the licensure of abortion facilities (hereinafter ... missed ectopic pregnancies, cardiac arrest,...
TRANSCRIPT
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retained in their current form, amended, or repealed.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.
Americans United for Life Comment 2 July 31, 2014
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).
Americans United for Life Comment 3 July 31, 2014
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.
Americans United for Life Comment 4 July 31, 2014
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
Americans United for Life Comment 5 July 31, 2014
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
4. Failure to ensure compliance with all building codes
Americans United for Life Comment 6 July 31, 2014
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
2. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
8. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
Americans United for Life Comment 7 July 31, 2014
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.
12. Failure to ensure compliance with all building codes
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
10. Failure to ensure compliance with all building codes
Statement of Deficiencies and Plan of Correction, dated December 12, 2012
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
Americans United for Life Comment 8 July 31, 2014
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
Statement of Deficiencies and Plan of Correction, dated August 2, 2012
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
4. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
violations of licensing/certification requirements
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
13. Failure to ensure compliance with all building codes
Americans United for Life Comment 9 July 31, 2014
Falls Church Healthcare Center
Statement of Deficiencies and Plan of Correction, dated August 2, 2012
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
3. Failure by governing board to name a person appointed to serve as clinic administrator
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
6. Failure by governing board to name a person appointed to serve as clinic administrator
in the absence of the regular administrator
7. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
Americans United for Life Comment 10 July 31, 2014
16. Failure to implement an ongoing, comprehensive, and integrated self-assessment
program of the quality and appropriateness of services and care
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
20. Failure to ensure compliance with all building codes
Statement of Deficiencies and Plan of Correction, dated December 6, 2012
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
Statement of Deficiencies and Plan of Correction, dated May 16, 2012
1. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
2. Failure to provide patients with information regarding complaints and concerns
3. Failure to ensure infection prevention:
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
6. Failure to have a preventive maintenance program to prevent equipment malfunctions
Americans United for Life Comment 11 July 31, 2014
7. Failure to ensure compliance with all building codes
NOVA Women’s Healthcare
Statement of Deficiencies and Plan of Correction, dated July 26, 2012
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
13. Failure to ensure medications that were opened and accessed were dated and discarded
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
18. Failure to ensure compliance with all building codes
Americans United for Life Comment 12 July 31, 2014
Statement of Deficiencies and Plan of Correction, dated December 15, 2012
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
2. Failure to ensure compliance with all building codes
3. Failure to implement and maintain a preventive maintenance program for all equipment
Americans United for Life Comment 13 July 31, 2014
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
11. Failure to ensure policies in place regarding:
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
16. Failure to document the clinical privileges for all staff
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
19. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
20. Failure to notify the state licensing agency regarding clinic ownership
Planned Parenthood-Blacksburg
Americans United for Life Comment 14 July 31, 2014
Statement of Deficiencies and Plan of Correction, dated July 31, 2012
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
violations of licensing/certification requirements
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
30. 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
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
33. Failure to ensure medical records complete for each patient
34. Failure to ensure that all abortions were reported to the appropriate state agency, as
required by law
35. Failure to ensure policy regarding the reporting of patients deaths to the state licensing
agency within 24 hours
36. Failure to ensure compliance with all building codes
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
Americans United for Life Comment 15 July 31, 2014
5. Failure to implement and maintain a preventive maintenance program for all equipment
6. Failure to ensure compliance with all building codes
Planned Parenthood-Roanoke
Statement of Deficiencies and Plan of Correction, dated July 21, 2012
1. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
6. 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
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 a Quality Assurance/Quality Improvement process was carried out
9. Failure to ensure policy regarding the reporting of patients deaths to the state licensing
agency within 24 hours
10. Failure to ensure compliance with all building codes
Roanoke Medical Center for Women
Statement of Deficiencies and Plan of Correction, dated July 18, 2012
1. Failure to document annual review of policies
2. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
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
8. Failure to implement an ongoing, comprehensive, and integrated self-assessment
program of the quality and appropriateness of services and care
9. Failure to ensure compliance with all building codes
Statement of Deficiencies and Plan of Correction, dated December 19, 2012
Americans United for Life Comment 16 July 31, 2014
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
Statement of Deficiencies and Plan of Correction, dated March 27, 2013
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
Statement of Deficiencies and Plan of Correction, dated May 10, 2012
11. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
12. Failure to ensure infection prevention:
a. Failing to wear/ change Personal Protection Equipment (PPEs) as needed
b. Improper storage of supplies
Americans United for Life Comment 17 July 31, 2014
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
17. Failure to ensure compliance with all building codes
Virginia League for Planned Parenthood
Statement of Deficiencies and Plan of Correction, dated May 18, 2012
1. Failure to ensure medications available for use were properly stored and not expired
2. Failure to ensure compliance with all building codes
Virginia Health Group
Statement of Deficiencies and Plan of Correction, dated August 7, 2012
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
3. Failure to ensure policies in place regarding:
a. Job descriptions
b. Verification of staff licenses
c. Reporting of certification/licensing violations
4. Failure to document the clinical privileges for all staff
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
7. Failure to ensure medications that were opened and accessed were dated and discarded
when expired
8. Failure to document discharge orders for all patients
9. Failure to ensure policy regarding the reporting of patients deaths to the state licensing
agency within 24 hours was in place
10. Failure to ensure compliance with all building codes
Americans United for Life Comment 18 July 31, 2014
Virginia Women’s Wellness
Statement of Deficiencies and Plan of Correction, dated May 6, 2012
1. Failure to notify the state licensing agency regarding clinic ownership
2. Failure to ensure Criminal Background Check Report on file for all employees with
access to controlled substances
3. Failure to provide patients with correct contact information for the state licensing
agency’s toll-free complaint line
4. Failure to ensure infection prevention:
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
7. Failure to implement an ongoing, comprehensive, and integrated self-assessment
program of the quality and appropriateness of services and care
8. Failure to ensure medical records complete for each patient
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
10. Failure to have a preventive maintenance program to prevent equipment malfunctions
11. Failure to have a monitoring program for fire and safety
12. Failure to ensure compliance with all building codes
Statement of Deficiencies and Plan of Correction, dated December 6, 2012
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
Statement of Deficiencies and Plan of Correction, dated March 19, 2014
1. Failure to implement an ongoing, comprehensive, and integrated self-assessment
program of the quality and appropriateness of services and care
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
Americans United for Life Comment 19 July 31, 2014
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
agency within 24 hours
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).
Americans United for Life Comment 20 July 31, 2014
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).
Americans United for Life Comment 21 July 31, 2014
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.