January 23, 2012

Re: Proposed Regulations on Women’s Health Centers

Dear Member of the Board of Health:

 I am writing regarding the Board’s development of permanent regulations for women’s health centers in the Commonwealth. I am a board certified practicing urologist for about 34 years in the Commonwealth.  I have served on numerous ethics and quality assurance committees at various hospitals in the Richmond area.

It is my understanding that the Board of Health is not required to hold a public hearing about the proposed regulations on women’s health centers.  I respectfully request that the Board hold a public hearing in the next phase of the regulatory process and also request that the Board appoint a regulatory advisory panel in order to supply professional and technical expertise to the Board.  I specifically request that experts in the areas of women’s health which would include obstetricians and gynecologists, experts on first trimester pregnancy and experts on healthcare facilities. be appointed to serve on this panel.

The Board of Health must seek and follow guidance regarding what is medically appropriate and in the interest of patient health for the regulation of women’s health centers, because the current temporary regulations are neither medically appropriate nor in the interest of patient health.  The current regulations have a political and not medical origin.  The Board should not be a political entity and should be professional medical entity and the guardian of the health of people in the commonwealth.

Intro to the regulations

·      The current temporary regulations are unnecessarily burdensome and medically inappropriate. 

·      The Board of Health has the ability to revise the regulations to reflect medically appropriate standards.

·      Regulations for women’s health centers should be based on evidence-based medical practices that advance the public health.

·      This will maintain access to essential reproductive healthcare from trusted medical providers. 

·      I am deeply concerned that a number of the provisions of the temporary regulations pose threats to patient access to health care and confidentiality.

The physical plant requirements

·      The temporary regulations place architectural requirements on existing health care facilities from three chapters of a manual called the 2010 Guidelines for Design and Construction of Health Care Facilities.

·      These Guidelines are being misapplied – they are intended to apply only to new construction, not to existing facilities.

·      Existing women’s health centers have been offering safe care for many years, so there is no need to require them to entirely rebuild their facilities under new construction requirements. Forcing them to do so could reduce access to care.

·      Abortion is one of the most common surgical procedures sought by women in the United States and is an essential part of the comprehensive range of women’s reproductive health care.  Abortion is one of the safest medical procedures performed in the United States.

·      Women’s health centers offer an array of preventive reproductive healthcare services to tens of thousands of women as well as men in the Commonwealth. Medically inappropriate and unnecessarily burdensome regulations would limit access to a wide range of preventive reproductive healthcare services including life-saving cancer screenings, family planning and sexually transmitted infection testing and treatment, as well as early abortion.

Patient/provider confidentiality

·      The regulations that affect patient and provider safety and confidentiality are also deeply troubling. 

·      First, Department of Health employees are permitted to review a wide variety of records, with no protections for patient confidentiality, or provider and patient safety.

·      To allow unredacted patient records to be reviewed without any confidentiality protections is a violation of patient privacy and probably a violation of HIPPA.  

·       Moreover, Department employees would even be permitted to have a list of patients that have received care at the facility during the past 12 months and potentially to talk to any person “under the facility’s control, supervision or direction” while they are present. This is problematic because it would also allow non-medical personnel in the department to interview patients in violation of their privacy. 

·      Department representatives are permitted to arrive on the premises at any time for inspections, and the facility is required to give them access to the center without any consideration of whether the medical facility is open that day or whether the visit is within normal business hours.

Conclusion

·      The Board of Health is charged with protecting the public safety of the Commonwealth and expanding access to health care.

·      The Board of Health has the responsibility to amend these regulations so that they comport with medical standards of care and ensure access to reproductive health care. 

·      If the regulations meet medical standards of care, women’s health centers will be able to continue to provide safe, accessible, comprehensive health care in Virginia.

Isaac Koziol, MD

729 Woodson Place

Manakin-Sabot, VA 23103

804-784-5757 Home

804-357-0758 Cell