COMPLIANCE WITH GOVERNMENT REGULATIONS ^13 ^98 ^143 ^315

State and federal government regulations have a substantial effect on the health care workplace. Practitioners and managers of medical offices and clinics should recognize the regulations that affect the office and clinic set­ting and properly implement the procedures required by law.

• Occupational Safety and Health Administration (OSHA) Regulations on Occupational Exposure to Bloodborne Pathogens (Appendix D)

• Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Appendix E)

• Emergency Medical Treatment and Labor Act (EMTALA) (Appendix F)

• Americans With Disabilities Act (Appendix G)

• Title VI of the Civil Rights Act (Appendix H)

• Health Insurance Portability and Accountability Act (HIPAA) (Appendix I)

• Mammography Quality Standards Act (MQSA)

The Patient Protection and Affordable Care Act passed by Congress in 2010 also may produce additional requirements on physician practices. There are ongoing federal and state implementation efforts around many of these provisions, which make it important for obstetrician-gynecologists to stay abreast of new developments (see Resources).

Occupational Exposure to Bloodborne Pathogens Standard

In 1991, OSHA issued regulations designed to minimize the transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other potentially infectious materials in the workplace. The regulations went into effect in 1992 and were last revised in 2001. They are meant to protect all employees who work in any health-related facility from “rea­sonably anticipated” contact or exposure to blood and other potentially infectious materials. The regulations require a control plan to minimize employees’ exposure to all bloodborne pathogens. The plan must contain the following components:

• Personal protective equipment for employees exposed to blood and other body fluids

• Adoption of healthy work practices (eg, hand-washing)

• Adequate equipment for hand-washing

• Proper disposal of needles

• Appropriate handling and storage of specimens

• Adequate housekeeping to clean contaminated areas

• Provision of HBV vaccination to employees

• Postexposure evaluation and follow-up procedures

• Employee training

• Use of warning labels

• Record-keeping requirements

These requirements are enforced by OSHA or, in the case of states that have OSHA-approved comparable job safety and health plans, by state agencies.

In 1999, OSHA issued a revised compliance directive for the bloodborne pathogens standard. This directive clarifies the standard and emphasizes that employers must use readily available technology in their safety and health programs. For example, employers must ensure that their exposure review plans are reviewed annually and reflect consideration and use of commercially available safer medical devices, such as shielded needles. The directive also includes the Centers for Disease Control and Prevention guidelines on vaccinations to prevent HBV and on postexposure evaluation and follow-up for HIV and hepatitis C virus. It requires employee training on new and safer medical devices. As mandated by the Needlestick Safety and Prevention Act in 2001, OSHA again revised its bloodborne pathogens standard to clarify the need for employers to select safer needle devices as they become available. Employees must be involved in identifying and choosing the devices. Employers also are required to maintain a sharps injury log. Several states have enacted needlestick laws, and many more are considering such legislation. Practitioners can expect this standard to continue to evolve. For detailed information on the OSHA bloodborne pathogens standard, see Appendix D.

Clinical Laboratory Improvement Amendments

In 1988, Congress enacted the CLIA in response to growing public con­cerns regarding the quality and accuracy of laboratory testing. There have been updates and revisions to these regulations (see Bibliography).

Under CLIA, federal oversight is required for all nonresearch laborato­ries, including physician offices, which perform tests on human specimens for the health assessment, prevention, diagnosis, or treatment of any dis­ease. All laboratories and offices that conduct these tests must register with the Centers for Medicare & Medicaid Services and receive appropriate cer­tification. The certification depends on the complexity and type of testing done.

1. Waived tests, eg, urine pregnancy tests, blood glucose tests (over- the-counter)

2. Tests of moderate-level complexity—These include provider- performed microscopy procedures (eg, microscopic analysis of urinary sediment) and most of the testing performed in clinical laboratories

3. Tests of high-level complexity—These include tests that are the most difficult to perform or are the most subject to error. They usually are performed by a large clinical laboratory and are subject to the Centers for Medicare & Medicaid Services survey. Examples include nonautomated procedures, such as histopathologic tests.

The level of testing determines the type of certificate a laboratory or office is issued. There are five types of certificates: 1) Certificate of Waiver, 2) Certificate for Provider-Performed Microscopy Procedures, 3) Certificate of Registration, 4) Certificate of Compliance, and 5) Certificate of Accreditation. Each category of testing has different regulatory require­ments; the more complex the category of testing, the more stringent the regulations. Most obstetrician-gynecologists’ offices conduct only waived tests or provider-performed microscopy procedures, a subset of the moder­ate complexity tests. Appendix E provides basic information on these two categories of tests and the CLIA regulations governing these procedures.

When a laboratory office initially applies for a Certificate of Compliance or a Certificate of Accreditation, to conduct tests of moderate-level or high-level complexity, it is issued a registration certificate. This certificate authorizes the laboratory or office to conduct moderate-complexity testing, high-complexity testing, or both until it is verified through either an on-site survey or a nonprofit accreditation program that the laboratory meets all requirements.

Emergency Medical Treatment and Labor Act

The EMTALA contains specific federal legal requirements that apply to patient screening in emergency departments, the transfer of patients by Medicare-participating hospitals, and the care of pregnant women. It is essential that institutions and health care providers understand their obligations under the law. All Medicare-participating hospitals must pro­vide an appropriate medical screening examination for any individual who seeks medical treatment at an emergency department, and EMTALA places strict requirements on the transfer of these patients. Even hospitals that are not capable of handling high-risk deliveries or high-risk infants and have written transfer agreements must meet all the screening, treatment, and transfer requirements before transferring a patient.

An ongoing education program should be developed to inform users about the interhospital transfer service. The institutions that refer and receive should understand the clinical capabilities and special resources available. Periodic updates should be used to inform all participants involved in the transport program about new changes or procedures. For detailed information about the EMTALA requirements, see Appendix F.

Health Insurance Portability and Accountability Act When Congress passed HIPAA in 1996, the law was known primarily for its provisions that provide stronger health insurance protection for people leaving jobs and people with preexisting medical conditions. Over time, however, regulations have been developed to protect the privacy and security of certain health information. If a physician’s practice stores or transmits patient health information electronically, it must comply with the HIPAA regulations.

Mammography Quality Standards Act and Program

In 1992, Congress enacted the MQSA in response to concerns about breast cancer and the quality of mammography services in the United States. To operate lawfully after 1994, all mammography facilities, including physi­cian offices, must be certified by the U.S. Food and Drug Administration (FDA) as providing quality mammography services. This regulation applies even if an office has only one mammography unit and the film is pro­cessed and interpreted elsewhere. A facility must be certified either by the FDA or by an approved state certification agency as capable of providing quality mammography. In addition, a facility’s clinical images and mam­mography equipment must be reviewed periodically, and the facility must employ specially trained personnel to obtain the mammograms and inter­pret data, be inspected annually, and meet federally developed standards. Comprehensive regulations govern the requirements for mammography personnel, quality control, record keeping, and medical audits.

It is required that all women be sent a lay summary of their mammog­raphy results directly from the facility. Physicians who refer patients to mammography facilities still receive the examination report.

For more information, go to the MQSA home page (see Bibliography), which has a searchable Policy Guidance Help System. The National Cancer Institute Cancer Information Service (see Bibliography) also can assist call­ers in finding a mammography facility certified by the FDA.

Bibliography

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.

Americans with Disabilities Act, 42 U.S.C. §12101 (2011). Available at: http://www. gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap126.

Bloodborne pathogens, 29 C.F.R. part 1910.1030 (2013). Available at: http:// www.gpo.gov/fdsys/pkg/CFR-2013-title29-vol6/pdf/CFR-2013-title29-vol6- sec1910-1030.pdf. Retrieved September 20, 2013.

Certification of laboratories, 42 U.S.C. § 263a (2011). Available at: http://www. gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A- subchapII-partF-subpart2-sec263a.pdf. Retrieved September 20, 2013.

Civil Rights Act, 42 U.S.C. §2000d-2000d1 (2011). Available at: http://www. gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap21- subchapV.pdf. Retrieved September 20, 2013.

Department of Health and Human Services, Office of Population Affairs. Affordable Care Act. Available at: http://www.hhs.gov/opa/affordable-care-act/index.html. Retrieved September 26, 2013.

Examination and treatment for emergency medical conditions and women in labor, 42 U.S.C. § 1395dd (2011). Available at: http://www.gpo.gov/fdsys/pkg/USCODE- 2011-title42/pdf/USCODE-2011-title42-chap7-subchapXVIII-partE-sec1395dd.pdf. Retrieved September 20, 2013.

Food and Drug Administration. Mammography quality standards act and program. Available at: http://www.fda.gov/Radiation-EmittingProducts/Mammography QualityStandardsActandProgram/default.htm. Retrieved July 10, 2013.

Forming a just health care system. Committee Opinion No. 456. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;115:672-7. [PubMed] [Obstetrics & Gynecology]

Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 100 Stat. 1936. Available at: http://www.gpo.gov/fdsys/pkg/PLAW-104publ191/ pdf/PLAW-104publ191.pdf. Retrieved September 20, 2013.

National Cancer Institute. Cancer Information Service. Available at: http://www. cancer.gov/aboutnci/cis. Retrieved July 10, 2013.

Resources

American Congress of Obstetricians and Gynecologists. Government relations and outreach. Washington, DC: American Congress of Obstetricians and Gynecolo­gists; 2013. Available at: http://www.acog.org/About_ACOG/ACOG_Departments/ Government_Relations_and_Outreach. Retrieved July 16, 2013.

American Congress of Obstetricians and Gynecologists. Health system reform: the law, your practice, your patients. Washington, DC: American Congress of Obste­tricians and Gynecologists; 2010. Available at: http://www.acog.org/About_ACOG/ ACOG_Departments/Health_Care_Reform. Retrieved July 16, 2013.

American Congress of Obstetricians and Gynecologists. Practice management and managed care. Washington, DC: American Congress of Obstetricians and Gynecologists; 2013. Available at: http://www.acog.org/About_ACOG/ACOG_ Departments/Practice_Management_and_Managed_Care. Retrieved July 16, 2013.