Cinneadh
Mr. X and Health Service Executive
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-134715-H0D2M3
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-134715-H0D2M3
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
NOTE: Due to the significant amount of sensitive personal information contained in this decision and having regard to our obligations under section 25(3), we have redacted parts of this decision prior to publication in order to protect the identity and privacy rights of the individuals involved. The parties have been provided with a complete copy.
Whether the HSE was justified in refusing to amend, under section 9 of the FOI Act, information contained in a clinical audit tool relating to the care of the applicant’s daughter
22 July 2024
On 4 October 2022, the applicant requested, under section 9 of the FOI Act, the amendment of certain information contained in a [redacted] Clinical Audit Tool concerning her deceased daughter’s care in a HSE hospital. She provided details of the 14 amendments sought.
Following correspondence between the parties, the HSE issued its decision on 28 November 2022 wherein it refused to amend the record on the ground that a number of the amendments sought were in respect of information that is not personal information for the purposes of the FOI Act and on the ground that the remaining information was not incomplete, incorrect or misleading.
On 28 November 2022, the applicant sought an internal review of the HSE’s decision. The HSE affirmed its original decision on 19 December 2022. It said that it in reaching this decision, it had regard to a review that had been undertaken by a consultant of the [redacted] data contained in the record at issue and which was particularly relevant to the amendments numbered 1, 5, 7, 8 and 13. It said that it had requested that a copy of this review report be added to the patient healthcare record and attached to the [redacted] section and that it will be available to any person consulting the medical file, who will be made aware of the conclusions of the reviewer in respect of those items. On 31 January 2023, the applicant applied to this Office for a review of the HSE’s decision.
I have now completed my review in this case. In conducting the review, I have had regard to the correspondence between the applicant and the HSE as set out above and to the correspondence between this Office and both the applicant and the HSE on the matter. I have also had regard to the contents of the record at issue and additional records submitted by the parties in support of their respective positions. I have decided to conclude this review by way of a formal, binding decision.
The HSE numbered the amendments sought by the applicant as 1 to 14, and I have adopted this numbering for the purposes of the review.
I note that the amendment described at number 11 above is the same as what is already on the record so I will give it no further consideration.
This review is concerned only with whether the HSE was justified in its refusal of the application for amendment of the remaining 13 items contained in the Clinical Audit Tool.
I wish to apologise for the length of time that it took to bring this case to a conclusion. While there were a number of factors that contributed to this, including the complexity of the case and a change in staff in our Office, it is nonetheless regrettable, particularly given the subject matter of the records, and what the applicant and her family have already gone through with the tragic loss of their daughter.
Section 9 provides a mechanism for the amendment of records held by FOI bodies which contain personal information relating to the applicant. It provides for the amendment of such records where the personal information in the record is incomplete, incorrect or misleading. Section 9(6) provides for the Minister to make regulations for the making of an application under section 9 for the amendment of personal information relating to deceased persons by specific categories of persons. The relevant Regulations are S.I. No. 53/2017 - Freedom of Information Act 2014 (Sections 9(6), 10(6) and 37(8)) Regulations 2017 (the 2017 Regulations), and they set out the circumstances in which an application made by a spouse or next of kin for amendment of a record under section 9 may be granted. In its decision letter of 28 November 2022, the HSE said that it accepted that the applicant had the right to access her daughter’s personal information as her next of kin. While it didn’t specifically refer to the right to amendment, it seems to me that the HSE has effectively accepted that the applicant has standing to seek the amendment of her daughter’s personal information.
An applicant seeking to exercise the right of amendment under section 9 must show that the information which is the subject of the application is incomplete, incorrect or misleading. The information concerned must be personal information within the meaning of the FOI Act. The amendment of a record under section 9 may be made in the following ways: (a) by altering it (b) by adding a statement, or (c) by deleting the information.
The Act is silent on the question of where the onus of proof lies in section 9 cases. This Office considers that in the absence of any express statement in the Act, the onus of proof lies on the applicant as the party asserting that the information is incomplete, incorrect or misleading.
The Act is also silent as to the standard of proof which should apply in such cases. This Office takes the view that the standard of proof required in such cases is that of "the balance of probabilities". It follows, therefore, that an applicant seeking to exercise the right of amendment under section 9 must show that the information which is the subject of the application is, on the balance of probabilities, incomplete, incorrect, or misleading.
This Office does not consider its his role, arising from section 9, as being to conduct its own comprehensive enquiry as to the accuracy or completeness of records held by a public body. Rather, we must have regard to the evidence actually provided by the applicant, and to any rebutting evidence put forward by the FOI body, and make a decision on that basis. In requiring an applicant to provide evidence that the information in a record is actually incomplete, incorrect or misleading, this Office is not making any prior judgement as to the accuracy of a record. The fact that an applicant fails to provide sufficient evidence to enable the Commissioner to conclude that the information in a record is incomplete, incorrect or misleading will cause the records to remain undisturbed, but this does not carry any judgement on the part of this Office that the record is, in fact, complete, correct and not misleading.
Furthermore, this Office would not be justified in directing an FOI body to amend its records on the sole basis of contrary statements or opinions, however strongly held, by the person seeking the amendment. Thus, an applicant's assertions alone will not form sufficient evidence to warrant an amendment, in the absence of supporting evidence.
It is not the role of this Office to investigate complaints about the manner in which records such as professional reports were created, or to consult with relevant experts in order to make findings on applications for the amendment of such records. The role of this Office does not extend to examining the professional judgment of a body or its staff in the creation of records. Neither is it our role to conduct a comprehensive enquiry as to the accuracy or completeness of records. Rather, as noted above, regard must be had to the evidence actually provided by the applicant, as well as to any rebutting evidence put forward by the FOI body, in order to make a decision on that basis.
Directing the amendment of information in a record held by an FOI body is a serious step and has particular implications for the evidential value of records. Interference with the integrity of a record of an FOI body is not something to be decided upon lightly. This Office takes the view that amendment should, as far as possible, not interfere with the historical accuracy of records, with the way the contents of a record serve to establish facts, or with the way the contents of a record explain subsequent actions and decisions of public bodies.
It is also important to note that, with certain limited exceptions, in cases where a section 9 application is refused, the FOI Act requires the FOI body to attach to the record concerned the application for amendment, a copy of the application or a note indicating that it has been made. This in itself is quite significant as it alerts all future users of the record that aspects of its contents are disputed by the applicant.
For a potential right of amendment under section 9 to exist, the information concerned must be personal information within the meaning of the FOI Act. Personal information is defined in section 2 of the Act as information about an identifiable individual that either (a) would ordinarily be known only to the individual or members of the family, or friends, of the individual, or (b) is held by an FOI body on the understanding that it would be treated by that body as confidential. The definition also details fourteen specific categories of information that is personal information without prejudice to the generality of the foregoing definition, including (i) information relating to the educational, medical, psychiatric or psychological history of the individual.
In its submissions to this Office, the HSE said that the purpose of the Clinical Audit Tool is to facilitate the standardised collection of information from hospital sites on their current [redacted] practices, and subsequent comparison to best practice guidelines. It said that while information relating to the medical history of an individual is personal information of that individual (within the meaning of Section 2 of the FOI Act), this does not mean that every item of information in records arising from a patient’s care will be personal information. Specifically, it said that amendments 1, 2, 6 and 9 did not relate to the amendment of the applicant’s daughter’s personal information and as such no right of amendment existed.
Having examined the Clinical Audit Tool, and having regard to the HSE’s submissions as to its purpose as an audit tool, I think it is reasonable to describe it as a record that relates to the applicant’s daughter and that it contains information relating to the medical care that was provided to her. Nevertheless, this does not mean that all of the information contained in the record is personal information that is amenable to amendment under section 9. In order for such a potential right of amendment to exist, the specific information for which amendment is sought must be personal information.
Accordingly, I have considered each of the amendments sought with a view to ascertaining whether the information at issue comprises, in and of itself, personal information relating to the applicant’s daughter. Having done so, I find that, for the reasons set out below, the information that is the subject of amendments 2 and 6 is not personal information relating to the applicant’s daughter.
Amendment 2 is a request to amend the clinical speciality recorded for the named Consultant/treating specialist. I am not satisfied that this is personal information relating to the applicant’s daughter for the purposes of section 9; rather, it is information concerning the doctor’s speciality.
Amendment 6 is a request to amend the answer to the question “Was [redacted] appropriately according to current [redacted] protocol?” from ‘yes’ to ‘no’. The HSE said that this assessment of whether or not the hospital carried out the protocol in line with policies and procedures is not personal information for the purposes of section 9. While I accept that the applicant disagrees with the assessment contained in the audit form that the [redacted] was carried out appropriately, and that she considers this to be a relevant factor in terms of the care provided to her daughter, I do not accept that the assessment recorded on the record comprises personal information that is amenable to amendment under section 9. Rather, I find that it reflects an assessment of the hospital’s response when compared to the required protocols.
It was the HSE’s position that two further amendments, 1 and 9, did not concern the amendment of the applicant’s daughter’s personal information. In respect of amendment 1, it said that recording the time a hospital protocol was initiated was not considered personal information. In respect of amendment 9, it said that whether a consultant was notified was not considered personal information as it related to a third party doctor.
While it is finely balanced, I am of the view that this information, i.e. the time that the [redacted] protocol was initiated and whether or not a consultant was notified, is directly linked to the medical history of the applicant’s daughter and the care that was provided to her, and I find that it is personal information that is potentially amendable to amendment under section 9.
Overall, I am satisfied that the information captured by the amendments 1, 3 - 5, 7 -10, 12-14 is personal information that falls to be considered for amendment.
The HSE first made some general submissions on the application to amend the record under section 9. It said that the purpose of a Clinical Audit Tool is to allow for the standardised collection of information from hospital sites on their current [redacted] practices, and subsequent comparison to best practice guideline. It said that the record is completed electronically and many sections provide a drop down box of predetermined responses to choose from. It provided this Office with a blank copy of the audit form, for reference.
The HSE said that the Clinical Audit Tool in question was completed with details known to the person completing the form at the time. It said that it forms part of a wider set of medical records for the applicant’s daughter, which contain detailed information across various different types of records and disciplines. It said that the Clinical Audit Tool was the subject of a subsequent [redacted] audit carried out by a [redacted] consultant dated 3 November 2022 which considered and clarified dates and times within the document, while recognising potential discrepancies which can arise with manual recording. It said that this audit record is now kept alongside the Clinical Audit Tool in the medical records and that the applicant has been provided with a copy. The HSE then made more specific submissions in respect of each of the amendments sought, which I will examine in turn.
Amendment 1
The applicant sought the amendment of the entry for the record field “Time of [redacted] Activation” from 16:10 to 15:50. In seeking this amendment, she referred to reports of two consultants [redacted] . In its initial submissions to this Office, the HSE said the applicant provided no evidence to indicate that the time the [redacted] Protocol was activated at 15.50 rather than 16.10. It said the Clinical Audit Tool was completed the day after the incident with details known to the person completing the form at the time. It noted that the applicant suggested that relevant evidence might be found in statements made by two consultants. It said statements are a personal recollection of events, and references to timings can differ across individual documents (to include statements) which could well be incorrect or misleading if considered on their own. It argued, however, that the record forms part of a wider suite of records which must be seen in context.
I have examined the various documents and records that were provided by the HSE and the applicant in the course of the review. In particular, I have had regard to:
[Redacted]
The HSE emphasised that in general, in this type of emergency, record keeping is not the priority and records may be completed retrospectively so times will not match up exactly and there will be discrepancies.
Having considered the various records and arguments made by the parties, reaching a definitive conclusion is not simple or straight forward. It seems to me that, in cases like this, it is important, when weighing up the evidence, to distinguish between contemporaneous records and retrospective review-type records which, one presumes, relied on contemporaneous records in reaching conclusions. Similarly, it is important to consider manual and electronic recording of information and the relative reliability of these sources, particularly in a time of emergency.
Taking all of the above into account, I believe, on balance, that the time of 16:10 contained in the Clinical Audit Tool as the time of activation of the protocol is most likely incorrect. In reaching this conclusion, I have given particular weight to the fact that a contemporaneous note [redacted] indicates that [redacted] and that the electronic [redacted] System indicates that [redacted] . I note the explanation [redacted] .
On this basis, I am satisfied, on the balance of probabilities, that the time of 16:10 contained in the Clinical Audit Tool as the time of activation of the [redaction] is incorrect, and that it should instead be recorded as 15:50. I find that the HSE was not justified in refusing this request for amendment.
Amendment 3
The applicant sought the amendment of the entry for the record field ‘Reason for admission’ from [redacted] to [redacted] . She stated that this more detailed reason for admission is evident from the hospital notes. The HSE said that the collection of this data on the audit form allows for filtering and reporting on specific patient groups and time frames. It said the information in the record is correct, and is not lacking requisite details required by the circumstances in which the record was created or the uses to which the record was put. It said the reason for the admission was completed on the form based on the information known at the time the form was completed. It said that while wider medical records may contain more specific or explicit details, the Clinical Audit Tool need not contain these details in a verbatim manner and the presence of additional information in other accompanying records does not necessarily mean that the Clinical Audit Tool is incomplete, incorrect or misleading for the purposes of section 9.
Personal information in a record is not incomplete merely because the record does not contain the level of detail that an applicant might like it to contain. This Office takes the view that the word incomplete in section 9 is used in the sense of imperfect or defective or lacking certain requisite items or details. In deciding whether the information can be so described, regard has to be had to the purpose for which the information is held or why the record was created. Having regard to the nature and purpose of the Clinical Audit Tool as outlined above and to the purpose for which the information at issue is held in the record, it seems to me that while the ‘reason for admission’ is described at a higher level and in less detail than the applicant might like, I find that she has not shown that the entry is, on balance, incorrect, incomplete or misleading. I find that the HSE was justified in refusing this request for amendment.
Amendment 4
Under the heading “Type of case”, the Clinical Audit Tool provides nine different options, and allows for the entry of “Yes” to be added to the appropriate case field. The case type selected in respect of the applicant’s daughter was [redacted] . The applicant requested that this be amended to indicate that the case type was [redacted] .
The HSE said collection of this data in the Clinical Audit Tool allows for filtering and reporting on specific patient groups. It said audit of these data points may assist the hospital in identifying particular patient groups at risk in the interests of patient care. It argued that the record is correct to state [redacted] . It seems to me that this entry is to do with the categorisation of the type of case in which the [redacted] . Having regard to the nature and purpose of the Clinical Audit Tool as outlined above and to the purpose for which the information at issue is held in the record, I find that the applicant has not shown that the entry is, on balance, incorrect, incomplete or misleading. I find that the HSE was justified in refusing this request for amendment.
Amendment 5
On the Clinical Audit Tool, in response to the question “Did the patient have [redacted] ?”, the completed field indicates “no”. The applicant requested that this be amended to “yes”. She stated that there was [redacted] . She also referred to the review conducted by the consultant [redacted] .
The HSE said that that the response to the question is picked from a drop down box of predetermined responses which gives the person completing the audit form the following options only: [redacted] . As the patient did not have a history of these, it argued that ‘no’ was correctly documented on the audit form and that the form is therefore correct in this respect and is not misleading.
While I acknowledge the comments made by the consultant [redacted] , the drop down list of options available does not include such an option. Rather, the options for ‘yes’ are limited to [redacted] . Given the limited options available to the person completing the form, and the purpose for which the question was asked, I am not satisfied that selecting “no” in response to whether there was a [redacted] , is, on balance, incorrect, incomplete or misleading. I find that the HSE was justified in refusing this request for amendment.
Amendments 7 and 8
These two amendment requests are connected and I will address them together. The Clinical Audit Tool asks [redacted] and the applicant requested that the response be amended from ‘no’ to ‘yes’; it then asks “If so, how many?” and the applicant requested that this response be amended from [redacted] .
[Redacted]
In these circumstances, I am satisfied that [redacted] and the information contained in the record is not incorrect, incomplete or misleading. Accordingly, I find that the HSE was justified in refusing the request for amendments 7 and 8.
Amendment 9
The Clinical Audit Tool, under [redacted] , asks “Was a consultant [redacted] notified?”, and the answer given is “yes”. The applicant sought an amendment of this answer, stating that the consultant [redacted] was not notified at 15:50, that he was notified at 19:40, [redacted] . She referred to a statement of the relevant consultant in support of this.
The HSE said that this part of the audit is seeking data on whether or not the [redacted] was notified of [redacted] . It said the time of the notification is not entered or required. It said the response to this question is picked from a drop down box of predetermined responses which gives the person completing the audit form the following options only: Yes, No, Not Applicable, Unknown.
Having regard to the nature and purpose of the Clinical Audit Tool as outlined above, and to the options available completing the form, it seems to me that to amend the record to ‘no’ would itself be misleading. The form does not provide an option to record when the consultant [redacted] was notified, or whether this was in a timely fashion; it simply asks whether or not a consultant [redacted] was notified. I am not satisfied that the information, is, on balance, incorrect, incomplete or misleading. I find that the HSE was justified in refusing this request for amendment
Amendments 10, 12 and 13
[Redacted]
In relation to each of these three requests for amendment, the HSE said that the information was not necessarily known to the person at the time they completed the form and therefore it was documented as 'unknown', or left blank. It said that whether or not [redacted] will be evident in the wider set of records. The HSE confirmed that [redacted] , and said that this is documented in the wider set of records. However, it said that this detail was not necessarily known by the person completing the form at the time it was completed and pointed to the dropdown options available on the audit form. In response to the question on [redacted] , the options available were: Yes, No, Not Applicable, Unknown. The options available in response to the question on [redacted] were: Yes and No. The options available in response to the question on [redacted] were: Yes, No, Unknown. The HSE said that while wider medical records may contain more specific or explicit details this record need not contain these details in a verbatim manner and this does not necessarily mean that a record is incomplete, incorrect or misleading for the purposes of section 9.
The applicant argued that the person filling in the form should have read the medical records where all the correct information was documented at the time the [redacted] occurred and that there is no excuse for not having the correct information documented. When asked to comment on this, the HSE said that this review is not concerned with what the person completing the form should have known, but what they actually knew. Furthermore, the HSE said while in general it would be expected that a person filling out a Clinical Audit Tool would do so with reference to the patient’s medical records, in this instance, the medical notes had been transferred to the Hospital Clinical Risk Department to preserve their integrity following the incident.
In respect of amendments 10 and 13, the fact that the Clinical Audit Tool provides ‘unknown’ as an option seems to me to indicate that it is anticipated that there will be instances where the person completing the audit tool will not have full access to the complete medical records at the time of completing the form. Bearing this in mind, and having regard to the purpose of the Clinical Audit Tool, which is an audit tool and does not purport to represent a complete and comprehensive account of the applicant’s daughter’s medical treatment, it seems to me that [redacted] was not known to the person completing the Clinical Audit Tool and that, in such circumstances, “unknown” was the appropriate option to select. This does not, it seems to me, indicate that this information is generally unknown, but that it was simply unknown to the particular person at the time of completing the audit form. For the question on [redacted] , the option of “unknown” was not available. It seems to me that leaving the answer blank was the most appropriate action to take if the information was not known to the person completing the form; to answer “yes” or “no” when they did not know would, in my view, have been misleading. For these reasons, I find that the information that the applicant has sought to have amended here is not incorrect, incomplete or misleading. I find that the HSE was justified in refusing the requests for amendments 10, 12 and 13.
Amendment 14
The Clinical Audit Tool asks “What was the outcome for [redacted] patients?” and the response given on the form is “Not Applicable”. The applicant requested that this be amended to reflect that her daughter suffered [redacted] , resulting in her death.
In its submissions, the HSE said that the patient was not a [redacted] patient so the current entry is correct. It said that the term [redacted] in the context of the Clinical Audit Tool form refers to a patient that falls within the speciality of [redacted] and does not refer to an outcome.
Having regard to the totality of the records in this case, it appears to me that there is no dispute that [redacted] led to the death of the applicant’s daughter. However, in respect of this particular amendment sought by the applicant, it seems to me that this question relates solely to cases that have been categorised as [redacted] cases. I refer to my findings in relation to amendment 4; this case was categorised as a [redacted] case rather than falling within one of the [redacted] categories. I find, therefore, that the response “not applicable” is not incorrect, incomplete or misleading. I find that the HSE was justified in refusing the requests for amendment 14.
Having accepted that the applicant has met the evidential bar in respect of one of her requests for amendment (amendment 1), the next question to determine is the appropriate method of amendment in respect of the information at issue. Given the nature of the Clinical Audit Tool and the purpose that it serves, I believe that altering it or deleting information from it would not be appropriate. Rather, it seems to me, a statement should be added to the Clinical Audit Tool, in accordance with section 9(1)(b).
I direct that the following statement be added to the Clinical Audit Tool: The wider records indicate that the [redacted] activation was 15:50 rather than 16:10.
Having carried out a review under section 22(2) of the FOI Act, I hereby vary the HSE’s decision. I find that the HSE was justified in refusing the requests for amendment numbered 2-14. However, I annul its decision in respect of amendment 1 and direct that a statement be added to the Clinical Audit Tool as outlined above.
Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated not later than four weeks after notice of the decision was given to the person bringing the appeal.
Stephen Rafferty
Senior Investigator