I FACILITIES AND EQUIPMENT

The facilities in which gynecologic care is provided—regardless of whether the setting is an office, an outpatient surgical facility, or an inpatient hospi­tal—should be safe, efficient, and conducive to the compassionate delivery of health care to all women.

General Requirements

Whether the facility in question is an office, an ambulatory surgical facility, or a hospital, there are certain requirements for optimal delivery of gyne­cologic care. Building codes are city, county, and state specific. Facilities should adhere to all applicable codes.

Specific plans and procedures should be established for the health and safety of patients and personnel. These should include the following:

• Disaster Plans and Procedures

— Mechanisms to minimize the risk of hazards from electrical and mechanical failure, explosion, fire, and loss of refrigeration

— Training in and knowledge of the proper use of safety, emergency, and fire-extinguishing equipment

— Facility evacuation plans for patients and personnel

• Medical Emergencies

— Management of medical emergencies that arise from services rendered

— Mechanism to transfer patients to backup hospital when neces­sary

— Training of personnel in cardiopulmonary resuscitation

— Proper preparation and administration of drugs

• Facilities

— Control and disposal of sharps (eg, needles, syringes, glass, and knife blades), and contaminated material

— Proper storage of medications and drugs

— Accessibility to individuals with disabilities (ie, safety and absence of barriers)

— Adequate maintenance and cleanliness of facilities

In addition, violence against physicians and other health care work­ers has raised concerns about personal safety in health care settings.

• Establish a relationship with the local police force and other security personnel.

• Obtain a security audit of the office or institution.

• Review emergency plans periodically.

• Restrict after-hours access.

• Improve lighting at entrances and in parking areas.

• Install security cameras, mirrors, and panic buzzers.

• Install deadbolt or electronic locks.

• Restrict access to all doors except the main entrance.

• Preprogram 911 (emergency telephone number) into all telephones.

• Enclose and secure reception areas.

• Develop an emergency notification system.

Electrical, lighting, air quality, and temperature systems need to function appropriately and safely. A program for regular maintenance should be in place and may require the services of an environmental engineer. Standards for electrical outlets and electrical equipment have been developed by The Joint Commission (see Resources).

Medical and other equipment should be well maintained and inspected at regular intervals for proper functioning and safety as specified by the manufacturer’s operations manual. This may require the assistance and services of a mechanical engineer, a biomedical technician, or both. A log should be maintained of routine checks, repairs, and service calls on medical equipment. Only properly trained and qualified personnel should operate medical equipment.

Emergency equipment and supplies should be readily available and maintained. All personnel in an office should know the location of critical emergency equipment. Personnel should be instructed periodically in the proper use of safety, emergency, and fire-extinguishing equipment. Plans should be developed for emergency situations, including assisting indi­viduals with special needs. Drills should be conducted regularly to ensure preparedness. Alternate sources of power should be available and adequate for staff to manage patients in the event of an emergency.

One of the primary concerns is the safety of the patient and any accompanying individuals. There should be proper lighting and floor­ing to minimize accidents. Avoid small rugs or rugs with loose edges; these are hazardous to everyone, particularly those with mobility issues. Examination rooms, restrooms, and other patient areas should be handi­cap accessible.

Safety extends to those accompanying the patient. As women often have young children with them, attention should be given to childproof­ing all reception and clinical areas. Move dangerous instruments and solu­tions to cabinets out of reach of small children, install childproof locks on cabinet doors, keep sharps containers away from the edge of countertops, and cover waste containers. Toys should be carefully evaluated for safety issues: avoid those with small parts that can be swallowed by infants and toddlers.

Specific Physical and Supply Requirements ^144

The specific physical and supply requirements for basic care in the office, ambulatory, and hospital setting will depend greatly on the type of practice and patients served. Box 2-1 lists basic equipment and supplies that should be available for gynecologic care.

Rooms should be designed to provide patient privacy at all times during the visit. Patient names on charts, specimens, and daily visit records should not be visible to other patients.

Box 2-1. Basic Equipment and Supplies for Gynecologic Care ^

• Patient drapes and examination table covers

• Sharps disposal containers

• Vaginal specula of various sizes

• Supplies for cervical cytology tests, wet mounts, and cultures, if per­formed in the setting

• Instruments for suture, staple, and clip removal

• Instruments for minor surgical procedures (eg, biopsies of the endome­trium, cervix, and vulva or insertion of implants and intrauterine devices)

• Cleaning and sterilization equipment, unless this is provided by an exter­nal service

Policies and procedures to keep the environment healthy and avoid potential hazards should be established:

• Ban smoking on the premises.

• Minimize or eliminate hazards that might result in accidents, electri­cal shock, or trauma.

• Minimize sources and dissemination of infections.

• Assess adequacy of the infection control program periodically (see also the “Infection Control” section later in Part 2).

• Ensure that there are systems in place for the identification, safe handling, and disposal of hazardous materials and waste (see also the “Practice Management” section later in Part 2).

• Minimize radiation exposure.

• Reduce or eliminate exposure risks to latex-sensitive individuals.

Latex Products

Latex products, particularly gloves, are ubiquitous in the medical setting, and many consumer products (eg, condoms and diaphragms) are made of latex. Allergy to natural latex rubber is a serious health risk for many health care workers and patients. Manufacturers of medical devices are required to label products that include natural rubber latex or dry natural rubber.

The prevalence of latex sensitivity in the general population has been estimated to be less than 1%, but it may be higher. Individuals who are at high risk include the following:

• Health care workers

• Patients with spina bifida

• Patients who have had multiple surgical procedures

• Individuals subject to occupational exposure

• Individuals who have a history of atopy

• Individuals who have food allergies, especially those allergic to avocados, bananas, chestnuts, kiwifruit, or passion fruit

Allergic reactions to latex range from mild skin reactions and mild swelling of the lips to systemic reactions, such as asthma and anaphylaxis, which may result in chronic illness, disability, career loss, hardship, or death.

Antigen avoidance is the cardinal principle in the management of latex allergy. Facilities should establish a protocol for achieving this goal and train all staff accordingly. For those individuals who have latex allergy, a latex-free environment should be provided, if feasible. Latex-allergic work­ers should use only nonlatex gloves, and others in the same environment should use nonlatex gloves or powder-free, low-protein gloves to minimize airborne latex exposure.

Reprocessing Single-Use Medical Devices

Reprocessing single-use devices involves reusing instruments that were designed and sold for single-use only. The reprocessing and reuse of single­use instruments has become increasingly common. Current law requires that the institutions or companies that reprocess single-use devices for repeat use be held to the original manufacturing specifications for the single-use instrument. Devices must be clearly labeled as manufactured by the reprocessor. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies that evaluate the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed.

The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. (For more information, refer to MedWatch, the U.S. Food and Drug Administration safety information and adverse event reporting program, which can be accessed at www.fda.gov/Safety/ MedWatch/default.htm.)

Office and Other Ambulatory Settings

The office or clinic, no matter how small or how large, should be well organized and clean. The reception area should be comfortable and should have adequate seating capacity to accommodate patients. Current general­interest reading material that is consistent with promotion of healthy life­styles and patient education materials should be available.

The facility should have a utility area, which should be separate from the examination rooms. It should be equipped with work counters, closed cabinets for storage, locked medicine cabinets, a refrigerator, and facilities for sterilization and hand washing. There should be a comfortable, private area for discussing confidential information and for interviewing and counseling the patient and her family.

The physician’s office may serve as a consultation room; however, depending on the size of the office or clinic, separate rooms, other than the physician’s office and examining rooms, are desirable for use by nurses, social workers, health educators, or other members of the health care team. The number of examination rooms, consultation rooms, and interview rooms will depend on the patient profile and the size of the practice. In general, a minimum of two examination rooms per practitio­ner is desirable.

Some obstetrician-gynecologists provide mammography screening in their offices. Mammography equipment is subject to regulation by the U.S. Food and Drug Administration. (For further details, refer to the “Compliance With Government Regulations” section in Part 1.)

An increasing number of invasive and potentially harmful procedures are moving from the more highly regulated surgery center of hospital sur­gery units into the office setting. Once patients have been invited into an office setting for procedures, they have the right to expect the same level of patient safety that occurs in the more regulated hospital setting. Any facility that performs outpatient surgery should have a designated medical director. The “Report of the Presidential Task Force on Patient Safety in the Office Setting” of the American College of Obstetricians and Gynecologists contains important checklists for the office setting, including the office setup checklist, preoperative checklist, intraoperative checklist, and post­operative checklist (see Bibliography).

Surgical Facilities

A freestanding surgical facility should be organized and equipped as a multidisciplinary unit. This includes the provision of preoperative, intra­operative, and postoperative care and arrangement for the transfer of a patient if an emergency arises. To ensure that high-quality care is main­tained, periodic assessment of care as well as review of practice procedures, governance, and outcome should be conducted. Patient safety should be incorporated into all aspects of patient care and is the hallmark for all care that is provided. The American College of Obstetricians and Gynecologists has been reluctant to mandate specific requirements for surgical care in the office or other ambulatory surgical settings because each facility is unique. General recommendations and guidance about office-based surgery and ambulatory surgical care are provided in the “Ambulatory Gynecologic Surgery” section in Part 4. Further information on minimal requirements is available from the American College of Surgeons (see Resources).

The appropriate physical design for an ambulatory surgical facility depends on the number and types of surgical procedures to be performed. The facility should provide a comfortable, safe environment with minimal architectural barriers. The requirements of the Occupational Safety and Health Administration, as well as state and local requirements, should be met. Traffic flow should be convenient and efficient. A multilevel facility should have elevators that can accommodate gurneys. The facility also should include adequate space for the following functions:

• Reception and waiting

• Administrative activities, such as patient admission, record storage, and business affairs

• Patient dressing and locker storage

• Preoperative evaluation, including physical examination, laboratory testing, and preparation for anesthesia

• Performance of surgical procedures

• Preparation and sterilization of instruments

• Radiographic capability (eg, to check for instruments, needles, and sponges when counts at the end of a procedure are not correct)

• Storage of equipment, drugs, and fluids

• Postanesthesia recovery

• Staff activities

• Janitorial and utility support

Inpatient Facilities

Inpatient hospital, emergency, and urgent care settings should include a private, secure examination room appropriate for gynecologic examina­tions. The room should be of adequate size with a door that locks from the inside or a curtain to pull across the doorway. It should be adequately equipped for a gynecologic examination (see also “Specific Physical and Supply Requirements” earlier in this section). Counter space or a tray stand should be available to hold the supplies needed for the examination. In essence, this room should be similar in size and layout to, and be equipped like, an examination room in an outpatient office.

High-quality care is more easily attained in a specialty service. When hospital size permits, the gynecologic inpatient service should be con­solidated in one designated area. In smaller hospitals, where the number of patients may not justify the establishment of a separate area, gyneco­logic patients may be treated in either a medical or surgical area. Gyne­cologic patients who do not have transmissible infections may be treated in the obstetric area, provided that hospital policy permits and their care does not interfere with the operation of the obstetric unit.

Bibliography

AAAAI and ACAAI Joint Statement concerning the use of powdered and non­powdered natural rubber latex gloves. Ann Allergy Asthma Immunol 1997;79:487. [PubMed]

American College of Obstetricians and Gynecologists. Report of the presidential task force on patient safety in the office setting. Washington, DC: American College of Obstetricians and Gynecologists; 2010.

Preparing for clinical emergencies in obstetrics and gynecology. Committee Opinion No. 590. American College of Obstetricians and Gynecologists. Obstet Gynecol 2014;123:722-5. [PubMed] [Obstetrics & Gynecology]

Reprocessed single-use devices. Committee Opinion No. 537. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:974-6. [PubMed] [Obstetrics & Gynecology]

User labeling for devices that contain natural rubber, 21 C.F.R. part 801.437 (2013). Available at: http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol8/pdf/CFR-2013- title21-vol8-sec801-437.pdf. Retrieved September 20, 2013.

Resources

American College of Surgeons. Guidelines for optimal ambulatory surgical care and office-based surgery. 3rd ed. Chicago (IL): ACS; 2000.

American Congress of Obstetricians and Gynecologists. HIPAA regulations and requirements explained. Washington, DC: American Congress of Obstetricians and Gynecologists; 2013. Available at: http://www.acog.org/About_ACOG/ACOG_ Departments/HIPAA. Retrieved July 16, 2013.

American Society of Anesthesiologists. Standards, guidelines, statements and other documents. Available at: http://www.asahq.org/For-Members/Standards- Guidelines-and-Statements.aspx. Retrieved July 16, 2013.

Association of periOperative Registered Nurses. Perioperative standards and recom­mended practices. 2013 ed. Denver, CO: AORN; 2013.

Ethical considerations for performing gynecologic surgery in low-resource settings abroad. Committee Opinion No. 466. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;116:793-9. [PubMed] [Obstetrics & Gynecology] Facilities Guidelines Institute. Guidelines for design and construction of health care facilities. 2014 ed. Chicago (IL): American Society for Healthcare Engineering of the American Hospital Association; 2014.

Food and Drug Administration. Reprocessing of single-use devices. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Reprocessing ofSingle-UseDevices/default.htm. Retrieved July 16, 2013.

National Institute for Occupational Safety and Health. Occupational latex allergies. Available at: http://www.cdc.gov/niosh/topics/latex. Retrieved July 16, 2013.

National Institute for Occupational Safety and Health. Preventing allergic reactions to natural rubber latex in the workplace. Available at: http://www.cdc.gov/niosh/ docs/97-135/pdfs/97-135.pdf. Retrieved July 16, 2013.

Occupational Safety and Health Administration. Compliance assistance/out- reach. Available at: https://www.osha.gov/dcsp/compliance_assistance/index.html. Retrieved September 26, 2013.

Occupational Safety and Health Administration. Latex allergy. Available at: https:// www.osha.gov/SLTC/latexallergy/index.html. Retrieved July 16, 2013.

Recommendations for development of an emergency plan for in vitro fertiliza­tion programs: a committee opinion. Practice Committees of American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Fertil Steril 2012;98:e3-5. [PubMed] [Full Text]

Sussman G, Gold M. Guidelines for the management of latex allergies and safe latex use in health care facilities. Arlington Heights (IL): American College of Allergy, Asthma and Immunology; 1996. Available at: http://www.acaai.org/allergist/aller gies/Types/latex-allergy/Pages/latex-allergies-safe-use.aspx. Retrieved July 16, 2013.

The Joint Commission. Comprehensive accreditation manual for ambulatory care: CAMAC. Oakbrook Terrace (IL): The Commission; 2014.