Primary Hospital.pdf

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ETHIOPIAN

STANDARD

Primary Hospital - Requirements

ES3617:2012

First edition

Tables of Contents

ACKNOWLEDGEMENT

FOREWORD

SECTION ONE: GENERAL

1. Scope

2. Normative References

3. Terminologies and Definitions

SECTION TWO: LICENSURE

2.1. General

2.2. Application for licensure

2.3. Initial/New Licensure

2.4. License Renewal Requirements

2.5. Removal Permits, Change of Operation and Forfeiture of License

2.6. Suspension and Revocation of a License

2.7. Right to Fair Hearing

2.8. Information to be Disclosed

SECTION THREE: GOVERNANCE

3.1. Governing Board

3.2. Chief Executive Officer

3.3. Chief Clinical Officer

3.4. Management Committee

SECTION FOUR: PATIENT RIGHTS AND RESPONSIBILITIES

4.1. Informed Consent

4.2. Patient Rights

4.3. Patient Responsibilities

SECTION FIVE: HUMAN RESOUCE MANAGEMENT

5.1. General Requirements

5.2. Staffing Plan

5.3. Job Description and Orientations

5.4. Staff Education

5.5. Medical Staff

5.6. Employee’s Health

5.7. Dress Code and Identification Badge

SECTION SIX: SERVICE STANDARDS

6.1 . Outpatient Services

6.2 . Inpatient services

6.3 . Maternal and Child Health (MCH) and Delivery Services

6.4 . Surgical Services

6.5 . Anesthesia Services

6.6 . Nursing Services

6.7 Emergency Services

6.8 . Rehabilitation Services

6.9 . Radiological Services

6.10 . Laboratory services

6.11 Pharmaceutical Services

6.12 Ambulance Services

6.13 Patient Flow

6.14 Health Promotion Services

6.15 Medical Recording

6.16 Morgue Services

6.17 Social Works Services

6.18 Infection Prevention

6.19 Hospital Sanitation and Waste Management

6.20 Food and Dietary Services

6.21 Housekeeping, Laundry and Maintenance Services

SECTION SEVEN: PHYSICAL PLANT STANDARDS

7.1. General

7.2. Site Selection Requirements

7.3. Construction Requirements

7.4. Building Space and Elements

7.5. Building Systems

7.6. Electrical System

7.7. Fire Protection System

7.8. Call Systems

7.9. Health Facility Environment

7.10. Specific Service Areas

7.11. Care and Treatment Areas

7.12. Ancillary areas

7.13. Bubble Diagrams

ACKNOWLEDGEMENT

Ethiopian Standard Agency, ESA would like to extend its special thanks to members of the technical working group organized by the Ethiopian Food, Medicine and

Healthcare Administration and Control Authority of Ethiopia, EFMHACA in developing the draft health facility standards.The members of the TWG were Dr.

Getahun Mengistu, Dr.Kidane Melles, Ato Yohannes Jorge, Dr Adefris Debalke, Dr.

Wondwossen Fantaye, Dr Faris Hussein, Dr Petros Mitiku, Dr David A.conteh, Dr

Ruth Lawson, Dr Birna Abdosh, Ato Liyusew Solomon, Ato Edmealem Ejigu, Dr

Solomon Tessema, Dr Endale Tefera, Ato Yihalem Tamiru, Dr Abyou Kiflie, Ato

K/mariam G/Michael, Sr Yeshialem Bekele, Ato Wondie Alemu, W/t Raey Yohannes, Ato Ayalew Adinew, Dr Zegeye Hailemariam, Dr. Tassew Tadesse, Dr Alem Michael, Dr. Aynalem Abraha, Dr. Mehrtu W/yes, Ato Zelalem mesele, Ato Salehunae, Dr

Daniel Admassie and Dr Tekle-ab Zaid.

In addition, the Agency would also thank all the workshop participants from the

Ministry of Health, Health Professional Associations, Universities, public and private hospitals, private clinics, non-governmental organizations and other governmental organizations for their commitment to enrich the draft document.

We are grateful to the USAID/PHSP-Ethiopia, MSH/SPS, Clinton Foundation and

Tulane University without whose support it would have been difficult to achieve the desired result.

The Agency would also like to express its appreciation to FMHACA for the commitment, effective coordination and overall leadership shown in the development of this standard.

FOREWORD

This Ethiopia Standard has been prepared under the direction of the Technical

Committee for Medical Care Practices (TC90) and published by the Ethiopian

Standards Agency (ESA).

The draft document (Working Draft, WD) has been submitted to the Secretariat by the Ethiopian Food, Medicine & Healthcare Administration and Control Authority

(FMHACA).

A Primary hospital shall provide services in accordance with this standard and shall comply with the requirements. The standard shall enter into force starting from the day of approval as Ethiopian Standard. This standard is approved by the convention of ……….. made on…..Application of this standard is MANDATORY with the intention to ensure the quality and public safety of health services through standardized licensure and inspection procedures, to promote access to quality health services and encourage health investment.

The Ethiopian Standard Agency recommends fulfilling all the requirements stipulated under this document. It has to be noted that the fruition of fulfilling these requirements will ensure the quality and safety of public health services through availing appropriate infrastructure, deployment and retention of qualified and competent health professionals that deliver best practices and by generating innovative ideas and methodologies to solve healthcare problems.

Finally, acknowledgement is made to the EFMHACA, Technical Working Group, participants of national workshop and EFMHACA collaborators for their commitment and unreserved contribution to the effort of developing Ethiopian

Standards for Health Facilities.

Ato………………W/O…………

Director General, Ethiopian Standard Agency

SECTION ONE: GENERAL

1. Scope

1.1. This Ethiopian standard shall be applicable for all primary hospitals new and existing, governmental and non-governmental.

1.2. The standard covers the minimum requirements with respect to practices, premises, professionals and products or materials put into use for primary hospitals.

1.3. Requirements of a primary hospital are stipulated under section two to seven of this standard.

2. Normative References

The latest editions of the following laws, regulations, directives and guidelines shall be taken as part and parcel of this Ethiopian Standard.

2.1. Ethiopian Food, medicine and Healthcare Administration and Control

Proclamation No. 661/2009

2.2. Ethiopian Food, Medicine and Healthcare Administration and Control

Regulation No. 189/2010

2.3. Federal Hospitals Administration Council of Ministers Regulation No.

167/2009

2.4. The Ethiopian Hospital Reform and Implementation Guidelines, March 2010

2.5. National Health Policy of the Transitional Government of Ethiopia, 1993

2.6. National Drug Policy of the Transitional Government of Ethiopia, November

2.7. Commercial Code of Ethiopia

2.8. Criminal Code of Ethiopia

2.9. Medicines Waste Management and Disposal Directive No 2/2011

2.10. Ethiopian National Guideline for Health Waste Management, 2008

2.11. Ethiopian Building Proclamation, No. 624/2009

3. Terminologies and Definitions

3.1 Appropriate Organ

Shall mean a state government organ authorized to implement food, medicine and healthcare administration and control activities at a state level;

3.2

Authority

Shall mean the Ethiopian Food, Medicine and Healthcare Administration and Control

Authority.

3.3

Proclamation

Shall mean the Ethiopian Food, Medicine and Healthcare Administration and Control proclamation No 661/2009.

3.4

Appropriate Law

Shall mean a law issued by a state to implement regulatory activities regarding food, medicine and healthcare.

3.5

Person

Shall mean any physical or juridical person

3.6

Authorized Person

Shall mean any hospital staff who is responsible for a given service

3.7

Primary hospital

Shall mean a health facility at primary level of healthcare which provides promotive, preventive, curative and rehabilitative services with a minimum capacity of 35 beds and provides at least 24 hour emergency services, general medical services, treatment of basic acute and chronic medical problems, basic emergency surgical intervention and Comprehensive Emergency Obstetric Care (CEOC) including laboratory, imaging and pharmacy services and other related services stated under this standard.

SECTION TWO: LICENSURE

2.1. General

2.1.1 This standard provides minimum requirements for the establishment and maintenance of primary hospital in order to protect the public interest by promoting the health, welfare, and safety of individuals.

2.1.2 No primary hospital shall be built or be functional by any person without prior permission of the appropriate organ.

2.1.3 The requirements set by this standard may not be waived unless otherwise for public interest and there is a substantial need for waiver. There shall be an assurance that the waiver will not create a hazard to the health and well- being of patients or others than the public interest.

2.2. Application for licensure

2.2.1. No person shall operate a primary hospital in Ethiopia, whether governmental, nongovernmental or private, without being licensed as required by appropriate law and this standard.

2.2.2. Any person desiring to operate a primary hospital shall:

a) Apply to the appropriate organ for on forms prescribed forms;

b) Pay the prescribed license fee; and

c) Provide additional information or document upon written request by the appropriate organ.

2.2.3. A person desiring to operate a primary hospital shall consult the appropriate organ on the plant design conformity with this standard before starting construction or renovation work.

2.2.4. An application for the initial licensure of primary hospital shall be submitted to the appropriate organ no later than sixty (60) days prior to the stated date of operation.

2.2.5. The first pre-licensing inspection shall be conducted by the appropriate organ upon application without service fee. In case of failure to comply with this standard during the first pre-licensing inspection, the applicant has the right to reapply not more than two times upon paying service fee. If the applicant fails to comply with this standard for the third time, its application for licensure shall be suspended for three months.

2.2.6. The application for a primary hospital license shall state each service for which the applicant undertakes to furnish hospital care and the number of beds allocated to each service, and shall furnish other information as may be required by the appropriate organ including,

(a) Hospital location and address;

(b) Name and address of the applicant (if the applicant is an authorized delegate, written delegation letter shall be submitted);

(c) Previous owner, license number for existing primary hospital;

(d) Name, qualification and address of the licensee/CCO;

(e) Total bed capacity;

(f) Surrounding environment/location;

(g) Number, type, work experience and original release of all technical staffs;

(h) Number of administrative staff;

(i) Physical plant/Hospital design and its description;

(j) Proposed use of idle space;

(k) CEO of the hospital;

(l) Chain organization (organizational structure);

(m) Owner of the building;

(n) Professional license and registration certificate of the licensee and all other health professionals responsible for each service in the hospital;

(o) Any other requirements set by the Authority

2.2.7. An application for a license or change in service shall be denied if the applicant cannot demonstrate that the premises, products, personnel and healthcare services are fit and adequate in accordance with this standard.

2.2.8. The appropriate organ shall consider an applicant's prior history in operating a health care facility either in all the regional states of the country in making licensure decision. Any evidence of licensure violations representing serious risk of harm to patients shall be considered by the appropriate organ, as well as any record of criminal convictions representing a risk of harm to the safety or welfare of patients.

2.3. Initial/New Licensure

2.3.1. Every primary hospital shall have a separate license. The appropriate organ shall issue each license in the name of the owner and chief clinical officer only for the premises and person named as applicant in the application and the license shall not be valid for use by any other person or at any place other than the designated in the license.

2.3.2. A primary hospital license shall specify the following:

a. Name and address of the primary hospital;

b. The name and professional license and registration number of the licensee;

c. Ownership of the primary hospital;

d. Name of the owner;

e. License number, issuance and expiration dates of the license;

f. Signature and stamp of the appropriate organ and

g. Notices/reminders prepared by the appropriate organ.

2.3.3. Prior to initial licensure of the hospital, the appropriate organ shall conduct an on-site inspection to determine compliance with the applicable laws and standards governing primary hospital.

2.3.4. The appropriate organ shall send a written report of the findings to the primary hospital after the conclusion of the inspection. If the primary hospital complies with the laws and standards, initial license valid for one year shall be issued to the applicant.

2.3.5. A primary hospital with deficiencies shall correct them and submit written proof of correction of deficiencies.

2.3.6. The appropriate organ shall deny the application for licensure to a primary hospital that has not corrected deficiencies. The applicant shall reapply for licensure when deficiencies are corrected.

2.3.7. The appropriate organ shall conduct an on-site inspection of the primary hospital to assess the hospital's continued compliance with the laws and standards governing the hospital.

2.3.8. The appropriate organ shall issue a replacement license where the originally issued license has been lost or destroyed upon the application supported by affidavit.

2.3.9. The original license shall be posted in a conspicuous place at reception at all times.

2.4. License Renewal Requirements

2.4.1. A license, unless suspended or revoked or under consideration in pending case, shall be renewable annually and the primary hospital shall submit an application for license renewal to the appropriate organ no later than sixty

(60) days before the expiration date of the current license.

2.4.2. Without prejudice to article 2.4.1;

(a) Subsequent to submitting renewal application, the owner shall pay the prescribed license fee

(b) License renewal shall be made during the first quarter of each fiscal year (Hamle 1 to Nehassie 30) based on routine inspection findings over the year

(c) In case of failure to renew license within the prescribed period, license may be renewed upon paying penalty (50% of renewal fee) within one month

(d) In case of failure to renew license as per article 2.4.2 (c), license shall be considered as cancelled

2.4.3. Every applicant who needs to renew a license shall:

(a) Apply to the appropriate organ in the prescribed form;

(b) Pay the prescribed license renewal fee; and

(c) Provide additional information or document upon written request by the appropriate organ.

2.4.4. The appropriate organ may conduct background checks on the applicant or licensee to determine its suitability or capability to operate or to continue operating a health care facility. Background checks shall consist of, but not be limited to, the following:

(a) Verification of licensure status;

(b) Verification of educational credentials;

(c) Verification of residency status;

(d) Verification of solvency; and

(e) Contacts with federal and State government officials to determine outstanding warrants, complaints, criminal convictions, and records of malpractice actions.

2.4.5. The appropriate organ shall renew a license for a primary hospital in substantial compliance with the applicable laws and this standard.

2.5. Removal Permits, Change of Operation and Forfeiture of License

2.5.1. No primary hospital or part thereof shall move from the premises for which a license has been issued to any other premises without first having obtained from the appropriate organ a permit to move to the premises not covered by the license issued to the hospital.

2.5.2. Without the prejudice to article 2.5.1, permit in change of address shall indicate the special conditions governing the moving of the primary hospital or part of it as the appropriate organ may find to be in the interest of the public health.

2.5.3. Without prior permission of the appropriate organ, change of owner and/or licensee shall not be made.

2.5.4. The hospital shall inform the appropriate organ any change in operation or professional. Change of operation means any alteration of services that is different from that reported on the primary hospital's most recent license application.

2.5.5. The license shall not be assignable or transferable to any other person or place without the prior approval of the appropriate organ and shall be immediately void if the primary hospital ceases to operate, if its ownership or licensee changes, or if it is relocated to a different site.

2.5.6. When change of ownership of a primary hospital is contemplated, the hospital shall notify the appropriate organ in writing and give the name and address of the proposed new owner.

2.6. Suspension and Revocation of a License

2.6.1. The appropriate organ may suspend or revoke a license or order closure of a service/ unit within the primary hospital or order removal of patients from the hospital where it finds that there has been a substantial failure to comply with this standard.

2.6.2. Without prejudice to grounds of suspension provided under relevant laws, the appropriate organ shall suspend the license for 3 to 12 months in any of the following grounds:

(a) Where the primary hospital is legally suspended;

(b) Where the primary hospital Fails to practice medical ethics;

(c) Where the primary hospital engages in rendering services which are outside the scope of the hospital for which the license is obtained;

(d) Where the primary hospital fails to allow inspection pursuant to relevant law and this standard;

(e) Where the primary hospital allows a practitioner, who has been suspended by appropriate organ from practicing his profession;

(f) Where members of the Governing Board, the Chief Executive Officer, a

Chief Clinical Officer, department head, or other key staff member are convicted of a serious offence involving the management or operation of a primary hospital, or which is directly related to the integrity of the facility or the public health or safety;

(g) Where the primary hospital fails to implement or fulfill comments and corrections given by the appropriate organ;

(h) Where the primary hospital has shown any act which constitutes a threat to the public health or safety;

(i) Where the primary hospital fails to observe laws relating to health services and this standard;

(j) Where the primary hospital fails to submit relevant information required under this standard.

2.6.3. Without prejudice to grounds of revocation provided under relevant laws, the appropriate organ shall revoke the primary hospital license from one to two years on any of the following grounds;

a. Where the license is proved to have been obtained by submitting false information;

b. Allows a practitioner, who is not licensed pursuant to the appropriate law or who has been revoked by appropriate organ from practicing his profession;

c. Where any of its permanent health personnel is found registered/ employed as a permanent staff in any other facility;

d. Where the faults referred to in Article 2.6.2 have been committed for the second time;

e. Where the license is found transferred or rented to another person;

f. Where the primary hospital changes types of services, name, address and the licensee without obtaining permission from the appropriate organ;

g. Where the license is not renewed in accordance with section 2.4 of this standard;

h. Where the primary hospital is legally closed or ceases operation;

i. Where the primary hospital is found operating while suspended by appropriate organ;

j. Where the primary hospital is found operating outside the scope of services stated under this standard;

2.6.4. At least 30 days prior to voluntary surrender of its license where approved by the appropriate organ, or order of revocation, refusal to renew, or suspension of license, the primary hospital must notify each patient and the patient's general medical practitioner or other clinical practitioners the intended closure.

2.6.5. Each license in the licensee's possession shall be the property of the appropriate organ and shall be returned to the appropriate organ immediately upon any of the following events:

(a) Suspension or revocation of the license;

(b) Refusal to renew the license;

(c) Forfeiture of a license; or

(d) Voluntary discontinuance of the operation by the licensee.

2.6.6. If the appropriate organ determines that operational or safety deficiencies exist, it may require that all admissions to the primary hospital cease. This may be done simultaneously with, or in lieu of, action to revoke license and/or impose a fine.

The appropriate organ shall notify to the hospital in writing of such determination.

2.6.7. The appropriate organ shall order and ensure in collaboration with appropriate local health authorities the immediate removal of patients from the primary hospital whenever it determines there is imminent danger to the patients’ health or safety.

2.6.8. The license shall be returned to the appropriate organ within five (5) working days from voluntary surrender, order of revocation, expiration, or suspension of license.

2.6.9. The appropriate organ shall issue to the primary hospital a written notification on reasons for denial, suspension or revocation of the license.

2.7. Right to Fair Hearing

2.7.1. Any applicant made subject to action by the appropriate organ for denial or suspension or revocation of license or who is assessed a fine under terms of this standard shall have the right to a fair hearing in accordance with relevant laws.

2.7.2. Fair hearing shall be provided/arranged by the appropriate organ whenever there is an official compliant submitted to this body.

2.8. Information to be Disclosed

2.8.1. Evidenced information received by the appropriate organ through inspection and other true sources about the primary hospital shall be disclosed to the public in such a way to indicate the public a decision maker or self regulator for its own health.

2.8.2. Whenever public disclosure is necessary, the appropriate organ shall forward inspection reports to the primary hospital at least 15 days prior to public disclosure.

2.8.3. Any citizen has the right to obtain information on the official profile of services of any licensed primary hospital from the appropriate organ.

2.8.4. Anyone who is interested in establishing a primary hospital shall have the right to be provided with information concerning the standards required by the appropriate organ at any working day.

SECTION THREE: GOVERNANCE

3.1. Governing Board

3.1.1. A governmental primary hospital shall have Governing Board, Chief Executive

Officer (CEO), Chief Clinical Officer (CCO) and other necessary staffs indicated in this standard.

3.1.2. Except for Share Company where its Board of Directors shall be deemed as

Governing Board, other private primary hospital licensed otherwise under the

Commercial Code shall not be required to have such organizational structure.

3.1.3. The Board of Management of nongovernmental primary hospitals licensed according to Charities and Societies Proclamation No. 629/2009 shall be deemed as Governing Board.

3.1.4. The Board shall have the authority and responsibility for the direction and policy of the primary hospital.

3.1.5. The Board of the hospital may issue its own rules and regulation of procedures.

3.1.6. Without prejudice to powers and duties provided by the relevant laws, the responsibilities Board shall include:

(a) Formulate all policies and guidelines to be used in the hospital;

(b) Maintaining the primary hospital’s compliance with all applicable laws, its policies, procedures and plans of correction;

(c) Systems are in place for ensuring the quality of all services, care and treatment provided to patients;

(d) Designating and defining duties and responsibilities of the CEO;

(e) Notifying the appropriate organ in writing within thirty (30) working days when a vacancy in the CEO position occurs, including who will be responsible for the position until another person is appointed;

(f) Notifying the appropriate organ in writing within thirty (30) working days when the CEO vacancy is filled indicating effective date of the appointment and name of person appointed;

(g) At least once a year, reviewing the medical care provided and the utilization of the hospital resources;

(h) Establishing a means for effective communication and coordination among the CEO, the medical staff and the various hospital departments; and

3.1.7. Minutes of the Board Meeting shall be recorded, signed, and retained in the hospital as a permanent record.

3.1.8. The CEO shall be the secretary and non voting members of the Board.

3.1.9. The Board shall at least develop the following policies and procedures that are revised at least every three years:

(a) For human resource management;

(b) For ensuring the hospital is smoke- free area;

(c) For the declaration of death of patients which shall accommodate the patient’s religious beliefs with respect to declaration of death. Such policies shall also include indicating the cause of death, medication given, examinations done, and practitioner who cares of the patient.

(d) For transfer of dead body to its family. If a patient dies in the facility, the body shall be handed over to the family within a day unless conditions dictate otherwise.

(e) For visitation which shall be in the best interest of patients, including, but not limited to, protection from communicable diseases, protection from exposure to deleterious substances and hazardous equipment and assurance of health and safety of patients.

3.1.10. The hospital shall develop and implement a complaint procedure for patients, families, visitors, and others. The procedure shall include, at least, a system for receiving complaints, a specified response time, assurance that complaints are referred appropriately for review, development of resolutions, and follow-up action.

3.1.11. There shall be an organizational chart of the primary hospital and each service that shows lines of authority, responsibility, and communication between and within services.

3.1.12. There shall be a formal mechanism for communication among the Board, CEO, CCO and the necessary medical staff.

3.1.13. The primary hospital shall establish a mechanism for involving consumers in the formulation of hospital policy and implementation of activities.

3.1.14. The Primary hospital shall develop and implement a complaint procedure for patients, families, visitors, and others.

3.2. Chief Executive Officer

3.2.1. The Manager of a primary hospital formed as Charities and business organization shall be deemed as CEO.

3.2.2. The CEO shall be responsible for planning, organizing, and directing and controlling the day to day operation of the hospital. The CEO shall report and be directly responsible to the Board in all matters related to the maintenance, operation, and management of the hospital.

3.2.3. The CEO shall be responsible for the operation of the hospital twenty-four (24) hours per day, seven (7) days per week.

3.2.4. Without prejudice to powers and duties provided in relevant laws, the CEO shall be responsible for:

(a) Providing for the protection of patients’ health, safety, and well- being;

(b) Maintaining staff appropriate to meet patient needs;

(c) Developing and implementing procedures on collecting and reporting information on abuse, neglect and exploitation;

(d) Ensuring that investigations of suspected abuse, neglect or exploitation are completed and that steps are taken to protect patients; and

(e) Ensuring appropriate response to reports from the appropriate organ;

3.3. Chief Clinical Officer

3.3.1. Each primary hospital shall have a Chief Clinical Officer who shall be accountable to the CEO.

3.3.2. The CCO shall be a medical doctor and oversee the clinical care provided by the hospital. In particular, the function of the CCO shall include:

(a) Facilitating communication among the medical staff members and with the hospital;

(b) Implementing the hospital and medical staff policies and procedures;

(c) Recommending the appointments to the medical staff and scope of clinical privileges;

(d) Ensuring the provision of continuing medical education;

(e) Taking other necessary actions necessary to govern the medical staff and relate to the hospital board.

3.4. Management Committee

3.4.1. A department head shall be assigned to each of the medical and administrative departments. The responsibility of department heads includes at least the following:

(a) Providing a written description of the services provided by the department;

(b) Ensuring coordination and integration of these services with other departments when relevant;

(c) Recommending space, staffing, and other resources needed to fulfill the department’s responsibility;

(d) Defining the education, skills, and education needed by each category of employee in the department;

(e) Ensuring that there is an orientation and continuing education program for the department’s employees;

(f) Developing and implementing a department quality improvement program.

3.4.2. Any primary hospital shall establish a Management Committee consisting of heads of the medical and administrative departments. The CEO shall be the chairperson of the Committee.

3.4.3. The Committee shall be an adviser of the CEO on the day to day management of the hospital.

3.4.4. The Committee shall meet upon regular basis. The minutes of the meeting shall be recorded and available to the appropriate organ upon request.

SECTION FOUR: PATIENT RIGHTS AND RESPONSIBILITIES

4.1. Informed Consent

4.1.1. Each primary hospital shall protect and promote each patient’s rights. This includes the establishment and implementation of written policies and procedures for the patient right.

4.1.2. For undertaking any type of procedures and treatments an informed consent shall be required from the patient or patient’s next of kin or guardian.

4.1.3. An informed consent may not be required during emergency cases or life threatening situations where the patient is not capable of giving an informed consent and his or her next of kin or guardian is not available.

4.1.4. Unless provided by the law or this standard or by the hospital policies and procedures that an informed consent shall be given in written form, an informed consent of the patient can be given orally or inferred from an act. A written consent shall be needed at least for the following:

(a) Surgery and invasive procedures;

(b) General anesthesia; and

(c) Blood transfusion.

4.1.5. The primary hospital shall comply with relevant laws, national and international codes of ethics in the cases of vulnerable groups like children, women, geriatric patients etc when someone other than the patient can give consent.

4.1.6. Patient consent forms shall be available in all applicable locations like areas where surgery or invasive procedures are done

4.1.7. No photographic, audio, video or other similar identifiable recording is made of without prior informed consent of a patient.

4.1.8. A primary hospital shall establish and implement a process to provide patients and/or their designee an appropriate education to assist in understanding the identified condition and the necessary care and treatment.

4.1.9. A primary hospital shall document its assessment of each patient's ability to understand the scope and nature of the diagnosis and treatment needed.

4.2. Patient Rights

Every primary hospital patient shall at least have the following rights,

4.2.1. To receive reasonable, respectful and safe access to health services by competent personnel that the hospital is required to provide according to this standard;

4.2.2. To receive treatment and medical services without discrimination based on race, age, color, religion, ethnicity, national or social origin, sex, sexual preferences, disabilities, diagnosis, source of payment or other status;

4.2.3. To retain and exercise to the fullest extent possible all the constitutional and legal rights to which the patient is entitled by law;

4.2.4. To be informed of the names and functions of all general medical practitioners and/or other clinical practitioners who are providing direct care to the patient.

These people shall identify themselves by introduction or by wearing a name tag;

4.2.5. To receive, to the extent possible, the services of a translator or interpreter to facilitate communication between the patient and the hospital's health care personnel if the patient can not understand the working language;

4.2.6. To receive from the patient's general medical practitioner(s) or other clinical practitioner(s) an explanation of his or her complete medical condition, recommended treatment, risk(s) of the treatment, expected results and reasonable medical alternatives in terms that the patient understands. If this information shall be detrimental to the patient's health, or if the patient is not capable of understanding the information, the explanation shall be provided to his or her next of kin or guardian and be documented in the patient's personal medical record;

4.2.7. To give informed, written consent prior to the start of specified nonemergency procedures or treatments only after a general medical practitioner or other clinical practitioner has explained specific details about the recommended procedure or treatment, the risks involved, the possible duration of incapacitation, and any reasonable medical alternatives for care and treatment in terms that the patient understands. If the patient is incapable of giving informed, written consent, consent shall be sought from the patient's next of kin or guardian or through an advance directive, to the extent authorized by law. If the patient does not give written consent, a general medical practitioner or other clinical practitioner shall enter an explanation in the patient's medical record;

4.2.8. To refuse medication and treatment and to be informed of the medical consequences of refusing treatment provided that he/she is mentally clear except conditions which are threatening the public health. The primary hospital shall develop a procedure on the management of the cases of patients who refuse treatment.

4.2.9. To be informed if the primary hospital has authorized other health care and educational institutions to participate in the patient's treatment. The patient also shall have a right to know the identity and function of these institutions, and may refuse to allow their participation in the patient's treatment;

4.2.10. To be informed by the attending general medical practitioner and/or other clinical practitioner about any continuing health care requirements after the patient's discharge from the hospital. The patient shall also have the right to receive assistance from the general medical practitioner and/or other appropriate hospital staff in arranging for required follow-up care after discharge;

4.2.11. To receive sufficient time before discharge to have arrangements made for health care needs after hospitalization;

4.2.12. To be informed by the hospital about any discharge appeal process to which the patient is entitled by law;

4.2.13. To be transferred to another facility only for one of the following reasons, with the reason recorded in the patient's medical record:

(a) The transferring hospital is unable to provide the type or level of medical care appropriate for the patient's needs. The hospital shall make an immediate effort to notify the patient's primary care general medical practitioner or other clinical practitioner and the next of kin, and document that the notifications were received; or

(b) The transfer is requested by the patient, or by the patient's next of kin or guardian when the patient is mentally incapacitated or incompetent;

4.2.14. To receive from a general medical practitioner or other clinical practitioner an explanation of the reasons for transferring the patient to another facility, information about alternatives to the transfer, verification of acceptance from the receiving facility, and assurance that the movement associated with the transfer will not subject the patient to substantial, unnecessary risk of deterioration of his or her medical condition. This explanation of the transfer shall be given in advance to the patient, and/or to the patient's next of kin or guardian except in a life-threatening situation where immediate transfer is necessary;

4.2.15. To be treated with courtesy, consideration, and respect for the patient's dignity and individuality i.e. the right to care that respects the patient’s personal values and beliefs;

4.2.16. To be free from physical and mental abuse, neglect, sexual harassment, sexual violence and exploitation;

4.2.17. To be free from chemical and physical restraints that are not medically necessary, unless they are authorized by a attending physician or other clinical practitioner for a limited period of time to protect the patient or others from injury;

4.2.18. To have personal and physical privacy during medical treatment and personal hygiene functions, such as bathing and using the toilet, unless the patient needs assistance for his or her own safety. The patient's privacy shall also be respected during other health care procedures and when hospital personnel are discussing the patient;

4.2.19. To get confidential treatment. Information in the patient's records shall not be released to anyone outside the hospital except the followings;

(a) If the patient has approved the request,

(b) If another health care facility to which the patient was transferred requires the information,

(c) If the release of the information is required and permitted by law.

(d) If the patient's identity is masked, the hospital may release data about the patient for studies containing aggregated statistics

4.2.20. To know the price of services and procedures;

4.2.21. To receive a copy of the hospital payment rates, regardless of source of payment.

Upon request, the patient or responsible party shall be provided with an itemized bill and an explanation of the charges if there are further questions.

The patient or responsible party has a right to appeal the charges. The hospital shall provide the patient or responsible party an explanation of procedures to follow in making such an appeal;

4.2.22. To have prompt access to the information contained in the patient's medical record as per the medical record section stated under this standard, unless a general medical practitioner or other clinical practitioner prohibits such access as detrimental to the patient's health, and explains the reason in the medical record. In that instance, the patient's next of kin or guardian shall have a right to see the record. This right continues after the patient is discharged from the hospital for as long as a copy of the record is kept;

4.2.23. To obtain a copy of the patient's medical record, as per the standards set under the medical record section of this standard.

4.2.24. To have access to individual storage space in the patient's room for the patient's private use. If the patient is unable to assume responsibility for his or her personal items, there shall be a system in place to safeguard the patient's personal property until the patient or next of kin is able to assume responsibility for these items;

4.2.25. To receive a medical certificate in English or Amharic or in a working language of the place where the hospital is located;

4.2.26. To present his or her suggestion or grievances, without fear of retribution, to the hospital staff member designated by the hospital to respond to questions or grievances about patient rights and to receive an answer to those grievances within a reasonable period of time without discrimination. The hospital shall post the names, addresses, and telephone numbers of the government agencies to which the patient can complain and ask questions.

4.2.27. To be given a summary of these patient rights, as approved by the appropriate organ, and any additional policies and procedures established by the hospital involving patient rights and responsibilities. The hospital shall be obliged to ensure that,

(a) The patient is informed of his or her rights during the admission process;

(b) This summary include the name and phone number of the hospital or hospital staff member to whom patients can complain about possible patient rights violations;

(c) This summary is provided in the patient's native language if 10 percent or more of the population in the hospital's service area speak that language;

(d) A summary of these patient rights is posted conspicuously in the patient's room and in public places throughout the hospital;

(e) Complete summary copies of the patient right is available at nurse stations and other patient care registration areas in the hospital.

4.2.28. To be informed and participate in decisions relating to their care and participates in the development and implementation of a plan of care and any changes.

4.3. Patient Responsibilities

4.3.1. Every patient shall have the following responsibilities:

(a) To provide, to the best of the patient’s knowledge, accurate and complete information regarding past medical history and issues related to the patient’s health, including unexpected changes, to the health professional responsible for the patient’s care;

(b) To follow the course of treatment and instructions proposed by the general medical practitioner or other clinical practitioner or to accept the consequences if treatment instructions is refused;

(c) To report any changes in his/her condition or anything that appears unsafe to the responsible health professional;

(d) To be considerate of the rights of other patients and to respect their privacy;

(e) To respect their caregivers;

(f) To fulfill the financial obligations as promptly as possible;

(g) To keep all appointments and notify hospital or the appropriate person when unable to do so;

(h) To observe the hospital policies and procedures, including those on smoking, alcohol or drug addiction, cellular phones, noise and visitors;

(i) Be considerate of the hospital facilities and equipment and to use them in such a manner so as not to abuse them;

(j) Not to litter the hospital premises.

(k) To sign on “Against Medical Advice Notice” if he / she refuses the recommended treatment or intervention.

4.3.2. The list of a patient’s rights and responsibilities shall be posted at various places of the primary hospital premises.

SECTION FIVE: HUMAN RESOUCE MANAGEMENT

5.1. General Requirements

5.1.1 The hospital shall have Human Resource Department (HRD) or focal person which carries out the major functions of Human Resource Management (HRM).

5.1.2 Each service units of the hospital shall maintain a sufficient number of staff with the qualifications, training and skills necessary to meet patient needs as per this standard.

5.1.3 All recruitment and selection shall follow consistent approach using the recruitment and selection manual approved by the hospital management/ governing board.

5.1.4 No health professional shall practice his/her profession in the hospital without having professional license from the appropriate organ. The hospital shall ensure that all health professionals recruited by the hospital are licensed as per the registration and licensing requirement of the appropriate organ.

5.1.5 Each hospital shall ensure and maintain evidence of current active licensure, registration, certification or other credentials for employees and contract staff prior to staff assuming job responsibilities and shall have procedures for verifying that the current status is maintained.

5.1.6 Whenever a licensed healthcare professional is terminated as a result of a job-related incident, the hospital shall refer a report of the incident to the appropriate organ.

5.1.7 Every health professional shall report to the hospital whenever he/she is infected with contagious diseases. The hospital shall also establish a mechanism for screening health professionals with contagious diseases. The health professional shall not practice his/her profession during the period of such infection and his/her rights provided under the relevant employment law and the hospital’s HR manual shall be respected.

5.1.8 Each person involved in direct patient care shall have an occupational health screening by a physician or other qualified health professional prior to entering active status and at least once every five (5) years thereafter. A health professional shall not conduct health examination for himself/ herself.

5.1.9 Each health screening shall include a medical history, physical examination, and any indicated laboratory work and investigations.

5.1.10 A report, signed by an examining physician or other qualified health professional, shall be made of each examination.

5.1.11 The report of each examination shall be kept on file in the hospital and shall be open to inspection by the appropriate organ.

5.1.12 Each person who is involved in direct patient care and who acquires notifiable illness shall, prior to returning to duty, obtain certificate of fitness, as provided in the hospital's policies, that he or she may return to duty without apparent danger to any patient.

5.1.13 Immunization against communicable disease shall be required of all employees and all other persons who routinely come in contact with patients or patient areas. Immunizations shall be in accordance with the current national immunization guidelines.

5.1.14 Each hospital shall maintain a current employment record for each staff. The record shall contain, at a minimum, information on credentials, health examination (fitness for duty), work history, current job description, evidence of orientation, in-service education/training and copies of annual evaluation

5.1.15 All health professionals shall abide with health professionals Code of conduct and respective scope of practice.

5.1.16 There shall be a policy or procedures for all health professionals to report any suggestive signs of child abuse, substance abuse and /or abnormal psychiatric manifestations by the patients under their care.

5.2. Staffing Plan

5.2.1. The hospital shall avail as a minimum the staff requirement stated under this standard.

5.2.2. A staffing plan shall be developed collaboratively by the different service units and management, which identifies the number and types of the staff

5.2.3. The planning process shall use recognizable process for estimating the staffing need like Workload Indicator for Staffing Need (WISN) method.

5.2.4. The staffing plan shall be reviewed on an ongoing basis and updated as necessary

5.2.5. The staffing plan shall define the following elements:

(a) The total number and types of staff needed for the hospital as a whole and for each service unit

(b) The total number and types of staff currently available for the hospital as a whole and each service unit

(c) The required education, skills, knowledge, and experience required for each position

(d) The process and time period for reviewing and updating the plan shall be indicated. (The plan is periodically reviewed and updated as required, but it shall be done at least every two years.)

(e) Expected workload

5.2.6. The primary hospital shall have at least the following summary of professionals and staffing:

Professionals required Minimum number required

CEO 1

MD (licensee) 1

MD 3

Emergency surgical officer 1

HO 2

Nurses (BSc) 5

Midwives 4 Nurse (Diploma) 20 BSc anesthetist/nurse anesthetist 2 Ophthalmic nurse 1 Psychiatric nurse 1 Dental professional 2 Radiology professional 1 Radiographer 2 Physiotherapist 1 Laboratory technologist 4 Laboratory technician 2 Pharmacist 4 Pharmacy technician (Druggist) 2 Environmental Health 1 Health Information 1 Cleaners 15 Reception/Archive 8

Maintenance officer (plumbing, electricity, general maintenance services)

Medical equipment maintenance technician 1 Food and dietary 10 Morgue attendant 1 Social workers 1 Compliant handling officer 1

5.3. Job Description and Orientations

5.3.1. All staffs shall be provided with current written job descriptions and be oriented to their specific job responsibilities at appointment

5.3.2. The job description shall include the title and grade of the position, specific function of the job, job requirement, reporting mechanism, evaluation criteria and description of job site and work environment.

5.3.3. The orientation program for all employees shall include three levels of orientation: hospital wide, service unit and job specific:

5.3.4. Orientation to hospital structure and administration shall be provided by hospital management.

5.3.5. Orientation to hospital policies, including all environmental safety programs, infection control, and quality improvement shall be provided

5.3.6. Staff members who are not licensed to independently practice shall have their responsibilities defined in a current job description.

5.3.7. Each hospital shall provide and maintain evidence of an orientation program for all new staff and, as needed, for existing staff who are given new assignments.

The orientation program shall include:

(a) Job duties and responsibilities

(b) Hospital's sanitation and infection control programs;

(c) Organizational structure within the hospital;

(d) Patient rights;

(e) Patient care policies and procedures relevant to the job;

(f) Personnel policies and procedures;

(g) Emergency procedures;

(h) The Disaster preparedness plan; and

(i) Reporting requirements for abuse, neglect or exploitation

5.4. Staff Education

5.4.1. The hospital shall ensure that staffs receive training in order to perform assigned job responsibilities.

5.4.2. Each staff member shall receive ongoing Continuing Professional Development

(CPD) to maintain or advance his or her skills and knowledge

5.4.3. The CPD shall be relevant to the setting in which they work as well as to the continuing advancement of the hospital

5.4.4. The hospital shall decide the type and level of training for staff in accordance with National CPD guideline and then carry out and document a program for this training and education.

5.4.5. The hospital shall provide and maintain evidence of…