprint requests to Dr. J. H. Silber: The Children,s Hospital of
Philadelphia, Center for Outcomes Research@, J535 Mar*et Street,
Suite 1029, Philadelphia, pennsylvania 19104. Address elecrromc mail
to: Silberj@Whafton. Upenn.Edu.
Anesthesiology, V 93, No l, Jul 2000
patlents whose anesthesla care was
performed
or
lrcrsonally
medicalty dtrected by an anestheslotoglst
wlth the outcom€s of
patlents whose anesthesla care was not p€r.sonally petformed
or medlcally dlrected by an anestheslologtst
Metbodt: Cases werne defined as belng elther "dlrected,
or
'undlrected,"
dependtng on the type of lnvolvement
of the
anestheslologls!
as detennlned
by Health Care Flnancing Ad_
minlstratlon
billtng records. Outcome rates were adiusted to
account for sevedty of dlsease and other provlder characterlstlcs uslng logtsttc regresslon models that lncluded 64 patlent
and 42 procedur,e covarlates, plus an ad.fitlonal
1l hospltal
charactedstics
often assoclated with qualtty of care. Medlcare
clalms lpqqrds were analyzd
for all elderly patlents ln pennsylvanla who underrent
general surglcal or ortholrdlc
procedures between tggl-1994.
The study tnvolved t94,Z3O dtrect€d
and 23,010 undlrected patlents among 245 hospttals. Outcomes
studled tncluded death rate wtttrtn 3O days of artmtqslon" ln_
hospital compllcatlon
rate, and the fallure-to-rescue
rat€ (d€fined as the rate of death after compllcatlons).
Ress&s.. Adiusted odds ratlos for death and fallule_to-rescue
wene greatef when care was not dtnected by anesthestologlsts
(odds ratto for death = 1,08, p < 0.04; odds ratlo
for f,allureto-r.escue = 1.10, .|' < 0.01), whereas compllcatlons
wene
not lncreased (odds ratlo for compllcatlon
= 1.0O, p < O.79).
Thls corresponds
to 2.5 excess deaths/1,000 pattents and
6.9 excess fallures-to-rescue (deaths) per 1,000
fatients wlth
compllcatlons.
Cottclttslons: Both 30-day mortaltty
rate and moftallty
fate
after complicatlons
(fallune-to-rcscue)
were lower when anesthestologtsts dhected anesthesla care. These results suggest that
surgical outcomes in M€dicare patlents afe associated wlth
anestheslologlst
dlr,ectlon, and may provtde tnsight regardfng
potential approaches for tmprovtng
surglcal outcomes. (Key
words: Anesthesiologtsts;
anesthesla care team; qualtty of care;
mortallty;
fallure-torescue;
compllcation;
Medlcare; general
surgefy; orthopedlcs.)
AS hospitals and physicians adapt to new financial chal_
lenges, the mix of healthcare providers has been chang_
ing. Throughout the healthcare system, there are examples of work rraditionally performed by specialiststhat is
now allocated to generalists or nonphysicians. Many of
the decisions regarding provider mix have been driven
by financial considerations or provider availabiliry,
rather rhan by patient outcome data, which would be
valuable for such decision-making. There are limited
outcome data regarding provider models in specific ar_
r53
ANESTHESIOLOGIST
DIRECTION
AND PATIENTOUTCOMES
eas, such as adult primary care office practice.r However, generalizations among specialties and provider
fypes may not be valid because of differences in the
intensity of the care rendered, the severity of illness of
the patient, or the extent of the intervention, among
others. Iarge-scaleoutcome data regarding the meaningful involvement of the anesthesiologistin surgical outcomes are few, yet the delivery of anesthesiaservices
provides a unique opportunity to observe the influences
of provider mix on outcomes in a complex medical
environment. Anesthesiologists and nurse anesthetists
have worked together or separatelyfor many years, in a
variety of provider models, ranging from independent
practice to the "anesthesiacare team" model.2
This study seeks to determine whether general and
orthopedic surgical outcomes differ depending on
whether the anesthesiologistis involved significantly in
the delivery of anesthesia services to etderly Medicare
patients. The answer to this question could have a signfficant impact on overall healthcare delivery because
each year approximately 1.3 million Medicare beneficiaries are admitred to United Stateshospitals for orthopedic and general surgical procedures that necessitate
anesthesia.3
Materials
and Methods
Data
All PennsylvaniaMedicare claims records for patients
65 yr or older were analyzedfor general and orthopedic
surgical admissions between l99l and 1994. The study
involved 194,430 "directed" and 23,010 ',undirected,
patients n 245 hospitals. Outcomes studied included
death rate within 3O days of admission, in-hospital complication rate, and the failure-torescue rate (defined as
the rate of death after complications). We obtained the
Medicare StandardAnalytic Files for all general surgical
and onhopedic DRGs(diagrrosis-relatedgroups) in pennsylvania berween l99l and 1994 (Medicare parr A data).
For each patient we created a longitudinal record by
appending all medical and surgical inparient and outpatient claims and physicians' claims (Medicare part B data)
during that time interval. Data also included the American Hospital Association Annual Surveysfor 199l-1993,
and the Pennsylvania Health Care Cost Containment
Council Data Basefor years 199l-1994.
Patient Selection
We developed predictive models for a random sample
of JO% of Medicare patients who underwent general
Anesthesiology, V 91, No 1, Jul 2O0O
Table 1, DRGs Included
ln Datas€t
GeneralSurgicalDRGS
OrthooedicDRGs
1 4 6& 1 4 7 ; 1 4 8& 1 4 9 ;1 5 0&
1 5 1 ;1 5 2& 1 5 3 ;1 5 4&
1 5 5 ;1 5 7& 1 5 8 ;1 5 9&
1 6 0 ;1 6 1& 1 6 2 ;1 6 4&
165;166& 167;170&
1 7 1 ;1 9 1& 1 9 2 ;1 9 3&
1 9 4 ;1 9 5& 1 9 6 :1 9 7&
1 9 8 ; 1 9 9& 2 0 O ; 2 0 1 : 2 5 7
& 2 5 8 ; 2 5 9& 2 6 0 ; 2 6 1 ;
262;263 & 264; 265 &
266: 267; 268; 286;287;
288; 289; 29O;291;292&
293; 285
209;21&
0 2 1 1 : . 2 1 3 : 2&
14
215;216:217;218& 219:
2 2 1& 2 2 2 ; 2 2 3
&224:
225;226& 227',228
&
229;23O;231;232;233
&
234
For DRG483 (tracheostomy),
we reassignedthe DRG that would have been
assignedusing the primary procedurecode had a tracheostomynot be€n
performed.
DRG = diagnosis-relatedgroup.
surgical or orthopedic procedures in pennsylvania between 1991-L994 and tested our results on the other
50%. Final results are reported regarding the ftrll sample
of 217,440 individual patients. The DRGs included in
this study are listed in table l The fust hospital admis.
sion for any one of these DRGs triggered the identi_frcation of a study hospital admission.
Defnltlons
During the years discussed in this study, the Healthcare Financing Administration QICFA) required that anesthesiacare be either medically directed or supervised
by a physician (supervision is defined as a level ofphysician participation that is less than that deflned by
medical direction). According to HCFA, the supervisor
or director must have been a licensed physician, but not
necessarily an anesthesiologist.aTo bill for medical direction, as defined by HCFA,5physicians must have met
all the criteria listed in table 2. Otherwise, the level of
involvement was defined as "supervision" and physicians
received markedly reduced payment.
Casesbilled to Medicare as "personally performed" or
directed by an anesthesiologist were defined in this
study as directed. Otherwise, cases were defined as
undirected.
Personally performed cases also included those in
which an anesthesiology resident was directed by an
attending anesthesiologist. (Anesthesiologist cases in
which residentswere directed were billed as personally
performed for the first 3 yr of the study interval, and
changes in the HCFA guidelines caused direction of
I
r54
SILBERET AL.
Table 2. Definltlon
of Anesthesla
Dlreation
Personalmedicaldirectionby a physicianmay be paid if the
followingcriteriaare met:
No more than 4 anesthesiaproceduresare being performed
concunently.
The physiciandoes not perform any other services(excepras
provided below)during the same time period.
The physicianis physicallypresent in the operatingsuite.
The physician:
performsa pre-anestheticexaminationand evaluation
prescribesthe anesthesiaolan
personallyparticipatesin the most demandingproceduresin
the anesthesiaplan,includinginductionand emergence
ensuresthat any procedurein the anesthesiaplan that he or
she does not perform are performedby a qualified
individual
monitorsthe course of anesthesiaadministrationat freouent
intervals
remainsphysicallypresentand availablefor immediate
diagnosisand treatmentof emergencies
provides indicatedpost anesthesiacare.
Medicars MedicarPoricyBuiletin.MedicarDirectionof Anesthesiaservices.
BulletinNo. A-7A,Januaryj, 1994.
resident casesto be billed as ,,directing 2- 4 cases,'in the
final year of the study.)
There were 23,OIO patients defined as undirected in
this study, of which 14,137 patients (610/0of the undirected group) were not billed for anesthesiaand g,g73
(39%o)were billed for anesthesia. The ,,nobill,, cases
were defined as undirected because there was no e\ridence of anesthesiologist direction, despite a strong fi_
nancial incentive for an anesthesiologistto bill Medicare
if a billable service had been performed. The cases in
which an anesthesiologybill was not submitted showed
billing data that indicated that a surgical procedure on
our study list was performed. These cases either were
supervised by a physician or a staff nurse anesthetist
employed directly by the hospital or rhey repres€nted
undirected anesthesiology r€sident cases. Of these
14,737nGbill cases,only l,Zg7 at most were anesthesia
resident cases(or 5.6%of all undirected cases),assuming
all nobill casesat institutions with anesthesiaresidenry
programs reflected resident cases.The remaining undirected cases consisted of 8,g73 patients (39% of the
undirected group) for which procedures were supervised but not directed by an anesthesiologistor directed
by a nonanesthesiologistphysician. None of these cases
included residents. Billing codes included ,,unknown
physician specialty" qcode 99) or ,,unknown provider"
(code 88) associatedwith a nurse anesthetist specialty
code 43 or nonanesthesiologist physician direction of
the nurse anesthetist, including many other specialry
Anesthesiology, V 93, No 1, Jul 200O
designations, such as parhology (code 22) or general
medicine (code ll). Of the 217,440 patients, 2O,O(fi
(9.9%) patients underwent anesthesia procedures on
more than 1 day during their hospital stay. We labeled a
patient undirected if on any day of the hospital sray, all
anesthesiaprocedures performed that day were not directed by an anesthesiologist.
In HCFA billing records the specialty code for anesthe_
siologist is denoted by an "05" designation. Anesthesiol_
ogist designation did not imply board certifrcation. We
used information from the American Board of Medical
Specialties (ABMS) to veriry Medicare data. In one instance, Medicare data indicated that the directing physi_
cian was a nonanesthesiologist, yet that same physician
was noted to be board ceftified in anesthesiologyaccord_
ing to the American Board of Medical Specialties files.
We therefore recoded that person as an anesthesiologist
for our pulposes.
Outconle Statistlcs
Death within 30 days of admission was determined
from the HCFA Vital Status file. Complications (table 3)
were identified using a set of 4l events defined by
Table f,. Compllcatlons:
Cod€s
Defined
Uslng ICD-9-CM and CpT
Cardiacevent(e.9.,seriousanhythmia)
Cardiac emergency(e.g., cardiac anest)
Congestiveheart failure
Postoperativecardiac complications
Hypotension/shock
Pulmonaryembolus
Deep vein thrombosis
Phlebitis
Stroke/CVA
TIA
Coma/other
Seizure
Psychosis
Nervoussystemcomplications
Pneumonia-Aspiration
Pneumonia-Other
Pneumothorax
Respiratorycompromise
Bronchospasm
Postoperativerespiratorycornplications
Intemalorgan damage
Perforation
Peritonitis
Gl or internalbleed
Seosis
Deep wound infection
Renaldysfunction
Anesthesiaevent
Gangreneof extremity
Intestinalobstruction
Returnto surgery
Decubitusulcer
Orthopediccomplication
Compartmentsyndrome
Malignanthyperthermia
HepatitiVjaundice
Pancreatitis
Necrosisof bone/thermal
or aseptic
Osteomyelitisfrom
procedure
Fat embolism
Electolytalfluid abnonnality
The algorithmsfor constructingthe complicationsusing ICD_9_CMand CpT
codes are availableupon request.
CPT = Physician'sCurrent procedural Terminology,4th edition; CVA :
cerebralvascularaccident; Gl : gastrointestinal;ICD_9_CM= International
Classificationof Diseases,gth revision,ClinicalModification;TIA : transient
ischemicattack.
!
r55
ANESTHESIOLOGIST
DIRECTION
AND PATIENTOUTCOMES
International Classification of Diseases, 9th revision,
Clinical Modification (ICD-9-C|O and CpT (physician's
Current Procedural Terminology, 4th edition) codes
available from HCFA databasesfor the hospital sray of
interest, previous hospital stays, and outpatient visits
within 3 months before the index hospital sray. CpI
codes billed before the hospital stay were used to determine long-standing conditions thar would aid in distinguishing complications from comorbidities. Failure-to
rescue rate (FR) was defined as the 3Gday death rate in
those in whom either a complication developed or who
died without a recorded complication. It can be expressed mathematically as follows: FR : D/(C + Dlno
C) or the number of patients who died (D) divided by
the number of patients with complications (C) plus the
number of patients who died without complications
noted in the claims data @lno C).6'7
Estimates of excess deaths/l,00o patients were de_
rived using a direct standardization approach using the
frrll data ser for both the directed and the undirected
cases.sUsing the final fi.rlly adjusted model, the probability of death was estimated rwice for each of the
217,440 patienrs in the study, once assuming each case
was undirected and once assuming the case was directed. The resultant difference between the sum of the
estimated death rates, divided by the sample size, and
mulriplied by I,000, provides the number of excess
deaths/l,0O0 patients when casesare not directed. The
same method was used to estimate the excessnumber of
failure-torescue cases in the undirected group, except
the denominator of casesincludes only those with complications. The advantage of this standardization ap
proach is that all patients are used for both estimates,
hence reducing bias.
Coefficients were not statistically different between
models derived in development and validation sets. pearson correlation coefficients between predicted out_
comes in the development set and the validation set
were always greater than 0.93. Final models were con_
structed using both the development and the validation
data sets.
Hospital Analyses
To account for hospital characteristics that may have
influenced our results, we adjusted the results using a list
of I I hospital characteristics that we, and others. reported previously.T'rl'12 Further, we constructed an indicator variable for each hospital and report restrlts
adjusted for each individual hospital in the logistic_re_
gression modeling. We also performed adiustments for
each hospital using Mantel-Haenszel testsr3 in a number
of ways. rVe estimated the odds ratio (OR) associated
with outcome and no direction by controlling for each
hospital and strati_fied,in some analyses,using the risk of
death or the propensity scoreta-r8 to predict lack of
direction. When,stratifying using the risk of death, we
refitted the mortality model, deriving new coefficients,
using a sepzuate data set of 1995-1996 pennsylvania
Medicare patients. This allowed for unbiased odds ratios
derived from the Mantel-Haenszel tests when applied to
the main study set comprising 199l-1994 data.
Results
Patient Descrtption
Table 4 describespatient casemix and table 5 displays
patient characteristicsthat were present in at least l% of
the study population among the anesthesiadirected and
Model Deaelopment and Valldation
nondirected groups. Two odds ratios are presented in
We developed three logistic-regressionmodels to ad_ table 5. The first is the unadjusted
odds ratio; the second
just for severity of illness and case mix, one for each
is the Mantel-Haenszelrs odds ratio after adjusting for
outcome in the 50% random or ,,development',sample.
DRG category and each of the 245 hospitals in the study.
Candidate variables were selected if signfficant at the
Undirected patients were more likely to be male; to have
O.O5level after univariate analysis for any of the three
a history of anhythmia, congestive heart failure, and
outcomes. DRG variables were grouped into DRG_prin_ non-insulindependent
diabetes; and to be admitted
cipal procedure categories to produce more homoge_ through the emergency
department. Undirected patients
neous risk groupings based on Haberman residualsT,e,ro were less likely to have
cancer.
and then included in each model. Each model included
There were some associationsbetween covariates and
42 DRG-principal procedure variables and 27 parient
direction status that were unexpected. Some of these
characteristics. A total of 37 interzction terms were in_
could be explained when we studied factors that were
cluded in the models, having been significant at the
predictive of directionra and factors predictive of proceBonferroni adjusted 0.05 level. We validated the derived
dures. For example, the unadjusted odds ratios in table 5
models for the remaining 5O% or ,,validation" sample.
suggestundirected caseshad gleater odds of occurrence
r56
SILBERET AL.
T"bt
4. Medlcal Dlagnostlc
Categorles (MDC) by Dlrectlon
Status
Directed
MDC6
Diseasesand disordersof the digestivesystem(146& 147:14g
& 1 4 9 ;1 5 0& 1 5 1 ;1 5 2& 1 5 3 ;1 5 4& 1 5 5 ;1 5 7& 1 5 8 ;1 5 9&
1 6 0 ;1 6 1& 1 6 2 ;1 6 4 ;1 6 5 ;1 6 6 ;1 6 7 ;1 7 0& 1 7 1 )
MDC 7
Diseasesand disordersof the hepatobiliary
system(191& 192;
193& 194;195& 196;197& 198;199& 200;201)
MOCI
Diseasesand disordersof the musculoskeletalsystem (2Og:210
& 211: 213:214 & 215i 216: 217: 21I & 219; 221& 222: 223 &
224; 225; 226; 227: 228 & 229: 230; 23i; 232: 2gg & 234: 257 &
258; 259 & 260; 261:'262;263 & 264\
MDC 9
Diseasesand disordersof the skin, subcutaneoustissu€. and
breast (265 & 266; 267; 268)
M D C1 0
Endocrine,nutritional,metabolicdiseasesand disorders(2g5:
286; 287: 288:.289;290; 291; 292 & 293)
Total
in patients with insulin-dependent diabetes. However,
undirected patients also had greater odds ofundergoing
wound debridement and skin grafts as a principal pro
cedure, as compared with directed patients (OR :
l0.l4;95% con_fidence
interval tCtl : 9.,t, 12.36).The
higher rate of diabetes in the undirected group may, in
part, have been causedby an increasedpropensity of the
caregiver to perform skin graft procedures, and there_
fore it would not be surprising that there was an associ_
ation between undirected cases and diabetes. Bickel ef
al,te have shown the importanc€ of such adiustments
when making inferences concerning selection bias in
Table 5.
ofPatlent
characterlstics
Age olderthan 85 yr
Male
Hx congestiveheart failure
Hx anhythmia
Hx aortic stenosis
Hx hypertension
Hx cancer
Hx COPD
Hx noninsulin-dependent
diabetes
Hx insulin-dependent
diabetes
Emergencydepartmentadmission
54,443
28.00
6,805
29.57
24,957
12.84
3,429
14.90
111,825
57.51
12,141
52.76
392
o.20
86
0.37
2,813
1.45
549
2.39
194,430
89.42
9.9
J+- I
2.6
2.9
1.8
6.6
aa,1
12.1
10.6
1.7
34.4
10.58
Ho spital Cltara cteristi cs
The distribution of hospital characteristics according
to the presence of anesthesiologistdirection is displayed
in table 6. Generally, the hospitals in which undirected
Drrrected cases)'
Unadjusted
Adjusted by DRG and Hospital
Odds Ratio
P Value
1.048
1.122
1.637
1.357
n o70
1.202
0.900
1.093
1.293
2.163
1.232
0.040
0.001
0.001
0.001
0.689
0.001
0.001
0.001
0.001
0.001
0.001
'odds ratio
denotesthe odds of a covariateof interestobservedin the undirectedgroup yersus
that of the directed group.
COPD : chronic obstructivepulmonarydisease;Hx = historv.
Anesthesiology, V 93, No l, Jul 2OOO
23,010
graduate school admissionspolicies. Hence, after adjustment, it would appear as though there was far less
imbalance in the covariates betwe€n directed and undirected cases than was initially appreciated. However,
given the remaining differences between groups, careful
severity corrections for all outcomes were performed
before results could be accurately interpreted.
(odds Ratto for undlrectedaerszs
Percentof Total
Population
Not Direct€d
Odds Ratio
1.044
1.053
.1.t59
1.092
0.996
1.017
0.903
1.O24
1.074
1.046
1.247
P Valu€
0.110
0.002
0.001
0.00't
0.946
0.578
0.001
0.312
0.003
0.387
0.001
r57
ANESTHESIOLOGIST
DIRECTION
AND PATIENTOUTCOMES
Table 6. Dlstrlbution
of Hospltal
Characterlstlcs
by Type of provlder
HospitalCharacteristics
Undirected
No. of beds greaterthan 2O0(%\
Nure-to-bed ratio (RNs/bed)
Percentageof anesthesiologystaff board certified (%)
Percentageof surgicalstaff board certified (%)
Trauma Center (%)
Lithotripsyfacility (%)
MRI facility(%)
Solid organ/kidneytransplant(o/o)
Bone manow transplantunit (%)
Approved residencytraining program (%)
Member,Councilof TeachingHospitals(%)
P Value
32.72
1.38
72.70
80.40
21.87
42.49
1.40
74.70
85.00
23.90
15.68
35.90
13.56
7.22
49.20
21.89
't7 4E
33.27
11 qO
c.J/
40.90
17.87
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
0.0001
MRI = magneticresonanceimaging;RN = registerednurse.
cases occruTed tended to be smaller, to have less specialized technology and facilities, and were less likely to
be involved with the teaching of medical students and
residents.
Adjusting for Patient Cbaracteristics and
DRG-Procedure Category
Unadjusted death, complication and failure-rorescue
rates were greater when caseswere undirected (table D.
Table 8 displays the influence of anesthesiadirection on
outcome after results were adiusted for 64 patient characteristics and interaction ter{ns, including demographic
information, history variables, whether the patient was
transferred from another shoft-tem{are
hospital,
whether the patient was admitted from the emergency
room, and 42 DRG-procedure categories used for this
study. As in the unadjusted model, mortality and faituretGf€scue rates were greater when an anesthesiologist
did not perform or direct care. The adjusted odds ratios
for death and failure-tGrescue were significantly increased: (OR for death = 1.O9, p < 0.021; OR for
failure-torescue : 1.12, P < 0.003) corresponding to
2.8 excess deaths/I,0o0 patients and g.4 excess deaths/
1,000 patients with complications. Adding patient race
to this model did not change these results.
A second analysis was performed adding admission
MedisGroups (MediQual Inc., I/estborough, MA) severTable 7. Unadiusted
ity score (a physiologic based score) obtained from the
Pennsylvania Health Care Cost Containment Counc[.6'2o-23During lggl-1994, MedisGroups scores were
recorded for only 72.9% of our study patients. The ORs
for the anesthesiadirection covariate were as follows:
(OR for death : 1.O9,P < 0.016; OR for failure-torescue = 1.12,P < 0.002; OR for complication : O.97,
P < O.O52).These results provided further evidence that
the models derived solely from the Medicare data were
adequatelyadjusted.
We also explored whether the increased odds of death
and failure-tGrescue in the undirected group were
caused by admissions through the emergency department. When the non-emergency department cases
were analyzed separately, the odds ratios for death and
failure-torescue remained greater for those patients who
did not receive anesthesiologist direction (adjusted OR
for death = 1.17,P < 0.007 and adjustedOR for failuretGrescue : 1.18,P < 0.005).
Adjusting for Patient and Hospital Cbaracteristics
The lower poftion of table g displays the results of
anesthesia direction when l l hospital variables were
included in the three outcomes models. Undirected
caseswere associatedwith greater death and fai_lure_to
rescue rates: (OR for death : 1.08, p < 0.040; OR for
failure-torescue: 1.10, P < 0.013), corresponding to
Outcomes
Outcome
UndirectedRate(%)
n = 23,010
Directed Rate (%)
n = 194,430
Death
Complication
Failureto rescue
4.53
47.87
9.32
3.41
411
. 5
A IA
Odds Ratio'
95oZConfidenceInterval
1.35
1.31
1.15
(1.26,1.44)
(1.28,1.35)
(1.08,1.24)
' odds ratio
denoies the odds of an outcome observedin the undirectedgroup yersusthat of the directed group.
Anesthesiology, V 93, No 1, Jul 2000
P Value
0.0001
0.0001
0.0001
158
SILBER ET AL.
Table 8. Loglsttc Regresslon
Results
Events
Adjustingfor patient characteristics
Death
Complication
Failure-to-rescue
Adjustingfor patient and hospital
characteristics
Death
Comolication
Failureto rescue
No. of Patients
No. of Events
c statistic
AdjustedOdds Ratio.
95% ConfidenceInterval
217,440
217,440
92,170
7,665
91,024
7,665
0.82
0.75
0.75
1.09
0.97
1.12
( 1 . 0 11, . 1 7 )
(0.94,1.00)
( 1 . 0 4 1, . 2 1 )
0.0208
0.0345
0.0025
217,440
217,440
92,170
7,665
91,O24
0.82
0.75
u ./ 5
1.08
(1.00,1.15)
(0.96,1.03)
(1.01,1.18)
0.0399
0.7941
0.0128
/,oof
. Odds ratio
denotes the odds of an outcome observedin the undirectedgroup y€rsusthat of the
2.5 excess deaths,/l,OOO
patients and 6.9 excess deaths/
I,O00 patients with complications, whereas the adjusted
OR for the complication rate was insignifcant (OR for
complication 1.0O,P < 0.796). When the MedisGroups
severity score was added to the analysis, death and
failure-torescue ORs were stable and the associated,P
values became slightly more significant. When a variable
reflecting the number of anesthesiaprocedures per hos_
pital stay was added to the model, we again found the
odds ratio estimates to be unchanged.
In a further analysis,we calculated the adjusted odds
ratios for each outcome using the Mantel-Haenszelodds
ratio, adiusting for all DRG categoriesand for each of the
245 hospitals in the study, and obtained very similar
results. The adjusted odds ratio for death was 1.14 (p <
O.O0l), the odds ratio for failure-terescue was l.l I (p <
0.008), and the odds ratio for complication was 1.06
(P < 0.001). We next constructed a model adjusting for
the same paticnt characteristics as in table g plus a
hospital identifier variable for each hospital (grouping
hospitals with fewer than lO deaths into one indicator
variable to allow for more stable coefficients). The re_
sults were almost identical to those in table g. The
adjusted odds ratio for death was l.O9 (p < 0.033), OR
for failure-torescue was l.l0 (p < 0.01d), and the OR for
complication was 1.02 (p < O.33r.
Furtber Analyses Using Mantel-Haenszel
AdJustments and tbe Propensity Score
We conducted an additional set of analysesconceming
the influence of the hospital provider on outcome in this
study. Using the fi.rll model for patient characteristics,as
defined in table 8, we refitted the model coefficients for
a separateset of 102,781 pennsylvaniaMedicare patients
from 1995 and lD6, using the sameprocedures as in the
199l-1994 study data set. We then calculated the inirial
risk of death before surg€ry for each parient in our
lnn
1. 1 0
p Value
directed group.
l99l-I994 study data set and, as suggested by Cochran,24we divided these risk scores at the quintiles of this
distribution, yielding five risk groups of equal sample
size. For each of the 245 hospitals in the data set, we
then formed 245 x 5 : 1,225 cells using these five risk
groups. This gave us a 2 X 2 X j X 24j contingency
table, recording death by direction status by mortality
risk strata by hospital. The associated Mantel-Haenszel
odds ratio computed from the 2 x Z X 5 X 245 cell
contingency table was l.16 (1.077, 1.246). This ratio
was almost exactly the same as the Mantel-Haenszel test
results with an odds ratio of 1.14, controlling for the
individual hospital and DRG (see previous section in
Results),whereas the logit model using hospital indica_
tors also found a very similar odds ratio (1.09). Hence.
we obtained almost identical results when the ORs were
derived from regression models or derived by performing a
Mantel-Haenszel analysis,controlling for risk of death, and
forcing all comparisons to be stratified within the same
hospital, thereby controlling for the ,,hospital effect."
To control for selection bias associatedwith direction
or lack of direction, we performed an additional set of
analysesusing the propensity score to predict direction.
Similar to the stratification of moftality risk previously
discussed,we divided the propensity score at the quintiles of its distribution, yielding five risk groups of equal
sample size. For each of the 245 hospitals in the data set,
we then formed a 2 (death status) X 2 (direction status) X 5 (propensity score risk strata) x 24i hospital
contingency table. The associatedMantel-Haenszel odds
ratio compured from the 2 X 2 X S X 245 cellcontingencytablewas 1.ll (1.O3,1.19).Again,the oddsratiofor
death associatedwith direction status wils almost identical
to that determined by our previous methods using logit
regression or methods without the propensity score.
Finally, we performed an adjustment strati-rying by
mortatity risk, propensity score, and hospital using a 2 X
r59
ANESTHESIOLOGIST
DIRECTION
AND PATIENTOUTCOMES
Table 9. The Margtnal and Partlal Influence
Adjusttng for Patlent Covadates
of Hospltal
characterlstics
and of Dlrcctlon
of Anesthesla
carfe on outcome,
AdjustedOdds Ratios (gsyoConfidenceInterval)
Hospitalbeds (>200 beds vs. <200 beds)
Registerednurse-to-bedratio (in units ol 2,o/oof the mean)
Magneticresonanceimagingfacility
Bone manow transplantation
unit
Organtransplantation
unit
Lithotripsyfacility
Traumacenter
Surgicalboard certification,% (in unitsof 25% of the mean)
Anesthesiaboard certification,% (in units of 25% of the mean)
Member,Councilof TeachingHospitals
Approved residencytraining program
Anesthesiologist-directed
care"
Outcome Measure
Marginal
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
Death
Failure-to-rescue
Complication
0.90(0.86,0.95)s
0.83(0.80,0.88)s
1.22(1.20, 1.25\s
0.95 (0.93,0.96)e
0.94 (0.92,0.96)s
1.04(1.03,1.04)s
0.96(0.92,1.01)
0.93 (0.89,0.98F
1.06(1.04,1.00)s
0.89 (0.80,0.98)b
0.79(0.72,0.88)s
1.34(1.29,1.39)s
0.91 (0.84,0.98F
0.83(0.77,0.89)s
1.26(1.22, 1.29\s
0.92(0.86,0.99)b
0.88 (0.82,0.94)f
1.10(1.07,1.13)s
0.93(0.88,0.99)b
0.89 (0.84,0.95)s
( 1 . 0 81, . 1 3 ) s
1.'10
0.97(0.94,1.00)f
0.94(0.91,0.98)s
1.07(1.05,1.08)s
0.99(0.97,1.01)
0.97 (0.95,0.99)d
1.05(1.04,1.05)s
0.91(0.85,0.96)d
0.84 (0.79,0.89)s
1.26(1.23,1.29)s
0.e4(0.89,0.e8F
0.87(0.83,0.91)s
1 . 2 1( 1 . 1 81, . 2 3 ) s
0.92(0.85,0.99f
0.8e (0.83,0.96)d
1.04(0.87,1.07)
0.90 (0.84,0.94d
0.87 (0.81,0.94)f
1 . 1 1( 1. 0 8 ,1 . 1 4 ) s
0.95 (0.92,0.97)s
0.95 (0.93,0.98)s
0.e8(0.98,
o.se)'
1.04(0.98,1.10)
1 . 0 5( 0 . 9 91, . 1 1 )
0.95 (0.93,0.98)s
0.99(0.88,1.11)
0.93(0.82,1.04)
1.17(1.12,1.22)s
1 . 0 3( 0 . 9 4 , 1 . 1 2 )
0.97 (0.89,1.07)
1 . 1 2( 1 . 0 8 , 1 . 1 6 ) s
0.97 (0.90,1.05)
0.97 (0.89,1.05)
1.01(0.98,1.0s)
1 . 0 3( 0 . 9 61, . 1 1 )
1 . 0 5( 0 . 9 8 , 1 . 3 4 )
0.94 (0.91, 0.97)s
0.99(0.96,1.03)
0.98 (0.95,1.02)
1.03(1.01,1.04)'
1.01(0.99,1.03)
1.00(0.98,1.02)
1 . 0 1( 1 . 0 01, . 0 2 ) d
1 . 0 3( 0 . 9 4 , 1 . 1 2 )
1 . 0 2( 0 . 9 3 , 1 . 1 1 )
1 . 1 0( 1 . 0 61, . 1 4 ) s
1 . 0 3( 0 . 9 71, . 1 1 )
0.99 (0.93,1.06)
1 . 0 7( 1 . 0 41, . 1 0 ) s
0.93(0.87,1.00)b
0.91 (0.85,0.99)b
1.00(0.97,1.04)
o
" < 0 . 1 ; < 0 . 0 5 ;c < 0 . 0 1 ;d < 0 . 0 0 5 ;" < 0 . 0 0 1 f; < 0 . 0 0 0 5s; < 0 . 0 0 0 1 .
odds ratio denotes the odds of an outcome observedin the diected group yelsus that of th€ undirectedgroup.
Marginalanalysisreportsthe odds ratiosassociatedwith hospitalcharacteristicsadded one at a time in
the logit modelthai includesil patientand 42 procedure
covariatesand interactionterms.
Partialanalysisreportsthe odds ratios associatedwith hospitalcharacteristicsadded all together
to the logit model that includes64 patient and 42 procedure
covariatesand interactionterms.
2 x 5 x 5 x 245 cell conringency table. Monaliry risk
was again estimated for the separate 1995-1g96 patient
population to avoid bias. This analysis yielded, again,
similar results to the logit model reported in table g, with
an OR of l.O7, (O.99,1.l5). The slightly lesssignificantp
value of 0.09 may reflect the fact that we were controlling for 5 times more strata than in the previous two
analyses.
Table 9 displays the results of the ,,firllyadjustedpari€nt
Anesthesiology, V 93, No 1, Jul 20OO
model," with the addition of all I I hospital characteristics
and the direction indicator for the three outcomes. For
each hospital variable, and the anesthesiologist direction
indicator, we present two results. The ,,marginal" result is
computed by adjusting the OR for direction by all patient
covariates and a single hospital variable or direction
indicator. The "partial" analysis displays the results of a
fully adjusted model using all patient covariates, all hos
pital covariates, plus the direction indicatof (this .par-
160
SILBER ET AL.
tial" model is also shown in table 8). The marginal
analysis showed that hospitals with more sophisticated
facilities, higher nurse staffing ratios, and more educational programs were consistently associated with reduced death and failure-terescue rates, whereas complication rates were greater in these hospitals. lfe reported
this same pattern in other studies.T'rr'22Simultaneously
adjusting for all the hospital variables and the anesrhesiologst direction variable, we found that tfuee factors
continued to show independent effects on death and
failure-tqrescue: hospital size, nurse-tobed ratio, and
direction by an anesthesiologist.
Furthermore, we asked whether the odds ratios assG
ciated with direction and outcome would have changed
had we used only patients who were billed, rather than
all records. The resulting logistic-regressionderived odds
ratios were unchanged. Finally, we asked whether add_
ing variables denoting the size of the metropolitan area
would account for the observed differences in outcome.
Adjusting for the l1 hospital variables and for five levels
of population size from rural to metropolitan areas
greater than I million, we found very little difference in
results (OR for death : 1.O7,p < 0.057; OR for failuretGrescue = 1.09, P < 0.021; OR for complication :
1.00,P < 0.853).
Discussion
ffier adjustments for severity of illness and other con_
founding variables, we found higher mortality and fail_
ure-tGrescue rates for patients who underwent opera_
tions without medical direction by an anesthesiologist.
Adjusted complication rates were not associated with
medical direction. This finding is not inconsistent with
the finding of higher mortality rates in the absence of
medical direction. Our previous work showed that com_
plication rates, as reflected in administrative claims data,
are indicators of severity of illness,T'11,22
but adjusted
complication rates are not well-correlated viith adjusted
death rates.I r'22'23ln Medicare surgical patients, complication rates are poor indicators of quality of care6,7and
are not accurately coded to discern specffic intraopera_
tive events. The complication rate in this study reflects
the number of patienrs who had complications, not the
number of complications per patient. The complication
list was developed to be inclusive and sensitive ro most
undesirable occurrences during the hospital stay, but
was not specific for perioperative complications. Spe_
cific perioperative complications may not appear in the
Medicare claims data, in which the limited number of
fields and variation in recording patterns may prevent
the complication rate from reflecting differences in quality. Hence, it is not surprising that adjusted complication
rates were not different among providers, whereas 3G
day mortality rate-a measure better defined and record_
ed-was different.
Becauseof these limitations in all studies involving the
Medicare database,the failure-torescue rate was devel_
oped and validated,6'7and complications were used as
an adjustment tool for severity of illness, rather than as
an isolated outcome measufe. Failure-to-rescueassesses
how complications are managed by studying the rate of
death only in those patients in whom comptcations
develop or in those who die without recorded compli_
cations. Failure-torescue may provide better insight re_
garding quality of care than either mortality or compli_
cation rates used alone6,7 because it can more easily
account for differences in severity. For the current study,
failure-torescue rates showed an even greater associa_
tion with provider characteristics than did death rates.
This suggests that advanced medical training may allow
for better management of complications, thereby decreasing the severity of such complications, and leading
to fewer subsequent deaths.
Adequate severity adjustment is always necessary for
studies of the type reported herein. Given the apparent
difference in the prevalence of specific comorbidities
between the directed and undirected groups, adequate
adjustment was especially impoftant. As seen in table 5,
much of the difference between groups could be ex_
plained by the different distribution of procedures found
in the directed and undirected groups. Hence, looking at
unadjusted prevalence rates of comorbidities can be
deceiving in data sets such as this. A classic example of
this same problem was provided by Bickel et al.le jn
their 1975 afticle of graduate admission bias using data
from The University of California at Berkeley. Although
unadjusted admission acceptance rates would suggest
females had been discriminated against because of the
observed overall lower admission rates, after adiustment
for the departments to which the female students ap
plied, it was shown that there was no significant bias.
This was because the female applicants more often ap
plied to departments with lower rates of acceptance (for
both males and females), whereas male applicants more
often applied to depaftments with higher rates of accep_
tance (for both males and females). Hence, the overall,
unadjusted numbers suggested an imbalance in admis"
sion rates (a bias against females), whereas such an
l6l
ANESTHESIOLOGIST
DIRECTION
AND PATIENTOUTCOMES
imbalance was not seen at the individual depanment
level.
It was reassuring that, in our study, after adjustment
for DRG and hospital, the difference in the prevalence of
covariates between the directed and undirected groups
became much smaller. In part, this was caused by a
tendency for undirected patients to be involved with
slightly more minor procedures in patients with a
greater number of comorbidities. Although adiustments
in table 5 helped to explain these di_fferencesin comorbidity rates ,rmong groups, more complete model-based
adjustments were made when reporting fnal results.
There is strong supporting evidence that the modelbased adjustments used in our study were adequate. Of
interest, unadjusted rates of death, number of complica_
tions, and failure-torescue rates were all increased in the
nondirected group. After using models that contained
identical patient covariates for each of the three out_
comes, we observed that the adjusted odds of develop_
ment of complications decreasedto l, whereas ORs of
death and failure-to-rescueremained greater than l Fur_
ther, the unadjusted OR associatedwith no direction and
fai-lure-torescue(table ) was almost identical to that in
the tully adjusted model (table 8). This finding is consis_
tent with a number of studies showing that a strength of
the failure-torescue concept is that the failure-to-rescue
rate appears to be less sensitive to omissions of severity
of illness data than is the death or complication rate.1,z2
Finally, when a physiologic severity adjustment measure,
MedisGroups Score, was added to the models, results
were virtually unchanged. If the association between
anesthesiologistdirection and outcome was an artifact of
failure of the model to adequately control for critical
aspectsof patient severity, we would have expected the
addition of the physiologic-basedpatient severity score
to alter the results. Together, these findings provide
consistent supporting evidence that the model was ad_
justed adequately for severiry of illness among groups.
Without further adjustment, these results might still
reflect differences in overall hospital quality, rather than
differences in the type of anesthesiologistinvolvement.
Therefore, the results were simultaneously adjusted for
patient and hospital characteristics, yet the effect of
anesthesiologist direction remained signi_ficant.When
we adjusted for the individual hospital using Mantel_
Haenszeladjustmentsand logistic-regressionmodels, our
results were unchanged. Further, adjustments for selec_
tion bias using the propensity score again revealed that
our results were very stable. It appeared that the increased risk of death associatedwith lack of direction
Anesthesiology, V 93, No l, Jul 20OO
was not caused by selection bias at the hospital. Thus,
these data support the concept that there is a benefit
associatedwith medical direction by an anesthesiologist
that is independent of the hospital effect and not a result
of selection bias.
Our results were consistent with other large studies of
anesthesiaoutcomes.2s't6Some studies suggest that the
best outcomes may occur when anesthesia is provided
by an anesthesiacare team directed by an anesthesiolc
gst.27 We also found that the single most impoftant
hospital variable associatedwith lower death and failure_
tGrescue rates was a higher registered-nurse_tobed ra_
tio,7 and the importance of nurse staffing has been noted
in several other studies.T'24-Jo
Our results also point to a cornmon misconception
when assessinganesthesiasafety. Since the early (1954)
study of Beecher and Todd3l reported an anesthesiarelated mortality rate of I death/1,56o patients, anesthe_
sia-relatedmonality has been the gold standard of gaug_
ing anesthesia safety. By t9gZ, the anesthesia-related
mortality had decreasedto I death/6,799 patients in the
United Kingdom,l2 and, by 1989, the anesthesiamortality rate had decreased to I deatV1g5,056 patients33;
whereas Eichhom,la in 1989, reported anesthesia-related mortality of I death/151,4O0patients among more
than 750,000 healthy (American Society of Anesthesiologists physical status I or II)15 patients in the United
States. These studies supported the concept that the
incidence of death directly related to anesthetic events
had decreased, but the concept of anesthesia-related
mortality was narrowly defined. Modern perioperative
intensive care (including that provided by anesthesiolo
gists) often prevents immediate postoperative mortality,
yet prolonged morbidity and delayed mortality may re_
sult even when the precipitating event occlllred preop
eratively or intraoperatively. Further, there is increasing
evidence that anesthetic practice influences subsequent
patient outcomes in ways that were not r€cognized previously. Even relatively simple measures, such as main_
taining normothefinia or supplying supplemental oxy_
gen in the perioperative period, can decrease the
incidence of subsequent morbid events, including perioperative cardiac morbidity (ischemia, infarction, car_
diac arrest),]6 and postoperative wound infection.37,38
Our study underscores the importance of anesthetic
practice in overall surgical outcome, potentially influenc_
ing mortaliry at the rate of 2.5 deaths/l,OO0patients or I
death/4oo patients, more than 300 times greater than
reported by Eichhorn3{ and others,lr.sl who used a far
!
r62
SILBERET AL.
more narrow definition of "anesthesiarelated" that did
not consider these wider associations.
This was a retrospective analysisbased on administrative claims data and is limited by the associatederrors
inherent in using such data. The accuracy of our definitions for anesthesiologist direction (or no direction) is
only as reliable as the bills (or lack of bills) submitted by
caregivers. Ve also cannot rule out the possibility that
unobserved factors leading to undirected cases were
associatedwith poor hospital suppoft for the undirected
zrnesthetistand patient. Local, temporal, even psycho
logic factors may play a part in patient outcome, and
such factors may not be noted in the available data set.
For example, if anesthesiologistshad a tendency not to
submit bills for patients who died within 3O days of
admission, our results could be skewed in favor of directed cases.Although our clinical experience suggests
that this scenario is quite unlikely, we cannot rule out
this possibility. We also cannot rule out the possibility
that undirected cases occur more often in emergency
situations that developed outside of the emergency department. For example, it may be that patients who
required multiple anesthesiaprocedures were more ill
and were cared for by an undirected anesthetistbecause
of an emergency reoperation that did not allow time for
the anesthesiologistto participate in care. Although we
could find no evidence ofthis, becauseour study results
were unchanged when a variable denoting multiple anesthesia procedures was added to the model, more extensive study involving individual chaft review may be
helpful for exploring these questions.
Future work will also be needed to determine whether
the moftality differences in this report were caused by
differences in the quality of direction among providers,
the presence or absence of direction itself, or a combination of these effects. To addressthese limitations, we
hope to pursue in-depth, large-scalemedical chaft review of surgical casesin the next phase of this research.
We anticipate that review of medical charts will provide
more detailed information that will assistin determining
the etiology of differences in outcomes among provider
type.
In summary, review of Medicare claims data in Pennsylvania suggeststhat medical direction by an anesthesiologist was associatedwith lower moftality and failure,
tGrescue rates. In light of the large numbers of Medicare
patients undergoing operations each day, future research must carefully identify the etiologic factors assc
ciated with these findings to define optimal provider
models and improve outcomes.
Anesthesiology, V 93, No I, Jul 2000
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