QA Program Reveals Safety Issues, Promotes Development of Guidelines

Casey D. Blitt, M.D.; Carol Kaufer-Bratt, R.N.; Joanne Ashby, R.N.; Julien R. Caillet, M.D.

Arizona Practice is Model

In the fall of 1987, we embarked upon a comprehensive program of Risk Management, Peer Review, Quality Assurance and Education. The primary goals of this program were to (1) ascertain degree of patient satisfaction, (2) optimize risk exposure, and (3) institute comprehensive educational programs. AU of these goals have the potential to positively affect quality of patient care. Secondary goals include, (1) improved record keeping/documentation, (2) modification of practice characteristics, (3) modification of risk of transfer costs, (4) opportunity for meaningful peer review, and (5) facilitation of claims identification and management.

The practice of medicine involved consists of the private practice of the specialty of anesthesiology and encompasses all areas of that specialty practice with the exception of pediatric open heart and transplant surgery. The anesthesia practice is a 26 person anesthesia group, all salaried employees of a single corporation (Old Pueblo Anesthesia, LTD.) practicing anesthesia with a one physician to one patient ratio on a fee for service basis at multiple heath care facilities. AU practitioners are physicians who have completed an approved residency training program in anesthesiology, are licensed to practice medicine in the state of Arizona and (with two exceptions) are either certified by the American Board of Anesthesiology or are in the examination process.

This report describes the implementation of this program and our experience during the first 70 months (September 1987 June 1993) of this risk management program.

Methods

Prior to implementation of the program, a physician was designated as the Risk Management Director and a Risk Management Nurse was hired. These two individuals were accorded salaried positions by the corporation and were charged with identifying problems or potential problems, evaluating the nature of the problems, selecting solutions to the problems, implementing the solutions and following up on implementation to evaluate efficacy. A comprehensive reporting system for identifying problems or complications related to the practice of anesthesia as well as determining degree of patient satisfaction was established. This reporting system was categorized and established in advance of implementation of the Risk Management Program (see Table 1).

The Risk Management Nurse and Risk Management Director are responsible for all aspects of the program. All of the practitioners and many other health care professionals are involved. AU patients cared for in the anesthesia practice are contacted either in person, by telephone or by mail to ascertain patient satisfaction and to identify problems or complications that may have been related to their anesthetic care. Additionally, all practitioners are encouraged to report their knowledge of complications, unusual occurrences, etc., whether they are related to their own patients or to an associate’s patients. Health care personnel, not in the practice of anesthesiology, are encouraged to report any problems or unusual occurrences. This includes nurses, other physicians, hospital risk management personnel, etc. All problems, complications, unusual occurrences, are documented, evaluated and entered into a computerized data base. When deemed necessary, patients are contacted by the Risk Management Director, Risk Management Nurse or by the anesthesia practitioner who rendered care to obtain more information and help promote patient satisfaction.

Results

The total number of anesthetic encounters during this 70 month period was 81,765. Of these, 60,336 were general anesthetics and 21,429 were classified as regional anesthetics. There were 1,959 perioperative problems reported for an overall incidence of 2.4%. There were 420 problems reported secondary to regional anesthetics for an overall incidence of 2.0%. Complication rates based upon classifications in Table I are described in Table 11. Incidences of specific problems of interest were 94 cases of peripheral nerve injury (0.11%), 25 cases of awareness under general anesthesia (0.04%), and 29 cases of dental injury during general anesthesia (0.05%).

Although there was some initial resistance (primarily by other physicians), the program was very well accepted by patients, health care facility personnel, and the anesthesia practitioners. At various times in the evolution of this program, practice recommendations were made. All recommendations were approved and instituted by the practitioners. Some of these recommendations required assistance and interaction of health care facilities and health care personnel for implementation. During the course of this Risk Management Program, the following recommendations/guidelines have been implemented:

New Guidelines

(1) Minimal anesthesia record documentation guidelines/standards.

(2) Avoidance of subarachnoid opioids.

(3) Administration of supplemental oxygen to all patients receiving subarachnoid/epidural anesthesia.

(4) Administration of supplemental oxygen to all patients having received general anesthesia during transport from the operating room to the post anesthetic care unit.

(5) The use of pulse oximeter on all patients in the post anesthetic care unit.

(6) Monitoring of all patients receiving general anesthesia to include end tidal carbon dioxide, pulse oximetry and temperature when indicated.

(7) Prompt consultation and treatment of all dental injuries.

(8) Prompt appropriate consultation for any medical specialty problem.

(9) Standardization of epidural opioid infusions. (10) Chest radiographs after all central vascular access procedures.

(11) Familiarization with a difficult airway management algorithm.

(12) Availability of transtracheal jet ventilization apparatus at all anesthetizing locations.

(13) Prompt recognition of fee problems with adjustment of professional fees when indicated.

(14) Prompt communication with other medical colleagues when a problem or complication is discovered.

(15) Electronic monitoring of obstetrical patients.

(16) Use of a peripheral nerve simulator on all patients who receive multiple doses of non-depolarizing neuromuscular blockers.

(17) Obtaining informed consent (operative permit) for central vascular access procedures.

(18) All vascular access procedures are performed in the preoperative holding area, except in patients who are hospitalized in critical care areas of the hospital.

(19) Documentation of indications for transfusion whether it be autologous or homologous.

(20) Patients sedated to facilitate any procedure must be appropriately monitored regardless of where in the hospital the procedure takes place.

(21) Patients with a greater than normal risk for perioperative neurological problems related to surgery or anesthesia should have the risks explained to them and documented in the medical record.

(22) Patients undergoing procedures associated with anesthesia where the possibility of awareness is greater than usual should be informed of the possibility of perioperative awareness and this should be documented in the medical record.

(23) Patients must be informed if any individual in any educational program will be observing or participating in the care of that patient.

(24) Adequacy of reversal of neuromuscular blockade should be documented in the medical record.

(25) A postoperative epidural pain control information card must be used on all patients who are receiving epidural opioids for postoperative pain management.

(26) This card must be readily available to the anesthesiologist responsible for the acute pain management service.

(27) All patients are assessed for adequacy of ulnar nerve function (motor and sensory) at time of discharge from PACU.

Continued on Next Page

________________________________

Table 1: Categorization of Perioperative Anesthesia Related Problems

I DEATHS (within 48 hours of anesthetic)

II NERVOUS SYSTEM INJURY

A. Coma or persistent vegetative state

B. Peripheral nerve injury

C. CVA (Intraoperatively or within 72 hours postoperatively)

D. Awareness

E. Miscellaneous

III. REGIONAL ANESTHESIA PROBLEMS

A. Post spinal or epidural headache

B. Nerve injury (see JIB)

C. Pneumothorax

D. Miscellaneous

IV. CARDIOVASCULAR PROBLEM

A. Perioperative MI (within 72 hours of anesthetic)

B. CHF

C. Significant new arrhythmia

D. Cardiac arrest (intraoperatively or in PACU)

E. Significant blood pressure variation F. Volume problems

G. Vascular access related problems (venous or arterial)

V. RESPIRATORY PROBLEMS

A. Difficult airway management

B. Respiratory arrest (intraoperative, PACU, patient care unit)

C. Aspiration, pulmonary edema, respiratory distress syndrome

D. Reintubation required

E. Inadequate reversal of neuromuscular blockade

F. Miscellaneous

VI. MISCELLANEOUS PROBLEMS

A. Dental injury

B. Equipment malfunction/incorrect usage

C. Eye injury

D. Adverse medication reaction

E. Patient dissatisfaction

F. Potentially compensable event (medical/ legal action)

________________________________________________________________

Table II: Frequency of Perioperative Anesthesia Related Problems

ABSOLUTE # RATE

Deaths 151 0.18%

Nervous System Injury 111 0.13%

Cardiovascular Problems 384 0.47%

Respiratory Problems 366 0.45%

Miscellaneous Problems 527 0.64%

_________________________________________________________________

The most rewarding part of the program has been the educational aspect. Practitioners are required to attend a minimum of nine hours per year of risk management-related educational meetings. During these meetings, various practitioners present their problems or complications. During these educational sessions (known to residents as morbidity/mortality sessions) all practitioners participate and meaningful information is exchanged, ideas are shared and recommendations for avoidance of future problems are made. This ” of educational process encourages the practitioner to research the problem and also provides a forum for input from associates in a nonthreatening manner. All cases to be presented are independently reviewed by the Risk Management Director to insure that presented information is factual and accurate. The educational sessions have been readily accepted by the practitioners, and the professional interaction has been very positive and satisfying. A current project in progress involves establishing a post partum unit with greater acuity of care capability so as to better care for complicated parturients in the post delivery period.

No Surprises in Lawsuits

During the period that this program has been in place, there have been six closed claims. None of the claims ‘surprised us” since we had previously been aware of the undesirable outcomes. These closed claims are as follows:

Peripheral Neuropathy

(1) Ulnar neuropathy in an elderly male undergoing transurethral resection of the prostate and inguinal hernia repair. The patient received a subarachnoid anesthetic. The anesthesiologist involved was dismissed early in the discovery process after the plaintiff s deposition.

Compartment Syndrome

(2) An elderly gentleman (65+ years) with preexisting cardiovascular disease sustained bilateral lower extremity compartment syndrome after a prolonged cancer operation for bladder and prostatic cancer performed in the lithotomy position. Failure to properly monitor and failure to properly position the patient were the allegations against the anesthesiologist. Subsequent to developing the compartment syndrome, the patient had a stormy hospital course and died approximately six months after the initial operation, The case was settled on behalf of two urologists, the anesthesiologist, a general surgeon, and the hospital.

Pneumothorax

(3) A middle-aged gentleman (40+ years) with renal failure and significant pulmonary disease sustained a tension pneurnothorax during insertion of a hemodialysis catheter via the subclavian route. Allegations against the anesthesiologist were failure to diagnose and treat the complication in a timely fashion. The patient expired within a week after developing the tension pneumothorax which resulted in cardiovascular collapse. The case was settled on behalf of the anesthesiologist.

Hemothorax

(4) A trauma patient (60+ years) undergoing open reduction and internal fixation of an acetabular fracture in the lateral position sustained a hemothorax, alleged to be secondary to improper performance of central vascular access technique. Allegations against the anesthesiologist included failure to detect the hemothorax in a timely fashion. The patient died in the immediate perioperative period. The case was settled on behalf of the anesethesiologist.

A Burn and a Fall

(5) An elderly patient (80+ years) sustained a burn in the axially area secondary to utilization of a warm fluid bag as an axillary roll. The patient was an insulin dependent diabetic and this no doubt contributed to the severity of the bum. This case was settled on the behalf of the hospital and anesthesiologist.

(6) A patient fell from an operating table during an orthopedic procedure to repair a hip fracture. The case was settled on behalf of the anesthesiologist, the hospital and the orthopedic surgeon.

During the course of this program, risk transfer costs have decreased from approximately $52,000 per individual to $17,000 per individual for comparable coverage.

Discussion

While we cannot conclusively prove that quality of care has been improved, we feel that risk exposure has definitely been minimized as a result of this program. We have encountered no instances of unrecognized airway management disasters (esophageal intubation, etc.) as a result of this monitoring policy. Incidentally there have been at least two airway management disasters in our community during the period of this report. The combination of educational activities and peer review has allowed practitioners to change their practice characteristics in a non-threatening manner. Peer pressure and opinions of associates are apparently strong motivating factors.

We are unaware of the existence of similar programs that are operative outside of educational/ residency facilities in the United States. The establishment and continuation of risk management, quality assurance, peer review, and educational activities in the private practice of the medical specialty of anesthesiology may have the potential to improve quality of care as well as to decrease practice costs. We have been able to identify a number of areas not included in our initial categorization list that are apparently of concern to patients. These include sore backs and sore throats secondary to regional anesthesia and endotracheal intubation, respectively. This is dearly an area of concern to the patients. Another area of concern to a large number of patients is perioperative nausea and vomiting. To this end, we have established a nausea and vomiting reduction protocol for patients receiving general anesthesia.

Areas of perceived future importance in risk management and anesthesiology include issues related to patient positioning and transfer, monitoring of patients outside of the operating room environment, undesirable outcomes of central vascular access and poor patient/ physician interaction with unreasonable expectations of outcome.

Dr. Blithe, Dr. Caillet, Ms. Kaufer-Bratt and Ms. Ashby are associated with Old Pueblo Anesthesia, Tucson, AZ.