Health records for the Elderly in Long-Term Care and Community Settings

Health Records for the Elderly in Long-Term Care and Community Settings

�� Hot Topic # 1: Privacy Considerations in Health Care Settings for the Elderly

�� Hot Topic # 2: Optimizing Health Records in Quality Improvement in 2014 –

Whose “Secret” Is It Anyway?

December 4, 2014

Prepared and Presented By:

Edward Mancinelli, Mancinelli PC

mancinelli pc A Professional Law Corporation

�� Hot Topic # 1: Privacy Considerations in Health Care Settings for the Elderly

Privacy Update on Privacy

•10-year anniversary of PHIPA, the Personal Health Information Protection Act, 2004, S.O. 2004, CH. 3, Sch. A. (the “Act”), (formerly Bill 31 - Health Information Protection Act, 2003 (“HIPA”)). PHIPA was based on “10 Fair Information Principles”.

•Frequent media coverage concerning privacy breaches in Ontario health care, e.g. Norfolk General Hospital(1,300 patients notified), Sault Area Hospital (144 inappropriate cases of “snooping” or accessing patient EHR files), etc.

•In terms of privacy regulation in Ontario, there have been numerous Orders of the Information and Privacy Commissioner (“IPC”). As a result, typical “lessons” learned for health organizations include that: Health information Custodians (HICs”) are responsible for their own “agents”, e.g. in “snooping” cases; lost USB sticks and laptops as well as unencrypted Personal Health Information (“PHI”) in electronic health record systems (“EHRs”) are all potential threats to privacy.

•When in force, the Electronic Personal Health Information Act, 2013 (“ePHIPA”) will double PHIPA fines levied to $100,000 for individuals and $500,000 for corporations.

•Hopkins v Kay, 2014 ON SC 321 – Facts: Approximately 280 patient records of the Peterborough Regional Health Centre were intentionally and wrongfully accessed. Query: Has PHIPA “occupied the field” such that the common law “tort of inclusion upon seclusion” (or breach of privacy) is precluded by PHIPA and patients (whose privacy has been breached) can sue directly?

Current Capacity Challenges in Health Care Settings for the Elderly

Current Sector Themes (LTCH Population)

•increased disease acuity and complexity (with comorbidities) for residents

•limited resources of HICs, e.g. LTCH resident to staff ratios on overnight shifts

•increased use of digital technologies, e.g. EMRs and Telemedicine carts by HICs

•frequency of disputes involving families, SDMs and HICs

Care Challenges for Elder Sector

•93% of newly admitted LTCH residents require extensive assistance, or are totally dependent on assistance with ADLs

•83% of LTCH residents were reported to show “high” or “very high” care needs, compared to 72% four years earlier [Canadian Institute of Health Information (“CIHI”)]

Current Capacity Challenges in Health Care Settings for the Elderly

Care Challenges (Continued)

•LTCH residents with an assessed diagnosis of dementia - 61.1%; with an assessed diagnosis of

hypertension - 61.3%; with some cognitive loss - 39.1%; with severe cognitive impairment -

28.6%; showing signs of depression - 32.7%; with some aggressive behaviour due to dementia or

other mental health challenges - 23.1%; with severe or very severe aggressive behaviour - 23.5%

- Continuing Care Reporting System, 2012-2013, CIHI / SAFER (Staffing Alliance for Every

Resident), 2014

•Only 17% of residents in complex continuing care facilities are involved in programs specifically

related to dementia [SAFER Report, 2014]

•In terms of drug utilization, about 28% of all seniors across various sectors in Ontario are taking

antipsychotic medications (33% in LTCH and 14% in Retirement Homes) - Medisystem Summary

Report, 2014

Current Capacity Challenges for the Elderly

What is the Cost?

•In 2011, 747,000 Canadians living with cognitive impairment, including dementia - 14.9% of Canadians 65 and

over.

•By 2031, this figure will increase to 1.4 million.

•In terms of burden of care, the current combined direct (medical) and indirect (lost earnings) costs of

dementia total $33 billion per year.

•This number is expected to climb to $293 billion a year by 2040.

•Reference: http://www.alzheimer.ca/en/About-dementia/What-is-dementia/Dementia-numbers

Health Records 101 – Who Owns What?

• For many years, the Courts have recognized that medical records are the property of the health facility or medical institution; however, the underlying health data is the property of the patient/resident/client. Therefore, the key issue then becomes the right of access - McInerney v MacDonald [1992] 2 S.C.R. 138.

• As a general rule, a patient/resident/client should have a right of access to his or her PHI.

• HIC has a corresponding obligation to provide PHI as a fiduciary that holds PHI in a fashion somewhat akin to a trust to be used by the provider for the benefit of the patient/resident/client.

Privacy Legislation – A Quick Look at PHIPA

• Balances individual’s right to privacy with the “legitimate” needs of organizations providing health care services. PHIPA also seeks to balance the proper protection of privacy with the communication rights within the health care team (i.e. “circle of care”) necessary to provide care.

• On the whole, PHIPA governs PHI in the custody or control of HICs, e.g. health care practitioners, hospitals, community care access centres (“CCACs”), psychiatric facilities, persons who operates a group practice of “integrated” health practitioners, LTCHs, care homes, pharmacies, laboratories, ambulance services, laboratory or specimen collection centres.

• The scope of PHI includes: identifying information about an individual in oral or recorded form that: relates to an individual’s physical or mental health; relates to the provision of health care to the individual; identifies the individual’s substitute decision-maker ("SDM").

• An agent of a HIC is a person that - with the authorization of a HIC - acts for or on behalf of a HIC in respect of PHI.

• Irrelevant whether or not the agent is employed by the HIC, remunerated by the HIC or has the authority to bind the HIC.

• HIC remains responsible for PHI collected, used, disclosed, retained or disposed of by an agent.

What are the Requirements for HICs?

• In Section 3(1) (11) (iv) of the Long-Term Care Homes Act, 2007, S.O. 2007, CH. 8 (“LTCHA”),

every resident under the Bill of Rights has the right to have his or her PHI kept confidential,

and to have access to his or her records of PHI, including his or her plan of care.

• Under Section 6(12) of the LTCHA, a LTCH licensee shall ensure that the resident, the

resident’s SDM and any other persons designated by the resident or SDM are given an

explanation of the plan of care; however, under Section 6(13) of the LTCHA, this does not

require the disclosure of information if access to a record of the information could be refused

under PHIPA except for a plan of care for a resident under Section 6(14) of the LTCHA.

• Under PHIPA, a HIC must safeguard PHI in their custody or control by taking steps that are

reasonable in the circumstances to: (i) ensure that PHI is protected against theft, loss and

unauthorized use or disclose; (ii) ensure that PHI records are protected against unauthorized

copying, modification or disposal; and (iii) ensure that PHI records are retained, transferred

and disposed of in a secure manner.

• Resident/patient/client or SDM must be given notice of theft, loss or unauthorized access

under Section 12 of PHIPA 12 (e.g. social media, USB keys, etc.).

What are the Requirements for HICs?

• In general, a HIC should not collect, use or disclose PHI unless the consent of the individual has been obtained. PHIPA sets out the three types of consent: (1) express, (2) implied and (3) assumed implied consent.

• (1) Express consent is commonly understood as consent that has clearly and unmistakably been given orally or in writing, and is required to: (i) disclose PHI to a person that is not a HIC; (ii) disclose PHI to a HIC for a purpose other than the provision of health care; (iii) collect, use or disclose PHI for marketing; and (iv) collect, use or disclose PHI for fundraising (if using more than the name and address of the individual).

• (2) Implied consent is commonly understood as a consent that a HIC concludes has been given based on an individual’s action or inaction in particular factual circumstances.

• (3) Assumed implied consent (under Section 20(2) of PHIPA) also known as the “Circle of Care” (although the term “circle of care” does not appear in PHIPA) occurs when a HIC that receives PHI for the purpose of providing health care or assisting in the provision of health care, is entitled to assume implied consent to collect, use or disclose PHI for the purposes of providing health care or assisting in providing health care, unless the HIC is aware that the resident / patient / client has expressly withheld or withdrawn consent.

Dealing with “Circle of Care” Uncertainties for HICs

• In developing some collaborative clinical care models in elder care, some uncertainties with

the "circle of care" could cause anxiety which may undermine such care.

• Section 20(4) of PHIPA provides that where a patient /resident /client provides information

about his or her religious affiliation, the facility is entitled to assume that it has the

individual’s implied consent to provide his or her name and location in the facility to a

religious representative as long as the HIC has “offered the individual the opportunity to

withhold or withdraw the consent and the individual has not done so.”

• Although residents/patients/clients have the right to withhold or withdraw consent to the

disclosure of their PHI for health care purposes by providing express instructions to HICs not

to use or disclose PHI (e.g. Section 37(1) (a) of PHIPA where the “individual expressly

instructs otherwise”), HICs must act reasonably and explain to the resident/patient/client

that only persons involved in his or her care would have PHI disclosed to them, e.g. a

physiotherapist.

Key Areas of Concern for Privacy Breaches

• Snooping, e.g. “intrusion upon seclusion” is a new tort or action recognized by the Ontario Court of Appeal. On the other hand, under Section 71(1)(a) and (b) of the Health Care Consent Act, 1996, S.O., c.2 (“HCCA”) may provide immunity to a HIC from an action for damages where anything done in the exercise of any of their powers or duties was in good faith and reasonable in the circumstances.

• Common use of unencrypted data storages devices such as USB keys, laptops and handheld tablets could create unwanted risks. Also, with digital clinical management systems, e.g. EMR systems that store PHI on an unencrypted basis to the Internet, i.e. “cloud software” with servers in another jurisdiction outside of Ontario.

• New LTCH use of Telemedicine carts. Reference: OTN Privacy Toolkit (Privacy in a Telemedicine Environment at Page 8) located at http://otn.ca/en/telemedicine-resources/privacy-toolkit.

Managing PHI in the Context of Resident/Patient/Client Capacity

• Capacity (and related tests to determine capacity) are applicable to LTCH residents including on admission. Specific health professionals known as “evaluators” may initially determine capacity and include: SLPs, RNs, OTs, MDs, PTs and psychologists; however, there are no specific requirements regarding capacity assessments.

• HCCA applies to treatment plans and admission to “care facilities” (and PSW services), where “Care facility” under Section 2(1) of HCCA means a LTCH, home for the aged and charitable home.

• In general, compelling evidence is required to override the presumption of capacity found in Section 2(2) of the Substitute Decisions Act, 1992, S.O. 1992, CH. 30 (“SDA”) and Section 4(1) of the HCCA. Mental capacity exists if a resident/patient/client is able to carry out his or her decisions with the help of others.

• Evaluator must maintain meticulous files and be “alive to” third parties harbouring “improper motives”. The resident / patient /client should be made aware of the significance and effect of a finding of incapacity. The warning is a requirement under Section 78(2) (b) of the SDA. Failure to warn rendered the evaluator and assessor’s findings of incapacity a nullity - Re Koch(1997).

When it Comes to PHIPA, When is a Resident/Patient/Client Capable?

• The Supreme Court of Canada has outlined a two-part capacity test in interpreting the use “capacity” with respect to consenting to collection, use and disclosure of PHI. A person is capable if that person is able to: (a) understand the information that is relevant to making a decision; and (b) appreciate the reasonable foreseeable consequences of a decision or lack of decision (similar to Section 4 HCCA test for capacity to consent to treatment) - Starson v. Swayze [2003] S.C.R. at 722:

• “The presumption of capacity [under Section 4.2 of the Health Care Consent Act, 1996, S.O., c.2] can be displaced only by evidence that a patient lacks the requisite elements of capacity provided by the Act. Capacity involves two criteria [under Section 4.1 of the Act]: first, a person must be able to understand the information that is relevant to making a treatment decision and second, a person must be able to appreciate the reasonably foreseeable consequences of the decision or lack of one.

• As capacity is presumed, a person may rely on a presumption of capacity unless there are reasonable grounds to believe that the person is incapable. Moreover, in M. N. v. Klukach, (2004) O.J. No. 394, the Court noted that the second branch of the test for capacity assesses the ability to evaluate, not just understand information, i.e. the ability to evaluate information as it relates to him or her, not just understand information.

Practical Tips for Maintaining Health Records

• HICs should be aware that a health provider’s notion of “best interests” is not always relevant; that is, it is the role of the Consent and Capacity Board (“CCB”) to ultimately determine whether a “treatment plan” is in a resident/patient/client’s “best interests”.

• If the patient is capable, then he or she has the right to make whatever decision he or she wishes. The resident/patient/client is entitled to disregard the clinical advice and/or make an “unwise” decision. Also, please consider that the mere failure to make decision is not the same as inability to make decision.

What is the Role of a Substitute Decision-Maker?

• In terms of “who” is an SDM, a SDM may be: a POA for personal care, a

representative appointed by the CCB, a spouse/partner, adult child, parent, person

lawfully entitled to provide consent, access parent, brother or sister, any other

relative or Public Guardian and Trustee (“PGT”) but not a non-relative.

• If person is incapable, a SDM must be capable and not prohibited by Court Order /

separation agreement from having access and must be available (i.e. to

communicate within reasonable time).

• If there is an SDM for treatment under the HCCA, that person also makes related

PHIPA information decisions. If, however there is no SDM, then you must go to the

ranking order in PHIPA - which is similar to Section 20(1) of the HCCA dealing with

ranking for consent.

List of SDMs - What is the Ranking Order?

• An SDM only has authority once the resident/patient/client is incapable.

• Therefore, a HIC should know the Section 20 “ranking” of SDMs in HCCA.

• Under Section 20(1) (1) to (8) of the HCCA, the list is as follows: (1) Guardian of the person;

(2) attorney for personal care; (3) personal representative; (3) spouse or partner; (4) child or

parent; (5) access parent; (6) brother or sister; (7) other relatives; and (8) Public Guardian

and Trustee (SDM of last resort).

• It is also important to understand in the context of treatment plans, which the SDM must act

in accordance with the resident / patient / client’s prior capable wishes taking into account a

series of “personal interests”; that is, values and beliefs and quality of life while balancing

risk and benefit.

Is Consent Required When Withdrawing Treatment?

• The Supreme Court of Canada, in Cuthbertson v Rasouli [2013] S.C.R., has recently decided the process to be followed where it is not possible to achieve consensus as between a physician and a patient’s SDM with respect to a medical recommendation to withdraw life-sustaining treatment. Please see Appendix A –Six Steps in Withdrawing Life-sustaining Treatment.

• In terms of medical records, you may wish to amend practices/policies to underscore the proposition that an SDM must provide consent for the withdrawal of life-support. You should also have policies and practices in place regarding disagreements between HICs and SDMs on other “health-related” matters (e.g. Emergency Department transfers for residents).

• Section 2(1) of HCCA extends specifically to cases involving the withholding of treatment as per the definition of “plan of treatment”, i.e. the “withholding or withdrawal of treatment” – EGJW v MGC, 2014 CanLII 49888 (ON HPARB)

Sharing PHI When Families Are Disputing

• Section 38(4) of PHIPA states that a HIC may disclose PHI about a resident/patient/client who is deceased,

(a) for the purpose of identifying the individual, (b) for the purpose of informing any person whom it is

reasonable to inform in the circumstances of (i) the fact that the individual is deceased or reasonably

suspected to be deceased, and (ii) the circumstances of death, where appropriate; or (c) to the spouse,

partner, sibling or child of the individual if the recipients of the information reasonably require the

information to make decisions about their own health care.

• Key question is who makes decisions to share the health record after the client dies? As there is no longer

an SDM, the Estate Trustee or “person responsible for the administration of the estate” makes the

decision.

• However, what if an SDM, e.g. adult child of resident instructs LTCH not to share PHI with other family

members including at end of life care? In this case, a HIC should try to negotiate a resolution and failing

which you may take the SDM to CCB on a Form G (to determine whether the SDM is acting in “best

interests” under subsection 37(1) and subsection 21(2) of the HCCA.

• Should also remind the SDM of his or her duty to seek to foster regular personal contact between the

resident and family members as per Section 32(4) of the Substitute Decisions Act, 1992.

• You should always advise a SDM to retain counsel unless there is a risk of harm in doing so.

Sharing PHI When Families Are Disputing (Continued)

• Section 40(1) of PHIPA states that a HIC may disclose PHI about a resident/patient/client if

the HIC believes on reasonable grounds that the disclosure is necessary for the purpose of

eliminating or reducing a significant risk of serious bodily injury to a person or group of

persons (i.e. public interest disclosure). You should be ready to use it!

• Section 38(1)(c) of PHIPA states that a HIC may disclose PHI about a resident/patient/client

for the purpose of contacting a relative, friend or potential substitute decision-maker of the

individual, if the individual is injured, incapacitated or ill an unable to give consent personally.

• SDM is entitled to have the entire PHI that person would have in order to make decision.

Health Research Involving Residents/Patients/Clients – Are there Issues?

• When seeking consent from vulnerable clients/patients/residents, a common law duty exists that if there is a potential risk, then you should not proceed without a reasonable assurance of safety.

• HIC may use PHI about a resident/patient/client under Section 37(1)(j) of PHIPA for the purpose of research (e.g. input or data sharing between organizations) conducted by the HIC but only if the HIC prepares a research plan under Section 44(2) of PHIPA and has a research ethics board approve it (or re-approve it) in writing as per Section 44(3) of PHIPA and Section 15 of ONTARIO GENERAL REGULATION 329/04 under PHIPA. When determining whether or not to approve a research plan, an ethics board must consider under Section 44(3) whether the objectives of the research can reasonably be accomplished without using the PHI that is to going to be disclosed.

• In terms of the collection, use and disclosure of PHI in health research where a health provider is an investigator (or co-investigator) in a “live” funded study, there is no implied or assumed implied consent (not within the “circle of care”) and is usually not protected quality of care information.

• Exemptions for certain “prescribed entities” in Ontario (e.g. Institute for Clinical Evaluative Sciences which is aprescribed entity under Section 45(1) ("Disclosure for planning and management of health system") of PHIPA and Section 18(1)(3) of O. Reg 329/04 under PHIPA for the purposes of disclosure for planning and management of the health system.

• As a practical matter, when in doubt, you should obtain express consent from the SDM. When it comes to the elderly such as LTCH residents, they are more likely than not to consent; however, you should emphasize choice. A non-care giver / provider should obtain consent.

Best Privacy Information Practices: Tips

• There is no general right of access to PHI - you should ask patient/resident/client who they want involved in and informed about the services they receive from you.

• As a rule of thumb, you should not provide information over the phone if you cannot confirm who is on the telephone. However, you may give general information to families; that is, you may use PHI to sort out who is the patient/resident/client’s SDM but take care when making assumptions about which family member should have this role - especially when there are disputing adult children.

• Statement / policy as to reasons and in what circumstances where you will disclose resident/patient/client’s PHI.

• Check all third party requests carefully as to who is making the statement and be very diligent regarding requests from “family” members, friends and volunteers.

• Anyone calling a LTCH can be told that resident/patient is there and general status.

• Under PHIPA, a HIC must ensure that PHI records are securely stored, e.g. health information residing on a portable device (laptops, memory sticks, tablets, etc.) must be encrypted.

• In terms of best practices, you should use PHI only for the purposes for which it was collected and intended and consider why PHI information is being collected, used and/or disclosed.

Best Privacy Information Practices: Tips

(Continued)

• In the event of a transfer of a PHI record to a successor or predecessor, Section 42(2) of PHIPA requires a HIC to make reasonable efforts to contact the patient before transferring records to another health care provider, or if that is not possible, as soon as possible after the transfer.

• Please consider that you (as a HIC) will usually be in a better position to respond to breaches (and complaints and civil litigation concerning breaches) if you are able to demonstrate that you have policies and practices in place that are appropriate with staff training on those policies and practices.

• One of the most significant protective measures is the establishment of a “culture of privacy” meaning that every staff member must understand the importance of safeguarding PHI records, e.g. be aware of a HIC’s obligations and realize the consequences of a breach or loss of PHI while ensuring that all stakeholders understand their rights and choices.

• In terms of privacy best practices, you should implement all required privacy management tools (privacy policies, fact sheets, confidentiality agreements, service agreements, data access forms (internal and external) and templates for consents.

�� HOT TOPIC # 2: Optimizing Health Records in Quality Improvement in 2014 –


• “Be a yardstick of quality. Some people aren’t used to an environment

where excellence is expected” ~ Steve Jobs (1991–2011)

�� HOT TOPIC # 2: Optimizing Health Records in Quality Improvement in 2014 –


Quality of CareQuality of CareQuality of CareQuality of Care

PerformancePerformancePerformancePerformance

ManagementManagementManagementManagement AccountabilityAccountabilityAccountabilityAccountability

Update on QCIPA

•The general rule is “once quality of care, always quality of care”

• Information prepared by or for a designated committee under QCIPA, the Quality of Care Information Protection Act, 2004, S.O. 2004, CH. 3, Schedule B, (formerly Bill 31 - Health Information Protection Act, 2003 (“HIPA”) is shielded from disclosure. This rule is subject to a right of appeal to the Information and Privacy Commissioner of Ontario (“IPC”) on any “decision” made by a health facility or to a right of action in the Ontario courts.

•10-year anniversary of QCIPA. However, there is a recurrent contentious theme in media coverage of a “secrecy enabling law” which appears to question the variability of use across health settings in Ontario, e.g. 2014 Brampton Civic Hospital suicide case.

•The current Ministry of Health and Long-Term Care (“MOHLTC”) review of Ontario quality improvement legislation is being co-led by Health Quality Ontario (“HQO”) and the Li Ka Shing Knowledge Institute (St. Michael’s Hospital) and they will report back to the MOHLTC towards the end of 2014 – The Star (August 14, 2014).

•There are two sides of the debate, i.e. patient rights (QCIPA enables health facilities to “hide” information from families, etc.) vs. community rights (Ontario health care system should allow for a “limited” class of protected information used to improve quality of care (e.g. infection prevention and control, medication errors and the recognition and management of various “adverse events”).

Update on QCIPA

(Continued)

• Quality of Care Information (“QCI”) protection has been recommended for many years in Ontario (e.g., Ontario Steering Committee, Into the 21st Century: Ontario Public Hospitals Report of the Steering Committee, Public Hospitals Act Review, (February 1992)).

• QCIPA is not hospital-specific.

• QCIPA recognizes that the best possible care requires commitment to continuous improvement and risk reduction. In the wider context, QCI forms part of a larger ‘ecosystem’ of health data (e.g. the calculation of the Case Mix Index or CMI for Long-Term Care Homes (“LTCHs”) from Canadian Institute of Health Information (“CIHI”) data generated from RAI-MDS input for each LTCH) which inform quality standards (e.g. balanced scorecards) and evidence-based practices for care plans, program design and decision tools, etc..

• Legislation protecting QCI is found in most other provinces and the U.S..

• In the absence of QCI under QCIPA, one may arguably rely on solicitor-client privilege or common-law privilege (i.e. the “Wigmore” test); however, this must be determined on a case by case basis and is not always reliable enough to foster open discussions.

• The current health regulations for quality improvement involves continuous evaluation to measure health outcomes, ensure accountability, track performance and assure quality (e.g. Quality Improvement Plans (“QIPs”) in LTCHs which are voluntary in 2014/2015 and will be required in 2015/2016 (e.g. pressure ulcers, falls, ED transfers and physical restraints).

Update on Current 2014 MOHLTC Review of the QCIPA

Health Quality Ontario Patient, Family, and Public Consultation closed on November 17, 2014.

Key HQO Survey Questions

•"# 4 Some quality incidents are very complex, and understanding their causes requires open discussion and

speculation amongst health care staff. Like most other jurisdictions, Ontario has legislation (QCIPA) that allows

hospitals and other health care organizations to keep confidential the discussions that health care staff have

about quality incidents. Many people who have investigated quality incidents report that without this

confidentiality, staff will not speak openly about what happened, speculate freely about what could have

been done to prevent the incident or share ideas about how similar incidents could be avoided. (Under QCIPA

the facts about a quality incident are not kept from patients, but speculations and opinions are kept

confidential). In light of this, do you have suggestions about how Ontario can strike the right balance between

harm prevention on the one hand and disclosure to patients, families, and the public on the other?"

•"# 5 Many people affected by a quality incident hope that what is learned from the investigation of that

incident will be used to prevent similar incidents from occurring in the future. In your view, what are the best

ways for health care organizations to share what they have learned from investigations of quality incidents

with each other and the public, while at the same time respecting patient confidentiality?“

•Reference: Patient, Family, and Public Consultation at http://www.hqontario.ca/about-us/quality-of-care-information-protection-

act-review (Section 10(1)(d), QCIPA - Lieutenant Governor in Council shall not make any regulation unless the Minister has

considered whatever comments and submissions that members of the public have made).

Quality Assurance – Key Regulatory Framework

• Section 4 of the Excellent Care for All Act, 2010 (“ECFAA”) provides that a quality committee oversee the preparation of quality improvement plans. These plans must be developed having regard to aggregated “critical incident” data as compiled based on disclosures of adverse incidents. A “health care organization” includes an entity in the Regulations that receives public funding.

• Section 84 of the Long-Term Care Homes Act, 2007, S.O. 2007, CH. 8 (“LTCHA”) provides that every LTCH shall develop and implement a quality improvement and utilization review system that monitors, analyzes, evaluates and improves the quality of the accommodation, care, services and programs provided to residents of the LTCH.

Which Organizations Can Designate a Quality of Care Committee (“QCC”)?

• The following health care providers can designate QCCs: hospitals, independent health facilities, psychiatric facilities governed by the Mental Health Act (1990), LTCHs, licensed medical laboratories and specimen collection centres. In addition, “health care improvers” can designate Quality of Care Committees (“QCCs”) namely, Ontario Medical Association, in respect of its quality assurance activities with licensed medical laboratories and specimen collection centres and Canadian Blood Services, in respect of its laboratories and specimen collection centres.

• Section 1, QCIPA of Regulation 297/04 outlines the definition of “Quality of Care Committee” and specifically includes under ss. (1) –“A long-term care home” within the meaning of the LTCHA.

Why Do We Need QCIPA?

• To enhance patient safety.

• To encourage health professionals to share information, speculations and opinions through open discussions within a quality review to improve patient care, without fear that the information will be used against them.

• Develop recommendations for quality improvement (including the level of skill, knowledge and competence of the persons who provide health care).

• QCIPA has supremacy over other laws in Ontario, e.g. personal health information (“PHI”) can be revealed to QCC but cannot be used as evidence in a legal proceeding (e.g., Court, Coroner or Colleges)

• Disclosure of QCI in contravention of the QCIPA is an offense as is retaliation against someone who participated in review process. A committee member of a QCC who discloses information in good faith or under the harm reduction provision under QCIPA will be granted immunity.

• No action may be taken against a QCIPA committee member and retaliation against someone who participated in such a process is an offence.

What is the Relationship between QCIPA and PHIPA?

• Under Section 37(1) (d) of Personal Health

Information Protection Act, 2004 (“PHIPA”), PHI

can be used without consent for risk (e.g.,

significant risk of bodily harm) and error

management and quality of care purposes.

• It is important to note that QCI is not necessarily

information that identifies any resident / patient

/ client once the subject health information has

been “properly” de-identified.

How Does a Quality of Care Committee Work?

• The “centrepiece” of QCIPA is the “Quality Committee”. It is noteworthy that this is not a Medical Advisory

Committee which committee is hospital-specific. Please refer to Appendix A – Steps to Be Taken For

Serious Incident Reviews: Simplified Flowchart.

• Under Section 3 of Ontario Regulation 297/04 of QCIPA, a QCC must be formally designated in writing by

the authorized entity and be conferred with a range of quality of care functions. The designation is

typically by way of resolution of the Board of Directors, QCC or senior management, consistent with the

health entity’s underlying governing structure (e.g. Terms of Reference, By-Laws, Articles, “Membership”

under Letters Patent, Operational Resolutions, Policies based on Level of Care Funding, Strategic Plan,

etc.).

• In terms of composition, at least one-third of the members of the QCC must be voting members of the

health care organization’s board. Every QCC shall report to its responsible body, e.g. Board of Directors.

• Terms of Reference of the QCC must be available to the public on request (Ontario QCIPA Regulation

297/04, Section 3(1)). This means that non-QCIPA reviews will not be protected, i.e. when they are

conducted by individuals or groups that have not been designated as a QCC. Do your Terms of Reference

require updating?


Multi-purpose Committees

• A multi-purpose quality assurance committee or QCC is not uncommon in many health settings and

performs quality of care functions possibly along with other operational functions.

• From a governance point of view, quality of care functions must be kept separate as per the definition of

“functions” under Section 4 of the ONTARIO GENERAL REGULATION 330/04 of QCIPA, i.e. “to carry on

activities for the purpose of studying, assessing or evaluating the provision of health care with a view to

improving or maintaining the quality of the health care or the level of skill, knowledge and competence of

the persons who provide the health care.”

• If a multi-purpose QCC structure is typically adopted, then the quality functions must be kept separate

from other functions such operational matters. This separation may involve a designated time period or

formal declaration, as well as separate minutes or notes. QCC minutes may reflect a limited quality review

• e.g. “Before we open the case for our review, I wish to remind everyone here of the intent of this quality

review. We are here to review the facts, circumstances surrounding the case, influencing factors, system

issues, or any contributing causes. It is an opportunity for us to examine our process of providing care to

see what we can do better in the future. As such, I wish to remind everyone what is discussed here is

confidential.”


• When reporting to a QCC, health providers and custodians should seek to avoid stating any causal connections (e.g. “while we did not conclude that our policy contributed to...we have now implemented…”).

• Measures to separate the functions of a multi-purpose QCC may sometimes be difficult to maintain as a practical matter.

• In turn, a QCC may delegate certain quality functions to another “sub-committee” and retain the required protection under QCIPA as per Section 3 of the ONTARIO GENERAL REGULATION 330/04 of QCIPA, i.e. "every person who participates or assists with the committee’s functions" as set out in the definition of “quality of care committee” in Section 1 of QCIPA is protected because it is engaged in the review as a delegate of the QCC.

• Delegates typically include experts, administrative staff, and ad hoc “sub-committees” which assist the main QCC in achieving its quality functions.

• The scope of QCC functions would typically include related oral facts, conclusions, evaluations, assessments, reports, speculation and expert advice under QCIPA.

• In some instances, a health facility does not wish to shield information from future uses, e.g. making use of a quality “peer” review for recommendations on staff appointments or discipline.


• From a governance point of view, unless there is a “good system” for reporting on “critical incidents” (and “near misses”) in the first instance, and bringing them into the quality review process, the information generated will not be properly protected under QCIPA.

• Any ad hoc review in the immediate aftermath of a “critical incident” may not be protected under QCIPA. As a result, any information generated outside of a QCC will only be privileged under uncertain “traditional” categories of privilege at law.

• It is important to note that “boiler plate” Terms of Reference and Policies are not recommended.

• Your health setting is unique. You should create its own quality review and improvement process based on its governance structure.

• QCCs typically make recommendations to the responsible body (e.g. Board of Directors) regarding quality improvement initiatives, QIPs, policies and programs as required (e.g., Resident Falls Prevention Program, Wound Care Program, Palliative Care Program, Resident Lifts/Transfers Program).

• In terms of best information practices, a QCC will ensure that health information is translated into materials such as forms and contracts that are distributed to employees and relevant providers and will then monitor the use of these materials and track performance for all stakeholders (e.g. LHINs).

Steps to Be Taken For Serious Incident Reviews: Simplified Flowchart

Incident

Occurs

QCC (or Board)

mandates / plans

quality review

Non-QCIPA Review

Refer back to

Program /

Administrator

YES NO

YES

QCC signs off

serious incident

as “closed”

Recommendations for Quality

Improvement to Administrator /

Appropriate Leadership (subject to

permitted disclosure rules)

Implement Quality

Improvement Workplan and

Annual QIP (e.g. s. 84 of the

Act requiring review program)

Report Submitted to

QCC

Review Implementation of Actions /

Performance Evaluation (e.g. LSSA,

Schedule D – Performance)

Post Review -

Share Learning /

Knowledge

Transfer with

Stakeholders

Inform Patient (or SDM), Director (statutory “Critical Incidents” under ss. 107(1) and (3) of Gen. Reg. 79/10) & others (e.g. insurer, etc.)

Report to Quality Team / Sub-committee (Administrator / Clinical Director / Program Director)

Undertake Investigation / QCIPA Review with

Protection (Single or Multi-function Quality

Committee)

What Are the Issues in Quality Assurance?

• Whether to proceed with a QCC review under QCIPA (to ensure absolute privacy protection subject to permitted disclosure rules) or a quality improvement review or others such as a Medical Advisory Committee (as required under the Public Hospitals Act, 1990 (“PHA”))?

• Consider how to structure the overall quality improvement process so that the protective rights offered by QCIPA can best be applied.

• Once QCI has been designated as such, it cannot be disclosed or made admissible in a "proceeding", which is defined under QCIPA as including: an Ontario court, tribunal, commission, arbitration or a [discipline] committee of a College within the meaning of the Regulated Health Professions Act, 1991.

• In practice, while QCI cannot be used in any proceedings against that health facility, it similarly may not be used in any proceedings in which the health entity is seeking to vindicate its actions. In order words, QCIPA is a like ‘double-edged sword’.

• If you are seeking to proceed under QCIPA should give careful consideration to any possible future uses of the information including legal matters.

• The decision to seek QCIPA protection is often complex. You may also seek outside legal counsel to ascertain the rights and interests of your health organization and stakeholders.

What Can a QCC Disclose?

• “Disclosure” is defined under Section 1 of QCIPA as making information available to a person who is not a member of the QCC subject to permitted disclosures.

• QCI may be disclosed to the management of a facility if the QCC believes that the disclosure is required for the purpose of maintaining or improving health care.

• Management may generally share QCI disclosed for the purpose of improving quality under Section 4(3) of QCIPA; and to employees and agents for quality of care purposes under Section 4(6) QCIPA; and to prevent serious bodily harmunder Section 4(4) of QCIPA.

• QCI retains its “privileged status” as such despite subsequent disclosures. More specifically, under Section 4(1) of QCIPA, a person to whom quality of care information has been disclosed, i.e. a recipient of QCI is restricted in his or her subsequent use and disclosure of the QCI who may only use the information for the purpose for which it was disclosed.

What is the Relationship between QCIPA and “Critical Incident” Reporting?

• It is noteworthy that there is varying language in quality assurance reviews (error, adverse event, sentinel event, incident, critical incident, etc.). For example, PHA Regulation 965 uses “critical incidents” and requires mandatory disclosure of “critical incidents” to patients or SDM as soon as practicable.

• Subsections 107(1) and (3) of the Amendment to General Regulation 79/10 under the Long-Term Care Homes Act requires reporting of statutory “critical incidents”. More specifically, subsection 107(5) of Regulation 79/10 also requires LCTHs to report an injury to a resident that results in “significant changes” to his or her health condition to the “Director” within three (3) business days. Must report all other “critical incidents” under General Regulation 79/10 in writing within ten (10) days of the critical incident.

• It is important to note that facts are not protected under QCIPA and would be allowable under the civil litigation discovery process, e.g. facts found in a patient/resident/client health record generated as a requirement of law (e.g. facts of Coroner’s report). Please refer to Appendix B – Summary of QCI.

When Should You Not Seek QCIPA Protection?

• Seeking QCIPA protection is typically not necessary when the contributing

factors of the critical incident (e.g. environmental problems) are already

known and where it is believed that no further relevant information will

be forthcoming.

• Under a QCIPA review, care should be taken to ensure that only facts and

implemented steps are disclosed, not recommendations that have not or

will not be implemented, and without any causal “link” between the

disclosure and the opinions from the QCIPA review.

What Are the Alternatives to QCIPA?

• (1) Solicitor-Client Privilege applies where legal counsel is employed or engaged by health facility to provide legal advice including in contemplation of litigation.

• (2) Traditional Common Law Privilege is the broadest and most “reliable” privilege.

• (3) “Litigation” Privilege protects health information generated for the predominant purpose of litigation and extends to information generated for this purpose.

What is Common Law Privilege?

• Quality reviews may be protected by traditional types of privilege using the “Wigmore Test” (Slavutych v Baker [1976] 1 S.C.R. 254) which has four conditions for establishing a privilege against the disclosure of a communication: (1) the communication must originate in a confidence that it will not be disclosed; (2) this element of confidentiality must be essential to the full and satisfactory maintenance of the relationship between the parties; (3) the relation must be one which in the opinion of the community ought to be sedulously fostered; and (4) the injury that would inure to the relation by the disclosure of the communication must be greater than the benefit thereby gained for the correct disposal of the litigation.

• Common law privilege in oral discovery related to health provider’s obligation is limited to disclosure of “material facts” only- Redman v Hospital for Sick Children(2010) ONSC.

• Health facility is not required to disclose identity of health professionals who participated in the quality review unless they were a material witness of fact to the care at issue - Redman v Hospital for Sick Children (2010) ONSC.

How Does Redman Apply to Medical Records?

• Common law privilege attaches to QCI in both documentary disclosure and in an oral discovery context.

• QCC reviews (and some quality “peer” reviews) are intended to be a confidential process which permits hypothesis, opinion and speculation.

• A witness to a material fact who participates in a QCC should be aware that his or her identity and contact details may have to be revealed in the context of a lawsuit; however, what he or she says is generally protected.

• A report arising from a critical occurrence review is privileged and the provider is not required to produce the report - Steep Litigation Guardian Of) v. Scott et al [2002] 62 O.R. (3d) 173; Leone v. The Hospital for Sick Children et al [2005] unreported - Toronto 70287/84).

How Do You Handle Certain Documents – Emails, Notes and Incident Reports?

• In general, what is not “privileged” are the recorded facts of a “critical incident”; that is, any recorded facts of an incident involving the provision of health care (prepared for the QCC) if these same facts are not in the patient’s chart. This may include Incident Reports, notes, emails or other documents for a QCC.

• Rule 30.01(a) of the Rules of Civil Procedure describes “document” as a sound recording, videotape, film, photograph, chart, graph, map, plan, survey, book of account, and data and information in electronic form (e.g. emails on servers, “smart phones” and other mobile devices). Therefore, all prior staff and provider emails about a “critical incident” may be subject to disclosure in civil litigation.

• Except under QCIPA, you may not always be in a position to claim privilege when you need to do so, e.g. where some documents contained elements of a quality assurance review but were not prepared exclusively or for the dominant purpose of a quality review, the Court found some documents to be privileged and ordered others to be produced - Doyle v. Green (1996) CanLII 4853 (NB C.A.).

Some Practical Tips

� Health organization should undertake a review of current practices (and underlying corporate governance structures such as Terms of Reference, By-Laws, Articles, “Membership” under Letters Patent, Operational Resolutions, Policies based on Level of Care Funding, Strategic Plan, etc.) with respect to QCIPA (and non-QCIPA) reviews.

� Consider how all quality assurance activities are being carried out. In particular, are there “isolated” activities done by individuals or on an ad hoc basis without direction from management, a committee or board?

� Develop its own “standard” system of documentation of quality reviews where you identify records as created for quality purposes.

THANK YOU!

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