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Whether the Hospital's decision to refuse the applicants' request for access to certain extracts from the Clinical Risk file into their child's treatment was justified under sections 21(1)(a) and (b) and 26(1)(a) of the FOI Act

Conducted in accordance with section 34(2) of the FOI Act by Elizabeth Dolan, Senior Investigator, who is authorised by the Information Commissioner to conduct this review

Background

The applicants' son, a minor, (DOB 16 July 2011) presented to the Hospital in January 2012 with respiratory symptoms. Following surgery, his condition deteriorated suddenly. A subsequent MRI identified significant hypoxic brain injury. The Hospital undertook a Clinical Review into the circumstances surrounding the adverse incident.

On 10 May 2012, the applicants sought all notes, records, documents and information of any nature and description in relation to their son while he was a patient in the Hospital. They also sought all documents which were created as part of any investigations undertaken by the Hospital into his care and treatment.

On 21 June 2012, the Hospital decided to grant the request to some records or parts of records and to refuse to grant access to others. The records withheld were refused under sections 20(1), 21(1)(a) and 21(1)(b) of the FOI Act.

On 15 August 2012, following Internal Review, the Hospital varied the original decision. It released additional records but refused access to the remaining records having regard to sections 21(1)(a), 21(1) (b) and 26(1)(a). The released material included healthcare records, x-rays, medication records, "near-miss" forms, The Clinical Review Report and correspondence between the parents and the Hospital.

The applicants wrote to this Office on 12 September 2012 seeking a review of the Hospital's decision.

Mr Willy O'Doherty, Investigator, wrote to the applicants on 11 September 2014 setting out his preliminary views. The applicants responded on 2 October 2014. Having noted the contents of the response, I have decided to conclude the matter by way of a formal, binding decision. In carrying out my review, I have had regard to the following matters:
the correspondence between the applicants and the Hospital in relation to the request;
the Hospital's decisions on the matter;
the application to this Office and subsequent submissions from the applicants;
the contacts between the Hospital and this Office including submissions received and,
the provisions of the FOI Act.

In the interests of clarity, I should point out that this review was carried out under the provisions of the FOI Acts 1997 -2003 notwithstanding the fact that the FOI Act 2014 has now been enacted. The transitional provisions in section 55 of the 2014 Act provide that any action commenced under the 1997 Act but not completed before the commencement of the 2014 Act shall continue to be performed and shall be completed as if the 1997 Act had not been repealed.

Scope of the Review

As detailed above, Records 1, 2, 3, 4 and 5 were released to the applicants following the initial request and the Internal Review. Record 7, which contains the statements made by staff to the Review Team, was released in full in the course of the current review.

Record 6, which contains 97 pages, is the Clinical Risk File. It comprises, among other items, correspondence and notes between members of the Clinical Risk Review Team. In particular, it contains a 10 page document entitled "Care / Service Delivery Issues for Discussion by the Review Team". It also contains a document entitled "Timeline for the Care Review Process" (pages 11 to 42 and pages 54 to 64) which identifies, in respect of the child's care, (a) various events, (b) the person involved, (c) the notable practice, (d) the Care / Service Delivery problem(s) and (e) further information required by the Clinical Review Team.

Record 6 was released in part by the Hospital at Internal Review stage. However, the Hospital refused to release the 10 page document entitled "Care / Service Delivery Issues for Discussion by the Review Team." In relation to the "Timeline for the Care Review Process", (pages 11 to 42 and 54 to 64) the Hospital released details of the various events, the person involved and the notable practice. However, it refused to release details in relation to (a) Care / Service Delivery problems and (b) further information required by the Team. In addition, the Hospital refused to release pages 44, 45, 52, 53, 69 to 76, 78 to 81, 83, 84, 90. It granted partial access to pages 46 - 49, 66 and 94 to 97. These latter pages contain, in the main, the working correspondence between the Clinical Review Team members.

Therefore, my review is confined to an examination of the Hospital's decision in relation to the remaining parts of Record 6 only, as identified above on the basis that they are exempt from release having regard to sections 21(1)(a) and (b) and section 26(1) of the FOI Act.

Analysis and Findings

Preliminary Matters
A review under section 34 of the FOI Act is de novo. This means that it is based on the circumstances and the law as they pertain at the time of the review by this Office. It is also relevant to note that under section 8(4) of the FOI Act, the actual or perceived reasons for a request must generally be disregarded by the decision maker, including the Information Commissioner (except insofar as such reasons are relevant to consideration of the public interest or other provisions of the Act). Furthermore, the Courts have taken the view that, under FOI, records are released without any restriction as to how they may be used and, thus, FOI release is regarded, in effect, as release to the world at large. Therefore, this is a factor which must be taken into account in balancing the various public interest arguments. In this regard, I must reject the suggestion by the applicant's solicitors that this position implies that the parents are not to be trusted with any information released. This is definitely not the intention; The Investigator's communication on this point was simply intended to draw attention to the fact that, unlike, for example, the situation as regards records subject to a Court Order for Discovery, the FOI Act places no restrictions on the dissemination of records obtained by any party.

I should clarify the approach to the granting of access to parts of records. Section 2 of the FOI Act defines "record" as including "anything that is a part or a copy" of a record. Section 13 of the FOI Act provides for the deletion of exempt information and the granting of access to a copy of a record with such exempt information removed. This should be done where it is practicable to do so and where the copy of the record thus created would not be misleading. However, this Office takes the view that neither the definition of a record nor the provisions of section 13 envisage or require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. Generally speaking, therefore, this Office is not in favour of the cutting or "dissecting" of records to such an extent.

In addition, I should explain that while the Commissioner is required by section 34(10) of the FOI Act to give reasons for his decisions, this is subject to the requirement of section 43 that he take all reasonable precautions to prevent disclosure of information contained in an exempt record. This constraint places some limitations on what this Office can say about the contents of the records in the course of this review. However, I do not believe that it would be in breach of section 43 if I was to refer to certain limited information about the circumstances and background to the case where this is necessary.

Finally, it is not disputed that the parents, and next of kin, of the child have a potential right of access to his personal information. Their right of access derives from section 28(6)(a) of the FOI Act and the relevant regulations, S.I. No. 387 of 2009. Article 4(1)(a)(i) of S.I. No. 387 states that, subject to the other provisions of the FOI Act, a request for access to records which involves the disclosure of personal information shall be granted where the requester is a parent or guardian of the individual to whom the record concerned relates and that individual has not attained full age. However, since access was not refused by reference to section 28, I am obliged to consider the exemption provisions relied upon by the Hospital.

The Hospital's Position
The Hospital provides details of the basis for and the methodology used in the investigation. My understanding is that Clinical Risk Management (CRM) is an approach to improving the quality and safe delivery of health care by (1) placing special emphasis on identifying circumstances that put patients at risk of harm and (2) acting to prevent or control those risks. The Hospital says that CRM is an extremely important function. The Hospital maintains that release of the particular records would undermine established and essential communication between Hospital management and clinical staff and adversely effect the Hospital's ability to complete clinical reviews and general clinical risk management. The Hospital says that, in order to ensure that clinical risk investigations are effective, it is critical that the Clinical Risk Review Team is free to assess professionally and, where necessary, criticise and challenge the conduct of their peers in handling the particular incident under review.

Expectation of harm
The Hospital emphasises that the participation in Clinical Risk Review Teams by staff is a voluntary role. It says that this process requires full and frank expression of professional opinions about peers in order to ensure a robust and objective outcome. The Hospital argues that, if record 6 is released in full, it will not be able to guarantee the confidentiality of the professional analysis aspect of the clinical review investigative process.

Furthermore, the Hospital says that release of this information could reasonably be expected to prejudice the effectiveness of these essential patient safety investigations and the procedures or methods employed for conducting them by deterring:
the giving of full factual incident reports to Review Teams in future;
open and frank discussion, assessment and critique between members of the Review Team and
voluntary participation of staff in Clinical Risk Review Teams.

Finally, the Hospital says that, given that members of the Review Team are peers of those under review, it is critical that reviews are conducted confidentially so that they feel free to make such assessments or criticisms, and to ensure that staff continue to participate voluntarily as Review Team members.

Information obtained in confidence
The Hospital considers that parts of record 6 contain information given to it in confidence by Review Team members, and on the understanding that it would be treated as confidential. The Hospital also considers that disclosure of this information would be likely to deter the giving to it of further similar information in future clinical risk investigations, and that it is imperative that such further similar information should continue to be given to it, in order for the clinical review process to function to its capacity.

Likeliness of harm
The Hospital says that in order to have a robust process to investigate care and service delivery issues, the Review Team must actively probe, challenge, question and debate the care provided by their peers involved in the incident. The Hospital submits that release of the remainder of record 6, would destroy its ability to validate, or rule out, issues and to engage in and manage a meaningful review of patient care. It says that this confidential forum is necessary for the members of the Review Team only who are investigating the incident. It clarifies that this confidentiality does not extend to staff members who were involved in the care and treatment of the patient.

The Applicants' Position
The applicants suggest that if a patient goes into Hospital and has an adverse outcome, the patient (above all) has an entitlement to see the investigation process that was carried out so that they can consider the matter. They suggest that the patient, who is at the centre of the care and treatment delivery function and the adverse incident, has a primary interest in finding out what happened. They feel that a dispute is likely to be resolved in favour of the clinician, if the patient is excluded from the process.

The applicants are not convinced that there is any evidence to suggest that communication may be hampered if the records in question were released. They suggest that it is important that the public have confidence in what is happening at clinical review meetings. They say that if there is a balancing act that requires resolution between competing interests that the public interest should take precedence. Furthermore, they say that there is no evidence that any of the information was provided in confidence on the understanding that it would be treated as confidential and not disclosed. They feel that this argument can be used as a cloak to prevent access to information. They suggest that the public interest is better served by transparency and that transparency is vitally important in the Clinical Risk Review process. Finally, the applicants say they are not aware of any evidence which might suggest that clinicians might be slow to criticise their peers if the knew the documentation was going to be released to the public.

I note here that the Investigator drew the applicants' attention to the approach taken by the Scottish Information Commissioner in relation to clinical peer reviews in his decision, dated 13 November 2006, involving the Greater Glasgow NHS Board, reference number 202/2006. In response, the applicants' solicitors argued that the case differed significantly from this one in that it involved audits of cancer services as opposed to an incident affecting an individual patient.

Section 21(1)
The Hospital relies on section 21(1)(a), which provides that a public body may refuse access to a record if it considers that access could reasonably be expected to prejudice the effectiveness of tests, examinations, investigations, inquiries or audits conducted by or on behalf of a public body or the procedures or methods employed for the conduct thereof.

It also relies on section 21(1)(b), which provides that a request for access to a record may be refused where access could reasonably be expected to have a significant, adverse effect on the performance by a public body of any of its functions relating to management.

In arriving at a decision to claim a section 21 exemption, a decision maker must, firstly, identify the potential harm to the functions covered by the exemption that might arise from disclosure and, having identified that harm, consider the reasonableness of any expectation that the harm will occur. The test of whether the expectation is reasonable is not concerned with the question of probabilities or possibilities; it is concerned with whether or not the decision maker's expectation is reasonable.

It is appropriate here to refer to the Supreme Court judgment in Sheedy v Information Commissioner, [2005] IESC 35 (the text of this judgment is available on this Office's website: www.oic.gov.ie). Mr. Justice Kearns commented, in relation to section 21(1), that "the onus to produce evidence of prejudice fell on the Department and in the absence of same the Commissioner was entitled, under section 34 of the Act of 1997, to hold against the Department. A mere assertion of an expectation [of prejudice] could never constitute sufficient evidence in this regard". Thus, in the present context, I consider that the Hospital must show some evidence of prejudice if its reliance on section 21(1)(a) is to be justified.

In the case of a claim under section 21(1)(b), a stronger showing of harm is required than under the "prejudice" standard of section 21(1)(a). When invoking section 21(1)(b), the public body must make an assessment of the degree of importance or significance attaching to the adverse effects claimed. Not only must the harm be reasonably expected, but it must also be expected that the harm will be of a more significant nature than that required under section 21(1)(a). Both sections 21(1)(a) and (b) are subject to a public interest test under section 21(2).

It is clear that public health services face increasing levels of scrutiny and a growing expectation that they are accountable for their actions. This focus on accountability is further reinforced by a heightened public expectation about transparency and disclosure regarding the performance of clinicians in the performance of their clinical duties. In this regard, clinical audit and quality assurance systems, including clinical risk reviews, are essential to the provision of good care and must be supported by access to high quality reliable data.

In this particular case, the Hospital has released considerable documentation, including the child's healthcare records, his X-rays, his Medication forms, the Incident / "Near Miss" Forms, the correspondence the parents had with the Hospital, the statements made by staff to the Review Team and the Clinical Review Report. The Clinical Review Report outlines, among other issues, the members of the Review Team, the investigating methodology, the incident classification (which it classified as "High Risk"), an analysis of the care received, the contributory factors and the root cause of the incident. It makes recommendations, provides additional information and includes feedback from the patient's parents. The Hospital has also released a Timeline for the Care Review Process which identifies (a) various events, (b) the person involved and (c) the notable practice. Therefore, to that extent, I am satisfied that the investigation process engaged with the applicants, was visible to them and that it explained what happened during the treatment of the child.

Having examined the documentation which was released, I am not persuaded, that, as contended by the applicants, the patient was excluded from the examination process. I accept, however, that the Hospital has stopped short of releasing details in relation to the correspondence between the Clinical Review Team members including Care / Service Delivery problems and further information required by the Team; I comment on this below.

It seems to me that a key consideration of the Clinical Review Process is that members of the Review Team are free to criticise and challenge the conduct of their peers in handling the incident or the process being reviewed. The peer review methodology, using peer clinicians from different services gives acceptance and authority to the Clinical Review process. It also enables a large number of health clinicians to participate and share their views and experience in an open, blame free environment. In my view, the level of confidentiality accorded to the Clinical Risk Review process and the trust developed between staff members, in the handling of sensitive information, is an important component for securing the necessary collaboration in conducting Clinical Risk Reviews. I consider that the principle of protecting the processes of the Review Team is capable of applying whether the investigation is primarily about what happened in the case of an individual patient or about a more general or systematic issue.

If this trust element were undermined in this case, I believe that it could reasonably be expected to prejudice the effectiveness of the Hospital's investigations under the Clinical Review Process. I accept that the Hospital's concerns are reasonably well founded and that the emphasis that is placed on trust and on frank participation is warranted in the circumstances. Accordingly, I find that section 21(1)(a) applies in this instance. Given this finding, it is not necessary to examine the section 21(1)(b) exemption provision further.

Section 21(2) - The Public Interest
Section 21(2) provides that subsection (1) shall not apply in relation to a case in which, in the opinion of the head concerned, the public interest would, on balance, be better served by granting than by refusing to grant the request. I have, therefore, considered the public interest in this case.

As argued by the applicants, there are a number of public interest factors in favour of release of the records. These include the public interest in requesters exercising their rights of access under the FOI Act and the public interest in people having access to records that relate to personal information about themselves and their children. There is also a public interest in public bodies being open and transparent in matters related to regulation and governance. The applicants argue that if there are competing interests, the patient's interests should take precedence. However, there is also a strong public interest in public bodies being able to carry out effective investigations into sensitive matters where those undertaking the investigations have to process information in a frank and open manner without fear that any confidences will be breached.

Furthermore, there is a public interest in public bodies being in a position to ensure that adverse clinical outcomes are properly investigated and considered. It seems to me that there are situations where the best method of dealing with such adverse medical incidents will be for a public body to conduct its own internal, formal inquiry, with appropriate assurances of confidentiality to the parties concerned. The choice of the most suitable procedures in individual cases rests with the public body. I would stress that assurances of confidentiality would not be warranted in every case. However, I accept the Hospital's position that there was an expectation of confidence in this case.

The FOI Act recognises in section 28(6), a public interest in parents having access to information about their children. However, the Supreme Court in The Governors and Guardians Rotunda Hospital v. Information Commissioner [2011] IESC 26 [the Rotunda Hospital case], held that the various exemptions in the FOI Act are to be considered separately and that the fact that a record may be available pursuant to one provision does not mean that it cannot be protected by another exemption. I consider that this case properly falls to be considered under the Section 21 exemption.

On balance, having considered the various arguments carefully, including the fact that release of records under the FOI Act amounts to disclosure to "the world at large", I take the view that the public interest in protecting the integrity of the Clinical Risk Management peer review system, and thus preserving a relationship of trust between management, the Clinical Review Team and staff in relation to the investigation of adverse clinical incidents outweighs the public interest that the withheld parts of record 6 be released. My conclusion in this regard is particularly influenced by the fact that the Hospital has released a considerable amount of records including substantial information gathered in the course of the investigation together with the final report of the Clinical Review.

Thus, my finding is that, on balance, the public interest in openness and transparency of public bodies has been sufficiently satisfied by the release of the majority of the records. I am also satisfied that those parts of record 6 which have been withheld have been withheld so as not to prejudice the effectiveness of the Hospital's investigations rather than to deny access to the documentation trail in relation to the Clinical Review Team's investigations.

Accordingly, I find that section 21(2) does not apply in this instance.

Section 26
As I have found the decision to exempt the relevant information in line with the provisions of section 21(1)(a) is justified, I do not consider it necessary to consider the application of section 26 to that same information.

Decision

Having carried out a review under section 34(2) of the FOI Act, I hereby affirm the decision of the Hospital in this instance.

Right of Appeal

A party to a review, or any other person affected by a decision of the Information Commissioner following a review, may appeal to the High Court on a point of law arising from the decision. Such a review must be initiated not later than eight weeks from the date of this letter.

Elizabeth Dolan
Senior Investigator