Complaints

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Complaints

• Section 4.8 Resolutions of Complaints
• The laboratory shall have a policy and
• procedures for the resolution of complaints or
• other feedback received from clinicians,
• patients or other parties. Records of
• complaints and of investigations and
• corrective actions taken by the laboratory
• shall be maintained, as required.

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Complaints

• What is a Complaint?
• It is a real or perseived grievance

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Complaints

• Who is the Complainant?

• Hospital Environment
• The Patient
• The Clinician
• The doctor
• The Nurse

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Complaints

• Main Elements of a Customer Complaints
• System
• Method of documenting complaints
• - Document from phone, fax, written.
• - Issue complaint forms to customers.
• A clear description of the issue.
• Method of telling customers where to send their
  complaints to. Identified in-
• - Quality Manual
• - Issued with products/ services

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Complaints

• Main Elements of a Customer Complaints
• System contd
• Trained staff to receive and record complaints.
• Classification system-
• - Minor (Define)
• - Major (Define)
• Complaints classified as major must be acted on
  immediately.

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Complaints

• Main Elements of a Customer Complaints
• System contd
• Report system
• - Acknowledgement e.g. written 3 days.
• - Corrective action - Restore service
• - Refund
• - Investigation
  (Identify cause)
• - Preventative action
• What has to be done to prevent repeat
  occurance.

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Complaints

• Customer Satisfaction
• Surveys - Patient
• - Customer
• Use questionnaire to measure customer
  satisfaction.

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Complaints

• What should surveys measure?
• Waiting times
• Staffs attitude towards the customer
• Turnaround time
• Quality of the product or service

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Complaints

• Data extraction, review and reporting.
• Each question should have a customer satisfaction
  gradient e.g. 1 5 where 1 is poor and 5 is
  excellent or
• Variable measurements should be recorded and
  compared to the target value e.g. max waiting
  time 1 hr. Use statistics or problem solving
  tools to extract and extrapolate the data.

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Identification and Control of Non Conformities
(4.9)

• 4.9.1 - Laboratory management shall have a
• policy and procedure to be implemented when
• it detects that any aspect of its examinations
• does not conform with its own procedures or
• the agreed upon requirements of its quality
• management system or the requesting
• clinician. These shall ensure that-

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Non Conformities

• Personnel responsible for problem resolution are
  designated.
• The actions to be taken are defined.
• The medical significance of the non conforming
  examinations is considered and where appropriate,
  the requesting clinician informed.
• Examinations are halted and reports withheld as
  necessary.

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Non Conformities

• Corrective action is taken immediately.
• The results of non conforming examinations
  already released are recalled or appropriately
  identified, if necessary.
• The responsibility for authorisation of the
  resumption of examinations is defined.

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Non Conformities

• Each episode of non conformity is documented and
  recorded, with these records being reviewed at
  regular specified intervals by laboratory
  management to detect trends and initiate
  preventative action.

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Non Conformities

• Non conforming examinations or activities
• occur in many different areas and can be
• identified in many different ways, including
• clinician complaints, quality control
• indications, instrument calibrations, checking
• of consumable materials, staff comments,
• reporting and certificate checking, laboratory
• management reviews and internal and external
• audits.

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Corrective Action (4.10)

• 4.10.1 - Procedures for corrective action shall
• include an investigative process to determine
• the underlying cause or causes of the problem.
• These shall, where appropriate, lead to
• preventative actions. Corrective action shall
• be appropriate to the magnitude of the
• problem and commensurate with the risks
• encountered.

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Corrective Action

• 4.10.3 Laboratory management shall
• monitor the results of any corrective action
• taken, in order to ensure that they have been
• effective in overcoming the identified
• problems.

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Preventative Action (4.11)

• 4.11.1 Needed improvements and potential
• sources of non conformities, either technical
• or concerning the quality system, shall be
• identified. If preventative action is required,
• plans shall be developed, implemented and
• monitored to reduce the likelihood of the
• occurrence of such non conformities and to
• take advantage of the opportunities for
• improvement.

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Preventative Action

• 4.11.2 Procedures for preventative action
• shall include the initiation of such actions and
• application of controls to ensure that they are
• effective. Apart from the review of the
• operational procedures, preventative action
• might involve analysis of data, including trend
• and risk analyses and external quality
• assurance.

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Non Conformities

• What is a non-conformity?
• Not meeting specifications or stated requirements
  of practice, policy or procedures.
• Examples
• Using wrong reagents
• Unlabelled samples
• Equipment not calibrated
• Failed EQAS schemes
• Failed QC checks
• Equipment failure

Man Method Machine Mileau Material
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Non Conformities

• Essential Elements of a Non-Conformance
• System
• A clear discription of the issue
• Identification of who reported the issue
• A description of the corrective action taken and
  by whom
• Classification of the non-conformance major or
  minor
• Timely corrective action - access impact
• - cost (if any)

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Non Conformities

• Essential Elements of a Non-Conformance
• System contd
• Valid preventative action
• Management systems
• - Quality Management Review
• - Monthly report
• Measurement of the effectiveness of corrective/
  preventative action.

Measurement
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Non Conformities

• Standard Operating Procedure should-
• Identify issues which impact on quality
• Provide mechanisms for investigation of issues
• Provide management (Heads of Department) with
  information that empower them to make changes or
  justify a request for change.

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Typical Non Conformances

• Turnaround times
• Receipt and delivery of samples
• Labelling
• Equipment failure
• Quality control failure
• Third party assessment schemes