Observers present during ophthalmic procedures

Anne M. Menke, R.N., Ph.D.
OMIC Patient Safety Manager

PURPOSE OF RISK MANAGEMENT RECOMMENDATIONS 
OMIC regularly analyzes its claims experience to determine loss prevention measures that our insured ophthalmologists can take to reduce the likelihood of professional liability lawsuits. OMIC policyholders are not required to implement these risk management recommendations.  Rather, physicians should use their professional judgment in determining the applicability of a given recommendation to their particular patients and practice situation. These loss prevention documents may refer to clinical care guidelines such as the American Academy of Ophthalmology’s Preferred Practice Patterns, peer-reviewed articles, or to federal or state laws and regulations. However, our risk management recommendations do not constitute the standard of care nor do they provide legal advice. Consult an attorney if legal advice is desired or needed. Information contained here is not intended to be a modification of the terms and conditions of the OMIC professional and limited office premises liability insurance policy. Please refer to the OMIC policy for these terms and conditions.
Version 10/23/20

Ophthalmologists or ophthalmic surgery/laser centers at times require or desire the presence of observers during an ophthalmic procedure.  Such observers include sales representatives from medical device or medical equipment manufacturing companies, visiting colleagues, or family members. The surgeon and the facility have the right to refuse such requests. If they agree to allow the observer, certain steps must be taken in order to honor the patient’s right to privacy and the physician’s and facility’s duty to protect the confidentiality of medical information, and to ensure the safety of patients, staff, and visitors. This document will provide an overview of the issues associated with observers, and provide a sample consent form.

SAFEGUARDS TO ADDRESS IN YOUR POLICIES AND PROCEDURES
•	What observer may or may not do
•	How to ensure that observer does not engage in the unlicensed practice of medicine (e.g., sales representative from company that manufactured new medical device only answers questions or calibrates instrument but does not act as a surgical assistant)
•	How observers are credentialed/authorized by the facility
o	The facility must authorize the presence of all persons. Visitors are limited to certain hours and units, facility employees are authorized during their hiring process, and physicians are authorized during the credentialing and privileging process. The facility must also screen and approve all observers, whether present at the request of the patient, physician, or facility.
•	How observers confirm that they have no medical conditions that could interfere with care of the patient, such as lapse of consciousness (fainting, epilepsy, narcolepsy), weak stomach, convulsions, diabetes, or heart problems (see observer sample form)
•	Physician acknowledgement of observer’s presence if the request for the observer did not come from that physician (see observer sample form)
•	Whether or not facility wants observer (generally a sales representative) and his or her employer to agree in writing to indemnify the facility for any outcome related to the observer’s presence 
o	Contact legal counsel for the facility
•	Training and orientation of observers
o	Patients’ rights and confidentiality of medical information (see consent process below)
o	Appropriate conduct
o	Infection control and techniques
•	How to prevent contaminating the sterile field
•	Universal precautions
•	How observers will be identified
o	Identification must be worn at all times
•	How presence of observers should be documented in the medical record
o	Name, purpose, role
o	Include consent forms

CONSENT AND CONFIDENTIALITY ISSUES
•	To protect both the patient’s right to privacy and the confidentiality of medical information, the patient must be informed of the role, purpose, and name of the observer, and sign a consent form that indicates this information. The observer should agree to protect confidentiality by signing either a business associate agreement or confidentiality agreement, depending upon the role played during the procedure. 

•	Observer present at patient’s request
o	Have patient fill out top section of patient form.
o	Ask patient to sign HIPAA authorization (see www.omic.com for a sample form).
o	Have observer and physician sign observer/physician form.

•	Observer present at physician’s or facility’s request but NOT involved in healthcare operations (e.g., family member or friend of physician or facility staff)
o	Have patient sign Form 1, Section B. 
o	Ask patient to sign HIPAA authorization (see www.omic.com for a sample form).
o	Have observer and physician sign observer/physician form.

•	Observer present at physician’s or facility’s request as part of healthcare operations (e.g., a representative from a medical device manufacturer calibrates equipment or instructs the ophthalmologist on its use; medical or nursing students)
o	Have patient sign Form 1, Section B.
o	Ask observer to sign HIPAA Business Associate Agreement, if he/she has not already done so. 
o	Have observer and physician sign observer/physician form.
Need confidential risk management assistance? 
OMIC-insured ophthalmologists, optometrists, and practices are invited to contact OMIC’s Risk Management Department at (800) 562-6642, option 4, or at riskmanagement@omic.com. 

PATIENT FORM_______________________________________
Patient Request For Presence of Observer During Medical Procedure
I, ______________________________(patient name), request permission for __________________ (oberserver’s name) to be present during the following medical procedure _____________________.  My observer and I have been instructed by ______________________ (name of doctor or facility staff member) about standard practices during this medical procedure.  I hereby release the physician and facility, their officers, directors, agents, and employees from any liability in the event the presence of the observer during the procedure leads to injury to me, the observer, or others.  
____________________________			________________________                          Signature of patient 					Date
____________________________			________________________                          Witness signature					Date

Patient Consent For Presence of Observer at Request of Physician/Facility
I, ______________________________(patient name), grant permission for ____________________ (oberserver’s name) to be present during the following medical procedure ______________________ and to _______________________________ (role, if, any, of the observer).  
____________________________			________________________                          Signature of patient 					Date
____________________________			________________________                          Witness signature					Date

OBSERVER/PHYSICIAN FORM
Observer Acknowledgement 
I, _________________________ (oberserver’s name) understand that during the medical procedure, the attending physician and facility staff must devote their full attention to the patient.  I therefore agree to:
•	Bring to the attention of the attending physician and the facility staff any serious medical problems I have which might interfere with the care of the patient, such as lapses of consciousness (fainting, epilepsy, narcolepsy, etc.), weak stomach, or heart disease.

•	Protect the confidentiality of the patient’s health information
•	Comply with all orders and directions of the attending physician and facility staff.
•	Leave the area immediately if considered necessary by the attending physician or facility staff.
I understand and agree that the facility, physicians, and other personnel have no duty to me and I hereby release the attending physician and _______________________ (name of facility), their officers, directors, agents, and employees from any liability in the event my presence during the medical procedure leads to injury to me, the patient, or others.
____________________________			________________________                          Signature of observer					Date
____________________________			________________________                          Witness signature					Date

Acknowledgement of Attending Physician 
I am the attending physician of the above-named patient.  I acknowledge that the above-named  observer will be present during the medical procedure.
 ____________________________			________________________                          Signature of physician 					Date