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Study Design. A review of issues linking advocacy, patient safety, and quality.

Objective. To heighten awareness of patient safety issues that require ongoing advocacy efforts by physicians treating spinal disorders.
Summary of Background Data. The 1999 Institute of Medicine report “To Err is Human. Building a Safer Health System” was a landmark publication that vaulted patient safety into the limelight of public awareness and media attention. The American Academy of Orthopedic Surgeons had addressed the wrong site surgery issue with its Sign Your Site Program even before the Institute of Medicine report. Several professional medical societies involved in spine care have made advocating for patient safety a priority.

Methods. A summary of areas of advocacy efforts involving patient safety and quality. These include the Sign Your Site Program from the American Academy of Orthopedic Surgeons, Sign, Mark and X-ray from the North American Spine Society, Joint Commission on the Accreditation of Healthcare Organizations Universal Protocol, and technology assessment. Advocacy on the Federal, state, and local levels concerning patient safety isreviewed.

Results. Awareness of patient safety issues has increased.
Several patient safety protocols (Sign Your Site,
Sign, Mark and X-ray, and the Universal Protocol) are inplace. There is increased monitoring of medical errors on the state and local, especially hospital, levels.

Conclusions. Patient safety is an absolute provision of health care. Physicians need to set a personal example for compliance with existing patient safety systems such as the Universal Protocol and be active advocates for patient safety.

Key words: patient safety, wrong site surgery, medical errors, technology assessment, advocacy. Spine 2007;32: S2–S8

This special supplement of Spine focuses on advocacy as it relates to various areas of spine care. Since publication of the Institute of Medicine1 report on medical errors “To Err is Human. Building a Safer Health System” in 1999, it has been recognized that efforts to address patient safety issues must encompass more than the clinical realm. One of the important nonclinical areas that plays a pivotal role in synthesizing effective patient safety interventions is the matter of advocacy.

This special supplement of Spine focuses on advocacy as it relates to various areas of spine care. Since publication of the Institute of Medicine1 report on medical errors “To Err is Human. Building a Safer Health System” in 1999, it has been recognized that efforts to address patient safety issues must encompass more than the clinical realm. One of the important nonclinical areas that plays a pivotal role in synthesizing effective patient safety interventions is the matter of advocacy.

In this paper, we will outline the interrelation of patient safety and advocacy that encompasses several tiers. This includes traditional advocacy on the congressional
and legislative side to regulatory and insurance issues. A reference table of abbreviations, acronyms, and terms for this topic area has been included (Table 1). We as physicians must be advocates for our patients. Many professional medical associations involved in spine care have made advocating for patient safety a priority. Safety is clearly in the patient’s best interest and a key component of quality spine care.

  • Issues From The Institute of Medicine Report “To Err Is Human. Building a Safer Health System”

“To Err is Human. Building a Safer Health System”1 must be considered a landmark publication. The level of awareness of patient safety issues in the minds of the
public/patients, the media, regulators, and elected officials and physicians was immediately heightened by headlines in the press suggesting that between 44,000 and 98,000 patients die in the United States every year as a result of medical errors. The 1999 Institute of Medicine
report1 was based on 2 papers. Both of these were reviews of hospital data. One report came from New York2 (part of the Harvard Medical Practice Study), and the other from Utah and Colorado.3 There were no spine specific data points collected. Some of the broad topics of
concern that may relate in a more general fashion to the spine were medication errors, infection, and technical problems of surgery. Nevertheless, the Institute of Medicine report served to focus attention on medical errors and their prevention. Other quality improvement databases such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Sentinel Events Program provided more spine-specific information that has been the impetus for advocacy efforts by physicians, professional medical associations, and the public concerning spine issues. The potentially preventable medical error that seemed to most directly involve the spine and serve as a focus for quality improvement efforts was wrong site surgery.

“To Err is Human. Building a Safer Health System”1 has spawned a number of Federal, state, and local patient safety initiatives that we will outline. Federal patient safety legislation has passed both houses of Congress, but the regulations governing the program have not yet
been written. The “Regs” will be critical to the determination of whether the Federal program is worthwhile. State and local patient safety programs predominantly involve stricter reporting of adverse events. The involvement of physicians and professional medical organiza-

Table 1. Outline of Abbreviations, Acronyms, and Terms
Abbreviation/Acronym Organization/Term (Web Site)
AAOS American Academy of Orthopaedic Surgeons (http://www.aaos.org)
ACS American College of Surgeons (http://acs.org)
AHRQ Agency for Healthcare Research and Quality (http://www.ahrq.gov/)
GDP Gross Domestic Product (http://en.wikipedia.org/wiki/Gross_domestic_product)
IOM Institute of Medicine (http://www.iom.edu/)
JCAHO Joint Commission on the Accreditation of Healthcare Organizations (http://www.jointcommission.org/)
MEPS Medicare Expenditure Panel Survey (http://www.meps.ahrq.gov/mepsweb/)
NASS North American Spine Society (http://www.spine.org)
NPSF National Patient Safety Foundation (http://www.npsf.org/)
NQF National Quality Forum (http://www.qualityforum.org/)
P4P Pay for Performance (http://www.spine.org/nass_payforperformance.cfm)
PL109-41 Patient Safety Legislation US Congress Official Bill No. (http://www.whitehouse.gov/news/releases/2005/07/20050729.html)
PSO Patient Safety Organization a provision of PL109-41
SMaX Sign Mark and X-ray (NASS Program) (http://www.spine.org/smax.cfm)
SYS Sign Your Site AAOS Program (http://www.aaos.org/about/papers/advistmt/1015.asp)
UP Universal Protocol JCAHO Program (http://www.jointcommission.org/PatientSafety/UniversalProtocol/)
WSS Wrong Site Surgery (http://www5.aaos.org/wrong/viewscrp.cfm#Start0)

tions in advocating appropriate and effective criteria for these proposals is vital. Several professional medical societies involved in spine care have been leaders in the development of patient safety and quality initiatives. There are a number of examples of key programs for
physician involvement and advocacy.

  • Advocacy Initiatives to Address Patient Safety and Quality Issues in Spine Care

Wrong site surgery of the spine has been more specifically analyzed by the American Academy of Orthopedic Surgeons (AAOS) as part of its background work for the original “Sign Your Site” patient safety initiative. A closed claims review found 11 cases of wrong level spine
surgery.4 In all instances, the incidents were related to a 1-level decompressive procedure. The clear trend was to err in operating at the level above the true pathologic segment (10 of the 11 cases).

The first AAOS Sign Your Site Program has been modified in recent years to include provisions for verification of the appropriate side and level in spinal surgery.5 A checklist is provided as a systems memory aid and documentation instrument. The Sign Your Site Program has always been a voluntary initiative among members of the AAOS. Utilization of the Sign Your Site Program among AAOS fellows has been somewhat mixed over the years. The Wrong Site Surgery Task Force estimated that about 1 in 4 orthopedic surgeons would be involved in a wrong site surgery in their practice lifetimes.5 This seemed to strike most members as a relatively low risk. Thus, advocacy efforts by the AAOS leadership to incorporate the Sign Your Site Program into daily practice have proven an uphill battle. Nevertheless,
the Academy has been recognized as a leader in proactively addressing quality and patient safety issues such as wrong site surgery. These efforts have influenced a number of initiatives in professional medical societies and regulatory agencies.

The North American Spine Society (NASS) refined theoriginal Sign Your Site advisory into a more detailed and comprehensive program dealing with the identification of the appropriate
 level and side of the spine for surgical intervention. This plan was christened the “Sign, Mark
and X-ray” program.6 The 3 essential components of the Sign, Mark and X-ray program are:

  1. Sign the surgical site before surgery (similar to the original AAOS Sign Your Site Program). In the marking process, it is helpful to note the level(s) of the surgery and sign the surgeon’s initials on the side of the approach if surgery is to be 1 sided (Figure 1).
  2. Mark the level in the operating room with a radiopaque indicator on a bony landmark, such as a towel clip on a spinous process.
  3. Radiograph the spine as a routine part of the procedure with the marker in place to confirm the level of pathology.
The program includes a more comprehensive checklist for the various steps that also addresses issues such as patient identification, verification of the surgical proce-

Figure 1. Example of lumbar spine site marking visible at draping. Head is to the top and buttocks to the bottom of the field. Initial indication of side and level are noted by marking the pathologic level(s), in this case L5–S1, to the left side of the spine as the patient had a left–sided herniated disc, and dissection was
planned from the left-sided approach only.

dure to be performed, and the presence of appropriate medical records, imaging studies, and equipment.
In terms of regulatory agencies advocating for patient safety and quality issues, the JCAHO has been a prime mover. The JCAHO “Sentinel Event” system began monitoring major quality issues in the late 1980s, about the same time as the original AAOS Sign Your Site Program was launched. A Sentinel Event is defined as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.”7 In addition to the statistical reporting aspect of the program, a quality review is triggered that requires a “root cause analysis” to try to determine factors contributing to the occurrence of a Sentinel Event. This analysis offers the opportunity to advocate preventive measures and solutions, and is a key provision beyond basic statistical reporting in the effort to improve quality of care.

The JCAHO also advocates a yearly set of “National Patient Safety Goals.”8 These goals are more general in nature and involve many areas of medical care. However,
some goals have indirect implications for the treatment of patients with spine pathology (patient identification, medication safety, reduce surgical fires). The JCAHO patient safety program that has the most direct implications for spine care is the “Universal Protocol” for the prevention of wrong person, wrong site, and wrong procedure surgery.9

  • JCAHO Universal Protocol

The Universal Protocol was a logical extension of the Sentinel Events quality improvement program. Wrong site surgery is considered a Sentinel Event. Because of the mandatory reporting of Sentinel Events, some of the best data on the incidence and anatomic location of wrong site surgeries come from the JCAHO. Interestingly, analysis of the Sentinel Events data revealed additional issues beyond wrong site incidents involving right versus left or spinal level. Before implementation of the Universal Protocol, the JCAHO analyzed 278 reports of wrong site surgery in the Sentinel Events database up to 2003.10 This review showed that in 10% of cases, the wrong procedure had been performed. In another 12%, surgery had been performed on the wrong patient. A further 19% of the reports characterized miscellaneous wrong sites such as the wrong digit on the correct hand or the wrong joint on the correct finger. Thus, it was felt that a protocol to address the issues must include provisions to avoid wrong patient, wrong procedure, as well as wrong site surgery.

In May of 2003, the JCAHO convened a “Wrong Site Surgery Summit” to look into possible quality initiatives in this area. The AAOS and the American College of Surgeons, two professional medical organizations that had already been strong advocates for quality interventions, cosponsored the meeting. Representatives of over 40 societies discussed the issues, reviewed data, and divided into work groups to consider solutions to some of the specific issues, such as site marking. The senior author(D.A.W.) represented the AAOS and NASS at the Wrong Site Surgery Summit. The products from the Summit work groups contributed to the initial formulation of the Universal Protocol.

The JCAHO also had field test results from institutions with various protocols to prevent wrong site surgery. The 3 most effective were designated as “Key Processes”
for: (1) patient identification; (2) surgical site marking; and (3) calling a “time out” before skin incision to verify factors such as the initial patient identification, patient allergies, completion of preoperative interventions such as intravenous antibiotics, the procedure to be performed, available medical records, imaging studies, equipment, etc. When correlated to Sentinel Event data, it was found that only 12% of wrong site surgeries occurred in institutions with 2 of 3 protocols in place. More importantly, no incidents of wrong site surgery had come from hospitals using all 3 key processes.11 The 3 “Key
Processes” thus became the core elements of the Universal Protocol (patient identification, surgical site marking, and “time out”). The JCAHO Universal Protocol became a mandatory quality screen in all JCAHO accredited hospitals July 1, 2004.

  • JCAHO Sentinel Event Statistics and the Spine
Figures are available from the JCAHO Sentinel Event database with specific reference to wrong site surgeries involving the spine. Analysis of the data up to 200310 showed wrong site surgery to be the third most frequent Sentinel Event, representing 278 of 2299 (12%) total incidents, following inpatient suicide 357 cases and operative/ postoperative complications 292 cases (Table 2). Of the 278 wrong surgeries, 8% involved the spine. The first full year’s statistics following implementation of the Universal Protocol on July 1, 2004, have recently been assembled (R. Croteau, unpublished data, 2006). In this time period, the proportion of wrong site surgeries involving the spine had dropped to 5% (Table 3), and rank fell from fourth to ninth.
  • Overall Wrong Site Surgery Statistics Before andAfter the Universal Protocol

 With the advocacy efforts of the AAOS, NASS, and JCAHO, as well as other professional medical and regulatory agencies, hope was high that the implementation
of the Universal Protocol July 1, 2004, would result in fewer cases of wrong site surgeries. The first 2 quarter statistics after implementation were encouraging.12 It
appeared that reports of wrong site surgeries had declined below the rate of approximately 70 cases per year for the previous 2 years. However, after a full year’s
statistics had been accumulated, it was found that the incidents of wrong site surgery had actually increased to about 88 for 2005 (R. Croteau, unpublished data, 2006).
Overall, wrong site surgery had climbed to the number 2 ranking in frequency of Sentinel Events (behind inpatient suicide) (Table 2). Whether these data represent a true increase in the frequency of wrong site surgery or are  

Table 2. Ranking JCAHO Sentinel Events Before and After the Universal Protocol by Frequency
Ranking Sentinel Events Before Universal
Protocol Analysis of 2299 Cases
January 1995–September 2003
% Ranking Sentinel Events After Universal
Protocol Analysis of 3548 Cases
January 1995–December 2005
%
1 Inpatient suicides 357 1 Inpatient suicides 464
2 Operative/postoperative
complications
292 2* Wrong site surgery 455
3* Wrong site surgery 278 3 Operative/postoperative
complications
444
4 Medication errors 264 4 Medication errors 358
5 Death related to delay in
treatment
145 5 Death related to delay in
treatment
269
6 Death patients in restraints 111 6 Patient falls 189
7 Patient falls 104 7 Death patients in restraints 138
8 Assault/rape/homicide 81 8 Assault/rape/homicid 121
9 Transfusion-related events 66 9 Perinatal death/injury 109
10 Perinatal death/injury 58 10 Transfusion-related events 94
Bold indicates the specific topic of interest (wrong site surgery).
* Wrong site surgery is the sentinel event with specific statistics referable to spine.

simply explained by better awareness and reporting is unclear at this time. The JCAHO is presently performing a subanalysis of the data for clarification.
This paradoxical result compared to the anticipated reduction in the incidence of wrong site surgery has caused some soul-searching at the AAOS, NASS, and
JCAHO. The three organizations are engaging in a dialogue to revamp and reinvigorate advocacy efforts to prevent wrong site, wrong procedure and wrong patient
surgery.

  • Advocacy Versus Apathy/Push Back for Patient Safety by the Individual Physician
Beyond the involvement of professional medical societies, effective advocacy on the individual physician level is required for systems solutions such as the Sign Your Site
Program, Sign, Mark and X-ray program, and Universal Protocol to be effective. On an individual, personal basis, physicians will generally respond that “of course” they
are patient safety advocates. Paradoxically, there has been considerable “push back” from physicians for implementation the Sign Your Site Program, Sign, Mark and X-ray program, and Universal Protocol. The AAOS, NASS, and JCAHO are contemplating different education and awareness strategies. For example, more emphasis on education and changing the culture of patient safety in the minds of residents and fellows has been
suggested. Established physicians, with a relatively low 1 in 4 surgeon (or approximately 1:36,600 career cases) risk of performing a wrong site surgery sometimes relate that they find the protocols intrusive and unnecessary. We should recognize, however, that 36,000 invasive procedures are about the average that is done at our 680-bed medical center. Thus, on an institutional basis, the risk for a case of wrong site surgery is about 1 per year, and, thus, definitely on the radarscope of chiefs of medical staff, hospital administrators, and patients. The issue of wrong site surgery has definitely not gone away in the years since the Institute of Medicine1 report. We as individual physicians can be better patient safety advocates.
  • Additional Thoughts on Why Medical Errors Such as Wrong Site Surgery Still Occur

A principle often heard at patient safety seminars is “Culture eats strategy for lunch.” This situation cer-

Table 3. Analysis of Anatomic Location of Wrong Site Surgeries Before and After the Universal Protocol
1 Knee 17 1 Knee 13
2 Foot/ankle 10 2 Mouth/pharynx/larynx 12
3 Hand/Wrist 9 3 Cranium 8
4* Spine 8 4 Hand/wrist 6
5 Cranium 6 5 Chest 6
6 Hip 6 6 Peripheral vascular 6
7 Hernia 5 7 Abdominal cavity 6
8 Chest 5 8 Eye 6
9 Male genitalia/prostate 5 9* Spine 5
10 Mouth/pharynx/larynx 5 10 Hernia 5
Percent cases by anatomic site.
Bold indicates the specific topic of interest (wrong site surgery).
* Wrong site surgery is the sentinel event with specific statistics referable to spine.


tainly applies to implementation of patient safety strategies. Ingrained and long-standing practice cultures of physicians, nurses, other health care providers, as well as clinics and hospitals, are sometimes difficult to change. The relatively low incidence of major medical error per medical provider also tends to generate a state of complaisance and apathy.

Another issue that tends to affect the persistent occurrence of medical errors is the status of medicine as a complex interactive system. Analysis of many medical errors suggests that systems factors are an ongoing concern, predisposing to the occurrence of medical errors.13
Examples of systems areas undergoing review are patient identification, medication identification and dosage confirmation, legible/understandable/accurate order entry, detection of drug interactions, and recognition of potential complications.

  • Advocacy for Patient Safety in the Federal Administration
Following introduction of the Institute of Medicine1 report “To Err is Human. Building a Safer Health System” in 1999, the Federal government convened an interagency task force to evaluate issues regarding medical errors in their agencies and to advocate strategies for improvement of patient safety. Dr. John Eisenberg, Director of the Agency for Healthcare Research and Quality (AHRQ), chaired the task force. There were 11 participating agencies and departments, including Health and Human Services, Veterans Affairs, and Labor. The report from this task force was sent to the president in 2000.14 The task force advocated creating a Center for Quality Improvement and Patient Safety within the AHRQ. A number of public/private cooperative initiatives were also suggested between the government and organizations, such as the National Quality Forum and National Patient Safety Foundation. The report also contained discussion of other strategies such as establishment of nationwide reporting systems, peer review protection for reporting of medical errors, safe use of drugs and devices, role of information technology, and building public awareness of medical errors. Many of these issues have been integrated into subsequent patient safety legislation.
  • Advocacy for Patient Safety in the Washington Legislative Arena

Important patient safety legislation has recently passed in both the U.S. House and Senate (PL109-41, signed into law July 29, 2005). The legislation provides for formation of “Patient Safety Organizations” (PSOs) to serve as recipients of patient safety reporting data. The 4
main provisions of the legislation are: (1) outline procedures for voluntary, confidential reporting of medical errors to PSOs; (2) specify PSOs as a government certified
entity; (3) provide legal protections/privilege for error reports; (4) authorize submission of nonidentifiable patient information to a national database to be established at the AHRQ for the purpose of analysis and identification of patient safety improvement solutions.

There have been significant advocacy efforts by the professional medical and spine societies regarding provisions of this legislation. The legislation itself was somewhat
vague as to whether all functions of a PSO would be considered protected peer review activity, and, thus, safeguard the organizations and participating physicians from lawsuits arising from legitimate quality improvement activities. Peer review protections are clearly a key element to having an effective patient safety reporting system.
The specific provisions governing the day-to-day application of any legislation passed into law are more specifically outlined in subsequently written “regulations” or “regs.” The regs for PL109-41 have not as yet been published. Ongoing advocacy efforts are in place to emphasize the importance of full peer review status for PSOs. Hopefully, these provisions will be included in the regulations and enhance efforts to develop a useful data reporting system while still protecting patient and physician confidentiality.
On another Federal level, the Center for Medicare and Medicaid Services has launched voluntary quality programs that include performance measures considered by some to be patient safety as well as quality issues. The measures having relevance to spine in the initial quality set are use of prophylactic antibiotics for surgery and appropriate use of prophylaxis for deep venous thrombosis. These measures may also have relevance to Federal Pay for Performance initiatives. Criteria for acceptable compliance with the quality measures have yet to be established.

  • Advocacy for Patient Safety and Quality on the State Level
State-based initiatives involve primarily reporting and education. Approximately 22 states have patient safety reporting systems. These are generally mandatory and are of limited scope, usually involving patient deaths, infections, or major life or limb-threatening adverse events. Even with mandatory reporting, there remains reluctance on the part of providers to report. Concerns generally center on the conflict between maintaining the confidentiality of the physician and patient versus sufficient disclosure of incident details to provide a basis for
the development of patient safety solutions. Fears persist concerning litigation, discoverability, and regression to the old “name, blame and shame” state of affairs.15 Most state reporting systems require reporting of hospital data only, and function as data repositories and public reporting agencies. The limited scope of these programs restricts their effectiveness in the patient safety and quality arena. However, it is still important to monitor these state organizations and advocate for appropriate handling of the data.
  • Advocacy, Patient Safety, and Tort Reform
The development of effective patient safety interventions is a data-dependent exercise. Thus, our present tort system is a major impediment to realization of a successful patient safety agenda. The basic incompatibility lies in the reluctance of physicians to report safety data under the potential hammer of our present professional liability structure. Other complex, interactive systems such as the airline industry have clearly demonstrated the utility of “no fault” reporting systems to generate the data required for identification of safety issues. Without effective problem identification, there can be no effective patient safety and quality interventions. Tort reform is thus an important element of our patient safety agenda and
worthy of additional advocacy efforts.
  • Advocacy, Patient Safety, and Technology Assessment

In the context of advocacy and patient safety, technology assessment must be viewed in broad terms. It encompasses evaluation of the safety of new technology as well as surveillance of existing technology for safety concerns. Consider new technologies such as total disc arthroplasty, where safety issues have been cited concerning anterior revision strategies and the potential for lifethreatening vascular complications.16,17 The use of bone morphogenic proteins has raised concerns about off label use in the cervical spine.18

Existing technology has ongoing patient safety challenges. In the last year, the NASS and AAOS have issued patient safety alerts concerning dangers of several existing technologies frequently used in spine surgery. Two such alerts have included bone allografts often used in
spine applications. Safety issues were raised concerning procurement and possible tissue contamination in 1 occurrence19 and with the processing of the tissue in a separate
instance.20 Another alert was issued relating to bacterial contamination of nearly 380,000 vials of Cephazolin, 21 the most commonly used antimicrobial for prophylactic intravenous antibiotic treatment before spinal surgery and a frequent addition to surgical irrigation used in spine procedures. Diligence and advocacy for patient safety must be maintained in the areas of both new and existing technology.

  • Discussion

Patient safety is an absolute provision of health care. Physicians have traditionally been the primary advocates of safety and quality. As far back as the Hippocratic era (460 –370 BC), “primum non nocere” (first do no harm)22 has been a key tenet of medical practice. Over
the millennia, major advances in medicine have required corresponding major advocacy efforts to define and prioritize the standing of those interventions, be they in regard to disease processes, diagnostic procedures, or various treatments alternatives. In our present health
care structure, advocacy and patient safety are clearly interactive components of a multifaceted delivery system.

Consider the standing and prioritization of spine care in our society. Luo et al23 analyzed expenditure data for low back pain for the year 1998, the most recent year for which U.S. Medicare Expenditure Panel Survey data were available. They found that the expenditures for
back pain in the United States totaled approximately $91 billion or about 1% of the U.S. gross domestic product. The total expenditure for health care was $1.2 trillion (13.6%) of gross domestic product.

With a recognized priority position in health care, strategies need to be developed (and advocated) to operationalize the integration of patient safety and advocacy for spine care. A systems approach has generally been proposed as a rational solution.24 Systems generally make it harder for good people to commit errors. Barriers to implementation of these systems have been recognized25,26 and strategies proposed to counter these obstructions. The late director of the AHRQ, Dr. John Eisenberg advocated an innovative strategy based on continuous medical education.27 Elimination of the traditional “name, blame and shame” approach to medical errors was a component of this strategy.

  • Summary
To err is indeed human. As physicians and advocates for our patients, each one of us needs to set a personal example for compliance with existing patient safety and quality systems such as the Universal Protocol. As recognized opinion leaders in the area of patient safety, spine practitioners can have a principal role in developing functioning and effective patient safety, quality, and advocacy systems for the future.
  • Key Points
    • Patient safety is an absolute provision of health care.
    • Physicians need to set a personal example for compliance with patient safety systems such as the Universal Protocol.
    • Physicians must be patient safety and quality care advocates.
    • Examples of patient safety systems are the JCAHO Universal Protocol for prevention of wrong person, wrong procedure, and wrong site surgery, Sign Your Site from the AAOS, and Sign Mark and X-ray from the NASS.

References

  1. Institute of Medicine. To Err is Human. Building a Safer Health System. Washington, DC: National Academies Press; 1999. Available at: http:// newton.nap.edu/catalog/9728.html. Accessed August 21, 2006.
  2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–6.
  3. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261–71.
  4. Canale ST, DeLee J, Edmonson A, et al. The American Academy of Orthopaedic Surgeons Report of the Task Force on Wrong-Site Surgery. 1998.
  5. American Academy of Orthopedic Surgeons. AAOS Advisory Statement: Wrong Site Surgery. Rosemont, IL: American Academy of Orthopedic Surgeons; October 2003. Available at: www.aaos.org/wordhtml/papers/ advistmt/1015.htm. Accessed August 21, 2006.
  6. Wong D, Mayer T, Watters W, et al. Prevention of Wrong Site Surgery: Sign. Mark and X-Ray (SMaX). La Grange, IL: North American Spine Society; 2001. Available at: http://www.spine.org/smax.cfm. Accessed August 21, 2006.
  7. Joint Commission on the Accreditation of Healthcare Organizations. Sentinel event program. Available at: http://www.jointcommission.org/ SentinelEvents/. Accessed August 21, 2006.
  8. Joint Commission on the Accreditation of Healthcare Organizations. National patient safety goals. Available at: http://www.jointcommission.org/ PatientSafety/NationalPatientSafetyGoals/. Accessed August 21, 2006.
  9. Joint Commission on the Accreditation of Healthcare Organizations. Universal protocol. Available at: http://www.jointcommission.org/ PatientSafety/UniversalProtocol/. Accessed August 21, 2006.
  10. Joint Commission on the Accreditation of Healthcare Organizations. Sentinel Event Alert. Oakbrook, IL: Joint Commission on the Accreditation of Healthcare Organizations; January 22, 2003.
  11. Joint Commission on the Accreditation of Healthcare Organizations. Universal Protocol Toolkit. Oakbrook, IL: Joint Commission on the Accreditation of Healthcare Organizations; 2004.
  12. Wong DA. The universal protocol: A one year update. AAOS Bulletin. American Academy of Orthopedic Surgeons. 2005;53:20.
  13. Wong DA. It’s more than human error–A systems approach to patient safety. Spine Line 2002;May/June:20–1.
  14. Quality Interagency Coordination Task Force (QuIC). Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Washington, DC: Agency for Healthcare Research and Quality; February 2000.
  15. Eisenberg JM. Continuing education meets the learning organization: The challenge of a systems approach to patient safety. J Contin Educ Health Prof 2000;20:197–207.
  16. Gamradt S, Wang J. Lumbar disc arthroplasty. Spine J 2005;5:95–103.
  17. van Ooij A, Oner F, Verbout A. Complications of artificial disc replacement: A report of 27 patients with the SB Charite disc. J Spinal Disord 2003;16:369–83.
  18. DiMarcantonio T. Larger doses. Placement of rhBMP-2 may cause anterior cervical spine complications. Orthopedics Today 2005;25:62.
  19. North American Spine Society. Spine Safety Notice. Public Health Notification on Human Tissue Recovered by BioMedical Tissue Services, Ltd. (BTS). Des Plains, IL: North American Spine Society; March 6, 2006.
  20. American Academy of Orthopaedic Surgeons. Patient Safety Member Alert. FDA Issues a Public Health Notification About Human Tissues Recovered by Donor Referral Services (DRS). Rosemont, IL: American Academy of Orthopaedic Surgeons; August 31, 2006.
  21. American Academy of Orthopaedic Surgeons. Patient Safety Member Alert: Hanford Pharmaceuticals Issues Nationwide Recall of Cefazolin for Injection. Rosemont, IL: American Academy of Orthopaedic Surgeons; March 2, 2006.
  22. Hippocrates. Epidemics. Book 1, section 5.
  23. . Luo X, Pietrobon R, Sun S, et al. Estimates and patterns of direct health care expenditures among individuals with back pain in the United States. Spine 2003;29:79–86.
  24. Wong DA. Spinal surgery and patient safety: A systems approach. J AmAcad Orthop Surg 2006;14:226–32.
  25. Longo D, Hewett J, Ge B, et al. The long road to patient safety: A status report on patient safety systems. JAMA 2005;294:2858–65.
  26. Wong D, Herndon J, Canale T. Medical errors in orthopaedics: Practical pointers for prevention: An AOA critical issue. J Bone Joint Surg Am 2002; 84:2097–100.
  27. Eisenberg J. Continuing education meets the learning organization: The challenge of a systems approach to patient safety. J Continin Educ Health Prof 20:197–207.