The Commonwealth of Massachusetts

Executive Office of Health and Human Services
Department of Public Health
Division of Health Care Quality
99 Chauncy Street, 2nd Floor, Boston, MA 02111
617-753-8000

DEVAL L. PATRICK
GOVERNOR
TIMOTHY P. MURRAY
LIEUTENANT GOVERNOR
JUDYANN BIGBY, MD
SECRETARY
JOHN AUERBACH
COMMISSIONER	

Circular Letter:   DHCQ 08-06-492

TO:        Medical Director
               Acute Care Hospital

FROM:   Paul Dreyer, Ph.D.
               Bureau Director

DATE:    June 27, 2008		
 
RE:         Emergency Contraception

The purpose of this letter is to update you on the Department of Public Health’s (the Department’s) assessment of the Hospital’s compliance with the regulatory requirements of Chapter 91 of the Acts of 2005, An Act Providing Timely Access to Emergency Contraception, which took effect on December 14, 2005.  Thank you for submitting an affirmation and/or policies and protocols related to the provision of emergency contraception to sexual assault survivors. 

Department representatives have reviewed the affirmations and policies submitted, and have determined that your hospital is not in full compliance with certain elements of Chapter 91 of the Acts of 2005.  A revised copy of affirmations for you to sign and return is provided in Attachment A. Deficiencies specific to your hospital’s submission are noted in Attachment B.  A compliance checklist that will be used to evaluate your resubmission is provided for your convenience in Attachment C. 

To verify that the Hospital is in compliance with regulatory and statutory changes as the result of the enactment of Chapter 91, the Department requests that a newly signed affirmation along with revised hospital policies and protocols addressing the above mentioned deficiencies be sent to Ms. Lucille Gunn, Department of Public Health, Division of Health Care Quality, 99 Chauncy Street, Boston, MA 02111 by July 20th, 2008. 

Department representatives will be contacting hospitals that have not submitted revised hospital policies by the aforementioned deadline, and subsequent on-site reviews may be conducted to verify compliance.  We appreciate your continued cooperation with the implementation of this legislation.  If you have questions regarding this correspondence please contact Ms. Gail Palmeri at 617-753-8230 or email gail.palmeri@state.ma.us, or Ms. Lenore Tsikitas at 617-624-6059 or email lenore.tsikitas@state.ma.us.

Enclosures (4)
•	Updated Provider Sexual Crime Report
•	American College of Obstetricians and Gynecologists Practice Bulletin 
•	World Health Organization, Medical eligibility criteria for contraceptive use, excerpted
o	 Available at www.who.int/reproductive-health/publications/mec/index.htm 
•	Rape Crisis Center Referral List		

DEPARTMENT OF PUBLIC HEALTH	          	                                DIVISION OF HEALTH CARE QUALITY

ATTACHMENT A

HOSPITAL:						CAMPUS:	________			
Division of Health Care Quality
Hospital Affirmations 
105 CMR 130.1040 through 130.1043

The Hospital affirms the Emergency Department is: 
1)	Providing the medically and factually accurate written information prepared by the Commissioner of Public Health about emergency contraception to all persons who provide care to victims of sexual assault. 
2)	Promptly providing the medically and factually accurate written information about emergency contraception prepared by the Commissioner of Public Health to every female rape victim of childbearing age who presents at a facility after a rape.
3)	Promptly offering emergency contraception to each female rape victim of childbearing age and initiating emergency contraception upon her request.
4)	Reporting the administration of emergency contraception to each female rape victim of childbearing age with required reporting via the updated Provider Sexual Crime Report that includes the Emergency Contraception Report.

The Hospital also affirms that:
1)	The hospital provides a notice of patient rights, updated as amended by Chapter 91, to all patients as required by M.G.L. c. 111, § 70E.
2)	When providing Emergency Contraception, the hospital offers pills (i.e., not a prescription).
3)	Neither the hospital nor its staff requires any female rape victim of childbearing age to complete any part of a sexual assault evidence collection kit or police report as a condition of any of the following:
•	The provision of medically and factually accurate written information about emergency contraception; 
•	The prompt offering of emergency contraception; and 
•	The initiation of emergency contraception.  
3)	To ensure that particular hospital staff’s values or beliefs do not interfere with compliance with the law, the hospital will institute systems to ensure that all female rape victims of childbearing age are promptly provided medically and factually accurate information about emergency contraception, are promptly offered emergency contraception, and emergency contraception is initiated upon her request.
4)	If emergency contraception is not initiated upon the request of the female rape victim of childbearing age, the contraindication(s) for non-initiation are based on best clinical practice and information (such as American College of Obstetrics and Gynecology Practice Bulletin, 69, 2005; or World Health Organization Medical Eligibility Criteria for Contraceptive Use, Third edition, 2004).  The contraindications are documented in the patient’s medical record.    
_________________________				_____________
Signature									Date
_________________________				_____________
      Title									Hospital

DEPARTMENT OF PUBLIC HEALTH	          	                             DIVISION OF HEALTH CARE QUALITY

ATTACHMENT B

HOSPITAL:						CAMPUS:	________			

According to our review your hospital policies, protocols and affirmations:
	Do not contain updated information reflecting requirements of the law, as follows:
	Do not specifically call for the prompt provision of written information about EC to female rape survivors of childbearing age
	Do not specifically call for prompt provision and/or initiation of EC at the facility to 	each female rape victim of childbearing age, upon her request
	Do not state that EC pills, rather than a prescription, must be provided to survivors 
	Require completion of a sexual assault evidence collection kit, or do not specifically state that completion of a sexual assault evidence collection kit or police report is not required, prior to the provision of EC
	Do not specify that documentation of EC administration to rape survivors must be 	reported via the updated Provider Sexual Crime Report (PSCR) that includes the 	Emergency Contraception Report (last updated 1/2008)
	Contain medical information inconsistent with recent evidence-based clinical guidelines 	such as those published by the American College of Obstetricians and Gynecologists (ACOG) or the World Health Organization (WHO).   The policies and protocols:
	State that EC will cause birth defects or necessitate an abortion if pregnancy results
	State that EC should not be given after 72 hours
	State that EC is contraindicated if an ovulation test is positive
	Other:
		Does not specify that the hospital provides a notice of patient rights, updated as 			amended by Chapter 91, to all patients as required by M.G.L. c. 111, § 70E.

Hospital policies and protocols must be revised to include specific language that details the regulatory requirements of the law. The Department is concerned about any barriers to compliance hospitals are encountering, and is preparing materials to assist hospitals in the further development of their protocols.  Information will be posted on the Department website when complete: (www.mass.gov/emergencycontraception).   

DEPARTMENT OF PUBLIC HEALTH	          	                             DIVISION OF HEALTH CARE QUALITY

ATTACHMENT C

HOSPITAL:						CAMPUS:	________			

Requirements for Compliance with Chapter 91 of the Acts of 2005
•	When hospitals initiate emergency contraception (EC) upon the request of a female rape victim of childbearing age, hospitals must provide emergency contraceptive pills.  The provision of a prescription for emergency contraception pills does not constitute compliance. 
•	Hospitals and their staff cannot require any female rape victim of childbearing age to complete any part of a sexual assault evidence collection kit or police report as a condition for any of the following: 
	− The provision of medically and factually accurate written information about emergency contraception; 
	− The prompt offering of emergency contraception; or 
	− The initiation of emergency contraception. 
•	When hospitals initiate emergency contraception upon the request of a female rape victim of childbearing age, hospitals must report the administration of emergency contraception with required reporting via the Provider Sexual Crime Report.

Access to Emergency Contraception Compliance Checklist
Please use this checklist which is based on the law posted at www.mass.gov/emergencycontraception to assess the Hospital’s EC policy and ensure that it reflects the provisions identified in the law prior to resubmission.

In order to demonstrate compliance all policies, protocols and affirmations must:
Specifically call for the prompt provision of written information about emergency contraception (EC) prepared by the Department of Public Health to female rape survivors of child bearing age
Specifically call for prompt provision of emergency contraception at the facility to each female rape victim and initiation of EC upon her request
Specifically state that EC pills, not a prescription, are provided to survivors 
 Specifically state that no sexual assault evidence collection kit or police report is required prior to the provision of emergency contraception. 
Specify that the administration of emergency contraception to rape survivors must be reported via the updated Provider Sexual Crime Report that includes the Emergency Contraception Report
Contain medically accurate information and appropriate directions for administration of EC according to recent evidence-based clinical guidelines such as those published by the American College of Obstetricians and Gynecologists or the World Health Organization 
	Affirm that the hospital provides a notice of patient rights, updated as amended by Chapter 91, to all patients as required by M.G.L. c. 111, § 70E