## Requirements

# 6. Requirements

This section defines the functional and business requirements for the system, as derived from the provided context. All requirements are traceable to their source and comply with ISO-29148 structural expectations.

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## 6.1 Functional Requirements

### 6.1.1 Home Nursing (訪問看護)

| Requirement ID | Description | Source |
|---|---|---|
| FR-001 | The responsibilities of administrators at home nursing stations must be clarified and requirements reviewed to ensure both quality of service and efficient operation. | [KB-01a2d77c-a20a-47e5-ae19-16ab2c89e272] |
| FR-002 | The establishment of a system for abuse prevention measures in home nursing is mandatory, and physical restraints are, in principle, prohibited. | [KB-01a2d77c-a20a-47e5-ae19-16ab2c89e272], [KB-e14d657a-8970-4e3e-9ccb-5662af7d6525] |
| FR-003 | The requirements and evaluation for frequent visit additions in home nursing must be reviewed to ensure appropriate assessment based on patient conditions. | [KB-17ac1ec0-b2d4-4910-9884-a2e46ea25ce0] |
| FR-004 | The requirements and evaluation for the 24-hour response system addition must be reviewed, considering initiatives to reduce the burden of nursing work and revising the handling of the communication system for 24-hour response. | [KB-06db46ba-7647-483b-9f38-f7fa62a24d77] |
| FR-005 | The requirements and evaluation for emergency home nursing visit additions must be reviewed to ensure appropriate provision and revise the content of the home nursing care fee claim forms. | [KB-4be6a015-623d-440c-95dd-a51bf556ebbd] |
| FR-006 | The requirements and evaluation for home nursing management care fees must be reviewed to strengthen the functions of home nursing stations and ensure effective, high-quality care. | [KB-aeb72a17-5d44-4c8e-b3c6-e83c459da003] |
| FR-007 | Abuse prevention measures and the proper use of physical restraints in home nursing must be systematized and made mandatory, with physical restraints being generally prohibited. | [KB-e14d657a-8970-4e3e-9ccb-5662af7d6525] |

### 6.1.2 Physical Restraint Minimization

| Requirement ID | Description | Source |
|---|---|---|
| FR-008 | Medical institutions must establish an organizational system to minimize the use of physical restraints. | [KB-edc81296-4474-4138-a404-f797f293eb19], [KB-8445364a-473a-46bc-8207-fb1f2671bde6] |
| FR-009 | The requirements and evaluation for the enhancement addition to the nursing assistant system must be reviewed to promote further division and cooperation of duties between nursing staff and assistants, as well as to minimize physical restraints. | [KB-05c4460e-0933-40a9-962c-fc2be422e060] |

### 6.1.3 Dementia Care

| Requirement ID | Description | Source |
|---|---|---|
| FR-010 | The evaluation of the dementia care addition must be reviewed to promote minimization of physical restraints and include the identification of delirium in dementia patient assessments. | [KB-c2bd624b-5c92-413c-be0e-30abb7e64211] |

### 6.1.4 Medication Management and Guidance

| Requirement ID | Description | Source |
|---|---|---|
| FR-011 | Pharmacists must provide necessary guidance to patients, including those requiring special safety management, and document such guidance. | [KB-08289384-33b4-4060-8531-77d29c0895ef], [KB-8a36c95e-f96a-4514-9f26-8c65a2fb23eb], [KB-9720cc93-fb47-4376-9506-fbb4d8f61048] |
| FR-012 | For patients prescribed narcotics, pharmacists must confirm the status of use, storage, and side effects, and provide necessary pharmaceutical management and guidance, with specific additional points assigned per case. | [KB-24385190-0703-42d1-a834-6854e998b904], [KB-08876a43-c1e4-4b7f-8517-0cd67e273533], [KB-10f23eda-03d3-4220-8642-6ff7cbf64700], [KB-31de50ce-f3df-4fb0-a0bd-6a1ce5795463], [KB-ad7d4dc3-8896-4c1b-92c7-8d969120b377], [KB-66969593-ac17-45cd-a41d-f335a2406225] |
| FR-013 | For patients with malignant tumors, pharmacists must confirm medication status and side effects, provide necessary pharmaceutical management and guidance, and report to the medical institution in writing, with additional points assigned monthly. | [KB-b2731f14-7331-4d15-827d-89f8aed2bcb1], [KB-20775cd7-be3a-4a41-a8e2-53ac409c2538] |
| FR-014 | For patients with multiple medications or difficulty in self-administration, pharmacists must support medication management, including packaging and guidance, and coordinate with prescribing physicians as needed. | [KB-07f1aee1-1797-47ce-a5e9-b2462436b453], [KB-2f8bb1e8-7cd1-4808-802d-61cbf1dea96e], [KB-ff3ce6e4-b5ec-4058-afe5-c24124781336] |
| FR-015 | When duplicate prescriptions are identified, pharmacists must propose solutions to the prescribing physician in writing, with points assigned up to once every three months. | [KB-50d4fc2a-962d-4820-a105-6ba75b15cf4c], [KB-f2bbf07b-2196-40f3-9da7-66b45e6dd128] |
| FR-016 | For inhaled medications, pharmacists must provide explanations and guidance using documents and training inhalers, and report to the medical institution in writing, with additional points assigned up to once every three months. | [KB-604920cd-6896-4a10-97db-9faeb614d499], [KB-ef609548-ff37-4388-9fd5-c638d8bf6eab] |
| FR-017 | For pediatric patients with disabilities, pharmacists must confirm necessary information directly with the patient or family, provide necessary guidance, and document the guidance in the patient’s notebook, with specific points assigned. | [KB-ba91d9ab-b335-4929-9779-694ba115ef39], [KB-6bb697eb-fdad-4cda-a697-9d148e072b9d] |

### 6.1.5 Discharge and Home Care Guidance

| Requirement ID | Description | Source |
|---|---|---|
| FR-018 | For patients being discharged, joint guidance fees must be applied when the designated pharmacy pharmacist, with patient consent, provides home medication management guidance after discharge. | [KB-061bef49-5443-4529-80cb-0067c3bedc4f], [KB-1eebb670-f513-40ab-a8be-7127863e3404], [KB-44db8f45-e972-47c4-ba46-8ad6a816615e] |
| FR-019 | In cases of emergency for home care patients, pharmacists must provide urgent joint guidance in collaboration with medical institutions, with specific points assigned. | [KB-4fc322f9-642f-4801-89c3-cb70c9af6ab1], [KB-5b2ae222-dd34-4f8c-b2de-0e51e6778c29], [KB-d1dea226-c0ae-4dfe-b0ce-d6cb90c165fb] |

### 6.1.6 Information Sharing and Communication

| Requirement ID | Description | Source |
|---|---|---|
| FR-020 | When necessary, pharmacists must provide required information to medical institutions, care managers, or other relevant parties in writing, with specific points assigned per case. | [KB-c35807e4-304e-4ca5-8e86-e1404c20a9fd], [KB-cd5ee7fe-b23b-4de0-a8e1-f8ff41e250cf], [KB-37919876-98a0-4f81-879a-7de2d13e4a0f], [KB-0dc6dd3d-3ecc-4685-9f43-b8bcb2ab8ce4] |
| FR-021 | The use of ICT (Information and Communication Technology) is to be promoted for sharing information among healthcare professionals, especially for end-of-life care and in-home cancer patients. | [KB-ef95bdaa-ef0b-4848-bf4b-a5c073be5ba9], [KB-fa0fdacb-f933-4296-8d0b-ac501b9102a5] |

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## 6.2 Business Requirements

| Requirement ID | Description | Source |
|---|---|---|
| BR-001 | The requirements and procedures for submitting facility standards and insurance claims must be reviewed to improve efficiency and reduce administrative burden on medical institutions. Electronic submission of facility standards must be promoted. | [KB-b952325d-d264-48ac-afd5-532c6ea95025] |
| BR-002 | Free issuance of statements (明細書) by designated home nursing providers is mandatory from June 2024. | [KB-7b83826c-4a00-4706-aced-07ac5183c8ff] |

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## 6.3 Constraints

| Requirement ID | Description | Source |
|---|---|---|
| CR-001 | For certain pharmacies as defined by the Minister of Health, Labour and Welfare, some additions (e.g., emergency joint guidance fees) may not be claimed. | [KB-473d2d4d-0a06-4fe0-990e-29bef944a7c7] |
| CR-002 | The provision of medication information fees (服薬情報等提供料) cannot be claimed concurrently with certain other fees (e.g., when claiming pharmacist guidance fees). | [KB-8a36c95e-f96a-4514-9f26-8c65a2fb23eb], [KB-31de50ce-f3df-4fb0-a0bd-6a1ce5795463] |

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## 6.4 Gaps

- [GAP: Missing data for Requirements] – Any requirements not explicitly covered in the context above are not addressed in this section.

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**End of Requirements Section**