ICSH Guideline for the Communication of Critical FBC Results

Barbara De la Salle Director, UK NEQAS Haematology

On behalf of the

ICSH Communication of Critical Results Working Group (Chair: Dr Tee Beng Keng)

Declarations

I have no financial interests to declare

Affiliation:

UK NEQAS Haematology and Transfusion operated by the West Herts Hospitals NHS Trust

The study was supported by the ICSH

Guideline accepted for publication in IJLH

For the ICSH Critical Results WG

• Dr Tee Beng Keng (lead author)

• Ms Barbara De la Salle

• Ms Gini Bourner

• Dr Anna Merino

• Dr Jin-Yeong Han

• Professor Yokho Kawai

• Professor Ming Ting Peng

• Mr Richard McCafferty

Outline

• Critical results and critical tests

• ICSH international questionnaire on current practice

• Critical results thresholds

• Critical results action list

• Critical results management protocol

• Defines the need for the laboratory to have a policy for the management of critical results 5.8.2 c) The laboratory shall ensure that critical results, where applicable are communicated effectively and meets the users’ needs

• An effective policy requires a list of critical results, tests and alert limits

ISO 15189: 2012

• A critical result is one that is so extremely abnormal that it represents a life threatening condition for which some corrective actions should be taken promptly – Lundberg GD. When to panic over abnormal values. Med

Lab Obs 1972;4:47-54

• A critical test is one so important that it should be reported immediately, whether normal or abnormal – Campbell CA, Horvath AR. Harmonization of critical result

management in laboratory medicine. Clinica Chemica Acta 2014;432:135-147

Critical results and critical tests

• What should be considered critical?

– Who defines critical tests and critical results?

– What are the alert thresholds?

• Are all abnormal results equally critical?

– Uniform alert thresholds for all patients?

– Allow exemptions by category of patient or by individual requesting clinician?

Defining a critical result

Massachusetts Coalition for the Prevention of Medical Errors

• Immediate danger of mortality or morbidity

• Direct notification to someone who can intervene

• Highly significant, not immediately threatening

• Notification by a high priority process

• May be significant if treatment not initiated in a timely manner

Massachusetts Coalition for the Prevention of Medical Errors (2005) Communicating critical test results – safe practice recommendations Jt Comm J Qual Patient Saf 31(2) 68- 80

• How quickly should results be notified?

• How are results notified?

• Who gives/receives results?

• How do you confirm receipt?

• Is information overload a danger?

• What action do you take if you can’t reach the responsible clinician or alternative?

• How do you balance the use of resources?

Notifying critical results/tests

ICSH Critical Results Questionnaire

• On-line survey (2014) • 21 questions: snapshot of laboratory practice

– Selected haematology tests • Critical results for FBC (CBC) • Critical blood film features

– Notification and documentation procedures

• 666 responses – Europe, Australasia, East Asia, SE Asia, N America,

Africa, Middle East – 384 complete data sets from laboratories with a

critical results management protocol

ALERT THRESHOLDS

Critical results management

Questionnaire Results: FBC alert thresholds

Parameter Lower Upper

Leucocytes (x109/L) 1.0 30

Neutrophils (x109/L) 0.5 Indeterminate

Haemoglobin (g/L) 70 200

Platelets (x109/L) 50 1000

• More gave a lower than an upper alert threshold • An upper threshold was more frequently stated for total

leucocytes than for neutrophils • Some limits appeared to be arbitrary Alert thresholds, as determined from the mode of the results returned :

ICSH Recommendations: FBC Alert Thresholds

Parameter Lower alert threshold Upper alert threshold

Leucocytes (x109/L) 2.0 100

Neutrophils (x109/L) 0.5 50

Haemoglobin (g/L) 70 200

Platelets (x109/L) 20 1000

Taking into account published literature and expert opinion the working group recommended the following thresholds, as a guide to the establishment of local alert thresholds:

Questionnaire Results: Critical Blood Film Features

ICSH Recommendations: Critical Blood Film Features

Acute Leukaemia (>20% blasts) Acute Promyelocytic Leukaemia Parasites, including Malaria Blood Film consistent with Thrombotic Microangiopathic Anaemia Blood Film showing bacteria

Images from - www.icsh.org/imagebank/ (Dr J Burthem, M Brereton) - Dr L Ahmed, Manchester UK - UK NEQAS Haematology

PROCEDURES

Critical results management

Questionnaire Results: Critical Results Management Protocol

Likelihood of the laboratory having a CRMP:

• 86.8% of accredited laboratories

• 63.7% of unaccredited laboratories

Review and audit rates were variable:

• 40.4% review annually

• 35.4% do not audit their CRMP

ICSH Recommendations: Critical Results Management Protocol (CRMP)

The CRMP must address: • The definition of critical results of tests

• The procedures for urgent notification of critical results to the clinical personnel responsible for the patient's care

• The ongoing review and audit process

The policy should be realistic and written with feedback from key stakeholders. The key stakeholders include but are not restricted

to laboratory staff, pathologists, and clinicians.

ICSH Recommendations: Review and Audit

• Review CRMP and update:

– Every 2 years

– Earlier if action thresholds or recommendations change

• Audit annually, possible indicators might be:

– % of critical results not communicated

– Average time taken to communicate critical results

– % of verbal notifications where read back received

– % of notifications not documented by the laboratory

Questionnaire Results: Critical Results Alert List

• Compiled from multiple sources – Professional experience (71%) – In consultation with requesting clinicians (64%) – Departmental review (49%) – Published literature (49%) – International / national guidelines (35%)

• 30% do not allow exception from notification – Others allow exception for certain patient groups,

individual clinicians, within certain timeframes etc.

• Delta checking used by 45% of laboratories to decide if a result is critical

ICSH Recommendations: Critical Results Action List (CRAL)

• The CRAL must contain – The names of the tests – The units of measurement – The alert thresholds – The time limit for notification

• Be defined by the laboratory director in consultation with clinicians

• May allow different limits for specific patient groups • Should discourage ‘opting out’ by clinicians • Include policy for repeatedly critical results • Use delta checking to identify rapid changes in results • Be available to all stakeholders

Total Testing Process and Critical Results Management

Exclude preanalytical and analytical errors

Ensure correct contact details

Questionnaire Results: Notification of Results

• By scientists (64.8%), pathologists (58.9%), technical assistants (34.9%)

• To physicians – For hospital inpatients (95.6%) – For community outpatients (92.7%)

• To nurses (79.2%) • Telephone the most usual means (98.2%) • Read back policy in 77.6% of cases • Documented by most labs (85.9%) • Variable policy in the event of difficulty contacting the

responsible caregiver • Variable or no documented time limits (“ASAP”)

ICSH Recommendations: Notification of Results

Critical Results Management Protocol must include: • The individuals who may give result • The individuals who may receive result • A method of mutual identification of the patient between

reporter and receiver • The date and time that the sample was collected • The abnormal test result with the unit of measurement and

reference range • The urgency or significance of the result must be made

clear • The confirmation of correct transmission or “read-back” • The maintenance of confidentiality

ICSH Recommendations: Documentation

The laboratory must maintain records showing urgent notification of critical results, including: • The identity of the individual who delivered the result, if verbally

communicated. • The identity of the recipient of the result • The identity of the patient tested • The date and time that the sample was collected • The test performed • The abnormal test result with the unit of measurement and reference

range • The date and time that the communication was made or

acknowledgement of receipt of the result • Other relevant factors, such as difficulties encountered in result delivery

or whether “read-back” of verbally communicated result was obtained

Summary • Prompt notification of a critical result is

– Essential for good patient care – Essential for effective use of resources – A professional responsibility

• Critical Results Alert List must – Define what requires notification – Define the timeframe for notification

• Critical Results Management Protocol must – Be clear, consistent and credible – Use standardised terminology, where possible – Include verbal and electronic notification procedures – Ensure adequate documentation of notification of results – Be subject to regular review and audit

The WG thanks the following organisations for their support in distributing the questionnaire

• China National Center for Clinical Laboratories (NCCL) • Institute for Quality Management in Healthcare Ontario (IQMH) • Irish External Quality Assessment Scheme (IEQAS) • Japanese Society for Laboratory Haematology (JSLH) • Korean Society for Laboratory Haematology (KSLH) • Royal College of Pathologists in Australasia Quality Assurance

Programs (RCPA QAP) • Societa Italicano di Patalogia Clinica e Medicina di Laboratorio

(SIPMeL) • Spanish Society of Laboratory Haematology and Hemotherapy

(SEHH) • UK National External Quality Assessment Scheme for Haematology

(UK NEQAS Haematology)