California Hospital Patient Safety Organization

1
California Hospital Patient Safety Organization

• Rory Jaffe, MD MBA
• Executive Director

2
Background

• We are in the midst of a health care quality
  revolution. The traditional assumption, that
  skilled and knowledgeable practitioners are the
  best defense against patient harm, is no longer
  true. Health care progressively has become more
  complexmore providers treating the same person,
  more complex equipment and diagnostic methods,
  and more varied and dangerous therapies. This is
  a natural consequence of our increased ability to
  treat illnesses, but was not foreseen when we
  started engaging in progressively more effective,
  complex and dangerous therapies.

3
History

• The Patient Safety and Quality Improvement Act of
  2005 (PSQIA)
• Notice of Proposed Rule Making February 12, 2008
• Final Rule November 21, 2008

4
PSQIA

• Non-controversial
• Passed Senate with unanimous vote
• Passed House 428-3
• http//www.govtrack.us/congress/bill.xpd?bills109
  -544

5
Motivation

• Recognition that there can be errors without
  negligence
• Even doctors are fallible
• Encourage the development of a safer health care
  system
• Encourage reporting of medical errors without
  fear that the reports will be used against the
  provider

6
Where did this come from?

• Growing realization that many patients are dying
  prematurely
• Equivalent of a 747 crashing each dayIOM
• As compared to other high-risk industries, the
  health care system is behind in its attention to
  ensuring basic safety.
• There is a need to enhance knowledge and tools
  to improve patient safety and break down legal
  and cultural barriers that impede such
  improvement. NPRM

7
People are not the only problem

• Traditional peer review protection is oriented
  towards deliberations about skills and knowledge
  of individuals
• By themselves, individual practitioners are no
  longer able to reliably provide good care
• Health care is too complex and dangerous
• Many people, machines, and resources involved in
  the care
• Safety is more about systems
• If a person is not evil, drunk, stupid or
  reckless, the failure is a systems failure
• Even if the person has some culpability, the
  system still could have helped protect the patient

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Outline

• Changes affecting providers
• Privilege and confidentiality
• Patient safety work product (PSWP)
• Patient safety activities
• Patient safety disclosures
• New information flows
• Nonidentifiable PSWP
• Standardized reporting
• PSO rules
• Just culture

9
Privilege and confidentiality
10
State rules on privilege

• Before this law and regulation, state laws
  generally promulgated the quality review
  privilege rules
• Vary among the states
• Focused on professional reviews, not system
  reviews
• May not even cover all professions in all
  settings
• May include system reviews if performed by a
  professional committee
• May not be enforceable in federal courts
• May have extensive gray areas
• Sharing information tends to break privilege

11
42 USC 299b22

• Presentation text does not have full text of
  lawdo not use the text here as an authoritative
  copy

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Privilege (subsection a)

• Notwithstanding any other provision of Federal,
  State, or local law, and subject to subsection
  (c), patient safety work product shall be
  privileged and shall not be
• subject to a Federal, State, or local civil,
  criminal, or administrative subpoena or order,
  including in a Federal, State, or local civil or
  administrative disciplinary proceeding against a
  provider
• subject to discovery in connection with a
  Federal, State, or local civil, criminal, or
  administrative proceeding, including in a
  Federal, State, or local civil or administrative
  disciplinary proceeding against a provider

13
Privilege (cont.)

• subject to disclosure pursuant to section 552 of
  title 5, United States Code (commonly known as
  the Freedom of Information Act) or any other
  similar Federal, State, or local law
• admitted as evidence in any Federal, State, or
  local governmental civil proceeding, criminal
  proceeding, administrative rulemaking proceeding,
  or administrative adjudicatory proceeding,
  including any such proceeding against a provider
  or
• admitted in a professional disciplinary
  proceeding of a professional disciplinary body
  established or specifically authorized under
  State law.

14
Confidentiality (subsection b)

• Notwithstanding any other provision of Federal,
  State, or local law, and subject to subsection
  (c), patient safety work product shall be
  confidential and shall not be disclosed.

15
Exceptions (subsection c)

• Exceptions from privilege and confidentiality
• Exceptions from confidentiality
• Exception from privilege
• Exceptions to the exceptions

16
Exceptions from privilege and confidentiality

• Disclosure of relevant patient safety work
  product for use in a criminal proceeding, but
  only after a court makes an in camera
  determination that such patient safety work
  product contains evidence of a criminal act and
  that such patient safety work product is material
  to the proceeding and not reasonably available
  from any other source.
• Disclosure of patient safety work product to the
  extent required to protect from retaliation a
  person who reports patient safety information.
• Disclosure of identifiable patient safety work
  product if authorized by each provider identified
  in such work product.

17
Exceptions from confidentiality

• Disclosure of patient safety work product to
  carry out patient safety activities.
• Disclosure of nonidentifiable patient safety work
  product.
• Disclosure of patient safety work product for
  research, evaluation, or demonstration projects
  authorized, funded, certified, or otherwise
  sanctioned by rule or other means by the
  Secretary, for the purpose of conducting research
  to the extent that disclosure of protected health
  information would be allowed for such purpose
  under the HIPAA confidentiality regulations.

18
Exceptions from confidentiality (cont.)

• Disclosure by a provider to the Food and Drug
  Administration with respect to a product or
  activity regulated by the Food and Drug
  Administration.
• Voluntary disclosure of patient safety work
  product by a provider to an accrediting body that
  accredits that provider.
• Disclosures that the Secretary may determine, by
  rule or other means, are necessary for business
  operations and are consistent with the goals of
  this part.

19
Exceptions from confidentiality (cont.)

• Disclosure of patient safety work product to law
  enforcement authorities relating to the
  commission of a crime (or to an event reasonably
  believed to be a crime) if the person making the
  disclosure believes, reasonably under the
  circumstances, that the patient safety work
  product that is disclosed is necessary for
  criminal law enforcement purposes.
• With respect to a person other than a patient
  safety organization, the disclosure of patient
  safety work product that does not include
  materials that
• assess the quality of care of an identifiable
  provider or
• describe or pertain to one or more actions or
  failures to act by an identifiable provider.

20
Exception from privilege

• Subsection (a) shall not apply to (and shall not
  be construed to prohibit) voluntary disclosure of
  nonidentifiable patient safety work product.

21
Exception to the exceptions

• Nothing in this section shall be construed to
  alter or affect the implementation of any
  provision of the HIPAA confidentiality
  regulations or administrative simplification
  section on enforcement of the Social Security
  Act (or regulations promulgated under such
  section)
• Exception to the exception to the exceptions
• except this law makes PSOs business associates
  and defines their activities as health care
  operations

22
Final Rule

• November 21, 2008. Federal Register / Vol. 73,
  No. 226. Pages 7073270814
• Presentation text does not have full text of
  ruledo not use the text here as an authoritative
  copy

23
Patient safety work product (PSWP)
24
Patient safety work product

• patient safety work product means any data,
  reports, records, memoranda, analyses (such as
  root cause analyses), or written or oral
  statements (or copies of any of this material)
• (i) Which could improve patient safety, health
  care quality, or health care outcomes and
• (A) Which are assembled or developed by a
  provider for reporting to a PSO and are reported
  to a PSO, which includes information that is
  documented as within a patient safety evaluation
  system for reporting to a PSO, and such
  documentation includes the date the information
  entered the patient safety evaluation system or
• (B) Are developed by a PSO for the conduct of
  patient safety activities or
• (ii) Which identify or constitute the
  deliberations or analysis of, or identify the
  fact of reporting pursuant to, a patient safety
  evaluation system..
• It does not include a patients medical record,
  billing and discharge information, or any other
  original patient or provider information nor
  does it include information that is collected,
  maintained, or developed separately, or exists
  separately, from a patient safety evaluation
  system.

25
What about reporting requirements?

• The fact that information is collected,
  developed, or analyzed under the protections of
  the Patient Safety Act does not shield a provider
  from needing to undertake similar activities, if
  applicable, outside the ambit of the statute, so
  that the provider can meet its obligations with
  nonpatient safety work product. The Patient
  Safety Act, while precluding other organizations
  and entities from requiring providers to provide
  them with patient safety work product, recognizes
  that the original records underlying patient
  safety work product remain available in most
  instances for the providers to meet these other
  reporting requirements. Final Rule p. 70732

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Patient safety activities
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Patient safety activities

• The following activities carried out by or on
  behalf of a PSO or a provider
• Efforts to improve patient safety and the quality
  of health care delivery
• The collection and analysis of patient safety
  work product
• The development and dissemination of information
  with respect to improving patient safety, such as
  recommendations, protocols, or information
  regarding best practices
• The utilization of patient safety work product
  for the purposes of encouraging a culture of
  safety and of providing feedback and assistance
  to effectively minimize patient risk

28
Patient safety activities (cont.)

• The maintenance of procedures to preserve
  confidentiality with respect to patient safety
  work product
• The provision of appropriate security measures
  with respect to patient safety work product
• The utilization of qualified staff
• Activities related to the operation of a patient
  safety evaluation system and to the provision of
  feedback to participants in a patient safety
  evaluation system.

29
Patient safety disclosures
30
Disclosures for patient safety activities

• Disclosure of patient safety work product for
  patient safety activities by a provider to a PSO
  or by a PSO to that disclosing provider.
• A provider or a PSO may disclose patient safety
  work product for patient safety activities to an
  entity with which it has contracted to undertake
  patient safety activities on its behalf. No
  disclosure by entity unless permitted in the
  contract.

31
Disclosures for patient safety activities (cont.)

• Disclosure of patient safety work product for
  patient safety activities by a PSO to another PSO
  or to another provider that has reported to the
  PSO, or by a provider to another provider that
  has reported to the PSO, if
• Use limited data set (per HIPAA), and
• Use limited data set for provider identifiers,
  unless
• All identified providers sign authorizations

32
Disclosures for patient safety activities (cont.)

• Disclosure of patient safety work product for
  patient safety activities by a provider to an
  affiliated provider.

33
Nonidentifiable PSWP
34
Nonidentifiable patient safety work product

• Patient deidentified
• HIPAA
• Provider deidentified
• Specifications similar to HIPAA

35
Standardized reporting
36
Standardized reporting

• May change way entities track incidents
• https//www.psoppc.org/web/patientsafety/paperform
  s

37
8/26/2008 0.1 beta release severity scale

• Death
• Severe permanent bodily or psychological injury
  includes disease, disability, disfigurement,
  dysfunction (DDDD), any of which may or may not
  require continuing treatment, social services,
  etc.
• Permanent bodily or psychological injury (DDDD,
  including increased susceptibility thereto), but
  not severe
• Bodily or psychological injury, but likely not
  permanent
• Additional treatment during admission or
  encounter and/or increased length of stay, but no
  other injury
• Mild and transient anxiety, emotional distress,
  or pain or physical discomfort, but without the
  need for additional treatment other than
  monitoring (such as by observation physical
  examination laboratory testing, including
  phlebotomy or imaging studies)
• Inconvenience (but no anxiety, distress or
  discomfort)
• Event reached patient, but no harm evident
• Unknown

38
PSO rules

• A partial list

39
Requirements for PSOs

• Entities that may not seek listing as a PSO
  include health insurance issuers or components
  of health insurance issuers.
• Special listing rules for (not discussed in this
  talk)
• Entities that accredit or license health care
  providers
• Entities that oversee or enforce statutory or
  regulatory requirements governing the delivery of
  health care services
• Agents of entities that oversee or enforce
  statutory or regulatory requirements governing
  the delivery of health care services and
• Entities that operate a Federal, state, local or
  Tribal patient safety reporting system to which
  health care providers (other than members of the
  entitys workforce or health care providers
  holding privileges with the entity) are required
  to report information by law or regulation

40
Fifteen general PSO certification requirements

• Eight patient safety activities
• Must have written PPs covering all eight
• Must perform all eight
• Seven PSO criteria
• Component organizations have an additional three
  requirements
• 18 requirements total

41
Eight patient safety activities

• The following activities carried out by or on
  behalf of a PSO or a provider
• Efforts to improve patient safety and the quality
  of health care delivery
• The collection and analysis of patient safety
  work product
• The development and dissemination of information
  with respect to improving patient safety, such as
  recommendations, protocols, or information
  regarding best practices
• The utilization of patient safety work product
  for the purposes of encouraging a culture of
  safety and of providing feedback and assistance
  to effectively minimize patient risk

42
Eight patient safety activities (cont.)

• The maintenance of procedures to preserve
  confidentiality with respect to patient safety
  work product
• The provision of appropriate security measures
  with respect to patient safety work product
• The utilization of qualified staff
• Activities related to the operation of a patient
  safety evaluation system and to the provision of
  feedback to participants in a patient safety
  evaluation system.

43
Seven PSO criteria

• Mission and primary activity is to improve
  patient safety and quality care
• Workforce members are qualified
• Enters into at least 2 bona fide contracts
• Neither a health insurance issuer nor a component
  of one
• Makes required disclosures to the Secretary
  (regarding contracts)
• To the extent practical and appropriate, collects
  data in a standardized manner permitting valid
  comparisons
• Utilizes PSWP for providing direct feedback and
  assistance to providers to minimize patient risk

44
Component organization requirements

• Maintain PSWP separately
• Not disclose PSWP to rest of organization (with
  very limited exceptions when assisting the PSO in
  its patient safety activities)
• Mission of PSO must not create a conflict of
  interest with the parent organization

45
Security

• Security management
• PPs and training for confidentiality, integrity
  and availability
• Distinguish PSWP
• Maintain PSWP physically and functionally
  separate from any other system of records or make
  it distinguishable in order to provide
  appropriate security
• Protect storage media
• Limit physical and virtual access to places and
  equipment
• Security control and monitoring
• Identify users and maintain audit capacity
• Security assessment
• Periodic assessments
• Monitor, control, and protect uses,
  communications, and transmissions

46
Just culture
47
Just culture

• Integral to the recognition that humans are
  expected to make errors is the understanding that
  punishment of all errors doesnt fix the
  underlying problem

48
Not blame-free

• People are still culpable in certain
  circumstances
• Evil
• Drunk
• Reckless
• Stupid
• Regardless of the extent (or not) of injury
• These types of actions represent future risks as
  well

49
(No Transcript)
50
The deliberate harm test (evil)

• In most patient safety incidents the individual
  had the patients wellbeing at heart. However, in
  some cases the intent was to cause physical or
  emotional harm.
• The Deliberate Harm Test asks questions to help
  identify or eliminate this possibility at the
  earliest possible stage.

51
Serial murder by healthcare professionals

• The number of patient deaths that resulted in a
  murder conviction is 317 and the number of
  suspicious patient deaths attributed to the 54
  convicted caregivers is 2113. These numbers are
  disturbing and demand that systemic changes in
  tracking adverse patient incidents associated
  with presence of a specific healthcare provider
  be implemented.

52
The physical/mental health test (drunk)

• If intent to harm has been discounted, the
  Physical/Mental Health Test helps to identify
  whether the individuals (not the patient's) ill
  health or substance abuse caused or contributed
  to the patient safety incident.

53
The foresight test (reckless)

• If intent to harm and incapacity have been
  discounted, the Foresight Test examines whether
  protocols and safe working practices were adhered
  to.

54
The substitution test (stupid)

• Finally, if protocols were not in place or proved
  ineffective, the Substitution Test helps to
  assess how a peer would have been likely to deal
  with the situation.

55
How do we get a just culture

• Revise HR processes and policies
• Train managers
• The sharp end the most difficult part where
  problems are likely to happen
• Leaders have to walk the talk
• Natural response to a bad event is to get angry
  and punish the culprit
• But when the culprit is the system, no one should
  be punished

56
Flip-side to just culture

• There still is a culprit, but it is invisible
• Health care delivery has evolved over many years
  based upon the assumption that good practitioners
  are error-free
• Need to consciously revise care delivery systems
  to account for human factors
• Near misses as wellwhy wait until someone gets
  hurt?

57
Summary

• Changes affecting providers
• Privilege and confidentiality
• Patient safety work product (PSWP)
• Patient safety activities
• Patient safety disclosures
• New information flows
• Nonidentifiable PSWP
• Standardized reporting
• PSO rules
• Just culture

58
What will CHPSO do?

• All this is voluntary
• Assistance to individual hospitals upon request
• Microcollaboratives
• Augment regional collaboratives
• Gather events and near-misses for analysis
• Administer culture surveys
• Work at state-wide level (programs, standards,
  priorities, etc.)

59
For more information

• http//www.chpso.org/ (pages on literature and
  just culture)
• rjaffe_at_calhospital.org
• Serial Murder by Healthcare Professionals,
  Yorker et al., J. Forensic Sci November 2006
  51(6)1362-1371