Preoperative Patient & Surgeon Mutual Protection Agreement

Enhancing Patient & Occupational Safety and Reducing Professional Liability:

According to the CDC, sharps injuries and exposure to blood and blood-borne pathogens during surgery are alarmingly frequent events, occurring approximately 1000 times per day in the United States.1 Because these adverse events are mostly preventable by the use of safety engineered surgical devices and safe surgical techniques, they should be viewed as never events which pose a serious occupational health risk for surgical care providers and for patients who may become infected. In fact, multiple instances of transmission of HIV, hepatitis C, hepatitis B and other infections have been documented following exposure of surgical care providers and patients to each others blood.2,3,4,5

Recognizing the need for the mutual protection of surgical care providers and patients, the American College of Surgeons has recommended that blunt tipped suture needles be used as the method of choice for closing fascia and muscle (incision closure).6 Every other surgical organization has endorsed this recommendation.7 This best safe practice, among others, is also mandated by federal regulations, including the Needlestick Safety and Prevention Act of 20008, OSHA, NIOSH, the CDC and the FDA. Prudent recommendations by surgical organizations include wearing two pair of gloves (double gloving) to prevent blood exposures, using a “Neutral Zone”, also known as “Safe Zone” or “Hands-free Passing”, for safer transfer of sharps between OR team members, instead of hand-to-hand passing, and using safety scalpels (scalpels with shielded or retracting blades) wherever possible (except where they may interfere with visibility of the operative site or otherwise compromise surgeon performance and patient care) and that all members of the surgical team wear appropriate personal protective equipment (eye and face protection, etc.).

In spite of these wide-ranging regulations and recommendations, compliance with these proven effective safe practices by surgical team members – especially surgeons – is sporadic at best.9 At a time when preventable medical harm to patients appears to be out of control and widely reported by the media, it seems appropriate that patients and patient safety advocates take steps to encourage surgeons to simultaneously protect their patients as well as themselves and their surgical team members. To that end, a novel variation of the standard surgical consent form has been developed by a coalition of surgeons, worker safety advocates and patient safety advocates The resulting “Preoperative Patient and Surgeon Mutual Protection Agreement” is designed to insure surgeons’ compliance with safe practices that protect everyone in the OR. Both the patient and the surgeon would receive a copy of the form signed by the surgeon.

Along with the protection afforded against exposure to bloodborne pathogens, additional stipulations of this safety, quality and compliance tool would have surgeons agree to: personally perform the proposed surgery (or specify who will perform which parts of the procedure), be board certified and credentialed to perform the procedure, be physically present during the surgical “time out” and personally mark the operative site(s), and attest to preoperatively explaining and discussing with the patient all alternatives to surgery, including the “wait and see” approach. Additionally, if a medical device is to be implanted, the surgeon would agree to supply the patient with the name, brand, serial number and manufacturer of the device, and if a non-hospital employee such as a device or pharmaceutical manufacturer representative is to be present during the procedure, the patient will be made aware, written permission will be obtained, and the names of the non-hospital employee and his/her employer will be provided.

Finally, if during the procedure there is an injury to the surgeon or anyone assisting the surgeon (collectively called “Care Providers”) involving a sharp instrument (a “sharps injury”) and the injured Care Provider’s hand re-contacts the patients tissues, both the patient and the injured Care Provider (surgeon or other assistant) would be tested for the blood borne pathogens HIV, hepatitis C and hepatitis B, and other pathogens where appropriate. Test results would be given to the patient and the injured care provider and would otherwise remain privileged and confidential; no one would share test results with anyone by any means of communication without the express written consent of the patient or care providers who were tested.

A prototype for the “Preoperative Patient and Surgeon Mutual Protection Agreement” referenced above is available for anyone’s inspection. Facilities could modify it to suit their particular needs. Widespread implementation of this tool would protect patients and care providers alike from preventable exposure to blood and bloodborne pathogens, reduce incorrect surgery and other medical errors, and limit professional liability through improved compliance with best safe practices

As Hippocrates suggested, the goal is to protect patients from preventable harm. This new tool does that while protecting surgical care providers from occupational risk and potential liability. This is clearly a win-win for patients, surgeons and facilities. Facility risk managers may reflexively take an opposing view but if they really think about it, the logical conclusion should be that it should be implemented expeditiously at every surgical facility. For more information on this “Preoperative Patient and Surgeon Mutual Protection Agreement” and to download a copy, go to www.healthwatchusa.org/surgeonsconsent/

Mark S. Davis, MD

Gynecologic Surgeon and Obstetrician
Author:  “Advanced Precautions for Today’s OR; The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures, 2015 Digital Edition” and
“Irresponsible: What Surgeons Won’t Tell You and How to Protect Yourself, 2015 Digital Edition”


References

1. CDC Estimate of Annual Sharps Injuries http://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html

2. Transmission of HIV Infection During Invasive Dental Procedures in Florida https://www.cdc.gov/mmwr/preview/mmwrhtml/00014428.htm

3. Probable transmission of HIV from an orthopedic surgeon to a patient in France. http://www.ncbi.nlm.nih.gov/pubmed/9890844

4. Transmission of HIV-1 from an obstetrician to a patient during a caesarean section. http://www.ncbi.nlm.nih.gov/pubmed/16511424

5. Transmission of hepatitis C virus by a cardiac surgeon. http://www.ncbi.nlm.nih.gov/pubmed/8569822

6. Statement on Sharps Safety – American College of Surgeons. https://www.facs.org/about-acs/statements/58-sharps-safety

7. Council on Surgical & Perioperative Safety
http://www.cspsteam.org/sharpssafety/sharpssafety.html

8. Needlestick Safety and Prevention Act https://www.osha.gov/needlesticks/needlefaq.html

9. Increase in sharps injuries in surgical settings versus nonsurgical settings after passage of national needlestick legislation.  http://www.ncbi.nlm.nih.gov/pubmed/20347743

 

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