The Governance Arrangements Safeguard the Health, Safety and Wellbeing of Patients And

Principle 1 -

The governance arrangements safeguard the health, safety and wellbeing of patients and the public

Standards

1.1 The risks associated with providing pharmacy services are identified and managed

1.2 The safety and quality of pharmacy services are reviewed and monitored

1.3 Pharmacy services are provided by staff with clearly defined roles and clear lines of accountability

1.4 Feedback and concerns about the pharmacy, services and staff can be raised by individuals and organisations, and these are taken into account and action taken where appropriate

1.5 Appropriate indemnity or insurance arrangements are in place for the pharmacy services provided

1.6 All necessary records for the safe provision of pharmacy services are kept and maintained

1.7 Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services

1.8 Children and vulnerable adults are safeguarded

Principle 1 / Examples of Evidence / Links to standard
How do you identify risks? / Details of services provided eg minor ailments scheme, supervision of meds.
SOPS are in place and subject to regular review. / 1.1, 1.2
How do you manage risk in the pharmacy? / Action taken to reduce dispensing errors or near misses. See CPS Near Miss/ Error Log Template
Business Continuity Plan developed
SOPs in place and reviewed regularly with all staff signing the SOPs
Evidence of Staff training
Evidence of Date Checking See CPS Date Checking Matrix
Medicines with similar names are separated / 1.1,1.2,
2.1,2.2,
4.2
How is the safety and quality of services reviewed? / SOPs are in place and followed which identify suitably trained staff and areas of responsibility. Review dates in place.
Patient feedback and complaints procedure in place and feedback acted upon.
The pharmacy clearly displays Patient Rights Act information / 1.1,1.2,
1.4, 4.2
How do staff know their roles and responsibilities? / Responsible pharmacist log used
RP SOPs in place covering roles and responsibilities of staff.
Dispensing audit trails / 1.1,1.2,
1.3,4.2
Do you have insurance? / Public Liability and professional indemnity insurance in place. Certificates displayed / 1.5
All required records kept? / Responsible Pharmacist logs are in use. CPS RP Log
CD register is maintained and balances are checked weekly. / 1.6
How is patient confidentiality assured? / PMR terminals are not readily accessible to the public.
Anti-virus software and secure N3 internet connection used. All ePharmacy requirements are kept up to date. / 1.7, 5.3
How are children and vulnerable adults safeguarded? / Procedure to concerns to GP around elderly patient not collecting their MDS or weekly dispensed prescription.
Appropriate Staff have PVG Certificate / 1.8

Principle 1 -

The governance arrangements safeguard the health, safety and wellbeing of patients and the public

Standards

1.1 The risks associated with providing pharmacy services are identified and managed

1.2 The safety and quality of pharmacy services are reviewed and monitored

1.3 Pharmacy services are provided by staff with clearly defined roles and clear lines of accountability

1.4 Feedback and concerns about the pharmacy, services and staff can be raised by individuals and organisations, and these are taken into account and action taken where appropriate

1.5 Appropriate indemnity or insurance arrangements are in place for the pharmacy services provided

1.6 All necessary records for the safe provision of pharmacy services are kept and maintained

1.7 Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services

1.8 Children and vulnerable adults are safeguarded

Principle 1 / Examples of Evidence / Links to standard
How do you identify risks?
How do you manage risk in the pharmacy?
How is the safety and quality of services reviewed?
How do staff know their roles and responsibilities?
Do you have insurance?
All required records kept?
How is patient confidentiality assured?
How are children and vulnerable adults safeguarded?

Principle 2

Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

Standards

2.1 There are enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided

2.2 Staff have the appropriate skills, qualifications and competence for their role and the tasks they carry out, or are working under the supervision of another person while they are in training

2.3 Staff can comply with their own professional and legal obligations and are empowered to exercise their professional judgement in the interests of patients and the public

2.4 There is a culture of openness, honesty and learning

2.5 Staff are empowered to provide feedback and raise concerns about meeting these standards and other aspects of pharmacy services

2.6 Incentives or targets do not compromise the health, safety or wellbeing of patients and the public, or the professional judgement of staff

Principle 2 / Examples of Evidence / Links to standard
Who works in the pharmacy and what qualifications to they have? / Evidence of a good mix of staff skills with ACT, dispensary technicians and counter assistants all trained with accredited courses.
Staff training in refreshed
The pharmacist has also completed a distance learning pack to improve their knowledge when delivering EHC, smoking cessation
Areas identified where training is required / 1.1, 1.2, 1.3, 2.1, 2.2, 2.3
How do the pharmacy team learn and improve? / Evidence of staff meetings and appraisals
Pre-reg student follows NES programme
The pharmacy has a near miss log which is reviewed and steps are taken to minimise risk See CPS Near Miss/ Error Log Template
Staff make suggestions to improve service
Whistleblowing policy in place / 1.1, 1.2, 1.3, 2.2, 2.4, 2.5
How is it ensured that targets and incentives do not affect patient care? / No targets in place other than those in the Scottish Government contract / 2.6

Principle 2

Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

Standards

2.1 There are enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided

2.2 Staff have the appropriate skills, qualifications and competence for their role and the tasks they carry out, or are working under the supervision of another person while they are in training

2.3 Staff can comply with their own professional and legal obligations and are empowered to exercise their professional judgement in the interests of patients and the public

2.4 There is a culture of openness, honesty and learning

2.5 Staff are empowered to provide feedback and raise concerns about meeting these standards and other aspects of pharmacy services

2.6 Incentives or targets do not compromise the health, safety or wellbeing of patients and the public, or the professional judgement of staff

Principle 2 / Examples of Evidence / Links to standard
Who works in the pharmacy and what qualifications to they have?
How do the pharmacy team learn and improve?
How is it ensured that targets and incentives do not affect patient care?

Principle 3

The environment and condition for the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public

Standards

3.1 Premises are safe, clean, properly maintained and suitable for the pharmacy services provided

3.2 Premises protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services

3.3 Premises are maintained to a level of hygiene appropriate to the pharmacy services provided

3.4 Premises are secure and safeguarded from unauthorised access

3.5 Pharmacy services are provided in an environment that is appropriate for the provision of healthcare.

Principle 3 / Examples of Evidence / Links to standard
How is the premise kept clean and safe? / A cleaner is employed or a cleaning rota with logs is in place. See CPS Cleaning Matrix
The dispensary floor is clean and tidy
Electrical equipment is tested and certified at regular intervals / 3.1, 3.3, 3.5
How is patient privacy and confidentiality protected? / The pharmacy has a consultation room which is used regularly
A quiet area is available for supervision of medication / 3.2, 3.5
How is the premises kept secure? / The pharmacy has a security alarm and CCTV
Metal shutters over the pharmacy windows and doors when closed
Designated key holders / 3.4

Principle 3

The environment and condition for the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public

Standards

3.1 Premises are safe, clean, properly maintained and suitable for the pharmacy services provided

3.2 Premises protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services

3.3 Premises are maintained to a level of hygiene appropriate to the pharmacy services provided

3.4 Premises are secure and safeguarded from unauthorised access

3.5 Pharmacy services are provided in an environment that is appropriate for the provision of healthcare.

Principle 3 / Examples of Evidence / Links to standard
How is the premise kept clean and safe?
How is patient privacy and confidentiality protected?
How is the premises kept secure?

Principle 4

The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.

Standard

4.1 The pharmacy services provided are accessible to patients and the public

4.2 Pharmacy services are managed and delivered safely and effectively

4.3 Medicines and medical devices are:

• obtained from a reputable source

• safe and fit for purpose

• stored securely

• safeguarded from unauthorised access

• supplied to the patient safely

• disposed of safely and securely

4.4 Concerns are raised when it is suspected that medicines or medical devices

are not fit for purpose.

Principle 4 / Examples of Evidence / Links to standard
How are services accessible to the public? / The pharmacy is accessible to wheelchair users
Pharmacy services such as CMS and MAS are advertised using approved posters / 3.2, 4.1, 5.1
How are services safe and effective? / Stock is date checked See CPS Date Checking Matrix
CDs are stored in accordance with legal requirements. Patient return CD are logged and destroyed promptly
Delivery service has an audit trail
Safe keys held by RP during opening hours
Procedure for owings in place
CD register in place, POM register in place / 1.1, 1.2, 1.3, 1.6,
4.2, 4.3
How is stock stored appropriately? / Fridge Temperature Record in place
Room temperature is appropriate for medicine storage
CD cabinet used / 1.1,1.2,4.2,4.3,5.2
How are waste medicines managed? / Yellow bins used
Out of date CDs segregated in CD cabinet
Patient returns of CDs recorded / 1.1,4.3, 5.2
How are drug recalls dealt with / There is a process in place for dealing with MHRA drug alerts and drug recalls See CPS Drug Alert Matrix / 4.4

Principle 4

The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.

Standard

4.1 The pharmacy services provided are accessible to patients and the public

4.2 Pharmacy services are managed and delivered safely and effectively

4.3 Medicines and medical devices are:

• obtained from a reputable source

• safe and fit for purpose

• stored securely

• safeguarded from unauthorised access

• supplied to the patient safely

• disposed of safely and securely

4.4 Concerns are raised when it is suspected that medicines or medical devices

are not fit for purpose.

Principle 4 / Examples of Evidence / Links to standard
How are services accessible to the public?
How are services safe and effective?
How is stock stored appropriately?
How are waste medicines managed?
How are drug recalls dealt with

Principle 5

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

Standards

5.1 Equipment and facilities needed to provide pharmacy services are readily available

5.2 Equipment and facilities are:

• obtained from a reputable source

• safe to use and fit for purpose

• stored securely

• safeguarded from unauthorised access

• appropriately maintained

5.3 Equipment and facilities are used in a way that protects the privacy and dignity

of the patients and the public who receive pharmacy services

Principle 5 / Examples of Evidence / Links to standard
How are the equipment and facilities required provided? / Tablet triangles were available with a triangle clearly marked for cytotoxic use
Measuring flasks were available with some measures clearly marked for methadone use / 4.2, 5.1, 5.2
How do you the equipment and facilities are fit for purpose? / Measuring flasks were available with some measures clearly marked for methadone use / 4.2,5.1, 5.2
How do the equipment and facilities protect patient confidentiality? / PMR and PCR have password protection
Secure N3 connection used / 1.7, 5.3

Principle 5

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

Standards

5.1 Equipment and facilities needed to provide pharmacy services are readily available

5.2 Equipment and facilities are:

• obtained from a reputable source

• safe to use and fit for purpose

• stored securely

• safeguarded from unauthorised access

• appropriately maintained

5.3 Equipment and facilities are used in a way that protects the privacy and dignity

of the patients and the public who receive pharmacy services

Principle 5 / Examples of Evidence / Links to standard
How are the equipment and facilities required provided?
How do you the equipment and facilities are fit for purpose?
How do the equipment and facilities protect patient confidentiality?

06/12/2013