Additional Guidelines are Unjustified and Unnecessary
Washington, D.C. — Today, the American College of Obstetricians and Gynecologists (ACOG) along with the National Partnership for Women & Families released the results of “The Project on Facility Guidelines for the Safe Performance of Primary Care and Gynecology Procedures in Offices and Clinics”. The Project was undertaken to support evidence-informed policy regarding procedures performed in these settings. The goal of the Project was to further healthcare quality, safety, affordability, and patient experience without imposing unjustified burdens on patients’ access to care or on clinicians’ ability to provide care within their scope of practice.
The findings were published in Obstetrics & Gynecology (The Green Journal) under the title: Consensus Guidelines for Facilities Performing Outpatient Procedures: Evidence Over Ideology. The authors—Barbara S. Levy, MD (American College of Obstetricians and Gynecologists), Debra L. Ness, MS (National Partnership for Women & Families) and Steven E. Weinberger, MD (American College of Physicians)—explore the context for the work and the guidelines themselves. The authors note that in policy and law, regulation of abortion is frequently treated differently from other health services. They cite that the safety of abortion is similar to that of other types of office- and clinic-based procedures, and facility requirements should be based on assuring high quality, safe performance of all such procedures. The article goes on to iterate that false concerns for patient safety are being used as a justification for promoting regulations that specifically target abortion.
“This collaborative effort among women’s groups and women’s health experts found that guidelines for facilities performing office-based procedures, including abortion, are already comprehensive and adequate,” said Barbara S. Levy, MD, ACOG Vice President of Health Policy. “Regulations or laws requiring changes to current accepted practices for such procedures are unwarranted and add burden to women and providers without improving safety. Our organizations must now focus on reducing burden to improve clinicians’ ability to provide care and women’s ability to access that care.”
“The creation of these guidelines was a thorough and collaborative effort in conjunction with numerous respected organizations,” said Debra Ness, President of the National Partnership for Women & Families. “The National Partnership is pleased to have led this endeavor with ACOG, which will help to ensure that women’s access to needed outpatient procedures is not impeded by ideologically driven barriers. We look forward to our continued work to establish and disseminate these guidelines.”
“By bringing together experts from the fields of primary care and women’s health, we were able to articulate a strong, evidence-informed statement of facility guidelines for the provision of procedures in offices and clinics. We hope this will guide providers and policymakers alike in increasing patient access and improving care,” said Dr. Steven Weinberger, Executive Vice President and CEO Emeritus of the American College of Physicians.
“The Project on Facility Guidelines for the Safe Performance of Primary Care and Gynecology Procedures in Offices and Clinics” was undertaken by clinicians, consumers, and representatives from accrediting bodies to review the available evidence and guidelines that inform safe outpatient care delivery.
To date, the organizations listed below have endorsed the guidelines:
- American Academy of Family Physicians (AAFP)
- American Academy of Nursing (AAN)
- American Academy of Physician Assistants (AAPA)
- American College of Nurse-Midwives (ACNM)
- American College of Obstetricians and Gynecologists (ACOG)
- American College of Osteopathic Obstetricians and Gynecologists (ACOOG)
- American College of Physicians (ACP)
- American Public Health Association (APHA)
- National Hispanic Medical Association (NHMA)
- National Partnership for Women & Families (NPWF)
- Nurse Practitioners in Women’s Health (NPWH)
- Planned Parenthood Federation of America (PPFA)
- Society of Family Planning (SFP)
- Society of General Internal Medicine (SGIM)
More about “The Project on Facility Guidelines for the Safe Performance of Primary Care and Gynecology Procedures in Offices and Clinics”
The Project was led by a Planning Committee made up of representatives from the American College of Obstetricians and Gynecologists, National Partnership for Women & Families, American College of Physicians, American Academy of Family Physicians, American College of Nurse-Midwives, Nurse Practitioners in Women’s Health, and the Society of Family Planning. From September 26, 2016, to July 11, 2018, the planning committee undertook intensive work focused on the following:
- Defined the scope of the Project
- Recruited a working group of experts and stakeholders, many of whom were also representatives of other health care organizations=
- Gathered and conducted a structured review of all available evidence
- Hosted an in-person meeting of the Procedures Working Group, a broader group of experts across 24 organizations, to discuss research evidence, provide expert opinion, and consider appropriate guidelines and/or practices
- Engaged in an iterative, virtual drafting process for crafting, and reaching agreement on, a final consensus document
- Solicited, considered and incorporated feedback through public comments; and
- Finalized the consensus guidelines.
The Procedures Working Group concluded that very little research evidence exists on the impact of outpatient facility factors on patient safety and patient experience and service availability. The Procedures Working Group found no evidence of any patient safety or quality of care problem related to the examined facility factors in offices or clinics that provide primary care and gynecology procedures. Given the available evidence, the Procedures Working Group concluded that there is insufficient research to find that particular facility factors have either a positive or negative impact on patient safety or experience (very little research has been conducted in these areas, and the findings from that limited research are not definitive). The Procedures Working Group also noted that research suggests the possibility that some facility requirements may result in decreased service availability.
Given this evidence base, the Procedures Working Group determined that facility guidelines requiring measures beyond current accepted practices would be unjustified. The Project had intended to articulate such measures for areas of facility operations or environment where available evidence identified potential problems arising from existing accepted practices. However, based upon thorough review and analysis of the available evidence, safety concerns were not identified in any area of study. Therefore, the Procedures Working Group concluded that requiring changes to current accepted practices was unwarranted, and it sought to articulate guidelines reflecting those current accepted practices.
Facilities’ policies, procedures, and supplies should be suited to the nature of the practice and procedures performed. In some facilities, appropriate policies, procedures, and supplies will be minimal. Solo or small practices that perform only occasional, limited procedures should assess which of the guidelines are appropriate to the practice given the procedures performed at the site. Guidelines are organized by the facility factors reviewed in the project, and are summarized below:
- Facilities should establish written policies and procedures for managing facility emergencies (e.g., natural disaster, fire) and patient emergencies (e.g., vasovagal reaction, hemorrhage) and should conduct periodic drills and staff trainings on those policies and procedures. A formal transfer agreement with a hospital is not required as transfers are rare and hospitals are required to accept patients with emergent needs. Good communications in the event of a transfer and working relationships with facilities that may receive or refer patients are encouraged.
- Facilities should have a staff person trained in basic life support onsite when procedures are performed and have a person other than the clinician performing the procedure onsite to provide assistance, call for additional assistance, or transport to a hospital in an emergency.
- Facilities should maintain adequate supplies for basic life support and medications and equipment needed to treat emergencies that may occur with the procedures performed.
- Facilities should provide basic emergency lighting (e.g., battery backup lighting, flashlights).
- Facilities should keep doorways and hallways free of obstructions that could impede exit by patients and staff or ingress by emergency personnel. Where the types and risks of procedures performed at the facility create a reasonable likelihood that patient transfer by stretcher may be needed, doorways and hallways in the path of egress should be sufficiently wide to permit passage by stretcher (note that this term includes chair stretchers, which can be maneuvered through typical office doorways and hallways).
- Facilities should provide wayfinding signage that is understandable to the patient population served.
Biological Material Handling
- Facilities should establish written policies and procedures for properly labeling, handling, and storing biological specimens to be sent to pathology or other laboratory. The decision of whether to send specimens for pathology evaluation is made by the clinician or on the basis of facility policies.
- Facilities should establish written policies and procedures for handling, storing, and disposing of hazardous materials in a manner that minimizes the risk of exposure and for reducing the risk of harm to individuals involved, should exposure occur. Tissue not sent to pathology should be disposed of in the same manner as other biological materials. Tissue used in research or commercial endeavors is subject to separate requirements not addressed in this document.
- Facilities should conduct periodic staff training on the policies and procedures described.
Physical Plant Specifications
- Facilities should consider patient privacy, confidentiality, and comfort in the design and flow of the facility.
- Facilities should perform procedures in exam rooms or procedure rooms adequate to accommodate the equipment and personnel involved in the procedure. Typical exam rooms are an adequate size for most procedures; a room larger than needed to accommodate the equipment and personnel involved in the procedure is neither necessary nor desirable.
- Facilities should have patients recover in the room in which the procedure was performed or in a separate recovery room or area. A separate recovery room is not required. Some procedures require no recovery time.
- Facilities should provide separate storage for clean and dirty supplies.
- If instruments are sterilized onsite, facilities should provide separate marked areas for soiled and clean instrument processing. Separate rooms for those functions are not required. Offsite sterilization services may also be used.
- Facilities should provide a source of emergency power for equipment if any of the procedures performed in the facility are ones where a power loss during the procedure would threaten patient safety.
- Facilities should have onsite, and maintain in good condition, the equipment needed for the procedures performed.
- Facilities should utilize adequate heating, ventilation, and cooling systems. Systems typical for offices are adequate in this context; no special heating, ventilation, or cooling systems are needed.
- Facilities that store specimens or medications requiring refrigeration should provide separate refrigerated storage for each.
(Note: We have included some physical plant-related matters in the guidelines for emergency preparedness.)
Facility Accreditation and Licensing
- Procedures should be provided in facilities that meet current accepted practices. Such accepted practices do not require facility accreditation or facility licensing.
Clinician Qualifications Beyond Licensing
- Facilities should ensure that clinical staff are trained in the procedures performed, equipment used in the facility, basic life support, cultural sensitivity, and any requirements governing the facility with regard to accommodations to facilitate safe and appropriate access to health services for individuals with disabilities or other conditions, including limited English proficiency. While some facilities will have no need for nursing staff, facilities should ensure that any clinical duties requiring nursing care are staffed appropriately.
- Facilities should designate a clinician responsible for ensuring that clinicians who perform procedures at the facility have established competence in those procedures. Such competence may be established through any of a variety of training, education, and assessment activities (which may be specified by the facility, a professional organization, or specialty). Neither board certification nor hospital privileges is required.
Other Policies and Procedures
- Facilities should establish written policies and procedures for infection control, conduct periodic staff training on those policies and procedures, and implement a plan to monitor compliance.
- Facilities that perform procedures on more than an occasional basis should establish a written quality improvement plan that includes recording and reviewing available facility data on select adverse outcomes related to procedures performed and ways to act on information gained.
- Facilities should establish a written policy and schedule for checking equipment functioning.
- Facilities should establish a written policy and schedule for managing medication inventory.
Note that there exist a variety of federal, state, and local laws (e.g., the Americans with Disabilities Act, state health care facility regulations) that may be pertinent to facility topics discussed in this document. The guidelines do not attempt to assess or describe those laws. Providers should be aware of relevant laws applicable to their facilities.
The guidelines can be found here.
The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 58,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. www.acog.org
National Partnership for Women & Families is a nonprofit, nonpartisan advocacy group dedicated to promoting fairness in the workplace, reproductive health and rights, access to quality, affordable health care, and policies that help women and men meet the dual demands of work and family. More information is available at NationalPartnership.org