1. Facility Standards for Abortion and Other Outpatient Procedures
Nancy Berglas, DrPH
Sarah Roberts, DrPH
Bonnie Scott Jones, JD
June 7, 2017
Abortion Researcher Incubator

2. Targeted Regulation of Abortion Providers (TRAP)
Source: UCSF.ANSIRH (Internal)

3. Targeted Regulation of Abortion Providers (TRAP)
Requirements for clinics and physician offices
including sites that use medication abortion only
Licensing standards comparable to ASCs
Physical plant requirements
Admitting privileges at local hospital
Transfer agreements with local hospital or physician
Board certification

4. Whole Women’s Health v. Hellerstedt
SCOTUS decision:
Burdens of a restriction cannot outweigh its benefits
Assessment must be based on credible scientific evidence
Abortion should be treated like other health care services in evaluating facility requirements
What would evidence-based facility standards look like in the context of abortion?

5. Looking to Other Procedures
There isn’t direct evidence on the relationship between facility requirements and patient outcomes for abortion
Provided in offices/clinics for 40+ years, with established safety record
Is there evidence for other procedures?
Academic/policy discussions of facility standards are new
Emerged as procedures moved from hospital  outpatient

6. Research Studies
1. How are facility standards set for other outpatient procedures, and how do they incorporate research evidence?
Key Informant Interviews
2. What is the state of the evidence base for facility standards for outpatient procedures?
Systematic Review
3. How do state facility laws governing abortion procedures compare to those governing office-based procedures?
Legal Research
4. What are the complications and costs of abortion in different types of outpatient settings?
Claims Data Analysis

7. What is the state of the evidence base for facility standards for outpatient procedures?
Team: Nancy Berglas, DrPH, Molly Battistelli, MPH, Richard Urman, MD, MBA, Wanda Nicholson, MD, MPH, MBA, Mindy Sobota, MD, Sarah Roberts, DrPH

8. Defining the Systematic Review
What facility standards?
What procedures?
What outcomes?
What study designs?

9. What Facility Standards?
Setting
ASC vs. Office/Clinic
Accreditation
Joint Commission/AAAASF/AAAHC
Emergency response
Transfer protocols/plans
Hospital admitting privileges
Staffing
Board certification
Residency training
Levels of nursing staff
Physical plant
Operating/procedure room Instrument processing rooms
Separate recovery room
Hall/door widths
Emergency power
Temperature/ventilation
NFPA for healthcare occupancies
etc.
Required policies
Quality improvement
Infection control
Risk management

10. Is there good comparison for abortion?
What Procedures?
Is there good comparison for abortion?
Other gynecology/primary care?
Relatively low-risk?
Commonly performed in outpatient settings?
Targeted by state laws or regulations?

11. What Outcomes? Patient safety Patient satisfaction
Service availability (“access”)
Cost

12. Two Research Questions
Q1: What is the effect of outpatient setting (ASC vs. office/clinic on patient safety, patient satisfaction, and service availability?
Q2: What are the effect of specific facility factors on patient safety, patient satisfaction, and service availability?
Accreditation
Emergency Response
Staffing
Physical Plant
Policies

13. Systematic Review Methods
Develop search strategy with reference librarian
Register study protocol
Set inclusion/exclusion criteria
Search EMBASE, PubMed, Web of Science, and gray lit
Title and abstract screen by 2 reviewers
Full text review by 2 reviewers
Assess risk of bias of included studies
Extract data from studies meeting minimum quality standards
Synthesize findings

14. Search Language Setting Outcome Facility Standard AND
(‘ambulatory care’ OR 'outpatient care'/exp OR 'outpatient care' OR 'outpatient department'/exp OR 'outpatient department' OR 'ambulatory care facility' OR 'ambulatory care facilities' OR 'outpatient clinics' OR 'outpatient clinic' OR 'urgent care centers' OR 'urgent care center' OR 'urgent care clinics' OR 'urgent care clinic' OR 'family planning centers' OR 'family planning center' OR 'ambulatory health center' OR 'ambulatory health centers' OR 'abortion centers' OR 'abortion center' OR 'abortion clinics' OR 'abortion clinic' OR ‘abortion facility’ OR ‘abortion facilities’ OR 'free-standing clinic' OR 'free-standing clinics' OR 'outpatient surgery facilities' OR 'ambulatory setting' OR 'physician office' OR 'physician offices' OR 'physicians office' OR 'office procedure' OR 'office procedures' OR 'office-based surgery' OR 'office-based surgeries' OR 'office-based anesthesia' OR 'office based anesthetic' OR 'office based anesthetics' OR 'ambulatory surgery center' OR 'ambulatory surgery centers' OR 'ambulatory surgery centre' OR 'ambulatory surgery centres' OR ‘ambulatory surgical center’ OR ‘ambulatory surgical centers’ OR ‘ambulatory surgical centre’ OR ‘ambulatory surgical centres’)
AND
('treatment outcome'/exp OR 'patient satisfaction'/exp OR ‘patient satisfaction’ OR 'patient safety'/exp OR ‘patient safety’ OR 'patient outcomes' OR 'treatment outcome' OR 'clinical effectiveness/exp' OR ‘clinical effectiveness’ OR 'patient-relevant outcome' OR 'patient relevant outcome' OR 'patient-relevant outcomes' OR 'clinical efficacy' OR 'treatment effectiveness' OR 'treatment efficacy' OR 'outcome assessment' OR 'outcome assessments' OR 'hospital admission' OR 'hospital admissions' OR 'adverse event' OR 'adverse events' OR 'adverse incident' OR 'adverse incidents' OR ‘morbidity’ OR ‘access’ OR ‘medication discrepancies’)
(‘Procedure room’ OR ‘Operating room’ OR ‘Operating room’/exp OR ‘Sterilization room’ OR ‘Soiled instruments’ OR ‘Recovery room ‘ OR 'recovery room'/exp OR ‘Hall widths’ OR ‘Door widths’ OR ‘Design requirements’ OR ‘Layout’ OR ‘Emergency power’ OR ‘Power supply’ OR ‘Temperature requirements’ OR ‘Temperature control’ OR ‘Ventilation requirements’ OR ‘Air flow’ OR ‘Air exchanges’ OR ‘Air filtration’ OR ‘Air filters’ OR ‘National Fire Protection Association’ OR ‘Business occupancy’ OR ‘Health care occupancy’ OR ‘Facility design’ OR ‘Facility designs’ OR ‘Health facility environment’ OR ‘Built environment’ OR ‘Physical environment’ OR ‘Physical design’ OR ‘Facility design’)
Setting
Outcome
Facility Standard

15. Covidence Software

16. Q1: Effect of ASC vs. Office on Patient Outcomes
Records identified through databases and “Grey Literature” (n=1418)
Records after duplicates removed
(n=1070)
Records screened
(n=1070)
Records excluded
(n=886)
Full-text articles assessed for eligibility
(n=182)
Full-text articles excluded
(n=173)
Studies included in synthesis
(n=9)

17. Q1: Effect of Facility Factors on Patient Outcomes
Records identified through databases and “Grey Literature” (n=2690)
Records after duplicates removed
(n=2100)
Records screened
(n=2100)
Records excluded
(n=1838)
Full-text articles assessed for eligibility
(n=262)
Full-text articles excluded
(n=250)
Studies included in synthesis
(n=12)

18. Assessing Risk of Bias

19. ROBINS-I Tool Domains of Bias
Confounding
Selection of participants into study
Classification of interventions
Deviations from intended interventions
Due to missing data
Measurement of outcomes
Selection of reported result
Risk of Bias: Low / Moderate / Serious / Critical

20. Common Methodological Problems
Studies with critical bias = Do not meet minimum quality criteria
Adverse event counts, with no denominator
Critically biased sample
Studies meeting minimum quality criteria (n=10)
No control for confounders
Imprecise classification of exposure
Risk of Bias
# Papers
Low
Moderate 4
Serious 6
Critical 11

21. Highest quality studies come from claims data
Preliminary Findings
Little research that examines the relationship between facility setting or factors and patient outcomes for outpatient procedures
Much of the research:
is poor quality
focuses on plastic surgery
Highest quality studies come from claims data
Inconclusive evidence about relationship between facility requirements and patient outcomes

22. “Evidence-Informed” Facility Standards
Do not look like this:
They look more like this:

23. Nancy Berglas, DrPH
Public Health Researcher
Sarah Roberts, DrPH
Associate Professor
Bonnie Scott Jones, JD
Senior Policy Advisor

24. How are facility standards set for other outpatient procedures, and how do they incorporate research evidence?
Team: Nancy Berglas, DrPH, Bonnie Scott Jones, JD, Sarah Roberts, DrPH

25. Key informant interviews (n=20)
Study Design
Key informant interviews (n=20)
Endoscopy, oral surgery, gynecology, plastic surgery
Interested in:
Motivations for developing standards
Processes used to develop standards
Use of research evidence in developing standards
Decision-making in absence of evidence
Lessons learned that may be applicable to abortion?

26. A Few Findings
Concerns about involvement of state legislatures. Support for professional and accreditation organizations
Volunteer clinician committees
Review existing guidelines, consider research, make recommendations
Requirements should be driven by anesthesia / invasiveness, not particular procedure
Interest in research evidence, but uncommon  In part because research doesn’t exist!
In absence of evidence:
Rely on clinical expertise, best practices, provider feedback
Ensure standards are not more burdensome than necessary

27. What are Lessons Learned for Abortion?
Typical to have those who perform the procedure involved in developing guidelines for patient safety
Evidence matters, but not realistic to expect a clear answer from randomized controlled trials
In the absence of evidence
Balance of patient safety and burden of requirement
Rely on clinical expertise of those who do the procedure

28. Conclusions
No evidence that facility requirements for outpatient procedures are associated with improvements in patient safety, patient satisfaction, or service availability
In the absence of conclusive evidence – if the goal is to treat abortion similar to other health care – it is important to
Ensure that facility requirements are not more burdensome than the procedure requires
Incorporate expertise of those who perform the procedure