(2014-10) Solomon Islands GBR Assessment Report

Assessment Report.
Aspen Medical Pty. Ltd.
ISO 9001:2008
2014
Solomon Islands GBR Medical Facility
Diane Flecknoe-
Report Author
Brown Page 1 of 26
Visit Start Date 09/10/2014
Assessment Report.
Introduction.
This report has been compiled by Diane Flecknoe-Brown and relates to the assessment activity detailed
below:
Visit ref/Type/Date/Duration Certificate/Standard Site address

8098548 FS 565793 Aspen Medical Pty. Ltd.
Continuing Assessment ISO 9001:2008 GBR Medical Centre
(Surveillance) Honiara
Solomon Islands
09/10/2014
1.5 day(s)
No. Employees: 39
The objective of the assessment was to conduct a surveillance assessment and look for positive evidence to
ensure that elements of the scope of certification and the requirements of the management standard are
effectively addressed by the management system and that the system is demonstrating the ability to
support the achievement of statutory, regulatory and contractual requirements and the organisations
specified management and clinical objectives, as applicable with regard to the scope of the management
standard, and to confirm the on-going achievement and applicability of the forward strategic plan and where
applicable to identify potential areas for improvement of the management system.
The scope of the assessment is the documented management system with relation to the requirements of
ISO 9001:2008 and the defined assessment plan provided in terms of locations and areas of the system and
Solomon Islands GBR medical facility to be assessed.
MANAGEMENT SUMMARY.
Overall Conclusion
The objectives of this assessment have been achieved.
I would like to thank all the audit participants for their assistance and co-operation which enabled the audit
to run smoothly and to schedule. Based on the objective evidence detailed within this report, the areas
assessed during the course of the visit were generally found to be effective. Enhanced detail relating to the
overall assessment findings is contained within subsequent sections of the report. MINOR Non Conformances
have been applied and need corrective action. Opportunities for improvement have been noted and
consideration is strongly encouraged.
Corrective actions with respect to nonconformities raised at the last assessment have been reviewed and
found to be effectively implemented.
A total of 8 nonconformities requiring attention were identified. These, along with other findings, are
contained within subsequent sections of the report.
A nonconformity relates to a single identified lapse, which in itself would not indicate a breakdown in the
management system's ability to effectively control the processes for which it was intended. It is necessary to
Diane Flecknoe-
Report Author
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Assessment Report.
investigate the underlying cause of any issue to determine corrective action. The proposed action will be
reviewed for effective implementation at the next assessment.
Please submit a plan to BSI detailing the nonconformity, the cause, correction and your proposed corrective
action, with responsibilities and timescales allocated. The plan is to be submitted no later than 12/11/2014
by e-mail or fax to the correspondence address below, referencing the report number.
AREAS ASSESSED & FINDINGS.

Overview :
The opening meeting was held in the facility with the Aspen Medical Quality Manager, the Solomon Islands
In-Country Manager and the Quality Coordinator.
Review of findings from last audit were reviewed for the effectiveness of the corrective action implemented
and it was identified that some findings are still being reviewed from corrective actions and continuing quality
improvement.
General Requirements
ISO 9001:2008 4.1
Since the last audit there have been some infrastructure changes, the Lorna unit is being decommissioned
for return to Australia. A new building module as a full Operating Theatre suite and recovery room with two
High dependency beds and anaesthetic bay has been installed and attached to the 10 bed ward unit. The
cssd unit has been refitted in the new suite. The helipad is in close proximity with a ramp access to enable
smooth transfer of a patient for medical evacuation.
The objectives of the mission at GBR in the is to provide primacy health care in a controlled setting and
emergency services with medical evacuation are the Participating Police Force and the ADF, High Commission
personnel and Customs, Oz Aide and DFAT and Toll.
The quality policy is stated in the quality manual is specific to the Solomon Islands - GBR project dated July
2014.
Changes and updates in the quality management system are still being conducted as the new Quality
Coordinator has been employed in the last 2 months It was identified that that the Quality Coordinator has
not had any formal training in the internal audit process nor a comprehensive handover of the quality
management system. The Quality Coordinator does not have a clinical background nor any clear education
and training in the audit process.
Exclusions: The quality manual has a statement that the element 7.3 is justified as no research, design or
development of process or product occurs at this site.
Documents and Records control

ISO 9001:2008 4.2
Document Control ISO 9001:2008 4.2.3

The document control processes are managed on site by the Quality coordinator; AMQMSI03, description of
the document the change controls, the version status, and date of release is documented.
The authority to manage document and approved the changes in the quality management system is with the
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Report Author
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Assessment Report.
In-Country Manager and the Quality Coordinator. The access to documents is via SharePoint and all staff has
access through the Solomon Islands GBR portal. The document construct consists of site specific standard
operating procedures and forms, planning, E documents and software programs. The Solomon Islands GBR
has access to the Aspen Medical corporate policy and procedures. Each document has naming convention
that is tabled in a matrix to enable identification of all documents in the quality management system.
External documents are on a described in section 4.10 and include the WHO basic Epidemiology, the
standard ISO 9001:2008. Solomon Islands local legislations and labor laws.
Record Control ISO 9001:2008 4.2.4

Records are managed as per the standard operating procedure and the records matrix capture the location,
type of records either hard copy or electronic copy, clinical records, finance records, equipment and service
agreements, invoices, time sheets, rosters, quality management system records such as internal audit
reports, minutes of meetings, non-conformance reports, operational records. The retention, storage,
archiving and authority to dispose and method of disposal are documented.
Customer Focus : ISO 9001:2008 5.2

The main client and patient groups are members of the Australian Federal Police, on occasions their family
members may seek medical assistance, plus persons attached to the diplomatic mission and RAMSI clients.
In the Primary Care area there was no evidence of an information brochure that may be provided to patients
about the services of the Solomon Islands GBR medical centre and services. There is only a sign at the door
to the clinic about the opening hours.
***There is no information about services offered, emergency services available and the patients’ Rights and
Responsibilities, ability to make a complaint or a compliment, or services provided for children.
Communication with patients who are returning to their home or quarters at the discharge stage is unclear as
to how or what clear written discharge instructions are provided to patients when being discharged to home.
Sighted a discharge information sheet for Dengue fever and post gastroenteritis only.
***Patients who have other illness treated in the Hospital such as skin conditions that may include cellulitis,
ulcers, bites, lacerations, trauma; plus post-surgery, influenza, dehydration, and hypoglycaemia have no
specific discharge instructions.
Contract Management including Health Services Management

It was identified that there are a number of outsourced services are utilised by the Solomon Islands GBR
Including food services for patients and accommodation for staff. The Biomedical equipment is services and
calibrated by NOVA and the records are available to the In-Country Manager and the Logistics manager.
Equipment sighted in the clinical areas was current for calibration and safety testing.
Customer Satisfaction and complaints : ISO 9001:2008 8.2.1

This information is managed by the primary care team and collated monthly and reports the AFP and RAMSI
clients by the In-Country Manager. Sampled It was identified that in 2013 ward patient had 31 surveys
offered and return rate of 49% in the primary care there were 2187 patients and 377 responded to the
survey with an average satisfaction rating of 4.94% over 5 key questions being 98.8 % were satisfied .
Diane Flecknoe-
Report Author
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Assessment Report.
Complaints management standard operating procedure AMCGP03 is in the ICMT tab on the quality
management system that may relate to patient safety, policy and clinical complaint.
These are referred to the In-Country Manager initially and then the clinical Senior Medical Officer; document in
the monthly report as per the key performance indicators with target of nil. To date there have been no
formal complaints.
Opportunity for improvement.

Type Area/Process Clause
Opportunity for Customer satisfaction and complaints 8.2.1
improvement
Scope FS 565793
Details: It was identified that staff satisfaction is not clearly captured or documented at
the Solomon Islands GBR.
Opportunity for improvement
Management Review : ISO 9001:2008 5.6

Internal communications are consistent with the daily briefing in the morning every day as per the guidelines
AMSIOGLo1 v 2 Oct 2013, A handover checklist is used and another handover occurs at 430pm when there is
a shift change. The daily briefing is documented by the In-Country Manager with the team on duty and the
daily report incudes HSE Logistics, communication, resources management, changes to policy and procedure
AMQMS the workplace. The weekly meetings are held with all staff and documented on AMSICMT 01 the
minutes. Minutes of the 17/09/2014, 26/09/2014 were sighted. A monthly report is generated to head
office at Aspen Medical and the quality meetings are held quarterly on site only.
The current management challenges include the sense of isolation from Australia, the climate, the local
politics, and the rewards are the team focus, patient care and right outcomes, with mostly positive feedback.
Service delivery Planning and Verification processes : ISO 9001:2008 7.1 7.2 7.5
CLINICAL GOVERNANCE
The services at the Solomon Islands GBR are in primary care and acute care. The Hospital is staffed by
Registered Nurses, Paramedics and a surgeon (qualified in South Africa not AHPRA registered) and an
anaesthetist are posted at this site to manage acute surgery and medical cases and trauma. Credentialing of
the Specialist Medical Practitioners is conducted at the Aspen Medical head office. The In-Country Manager is
notified of the changes in postings and currently accepts the postings. Currently the surgeon is on a one
year contract, the anaesthetist (qualified in Germany and not AHPRA registered) who attended during the
audit was on a one week rotation. During the audit the In-Country Manager commented that a surgeon had
been posted the Solomon Islands GBR who had restrictions on AHPRA registration for prescribing dangerous
drugs.
The ward has 10 acute care beds - 2 are isolation beds. Emergency equipment, clinical consumables, medical
gases are in supply and accessible to each bed the nurse station is central and all patients can be observed.
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Report Author
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Assessment Report.
Operating Theatre work instructions

It was identified that the standard operating procedure for managing a surgical count IAW Acorn standards is
not in the quality management system - regardless of the type of surgical procedure. Clinical Governance
process.
***Currently the onsite Clinical Governance to review clinical policy and procedures, relative to the in-patient
unit to ensure right practice, is not monitored in a regular meeting by the In-Country Manager, the senior
Paramedic or Registered Nurse and the Senior Medical Officer.
Dental services have been discontinued and there is no pharmacist at the GBR
Medication Safety
The Solomon Island GBR has a supply of medication in the primary care area and in the Hospital. Anaesthetic
agents are kept in the Operating Theatre. Currently there is no pharmacist and the medication are prescribed
and dispensed by the Senior Medical Practitioner. Paramedics have a stock of s4 and s8 medication in their
kits for the ambulances. In the Hospital the NIMC is being applied for each patient.
Vaccines are stored in the drug fridge. Fridges are temp monitored and logs are kept daily. The evidence
was sighted during the audit to verify the process.
Dangerous drugs are maintained in the locked cupboards and a register is maintained.
Antibiotics are regularly prescribed in primary care and in the hospital. The use and volume of drugs used
are reported in the monthly management report. Patients having medication usually have associated
pathology specimens collected and sent to a major Laboratory in Brisbane (S&N).
Emergency services
Emergency services include admission of patients with acute surgical and medical conditions. Patients who
require escalated care are evacuated to either Brisbane or Darwin by Care flight. The aircraft have access to
the medical centre by the helipad adjacent to the hospital. Aero medical retrievals and evacuation may occur
up to 15 times per month and the local patients are transported to the National Referral Hospital off base or
expats are transported to Australia.
It is noted that the Solomon Islands national general elections are due in the near future and it is anticipated
that there will be considerable civil unrest. The last riot in Honiara was a few months ago and there were
several injured AFP personnel who required clinical attention at the GBR centre. The In-Country Manager
commented that e GBR is preparing to meet the potential challenges of emergency response.
Currently staffing is a limited complement. The ward is only staffed by a paramedic during the day and a
Registered Nurse is on duty at night and on weekends. During the day a Paramedic manages in patients
under guidance of a Medical Practitioner. A Registered Nurse is on call if required during the week days.
Blood Transfusion And Blood Products Management

The Solomon Islands GBR has a supply of blood for emergency use. The blood is stored in a monitored blood
fridge in the triage room. The 12 units of red cells are always rotated before expiry and logged in the blood
register. Blood is supplied via the red Cross in Brisbane and transported by air every 3rd Thursday. and the
process for managing expired blood the target wastage target is 5%.
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Report Author
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Assessment Report.
Observation: It was identified that the target is not consistent with the National Blood Authority Guidelines
being 2%.
*** It was identified on the 25th Sept a supply of 6 units of blood dispatched to the Solomon Islands by Red
Cross was lost in transit. The email trail between the site and the logistics officer at the site at head office in
Brisbane revealed the airline had not managed the delivery as requested.
Infection Control
Infection control is not documented in policy and procedure. However Hand Hygiene is applied with solutions
disposable gloves and isolation capability for patients, the ward and other suite and working areas are air-
conditioned, clinical waste chemical waste and the sharps waste is managed by sharps containers and yellow
bags that are removed for incineration.
***It was identified that there is no clear infection control plan for management in the ward or the Operating
Theatre and cssd, High Dependency Unit or primary care department.
***It was identified that there is no competency assessment on the matrix for infection control or Hand
Hygiene. Hand Hygiene signage is not evident in all clinical areas and hand washing facilities including food
prep areas in the Hospital.
Outbreak management is in place for gastroenteritis, dengue fever, influenza. The policies and procedures
and process were demonstrated during the audit. A comprehensive PowerPoint presentation is on the
quality management system to educate staff and map out the management processes.
Radiation safety is observed and managed by the radiographer certificate of currency. This process and
evidence was sighted during the audit in the Operating Theatre unit.
Education, training and clinical competency

There is a training matrix and it is site specific to capture each person on site and the scope of the training is
document, It was identified that there are some areas where further assessment is required for clinical staff
such as basic life support advanced life support.
Patients Process sampled

During the audit a patient had been admitted for assessment of an illness. 09/10/2014
The medical record is generated in hard copy to include patient identification bradma labels; the identification
number is referred to by the AFP unit number. The patient is to be logged into the admission and discharge
book the last entry was on the 08/10 Sept. therefore no admissions have been logged for about 10 days.
Notification of admission is required to relevant Executive and reporting officers. In the case of an infection
status or diagnosis the Environmental officer is alerted.
The patient profile is captured on the patient history form and scanned in to the file on Medical Director.
The ward is alerted by a call.
The patient identifiers are 2 identifiers and an allergy alert as well as admission number.
This process could be improved to be in line with Australian guidelines.
The patient identification band is applied as per the national guidelines- a white band is applied and if there
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Report Author
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Assessment Report.
is a clinical alert a red band is applied. The only clinical alert noted 1 allergy; this could be reconsidered in
line with best practice.
In patient clinical documentation includes the nursing care plan - AMSIWARDF13 v 2 - dated 2012 (needs
review), FRAT, the Observation chart is still in the old format and a new track and trigger form is yet to be
introduced.
It was identified that the patient who was admitted had documentation to include a triage assessment form
AMSSICLINF01 dated sept 2013, iv fluids orders, fluid balance chart, a nursing care plan, NIMC to log
medications, nursing progress notes are documented in Medical Director.
***It was identified that a draft copy of a form was sighted that reflected the format of a track and trigger
but was not approved for use and the Observation form was not consistent with national specifications or
document controlled, nor approved in a Clinical Governance process.
The Senior Medical Officer writes a discharge letter in hand writing that is sent to the receiving health
service. The Medical Practitioner also writes notes in the Medical Director program.
Internal Audits : ISO 9001:2008 8.2.2

The annual internal audit plan is in place. It was identified that that the plan is not clearly risk rated to
identify areas of importance to ensure more rigor in the internal auditing especially in the high risk clinical
areas of the Hospital. It was identified that some internal audits were overdue however the Aspen Medical
Quality Manager has assisted in a comprehensive internal audit prior to the external audit.
***It was identified that the Operating Theatre the recovery room, anaesthesia, medication safety, infection
control aseptic technique was audited in sept 2014 yet the corrective action has not been applied for the non-
conformances, compliance with AS 4187, compliance with ACORN standards, anti-microbial stewardship, blood
safety. Audits of completion of documentation in medical records. Right practice in clinical governance.

Opportunity for Internal Audits 7.2.1
improvement
Scope FS 565793
Details: 1 It was identified that currently there is no active anti-microbial stewardship
being applied or monitored to validate the use and appropriateness and
effectiveness of the antibiotics prescribed as required by Australian national
Guidelines.
2 It was identified that the Quality Coordinator and the Senior Medical Officer
have recently conducted an internal audit (Aug 2014) that identified 9 non-
conformances out of 13 indicators regarding the use and management of S8
medication. Corrective action is required and a repeat internal audit asap.
Diane Flecknoe-
Report Author
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Assessment Report.

Opportunity for Internal Audits 6.4
improvement
Scope FS 565793
Details: It was identified that the hot water in the ward and in the new clinical area in
the Operating Theatre
Suite is not temperature controlled and the temperatures are not measured
and or logged on a regular scheduled.
Staff are at risk of scalding water is currently being tested for cleanliness in
contamination prior to the new Operating Theatre opening. Occupational
Health and Safety issues.
Data analysis and key performance indicators : ISO 9001:2008 8.4

The Solomon Islands GBR management report measures of performance quarterly to the AFP management,
RAMSI agents and Aspen Medical. The 9 key measures are based on the key service requirement in the
contract with the AFP. The trends and tracking of performance is graphed. The dependency client base, for
the year and each month, daily attendance rates in primary care, paediatric attendance rates, clinical case
mix included dermatological conditions, routine medicals, counselling and specimen collection, top 10
conditions, inpatient days, use of mobile surgery unit – 0 in three months, allied health pathology specimens,
radiology investigations, medication useage food safety notifiable incidents, complaints. The target for
each key performance indicators per criteria is documented. Noticeable spikes in trends related to outbreaks
of gastroenteritis. An outbreak had been alerted during the audit.
***It was identified that there are no clear clinical indicators in place at the Solomon Islands GBR health
services. The measurement of performance for clinical outcomes is not in place.
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Report Author
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Assessment Report.
Non Conformance Reporting : ISO 9001:2008 8.3

The standard operating procedure is in place in the quality management system AMQMS02 and the process
includes a reporting form and Riskman is the primary reporting vehicle the challenges in the Solomon Islands
GBR is that the internet access is not always strong and the option of reporting and non-conformance
reporting is the Non Conformance Reporting incident form.
It was identified that the non-conformance reporting register also includes opportunity for improvement that
are raised in the internal audits. Since January 2014 a total of 26 Non Conformance Reporting / opportunities
for improvement have been raised and 4 remain outstanding since Sept. 2014 in the Lorna and these issues
will be reviewed and closed out at the next staff meeting.
Observations.
Observations Non Conformance Reporting 8.3
Scope FS 565793
Details: Observation: Entries in Riskman in the past year are unclear as the In-Country
Manager has access to the entries and journal of progress for each entry and he
was unavailable at the time of this audit process during the audit.
Corrective action : ISO 9001:2008 8.5.2

The corrective action standard operating procedure is documented in the quality management system quality
manual. The process is applied after the internal audit and documented in the register and evidence of the
progress is summarised. The evidence was demonstrable during the audit.

Opportunity for Corrective action 8.5.2
improvement
Scope FS 565793
Details: Observation: It was identified that the report register does not have a column to
identify that the issues are actually closed out and linked to the non-conformance
reporting report form and the date and authority to close out to enable
accountability.
Diane Flecknoe-
Report Author
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Assessment Report.
Preventive action :
ISO 9001:2008 8.5.3
The standard operating procedure is AMQMS02 incorporated in the non-conformance reporting process
management. This was sighted during the audit. Riskman is able to generate reports to present at the quality
meetings to identify high risk issues, track and trend of issues as well as enable decision making to prevent
ongoing adverse events. Preventive action is applied through the internal audit program to ensure that policy
and procedure are current and appropriate, the controls on purchasing and stock management, the
equipment services calibration provided by Nova Medical, environmental management.
Continuing quality improvement

ISO 9001:2008 8.5
The quality management system needs to be reviewed to include more clinical standard operating
procedures related to the ward and the Operating Theatre and anaesthetic practices, in line with right
practice in acute care service delivery.
The system is fragile and at risk of not being comprehensively managed to support all the activities in the
clinical, operational and business of the Solomon Islands GBR. The new Quality Coordinator has no
background in the health sector and has had no formal training in the standard nor internal auditing and this
is a concern.
In the recertification audit all areas will be reviewed for conformance and compliance to ISO 9001:2008.
During the course of the visit logos were found to be used correctly.
Diane Flecknoe-
Report Author
Brown Page 11 of 26
Assessment Report.
Nonconformities Raised at Last Assessment.

Ref Area/Process Clause
975186N10 PERFORMANCE MEASURES 4.2.3
Scope FS 565793
Details: It was identified that that e policy and procedure are in policies and procedures
however the documents include hand written amendments and need to be reviewed
by the Quality Clinical Team for updates and ensure currency to incorporate the
required changes.
Requirements:
Control of documents
Documents required by the quality management system shall be controlled. Records
are a special type of document and shall be controlled according to the requirements
given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are
identified,
d) to ensure that relevant versions of applicable documents are available at points of
use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are
identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
Objective Changes to work instruction and policy are written in handwriting and are nor
Evidence: approved as per the document control process
Actions: 08-10-2014 - A review of the effectiveness of the corrective action implemented.
There was a staff meeting in August 2014 to advise new staff that eh poo in the
quality management system are not to be changed or amended without authority by
the Project Manager. A process map to define and IAW the document control
procedure is being added to the document control protocol to educate new
personnel.
This finding can be closed out however in the ongoing internal audits and monitoring
of the quality management system by the new Quality Coordinator will manage the
document control as the gatekeeper as approved by the In Country Manager. This
process will be assessed in the recertification audit as it is a mandatory procedures
as required by the standard. 4.2.3
Closed?: Yes
Diane Flecknoe-
Report Author
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Assessment Report.

975186N3 HUMAN RESOURCES 6.2.2
Scope FS 565793
Details: Clinical competencies are not specifically linked to the position descriptions and the
clinical governance process is not robust to ensure that the required competencies
are verified.
Requirements:
Competence, training and awareness
The organization shall
a) determine the necessary competence for personnel performing work affecting
conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary
competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see
4.2.4).
Objective There was no clear evidence of this requirement for clinicians in high risk areas.
Evidence:
Actions: 08-10-2014 - review of the effectiveness of the corrective action implemented.
There is a training matrix and it is site specific to capture each person on site and
the scope of the training is document. It was identified that there are some areas
where further assessment is required for clinical staff such as basic life support
advanced life support.
It was identified that there is no competency assessment on the matrix for infection
control or Hand Hygiene. Further monitoring of this process is required by the
Quality Coordinator. A finding will be raised on this issue.
Closed?: Yes

975186N5 CLINICAL PROCESSES 7.2.1
Scope FS 565793
Details: It was identified that there is no work instruction in place to scope the admission of a
child, nor the notation of a minimum or maximum child age group up to 16 years to
support clinical processes and treatments, no reference to accompanying parent or
guardians, medication management or dietary considerations for children.
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Assessment Report.
Requirements:
Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery
and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended
use, where known,
c) statutory and regulatory requirements applicable to the product, and
d) any additional requirements considered necessary by the organization.
Objective Children are admitted to the hospital from time to time and up to four or five days at
Evidence: a time.
The standard operating procedure AMSCLINP 27 is dated July 2014 states ate
purpose of the policy for the admission of children to the GBR in Patient facility. The
child must be a dependant of an AFP person a parent or guardian who must be in
attendance; non critical conditions are accepted. The new policy and procedure has
protocols for the admission of a child to identify the clinical criteria to accept an
admission, and document parental consent. Required clinical expertise to manage
the sick children needs to be identified in line with clinical guidelines and right
practice.
The evidence was sighted during the audit to verify the process
Closed?: Yes

975186N7 CLINICAL PROCESSES 7.2
Scope FS 565793
Details: There was no clear evidence of a work instruction for the clinical administration of
blood red cells and blood products.
A minor non conformance is applied
Requirements: Customer-related processes
Objective It was identified that there is no cold chain process documented for the use and
Evidence: discard of blood and unused blood, there is no set target for blood product wastage
in line with the national Blood authority.
It was identified that the cold chain process for the management of blood red cell
pack is AMSIHO15 dated Sept 2014. and blood products the standard operating
procedure describes the process for maintaining the 12 units of red cells incoming
and the process for managing expired blood the target wastage target is 5%.
Sufficient evidence was sighted to close this finding. Blood integrity and
temperature is monitored by a tiny tag.
Diane Flecknoe-
Report Author
Brown Page 14 of 26
Assessment Report.
Closed?: Yes

975186N8 PRESERVATION OF THE SERVICES. 7.5.1
Scope FS 565793
Details: It was identified that a number of work instructions are not in place to support the
clinical processes
Requirements:
Control of production and service provision
The organization shall plan and carry out production and service provision under
controlled conditions. Controlled conditions shall include, as applicable,
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of product release, delivery and post-delivery activities.
Objective A deficiency in work instruction fro clinical processes such as surgical count
Evidence: admission of children the Solomon Islands GBR ward for in-patient care, the cold
chain management of blood transfusion and blood products, no set target for blood
wastage.
The standard operating procedure for managing blood transfusion and blood
products the standard operating procedure. Plus the standard operating procedure
for managing a child in the Operating Theatre is in place. Time in and time out is in
place, patient identification and consent process are captured on the form.
It was identified that the standard operating procedure for managing a surgical
count IAW Acorn standards is not in the quality management system. A new finding
will be raised to address this deficiency.
Closed?: Yes

975186N9 PERFORMANCE MEASURES 8.2.2
Scope FS 565793
Details: It was identified that tat e clinical process is in the Operating Theatre are not audited
to the ACORN standards. That aseptic technique is not audited across the clinical
workforce, the processes for scrubbing gowning and gloving, surgical count, as per
the standard operating procedures are not audited.
Diane Flecknoe-
Report Author
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Assessment Report.
Requirements:
Internal audit
The organization shall conduct internal audits at planned intervals to determine
whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this
International Standard and to the quality management system requirements
established by the organization, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and
importance of the processes and areas to be audited, as well as the results of
previous audits. The audit criteria, scope, frequency and methods shall be defined.
The selection of auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and
requirements for planning and conducting audits, establishing records and reporting
results.
Records of the audits and their results shall be maintained (see 4.2.4).
The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue delay to
eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the
reporting of verification results
(see 8.5.2).
NOTE See ISO 19011 for guidance.
Objective The scope for Internal audits is not robust or risk planned in the clinical processes.
Evidence:
The internal audit plan is in place for 2014 the internal audit is inclusive of clinical
process and is continuing to developed the new Quality Coordinator has the
responsibility to manage the internal audit process as per the plan. The internal audit
re assigned to individuals and will be assured that they do not audit their own
workstation. It has been determined that the new Quality Coordinator will also
supervise all internal audit being conducted to ensure the integrity of the internal
audit process. This was approved by the In-Country Manager.
Internal audit process and planning will be assessed for effectiveness and scope in
depth at the recertification audit.
Closed?: Yes
Diane Flecknoe-
Report Author
Brown Page 16 of 26
Assessment Report.
Minor Nonconformities Arising from this Assessment.

1118585N1 Customer Focus 7.1
Scope FS 565793
Details: Planning of product realization
Requirements:
The organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as
appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources
specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test
activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting
product meet requirements (see 4.2.4).
The output of this planning shall be in a form suitable for the organization's
method of operations.
NOTE 1 A document specifying the processes of the quality management system
(including the product realization processes) and the resources to be applied to a
specific product, project or contract can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the
development of product realization processes.
Objective There is no information about services offered, emergency services available and
Evidence: the patients’ Rights and Responsibilities, ability to make a complaint or a
compliment, or services provided for children.

1118585N2 Customer Focus 7.2.1
Scope FS 565793
Details: a) requirements specified by the customer, including the requirements for delivery
use,
Requirements:
Determination of requirements related to the product
The organization shall determine
Diane Flecknoe-
Report Author
Brown Page 17 of 26
Assessment Report.
a) requirements specified by the customer, including the requirements for delivery

use, where known,
c) statutory and regulatory requirements applicable to the product, and
d) any additional requirements considered necessary by the organization.
NOTE Post-delivery activities include, for example, actions under warranty
provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal.
Objective Patients who have other illness treated in the Hospital such as skin conditions that
Evidence: may include cellulitis, ulcers, bites, lacerations, trauma; plus post-surgery,
influenza, dehydration, and hypoglycaemia have no specific discharge instructions.

1118585N3 Internal Audits 7.1
Scope FS 565793
Details: Planning of service realization in a clinical setting a b c d
Requirements:
appropriate:
Objective ***It was identified that the Operating Theatre the recovery room, anaesthesia,
Evidence: medication safety, infection control aseptic technique was audited in sept 2014 yet
the corrective action has not been applied for the non-conformances, compliance
with AS 4187, compliance with ACORN standards, anti-microbial stewardship, blood
safety. Audits of completion of documentation in medical records. Right practice in
Diane Flecknoe-
Report Author
Brown Page 18 of 26
Assessment Report.
clinical governance.
A MINOR Non Conformance is applied

1118585N4 Internal Audits 7.2.2
Scope FS 565793
Details: Review of requirements related to the services in a high risk clinical setting
Requirements:
Review of requirements related to the product
The organization shall review the requirements related to the product. This review
shall be conducted prior to the organization's commitment to supply a product to
the customer (e.g. submission of tenders, acceptance of contracts or orders,
acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are
resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be
maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the
customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that
relevant documents are amended and that relevant personnel are made aware of
the changed requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for
each order. Instead the review can cover relevant product information such as
catalogues or advertising material.
Objective Currently the onsite Clinical Governance to review clinical policy and procedures,
Evidence: relative to the in-patient unit to ensure right practice, is not monitored in a regular
meeting by the In-Country Manager, the senior Paramedic or Registered Nurse and
the Senior Medical Officer.

Scope FS 565793
Details: Control of nonconforming service
Requirements:
The organization shall ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery.
A documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.
Diane Flecknoe-
Report Author
Brown Page 19 of 26
Assessment Report.
Where applicable, the organization shall deal with nonconforming product by one
or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application;
d) by taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.
When nonconforming product is corrected it shall be subject to re-verification to
demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained, shall be maintained (see 4.2.4).
Objective Control of nonconforming product

Evidence:

Scope FS 565793
Details: Planning of service realization and delivery
Requirements:
appropriate:
Objective It was identified that there is no clear infection control plan for management in the
Evidence: ward or the Operating Theatre and cssd, High Dependency Unit or primary care
Diane Flecknoe-
Report Author
Brown Page 20 of 26
Assessment Report.
department.
***It was identified that there is no competency assessment on the matrix for
infection control or Hand Hygiene.
Hand Hygiene signage is not evident in clinical areas.

1118585N7 Internal Audits 4.2.3
Scope FS 565793
Details: Control of documents
Requirements:
Documents required by the quality management system shall be controlled.
Records are a special type of document and shall be controlled according to the
requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are
identified,
d) to ensure that relevant versions of applicable documents are available at points
of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are
identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
Objective It was identified that a draft copy of a form was sighted that reflected the format
Evidence: of a track and trigger but was not approved for use and the Observation form was
not consistent with national specifications or document controlled, nor approved in
a Clinical Governance process.

1118585N8 Data analysis and key performance indicators 8.4
Scope FS 565793
Details: Analysis of data
Requirements:
Diane Flecknoe-
Report Author
Brown Page 21 of 26
Assessment Report.
The organization shall determine, collect and analyse appropriate data to

demonstrate the suitability and effectiveness of the quality management system
and to evaluate where continual improvement of the effectiveness of the quality
management system can be made. This shall include data generated as a result of
monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to

a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products, including opportunities for
preventive action (see 8.2.3 and 8.2.4), and
Objective It was identified that there are no clear clinical indicators in place at the Solomon
Evidence: Islands GBR health services. The measurement of performance for clinical
outcomes is not in place
Shift Details.
The shift patterns within the Solomon Islands GBR medical facility rotate on a regular and frequent basis
ensuring that a representative sample of shifts and appropriate staff are interviewed and seen over the
certification cycle. The centre operates 24 hours a days seven days per week with staff rostered according to
the workloads.
Other - see comments in the main body of this report
Diane Flecknoe-
Report Author
Brown Page 22 of 26
Assessment Report.
Assessment Participants.
On behalf of the organisation:
Name Position
Mr Vinod Gandhi Aspen Medical Quality Manager
Gavin Whiteside In-Country Manager
Rajeev Surgeon
Mata Witcombe Quality Co ordinator
Regitered Nurses Hospital
Tom Paramedic / Deputy In-Country Manager
Marcus Anaesthetist
The assessment was conducted on behalf of BSI by:
Name Position
Diane Flecknoe-Brown Team Leader
Continuing Assessment.
The programme of continuing assessment is detailed below.
Site Address Certificate Reference/Visit Cycle

Aspen Medical Pty. Ltd. FS 565793
GBR Medical Centre
Visit interval: 12 months
Honiara
Solomon Islands Visit duration: 2 Days
Next re-certification: 01/10/2015
Re-certification will be conducted on completion of the cycle, or sooner as required. An entire system re-
assessment visit will be required.
Diane Flecknoe-
Report Author
Brown Page 23 of 26
Assessment Report.
Re-certification Plan.
ASPEN -0047277612-006|FS 565793
Visit Visit Visit Visit Visit Visit

1 2 3 4 5 6
Business area/Location Date (mm/yy): 09/11 09/12 09/13 09/14 09/15 09/16
Duration 1.0 2.0 1.5 1.5 2 1.5
(days):
Communication & committees X X X X X
Continual Improvement X X X X X X
Contract Management including Health Services X X X
Management
Corrective and Preventive action X X X X X
Customer and staff satisfaction X X X X X X
Data Indicator Analysis Trending X X X X X X
Dental Services X X X
Diagnostic Services including pathology & radiology X X X
Documents and records control X X X X X X
Education and Training X X X X
Emergency Resuscitation X X X
Environmental Services X X X
General requirements & system planning X X X X X X
Governance - Clinical X X X X X
High Dependency Unit X X X X X
Human Resources X X X X
Infection Control and CSSD X X X
Infrastructure & Provision of Resources X X X X
Inpatient Services X X X X X
Internal Audits X X X X X X
Logistics including purchasing and stores X X X
Maintenance & Calibration X X X X
Diane Flecknoe-
Report Author
Brown Page 24 of 26
Assessment Report.
Management of customer property X X X X X

Management Review X X X X X X
Management commitment X X X X X X
Medical Retrieval Services X X X X
Non conformance Incidents and Complaints a X X X X X
Objectives & policies X X X X X X
OH&S -Emergency Procedures X X
Medication Safety X X X X
Primary Health Services X X X X
Quality planning X X X X X X
Next Visit Plan.

Visit objectives:
The scope of the assessment is the documented management system with relation to the requirements of
ISO 9001:2008 and the defined assessment plan provided in terms of locations and areas of the system and
organisation to be assessed.
Re-certification Opt 2
The objective of the assessment is to conduct a re-assessment of the existing certification to ensure the
elements of the proposed scope of registration and the requirements of the management standard are
effectively addressed by the organisation's management system.
Diane Flecknoe-
Report Author
Brown Page 25 of 26
Assessment Report.
Please note that BSI reserves the right to apply a charge equivalent to the full daily rate for cancellation of
the visit by the organisation within 30 days of an agreed visit date.
Notes.
The assessment was based on sampling and therefore nonconformities may exist which have not been
identified.
If you wish to distribute copies of this report external to your organisation, then all pages must be included.
BSI, its staff and agents shall keep confidential all information relating to your organisation and shall not
disclose any such information to any third party, except that in the public domain or required by law or
relevant accreditation bodies. BSI staff, agents and accreditation bodies have signed individual
confidentiality undertakings and will only receive confidential information on a 'need to know' basis.
This report and related documents is prepared for and only for BSI’s client and for no other purpose. As
such, BSI does not accept or assume any responsibility (legal or otherwise) or accept any liability for or in
connection with any other purpose for which the Report may be used, or to any other person to whom the
Report is shown or in to whose hands it may come, and no other persons shall be entitled to rely on the
Report.
Should you wish to speak with BSI in relation to your registration, please contact your customer service
officer.
BSI Group ANZ Pty Ltd

Suite 2, Level 7
15 Talavera Road
Macquarie Park
NSW 2113
Tel: 1300 730 134 (International: +61 (2) 8877 7100)
Fax: 1300 730 135 (International: +61 (2) 8877 7120)
E-mail (for corrective action plans): Please e-mail your corrective action plan to clientservices@bsigroup.com
Diane Flecknoe-
Report Author
Brown Page 26 of 26

(2014-10) Solomon Islands GBR Assessment Report

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Assessment Report.

Aspen Medical Pty. Ltd.

Solomon Islands GBR Medical Facility

Visit ref/Type/Date/Duration Certificate/Standard Site address

AREAS ASSESSED & FINDINGS.

Documents and Records control

Document Control ISO 9001:2008 4.2.3

Record Control ISO 9001:2008 4.2.4

Customer Focus : ISO 9001:2008 5.2

Contract Management including Health Services Management

Customer Satisfaction and complaints : ISO 9001:2008 8.2.1

Opportunity for improvement.

Management Review : ISO 9001:2008 5.6

Operating Theatre work instructions

Blood Transfusion And Blood Products Management

Education, training and clinical competency

Patients Process sampled

This process could be improved to be in line with Australian guidelines.

Internal Audits : ISO 9001:2008 8.2.2

Opportunity for improvement.

Type Area/Process Clause

Data analysis and key performance indicators : ISO 9001:2008 8.4

Non Conformance Reporting : ISO 9001:2008 8.3

Corrective action : ISO 9001:2008 8.5.2

Opportunity for improvement.

Continuing quality improvement

Nonconformities Raised at Last Assessment.

Ref Area/Process Clause

Ref Area/Process Clause

Ref Area/Process Clause

Ref Area/Process Clause

Ref Area/Process Clause

Minor Nonconformities Arising from this Assessment.

Ref Area/Process Clause

Ref Area/Process Clause

a) requirements specified by the customer, including the requirements for delivery

Ref Area/Process Clause

Ref Area/Process Clause

Ref Area/Process Clause

Objective Control of nonconforming product

Ref Area/Process Clause

Ref Area/Process Clause

Ref Area/Process Clause

The organization shall determine, collect and analyse appropriate data to

The analysis of data shall provide information relating to

Other - see comments in the main body of this report

The assessment was conducted on behalf of BSI by:

Site Address Certificate Reference/Visit Cycle

ASPEN -0047277612-006|FS 565793

Visit Visit Visit Visit Visit Visit

Management of customer property X X X X X

Next Visit Plan.

BSI Group ANZ Pty Ltd

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