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Americans United for Life Comment 1 July 31, 2014

SUBMITTED ELECTRONICALLY

July 31, 2014

Denise M. Burke, Esq.

Vice President of Legal Affairs

Americans United for Life

655 15th Street, N.W., Suite 410

Washington, DC 20005

Mr. Erik Bodin

Director, VDH, Office of Licensure and Certification

9960 Maryland Drive, Suite 401

Henrico, VA 23233

Dear Mr. Bodin:

Pursuant to Executive Order 14 (2010), §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, and

Executive Directive ED-01 (May 12, 2014), the Virginia Board of Health has been directed to

conduct a periodic review and small business impact review of 12 VAC 5-412, Regulations for

the Licensure of Abortion Facilities (hereinafter, “Virginia clinic regulations”). In connection

with this review, public comment has been sought on any issue relating to these regulations,

including whether the regulations are necessary for the protection of public health, safety, and

welfare. Opinion has also been sought as to whether the Virginia clinic regulations should be

retained in their current form, amended, or repealed.

For more than a decade, Americans United for Life (AUL) has been recognized as a leading

authority on comprehensive and medically appropriate regulation and oversight of abortion

facilities. Our expertise includes drafting model legislation providing medically appropriate

health and safety standards for abortion facilities, participating in administrative rule-making

proceedings, and defending abortion facility regulations that are challenged in federal and state

courts. AUL previously provided input on and analysis of the Virginia clinic regulations and

testified on two occasions before the Virginia Board of Health in support of the regulations.


I have thoroughly reviewed the Virginia clinic regulations and specifically compared them to

nationally recognized standards for ambulatory surgical centers, regulatory schemes in other

states, and to abortion facility regulations that have been approved by both state

administrative authorities and the courts.

Based on this extensive review, I concluded that the Virginia clinic regulations are necessary to

protect public health and safety, to comport with standards promulgated by national medical

authorities, and to conform to U.S. Supreme Court decisions and other legal precedent. As

such, they should be retained in their current form.

The Virginia clinic regulations are necessary to protect public health and safety.

The Virginia clinic regulations are necessary to protect public health and safety for three

primary reasons: (a) abortion is an invasive surgical procedure that can lead to numerous and

serious medical complications; (b) even conservative estimates of abortion complication rates

support the need for the Virginia clinic regulations; and (c) inspections of abortion facilities in

Virginia have revealed that many have failed to comply with commonsense health and safety

standards including the Virginia clinic regulations.

Abortion is an invasive surgical procedure that can lead to numerous and serious medical

complications.

Potential complications for first-trimester abortions include, among others, bleeding,

hemorrhage, infection, uterine perforation, blood clots, cervical tears, incomplete abortion

(retained tissue), failure to actually terminate the pregnancy, free fluid in the abdomen, acute

abdomen, missed ectopic pregnancies, cardiac arrest, sepsis, respiratory arrest, reactions to

anesthesia, fertility problems, emotional problems, and even death.1

Moreover, the risks for second-trimester abortions are greater than for first-trimester

abortions. The risk of hemorrhage, in particular, is greater, and the resultant complications

may require a hysterectomy, other reparative surgery, or a blood transfusion.2

As the author of a leading abortion textbook writes, “[T]here are few surgical procedures given

so little attention and so underrated in its potential hazard as abortion.”3

Published abortion complication rates support the need for the Virginia clinic regulations.

1 Information on abortion complications is drawn from depositions, responses to interrogatories, and other

discovery in Tucson Woman’s Clinic v. Eden, No. CIV 00-141-TUC-RCC (D. Ariz. Oct. 1, 2002). 2 See id. 3 Warren M. Hern, Abortion Practice 101 (1990).


Relying on the abortion industry’s own conservative estimates of complication rates along with

the pro-abortion Guttmacher Institute’s latest report on induced abortions, in 2011 alone, more

than 26,000 women experienced abortion-related complications, and more than 3,000 of these

women required hospitalization.4 These numbers are not insignificant. Instead, they attest to a

serious public health concern.

Virginia abortion facilities have repeatedly failed to comply with health and safety standards.

Beginning in 2012, Virginia abortion facilities were inspected by state health officials for

compliance with the Virginia clinic regulations. At least 17 Virginia abortion facilities were cited

for violations. Some of these clinics were cited in early 2012 and were again cited later that

same year, in 2013, and/or in 2014.

Some of the deficiency reports from the inspections were dozens of pages long, enumerating

numerous incidents of inferior care, substandard conditions, and serious and obvious disregard

for patient welfare in the cited abortion facilities. Some reports also noted repeat violations

that had not been corrected after earlier inspections, despite plans of correction purportedly

agreed to by the abortion facilities. Clearly, the substandard conditions and practices in Virginia

abortion facilities cannot be permitted to continue.

Importantly, a careful review of the Statement of Deficiencies and Plan of Correction issued by

Virginia health inspectors confirms that the Virginia clinic regulations must be retained in their

current form and properly enforced. Among the deficiencies commonly cited by state

inspectors was failure to maintain the facility’s physical plant, existence of unsanitary

conditions and practices in the abortion facilities, presence and apparent use of expired

medications, failure to properly document patient and employee records, and failure to have

needed policies and procedures in place. Other violations included failure to ensure that

physicians were competent to perform abortions, failure to wash hands and disinfect

examination tables between patients, and failure to comply with the state’s parental

involvement law.

4 See “Induced Abortion in the United States,” dated February 2014, available at

http://www.guttmacher.org/pubs/fb_induced_abortion.html (last visited July 22, 2014). Guttmacher reported

1.06 million abortions in 2011. Abortion advocates routinely claim that 2.5% of women who have a first-trimester

abortion “undergo minor complications,” and that “fewer than 0.3%” experience a complication requiring

hospitalization. See, e.g., Planned Parenthood v. Abbott, No. 13-51008 at *8 (5th Cir. Mar. 28, 2014), available at

http://www.ca5.uscourts.gov/opinions%5Cpub%5C13/13-51008-CV1.pdf (last visited July 22, 2014). Using these

figures for base-line calculations, you can estimate that, in 2011 alone, 26,500 women experienced complications

and approximately 3180 women required post-abortion hospitalization.

http://www.guttmacher.org/pubs/fb_induced_abortion.html

http://www.ca5.uscourts.gov/opinions%5Cpub%5C13/13-51008-CV1.pdf


Below is a summary of the deficiency reports issued to each of the 17 abortion facilities (in

alphabetical order):

Alexandria Women’s Health Clinic

Statement of Deficiencies and Plan of Correction, dated July 19, 2012

1. Failure to ensure governing body appointed clinic administrator and that clinic staff

were given privileges to practice in the facility

2. Failure to ensure policies in place regarding:

a. Types of elective services

b. Types of anesthesia

c. Admission and discharge criteria

d. Obtaining of patient consent

e. Management and response to fire

f. Disaster preparedness

g. Patients’ rights

3. Failure to ensure that governing body appointed, in writing, the person to act in the

absence of the administrator

4. Failure to ensure verification of medical licenses of nursing and medical staff

5. Failure to ensure Criminal Background Check Report on file for all employees with

access to controlled substances

6. Failure to ensure policy in place regarding the initial and ongoing training and education

of staff

7. Failure to have policy in place regarding the reporting to the appropriate board, of any

violations of licensing/certification requirements

8. Failure to ensure physicians were licensed to practice in Virginia and have necessary

training and experience to perform abortions

9. Failure to ensure each patient was given a copy of their rights and responsibilities upon

admission

10. Failure to ensure a person was designated to handle intake investigation and resolution

and notification of complaints

11. Failure to ensure staff followed infection prevention program

12. Failure to ensure policies regarding how scrub attire and blankets for patient use were

to be laundered to prevent spread of infections

13. Failure to have policy in place regarding criteria for discharge from anesthesia care

14. Failure to maintain records regarding drugs in such a manner as to be able to regularly

perform a narcotic count


15. Failure to ensure equipment was maintained to prevent infection and to ensure expired

supplies were not available for use

16. Failure to implement an ongoing, comprehensive, integrated self-assessment program

of the quality and appropriateness of services and care

17. Failure to implement policies regarding fire and disaster safety

18. Failure to ensure firefighting equipment inspected and safely secured

19. Failure to ensure compliance with all building codes

Statement of Deficiencies and Plan of Correction, dated March 27, 2013

1. Ten repeat violations from July 19, 2012

2. Governing body failed to ensure facility operated in compliance with state regulations

regarding:

a. Staff training

b. Infection control

c. Appointment of administrator

d. Licensing

e. Reporting of violations

3. Failure to ensure suitable equipment available for use in patient care areas

4. Failure to ensure drugs were not expired and staff were educated on drugs available

5. Failure to ensure staff trained on proper infection control procedures such as proper

hand-washing and safe injection practices.

Amethyst Health Center for Women

Statement of Deficiencies and Plan of Correction, dated June 1, 2012

1. Failure to ensure staff followed infection prevention program

2. Failure to ensure drugs and supplies available for administration were properly stored

and not expired

3. Quality Assurance Meeting minutes, failed to address the following subjects:

a. Staffing patterns and performance

b. The level of supervision, appropriate to the level of service

c. Patient records

d. Patient satisfaction

e. Infections

f. Complaint resolution

g. Complications and other adverse events

h. Staff concerns regarding patient care



5. Failure to have clean utility room in which patient medications can be prepared

Statement of Deficiencies and Plan of Correction, dated December 11, 2012

1. One repeat violation from June 1, 2012 report



3. Failure to ensure supplies were not expired, that proper cleaning of the instruments was

done, once removed from its protective covering IV solution was dated as to when it

would expire, proper cleaning of equipment used on patients was done, and that proper

hand hygiene was performed following patient care

4. Failure to document adequately the complete examination of the products of

conception for all patients

5. Failure to ensure medications available for use were not expired

6. Failure to ensure all Schedule II-V drugs received, administered, and disposed of was

done so in accordance with the Drug Control Act:

a. Narcotic log book contained documentation of information that had scribbling

over dates, patient names, and amounts of medications administered and

arrows rather than documentation of what and how much of a medication was

administered

b. The narcotics log also did not contain witnessed wastage of narcotics. The facility

administered Propofol (unscheduled), Fentanyl (Schedule II), Versed (Schedule

III) for conscious sedation and failed to document the medications' wasting

7. Failure to ensure the medical record was accurate and complete for all patients

Capitol Women’s Health Clinic

Statement of Deficiencies and Plan of Correction, dated May 21, 2012



9. Failure to ensure infection prevention:

a. Failure to wear PPEs

b. Reuse of sponges to clean equipment

c. Failure to ensure cleaning supplies not expired

d. Improper cleaning of soiled linens

e. Placement of soiled linens and biohazard waste receptacles

f. Failure to perform hand hygiene between glove changes

10. Failure to maintain adequate medical equipment


11. Failure to ensure medical equipment kept in good repair, free of hazards, or to maintain

infection prevention precautions for the cleaning and disinfection of all surfaces.


Charlottesville Medical Center for Women

Statement of Deficiencies and Plan of Correction, dated August 1, 2012

1. Failure by governing board to identify the person or organizational body responsible for

formulating policies

2. Failure to ensure policies in place regarding the initial and ongoing training of staff

3. Failure to ensure policies in place regarding the annual training of all staff in

recommended infection protection practices

4. Failure to have a policy in place regarding the handling, storing, processing, and

transporting of regulated medical waste

5. Failure to develop, implement, and maintain policies for patient education, follow up

and reporting, including:

a. Discharge instructions related to signs of infection

b. Procedures for surveillance, documentation, tracking, and reporting of infections

6. Failure to ensure all laboratory supplies were monitored for expiration dates

7. Failure to have policy in place regarding the criteria for discharge from anesthesia care

8. Failure to have required equipment and supplies when administering moderate or

conscious sedation

9. Failure to implement an ongoing, comprehensive, and integrated self-assessment

program of the quality and appropriateness of services and care



1. Five repeat violations from August 1, 2012 report

2. Failure by governing body to ensure the facility plan of correction was implemented and

that the facility was in compliance with state regulations

3. Failure to ensure employee records contained a written application and verification of

training, experience or education

4. Failure to implement its policies related to orientation and training specific to staff

duties

5. Failure to ensure employee records contained job descriptions and documentation that

the employee received a current job description

6. Failure to maintain complete and accurate employee records


7. Failure to ensure discharge orders were signed after an assessment of the patient

indicating the patient was safe for discharge

8. Failure to implement necessary controls to prevent the transmission of infections,

specifically the facility failed to perform weekly spore testing for one autoclave

9. Failure to implement policies and procedures regarding patient education and failure to

implement infection monitoring and reporting activities

10. Failure to ensure a medical history and physical examination was completed for all

patients

11. Failure to implement its policy regarding criteria for discharge from anesthesia care

12. Failure to ensure an ongoing, comprehensive, and integrated self-assessment/Quality

Assurance program was implemented

13. Failure to maintain accurate and complete clinical records for all patients

Charlottesville Planned Parenthood


1. Failure by governing board to incorporate a provision in their bylaws for the selection

and appointment of clinical staff and for the granting of clinical privileges

2. Failure by governing board to name a person appointed to serve as clinic administrator

3. Failure to obtain verification of licensure for all staff



5. Failure to ensure policies in place regarding the initial and ongoing training of staff

6. Failure to have policy in place regarding the reporting to the appropriate board, of any


7. Failure to provide patients with contact information for person designated to receive

complaints or concerns

8. Failure to ensure person designated as infection preventionist had the training and

expertise necessary to direct an infection control program

9. Failure to ensure exam tables and recovery chairs were free of tears that posed a risk for

the spread of infection

10. Failure to document discharge orders for all patients

11. Failure to ensure medications that were opened and accessed were dated and discarded

when expired and failure to follow Virginia Department of Health guidelines for the

repacking of medications

12. Failure to develop, implement, and maintain polices to ensure safety in regards to the

storage of sharps containers



Falls Church Healthcare Center


1. Failure by governing board to ensure staff followed infection prevention program and

the required components for the quality improvement program and to have written

bylaws for the facility

2. Failure by governing board to make policies available to the Office of Licensure and

Certification as required by law


4. Failure by governing body to have written policies in place regarding:

a. Obtaining criminal background records checks

b. Reporting violations to the appropriate Boards

c. Job descriptions that describe authority

5. Failure to notify the state licensing agency regarding change of administrator


in the absence of the regular administrator



8. Failure to ensure that job descriptions for all employees were reviewed annually

9. Failure to ensure all staff obtained required vaccines

10. Failure to ensure policies in place regarding the handling of complaints

11. Failure to have a policy in place to prevention of infections:

a. Failure to ensure implementation of safe injection practices

b. Failure to follow OSHA blood-borne pathogen training requirements

c. Failure to monitor staff adherence to infection prevention

d. Failure to develop plan for annual staff training on infection prevention

12. Failure to:

a. Ensure linens and other items were handled in a manner to prevention

contamination and infection

b. Perform appropriate cleaning of surfaces

c. Ensure proper storage of all items

13. Failure to comply with all employee health program health requirements

14. Failure to have a procedure for the documentation and tracking of reported infections,

as well as failure to have policy for the required reporting of said infections to the local

health department as required by law

15. Failure to ensure emergency supplies were available in all procedure rooms and that all

emergency supplies were checked for expiration dates




17. Failure to ensure policy in place regarding the reporting of sexually transmitted

infections

18. Failure to ensure policy regarding the reporting of patients deaths to the state licensing

agency within 24 hours

19. Failure to have a preventive maintenance program to prevent equipment malfunctions



1. Three repeat citations from August 2, 2012 report

2. Failure to ensure job descriptions for all employees were signed and included in the

employee personnel files

3. Failure to implement its policies related to safe injection practices and to expired

medications available for administration

4. Failure to ensure that emergency medications and intravenous fluids available for

administration to patients were not expired

Hillcrest Clinic




2. Failure to provide patients with information regarding complaints and concerns


a. Failure ensure staff followed manufacturers’ instructions when using cleaning

agents for the cleaning of reusable medical equipment

b. Failure to follow hand hygiene between patients

c. Improper cleaning of soiled linens

d. Improper storage of soiled linens

e. Failure to ensure exam tables and recovery chairs were free of tears that posed a

risk for the spread of infection

4. Failure to maintain medical equipment and supplies in safe operating condition:

a. Rusty equipment

b. Expired supplies

5. Failure to develop, implement, and maintain polices to ensure safety in regards to the

storage of sharps containers




NOVA Women’s Healthcare


1. Failure by governing body to ensure policies in place regarding:

a. Delineation of privileges for all physicians

b. Physicians signing, dating, and timing orders for medications and discharge

c. Completion of a patient medical history and examination by physician prior to

abortion

d. Staff training and competency for identifying anatomy associated with “products

of conception”

2. Failure to ensure that staff training and competency for identifying anatomy associated

with “products of conception” was documented

3. Failure to document the clinical privileges for all staff

4. Failure to ensure written discharge orders for all patients

5. Failure to ensure each patient was given a copy of their rights and responsibilities upon

admission

6. Failure to ensure policies in place regarding the handling of complaints

7. Failure to provide patients with correct contact information for the state licensing

agency’s toll-free complaint line

8. Failure to provide staff with training in the prevention of infection

9. Failure to:

a. Enforce policies for the disinfection of equipment between patients

b. Ensure an effective pest control program

10. Failure to ensure a medical history and physical examination was completed for all

patients

11. Failure to ensure policies in place regarding providing patients with pre-operative

counseling

12. Failure to accurately document anesthesia levels for all patients


when expired

14. Failure to ensure that quality assurance documentation was kept regarding failures and

corrective actions taken

15. Failure to ensure medical records complete for each patient

16. Failure to ensure policy in place regarding facility security

17. Failure to ensure equipment was maintained and safe for use




1. Seven repeat violations from July 26, 2012 report

2. Failure to post its license in a readily visible and accessible manner

3. Failure by governing body to monitor and to ensure that the following

policies/procedures and processes were implemented concerning:

a. Delineation of privileges for all physicians

b. Ensuring Quality Assurance/Performance Improvement meetings were held to

monitor facility quality

c. Notify the state licensing office related to a change in administrators

4. Failure to notify State licensing office regarding a change in administrators

5. Failure to ensure that physician privileges were documented for all physicians

6. Failure to correct and maintain safe injection practices:

a. The facility had opened medication vials accessed with an open needle in the

vial's rubber septum, expired medications, opened undated medications, opened

single use vials stored, expired intravenous (IV) solutions, and medications

opened after their expiration dates were available for administration to patients

7. Failure to ensure the proper cleaning and disinfection of equipment between patients

8. Failure by anesthesiologist to store medications used for anesthesia in a manner that

restricted access to unauthorized staff. In addition, the anesthesiologist stored

anesthesia medications in the lock box with open needles penetrating the septum of the

vials.

9. Failure to ensure staff stored medications used for anesthesia in a manner that

restricted access to unauthorized staff and failure to ensure that the anesthesiologist

did not store anesthesia medications in the lock box with open needles penetrating the

septum of the vials

10. Failure to ensure a Quality Assurance/Quality Improvement process was carried out

which addressed the adequacy and appropriateness of services and identification of

trends and occurrences

11. Failure to ensure all equipment was kept in good repair and operating condition by the

implementation and continued monitoring by a preventative maintenance system

Peninsula Medical Center for Women

Statement of Deficiencies and Plan of Correction, dated May 31, 2012 (partial)

1. Failure to ensure the medications were not expired


3. Failure to implement and maintain a preventive maintenance program for all equipment


4. Failure to store sharps containers and safe manner and to clean exam tables between

patients

5. Failure to implement Quality Assurance program to evaluate the following:

a. Staffing patterns and performance

b. Supervision appropriate to the level of service

c. Patient satisfaction

d. Patient records

6. Failure to ensure the necessary medical equipment and supplies were available to care

for patients in the event of an emergency

7. Failure to ensure the necessary medical equipment and supplies were available to care

for patients

8. Failure to ensure complete examination of the “products of conception” for all patients

9. Failure to ensure policy regarding the dispensing of medications

10. Failure to ensure policies in place regarding providing patients with pre-operative

counseling


a. Hand hygiene

b. Cleaning, disposal, storage, and transport of equipment, linen, and supplies

c. Product-specific instructions for the use of cleaning agents

d. Procedures for handling, storing, and supporting medical waste

e. Pest control

f. Infection prevention procedures

12. Failure to ensure policies in place regarding the screening of incoming patients and

visitors for acute infectious illnesses

13. Failure to ensure person designated as infection preventionist had the training and

expertise necessary to direct an infection control program

14. Failure to ensure policies in place regarding services for a minor who is not emancipated

15. Failure to ensure physicians have necessary training and experience to perform

abortions


17. Failure to ensure employee records contained job descriptions and documentation that

the employee received a current job description

18. Failure to ensure verification of medical licenses of nursing and medical staff



20. Failure to notify the state licensing agency regarding clinic ownership

Planned Parenthood-Blacksburg



21. Failure by governing board to ensure staff followed infection prevention program and

the required components for the quality improvement program

22. Failure to notify the state licensing agency regarding change of ownership

23. Failure to incorporate a provision in their bylaws for the selection and appointment of

clinical staff and for the granting of clinical privileges

24. Failure to ensure a documented method developed for the annual review of policies for

personnel and failed to develop infection prevention policies

25. Failure to ensure a policy in place for reporting immediately, any changes in

administrator to the state licensing agency

26. Failure to have policy in place regarding the reporting to the appropriate board of any


27. Failure to have policy regarding the writing of discharge orders for patients

28. Failure to disinfect sonogram procedure table between patients

29. Failure to ensure policies regarding to employee health included the recommended

vaccines



health department, as required by law

31. Failure to have required emergency equipment on site

32. Failure to ensure that quality assurance documentation was kept regarding failures and

corrective actions taken


34. Failure to ensure that all abortions were reported to the appropriate state agency, as

required by law




Planned Parenthood of Metropolitan Washington-Falls Church

Statement of Deficiencies and Plan of Correction, dated June 29, 2012

1. Failure to ensure staff certification in CPR

2. Failure to ensure the proper cleaning and disinfection of exam tables and recovery

chairs between patients

3. Failure to ensure medications available for use were properly stored and not expired

4. Failure to ensure mixing of medications was done in accordance with Board of Medicine

regulations


5. Failure to implement and maintain a preventive maintenance program for all equipment


Planned Parenthood-Roanoke




2. Failure to ensure job performance reviews were annually performed for all staff

3. Failure to ensure development and implementation of infection prevention policies

4. Failure to ensure equipment disinfected between patient use

5. Failure to comply with all employee health program health requirements



health department as required by law

7. Failure to have policy in place regarding the reporting to the appropriate board of any


8. Failure to ensure a Quality Assurance/Quality Improvement process was carried out




Roanoke Medical Center for Women


1. Failure to document annual review of policies



3. Failure to ensure employee records contained job descriptions and documentation the

employee received a current job description

4. Failure to document annual review of infection prevention policies

5. Failure to implement infection prevention policies

6. Failure to follow OSHA blood-borne pathogen training requirements

7. Failure to have procedure for tracking infections






1. Four repeat violations from July 18, 2012 report

2. Failure to ensure the Quality Assurance Committee met, identified deficiencies,

recommended corrections, and reported its findings to the governing body

3. Failure to specify authority, responsibility, and qualifications for each job description

4. Failure to ensure informed written consent was obtained from the minor's parent or

guardian for all minor patients who had a procedure to terminate pregnancy

5. Failure to document that all patients received and understood their rights and

responsibilities and the complaint/grievance process

6. Failure to ensure:

a. Staff used safe injection and medication practices by ensuring expired

medications were not available for administration to patients

b. Staff practice correct hand hygiene and hand washing to prevent the spread of

infections

7. Failure to implement polices/procedures for the prevention and control of infections as

evidenced by:

a. Not providing adequate hand hygiene equipment in the "dirty" staff utility room

b. Not ensuring disinfection between patients

8. Failure to document the medical diagnosis and gestational age within the clinical record

for all patients

9. Failure to implement their discharge criteria policy and procedures for all patients that

received local anesthesia or conscious sedation

10. Failure to implement its quality assurance policies and procedures

11. Failure to maintain complete and accurate medical records for all patients


1. Two repeat violation from December 19, 2012 report

2. Failure to ensure that recovery chairs were free of tears that posed a risk for the spread

of infection

3. Failure to ensure drugs were not expired

Tidewater Women’s Health Clinic





a. Failing to wear/ change Personal Protection Equipment (PPEs) as needed

b. Improper storage of supplies


c. Unsanitary surfaces

d. Use of unsanitary water for cleaning

e. Supplies scheduled for later use opened and left uncovered on counter

13. Drugs labeled for single use were used as multi-use

14. Injectable medications not mixed and labeled properly

15. Failure to maintain medical equipment and supplies in safe operating condition:

f. Suction machine rusted

g. Oxygen tanks not secured

h. Recliners in recovery room torn, and sticky residue on arms

16. Failure to maintain wall paper in recovery room to prevent growth of mold


Virginia League for Planned Parenthood


1. Failure to ensure medications available for use were properly stored and not expired


Virginia Health Group


1. Failure to document that all patients received and understood their rights and

responsibilities and the complaint/grievance process

2. Failure to ensure that governing body appointed, in writing, the person to act in the

absence of the administrator


a. Job descriptions

b. Verification of staff licenses

c. Reporting of certification/licensing violations


5. Failure to provide patients with contact information for person designated to receive

complaints or concerns

6. Failure to ensure disinfection of equipment between patients


when expired

8. Failure to document discharge orders for all patients


agency within 24 hours was in place



Virginia Women’s Wellness


1. Failure to notify the state licensing agency regarding clinic ownership



3. Failure to provide patients with correct contact information for the state licensing

agency’s toll-free complaint line


a. Disinfection of equipment between patient use

b. Transporting, storage, and cleaning of soiled linens

c. Cleaning of surfaces

5. Failure to follow manufacturers’ directions for the administration of controlled

substance single dose vials

6. Failure to ensure mixing of medications was done in accordance with Board of Medicine

regulations




9. Failure to ensure all equipment kept in good repair, free of hazards, or to maintain

infection prevention precautions for the cleaning and disinfection of all surfaces


11. Failure to have a monitoring program for fire and safety



1. One repeat violation from May 6, 2012 report

2. Failure to have a system for logging receipt of, investigation of, and resolution of patient

complaints

3. Failure to store controlled substances and other medications in a safe manner




2. Failure to implement facility’s own policies regarding maintenance

3. Failure to implement facility’s own policies regarding employee records

4. Failure to document the investigation of and resolution of all patient complaints


5. Failure to ensure staff trained on proper infection control procedures such as proper

hand-washing and safe injection practices

6. Failure to ensure proper disinfection of equipment between patients and proper storage

of cleaning agents

7. Failure to have policy in place regarding criteria for discharge from anesthesia care

8. Failure to ensure policy in place regarding the proper storage of medications

9. Failure to maintain medical equipment and supplies in safe operating condition

10. Failure to have required emergency drugs on site

11. Failure to ensure the medical record was accurate and complete for all patients

12. Failure to ensure the medical records of all patients were properly stored and secure

13. Failure to ensure policy regarding the reporting of patient deaths to the state licensing


14. Failure to ensure the proper storage of supplies

15. Failure to ensure facility’s structure in good repair and operating condition

The Virginia clinic regulations comport with standards promulgated by national

medical authorities.

Notably, the current Virginia clinic regulations closely track nationally recognized standards for

ambulatory surgical centers. Specifically, the standards delineated in the Virginia clinic

regulations parallel those contained in the Joint Commission Standards for Ambulatory Care

(sometimes referred to as the “JCAHO standards”).5

The Joint Commission is an independent, not-for-profit organization that accredits and certifies

more than 20,500 healthcare organizations and programs in the United States. Joint

Commission accreditation and certification is recognized nationwide as a symbol of quality that

reflects an organization’s commitment to meeting high performance standards.6

Importantly, women undergoing abortions deserve the high standard of care mandated by the

Virginia clinic regulations – and similarly required by the JCAHO standards. Indeed, this

rigorous standard of care has been mandated for many other surgical procedures and in many

other medical contexts. For example, the federal government requires that ambulatory surgical

5 More information about the Joint Commission and its standards for ambulatory care can be found at

http://www.jointcommission.org/accreditation/ambulatory_healthcare.aspx (last visited July 23, 2014). 6 See generally, “About the Joint Commission,” available at

http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx (last visited July 23, 2014).

http://www.jointcommission.org/accreditation/ambulatory_healthcare.aspx

http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx


centers providing care to patients under Medicare met similarly high standards for patient care

and facility safety. 7

The Virginia clinic regulations conform to U.S. Supreme Court decisions and

other legal precedent.

The U.S. Supreme Court and other courts have repeatedly recognized and supported the need

for stringent and protective abortion facility regulations. In fact, comprehensive regulatory

schemes for abortion facilities in other states have repeatedly withstood judicial scrutiny.8

Since Roe v. Wade,9 the U.S. Supreme Court has repeatedly acknowledged that a state has “a

legitimate interest in seeing to it that abortion, like any other medical procedure, is performed

under circumstances that ensure maximum safety for the patient.”10 Specifically, the Supreme

Court has determined that the state’s legitimate interest in regulating abortion to protect

maternal health, “obviously extends at least to [regulating] the performing physician and his

staff, to the facilities involved, to the availability of after-care, and to adequate provision for

any complication or emergency that may arise.”11

Importantly, abortion facility regulations protect women and do not impose an “undue

burden.”12 Federal courts have repeatedly and summarily rejected the argument that abortion

facility regulations impose an “undue burden” on women seeking abortions by increasing the

cost of abortions or by decreasing the number of providers.13

The abortion right has been specifically defined by the U.S. Supreme Court as “the right of the

women herself,”14 not as the “right” of abortion facilities or individual providers to practice

7 See 42 C.F.R. 416 et seq.

8 See, e.g., Greenville Women’s Clinic v. Bryant, 222 F.3d 157 (4th Cir. 2000) (South Carolina’s abortion facility

regulations); Women’s Med. Ctr. v. Bell, 248 F.3d 411 (5th Cir. 2001) (Texas’ pre-2014 abortion facility regulations);

and Tucson Woman’s Clinic v. Eden, 379 F.3d 531 (9th Cir. 2004) (Arizona’s abortion facility regulations). 9 Roe v. Wade, 410 U.S. 113 (1973). 10 Roe v. Wade, 410 U.S. at 150; see also, Planned Parenthood of Southeastern Penn. v. Casey, 505 U.S. 833, 847

(1992). 11 Roe v. Wade, 410 U.S. at 150. 12 Since the U.S. Supreme Court’s 1992 decision in Planned Parenthood v. Casey, the “undue burden” standard is

the current standard of judicial review for abortion-related restrictions and regulations. See generally, Planned

Parenthood of Southeastern Penn. v. Casey, 505 U.S. 833 (1992). 13 See, e.g., Greenville Women’s Clinic, 222 F.3d 157 (4th Cir. 2000); Women’s Med. Ctr. v. Bell, 248 F.3d 411 (5th

Cir. 2001); Bristol Reg’l Women’s Ctr., P.C. v. Tenn. Dep’t of Health, No. 3:99-0465 (D. Tenn. Oct. 22, 2001). 14 Planned Parenthood of Southeastern Penn. v. Casey, 505 U.S at 877 (1992).


without appropriate regulation or oversight, to charge a certain fee for their services, or to

make a profit.

In evaluating challenges to abortion facility regulations, federal courts have repeatedly

determined that the simple fact that health and safety regulations may inconvenience some

abortion providers or may result in an expenditure of time and money to come into compliance

with the regulations does not create a burden on the woman seeking an abortion (as opposed

to placing a burden on the abortion facility or provider).

Finally, even assuming the specific regulatory scheme would lead to an increase in the cost of

abortions in the state and/or result in fewer abortion providers, the U.S. Supreme Court has

held “the fact that a law which serves a valid purpose, one not designed to strike at the

[abortion] right itself, has the incidental effect of making it more difficult or more expensive to

procure an abortion cannot be enough to invalidate [the law].”15 Clearly, protecting maternal

health is a valid and compelling reason for regulating abortion clinics.

For these reasons and others, comprehensive abortion facility regulations have repeatedly

withstood legal challenges from abortion providers and abortion advocacy groups.

Conclusion

In conclusion, the Virginia clinic regulations are clearly necessary for the protection of maternal

health and comport with recognized medical and legal standards. AUL, therefore, urges the

Virginia Board of Health to retain the Virginia clinic regulations in their current form.

If you have any questions or if I can be of any further assistance, please feel free to contact me

at (202) 683-6107 or [email protected].

Sincerely,

Denise M. Burke, Esq.

Vice President of Legal Affairs

15 Id. at 874.

mailto:[email protected]

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