Statement of Principles concerning Graves disease (Reasonable Hypothesis) (No. 7 of 2022)

The central concept is "Graves disease", defined in section 7(2) as a chronic autoimmune disease primarily affecting the thyroid gland, where thyroid antibodies activate the thyroid-stimulating hormone receptor, causing thyroid hyperplasia and excessive thyroid hormone synthesis and secretion. The notes to this subsection clarify that thyroid-stimulating immunoglobulins can also affect the eyes (Graves orbitopathy) and less commonly the skin (pretibial myxoedema). Presenting features typically include a diffuse hyperplastic goitre and hyperthyroidism, although some patients may be euthyroid or hypothyroid during the course of the disease. The disease may present as a thyrotoxic crisis, which is defined separately in Schedule 1 as a constellation of severe and life-threatening symptoms of rapid onset with biochemical evidence of elevated thyroid hormones, including fever, marked tachycardia, heart failure, tremor, nausea and vomiting, diarrhoea, dehydration, restlessness, extreme agitation, delirium and coma.

The second core concept is "reasonable hypothesis". This is not defined in the instrument itself, but the instrument operates within the framework of the VEA and MRCA, where the reasonable hypothesis standard is the threshold for linking disease to service under section 120A of the VEA and section 338 of the MRCA. The instrument does not alter that standard; it merely specifies factors that must exist for a reasonable hypothesis to be raised in the specific context of Graves disease.

"Iodine excess" is defined in Schedule 1 as either: (a) an average intake of more than 1,100 micrograms of iodine per day for adults, or more than 900 micrograms per day for those aged 18 years and under, for a continuous period of at least 3 months; or (b) a urinary iodine concentration of greater than 300 micrograms per litre, or greater than 500 micrograms per litre for pregnant women. This definition is critical because iodine excess appears twice in the factor list: for clinical onset (section 9(1)) and for clinical worsening (section 9(12)). The note to those subsections indicates that iodine excess may be due to consuming foods, dietary supplements or medications with a high content of iodine.

"Specified list of drugs" is defined in Schedule 1 as: antiretroviral therapy, immune checkpoint inhibitors, interferon alpha, interleukin-2, or tyrosine kinase inhibitors. This list is closed; no other drugs qualify under this factor. Taking a drug from this list within the 2 years before clinical onset or worsening is a separate factor (sections 9(2) and 9(13)). Amiodarone is treated separately in sections 9(4) and 9(15), requiring continuous use for at least 6 weeks within the 2 years before onset or worsening. Alemtuzumab or antithymocyte globulin treatment within the 10 years before onset or worsening is also a separate factor (sections 9(3) and 9(14)).

"One pack-year" is defined as the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products. Note 1 clarifies that an equivalent amount is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination. Note 2 provides the calculation method: dividing the number of cigarettes smoked per day by 20 and multiplying by the number of years smoked. The smoking factor (sections 9(7) and 9(18)) requires at least 3 pack-years before clinical onset or worsening, and if smoking ceased before onset or worsening, then onset or worsening must occur within 10 years of cessation.

"Relevant service" is defined in Schedule 1 as: operational service under the VEA; peacekeeping service under the VEA; hazardous service under the VEA; British nuclear test defence service under the VEA; warlike service under the MRCA; or non-warlike service under the MRCA. This defines the universe of claimants who can rely on this SOP.

"Acute precipitating event" is defined as a physical or psychological stimulus or event that causes a sudden, intense psychological or physical response. The note lists examples including abrupt cessation or lowering of anti-thyroid therapy, acute illness such as acute myocardial infarction, stroke and congestive heart failure, acute iodine load, experiencing an acute severe emotional stressor, infection, parturition, physical trauma or injury, and surgery. This definition applies only to sections 9(11) and 9(22), which are limited to cases where Graves disease first presents as thyrotoxic crisis or where thyrotoxic crisis occurs as a clinical worsening.

"Terminal event" is defined in Schedule 1 as the proximate or ultimate cause of death, including pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This definition is used in section 7(5) to extend the meaning of Graves disease to include death from a terminal event or condition that was contributed to by the person's Graves disease.

The instrument directly affects any person who has rendered relevant service and who suffers from Graves disease or has died from it, and who makes a claim for compensation under the VEA or MRCA. "Relevant service" is defined in Schedule 1 and includes operational service, peacekeeping service, hazardous service, and British nuclear test defence service under the VEA, as well as warlike and non-warlike service under the MRCA. This covers current and former members of the Australian Defence Force, veterans of certain overseas deployments, peacekeepers, and those who served in British nuclear tests. The instrument does not apply to claims under other legislation, such as the Safety, Rehabilitation and Compensation Act 1988 (Commonwealth workers' compensation) or state workers' compensation schemes.

The instrument also affects the decision-makers who assess these claims. The Department of Veterans' Affairs, the Military Rehabilitation and Compensation Commission, and the Veterans' Review Board must apply this SOP when determining whether a reasonable hypothesis exists. The Administrative Appeals Tribunal and the Federal Court may also be required to consider the SOP on review or appeal. The instrument reduces the discretion of these decision-makers by prescribing a closed list of factors; if a claimant does not satisfy any of the 23 factors, the claim must fail at the reasonable hypothesis stage, regardless of other medical evidence that might suggest a connection to service.

Medical practitioners who provide reports for claimants are affected because they need to be familiar with the specific factors and their temporal requirements. For example, a doctor must be able to date the clinical onset of Graves disease, quantify iodine intake, confirm smoking history in pack-years, and identify the relevant drug exposures. The instrument does not create any new obligations for treating doctors outside the claims context, but it shapes the evidence that is relevant to a successful claim.

The instrument also affects other persons who might have claims based on the same disease. For example, if a veteran dies from Graves disease, the dependants may make a claim under the VEA or MRCA. Section 7(5) extends the SOP to death from a terminal event contributed to by Graves disease, so the same factors apply. The instrument does not impose any costs on the general public, but it does allocate resources within the compensation system: successful claims result in payments funded by taxpayers, while unsuccessful claims impose transaction costs on claimants and the administering bodies. The instrument does not affect private enterprise, competition, or prices directly, but it does influence the incentive structure for claimants and the administrative burden on the Department of Veterans' Affairs.

The instrument does not create any duties or rights in the traditional sense; it operates as a finding standard within the existing claims framework. The key requirement is that at least one of the factors listed in section 9 must exist before it can be said that a reasonable hypothesis has been raised connecting Graves disease or death from Graves disease with the circumstances of a person's relevant service. This is a necessary condition, not a sufficient one; other elements of the claims framework still apply.

Section 10 imposes a relationship requirement: the existence of any factor referred to in section 9 must be related to the relevant service rendered by the person. This means that even if a claimant has, for example, smoked 3 pack-years and developed Graves disease within 10 years of cessation, that factor must be related to their service. If the smoking occurred entirely before service or after service and is unrelated to service, the factor will not satisfy section 10. The instrument does not define what "related to the relevant service" means; that is left to the broader VEA and MRCA framework and case law.

Section 10(2) limits the application of factors 12 to 23. These factors apply only to material contribution to, or aggravation of, Graves disease where the person's Graves disease was suffered or contracted before or during (but did not arise out of) the person's relevant service. This means that for claimants who already had Graves disease before service, or who contracted it during service but not due to service, they must rely on factors 12 to 23 to show clinical worsening. Factors 1 to 11 apply only to clinical onset, which is appropriate for claims where the disease first manifested after service.

Section 11 incorporates other Statements of Principles by reference. If a factor in section 9 refers to an injury or disease covered by another SOP, then the factors in that other SOP apply according to its terms as in force from time to time. This creates a dynamic cross-reference; the claimant must satisfy not only the current Graves disease SOP but also any other relevant SOP if the factor involves another condition. For example, if a claimant relies on the factor of "undergoing a course of therapeutic radiation for cancer" under sections 9(5) or 9(16), the cancer itself must satisfy the relevant SOP for that cancer if the claimant is also alleging that the cancer is service-related. This adds complexity and increases the evidentiary burden on claimants.

The claimant has the right to present evidence that one of the factors exists and is related to their service. The decision-maker has the duty to consider the evidence in light of the SOP. If the claimant succeeds in raising a reasonable hypothesis, the claim proceeds to the next stage where the decision-maker must determine whether the hypothesis is disproved beyond reasonable doubt (under the VEA) or on the balance of probabilities (under the MRCA). The SOP does not guarantee success; it only opens the door to the next stage.

The instrument does not confer any rights on any person other than claimants. It does not create any private rights of action, and it does not impose any duties on employers, insurers, or medical practitioners outside the claims process. The Repatriation Medical Authority has the duty to determine these SOPs under the VEA, but the instrument itself does not impose ongoing obligations.

This instrument does not contain any penalties or enforcement provisions. It is not a regulatory instrument that prohibits conduct or imposes sanctions for non-compliance. The consequence of not satisfying the instrument's requirements is procedural rather than punitive: a claim for compensation will fail at the reasonable hypothesis stage. This means the claimant will not receive compensation for Graves disease or death from Graves disease under the VEA or MRCA, unless they can invoke a different SOP or a different pathway.

The enforcement mechanism is the claims adjudication process itself. The Department of Veterans' Affairs, the Military Rehabilitation and Compensation Commission, and the Veterans' Review Board apply the SOP when assessing claims. If a decision-maker incorrectly applies the SOP, the claimant can seek review by the Administrative Appeals Tribunal and ultimately the Federal Court. There are no fines, criminal penalties, or civil pecuniary penalties associated with non-compliance because the instrument does not impose any obligations on any person. The only party that could be said to have a duty to comply is the decision-maker, whose duty arises from the VEA and MRCA rather than from this instrument itself.

There is a risk of error in application. The temporal windows in the factors are precise, and definitions such as "iodine excess" require specific quantification. If a decision-maker misinterprets the definition of "one pack-year" or "continuous period of at least 3 months" for iodine excess, a claimant may be incorrectly denied compensation. Conversely, if a decision-maker applies the factors too generously, a claimant may receive compensation that would not be justified under a stricter reading. The instrument does not provide any mechanism for auditing or correcting such errors other than the usual review and appeal rights.

The instrument also has no direct effect on third parties such as medical practitioners. A doctor who provides a report that incorrectly diagnoses Graves disease or misstates the timing of onset does not face any penalty under this instrument. The doctor's liability, if any, arises under general law or professional standards, not from this SOP. Similarly, a claimant who fabricates evidence to satisfy a factor may face consequences under the Criminal Code for fraud, but that is not an enforcement mechanism of this instrument.

The practical enforcement lever is the requirement that the factor must be related to relevant service under section 10. This connects the medical factor to the service context, which is the core of the compensation system. Without this connection, the claim fails regardless of the medical evidence.

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. It is a delegated legislative instrument, not a statute, and it operates within the framework of the VEA and the MRCA. Section 5 states that it applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies. These are the provisions that set the standard of proof for claims relating to injury or disease: for the VEA, the reasonable hypothesis standard; for the MRCA, a similar but not identical standard. The SOP does not override those provisions; it fills in the medical content that those provisions require.

The instrument repeals the earlier Statement of Principles concerning Graves' disease No. 33 of 2013 (section 4). This means that any claim lodged after 31 January 2022 must be assessed under this new SOP, not the old one. The old SOP is no longer in force. This repeal has retrospective effect in the sense that it applies to claims made after commencement, even if the disease onset or service occurred many years earlier. There is no savings provision for claims that were pending at the date of repeal; the new SOP applies to all claims to which section 120A or section 338 applies from the commencement date.

Section 11 provides a mechanism for cross-referencing other SOPs. If a factor in section 9 refers to an injury or disease for which another SOP has been determined under subsection 196B(2), then the factors in that other SOP apply according to its terms as in force from time to time. This means that the Graves disease SOP does not operate in isolation; it forms part of a network of SOPs. For example, factor 9(5) refers to "undergoing a course of therapeutic radiation for cancer". If the radiation was for a cancer that itself is the subject of a SOP, the claimant may need to satisfy that cancer SOP as well, depending on how the claim is framed. This interaction increases complexity and the potential for multiple SOPs to apply to a single claim.

The instrument also references the ICD-10-AM coding system. Section 7(3) notes that Graves disease attracts ICD-10-AM code E05.0 or E05.5, but the meaning of Graves disease for the purposes of the SOP is the substantive definition in section 7(2), not the code. This means a diagnosis code alone is insufficient; the condition must meet the definition. This can create tension with clinical records that may use a less precise code for billing or administrative purposes.

The instrument does not interact with the National Disability Insurance Scheme, the Social Security Act, or state compensation schemes directly, because it is limited to claims under the VEA and MRCA. However, compensation received under those Acts may affect eligibility for other benefits due to income or asset tests in other legislation. The instrument itself does not address those interactions.

There is also interaction with the general law of evidence. The SOP does not dictate what evidence is admissible; it only specifies what factors must exist. Claimants may use any admissible evidence to prove those factors, subject to the rules of the tribunal or court. The definition of "iodine excess", for example, may require urinary iodine concentration testing or dietary recall evidence, both of which are matters of evidence, not of the SOP itself.

The instrument was made on 24 December 2021 and commences on 31 January 2022. It repeals and replaces the Statement of Principles concerning Graves' disease No. 33 of 2013 (Federal Register of Legislation No. F2013L00736), which was made under subsections 196B(2) and (8) of the VEA. The source text does not specify the precise differences between the 2013 and 2022 versions, but a comparison of the two instruments would be necessary to identify changes. The user has provided only the 2022 instrument, so I cannot detail the amendments. However, I can note structural observations from within the instrument.

The 2022 instrument introduces a new factor for "having ethanol injection into the thyroid gland for the treatment of a thyroid adenoma" within the 6 months before clinical onset (section 9(9)) or clinical worsening (section 9(20)). This factor did not appear in the 2013 version as summarised in the F2013L00736 register entry. Similarly, the 2022 instrument includes trauma to the eye as a factor (sections 9(10) and 9(21)), which was not present in the 2013 version. The 2022 instrument also extends the postpartum period from 12 months to 18 months for both onset (section 9(8)) and worsening (section 9(19)). This change would expand the class of claimants who can satisfy the pregnancy/postpartum factor.

The smoking factor has been tightened in the 2022 instrument. The 2013 version required 3 pack-years and a cessation period of 10 years, but the 2022 instrument adds a third condition: if smoking has ceased before the clinical onset or worsening, then that onset or worsening must occur within 10 years of cessation. This is expressed in sections 9(7)(b) and 9(18)(b). The 2013 version may have had a different formulation on this point, but I cannot confirm from the source alone.

The specified list of drugs has been updated in the 2022 instrument. The 2013 version included antiretroviral therapy, interferon alpha, and interleukin-2, but the 2022 version adds immune checkpoint inhibitors and tyrosine kinase inhibitors. This reflects changes in medical practice and the recognition of newer drug classes as potential triggers for Graves disease. The 2022 instrument also adds a specific factor for alemtuzumab and antithymocyte globulin therapy, which was not separately listed in the 2013 version.

The 2022 instrument also introduces a factor for having received iodine-131 for the treatment of nodular goitre within the 10 years before clinical onset (section 9(6)) or worsening (section 9(17)). This factor was not present in the 2013 version. The 2022 instrument also includes the factor of "undergoing a course of therapeutic radiation for cancer, where the thyroid gland was in the field of radiation" within the 25 years before clinical onset (section 9(5)) or worsening (section 9(16)), which was present in the 2013 version but with a different timeframe.

The instrument itself has not been amended since its making; there are no later amending instruments referenced in the source. The only amendment history is its own repeal of the 2013 SOP.

The source text does not reference any litigation. It is a legislative instrument, not a court decision. No cases are mentioned in the text. I cannot invent cases or statistics. However, I can note that Statements of Principles under the VEA are frequently the subject of litigation in the Administrative Appeals Tribunal and the Federal Court, where claimants challenge the application of the SOP or argue that the Repatriation Medical Authority erred in determining the factors. The source text does not provide any such history for this specific instrument.

The instrument itself may be challenged on judicial review grounds, such as whether the Repatriation Medical Authority had the power to make the determination, whether the factors are supported by sound medical-scientific evidence, or whether the definitions are consistent with the VEA. The source text does not indicate that any such challenge has occurred for this 2022 instrument.

Given the absence of any litigation reference in the source, I cannot provide any substantive analysis of litigation history. The instrument is relatively new, having commenced on 31 January 2022. It is possible that litigation has occurred since then, but the source text does not disclose it. The reader should consult the Federal Court of Australia and Administrative Appeals Tribunal databases for any decisions that interpret or apply this SOP.

Several features of this instrument can trap unwary claimants or their advisors. The first is the definition of "iodine excess" in Schedule 1. It requires either an average intake of more than 1,100 micrograms per day for adults (or more than 900 micrograms for those aged 18 and under) for a continuous period of at least 3 months, or a urinary iodine concentration of greater than 300 micrograms per litre (or greater than 500 for pregnant women). This is a high threshold. Many people consume iodised salt or seafood without reaching these levels. A claimant who merely says they ate a lot of seaweed or took a kelp supplement will not satisfy the factor unless they can show the quantitative thresholds. The requirement of a "continuous period of at least 3 months" also means that sporadic high intake will not qualify.

The second trap is the smoking factor. It requires at least 3 pack-years before clinical onset or worsening, and if smoking ceased before onset or worsening, then onset or worsening must occur within 10 years of cessation. This 10-year sunset is easy to miss. A claimant who smoked 3 pack-years but quit 11 years before Graves disease developed will not satisfy the factor, even if the total exposure was substantial. The pack-year calculation itself can be tricky for those who smoked pipes or cigars, as the note requires conversion to grams of smoking tobacco (7,300 grams per pack-year). Many claimants will not have accurate records of the weight of tobacco consumed.

The third trap is the factor for amiodarone (sections 9(4) and 9(15)). It requires taking amiodarone for a continuous period of at least 6 weeks, within the 2 years before clinical onset or worsening. Short-term use or intermittent use will not satisfy this factor. Similarly, the specified list of drugs for factors 9(2) and 9(13) is closed; only antiretroviral therapy, immune checkpoint inhibitors, interferon alpha, interleukin-2, and tyrosine kinase inhibitors qualify. Other drugs that might be suspected of triggering Graves disease, such as lithium or certain antibiotics, are not included.

The fourth trap is the limitation in section 10(2). Factors 12 to 23 apply only to material contribution to, or aggravation of, Graves disease where the person's Graves disease was suffered or contracted before or during (but did not arise out of) the person's relevant service. This means that if a claimant's Graves disease first manifested after service, they cannot rely on factors 12 to 23 to show clinical worsening; they must rely on factors 1 to 11 for clinical onset. Conversely, if the disease existed before service, they cannot rely on factors 1 to 11 for clinical onset; they must use factors 12 to 23 for worsening. Getting this classification wrong will result in a failed claim.

The fifth trap is the "acute precipitating event" factor (sections 9(11) and 9(22)). It applies only to cases where Graves disease first presents as thyrotoxic crisis, or where thyrotoxic crisis occurs as a clinical worsening. The event must occur within the 48 hours before the clinical onset or worsening. This is a very narrow window. The definition of "acute precipitating event" is broad, but the 48-hour requirement is strict and will often be difficult to prove with evidence.

The sixth trap is the cross-reference in section 11. If a factor refers to another injury or disease that is covered by another SOP, the factors in that other SOP also apply. This can create multiple hurdles. For example, a claimant who relies on therapeutic radiation for cancer must also show that the cancer itself is service-related under the relevant cancer SOP, unless the claim is framed differently. This interaction is easy to overlook.

The seventh trap is that the instrument uses the term "Graves disease" rather than "Graves' disease" with an apostrophe. The definition in section 7(2) is the controlling definition, not the ICD code. A diagnosis of "Graves disease" in medical records that does not meet the definition, for example if the diagnosis is based solely on hyperthyroidism without evidence of autoimmune antibodies, may not be sufficient. Claimants should ensure their diagnosis meets the specific definition.

The eighth trap is the death provision in section 7(5). For death from Graves disease, the claimant must show that the terminal event was contributed to by Graves disease. The definition of "terminal event" includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This requires a causal link between Graves disease and the terminal event, which may be difficult to establish if the deceased had multiple comorbidities.

Compliance with this instrument is relevant only for claimants seeking compensation under the VEA or MRCA for Graves disease or death from Graves disease, and for the decision-makers who assess those claims. There are no external compliance obligations for the general public, medical practitioners, or businesses.

For claimants, the first step is to obtain a diagnosis of Graves disease that meets the definition in section 7(2). This requires clinical evidence of a chronic autoimmune disease primarily affecting the thyroid gland, with thyroid antibodies activating the thyroid-stimulating hormone receptor, causing thyroid hyperplasia and excessive thyroid hormone synthesis and secretion. Simply having hyperthyroidism or a goitre is insufficient; the autoimmune mechanism must be established. The diagnosis should be confirmed by a specialist endocrinologist where possible.

The second step is to determine the date of clinical onset of the disease. This is the date when the symptoms first became manifest or when the disease was first diagnosed. For claimants who already had the disease before service, the date of clinical worsening must be identified instead. The instrument uses "clinical onset" for factors 1 to 11 and "clinical worsening" for factors 12 to 23. The distinction is important because different factors apply depending on whether the disease was pre-existing or first manifested after service.

The third step is to gather evidence for each of the 23 factors in section 9 to see which ones are available. The evidence must satisfy the specific temporal and quantitative requirements. Key categories of evidence include:

For smoking (sections 9(7) and 9(18)): detailed smoking history, including number of cigarettes per day, type of tobacco product, number of years smoked, and date of cessation if applicable. Calculations of pack-years must use the formula in Schedule 1. Evidence of cessation date is critical if the claimant quit smoking, because the 10-year window runs from cessation to clinical onset or worsening.

For iodine excess (sections 9(1) and 9(12)): dietary recall or food diaries showing average daily iodine intake exceeding 1,100 micrograms (adults) or 900 micrograms (under 18) for at least 3 continuous months, or urinary iodine concentration test results exceeding 300 micrograms per litre (500 for pregnant women). Sources of excess iodine may include seaweed, kelp supplements, iodine-containing medications, or radiographic contrast media.

For drug exposures (sections 9(2), 9(3), 9(4), 9(13), 9(14), 9(15)): pharmacy records, prescribing records, or hospital charts showing the specific drug, dosage, and dates of administration. For amiodarone, continuous use for at least 6 weeks must be shown. For the specified list of drugs, only those five categories qualify.

For therapeutic radiation (sections 9(5) and 9(16)): oncology records showing the type of cancer, the radiation field, and evidence that the thyroid gland was in the field. The radiation must be for cancer treatment, not for benign conditions.

For iodine-131 treatment (sections 9(6) and 9(17)): nuclear medicine records showing the administration of radioactive iodine for nodular goitre.

For pregnancy and postpartum (sections 9(8) and 9(19)): evidence of pregnancy and that clinical onset or worsening occurred during pregnancy or within 18 months after delivery.

For ethanol injection (sections 9(9) and 9(20)): medical records showing the procedure and the date.

For trauma to the eye (sections 9(10) and 9(21)): medical records or other evidence of blunt or penetrating physical injury to the eye within the 6 months before clinical onset or worsening.

For acute precipitating event and thyrotoxic crisis (sections 9(11) and 9(22)): evidence of thyrotoxic crisis as defined, plus evidence of an acute precipitating event within the 48 hours before onset or worsening.

For inability to obtain appropriate clinical management (sections 9(23)): evidence that the claimant was unable to access appropriate medical treatment for Graves disease, which led to clinical worsening. This is a catch-all factor but requires proof of a causal link between the lack of management and the worsening.

The fourth step is to show that the factor is related to the claimant's relevant service under section 10. This requires evidence linking the factor to operational service, peacekeeping service, hazardous service, British nuclear test defence service, warlike service, or non-warlike service. For example, if smoking is the factor, the claimant must show that smoking was related to their service, such as through stress, availability of cigarettes on deployment, or other service-related factors. The relationship must be more than coincidental.

For decision-makers, compliance means applying the instrument strictly according to its terms. The factor must exist, the temporal requirements must be met, and the relationship to service must be established. The decision-maker should not accept vague evidence or unquantified claims of iodine excess or smoking. The definitions in Schedule 1 must be applied precisely. If the claimant fails to produce evidence that satisfies any of the 23 factors, the reasonable hypothesis cannot be raised, and the claim must be rejected at that stage. The decision-maker should also consider section 11 cross-references if the factor involves another condition covered by another SOP.