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National Health Regulatory Authority Kingdom of Bahrain

A GUIDE TO THE APPLICATION PROCEDURE AND RULES FOR LICENSING PHARMACY AND

PHARMACEUTICAL FACILITIES IN THE

KINGDOM OF BAHRAIN

THE PURPOSE OF THIS DOCUMENT IS TO SET OUT THE REGISTRATION AND LICENSING PROCESS FOR A PHARMACY AND PHARMACEUTICAL FACILITIES: APPLYING FOR A LICENSECOMPLYING WITH THE RULES AND

REQUIREMENTS TO RETAIN A LICENSE ON THE PHARMACY AND PHARMACEUTICAL FACILITIES REGISTER

ADDITIONAL GUIDES ARE ALSO AVAILABLE FOR OTHER HEALTH CARE FACILITIES LICENSED IN THE KINGDOM OF

BAHRAIN

VERSION 1.0 - EFFECTIVE: 22nd May 2013

THIS GUIDE WAS LAST UPDATED IN 22nd May 2013 PLEASE ENSURE YOU READ THE MOST UP-TO-DATE GUIDE AVAILABLE ON OUR WEBSITE

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Introduction The NHRA Pharmacy and pharmaceutical facilities Licensing Guide has been developed to serve as a reference for applicants during the preparation, consultation and inspection processes for all pharmacies and pharmaceutical facilities licensed to operate in the Kingdom of Bahrain. It is designed to help you learn about the NHRA application processes, the minimum design standards for pharmacies and pharmaceutical facilities and the operational standards required in maintaining Pharmacy and pharmaceutical facilities. This overview will provide important information about the NHRA, pharmacy and pharmaceutical facilities legislation and standards, eligibility for licensing, how to request for a licensing inspection, inspection preparation, on-site inspection and the NHRA licensing rules. To fulfil our mission as a driver for continuous improvement, the development of the NHRA licensing and regulatory systems is and will remain a dynamic process. Further modifications will be communicated to licensees through later editions and amendments. Our appreciation and gratitude goes to the NHRA Facilities Licensure Inspection Team that contributed to the development, compilation, design, review, revision, and production of this guide. We extend our appreciation to the pharmacist professionals who were generous with their feedback and suggestions to ensure the fulfilment of our mission. Thank you, Dr Wahid Ali Agab NHRA Chairman

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TABLE OF CONTENTS

PARAGRAPH DESCRIPTION PAGE

THE REGISTER

1. RELEVANT LEGISLATION / WHY REGISTER? 4

2. REGISTER OF PHARMACY FACILITIES AND DEFINITIONS 5

3. ELIGIBILITY 6

APPLYING FOR PHARMACY FACILITY LICENSE

4. THE APPLICATION PROCESS 7

5. THE APPLICATION FORMS 8

6. 7.

THE LICENSE PROPOSAL FEES

8 10

8. 9.

THE NHRA ASSESSMENT PROCESS THE NHRA DECISION MAKING PROCESS

10 10

10. ADDITIONAL DOCUMENTATION 11

PHARMACY AND PHARMACEUTICAL FACILITIES REGULATION

11. INSPECTION REQUEST AND PROCESS 13

12. FACILITY MONITORING 14

LICENSING STANDARDS

13. MINIMUM DESIGN STANDARDS 15

14. PHARMACY AND PHARMACEUTICAL FACILITIES OPERATIONAL STANDARDS 17

INFORMATION FOR LICENSED PHARMACY AND PHARMACEUTICAL FACILITIES

15. FACILITY LICENSURE AND REGISTRATION 44

16. OBLIGATION TO NOTIFY NHRA OF ANY CHANGES 44

17. RENEWAL PROCESS 45

NONCOMPLIANCE AND ENFORCEMENT

18. 19.

THE PRINCIPLES OF NONCOMPLIANCE NHRA NONCOMPLIANCE LEVELS

46 47

20. RESTORING A LICENSE FOLLOWING REMOVAL 49

INFORMATION FOR EMPLOYERS

22. EMPLOYING PHARMACY PROFESSIONALS 51

22. 23.

VISAS AND WORK PERMITS COMPLAINTS ABOUT PHARMACEUTICAL FACILITIES

51 51

USEFUL LINKS 52

NHRA FEEDBACK SURVEY 53 APPENDICES APPENDIX A 1 APPLICATION FORMS – PHARMACY AND PHARMACEUTICAL FACILITIES 55 2 LICENSE PROPOSAL TEMPLATE 59 3 NHRA INSPECTION REQUEST FORM 70 4 NHRA FACILITY INSPECTORS “CODE OF CONDUCT” 72 6 NHRA “WHAT TO EXPECT WHEN AN INSPECTOR CALLS” 73

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THE REGISTER This section contains information about:

1. Relevant legislation / why register? 2. The Registers of Pharmacy Facilities and Definitions 3. Eligibility

1. RELEVANT LEGISLATION / WHY REGISTER? 1.1 Legal obligations

The NHRA and its responsibilities to license health care facilities are legally bound by the provisions in Legislative decree No. 38 of 2009. This law is supported by Legislative Decree No. 18 of 1997 with respect to the Practice of Pharmacists and Pharmaceutical Centres. This legislation dictates that all health care facilities must be licensed to operate and provide healthcare services in the Kingdom of Bahrain, and they must fulfil the criteria set out in guidance and the relevant standards published by the NHRA. This Guide to the application procedure and rules for licensing pharmacies and pharmaceutical facilities in the Kingdom of Bahrain outlines the application process for pharmacy and pharmaceutical facility licensees with regard to the registration and regulation of all pharmacy and pharmaceutical facilities. In addition to the requirement for pharmacy and pharmaceutical facilities to be licensed, all pharmacy professionals working within a licensed pharmacy and/or pharmaceutical facility are obliged to be licensed appropriately at all times when they practise their profession in the Kingdom of Bahrain and to comply with all other requirements in the Law. (See the NHRA Guide to the Application Procedure and Rules for Licensing Health Care Professionals in the Kingdom of Bahrain.) Understanding the legislation All new applicants for a licensed pharmacy and/or pharmaceutical facility should be aware of the legislation relating to the registration and licensure of their facility. The legal terminology in the legislation can be confusing for anyone who is not familiar with the laws or with legislation in general. In this Guide, the NHRA has tried to convey the legal requirement in plain language but it is important to note that in the case of a dispute or discrepancy, the provisions of the law take precedence over any interpretation made in this guide.

1.2 Why should Pharmacy and pharmaceutical facilities be licensed?

If a pharmacy and/or pharmaceutical facility is to provide dispensary services and sell over the counter (OTC) medications, preparations and/or any other health products or treatments in the Kingdom of Bahrain, it is required by law to be licensed by the NHRA. It is a criminal offence for any pharmacy and/or pharmaceutical facility to dispense or sell medications/drugs, preparations, treatments, or provide health products/treatments or practices within the Kingdom of Bahrain, or to advertise its services, if it does not have a license, or its license is expired. Each pharmacy and pharmaceutical facility licensee is responsible for ensuring that their license is current and appropriate for the type of facility they have. Failure to do so could result in criminal proceedings against them.

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1.3 Unlicensed pharmacy or pharmaceutical facilities Providing pharmacy and pharmaceutical services and practising as a pharmacist professional while unlicensed is an offence under Bahraini law. The NHRA will take action against any pharmacy and/or pharmaceutical facility owner that is found to be operating while unlicensed. The NHRA could, at its discretion, decide to suspend or refuse an application for license following a period of unlicensed activity due to expiry or failure to meet the license requirements. The Ministry of the Interior may be informed of any unlicensed pharmacy and/or pharmaceutical facility or professional who, to the NHRA’s knowledge, is providing dispensary or over the counter (OTC) medication/drug or health products/services, treatments or practising while unlicensed.

2 THE REGISTERS OF PHARMACY AND PHARMACEUTICAL FACILITIES 2.1 Structure of the Registers

There are four legislative decrees which govern the facility registers in the Kingdom of Bahrain. These four registers identify all healthcare facilities licensed in the Kingdom, within these registers there are sub-categories that identify the type of facility which is licensed

Table 1: NHRA Registers of Healthcare Facilities

LEGISLATION LEGISLATIVE DECREE NO. 23 OF 1986

LEGISLATIVE DECREE NO. 18 OF 1997

LEGISLATIVE DECREE NO. 7 OF 1989

LEGISLATIVE DECREE NO. 2 OF 1987

REGISTER HOSPITALS PHARMACIES AND PHARMACEUTICAL FACILITIES

CLINICS / CENTERS ALLIED HEALTH FACILITIES/CENTERS

SUB-CATEGORIES

PRIVATE HOSPITALS

SPECIALIST HOSPITALS

GOVERNMENT HOSPITALS

PHARMACY WAREHOUSE

PUBLIC PHARMACY

PRIVATE PHARMACY

PRIVATE CLINICS/CENTERS

SPECIALISED CLINICS/CENTERS

POLYCLINIC

24 HOUR CLINIC

COMPANY CLINIC

LABORATORIES

RADIOLOGY

OPTICIANS

PHYSIOTHERAPY

NUTRITION

2.2 Register of Pharmacies and Pharmaceutical facilities

This register is for establishments where prescription drugs are prepared and dispensed by a licensed pharmacist. The establishment can also be a place where preparation, composition, separation, bottling or packing and the selling of any medicine or health product for protection or treatment of humans take place. Subcategories:

2.2.1. Public pharmacy 2.2.2. Private pharmacy 2.2.3. Pharmaceutical centres 2.2.4. Pharmacy manufacturing / warehouse

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2.3 Definitions

2.3.1 A Public Pharmacy is a pharmacy which is designed to prepare prescriptions and sell medicine to the public. It is open to any member of the public for the purpose of obtaining OTC or prescription medicines and/or health products. Advice, education and counselling services can also be provided relating to medications, drugs, interactions and adverse effects. 2.3.2 A Private Pharmacy is a pharmacy which is part of a medical facility or a pharmacy that is designated for a specific group of people. It is usually part of a hospital (government or private) or Ambulatory Care facility (government or private) and provides pharmaceutical services for patients of the hospital or facility. 2.3.3 Pharmaceutical Centres are all type of public pharmacies and their branches and private pharmacies. They include retail and private pharmacies in which medicines are stored and licensed professionals prepare, dispense and provide medicines, either over the counter (OTC) health products or in accordance with a prescription written by a licensed medical practitioner. Advice, education and counselling services can also be provided relating to medications, drugs, interactions and adverse effects 2.3.4 A Pharmaceutical Manufacturing Factory / Warehouse is a facility where the preparation, formulation or production and processing takes place for retail medicines with the intention of selling in bulk. It is a facility which is intended for bulk distribution of medicines and drugs to pharmaceutical centres/shops or other legal retail outlets.

Under the existing legislation, a licensed pharmacy and/or pharmaceutical facility cannot advertise prescription only medication. It is their duty and obligation to advertise in an honest and ethical way that does not deceive the consumer or general public. Pharmaceutical facilities are required to be licensed for the dispensing services and practices they provide in Bahrain and must comply with all the relevant licensing requirements, including the license renewal and inspection processes put in place by the NHRA.

3. ELIGIBILITY

3.1 A person or organisation must obtain a license from the National Health Regulatory Authority (NHRA) to operate any type of Health Care Facility in the Kingdom of Bahrain. This applies to any facility whether government, private or non-profit.

3.2 The Pharmacy and pharmaceutical facilities license must be applied for under the sub categories

and definitions as defined in 2.3 above.

3.3 To be eligible for preliminary approval for a pharmacy and/or a pharmaceutical facility, the owner of the facility must be a qualified pharmacist, a Bahraini national and must be over 21 years of age.

3.4 If a company is applying for a pharmacy and pharmaceutical facilities license, the ownership must

have 50% of its capital owned by a licensed Bahraini pharmacist. 3.5 Eligibility for Pharmacy and pharmaceutical facilities registration will be determined by the NHRA on

assessment of each application, following which the license applicant will be informed if they are eligible to obtain a license.

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APPLYING FOR A PHARMACY AND PHARMACEUTICAL FACILITIES LICENSE This section contains information about:

4 The Application Process 5 The Application Form 6 The License Proposal 7 Fees 8 The NHRA assessment process 9 The NHRA decision-making process 10 Additional Documentation

4. THE APPLICATION PROCESS

There are 4 steps in the licensing process of any healthcare facility including pharmacies and/or pharmaceutical facilities. Step 1 – Application for preliminary approval Step 2 – Detailed Application for full license Step 3 – Interim Inspection Step 4 – 100% Completion Inspection Step 1 - Application for Preliminary Approval All new applications must be submitted on the pharmacy and pharmaceutical facilities License Application Form (see appendix 1) for the approval and licensing of all pharmacy and pharmaceutical facilities. Applicants should be familiar with the legislation relevant to pharmacy and pharmaceutical facilities licensing. It is recommended that applicants familiarize and address the requirements contained in this guide and develop their proposal in consultation with the NHRA Health Care Facilities Licensure and Regulation Department. To apply for preliminary approval, the applicant must: 4.1 Find out if the proposed pharmacy and/or pharmaceutical facility is eligible to be licensed in the

Kingdom of Bahrain. 4.2 Review the minimum design standards required for a pharmacy and pharmaceutical facilities (see

section 13) 4.3 Review the pharmacy and pharmaceutical facilities operational licensing standards required for a

pharmacy and pharmaceutical facilities (see section 14) 4.4 Complete the relevant application form (see appendix 1) 4.5 Develop a license proposal for consideration ( see section 6 below and appendix 2) 4.6 Submit the application form with the license proposal and other relevant documentation for NHRA

consideration. 4.7 Obtain preliminary approval from the NHRA

Step 2 - Detailed application for full license consideration Applicants proceeding to submit an application for full license consideration must:

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4.8 Obtain the required approval documentation from the Ministry of Industry and Commerce, the local

Municipality and any relevant approval requirements from the Ministry of Health and in order to progress to construction.

4.9 Submit additional license proposal requirements outlined in section 6.4 and in the template in appendix 2

Step 3 - Interim Inspection 4.10 Applicants must submit an interim inspection request for licensure inspectors to visit the facility

and provide ongoing inspection support. (See appendix 3) 4.11 Ensure all outstanding issues from the interim inspection report are addressed.

Step 4 - 100% Completion Inspection 4.12 Applicants must submit 100%completion inspection request prior to final licensure application

(see appendix 3). 4.13 Final inspection and licensure granted if the facility meets all the relevant legislation

requirements and NHRA licensing standards.

5. THE APPLICATION FORM Whether applying for a license for the first time, renewing a license or making changes to the facility license requirements, the application process works as follows: 5.1 Complete the appropriate sections of the pharmacy and pharmaceutical facilities license application

form (see appendix 1); ticking the appropriate boxes for new license, renewal of license or changes to license and completing the relevant sections.

5.2 Applicants should follow the instructions on the form. Each relevant section of the form should be

completed. Applicants should ensure that they:

write legibly,

personally sign and date the declaration on the application form,

include the signatures of all relevant stakeholders,

submit a comprehensive license proposal and

submit all required documentation as requested.

Failure to provide all documentation in the required format will result in a delay in processing an application.

5.3 Once the applicant receives notification that they have received preliminary approval and are eligible to continue their application for consideration of a full license, they must submit the remaining documentation required and follow the inspection process.

5.4 Once the NHRA has received these documents in an acceptable format and the fees have been paid,

the inspectors will conduct the interim inspection, and subsequently the final inspection before providing a report to the NHRA who will issue the facility license.

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6. THE LICENSE PROPOSAL

In the best interests of patient care and public protection, the National Health Regulatory Authority (NHRA) seeks to ensure that the issue of quality and patient safety are systematically and comprehensively addressed, across all health care services including Pharmacy and pharmaceutical facilities services in the Kingdom of Bahrain.

Continuous quality assurance and improvement strategies should be evident within the proposal including:

Strategic direction and consideration of the Kingdom of Bahrain’s overall goals in healthcare; Current international best practice; Management of operational performance including expected outcomes/adverse events/near

misses; Development of quality assurance programs that reflect the use of both internal and external

standards and reviews. This can include accreditation by recognised external bodies; and Risk management strategies.

The applicant/s are encouraged to discuss the development of the proposal and application, in particular the conceptual plans (design layout) and the continuous quality assurance/ improvement aspects, with the NHRA licensure inspectors prior to submission. The Information required in the proposal should include:

6.1 Personal and professional details of the applicant and of the Board of Directors if the applicant is or is to be a registered organisation;

6.2 Facility name and contact details, (address, contact numbers etc.);

6.3 Outline of the pharmacy and/or pharmaceutical facility proposal:

6.3.1 A comprehensive statement of the strategic direction and goals of the facility; 6.3.2 Details of the proposed management team and organisational structure, if staff are

already employed/identified, include their names and license numbers (if appropriate) beside their roles. In particular identify the Chief Operating Manager and Chief Pharmacist, if this information is available;

6.3.3 Identification of the proposed services and supporting services including service levels and responses to the requirements contained in the NHRA pharmacy and pharmaceutical facility minimum design standards and the NHRA pharmacy and pharmaceutical facility operational licensing standards;

6.3.4 Evidence of consideration of key demographic data to support the proposed location of the pharmacy and/or pharmaceutical facility;.

6.3.5 Evidence of how you will comply with infection prevention and control standards, medical waste standards, and fire health and safety standards,

6.4 Outline of the physical facility proposal: ( this section can be submitted when preliminary approval has been obtained)

6.4.1 A clear overview of the proposed site plan which specifically identifies the facility

when constructed or renovated for use as a pharmacy and/or pharmaceutical facility.

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6.4.2 The location of the proposed facility, including roads, frontages and adjoining properties.

6.4.3 Architectural drawings: in both soft and hard copies (can be submitted after preliminary approval

6.4.3.1 One of size and scale A1 or A2 of scale 1:100 of the proposed plans, including site plan.

6.4.3.2 One of size and scale:A3 of scale 1:200 of the proposed plan including the site plan

6.4.4 Details of any proposed leasing arrangements, including description of lease agreements.

7 FEES

Each health care facility license applicant must pay the appropriate fee to the NHRA, when submitting their application. Fees are non-refundable. For further information about fees and acceptable methods of payment, see NHRA’s website at: www.nhra.bh

8. THE NHRA ASSESSMENT PROCESS

8.1 On receipt of your initial application, it will be acknowledged by email within 10 working days and

you will be issued with a healthcare facility license application number which should be quoted in all future transactions with the NHRA. Please allow a reasonable time for your initial application to reach the NHRA before receiving an acknowledgement.

8.2 Upon receipt of a completed healthcare facility license application, the facilities licensing department

shall conduct a detailed review of the submitted application form, license proposal and documentation/material to determine eligibility, compliance and suitability for further processing.

8.3 Your application will be assessed and you will be informed if there is any outstanding

documentation/information which you are required to submit. 8.4 Once the NHRA is satisfied that all required information has been received, the NHRA will make a

decision on the application. 8.5 If the initial application for a new healthcare facility to be established is successful, the NHRA shall

issue a preliminary approval letter, with defined services and restrictions particular to the facility/applicant circumstances. This letter will be required to complete the procedures of authorities including but not limited to:

8.5.1 The Ministry of Industry and Commerce in Bahrain. 8.5.2 Bahrain Telecommunications Authority. 8.5.3 Bahraini Local Municipalities., Incl. Electricity and Water Authority 8.5.4 Civil Defence Authority incl. Fire certification/approval. 8.5.5 NHRA approval for Medical Devices and / or equipment and/or Radiation approvals, if

required

NB: Applications are processed as promptly as possible but this is only possible when a complete application is received. Pharmacies and pharmaceutical facilities must not commence practice within the Kingdom of Bahrain unless and until they are fully licensed. Preliminary approval does not confer a license to operate.

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9. THE NHRA DECISION-MAKING PROCESS

9.1 Decision

The decision-making process is mapped below. All standard applications are processed by NHRA staff and endorsed by the appropriate NHRA Committee. Non-standard issues/applications are referred for more detailed consideration. The Committee is authorised by the NHRA to make decisions in the first instance.

9.2 Refusing a License – Your Rights If an applicant is refused a facility license by the relevant NHRA Committee, they may, within two months of the date of the decision, request in writing that the decision be reviewed. The CEO will request an appropriate person/group/panel to review the application and report to the Board. The Board will consider the review report and make a final decision on the application.

9.3 Incomplete Applications

Applicants should follow all instructions on the application form and ensure that they submit a business proposal and any supporting documentation in the requested format. A complete application should be submitted in order for the NHRA to consider the applicant’s eligibility for a facility license. The NHRA reserves the right to:

(a) return incomplete applications to the applicant at the correspondence address provided on their application; and/or (b) declare an application invalid if the applicant submits an incomplete application form and fails to provide any required information within a specified time period. In these circumstances, if the applicant wishes to re-apply, they must submit a new, complete application.

9.4 Fraudulent Applications/Documentation

The NHRA will revoke the license of any facility that was licensed but was subsequently found to have submitted fraudulent documentation or misrepresented the facility functions and scope of services.

10. ADDITIONAL DOCUMENTATION

Following the NHRA’ decision to grant Preliminary approval, the NHRA reserves the right to seek further information or documentation from the applicant or make any enquiry/ies with any person(s) or body/ies regarding the application for a full facility license. In certain circumstances, applicants are required to provide additional documentation. Examples of additional documentation that may be required by the NHRA are:

Local municipality approval, incl Water and Electricity Regulation approval, Civil defence approval and Roads approval.

Radiation compliance approval for lead shielding installations, if applicable. Engineering approval for all proposed medical devices and installations from NHRA

These are merely examples and not a comprehensive list of additional documentation that may be required. The NHRA also reserves the right to request an applicant to attend its offices where a personal interview is seen as appropriate to their application.

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NHRA APPLICATION PROCESS FOR HEALTHCARE FACILITY LICENSING

NH

RA

Ap

plic

ant

FINAL LICENSE APPROVAL PROCESSPRELIMINARY LICENSE APPROVAL PROCESS

Application Form, License proposal

and other requirements

Facility Licensing Department:

reviews documentscomplete

application

meets requirements

does not meet requirements

Acknowledgement +/- request for

complete application

Rejection letter (with reasons)

Preliminary approval letter

Licensing Committee

Full functional & technical specs and other requirements

Facility Licensing Department:

reviews documents

Acknowledgement +/- request for

further information

complete documentation

Rejection letter (with reasons)

Approval letter

does not meet requirements

meets requirements

Request for Interim inspection &

feedback

Request for final inspection

Facility Licensing Department:

conducts inspection

Licensing Committee

Licensing Committee

License Issued after satisfactory final

inspection

meets requirements

Letter detailing problems

does not meet requirements

Construction/development

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HEALTH CARE FACILITY REGULATION This section contains information about:

11. Inspection Request and Process 12. Facility Monitoring

11. STEP 3 and STEP 4 REQUEST FOR INSPECTION AND INSPECTION PROCESS

11.1 Healthcare facility licensure Inspectors shall inspect any new facility in two stages. The applicant

must submit a request for inspection when the facility is at a stage where external works have been completed and internal fit out has commenced. This provides an opportunity for any areas that do not comply to be addressed prior to the final inspection. See appendix 3.

11.2 The applicant must then submit a request for inspection when the facility has been 100%

completed and is ready for commissioning. See appendix 3 11.3 The facility licensure inspectors will inspect against the NHRA Minimum Design Standards and the

relevant operational standards developed for the type of facility. (See sections 13 and 14 for more details)

11.4 The NHRA inspectors will carry out a physical inspection of the building(s) and also inspect the

proposed operational and maintenance policies and processes. While performing the physical inspection, the NHRA inspectors shall verify in detail that all equipment commissioning and maintenance inspections have been carried out satisfactorily.

11.5 Pharmacy and Pharmaceutical Facility Inspection

The pharmacy and/or pharmaceutical facilities may consist of new or existing building(s) that shall be thoroughly inspected according to specific procedures that include but not limited to the following elements:

11.5.1 New Building(s): At the completion of the construction, the facility shall submit to NHRA a comprehensive Commissioning Report/ Statement of Completion, supported by all: 11.5.1.1 As-Built drawings and schedules, 11.5.1.2 Contractors and third party testing and commissioning reports, 11.5.1.3 Operation Procedures and Maintenance Manuals

11.5.2 Existing Building(s): At the completion of the renovation work, the facility submits to NHRA a comprehensive Commissioning Report/ Statement of Completion, supported by all: 11.5.2.1 Approved drawings and schedules, 11.5.2.2 Contractors and third party testing and commissioning reports, 11.5.2.3 Operation Procedures and Maintenance Manuals 11.5.2.4 Preventative maintenance management programs (PPMs) in place (including

inspections schedules, reports, checklists) While performing the physical inspection, the inspectors will verify in detail that all maintenance inspections have been carried out satisfactorily according to Proactive Preventative Maintenance (PPM) requirements.

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11.5.3 Inspection stages The inspection of a pharmacy and/or pharmaceutical facility consists of three stages: the desk top review of documents, the physical inspection, and the review of operational documentation where the inspectors shall: Stage 1 – carry out a “Desk Top” review of the Commissioning Report / Statement of Completion checking it against the originally reviewed / approved design drawings and documentation. Stage 2 – carry out a physical condition inspection of the building to determine the degree of conformity of the building with the approved final design, drawing and specifications and any authorized changes. Stage 3 Carry out the review of all operational and maintenance manuals/policies and proposed procedures.

12. FACILITY MONITORING

The NHRA plays a major role in ensuring quality of health care and assisting healthcare facilities to maintain agreed standards through a regulatory licensing and relicensing process. Central to the licensing and re-licensing processes are the facility licensure inspectors who have jurisdiction to enter any licensed healthcare facility at any time to inspect against the published licensing standards. It is the healthcare facility licensee’s responsibility to ensure that the facility is operating safely and is compliant with regulatory legislation and the NHRA licensing standards. An NHRA Inspectors handbook provides guidance to the NHRA Inspectors when conducting inspections of all health care facilities in Bahrain. It sets out the code of conduct expected from the NHRA Inspector, (see appendix 5) and the inspection process that should be followed regardless of the facility being inspected. A Guide on “What to expect when an Inspector Calls” has also been developed and published for Pharmacy and pharmaceutical facilities Licensees and this can be accessed through the NHRA website, www.nhra.bh.

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PHARMACY FACILITY STANDARDS This section contains information about:

13. Minimum Design Standards 14. Pharmacy Operational Standards

13. MINIMUM DESIGN STANDARDS

The size and type of services to be provided in the pharmacy and/or pharmaceutical facilities will depend upon the type of drug distribution system used, number of patients/public being served, and the extent of contracted services. These must all be described in the License Proposal and Operational Policies and Procedures of the facility. The facility must provide space and equipment for supplies, packaging, labelling, and storage, as well as for the dispensing. Health facilities should anticipate, address and manage operational requirements in the facility planning and design. These include:

Safety - Incorporate a safety focus into the design and planning process Emergency Management – Provide design layouts that support emergency preparedness Security – Address security risk mitigation through appropriate building design Infection Control – Facilities and fixtures must be included in design layouts of patient

care areas that helps prevent and control the spread of infection Risk Assessment –Identify risks which

impact on the patient care environment, and whose effect can be reduced or eliminated through appropriate design changes – other factors to be addressed include designs that minimise human stress, fatigue, distractions, interruptions, errors, etc.

Utilities Management – Infrastructures and engineering systems that provide for best practice in the management of utility services. This includes servicing of electric/water mains and any other equipment without major outages, and energy management systems

Medical Equipment Management – For fixed equipment assess , future installation and/or replacement requirements to be incorporated into the building and services design.

Building Facades – Designers must consider and incorporate into specifications the on going requirements for accessing the façade of buildings, including maintenance and window cleaning

13.1 In addition to all relevant standards required by local authorities and Bahrain legislation relating to

buildings and utilities, Specific pharmacy design considerations must include: Required through legislation: 13.1.1 The pharmacy and/or pharmaceutical facilities should ideally be a single self-contained

facility, which has its own entrance/exits. 13.1.2 The pharmacy and/or pharmaceutical facilities must be 250 meters or more from the

nearest pharmacy and /or pharmaceutical facility in the area 13.1.3 The pharmacy and/or pharmaceutical facility must show its name clearly in both English and

Arabic outside the facility.

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Required by NHRA licensing standards: 13.1.4 The pharmacy and/or pharmaceutical facilities should be divided into “accessible” and

“restricted” functional areas. RESTRICTED AREAS SHOULD INCLUDE:

clearly marked dispensing areas stock storage, assembly and dispatch areas preparation and/or manufacturing areas - non-sterile bulk store & de-cartoning/unpacking area secure storage for controlled drugs and CD recording documents refrigeration storage storage of flammable/poisonous goods drug information, education, counselling areas staff offices and amenities Access and clear passage for delivery of bulk supplies. Consideration needs to be given

to requirements for storage of large volumes of drugs/health products in the event of a major disaster.

13.1.5 The facility should have sufficient HVAC – Heating, Ventilation and Air Conditioning (HVAC)

that includes thermostatic control. There must be means to control temperature and humidity for drug storage. 13.1.5.1 Internal temperatures should be monitored and not rise above 25°C.

13.1.6 Waste Disposal: Consideration must be given to the safe collection of pharmaceutical waste. Pharmaceutical waste must be disposed of through a licensed and controlled waste facility and must not be disposed through a sewerage system.

13.1.7 The facility should have piped water services and hand washing facilities should be provided

in each room/space where products are handled.

13.1.8 The facility should have adequate electrical and lighting power supply and outlets and consideration must be given to emergency power supplies including emergency power generation.

13.1.9 The facility must have adequate fire protection and means to fight fire, should it be required.

13.1.10 The facility must have a backup power supply in case of power failure especially for

temperature sensitive drugs.

13.1.11 The bench/table top areas where drugs and medicines are handled /prepared should be non-absorbent and easy to clean.

Any proposed changes to the design during the renovation / construction which may change or contradict previous approvals by NHRA will require a revised submission to the NHRA for approval. Such changes should be submitted in sufficient time for approval before either of the required inspections are undertaken by NHRA Licensure Inspectors.

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14. PHARMACY AND PHARMACEUTICAL FACILITIES OPERATIONAL STANDARDS

The NHRA pharmacy and pharmaceutical facilities licensing standards are assembled around key services and functions which have been divided into separate elements that are considered important for licensure. Each element has an introduction which provides an explanation about the relevance and contribution to safety and high quality patient care. Each element has a statement and when required sub-standard elements are identified to clarify further requirements. Each element has identified Evidence of Compliance (EoC) to assist the licensees in addressing the standard. Elements 14.1 to 14.7 are applicable to all pharmacy and /or pharmaceutical facilities:

14.1 Governance, Management and Leadership 14.2 Human Resources 14.3 Patient and Family Rights 14.4 Quality and Safety 14.5 Management of Information and Pharmacy Records 14.6 Pharmacy Premises and Equipment 14.7 Medication Storage and Stock

Element 8 and 9 are additional to elements 1 to 7 and are applied to warehouse and storage facilities. These elements specifically address good storage and distribution practices and can be applied when drugs and medicines are stored and distributed within the Kingdom of Bahrain.

14.8 Warehouse Procurement and Storage 14.9 Warehouse Transportation

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14.1 Governance, Management and Leadership Introduction For any pharmacy and/or pharmaceutical facility, quality and patient safety depend on effective leadership and good organization. It is important for pharmaceutical facilities and all dispensing pharmacy facilities to have clearly stated objectives and a mission. It is the responsibility of the leadership of the facility to develop the objectives and mission and provide adequate resources to fulfil these. Pharmacies and pharmaceutical facilities in the Kingdom of Bahrain vary in size, type of ownership, and complexity of services. Each pharmacy and pharmaceutical facility regardless of its size and/or complexity of services should have an accountable body or person(s) that provides leadership and direction. A large pharmacy or chain of pharmacies may often have a governing body ultimately accountable for the operation and performance of their services. In smaller pharmacies, these responsibilities may be handled by just one or two individuals. This element addresses the roles and responsibilities of the leadership group that are responsible for the governance processes required, including:

• Development of a mission statement • Development of an organizational structure and accountability chart for all levels of

the organization • Development and promotion of professional ethical conduct • Formulation and construction of a strategic plan • Planning and designing services and structures which includes patient and stakeholder

engagement • Processes for collaboration, coordination, and communication internally and externally • Financial management

Governance, Management and Leadership - Minimum Criteria Governance elements 14.1.1 to 14.1.3 apply to all pharmaceutical facilities, pharmacies or chain of pharmacies that have a governing body in place:

14.1.1 The governing body responsibilities are defined in written documents such as bylaws, policies and procedures and reflect the legal responsibilities and accountability it has to the patients and public.

EoC: Governance responsibilities and accountabilities are described in documents. This should include responsibility for the quality of care provided and patients’ safety. 14.1.2 The governing body fosters communication and coordination between the pharmacy

facilities governance function and management within the pharmacy.

EoC: There is evidence of communication and coordination between the pharmacy governance function and management. The governance body approves the mission statement, scope of services, strategic and management plans implemented through the management and leadership function. 14.1.3 The governing body performs periodic evaluation on both its own effectiveness and that

of the leadership and management team, including review of plans, budgets, policies and procedures.

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EoC: There is evidence of periodic evaluation of the governing body effectiveness and that of the management and leadership function within the facility which includes plans, budget, policies and procedures. 14.1.4 The pharmacy leadership and management ensure that it complies with the laws and

Regulations in the Kingdom of Bahrain. EoC: The pharmacy has a current NHRA License and adheres to the current Kingdom of Bahrain laws. 14.1.5 The management structure is defined with a clear, current organizational and

accountability chart identifying name/s and line/s of authority and responsibility of those leading, including the governing board /person(s) where appropriate.

EoC: The management structure is defined, updated, and circulated throughout the pharmacy: It shows the names and titles of those responsible for management and leadership, clear lines of authority and accountability. 14.1.6 The pharmacy facility should have a clear mission statement which is regularly reviewed

and is communicated to all staff, patients and visitors. EoC: There is a written mission statement publicly posted within the pharmacy and staffs are aware of the mission statement. 14.1.7 The pharmacy should have a documented scope of services and practices provided. EoC: The pharmacy has an approved and documented scope of services and practices provided including the dispensing prescribed drugs, controlled drugs, OTC drugs, Advice and Education, counselling, provision of health foods services etc. 14.1.8 The pharmacy should have a strategy for providing the identified scope of services /

practices which includes the provision of adequate resources (manpower, consumables, and capital assets).

EoC: Adequate resources are available for the pharmacy to provide the approved scope of services, including adequate manpower, adequate consumables, adequate equipment and adequate contracted services where required. 14.1.9 A full-time person should be assigned to manage the pharmacy in accordance with

applicable laws and regulations. They should have a clear written job description covering all aspects of their role.

EoC: An appropriately qualified person is appointed and in post as the person who is held accountable for overall pharmacy management and there is evidence of his/her performance being managed.

14.1.10 The pharmacy fosters open and transparent communication and coordination between

its management and leaders and the staff. EoC: There is evidence of communication between management and staff through newsletters, meetings, training and education, notice boards, staff initiatives etc.

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14.1.11 The pharmacy promotes a top down and bottom up approach to performance

improvement, patient safety, and a risk management program by collating, regularly reviewing and acting upon reports and trends.

EoC: There are systems in place for collating performance improvement, patients’ safety and risk management statistics and information. There is evidence that this information is regular reported and reviewed including: • Performance improvement activity • Patient safety initiatives • Risk management activities • Trending reports and actions taken 14.1.12 The pharmacy owner/leaders are aware of the current and future demands for their

service within the community and plan services accordingly. Planning includes engaging with staff, patients and community.

EoC: There is evidence that the pharmacy owner/ leadership collaborate with community and other stakeholders including patients to plan services required within the community. 14.1.13 The pharmacy leaders use evidence and best practice information to develop and

improve services. EoC: The leaders while designing and improving services use and encourage staff to use evidence and best practice information. 14.1.14 The facility can provide annual reporting information regarding:

14.1.14.1 The range of services provided 14.1.14.2 The age groups of patients attending. 14.1.14.3 The number of patients seen annually. 14.1.14.4 Number of complaints received 14.1.14.5 Number of incidents occurred

EoC: Annual reporting information is available for elements 14.1.14.1 to 14.1.14.5 14.1.15 There is a written policy for controlling the development and maintenance of policies

and procedures for key functions and processes, Policy development should include: 14.1.15.1 A unique identification for each policy with title, number, and dates of

issue and updates. 14.1.15.2 Policies being developed, approved, revised, and terminated by

authorized individuals. 14.1.15.3 Policies being revised according to a defined revision due date that does

not exceed (2) years or when required. 14.1.15.4 All Policies are dated and current. 14.1.15.5 Policies being communicated to staff and training provided where

applicable. 14.1.15.6 Staff sign off on polices being implemented, ensuring staff understand

their role in implementation.

EoC: There is a policy on policies and procedures, how the policies are developed, approved, revised, tracked, communicated, monitored and terminated.

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There is staff understanding on the policy on policies and procedures 14.1.16 There is oversight regarding all external contracts for clinical or operational services,

ensuring the services to be provided are clearly identified and the services meet the applicable laws and regulations and are consistent with the standards required.

EoC: There is evidence of a contract oversight process which ensures that services to be provided are clearly identified and they are provided in a way that is consistent with the standards required for regulation and licensing. 14.1.17 The pharmacy management and leadership have basic knowledge of quality

management concepts which includes: 14.1.17.1 How to analyse data. 14.1.17.2 How to use an improvement cycle (e.g., PDSA or another model) to make

improvements. 14.1.17.3 How to work using work flow processes.

EoC: There is evidence of leadership involvement and educational programs on quality management concepts, data analysis, PDCA, RCA and team work.

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14.2 Human Resources Introduction All pharmacies must have qualified staff with the right amount and mix to meet its purpose. The roles and responsibilities of each staff must be clearly defined in a current job description. Staff must be oriented to the pharmacy facility, their department, and job. Their knowledge, skills, and abilities must be continually upgraded and their performance assessed regularly. An on-going education program must be in place. Additionally, when gaps in knowledge, skills, or abilities are identified the staff must receive appropriate training. A current, updated personnel file must exist for each employee and should contain all relevant personal details. Human Resources Standards - Minimum Criteria

14.2.1 The pharmacy facility maintains a personnel file for each employee, which is complete,

up to date and maintained in a confidential manner. EoC: There is a personnel file for each employee and there is a written policy which is implemented for maintaining confidentiality. 14.2.2 All new employees receive a comprehensive induction and orientation program which

includes but is not, limited to: 14.2.2.1 The pharmacy mission and organizational chart. 14.2.2.2 Staff role in disasters and emergencies. (i.e., Fire, evacuation) 14.2.2.3 General information about hazardous materials including Material Safety

Data Sheets (MSDS) 14.2.2.4 General information on standard infection control measures and sharps

disposal. 14.2.2.5 Electrical safety. 14.2.2.6 General information on communication: paging, telephone system,

bleeps, fax, filing, record keeping etc. 14.2.2.7 General information on staff performance evaluation processes. 14.2.2.8 The definition of Incidents, adverse events and near miss events along

with the process of reporting including Who should report, When to report, How to report, and to Whom the report is sent to.

14.2.2.9 Information on dealing with patient complaints 14.2.2.10 General information about the quality improvement and patient safety

processes of the pharmacy facility and the importance of involvement of every member of staff.

14.2.2.11 Information on the expected ethical conduct of the staff and the expected professional communication in his/her interactions with others.

14.2.2.12 Information on protection of patients’ rights, privacy and confidentiality. 14.2.2.13 All policies are provided and are signed that they have been read and

understood.

EoC: Attendance records show that all new employees attended a mandatory general orientation and are documented in each employees personnel file. The orientation includes points 14.2.2.1 to 14.2.2.13 and is documented and signed off in the individuals personnel file. 14.2.3 The pharmacy has a policy that addresses methods for dealing with staff complaints and

managing resolution of conflicts between staff.

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EoC: The pharmacy has a policy for handling staff complaints and staffs are aware of this policy. 14.2.4 All staff positions in the pharmacy have a clearly written job description that is reviewed

and revised at least every (3) years and as needed and: Is used when selecting employees for hire, internal promotions, and transfer. Outlines the necessary knowledge, skills, and attitude to perform the role. Is provided to every employee on hiring and is located in every employees

personnel file. EoC: There is a job description policy which ensures all job descriptions follow a described format that outlines the necessary knowledge, skills and attitude required to perform the role and is reviewed every three years. All staff has a copy of their job description. 14.2.5 Staff are educated and trained on the safe operation of equipment, including medical

devices, and there is a clear process to ensure that only trained and competent staff operates specialized equipment.

EoC: There is evidence of staff education on the safe operation of equipment together with tools to ensure competency of staff. 14.2.6 All staff members who have received training in basic cardiopulmonary resuscitation,

updated as required. EoC: The basic cardiopulmonary resuscitation training for staff members who have direct contact with the patient is valid and repeated every 2 years. 14.2.7 The pharmacy has processes in place to address the health and safety of staff: based on

assessment, and where necessary, reduction of occupational health and safety risks. The facility has an employee health program which includes, but is not limited to: 14.2.7.1 Pre-employment medical evaluation of new employees including

preventative immunizations. 14.2.7.2 Measures to reduce occupational exposures and hazards, including use

of protective equipment and clothing, stress management, and ergonomic positioning.

14.2.7.3 Staff education on the risks within the environment as well as on their specific job-related hazards, e.g., lifting techniques, using equipment safely, and detecting, assessing, and reporting risks. Management and documentation of staff incidents, e.g., injuries or illnesses, taking corrective actions, setting measures in place to prevent recurrences.

EoC: The facility has policies which address points 14.2.7.1 to 14.2.7.3 in the standard. All issues related to staff medical fitness and wellness are documented in their personnel file. 14.2.8 The facility ensures that all healthcare professionals (, full time, part time, locum,

etc.).are licensed with the Kingdom of Bahrain NHRA, and maintains a register of the current professional licenses.

EoC: There is evidence that all professional staff are currently licensed to work in the Kingdom of Bahrain.

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14.3 Patient and Family Rights Introduction Every client/customer/patient is unique with his/her own needs, values and spiritual beliefs. In alignment with these issues, the pharmacy facility is responsible for ensuring that patient and family rights are defined and respected within the facility. There is a need to establish confidence, trust and clear communication with clients and to understand and protect each person’s cultural, psychosocial and spiritual beliefs.

Patient and Family Rights – Minimum Criteria

14.3.1 The pharmacy facility supports and protects patient and family rights by: 14.3.1.1 Developing and maintaining a Patient Rights and Responsibilities

statement and policy to outline and support patient rights. These should include aspects such as. Treating patient with respect and dignity at all times. Respecting patients’ cultural, psychosocial, spiritual and personal values and beliefs. Providing all the information regarding the identity and the professional status of his/her pharmacist. Respecting the patients’ need for privacy Ensuring complete patient confidentiality by never discussing the patient in public, never revealing the patient name or any information about them, and not publicizing any information. Not neglecting patients’ demands and/or needs, and respecting their right to complain. Allowing patients to submit verbal or written complaints or proposals with no effect on the quality of care provided. Protecting patients from verbal abuse from any member of staff.

14.3.1.2 Ensuring patients are informed about their rights and responsibilities in a manner they can understand

14.3.1.3 Clarifying and helping resolve issues that involve patient’s rights. 14.3.1.4 Making patient rights and responsibilities available to patients and

families. 14.3.1.5 Providing staff training and education on patient and family rights and

responsibilities.

EoC: There is a written patient’s rights and responsibility statement and policy that include identified areas. Staff and patients are aware of the statement and policy in place. There is evidence of patients’ rights being discussed at senior management level and staff receives training on this area. 14.3.2 An administrative policy is developed and implemented regarding everyone’s roles and

responsibilities in supporting patient and family rights. EoC: There is an administrative policy that outlines staff roles and responsibilities in implementing patient and family rights. 14.3.3 The facility offers equal treatment to patients and they know the estimated cost of any

drugs / treatment in advance.

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EoC: There are standardised processes for patient care and treatments. Cost of drugs / treatment is published and displayed for all patients. 14.3.4 The facility assists disabled patients by offering the necessary assistance to patients with

special needs where needed (e.g. identified parking spaces near the entrance) EoC: The facility is friendly for disabled and elderly patients (e.g. parking spaces near the entrance, ramps where necessary) 14.3.5 The pharmacy facility has an effective structure to handle complaints and can show

satisfactory resolution for the complainant. EoC: There is a designated person within the facility who is responsible for complaint management. There is a complaint management policy that is implemented and there is oversight of the patient complaint process and outcomes. 14.3.6 All complaints are trended, aggregated and analysed on a quarterly basis and a summary

report is presented to the management and leaders in the facility for discussion and action as appropriate.

EoC: There are trended reports concerning complaints which allow the facility to identify problem areas for improvement. 14.3.7 The facility has a system including policy, forms and process to conduct on-going

satisfaction surveys and makes improvements based on the trended survey results. EoC: There is a policy and form for on-going satisfaction survey which is trended and provides reports for improvement actions to be taken. 14.3.8 The facility adopts an ethical approach to advertising and marketing, honestly portraying

its services to patients. The facility must uphold Bahraini law regarding the advertisement of prescription only medication.

EoC: The facility has a code of ethics and markets its services honestly. It upholds Bahraini law and does not advertise or promote prescription only medication.

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14.4 Quality Management and Safety Introduction A pharmacy should operate a structured drug and error handling system which ensures that when an adverse event occurs, the safety of the patient is the primary focus and learning from the incident occurs to prevent or reduce the risk of re-occurrence. It should have a policy, which requires evaluation and on-going amendment, of administration and dispensing systems to prevent and/or minimise the risk of error in the management and supply of medicines and information. Any adverse incident occurring in a pharmacy should be dealt with promptly, efficiently and professionally and should always ensure that the welfare and safety of the patient is the primary focus. The pharmacy policy should accept that errors will occur, and should foster conditions which allow assessment and management of the interaction of processes, facilities, staff and error-inducing conditions. This policy should aim to reduce the probability of an error occurring, and minimise potential consequences. An incident reporting system should be used to address ‘near miss’ incidents and allow learning from these incidents. This should provide a mechanism to identify and anticipate probable future issues and allow for the institution of appropriate preventative action.

Quality Management and Patient Safety - Minimum Criteria

14.4.1 There is a person identified who coordinates and leads quality concepts and principles within the pharmacy facility. EoC: There is a named person within the pharmacy who coordinates and leads quality concepts and principles. 14.4.2 The pharmacy facility develops and implements a quality improvement and risk

management plan that is systematic, continuous, facility-wide, supports innovation, and covers all aspects of performance. The plan should include, but is not limited to, the following: 14.4.2.1 Scope and objectives of the plan. 14.4.2.2 Staff responsible for the plan. 14.4.2.3 A systematic process to identify and analyse potential risks for severity

and likelihood of occurrence. 14.4.2.4 Development of interventions to manage potential

risks/hazards/incidents (e.g., reduction, prevention). 14.4.2.5 Documentation of risk management and quality improvement activities. 14.4.2.6 Staff education on their roles and responsibilities related to the plans. 14.4.2.7 Describing the criteria used for selection of indicators, collection of data,

data analysis, and implementation and evaluation of improvements. 14.4.2.8 Identifying monitoring indicators (including temperature controls, expiry

date checking, controlled drug usage, adverse reactions, counterfeit drugs etc. 14.4.2.9 Regular review of the plans to ensure that the plans are effective:

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EoC: There is evidence that the pharmacy staff use a planned approach to identify, analyse potential risk/near miss processes and implement interventions to eliminate or minimise the potential risks. 14.4.3 Quality Improvement is considered in staff meetings, either as a standalone concept or

within the team meetings. EoC: There is evidence that the staff participates in quality improvement discussions and implements actions identified from discussions. There should be minutes available for inspection. 14.4.4 The pharmacy facility has an incident (occurrence/variance/accident) reporting system

(policy and form) that staff follows and use when reporting errors, adverse events and near misses. 14.4.4.1 Reportable incidents, errors and near misses are identified. 14.4.4.2 An identified staff member is responsible for managing the incident

reporting system. 14.4.4.3 All Errors / incidents / near misses are reported, investigated and

addressed promptly, efficiently and professionally. 14.4.4.4 Immediate actions are taken as well as identifying learning outcomes for

action to prevent recurrence. 14.4.4.5 Patients are informed when involved in incidents with documentation

errors etc. 14.4.4.6 Incidents are monitored over time and trended information is used for

improvements. 14.4.4.7 All staff are educated on the incident reporting system used within the

facility. EoC: The pharmacy facility has a policy, forms, and process in place for reporting incidents and near misses. Aggregated incident reports can be produced to show trending of incidents and near misses. 14.4.5 The pharmacy facility adopts a checking process for all medications being dispensed and

a process that requires a qualified pharmacist and preferably one other to check whenever dispensing controlled medications.

EoC: The pharmacy facility has a policy for ensuring prescriptions are double checked before dispensing and that a qualified pharmacist and preferably one other check whenever dispensing controlled medications. 14.4.6 The pharmacy facility has a process for the safe storage and handling of all medications,

medicated creams, IV fluids and other medicinal preparations. EoC: There is a policy and process for the safe storage and handling of all medications, medicated creams, IV fluids and other medicinal preparations. 14.4.7 The pharmacy facility develops and implements a set of indicators that are collected and

aggregated on a regular basis and are used for quality improvement as well as strategic and operational planning. These may include:

Staff satisfaction. Customer satisfaction.

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Adverse effects / reactions Near miss events. Patient complaints. Medication errors.

EoC: Quality indicators as suggested are identified and set by the leaders in the facility. These indicators are monitored and reviewed to inform quality improvement activity.

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14.5 Management of Information and Pharmacy Records Introduction - Management of Information A pharmacy must recognise the importance of data management and provide for the associated responsibilities. Suitable procedures must be provided that make due provision for the safe management of personal patient information, and allow for records to be maintained that are compliant and satisfy all legal and ethical responsibilities. One of the most valuable resources for any facility is information. Accurate information is necessary to support decision making. Information that is trended over time can be evaluated to see if any improvements need to be made or to evaluate the effectiveness of an improvement that has been done. The ambulatory care facility should have a process to meet the information needs of its clinical and managerial leaders and to compare its performance with other databases when relevant. Among the main requirements of this function are: • Information needs assessment • Information planning • Data collection and analysis • Information flow and reporting requirements • Security, integrity, and confidentiality Introduction - Pharmacy Records Pharmacy Records are considered one of the important elements in a quality program. The quality of all records is essential. To ensure appropriate management of pharmacy records, the facility should have processes for recording ordering/ delivery of medications, expiry date recording, dispensing records, error and incident management records, controlled drugs records.

Management of Information- minimum standards

14.5.1 The pharmacy facility develops and implements information management policy and processes to meet the information needs for those who manage the facility and adheres to all legislative requirements, this should include:

14.5.1.1 A definition of data, information, security, confidentiality and integrity. 14.5.1.2 A categorization of data available (both manual and electronic) 14.5.1.3 A description of how confidentiality, security, and integrity of the data

and information will be maintained. 14.5.1.4 A description of the various kinds of reports, the frequency of the

reports, and who will receive them. 14.5.1.5 An educational/training schedule for decision makers and other

appropriate staff on the principles of data management for decision-making. 14.5.1.6 A description of the roles and responsibilities of the leadership and

department heads in relation to implementation and evaluation. EoC: There are comprehensive information management processes developed by the leadership including 14.5.1.1 to 14.5.1.6

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14.5.2 The pharmacy facility should determine the roles and responsibilities for data entry (completion of forms), data collection, data analysis, and reports generation and this includes: 14.5.2.1 Data elements being defined and forms developed for designated staff

to enter the necessary data. 14.5.2.2 Establishing time frames for collecting data. 14.5.2.3 Displaying and analysing data 14.5.2.4 The leadership deciding reporting requirements and ensuring they are

implemented. E.g. controlled drug usage, adverse reaction reports, and near miss/incident reports.

EoC: There is policy and process for all data recording and management; this includes data elements being defined and process for collation being defined. 14.5.3 The pharmacy facility contributes to external databases in accordance with Bahraini laws

and regulations. EoC: There is contribution to external databases in accordance with Bahraini laws and regulations. 14.5.4 When there is automation of data, there is a planned, documented recovery system in

proposal of computer malfunction to include system linked and standalone computers. EoC: There is documented recovery system for automated data on all computers. 14.5.5 The pharmacy has a process in place that facilitates controlled access to pharmacy

records and confidential information. this should also include a secure method for disposing of obsolete confidential information

EoC: Files and pharmacy records are stored in a secure locked area with access to authorised individuals only.

Element 5 - Pharmacy Record Standards 14.5.6 There is a process in place for recording the following information for every prescription

dispensed. E.g. in a daily prescription/audit book: 14.5.6.1 The date of supply 14.5.6.2 The name, quantity, form and strength of the product supplied 14.5.6.3 Name of prescriber and where the prescriber is not known to the

pharmacist, his/her address. 14.5.6.4 The name, CPR and address of the patient 14.5.6.5 The date of prescription 14.5.6.6 Date of supply and reference number of original entry when repeat

prescriptions is being dispensed 14.5.6.7 The name and address of the pharmacy and reference number if the

prescription is dispensed form another pharmacy EoC: there is evidence that the pharmacist records the information required for dispensing which includes 14.5.6.1 to 14.5.6.7

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14.5.7 The pharmacy has an appropriate filing system used for all prescriptions dispensed at the facility. The process /system should 14.5.7.1 Facilitate prompt retrieval of each and every prescription dispensed and

retained at the pharmacy 14.5.7.2 Provide a system for filing repeat prescriptions that are retrievable when

subsequent dispensing occurs 14.5.7.3 Facilitate a mechanism for reviewing repeat prescription files for regular

removal and updating to minimise the risk of inappropriate prescribing and dispensing.

EoC: There is evidence that the pharmacy has an appropriate filing system that facilitates easy retrieval and checking of any/all prescriptions dispensed in the pharmacy. 14.5.8 All dispensed controlled drug prescriptions should be retained for five years after the

date of dispensing and all other dispensed prescriptions should be maintained for two years after the date of dispensing, in accordance with Bahraini law.

EoC: there is evidence of all prescriptions being retained in an orderly and secure way that is accordance with the requirements in Bahraini law. 14.5.9 All prescriptions should be annotated and/or endorsed at time of dispensing EoC: All prescriptions are annotated /endorsed as being dispensed at the time of dispensing. 14.5.10 The Controlled Drugs register should be maintained in the form of a bound book with

one preparation per page and in accordance with relevant legislation. It should be 14.5.10.1 Up to date and accurately reflect the content of the controlled drugs

cupboard 14.5.10.2 Legible, with all entries clear and written correctly 14.5.10.3 Retained on the pharmacy premises for two years after the date of the

last entry. EoC: There is evidence that a controlled Drugs book is used, maintained and has the correct balance/ running total for each controlled drug being held in stock. 14.5.11 Prescription labels should be clear and legible and contain:

14.5.11.1 Date of dispensing 14.5.11.2 The name of the patient 14.5.11.3 The name and address of the pharmacy who supplied the preparation 14.5.11.4 The proprietary name of the preparation or the generic name with the

name of the producer. 14.5.11.5 Directions for use and any precautions specified on the prescription 14.5.11.6 Any required cautionary or warning notices relating to the preparation 14.5.11.7 The words “keep out of reach of children” 14.5.11.8 If for external use only, the words “for external use only”

EoC: The prescription labels are clear and legible and contain the information required in 14.5.11.1 to 14.5.11.8

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14.5.12 The pharmacy should have recorded systems and processes for recording 14.5.12.1 Non compliance 14.5.12.2 Side effects/adverse reactions/interactions 14.5.12.3 Drug regime changes

EoC: there is evidence that the pharmacy has processes and systems which facilitate recording and trending of 14.5.12.1 to 14.5.12.3.

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14.6 Pharmacy Premises and Equipment Introduction All aspects of the pharmacy premises should be well maintained; the premises should enable and facilitate a safe and effective working environment. The patient is entitled to expect that any part of the premises from which professional services are provided is readily identifiable and maintained. The professional dispensing activity of the pharmacist is inherently dependent on the environment in which the core activities of the pharmacy occur. The dispensary should be of sufficient size for the safe and proper storage, handling, compounding and preparation of prescription medicines. All equipment should be located, adapted and maintained to suit the professional operations carried out in the pharmacy environment. The suitability, accessibility, maintenance and cleaning of equipment should be ensured to prevent any adverse impact on the quality of pharmaceutical products processed therein.

Pharmacy Premises – Minimum Criteria

14.6.1 The Pharmacy should be separate from other retail facilities and should be out with the recommended distance stated in Bahraini Law. EoC: The pharmacy facility should have its own entrance and should be out with the recommended distance between pharmacy facilities as stated in Bahraini law. 14.6.2 All aspects of the pharmacy should be well maintained and facilitate a safe working

environment, with the professional services area identifiable to the patient, which include but limited to: 14.6.2.1 Suitable wall, floor and ceiling coverings. 14.6.2.2 Security system in place 14.6.2.3 Areas for authorised personnel only 14.6.2.4 Routine maintenance schedules adhered to. 14.6.2.5 Fire alarm and exits maintained 14.6.2.6 No smoking environment

EoC: There is evidence that the facilities are maintained to facilitate a safe working environment that includes as a minimum 14.6.2.1 to 14.6.2.6. The dispensary area/professional services area is easily identifiable for the customer. 14.6.3 Staff changing, rest room, toilet and hand-wash facilities should be provided and should

not open directly into the dispensary. All staff should use these facilities to : 14.6.3.1 Eat or drink away from the dispensing area, 14.6.3.2 Wash their hands, A ‘Wash your hands’ notice should be displayed.

EoC: There is evidence that staff have changing, rest, toilet and hand washing facilities. Staff has an area that they can eat or drink away from the dispensing area and use hand washing facilities when required. 14.6.4 The pharmacy should be maintained in a clean and good working condition. Appropriate cleaning schedules should be detailed and recorded. Adequate heating, lighting, ventilation and air conditioning should be provided and maintained.

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EoC: There is evidence that the pharmacy is cleaned and maintained regularly. There are cleaning schedules available for inspection. There is evidence that adequate heating, lighting, ventilation and air conditioning is provided and maintenance schedules are available for inspection. 13.6.5 Temperature and humidity conditions should be controlled and monitored with due regard to the requirements to store medicinal products within certain specified temperature parameters. EoC: There are temperature and humidity recording carried out on an on-going basis and past/present recordings are available for inspection. There is evidence that drugs are maintained in the environment required as per manufacturer’s instructions. 13.6.6 All signage on windows and doors should be kept to a minimum in accordance with relevant security guidance. Notices relating to opening hours, duty rotations, after hours’ service, prices etc. should be factual and available for the public to see. EoC: there is evidence of signage being kept to a minimum in the window. All notices are factual and are made available to the public. 13.6.7 The facility license and professional registration certificate of the supervising pharmacist responsible for the professional activity of the pharmacy should be on public display. EoC: The facility license and the registration of the pharmacist in charge is on display. 13.6.8 Medicine sales counters should not be cluttered. All pharmacy medicines should be located behind the counter so that the pharmacist is able to intervene personally in the supply of a medicinal product. The pharmacy should site hazardous products out of the reach of children. EoC: All prescription medicines or those medicines that can be used to cause harm or abuse are kept behind the dispensing counter where the pharmacist can control the dispensing. All hazardous products are kept out of reach of children. 14.6.9 The pharmacy should provide a patient services area in which counselling can take place. EoC: There is evidence of a quiet area available for the pharmacist to offer counselling services to the patient if required. 14.6.10 The physical environment and layout of the dispensary must be robust, hygienic and provide for the safe delivery of patient care and should:

14.6.10.1 Be a sufficient size to allow effective workflow and take account of practice-specific variables such as staffing, work-flow and prescription volume.

14.6.10.2 have adequate means of storage and waste disposal. 14.6.10.3 Have a lockable drug cabinet for safe storage of controlled drugs. The

keys should be kept solely by the pharmacist in charge. 14.6.10.4 Have a refrigerator that is cleaned and maintained regularly and

temperature records maintained daily at intervals. 14.6.10.5 Have an approved fire extinguisher present, that staff are trained to use

EoC: The dispensary area meets the minimum requirements 14.6.10.1 to 14.6.10.5

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14.6.11 The pharmacy facility should have appropriate and adequate dispensing equipment to

carry out the operations of the pharmacy, which is adequately stored and maintained. This should include 14.6.11.1 Dispensing, measuring, weighing, recording and control equipment. 14.6.11.2 Adequate Labelling equipment, using electronic or mechanical printer

systems. 14.6.11.3 A suitable means of counting tablets accurately. 14.6.11.4 All equipment should be regularly serviced, checked and calibrated,

records maintained for inspection. 14.6.11.5 Dispensary equipment should be for the sole purpose of preparing and

dispensing medicines. 14.6.11.6 A sink/wet area used for dispensing purposes only

EoC: There is equipment available in the dispensary as described in 14.6.11.1 to 14.6.11.6 14.6.12 Pharmacy areas should have adequate drug information resources including but not

limited to:

14.6.12.1 Kingdom of Bahrain National Formulary.

14.6.12.2 Middle East Medical Index.

14.6.12.3 Posting and making available telephone number for the nearest

poison control centre.

EoC: There are adequate drug information resources. Telephone number for the nearest

poison control centre is posted.

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14.7 Medication Storage and Stock Introduction A pharmacy practice should operate a comprehensive, auditable system for the control and maintenance of an appropriate level of legitimate stock which is held within prescribed storage conditions and facilities. Stock must be sourced from a licensed supplier to ensure that the requirements of safety, quality and efficacy are upheld and the risk of counterfeit stock entering the supply chain is eliminated. Appropriate controls must be exercised internally to ensure appropriate receipt of goods and an appropriate accountability chain within each pharmacy. Stock must be stored in appropriate and auditable environmental conditions. Appropriate conditions of light, humidity, ventilation, temperature and security should be ensured. All medicinal products must be stored in accordance with the manufacturer’s directions and within the terms of product authorisations. There should be appropriate classification and retrievability of stock to ensure safe and efficient practice.

Medication Storage and Stock - Minimum Criteria Standards 14.7.1 Appropriate control and operational policies and procedures should be in place to

ensure the control, accessibility, receipt, storage and maintenance of stock. This should include: 14.7.1.1 Maintenance of cold chain and temperature mapping 14.7.1.2 Procedures when cold chain fails 14.7.1.3 Expiry date checking and follow up procedures 14.7.1.4 Ordering and Receiving medications and checking procedures

EoC: There is evidence of policies and procedures that are in place and implemented to ensure appropriate controls are adhered to. Including 14.7.1.1. to 14.7.1.4

14.7.2 Stock must be sourced from a licensed supplier to ensure that the requirements of

safety, quality and efficacy are upheld and the risk of counterfeit stock entering the supply chain is eliminated.

EoC: There is evidence that medication stock is sourced from licensed supplier through appropriate invoicing and receipts. Wholesale suppliers’ license is available on request. 14.7.3 Appropriate controls must be exercised internally to ensure appropriate receipt of goods

and an appropriate accountability chain within each pharmacy. These controls should include written policies and procedures for 14.7.3.1 All medicines being retained in their original manufacturers packaging 14.7.3.2 Any damaged products received should be quarantined and returned to

supplier 14.7.3.3 All drugs should have batch number and expiry dates recorded and a

documented procedure in place for systematically checking expiry dates 14.7.3.4 Medicines must not be removed from blister or foil packs 14.7.3.5 Care should be taken when different medications are stored in similar

packaging 14.7.3.6 All disposal of medications should be carried out in a manner consistent

with the legal requirements 14.7.3.7 Any patient returned medications should not be re-dispensed and

should be disposed of as soon as possible.

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14.7.3.8 A medicine and product recall procedure should be developed, documented and regularly reviewed to ensure efficient response to recall notifications.

EoC: there are written policies and procedures that are adhered to and implemented to ensure the proper receipt of medications and the accountability chain is maintained. Elements 14.7.3.1 to 14.7.3.8 are included. 14.7.4 Stock must be stored in appropriate and auditable environmental conditions.

Appropriate conditions of light, humidity, ventilation, temperature and security should be ensured. All medicinal products must be stored in accordance with the manufacturer’s directions and within the terms of product authorisation

14.7.4.1 Environmental conditions, (temperature, humidity etc.), in the pharmacy

should be monitored and recorded twice daily using regularly calibrated equipment.

14.7.4.2 Medicines should not be stored in close proximity of where food and drink is stored, prepared or eaten.

14.7.4.3 Hazardous substances, including poisons should be kept separate from the main pharmacy stocks.

EoC: All medications should be stored in accordance with their manufacturer’s instructions. There is evidence that environmental conditions are monitored on a daily and twice daily basis. Segregated areas are identified and 14.7.4.1 to 14.7.4.3 are considered. 14.7.5 There should be appropriate classification and retrievability of stock to ensure safe and

efficient practice. EoC: there is a written policy and procedure to ensure appropriate classification and retrievability of stock is implemented. 14.7.6 When a delivery is received by the pharmacy, the invoice and/or delivery note should be

examined for the presence of: 14.7.6.1 Controlled drugs that need to be checked and removed immediately to

the controlled drug cupboard 14.7.6.2 Any medications that require refrigeration. They must be checked and

immediately taken to the refrigerator. EoC: There is a policy and procedure for the delivery of medications that is implemented to ensure that the integrity of the medication is not compromised on during transport and arrival at the pharmacy. 14.7.7 Careful consideration is given to all OTC drugs, where there is potential for misuse, such

as preparations including codeine, cough suppressants, slimming products, laxatives and paracetamol. These should be stored behind the counter.

EoC: All drugs with a potential for misuse are stored behind the counter. 14.7.8 All pharmacy waste should be handled and disposed of in a safe and effective manner

that complies with the relevant legislation on this issue.

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EoC: There is a contract in place with the medical waste contractor and there is evidence that medical waste is disposed of in a safe and effective manner. There is a written procedure which is implemented for the disposal/destruction of controlled drugs and other medicines.

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14.8 Warehouse Procurement and Storage Introduction Patients are entitled to expect that medicines and health products sold from a Pharmacy and pharmaceutical facilities are fit for their intended purpose. Control of storage temperatures is essential in maintaining the quality of medicines and to protect patients from ineffective products that may result from inadequate control. Pharmaceutical wholesale warehouse procurement and distributors are obliged to exercise control over the distribution chain to ensure that the quality of medicines is maintained up to delivery to the pharmacy. Critical in this regard is control of the environmental conditions under which medicines are stored and transported. This standard focuses on the issues relating to the storage and distribution of pharmaceutical products.

14.8.1 All pharmaceutical products in the warehouse are licensed for use and distribution in the

Kingdom of Bahrain EoC: There is evidence that all pharmaceutical products stocked in the warehouse are licensed for use in Bahrain

14.8.2 The warehouse distribution centre must be licensed to operate in the Kingdom of

Bahrain through the NHRA. EoC: The warehouse distribution Centre has valid NHRA license to operate.

14.8.3 Stock must be sourced from a licensed manufacturer to ensure that the requirements of safety, quality and efficacy are upheld and the risk of counterfeit stock entering the supply chain is eliminated.

EoC: There is evidence that medication stock is sourced from licensed manufacturer through appropriate invoicing and receipts. Manufacturers and wholesale suppliers’ licenses are available on request.

14.8.4 There should be evidence that the warehouse and distribution practices are in accordance with the Ministry of Health vaccine quality guidelines, where shipment, storage and transportation requirements are identified. EoC: There is evidence that the warehouse adheres to the MoH guidance on the shipment, storage and transportation of all vaccines

14.8.5 Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities. The system for managing quality should encompass as a minimum: 14.8.5.1 The organizational structure, procedures, processes and resources, as

well as activities necessary to ensure confidence that the product is delivered safely. Examples of which are: 14.8.5.1.1 Expiry date checking and follow up procedures 14.8.5.1.2 Ordering and Receiving medications and checking procedures 14.8.5.1.3 A program of calibration of temperature measuring devices,

particularly in cold chain storage areas.

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14.8.5.1.4 Procedures for monitoring all storage facilities and areas 14.8.5.1.5 temperature mapping of storage area and vehicles 14.8.5.1.6 procedures when cold chain fails 14.8.5.1.7 transport arrangements are validated and monitored 14.8.5.1.8 there is a comprehensive staff training program including drivers 14.8.5.1.9 there is a technical agreement with couriers 14.8.5.1.10 there is a periodic audit and review of quality assurance activities

EoC: There is evidence of policies and procedures that are in place and implemented to ensure appropriate controls are adhered to. Including 14.8.5.1.1 to 14.8.1.1.10 14.8.6 Additional control and operational policies and procedures should be in place to ensure

the control, accessibility, receipt, storage and maintenance of high risk stock, particular some cold chain products, such as: 14.8.6.1 vaccines, insulin, biotech products and those derived from blood or

plasma, which are classified as high risk because they are at risk from freezing as well as from elevated temperatures.

14.8.6.2 chloramphenicol eye drops and fatty-based suppositories are chemically unstable at elevated temperatures so they need to be maintained between 2 and 8°C temperature

EoC: There is evidence of policies and procedures that are in place and implemented to ensure appropriate controls are adhered to for high risk products as identified in 14.8.2.1. to 14.8.1.2

14.8.7 Returned cold chain products cannot be considered for resale and must be immediately

stored in a dedicated and marked area awaiting disposal. EoC: there is evidence to show that a process is in place and implemented for the returned cold chain products that must not be submitted for resale and must return to the manufacturer.

14.8.8 Standard domestic refrigerators are not suitable for storing cold chain products. A purpose-built pharmaceutical refrigerator is recommended for the storage of cold chain products, and must 14.8.8.1 not be sited in an environment where elevated temperatures will affect

their performance. 14.8.8.2 Be monitored using a calibrated electronic min/max thermometer, with

an accuracy of ±0.5C, which can be read without opening the refrigerator door. 14.8.8.3 Have a temperature alarm fitted EoC: there is a pharmaceutical fridge in use in the warehouse which complies with 14.8.8.1 to 14.8.8.3

14.8.9 The warehouse should be temperature mapped every 2 to 3 years to determine the temperature distribution under extremes of external temperature. Medicines should not be stored in areas shown by temperature mapping to be unsuitable, e.g., at high level in poorly insulated stores.

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EoC: There is evidence that the warehouse is temperature mapped every 2 to 3 years or following any major changes in the layout or storage solutions.

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14.9 Warehouse Transportation Introduction Following dispatch from a manufacturing facility, the distribution chain for medicinal products can be

complex, potentially involving a number of storage locations, wholesalers and modes of transport,

before the product finally reaches the pharmacy. The transportation arrangements should be regarded

as an extension of the storage activities and distributors are expected to treat each journey as unique

with its length and complexity, as well as any temperature and humidity variations, being considered

when choosing the packing method and mode of distribution.

14.9.1 Products should be packed in such a way as to ensure that the required temperatures are maintained throughout the journey and the medicines are transported in accordance with their manufacturers and labeling requirements to prevent jeopardizing their quality. EoC: There is evidence that product packaging is robust and products are transported according to the manufacturer’s instructions.

14.9.2 Temperature and humidity records, either of the vehicle or the actual product, through temperature and humidity loggers, must be available. The temperature and humidity records for each consignment should be reviewed and there should be a procedure for implementing corrective action in the proposal of adverse events.

EoC: Temperature and humidity records are being maintained and available when each consignment of products are transported in vehicles across Bahrain.

14.9.3 Products are inspected before and after transportation to assure quality is maintained.

EoC: Records are maintained and available for inspection of all products damaged

during transportation.

14.9.4 All temperature and humidity recording devices should be calibrated annually against a

certificated standard.

EoC: There is evidence that the temperature and humidity recording devices are

calibrated and tested annually

14.9.5 Distributors should also ensure that consignments of refrigerated goods are clearly labeled with the required storage and transport conditions to be maintained. EoC: There is evidence that all consignments requiring refrigerated transport are clearly labeled

14.9.6 When wholesalers employ couriers, they must have a technical agreement with their chosen courier in order to ensure that the courier also adheres to the above.

EoC: There is evidence of a technical agreement/contract with the chosen courier.

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INFORMATION FOR LICENSED PHARMACIES AND PHARMACEUTICAL FACILITIES This section contains information about:

15. Facility Licensure and Registration 16. Obligation to notify the NHRA of changes in contact or other details 17. Renewal Process

15. FACILITY LICENSURE AND REGISTRATION

On being granted a license to operate, the license holder will be issued with a Certificate of Licensure which is valid for three years. The Certificate of Licensure will display the following information about the licensee: • License number; • Date of registration; • Category of License/type of facility; • Full name and title of owner; • Branch Name (if appropriate); • “Conditions Attached”, if there are any conditions imposed on the license; • Address of the Facility; • Expiry date. This Certificate of Licensure must be displayed within the healthcare facility at all times.

The following information will be retained on the NHRA database and Register: • type of facility, & Specialty; • license number; • registration number; • owners name; • owners CPR, or CR. No; • contacts details for the owner; • address of the facility; • Manpower list - CPR- Job titles; • Facility Structure – e.g. storage rooms, dispensaries, consultation rooms, compounding room etc.

16. OBLIGATION TO NOTIFY THE NHRA OF CHANGES IN CONTACT OR OTHER DETAILS

Legal Obligation on the Pharmacy and/or pharmaceutical facilities Licensee Licensees are legally obliged to inform the NHRA of any change in the details entered in the Register, e.g. change of address, change of ownership, change to person in charge, changes to the scope of services, temporary closure etc. To notify the NHRA of any of these changes, the licensee must complete the appropriate sections of the application form. (see appendix 1)

Change of Registered Name Facility licensees may at any time apply to change their registered name, address or any other details. Where a licensee wishes to change their registered name, they should submit a request in writing supported by approval obtained from the Ministry of Industry and Commerce, quoting their current registered name, license number and their MOIC commercial registration number.

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17. LICENSE RENEWAL PROCESS At any time, a pharmacy and/or pharmaceutical facilities license may only be granted for a maximum of three calendar years. To have the registration renewed, all licensees must pay the appropriate fee and complete the renewal process specified by the NHRA. A renewal notice is normally sent to the facility licensee one month before expiry of their license. Failure to pay the renewal fee on time may incur a late payment penalty. Pharmaceutical facilities regulated by the NHRA that fail to renew their license must not operate in the Kingdom of Bahrain when their license has expired, and until their license has been renewed. At the time of renewal, licensees will be required to check and update their registration details and inform the NHRA of any material matter which would be likely to affect the continuation of their registration. The licensee is obliged to provide any relevant information to the NHRA and the NHRA may correct the register, where necessary.

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NON COMPLIANCE AND SANCTIONS This section contains information about:

18. The Principles of Non Compliance 19. NHRA Non Compliance levels 20. Restoring a license following removal

18 THE PRINCIPLES OF NON COMPLIANCE The NHRA’s overarching concern and priority is to protect and promote the health, safety and welfare of people who use the healthcare services that we regulate, and to improve the quality of care they receive. Owners and licensees of licensed health care facilities have a duty to make sure that the regulated activities they are responsible for are carried out and managed in a way that complies with legislation and our standards. To facilitate shared responsibility and an open and transparent approach to regulation, the NHRA believes in a firm but fair approach to noncompliance. This is informed by the following principles: 18.1 Proportionality

Proportionality means relating noncompliance action to the risks identified. Sanctions will be identified using a proportionate manner and will be linked to risks relating to health and safety, or to the seriousness of the concern, which includes any actual or potential harm arising from a poor practice.

18.2 Targeting Targeting means making sure that regulation is targeted primarily on the activities which give rise to the most serious risks or where the hazards/concerns are least well controlled; and that action is focused on the license holders who are responsible for the risk and who are best placed to control it – whether they are owners, employers, suppliers, or others. 18.2.1 The NHRA has a rolling program of annual inspections which is part of the regulatory license requirement. However additional inspections may take place as part of an investigation into incidents, complaints, near misses etc. these will take priority according to the nature and extent of risks posed by a license holder’s operations. 18.2.2 The NHRA will monitor license holder’s management competence, this is important, because a relatively low hazard site poorly managed can entail greater risk to the public than a higher hazard site where proper and adequate risk control measures are in place. Certain sites will receive regular inspections so that the NHRA can give public assurance that such risks are properly controlled. 18.2.3 Any noncompliance action will be directed against the identified license holders of the facility. Where several license holders have responsibilities, such as both facility license holder and professional license holder, the NHRA may take action against more than one when it is appropriate to do so in accordance with this policy.

18.3 Consistency

Consistency of approach does not mean uniformity. It means taking a similar approach in similar circumstances to achieve similar ends across all healthcare facilities. Facility license holders managing similar risks will receive a consistent approach from the NHRA in the advice provided; the use of noncompliance actions, approvals etc.; decisions on whether to restrict or revoke a license; and in the response to incidents.

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Decisions on noncompliance action are discretionary, involving judgment. The NHRA and its inspectors have arrangements in place to promote consistency in the exercise of discretion, including effective arrangements for liaison with other inspectors and escalation to senior management for decision making.

18.4 Transparency Transparency means helping license holders to understand what is expected of them and what they should expect from the NHRA. It also means making clear to license holders not only what they have to do but, where this is relevant, what they don’t. That means distinguishing between statutory licensing requirements and advice or guidance about what is desirable but not compulsory.

18.5 Accountability

The NHRA is accountable to the public for their actions. This means that it must has policies and standards against which they can be judged, and an effective and easily accessible mechanism for dealing with comments and handling complaints. The NHRA will use its discretion in deciding whether incidents, proposals of ill health, or complaints should be investigated, Investigations that are undertaken will determine:

• causes; • whether action has been taken or needs to be taken to prevent a recurrence and

to secure compliance with the law and to ensure patient safety; • lessons to be learnt and to influence the law and further guidance; • what response is appropriate to a noncompliance of the standards and or the

law.

19 NHRA NON COMPLIANCE LEVELS

The NHRA has developed a stepped approach in seeking to secure compliance with the law and licensing standards to ensure a proportionate response is taken to all non-compliant areas. The stepped approach and identified levels are outlined below:

19.1 Level 1 – Remedial Actions

Remedial actions are a precursor to noncompliance action and they inform the health care facility license holder that they are not compliant with the relevant legislation and/or standard/s that have been set by the NHRA. Remedial actions are written within the Inspection report and action plan and are an important and significant step to take in ensuring that patient safety is maintained in all Health Care Facilities. Where a license holder is not complying with a regulation, but people are not at immediate risk of harm, we will use our power to request an action plan showing how the health care facility will achieve compliance and the action they will take to do so. Failure to send us a report/action plan can in itself lead to further non-compliance action. We will say which regulation and /or standard is not being met when identifying the remedial action required within the inspection report. We will request an action plan with timescales to be returned by the facility license holder showing the action they will implement to achieve compliance.

19.2 Level 2 - Improvement or Restrictive Practice Notices

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Improvement or Restrictive Practice Notices tell the health care facility license holder that they are not complying with a condition of the facility license, requirement in the law/standards, or any other requirement that we think is relevant to maintaining patient safety. We can serve an improvement or restrictive practice notice when there has been a previous failure to comply with remedial action. Where an improvement or restrictive practice notice is about continuing non-compliance it will include a timescale by when compliance must be achieved. If the facility license holder is still not complying with the requirement when the timescale expires, we will consider our response, which could lead to further non-compliance action. Improvement and restrictive practice notices may be published, in this event the facility license holder will be given the opportunity to make any representations where we intend to publish.

19.3 Level 3 - Restricted license conditions Imposing, varying and removing conditions of the license is a flexible noncompliance process that we can use in a variety of different ways to keep people safe and ensure that legal requirements and standards are met. For example, we may use a condition to stop a regulated activity at one location while the licensed activities can continue at other locations. We may restrict the scope of services being provided within the facility or restrict services such compounding or dispensing controlled drugs when the required assurance is unavailable. We will begin the restricted license proceedings in relation to amending conditions of the facilities’ registration by sending the license holder a full inspection report that sets out our proposal. Facility license holders have a right to make representations to us against our report before we make a final decision to restrict the facility license conditions. We also have powers to impose, vary or remove conditions using urgent procedures (see below).

19.4 Level 4 – Suspension of license We can suspend the license of a licensed person or licensed facility for a specified period of time, and also extend a period of suspension. Suspension of a facility license is a serious step that can have major consequences for the facility license holder. Suspension affects the whole health care facility where the relevant regulated activity is being carried out or managed. We will therefore give particular attention to the likely outcomes of taking this action. Suspension can, however, give a facility owner and /or license holder the chance to work towards achieving compliance and then resume carrying on and managing the on-going activity. We follow the same notice procedure described above when we wish to suspend the license. We can also suspend or extend a period of suspension using urgent procedures. (see below).

19.5 Level 5 – Revoke/Remove the license Our most powerful sanction is to revoke/remove a license. The removal of a license normally follows considerable efforts to get the facility license holders to comply with legal requirements and the licensing standards set down by the NHRA. Where necessary and in extreme proposals where it is thought that patient safety is severely compromised, we can use the removal of license process without first having followed other processes. We can also remove the license using urgent procedures (see below).

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19.5.1 At the NHRA’s discretion, the license of any licensee who fails to pay the appropriate renewal fee and complete the renewal process within a specified period of time may be revoked. A renewal notice is sent to each licensee and a reminder is also sent, prior to revoking their license for non-payment of fees. 19.5.2 If a Pharmacy and pharmaceutical facilities license is revoked, the facility must not practise or provide pharmaceutical services in the Kingdom of Bahrain unless and until they apply for and are issued with a new license.

19.6 Level 6 - Urgent procedures

When using our urgent powers to vary or impose conditions, or suspend/remove a license, we will issue an urgent notice/letter of action to the license holder. We will only take this step if we believe that if we do not, a person will, or may be, exposed to the risk of severe harm/potential death. We will consider using urgent procedures to remove a license as a last resort where the problem cannot be resolved in any other way and where a person(s) is at serious risk to their life, health or wellbeing. When using our powers to remove a license using urgent procedures, we will refer to the legal process. In these circumstances we will wherever possible:

Tell the license holder in advance about our application to remove/revoke their license using urgent procedures.

Only make an application without telling and involving the license holder in exceptional circumstances, such as when their whereabouts are not known and after considerable effort has been made to locate them.

Where we cannot give the facility license holder notice of our application, we will make a full and frank disclosure of all relevant evidence and confirm that we have done so in our application.

When serving an urgent notice of action on a license holder using urgent procedures, it will always include information about how the license holder can appeal against the urgent removal of license. Where a license holder demonstrates 'low level' but continuous or frequent failure to comply with legal requirements and/or licensing standards, we will usually escalate our noncompliance action so that problems are dealt with swiftly and firmly. We will always follow up noncompliance action to ensure that compliance is achieved.

For further information about the NHRA’s noncompliance and sanctions process, please see the NHRA’s website at www.nhra.org.bh

20 OBTAINING A NEW LICENSE IF YOUR LICENSE HAS BEEN REVOKED

20.1 Obtaining a new license if your license was revoked for failing to renew

Pharmacy and pharmaceutical facilities wishing to get a new license, after their last license was revoked for failing to renew should complete a new application, ticking the renewal box and submit it with all fees due and the required documentation to the NHRA.

20.2 Obtaining a new license if your license was revoked due to violation of the law

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If a pharmacy and/or pharmaceutical facilities license is revoked following a finding that they have violated the law or are non-compliant with the licensing standards set by the NHRA, they can apply to have their license restored to the register when remedial action has been taken. NOTE: On application for re-instatement, the pharmacy and/or pharmaceutical facilities license holder must submit the required documentation to the NHRA. The application for re-instatement will be reviewed by an appropriate committee of the NHRA. The committee will then make a recommendation to the Board of the NHRA, which will make a decision either to grant or refuse the license. Applications will be considered on a case by case basis.

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INFORMATION FOR EMPLOYERS This section contains information about

21 Employing Pharmacist Professionals 22 Visas and Work Permits 23 Complaints about Pharmacy facilities

21. EMPLOYING PHARMACY PROFESSIONALS

Pharmacy and pharmaceutical facilities license holders should ensure that all pharmacy professionals employed are licensed with the NHRA in accordance with the law prior to allowing them to commence employment. Pharmacy professionals must present to their employer a valid Certificate of Registration and License. The employer should record the registration status of all pharmacy professionals employed by them, noting the date of expiry of their license, for the duration of the Pharmacy professional’s employment. It would greatly assist the NHRA to receive notification from employers when a licensed Pharmacy professional leaves their employment.

22. VISAS AND WORK PERMITS

The NHRA does not request visas or work permits as part of the registration process. It is the responsibility of every employer to ensure that each and every Pharmacy professional they employ holds the appropriate visa/permit for the purposes of practising their profession within the Kingdom.

23. COMPLAINTS ABOUT PHARMACY AND/OR PHARMACEUTICAL FACILITIES Employers play a vital role in receiving, assessing, investigating and acting on complaints. All pharmacy and pharmaceutical facilities should establish systems for managing complaints about their services or employees. In most proposals, a complaint made to a facility should be dealt with by the facility. However, there are circumstances where it is appropriate and important for a facility to refer a matter to the NHRA. It is essential that facilities understand their role to avoid confusion, overlap, delay and inefficiency in the complaint management process. The NHRA has published guidelines for employers to help them understand their role in complaint management in relation to the NHRA. For further information, please contact the NHRA directly.

NOTE: THIS GUIDE MAY BE SUBJECT TO AMENDMENT/CHANGES IN WHOLE OR IN PART AT ANY TIME AT THE DISCRETION OF THE NHRA. THIS GUIDE DOES NOT CONSTITUTE AN OFFER OR GUARANTEE OF REGISTRATION/LICENSURE.

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USEFUL LINKS Bahrain Websites:

NHRA – www.nhra.bh

E- Government, Kingdom of Bahrain http://www.ega.gov.bh/

Ministry of Health, Kingdom of Bahrain http://www.moh.gov.bh/en/

Civil Defence Authority, Kingdom of Bahrain. http://www.moic.gov.bh

Electricity and Water Authority, Kingdom of Bahrain. http://www.mew.gov.bh Other Countries:

NFPA 99 (National Fire Protection Association) Manual for fire safety http://www.nfpa.org .

Heating, Refrigerating and Air Conditioning Engineers Incl.: HVAC-Design Manual for Hospitals and Clinics (www.ashrae.org)

British Standards for Concrete Work-Part 1, 2 & Part 3 (Design and Construction of concrete works)

(http://www.bsistandards.co.uk)

British standards for Steel Work (Design and Construction of steel work) (http://www.bsistandards.co.uk)

Lighting guide, Hospital and Health Care buildings, CIBSE, London (www.cibse.org)

Requirements for Electrical Installations: IEE wiring Regulations (British standard) www.iee.org

Planning, Design, and Construction of Health Care Environments, Published by the Joint Commission on Accreditation of Healthcare Organizations www.jointcommission.org

Medical Gas Guidelines – HTM 02 part 1 & 2, http://shj.co.uk/pdfs/divav.pdf

. Food & Drug Administration. www.fda.gov

. Association for the Advancement of Medical Instrumentation. www.aami.org

Institute of Electrical and Electronics Engineers. www.ieee.org

European Union Medical Device Directive MDD http://ec.europa.eu/health/medical-

devices/documents/revision/index_en.htm

NHRA Guidance Feedback Survey Did you find the information in this Guide useful? We’d like to know what helped and what didn’t.

Please answer the following questions and return to the NHRA at the address provided overleaf.

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1. Which of the following best describes your reason for reading the Guide to Licensure?

New Healthcare facility applying for a license

Healthcare facility applying to renew a license

Healthcare facility applying to change license conditions

Healthcare Facility requesting temporary closure

None of the above. Seeking information for the following reasons (please state reason

below):

2. Did you find the information you were looking for?

Yes

No

Not applicable

3. If you answered “no” to question 2, please tell us what information was not provided:

4. In general, how useful did you find the contents of the Guide?

Very useful

Useful

Not very useful

Not at all useful

5. Which sections of the Guide did you find useful/very useful? Tick as many as apply.

RELEVANT LEGISLATION / WHY REGISTER?

REGISTER OF PHARMACEUTICAL FACILITIES AND DEFINITIONS

ELIGIBILITY

THE APPLICATION PROCESS

THE APPLICATION FORMS

THE BUSINESS PROPOSAL

FEES

THE NHRA ASSESSMENT PROCESS

THE NHRA DECISION MAKING PROCESS

ADDITIONAL DOCUMENTATION

INSPECTION REQUEST AND PROCESS

FACILITY MONITORING

MINIMUM DESIGN STANDARDS

PHARMACY AND PHARMACEUTICAL FACILITIES OPERATIONAL STANDARDS

FACILITY LICENSURE AND REGISTRATION

OBLIGATION TO NOTIFY NHRA OF ANY CHANGES

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RENEWAL PROCESS

THE PRINCIPLES OF NONCOMPLIANCE

NHRA NONCOMPLIANCE LEVELS

RESTORING A LICENSE FOLLOWING REMOVAL

EMPLOYING PHARMACY PROFESSIONALS

VISAS AND WORK PERMITS

COMPLAINTS ABOUT PHARMACEUTICAL FACILITIES

APPLICATION FORM – PHARMACEUTICAL FACILITIES

LICENSE PROPOSAL TEMPLATE

NHRA INSPECTION REQUEST FORM

NHRA HEALTHCARE FACILITY APPLICATION FEES

NHRA FACILITY INSPECTORS “CODE OF CONDUCT”

NHRA “WHAT TO EXPECT WHEN AN INSPECTOR CALLS”

6. In general, how easy was it to understand the Guide?

Very easy

Easy

Somewhat difficult

Very difficult

7. Did you learn new information?

Yes

No

8. Is there anything else you would like to see covered in this Guide? Any comments or suggestions?

9. Do you wish us to contact you about any of the issues you have raised in this survey? If so, please provide your contact details below:

Name:

Telephone No.

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(Day)

Email address:

Thank you for taking the time to complete this survey. Please return it to:

National Health Regulatory Authority, PO Box 11464, Manama, Bahrain.

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APPENDIX 1

Tel : +973 17 11 33 33

eMail : info@nhra.bh Website : www.nhra.bh P.O. Box : 11464, Manama Kingdom of Bahrain

APPLICATION FOR A PHARMACY AND/OR PHARMACEUTICAL FACILITIES LICENSE KINGDOM OF BAHRAIN

IMPORTANT: Please follow these instructions completely. Failure to submit the necessary items/information will

delay the processing of your application. You must complete and submit all of the requested information.

Please tick the relevant box:

New Facility Complete all sections

Renewal / Reinstatement* Complete sections 1 to 6

Change of Ownership Complete sections 1, 2, 3 and 6

Change of location Complete sections 1,2 and 6

Change of Facility Name Complete sections 1, 2 and 6

Change of Person in Charge Complete sections 1,2, 4 and 6

Change in Operational Function Complete sections 1,2, 5 and 6

Temporary Closure Complete section 1,2 and 5

*If reinstatement, due to: Lapse of license or Suspension or Revocation of a license

1. MAIN APPLICANT DETAILS Applicants Full name (as it appears in passport):

Previous name (if different from above):

Address:

Telephone Nos. (Mobile):

(Business):

Fax No.:

Email address:

CPR No.:

Passport No.:

Date of Birth: DD / MM / YYYY

Country of Issue:

Gender (please tick): Male Female Nationality:

For office use: application number:

________________________________

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Profession: License No; (if applicable)

Name of lessor/renter or owner if different from name of application:

Name: CPR No:

Address:

Contact No:

A COPY OF THE LEASE AGREEMENT MUST ACCOMPANY THIS APPLICATION

3.OTHER STAKEHOLDERS

OWNERSHIP TYPE check one:

Corporation Partnership Individual Other

LIST OF OWNERS/OFFICERS AND RESIDENCE ADDRESSES BELOW OR LIST IS ATTACHED

Name: CPR No:

Residence Address:

Profession: License No: (if applicable)

Name: CPR No:

Residence Address:

Profession: License No: (if applicable)

Name: CPR No:

Residence Address:

Profession: License No: (if applicable)

2. FACILITY DETAILS

Current Name of Facility:

Name Change: (if applicable)

Current Name in Arabic: Name Change: (if applicable)

Address of Facility:

Is this a changed location: Y / N (circle)

If Yes, Previous location:

Is a current Pharmacy and pharmaceutical facilities license is held: Y / N (circle)

NHRA license number:

Is there a current MOIC Commercial license:

Y / N (circle)

MOIC Commercial License No:

Premises Leased/Rented Premises Owned

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4. PROFESSIONAL STAFF

LIST OF PHARMACISTS PRACTICING AT THIS PHARMACY INCLUDING CHIEF PHARMACIST/PERSON IN CHARGE BELOW OR LIST IS ATTACHED

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

Name: License No. CPR No:

5. OPERATIONAL INFORMATION

Expected Hours of Operation:

Sunday : From ________ To ________ Thursday From ________ To ________

Monday: From ________ To ________ Friday; From ________ To ________

Tuesday: From ________ To ________ Saturday: From ________ To ________

Wednesday From ______ To ________ On call hours: From ________ To ________

Scope of Services: Attach list of any additional services.

Dispensary Compounding / preparation

Retail OTC Alternative Medicines

Health Products Counselling / Advice

Other:

Expected Opening, Moving, or Completion Date:

Preferred pre-license Inspection Dates : From: To:

Temporary Closure Notification (insert dates) From : To:

A 14-day notice is required for scheduling an opening or change of location inspection. Drugs may not be stocked prior to inspection and approval.

An inspector will call prior to the requested date to confirm readiness for inspection. If the inspector does not call to confirm the date, the responsible party should call the Facility Licensure Office at the NHRA to verify the inspection date with the inspector.

FOR NHRA USE ONLY: Acknowledgement of Inspection Request

Date Processed: Assigned Inspection Date:

Application Number Assigned

Date Inspected

License Number

Date Issued

6. DECLARATION

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I/We the undersigned, certify that I/we am/are the person/s referred to in the foregoing application for licensure

registration in the Kingdom of Bahrain, and that the statements herein are true to the best of my/our knowledge,

information and belief. I/we understand that, should I/we furnish any false information in this application, such act shall

constitute cause for denial, suspension or revocation of the facility license in the Kingdom of Bahrain.

_________________________________ _______________________________

Signature Date

_________________________________ _______________________________

Signature Date

_________________________________ _______________________________

Signature Date

_________________________________ _______________________________

Signature Date

_________________________________ _______________________________

Signature Date

PLEASE DO NOT SUBMIT YOUR APPLICATION UNTIL YOU CAN ENCLOSE ALL REQUIRED DOCUMENTATION.

7. CHECKLIST Please use the checklist to make sure that you have attached all necessary documents.

Preliminary Approval Full License Approval

Copy of CPR

Copy of passport

License proposal outline

Full license proposal

Architectural Drawings (hard and soft copies)

Copy of lease agreement with the owner of the real estate on which the facility is built.

Copy of previous license (if applicable)

Copy of all approvals obtained from required departments and organizations in the Kingdom of Bahrain e.g.

The Ministry of Industry and Commerce in Bahrain

Bahraini Local Municipalities., Incl. Electricity and Water Authority, telecommunications.

Civil Defence Authority incl. Fire certification/approval.

Medical device and equipment engineering approvals

Radiation level approvals. If applicable

Receipt evidencing payment of license fees.

Certificate of insurance

Other:

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APPENDIX 2 – LICENSE PROPOSAL TEMPLATE

(Type) Health Care Facility License

License Proposal Template

National Health Regulatory Authority

Date _________

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Table of Contents

Insert Table of contents when license proposal is complete

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Introduction

In the best interests of patient care and public protection, the National Health Regulatory Authority (NHRA) seeks

to ensure that the issue of quality and patient safety are systematically and comprehensively addressed, across

all health care services in the Kingdom of Bahrain.

To this end all heath care facility license applicants are required to complete a license proposal outlining key areas. Continuous quality assurance and improvement strategies should be evident within the proposal including:

Current best practice

Monitoring of outcome/ adverse events/near misses

Development of local quality assurance programs that reflect the use of both internal and

external standards and reviews. This can include accreditation by recognised bodies.

Risk management strategies

Applicants are encouraged to discuss the development of the proposal and application, in particular the

conceptual plans (design layout) and the continuous quality assurance/ improvement aspects, with the NHRA

licensure inspectors prior to submission. However the discretion to grant or refuse to grant preliminary approval,

a full license, or renewal of a license remains at all times with the NHRA.

This document has been designed as a template for producing a proposal for presenting to the NHRA. The

proposal is a presentation of key facts to seek initial preliminary approval and then full licensure for a healthcare

facility license.

Using this Template

To create a proposal from this template, simply do the following:

Delete this page.

Replace the title on the cover page with “License Proposal:” the name of your project, and the

organization/facility information, incl Type of facility, Facility Name, address and contact details

Complete only Step 1 of the template when applying for preliminary approval with the NHRA.

Complete the entire template when preliminary approval has been approved and entering into the full

license application process

Each section contains brief instructions, shown in italics, which can be removed once your document is finalized.

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Step 1 Preliminary Approval Application

Please complete step 1 sections 1 to4 when applying for preliminary approval.

Section 1: Authority Signatures

This section contains the signatures of key stakeholders, indicating that they agree with the license proposal as it

is presented.

_______________________________________ _______________________

Full name Date

Main License Applicant

_______________________________________ _______________________

Full name Date

Stakeholder

_______________________________________ _______________________

Full name Date

Stakeholder

_______________________________________ _______________________

Full name Date

Stakeholder

_______________________________________ _______________________

Full name Date

Stakeholder

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Section 2: Executive Summary

Provide an executive summary (high level) that captures only the essential elements of the proposal being

presented. Include the proposal’s most pertinent facts in a clear, concise, and strategic overview. This should

include a comprehensive statement of the strategic direction and underlying goals of the facility

Checklist:

The pertinent facts of the license proposal are provided in a clear and concise fashion.

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Section 3: The Strategic Context

Health Care Needs and Desired Outcomes

Complete this section to identify the need (problem or opportunity) and the desired healthcare outcomes and

service provision. Include identified need and any demographic evidence which supports the identified need and

how the facility goals will fit with the strategic goals of healthcare in the Kingdom of Bahrain.

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Section 4: Proposal

4.1 Describe the Proposal

Describe the Proposal (high level).

4.2 Organizational Structure and Overview

To build a strong rationale for a proposed healthcare facility, the current environment needs to

be described. The organization/facility overview should include:

4.2.2 Mission

4.2.3 Strategic vision, goals, and service objectives

4.2.4 Proposed activities and scope of services,

4.2.5 Key stakeholders and clients

4.2.6 Proposed organizational structure, including details of the proposed management team,

including names and professional experience when available.

4.2.7 Proposed capacity—financial and human resources including strategies for recruiting

appropriately trained staff to the facility.

4.3 Scope of Services

Provide a complete description of the proposed services and supporting services including service

levels and responses to the requirements contained in the NHRA Facility Minimum Design

Standards and the NHRA Operational Licensing Standards that have been developed for specific

facilities.

4.4 Implementation Considerations

Outline how the project will be implemented. Provide an implementation plan (strategic work plan) to

demonstrate that the proposal has been appropriately thought through and that the proposals are within

an acceptable degree of accuracy.

Demonstrate that the minimum design and building standards required in Bahrain are being considered

within the design. You should also include evidence of how you will comply with Infection Prevention and

Control Standards, Medical Waste Standards, Fire Health and Safety Standards, International Best

Practice Standards.

4.2.2 Schedule and Approach

Identify the core work streams and associated milestones.

4.4.2 Anticipated Risk

Identify the risks anticipated with the project. Provide an option risk summary, which should

include risk, probability, impact, mitigation and contingency, outcome, tolerance, and a risk

assessment summary rating.

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Step 2 – Application for full license consideration

When preliminary approval has been obtained, complete section 5 to 8 and submit for full license application

approval.

Section 5 – Physical Plans

5.1 Physical Facility Layout

A clear overview of the proposed site plan which specifically identifies the facility when constructed or renovated for use as a healthcare facility

5.1.1 Proposed Site Plan

This should include roads, frontages and adjoining properties and show the proposed facility when

constructed or renovated for use. It must include the following architectural drawings: (3D

drawings are optional)

5.1.1.1 Architectural Drawings of the proposed plans, showing floor plans, elevations and

sections.

5.1.1.2 Architectural drawings of the proposed plan including the site plan, site boundaries,

showing

5.1.1.2.1 Surrounding streets and accesses, total land area, total built up areas,

5.1.1.2.2 Car parking and car access( on ground and in building if applicable)

5.1.1.2.3 Pedestrian routes, access and ramps

5.1.1.2.4 Emergency access if required (ambulance, helicopter etc.)

5.1.1.2.5 Service routes, back door access, delivery access etc.

5.1.2 Details of any proposed leasing arrangements, including description of lease agreements.

5.1.3 Identify and list the medical devices that will require engineering approval for installation,

operation, performance and maintenance. Confirm that the proposed devices conform to the

importation requirements in the Kingdom of Bahrain.

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Section 6 External Agency Requirements

If the initial application is successful for a healthcare facility to be constructed, the NHRA shall issue a Preliminary

Approval letter for the facility, with defined services and restrictions particular to the facility/applicant

circumstances. This letter will be required to complete the facility licensing procedures and gain approval from

local and national authorities including but not limited to:

The Ministry of Industry and Commerce in Bahrain.

Bahrain Telecommunications Authority.

Bahraini Local Municipalities .incl Electricity and Water Authority, road authority etc.

Civil Defence Authority re: fire defence cover etc.

Ministry of Health incl. Medical Engineering and Radiation inspection and approval

6.1 Provide approval letters from all authorities involved in the building process

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Section 7: Management and Capacity

7.1 Governance and Oversight

Identify and demonstrate the governance structures and oversight within the proposed facility. This

should include organisational structures, committee structures, policies, procedures, operational

management of high risk areas. Management of complaints/incidents and identified risks.

7.2 Performance Measurement Strategy

Indicate how the organization will address operational performance measurement for the facility post

project implementation and benefits realization. This should include any proposed contracted activity,

clinical and support services activity and identified high risk activity.

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Section 8 - Appendices (TO BE ATTACHED IF REQUIRED)

1.1 Attach appendices as required, for example,

Approval letters from other regulatory authorities in Bahrain.

Architectural drawings

Proposed governance documentation

Proposed operational policies and procedures

Proposed staffing levels

Proposed organisational structure and persons appointed.

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APPENDIX 3 –INSPECTION REQUEST FORM

NHRA INSPECTION REQUEST FORM

Application Details Please select one:

New facility License Renewal Facility License

Adding new service/specialty

Other

New Facilities request:

Interim Inspection Completion 100% Completion

Type of facility

Hospital Clinic/Centre Pharmacy Opticians

Laboratory Radiology Facility Name:

_________________________________________ Application Reference Number

______________________

License applicants name:

_______________ Address: ___________________

_______________ ___________________ _______________ ___________________ I hereby confirm that all the requirements are fulfilled and the NHRA has the authority to reject the facility license application if the Criteria are not met after two inspections. (there will be extra charge for additional inspections) Signature:_________________________________________________ For Official NHRA Use:

Coordinating Inspector

_______________ Date of Inspection

__________________ Fulfills all requirements

Yes / No Notes: ____________________________________________

____________________________________________________________________________________________________________________________________

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APPENDIX 4– HEALTHCARE FACILITIES LICENSURE INSPECTORS CODE OF CONDUCT

NHRA PROCEDURAL

CODE OF CONDUCT FOR INSPECTION STAFF

Where an inspection involves two or more inspectors, the coordinating inspector will

take the lead role in discussions and interviews.

Inspectors will refrain from any public display of opinions that are at variance with those

officially expressed.

Inspectors will identify themselves by showing their NHRA ID card.

NHRA ID cards or other appropriate identification is to be worn at all times when

conducting an inspection unless site health and safety considerations require otherwise.

A professional appearance will be presented at all times.

A firm but courteous attitude must be adopted at all times.

Irrelevant discussion will be avoided to minimize the disruption to services.

Questions to health care workers and managers will be courteous and carefully

considered to ensure relevant information is obtained.

Open questions will be used to ensure that the answer received includes the expected

information on the specific subject of interest.

Where practicable, issues should be discussed as they arise.

Inspectors will avoid open criticism of individuals especially in the presence of health

care colleagues.

Inspection staff should not act as consultants on means of achieving regulatory

requirements. (However inspectors may need to provide assistance on practical

implementation, particularly if written guidance has not yet been developed by the

NHRA as a regulatory body).

Advice to facilities as to how compliance can be achieved may be given but, while doing

it, it should be stressed that the practical actions necessary are, and will continue to be,

the responsibility of the authorized license holder.

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APPENDIX 5 – WHAT TO EXPECT WHEN AN INSPECTOR CALLS

This leaflet is intended for Licensees of health care facilities in the Kingdom of Bahrain, and those in control of health care facilities workplaces. It explains what you can expect when an NHRA inspector calls at your workplace. It also tells employees and their representatives what information they may expect from an inspector during a visit. Who enforces health care regulation? Health care related law in Bahrain is enforced by the NHRA CEO, board and committees. The NHRA inspectors play a key role in providing the NHRA Board and Committees the required inspection reports that inform the decision making process. Inspectors have the right to enter any licensed or non-licensed health care facility workplace without giving notice, though notice is usually given where the inspector thinks it is appropriate. On a normal annual inspection visit an inspector would expect to look at the facility as a whole, the workplace, the work activities, the management of those work activities, and to check that the facility is complying with health care legislation and the relevant health care facility standards.

Enforcing Health Care Facility Legislation On finding a breach of health care legislation and /or standards, the inspector will report their findings to the NHRA Facilities Director. And in some cases the NHRA CEO and Board. Every effort is made to work with the health care facility to ensure the noncompliance with the standards and legislation does not affect patient safety at any time. The action identified will depend on the nature of the breach, and will be based on the principles set out in the NHRA Compliance Policy Statement. The NHRA may take compliance action in several ways to deal with a breach of the law and /or standards. In most cases these are: Informal, where the breach is relatively minor, the NHRA inspector may tell the license holder, what to do to comply and explain why. The inspector will, if asked, write to confirm any advice, and to distinguish between legal requirements from best practice advice. Improvement notice, where the breach is more serious, the NHRA may issue an improvement notice to tell the license holder to do something to comply. The NHRA will discuss the improvement notice and, if possible, resolve points of difference before serving it. The notice will say what needs to be done, why, and by when. The time period within which to take the remedial action will be at least 21 days, to allow the license holder time to address the issues raised.

Service restriction notice, where an activity involves, or will involve, a risk of serious injury or illness, the NHRA may serve a restriction notice prohibiting or restricting further activity to take place within the health care facility for specified time period, and not allowing it to be resumed until remedial action has been taken. Licensed revoked, where an activity involves serious risk and / or the prohibition notice requirements have not been complied with, the NHRA Board and CEO will revoke the facilities and/or professionals license. The NHRA will only ever revoke a license having discussed and attempted to address the noncompliance issues through the two previous methods of enforcement. The inspection process The licensure inspector may offer guidance or advice to help you. They may also talk to employees and their representatives, take photographs, documents and samples, if there is a risk to the health and safety of patients or others which need to be dealt with immediately, they will report it immediately to senior managers in the NHRA and any other relevant authorities in Bahrain.

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