I ANCILLARY SERVICES
Ancillary services, including pharmacy, radiology, laboratory, and anesthesia, are a component of patient care. The following recommendations for ancillary services should be considered general recommendations and are not necessarily requirements or mandates.
Such services, whether on site or off site, should be accredited. Physicians should check state and federal laws and regulations on self-referral prohibitions before referring a patient for health care services in which the physician or an immediate family member has a financial interest (see also the “Human Resources” section in Part 1). These laws and regulations continue to evolve, and current requirements should be reviewed. All ancillary services must meet all applicable federal and state requirements.Pharmacy Services
An appropriate selection of medications and means for obtaining medications not onsite should be available. Prescribing, preparing, and dispensing medication should follow established procedures that are in compliance with legal regulations, licensure, and professional practice standards. Appropriate records and security are essential to maintain the safe and controlled dispensing of medications and to allow patient notification in the event of a drug recall or newly reported complications. The pharmacy must be supervised by a licensed pharmacist or physician.
When medications are dispensed, patients should be given instructions and important medication information. The quality and appropriateness of the medications used should be monitored as part of the quality improvement program. Adverse medication effects should be monitored and addressed. The U.S. Food and Drug Administration (FDA) has established MedWatch, the FDA Safety Information and Adverse Event Reporting Program, to provide safety information about prescription and over-the- counter drugs, biologics, medical devices, and dietary supplements.
The American College of Obstetricians and Gynecologists, a MedWatch Partner, encourages women’s health care clinicians to participate in MedWatch. More information is available on the FDA web site at www.fda.gov/Safety/ MedWatch/default.htm. Reports also can be made online.Drug samples must be stored in a secure location. Thorough documentation and records of drug samples received and dispensed should be maintained and should include information regarding drug name, lot number, date of receipt, inventory, and dispensing details. There must be complete accountability and auditing of drug sample stocks. Proper disposition of expired or recalled drug samples must be documented. The Prescription Drug Marketing Act of 1987 governs the distribution of drug samples and forbids their sale. This regulation extends to charging a dispensing fee for a prescription drug sample. When dispensing drug samples, physicians should be cognizant of the effect that free samples may have on their subsequent choice of pharmacotherapy. Physicians may choose to provide samples or vouchers; however, they should be aware that providing samples may promote patients’ ongoing use of a particular medication, when other potential alternatives exist. When vouchers or samples are dispensed, consideration should be given to providing them preferentially to those patients with a true need and dispensing a supply sufficient for a full course of therapy.
State laws differ in requirements for the labeling of drug samples provided to patients. Drug samples that are dispensed should be in the required packaging and should include the name and strength of the drug, directions for use, and the expiration date of the product. Federal and state laws require a note in the patient’s chart indicating that a drug sample has been dispensed.
The pharmacy compounding law includes a limited exception to the requirement that prescription drugs be approved by the FDA based on studies that demonstrate their safety and effectiveness.
Because preapproval drug studies are performed on a very specific drug formula and dosage, even relatively small compounding changes can convert an approved drug into an unapproved one with different risks and effects. Most compounded products have not undergone any rigorous clinical testing for either safety or efficacy, and issues of quality assurance regarding the purity, potency, and quality of compounded products are a concern.However, compounded drugs may be considered in some circumstances. Examples include a situation in which there is no FDA-approved drug formulation for the patient’s condition or individual situation (eg, the patient cannot use the standard version of a drug because of an allergy to one of its inactive ingredients) or a situation in which it is necessary for a commercially available drug product to be compounded into a powder, liquid, lozenge, suppository, or other form to facilitate use.
The FDA’s pharmacy compounding law was designed to provide protections against unsafe and ineffective compounded products. The main provisions of this law include the following:
• The compounded product must be prescribed for an identified patient.
• The drug’s active ingredient can qualify for use in compounding if any of these conditions are met:
— It is currently part of an FDA-approved drug.
— It is recognized and listed in the book of widely used drug substances published by the U.S. Pharmacopeial Convention, an independent standard-setting organization.
— The FDA has acknowledged it as acceptable for pharmacy compounding.
• Previously marketed drugs found to be unsafe or ineffective and removed from the market may not be compounded.
• Drug products listed in FDA regulations as difficult to compound may not be compounded.
More information on pharmacy compounding is available on the FDA’s web site at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma tion/PharmacyCompounding/default.htm.
Laboratory and Pathology Services
Laboratory and pathology services must serve patient and clinician needs and meet professional practice standards and state and federal legal requirements.
Quality-control procedures should include validating test results through the use of standardized controls and appropriate documentation. A written report should be generated for all laboratory and pathology examinations performed. This report should be included in the patient’s medical record, and there should be documentation of review by the clinician. A qualified physician should oversee the laboratory. Competent, appropriately trained personnel should conduct the laboratory work.Imaging Services
Diagnostic imaging services, including but not limited to radiographic, fluoroscopic, and ultrasonographic services, must be available to meet patient and clinician needs. There should be adequate space and equipment to ensure the safe delivery of these services. Such provision should include policies for handling, storing, and disposing of potentially hazardous materials and for proper shielding where potentially hazardous energy sources are used. Performance and interpretation of imaging services should be permitted in offices or ambulatory surgical centers when these conditions are met.
A written report, signed by the interpreting physician, should be considered an integral part of the performance and interpretation of an imaging study. For optimal patient care, imaging studies should be performed and interpreted in a timely manner. Dated reports of service must be maintained and available in the patient’s file. Quality assurance must be maintained by periodic review. Imaging services should be performed only on the order of a qualified clinician.
Obstetrician-gynecologists who are experienced in diagnostic imaging methods should receive privileges to perform and interpret imaging studies on the basis of their training, experience, and demonstrated current clinical competence. Obstetrician-gynecologists can perform the immediate and timely interpretation of imaging studies, correlate these studies with clinical findings, counsel the patient, and assume the responsibility for determining the treatment of the patient.
Any policy that prohibits obstetrician-gynecologists from performing and interpreting imaging studies at which they are demonstrably competent interferes with the patient’s access to optimal care. The American College of Obstetricians and Gynecologists reaffirms that current certification by the American Board of Obstetrics and Gynecology, Inc., and maintenance of certification by obstetrician-gynecologists is validation of the medical, surgical, imaging, and laboratory knowledge and patient care skills relevant to the practice of the specialty. No additional certification should be required for credentialing for those procedures and care which fall within the scope of an individual’s current certification by the American Board of Obstetrics and Gynecology, Inc.Radiation monitoring devices should be provided to personnel who might be exposed to harmful energy, and personnel exposure records should be maintained in accordance with relevant regulations. Proper warning signs must be posted to alert the public and office personnel to the presence of hazardous energy fields, with particular attention given to pregnant women and patients with pacemakers.
Gynecologic ultrasonography can help in assessment of a patient’s pelvic anatomy as an adjunct to physical examination and other diagnostic modalities to confirm the presence or absence of a suspected problem. In addition, gynecologic ultrasonography can be of assistance when a pelvic examination either provides insufficient information because of the difficulty of examination, or findings are abnormal and more information is desired. The clinician should use the technique that allows for optimal examination of the targeted organ. The American Institute of Ultrasound in Medicine has published standards for performance of ultrasonographic examination of the female pelvis and documentation of such examination; these standards are available at www.aium.org/resources/guidelines/pelvic.pdf.
Results from ultrasonographic examination are considered part of the medical record and should be documented and stored appropriately.
The report, signed by the interpreting physician, should be placed in the patient’s medical record. Vaginal probes must be covered (with a nonlatex covering for latex-allergic patients) during use, and a policy for cleaning the probe between uses must be in place (see also the “Infection Control” section earlier in Part 2).Gynecologic ultrasonographic procedures should be explained fully to the patient in advance. Consideration should be given to the patient’s privacy and sensitivity because the transvaginal ultrasonographic examination can be physically problematic, psychologically problematic, or both for some women. Because of the sensitive nature of the transvaginal examination, it may be advisable to have a chaperone present. Personnel who can serve as chaperones should be available whenever there is a request from the clinician or a patient.
Obstetrician-gynecologists with adequate training and experience are qualified to perform and interpret ultrasonographic examinations. Training in performance and interpretation of gynecologic ultrasonography may be acquired during residency training or from courses supplemented by supervised experience and follow-up. The American Institute of Ultrasound in Medicine and the American College of Radiology offer ultrasound facility accreditation. Practices, not individuals, may be accredited. Physicians must be aware that they are responsible for the quality and accuracy of ultrasound examinations performed in their names, regardless of whether or not they personally produced the images; they also are responsible for the quality of the documentation and the quality control and safety of the environment and procedures.
Anesthesia and Analgesia
When anesthesia is necessary, the level and type of anesthesia administered should be dictated by the procedure, patient’s medical condition, and patient preference. Adequate space and equipment should be provided for the safe delivery of anesthesia services, and no explosive anesthetics should be used. A preanesthesia assessment should be conducted for any patient for whom anesthesia is planned. Before the administration of any sedation, staff must confirm that the patient has an escort to drive her home.
A person responsible for administration of medication and monitoring the patient must be present in the procedure room. The administration of any anesthetic must be performed or supervised by a qualified physician. Depending on the level of anesthesia, patient monitoring might be assumed by a medical assistant, nurse, certified nurse anesthetist, or anesthesiologist. In all but the last case, these individuals must work under protocols with the surgeon assuming responsibility. Physicians who administer or supervise moderate sedation or analgesia, deep sedation or analgesia, or general anesthesia should have appropriate education and training.
An adequately staffed, designated recovery area must be available. The patient must be monitored closely for depth of sedation, using all recommended monitoring equipment and procedures, regardless of the mode of delivery (oral versus intravenous); monitoring should continue during and after the procedure until the patient has adequately recovered. For more information, see the “Ambulatory Gynecologic Surgery” section in Part 4.
Follow-up Services
Discharge or transition care planning should begin the first day of hospitalization and address the patient’s needs in all of the following areas: physical, emotional, social, activities of daily living, and transportation. A partial list of follow-up services includes adult foster care, case management, home health services, hospice, wound care, long-term care, ambulatory care, support groups, and rehabilitation services.
Some services are best provided in an outpatient ambulatory setting or a freestanding specialized facility, such as a nursing home. For individual care delivered to the patient at home, visiting nurses are recognized for their expertise at providing a wide range of home health and hospice care. The Visiting Nurse Associations of America are community-based, nonprofit home health and hospice providers who care for patients of all ages from infants to the elderly and offer maternal-child health programs, case-based management, infusion therapy, rehabilitation, hospice care, behavioral therapy, wound care, pain management, telemedicine, and other home health services. These services often are available regardless of ability to pay.
Transition Care
Because of the current fragmented health care system, there often exists a vacuum of care when a patient is transitioned between inpatient and outpatient care or from one location to another. Good transitional care is based on a comprehensive plan, the availability of well-trained staff who have current information about the patient’s clinical status, and coordination among health care providers involved in the transition. Ineffective coordination may lead to treatment delays, medication errors, adverse events, litigation, and increased costs. Effective coordination requires a team effort, and some physicians may choose to delegate this responsibility to a health care provider on their staff, such as an advanced practice nurse or physician assistant.
It is the responsibility of the physician or his or her designee to see that practitioners who provide follow-up care receive a summary of the care previously provided, the patient’s progress toward goals, and information regarding instructions and referrals provided to the patient. The patient, her family, her primary health care providers, and her ancillary practitioners should communicate clearly with one another and understand the patient assessment and plan. The use of an integrated electronic health record greatly facilitates this process. The patient and her family should receive written and verbal education regarding their responsibilities for daily care and follow-up appointments, the safe use of prescribed medications, adverse reactions or complications that must be reported to the clinician, and the name and phone number of a person to call in an emergency. The patient or family should be referred to community resources, including mental health, social services, and financial services, as needed. Tools to assist individuals and institutions in improving transitional care are provided by the Society of Hospital Medicine (www.hospitalmedicine. org/ResourceRoomRedesign/RR_CareTransitions/CT_Home.cfm) and the National Transitions of Care Coalition (www.ntocc.org/WhoWeServe/ HealthCareProfessionakaspx).
Physicians should consider carefully the agency to which they are referring patients for follow-up care. It is recommended that such agencies be accredited by a third party, such as the The Joint Commission, Community Health Accreditation Program, or Accreditation Commission for Health Care. It also is recommended that the agency hold a current state license.
Ethics in Aftercare
Physicians and other health care providers must provide and document “patient choice” in selecting aftercare. Many hospitals and some physicians are stakeholders in home health agencies or aftercare companies. A conflict of interest exists when the patient’s well-being (primary interest) and the physician’s financial well-being (secondary interest) are in conflict. Such a conflict of interest is not by its nature wrong, but creates an opportunity for the physician to breach a primary obligation to the patient. Such conflicts should be avoided whenever possible; if they are unavoidable and material to a patient’s decision-making process, it is the physician’s responsibility to disclose any such conflicts to the patient. Physicians should be aware of federal government legislation and any state “anti-kickback laws” that might be applicable.
Bibliography
American College of Obstetricians and Gynecologists. Certification and procedural credentialing. College Statement of Policy 84. Washington, DC: American College of Obstetricians and Gynecologists; 2012.
American Institute of Ultrasound in Medicine. AIUM practice guideline for the performance of pelvic ultrasound examinations. Laurel, MD: AIUM; 2009. Available at: http://www.aium.org/resources/guidelines/pelvic.pdf. Retrieved July 19, 2013.
Communication strategies for patient handoffs. Committee Opinion No. 517. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 119:408-11. [PubMed] [Obstetrics & Gynecology]
Food and Drug Administration. Compounding Quality Act. Available at: http:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy Compounding/default.htm. Retrieved July 19, 2013.
Practice guidelines for sedation and analgesia by non-anesthesiologists. American Society of Anesthesiologists Task Force on Sedation and Analgesia by NonAnesthesiologists. Anesthesiology 2002;96:1004-17. [PubMed] [Full Text] Professional relationships with industry. Committee Opinion No. 541. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:1243-9. [PubMed] [Obstetrics & Gynecology]
Accreditation Commission for Health Care. Available at: http://www.achc.org/. Retrieved July 19, 2013.
American Association of Blood Banks. Standards for blood banks and transfusion services. 27th ed. Bethesda (MD): AABB; 2011.
American College of Radiology. Accreditation. Available at: http://www.acr.org/ Quality-SafetyZAccreditation. Retrieved July 19, 2013.
American College of Radiology. Practice parameters and technical standards. Available at: http://www.acr.org/Quality-Safety/Standards-Guidelines. Retrieved July 19, 2013.
American Institute of Ultrasound in Medicine. AIUM ultrasound practice accreditation. Available at: http://www.aium.org/accreditation/accreditation.aspx. Retrieved July 19, 2013.
Centers for Medicare and Medicaid Services. Home health compare. Available at: http://www.medicare.gov/homehealthcompare/search.html. Retrieved July 19, 2013.
Community Health Accreditation Program. Available at: http://www.chapinc.org/. Retrieved July 19, 2013.
Compounded bioidentical menopausal hormone therapy. Committee Opinion No. 532. American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine. Obstet Gynecol 2012;120:411-5. [PubMed] [Obstetrics & Gynecology]
Food and Drug Administration. MedWatch: the FDA safety information and adverse event reporting program. Available at: http://www.fda.gov/Safety/MedWatch/ default.htm. Retrieved July 19, 2013.
National Transitions of Care Coalition. Available at: www.ntocc.org. Retrieved July 19, 2013.
Seeking and giving consultation. ACOG Committee Opinion No. 365. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:1255-60. [PubMed] [Obstetrics & Gynecology]
Society of Hospital Medicine. Overview: project BOOST implementation toolkit. Available at: http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_Care Transitions/CT_Home.cfm. Retrieved July 19, 2013.
The Joint Commission. Comprehensive accreditation manual for laboratory and point-of-care testing: CAMLAB. Oakbrook Terrace (IL): The Commission; 2014.
The Joint Commission. Comprehensive accreditation manual for ambulatory care: CAMAC. Oakbrook Terrace (IL): The Commission; 2014.
Visiting Nurse Associations of America. Available at: http://vnaa.org. Retrieved July 19, 2013.