The Anaesthetic Period: Records
Anaesthesia records Ownership of records Signing of records and official documents The anaesthetist’s prescription Records of incident and death reporting Aggregated clinical data and registries Personal information and health data: confidentiality and access SASA supports the following WFSA standards: A record of the details of each anaesthetic (preoperative assessment, anaesthetic plan, intra-
Signing of records and official documents
The anaesthetist’s prescription
Records of incident and death reporting
Aggregated clinical data and registries
Personal information and health data: confidentiality and access
SASA supports the following WFSA standards:
- A record of the details of each anaesthetic (preoperative assessment, anaesthetic plan, intra- and postoperative course) should be made (highly recommended).
- It is recommended that individuals, departments, and regional and national groups collect cumulative data to facilitate the progressive enhancement of the safety, efficiency, effectiveness, and appropriateness of anaesthesia care.
Anaesthesia records
A full contemporaneous record relating to the continuum of anaesthetic care, i.e., records relating to preanaesthesia, intraoperative and postanaesthesia care, should be made by the practitioner delivering an anaesthetic. Any anaesthesia-related complications should be documented in the patient file. The following has been adopted from the Canadian Anesthesiologists’ Society guidelines, with permission:
All monitored physiologic variables should be charted at intervals appropriate to the clinical circumstances. Heart rate and BP should be recorded at least every five minutes. O2 saturation must be monitored continuously and should be recorded at frequent intervals for all patients. End-tidal carbon dioxide concentration must be constantly monitored and recorded at frequent intervals. Reasons for deviation from these charting guidelines should be documented in the anaesthetic record. Monitors, equipment, and techniques, as well as time, dose, and route of all drugs and fluids should be recorded. Intraoperative care should be recorded.
The anaesthesia record should include the patient’s level of consciousness, heart rate, BP, O2 saturation, and respiratory rate as first determined in the PACU.
All practitioners must provide and maintain documentation to support the execution of any tasks as set out in these Practice guidelines in as much detail as is practical and useful. The practitioner may be required to submit this information to named authorities willingly if patient confidentiality is maintained.
The HPCSA states that “healthcare practitioners should enter and maintain at least the following information for each patient consulted”:
- Personal (identifying) particulars of the patient.
- The bio-psychosocial history of the patient, including allergies and idiosyncrasies.
- The time, date, and place of every consultation.
- The assessment of the patient’s condition.
- The proposed clinical management of the patient.
- The medication and dosage prescribed (all prescriptions must comply with the provisions of the Medicines Act and regulations).
- Details of referrals to specialists, if any (including the reports from such specialists, or any other conversations had with such specialists).
- The patient’s reaction to treatment or medication, including adverse effects, bearing in mind that the Medicines Act makes the reporting of adverse events to the manufacturer of the product, or directly to SAHPRA, compulsory.
- Test results.
- Imaging investigation results.
- Information on the times the patient was booked off from work and the relevant reasons.
- Where applicable, written proof of informed consent or some record or note in the patient file that consent has been obtained.
The entity holding and processing the information must consider and adhere to the following:
- The patient is entitled to see data being stored.
- The information being collected and processed must be adequate and necessary in view of the purpose to which the patient has consented.
- The holder of the information is obliged to ensure the accuracy, quality and security of the information they hold.
- Haemodynamic printouts or electronic data collected by facilities concerned as documentation of patient vital signs during anaesthesia can only be collected with the patient’s and anaesthetist’s prior consent.
Each record and printout must possess clear identifiable patient details. Any patient data collected that would reasonably be considered to be part of the patient-doctor notes may only be reviewed by or shared with any party other than the clinician or patient directly with prior written consent of the patient and, when shared, with notification to the clinician concerned (and this includes any legal representatives of facility groups).
Ownership of records
- The information on a health record belongs to the patient.
- The record itself, however, belongs to the entity. However, this does not give the entity the right to disclose the information contained in the record in any manner other than as is determined by law.
- The entity referred to above is the person/persons legally holding the patient’s record.
- For state practice, standard documents approved by the authority, e.g., provincial administration, are used.
- Outside of the public sector, records on personally owned stationery guarantees the anaesthetist’s ownership of the record. SASA recommends that anaesthetists in private practice, as far as is permissible, enter medical records onto personally owned stationery.
- All recorded patient information, both written and digital, should be preceded by an informed consent process.
- The patient has a right to the information as contained in their record and may petition under the Promotion of Access to Information Act (PAIA) for a copy of said record.
- SASA recommends that where records are made available to patients, the responsible practitioner personally discloses/ explains the shared information.
- The only acceptable grounds for refusal of access to patients’ records is if access might cause serious harm to their physical or mental wellbeing.
Signing of records and official documents
- Practitioners are, through the ethical rules, obliged to sign official documents and instructions generated by them. According to the HPCSA’s ethical rules, this signature must be accompanied by the initials and surname of the practitioner in block letters. This also validates the instruction or record and the date it was issued.
- Sick certificates must comply with the requirements of the ethical rules. They can only include the diagnosis in a lay person’s language if the patient has provided written consent to such disclosure.
The anaesthetist’s prescription
The HPCSA’s ethical rule 23 stipulates that the medical practitioner “shall not engage in or advocate the preferential use or prescription of any medicine or medical device which would not be clinically appropriate or the most cost-effective option” and that such prescription or supply shall be based on “the diagnosis of the patient concerned through a personal examination of the patient or by virtue of a report by another practitioner under whose treatment the patient is or has been and such medicine or medical device is clinically indicated, considering the diagnosis and the individual prognosis of the patient, and affords the best possible care at a cost-effective rate compared to other available medicines or medical devices and the patient is informed of such other available medicines or medical devices”.
This ethical rule means that
Practitioners may prefer certain products over others, provided that:
- Diagnoses should precede prescriptions.
- Prescriptions must be clinically indicated.
- Patients must be informed of the medicines available to them
Ethical rule 27A requires practitioners to respect patients’ choices, and read with the NHA, requires practitioners to give patients the options generally available to them.
Ethical rule 17 requires all prescriptions to be issued under the personal and original signature of the medical practitioner. The format of a prescription, i.e., whether on a separate sheet entitled “prescription” or whether in the form of a medicines record as kept by anaesthetists in theatre, is not prescribed.
The Medicines and Related Substances Act 101 of 1965 (the Medicines Act) stipulates the conditions under which the various scheduled medicines may be prescribed and supplied to the public. Section 22A determines that:
- Schedule 2, 3 or 4 substances may only be repeated if the person who issued the prescription has indicated thereon the number of times it may be dispensed, but not for longer than six months.
- Schedule 5 substances shall not be repeated for longer than six months, and only if the authorised prescriber has indicated on the prescription the number of times and the intervals at which it may be dispensed. Where the Schedule 5 substance is used for:
- its anxiolytic, anti-depressant, or tranquillising properties, it shall not be prescribed for longer than six months unless the authorised prescriber has consulted a registered psychiatrist before issuing a new prescription; or
- its analgesic properties, it shall not be prescribed for longer than six months unless the authorised prescriber has consulted another medical practitioner before issuing a new prescription.
- Schedule 6 substances shall not be repeated without a new prescription being issued.
- Schedule 7 or 8 substances may only be acquired by the Director-General, who may provide a medical practitioner therewith, on the prescribed conditions for the treatment or prevention of a medical condition in a particular patient.
Regulation 28 of the General Regulations to the Medicines Act requires certain particulars to be on a prescription or order for a medicine:
- the name, qualification, practice number and address of the prescriber;
- the name and address of the patient;
- the date of issue of the prescription or order;
- the approved name or the proprietary name of the medicine;
- the dosage form;
- the strength of the dosage form and the quantity of the medicine to be supplied;
- in the case of a prescription, instructions for the administration of the dosage and frequency of administration;
- the age and sex of the patient;
- the number of times the prescription may be repeated; and
- the International Classification of Diseases code (ICD code) should be stated where a prescription is to be funded by a third-party funder
In SASA’s opinion, the medicines record in theatre constitutes a lawful format in which regulation 28 is complied with, provided that the information set out above is included in the record.
A prescription constitutes an order to a pharmacist to dispense medication to a patient or guardian who will then administer the medication and/or a delegation of authority to a registered nurse to dispense/administer a medication to a patient on the medical practitioner’s behalf. A prescription per patient is not required for drugs directly administered by the anaesthetist perioperatively. It is, however, incumbent on the anaesthetist to accurately record all drugs administered to each patient (time, dosage, route and relevant information.
Regulation 28 also requires pharmacists to verify the authenticity of telephonic, faxed, or electronic prescriptions, requiring that it be followed by the original prescription or order within seven working days.
Regulation 28 also stipulates that the prescriber must keep records of the diagnosis relevant to the prescription and indicate the diagnosis on the prescription where the patient consents.
Practitioners should not demand any valuable consideration in return for prescribing products and/or for supporting suppliers of medicines. Prescription data shall only be made available to third parties (even if through intermediaries such as switching or clearing houses and software companies) with the patient’s informed consent that data may be passed on and reworked by other companies.
Records of incident and death reporting
The requirements for reporting adverse incidents (an institutional process) and death (a statutory process) are discussed in the Peer review and Incident Reporting sections of these Guidelines.
South African law requires any death considered unnatural to be reported for medicolegal investigation. Unnatural death related to anaesthesia is provided for in the Health Professions Act. In July 2008, a revised version of this statutory obligation came into effect with the proclamation of the Health Professions Amendment Act.
Previously the law stated that “the death of a person whilst under the influence of a general anaesthetic or local anaesthetic, or of which the administration of an anaesthetic has been a contributory cause, shall not be deemed to be a death from natural causes as contemplated in the Inquests Act 58 of 1959, or the Births, Marriages and Deaths Registration Act 81 of 1963“. This has now been amended and states that “the death of a person undergoing, or as a result of a procedure of a therapeutic, diagnostic or palliative nature, or of which any aspect of such a procedure has been a contributory cause, shall not be deemed to be a death from natural causes as contemplated in the Inquests Act 58 of 1959, or the Births and Deaths Registration Act 51 of 1992”.
It is essential that the following documentation is completed and made available to the state pathologist who will perform the autopsy in the instance of a procedure-related death:
- Contemporaneous anaesthetic record and notes.
- GW7/24 medicolegal form (The current South African [SA] procedure-related death notification [PRDN] instrument), the GW7/24 form (Report of person whose death is associated with the administration of an anaesthetic or a diagnostic or therapeutic procedure), originally published in the 1970s.
- Relevant documents from the patient’s file.
Maternal deaths
Definition: The maternal mortality ratio (MMRatio) is the annual number of female deaths per 100 000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes). The MMRatio includes maternal deaths occurring during pregnancy and childbirth. This also includes deaths occurring within 42 days of termination of pregnancy, irrespective of the duration of the pregnancy.
In cases of a maternal death where an anaesthetic was involved, the following is essential:
- Completion of the same documentation as with a procedurerelated death and completion of the maternal death notification form (MDNF) with the entire maternity team.
Integrated reporting of an adverse incident and procedure-related death
It is recommended that the processes of adverse incident and procedure-related death reporting is integrated for the following reasons:
1. To improve the quality of record keeping.
- The anaesthetic record, whether in electronic or printed/handwritten format, should be the basis of all record-keeping contributions from the anaesthesia provider.
- It is recommended that supervisors or other colleagues guide less experienced providers to ascertain that the record contains all relevant information. This may be facilitated in the process of adverse incident reporting, as described by the NDoH in their policy document, with regards to Step 4 to 7: Notification, Investigation, Classification and Analysis.
- It is highly recommended that the anaesthetic record is attached to the GW7/24 medical report to the forensic investigator in case of a procedure-related death.
- It is also highly recommended that the names of senior colleagues that reviewed (Ensuring that relevant information is included) the anaesthetic record AND the full report is added to the GW7/24.
- It is recommended that individuals and institutions participate in the collection of adverse event data using the tool developed by the NDoH, or a similar tool.
- Incorporating record keeping in a standard workflow process for incident reporting may improve the quality of the record.
2. To facilitate root-cause analysis and the institution of quality improvement programmes.
Aggregated clinical data and registries
The Perioperative Shared Health Record and Integration with a Perioperative Clinical Registry
The Perioperative Shared Health Record (PSHR) is a web-based platform administered by Safe Surgery SA (SSSA) that enables patient-centred information exchange between different members of the care team for a patient undergoing a surgical procedure. Central to its function is its interoperability – the ability to integrate with other data sources using similar health data standards, or to integrate existing electronic case- or administrative perioperative information. It will contribute to the basic dataset for a Perioperative Clinical Registry – a clinician-driven platform inclusive of all physician service providers. The PSHR will allow for individual practice benchmarking. Using appropriate governance mechanisms, the Perioperative Clinical Registry will allow for clinician-driven quality assessment and research.
The final results of this were published in the 2019 South African Health Review, and SASA continues to engage with all stakeholders on this and other platforms.
Personal information and health data: confidentiality and access
The ethical duty of healthcare professionals to preserve patient confidentiality is intrinsically related to the trust that patients place in practitioners. Laws such as the NHA, PAIA and POPIA all address the right to confidentiality and the circumstances under which disclosure would be authorised. Record-keeping is critical in risk management in medical practices and health establishments. The following section is informed by POPIA.
Summary of the act
- to promote the protection of personal information processed by public and private bodies;
- to introduce certain conditions so as to establish minimum requirements for the processing of personal information;
- to provide for the establishment of an Information Regulator to exercise certain powers and to perform certain duties and functions in terms of this Act and the Promotion of Access to Information Act, 2000;
- to provide for the issuing of codes of conduct;
- to provide for the rights of persons regarding unsolicited electronic communications and automated decision making;
- to regulate the flow of personal information across the borders of the Republic; and
- to provide for matters connected therewith.
Types of data and information that are protected
- According to the NHA all information about a person’s stay and/or visit to a health establishment, as well as information relating to his/her health status, treatment and care are confidential. This includes information provided by the patient, as well as information generated by healthcare professionals (e.g., prescriptions, notes in a patient file, etc.)
- In addition, all names, addresses, and similar personal information, as well as financial and biometric information and the likes are protected by POPIA. Information that is truly de-identified and cannot be relinked to an identifiable person is excluded from this protection. However, consent must be obtained from a person whose information starts out (e.g., is collected) as identifiable information, and then subsequently becomes de-identified. The person must know that information will be reworked, and what the purpose of that reworking will be.
- The above means that all recordings, written and/or typed notes, documents or reports, x-rays, prescriptions, laboratory test results, certificates, clinical research records, etc. are included in the definition of information that is protected.
- Information relating to health is considered “special information” within POPIA, attracting greater expectations for confidentiality.
Patient consent to disclosure
POPIA and NHA state that patients may consent to disclose their information, but such consent must be in writing. The HPCSA ethical rules require consent to be ‘explicit’. SASA recommends that consent to disclosure be made in writing.
Third-party access: Under the terms of POPIA, the arrangements around third-party access to patient information broadly match the guidelines set out by the HPCSA. This means that patient consent is essential.
Exceptions to consented disclosure of personal information must align with NHA 2003, particularly sections 15 and 16.
Please note that both the NHA and POPIA provide automatic exemption on the sharing of information for the purposes of providing the service. This specifically includes sharing clinical information with the healthcare team providing care to the patient and the information required to be shared to bill for services provided. Please note that this exemption does not extend beyond this, such as sharing clinical information with family members, or information gathered for clinical and/or other research. Although billing processes are implicitly included in the permissions, it is recommended that patients be made aware that you use an external billing company, if this is the case, and that you will be submitting an invoice to their medical scheme. The SASA Green Consent Form includes such a statement.
Legal requirement or court order to disclose
- The NHA also authorises disclosure if a law explicitly requires disclosure. For example, notifiable diseases are declared as such by law and disclosure to the specific authorities can then be made. Another example is the medical schemes regulation that requires disclosure of an ICD-10 code on a bill to a medical scheme.
- The same applies if someone obtains a court order – such an order may compel the disclosure of the information.
- Practitioners may rely on ethical principles to not disclose under these circumstances. They may even challenge the constitutionality of the court order or the law that authorises or requires the disclosure.
The anaesthesiologist and other practitioners and facilities
- Each entity collecting and recording personal information is bound by the provisions of POPIA, and each entity must preserve the confidentiality of the information it holds in its possession. Entities cannot share information without the patient’s written consent, and the entity must ensure that the receiving party has the same or similar protections for confidentiality in place.
- POPIA advocates that all personal information held must be protected from loss, damage or unauthorised destruction, and unlawful access. The legal expectation is the implementation of reasonable technical and organisational measures to ensure information protection.
- In the public sector, the employees of a hospital are bound with the hospital in relation to matters of confidentiality, disclosure, and information processing. In the private sector, the practitioners and the hospital are two different legal entities, and the provisions of consent and similar protections must be adhered to by both, i.e., two separate sets of forms may be required to give effect to consent to disclosure, and there may be two sets of policies relating to how health records are handled, shared, etc.
Collection, use, dissemination, and reworking of information
No personal information may be collected, recorded, stored, reworked or otherwise dealt with, without compliance with the following criteria as set by POPIA, all of which the patient must consent/agree to:
- The patient must know that their information is collected, reworked, stored, or disseminated (“processing”).
- The patient must know what the purposes of the processing are, and such purposes must be lawful (e.g., a research protocol must be in place, or the information is collected and sent on based on the provisions of the Medical Schemes Act, etc.). The description of these purposes must be clear and delineated and not overbroad and vaguely described.
- The patient must know if there will be further processing of their information (e.g., a record used for health research purposes, inclusion in any clinical review panels, even if internal, etc.).
- The duration for which the record will be kept: Normally, records would have to be destroyed after they have served the purpose(s) for which they were created, reworked, or stored. See section 16 of POPIA for the required duration of record keeping.
- Should the practitioner share information with another entity to provide services (such as a billing agency), the practitioner remains the “responsible party” in terms of the definitions within POPIA. The other entity becomes the “operator” in POPIA terms. It is essential that the responsible party has a written agreement in place with the operator that addresses confidentiality and confirms that the operator is POPIA compliant. If the operator is an international organisation (as is the case if your information is stored through companies like Google or Amazon), the international company must comply with legislation equivalent to or more stringent than POPIA. Most international companies, including Google and Amazon, comply with General Data Protection Regulations (GDPR) in Europe, which is considered sufficient.
- The confidentiality requirements extend to any staff working for a clinician. It is expected that employment contracts for staff exist and explicitly include confidentiality clauses. It is also required that staff are trained in POPIA and that such training is recorded.
- Failure to comply with POPIA may lead to complaints lodged with the Information Regulator, resulting in civil and/or criminal prosecution.
Information storage: duration, type/nature, and destruction
- The HPCSA requires records to be stored for at least seven years, and for children’s records to be kept until they reach maturity (18 years of age). The NHA requires records to be stored for 20 years.
- The HPCSA permits storage in electronic format. It should, however, be borne in mind that unless reputable electronic storage mechanisms are used, the document’s authenticity might be placed in dispute.
- The HPCSA requires that records be kept in non-erasable ink, erasure fluid should not be used, and changes should be made on the original, erroneous document, with a signature and date next to the amendment.
- The words “no substitution” next to a line item on a prescription may not be electronic or affixed by a stamp and must be in the practitioner’s own handwriting.
Children and confidentiality
The HPCSA ethical rules and the 2005 Children’s Act award children the right to confidentiality from the age of 12 years onwards, insofar as treatment is concerned. With surgical interventions, as the parents/legal guardians support the child in reaching the decision, they would have to have access to the child’s personal information.
Additional POPIA requirements
- The promulgation of POPIA has created some specific additional requirements for every entity. This is based on the entity being a juristic entity. In the public sector, the hospital is likely to be the juristic entity, and it would be the responsibility of the hospital management to ensure compliance with these requirements. In the private sector, each juristic entity would be required to comply. This would, therefore, apply to every partnership, association, solus practitioner or individual member of an association if the association is not a legal or juristic entity.
- Over and above the items outlined above, the specific requirements include, but are not limited to:
- A PAIA Manual (a template is available from SASA sasa@sasaweb.com) and its lodging with the Information Regulator
- The designation and registration with the Information Regulator of an Information Officer (which would likely be the practitioner themselves)
- The training of the Information Officer for their role and a record of such training
- A data breach policy, whereby the steps that will be taken in the event of such a breach are outlined. This must include how the affected people will be notified of the breach.
Example of policy document
This document is only available as part of the online publication of the SASA Practice Guidelines 2022 Revision.
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South African Society of Anaesthesiologists (SASA) Practice Guidelines_2022_Reviewed by: R Davids, C Lundgren, A Roux, D Shead and N Zimmelman