Select Committee on Health Written Evidence


APPENDIX 20

Memorandum by the Royal College of Pathologists (GP25)

"Out of Hours" reporting of markedly abnormal laboratory test results to primary care: whose responsibility and what to do?

1.  DEFINITIONS

  Out of Hours: That period of the working week when the Primary Care Centre is unmanned and/or responsibility for patient care has been passed from the normal General Practitioner (GP) to a deputising service.

  Markedly Abnormal Laboratory Test Result: A markedly abnormal result that may signify a pathophysiological state that may be life threatening or of immediate clinical significance and which requires urgent action. A list of such markedly abnormal laboratory test results requires to be agreed between stakeholders. Please see Annex listing suggested triggers for contacting primary care services Out of Hours.

2.  INTRODUCTION

  The Royal College of Pathologists (RCPath) has recently become aware of several serious untoward incidents, relating to the inability of laboratory staff to find an appropriate primary care physician to act on a life-threatening or markedly abnormal test result. The Regional Councils of the RCPath provided examples of such incidents or near misses and these have been collated to identify important themes and to form the basis of these guidelines.

  The problems in reporting and acting on markedly abnormal laboratory test results fall into three main areas.

    —  Laboratory staff knowing whom to contact when a GP surgery is closed and knowing how to make that contact.

    —  Staff at the GP deputising service appreciating the importance of the abnormal result and being willing to accept responsibility for a result that was generated through a request made by the GP or other appropriate primary care staff within normal working hours.

    —  Staff at the GP deputising service being able to contact the patient and access patient records as part of the corrective action.

Examples:

    "The telephone receptionist who answered the phone and took the results had no idea how abnormal the results were and was relying on my judgement to call a doctor, which she seemed reluctant to do."

    "Some years ago we established that it is the responsibility of the General Practitioner Deputising Service (GPDS) to follow up abnormal results out of hours. The problem that we now face is that the request form often does not include the patient's address (the return address is given as the GP's surgery, which is closed out of hours). Therefore when we contact the GPDS with grossly abnormal results, they cannot act on them in a high proportion of cases. The GPDS then returns to the laboratory asking for further contact information which may not be available!"

3.  GENERAL PRINCIPLE

  The responsibility of the laboratory staff is to communicate the markedly abnormal test result to the clinical team—either to the GP who made the request or to the GP deputising service. It is the responsibility of the clinical team to act upon that abnormal result in the interests of the patient (or the community in the event of an infectious disease).

4.  IDENTIFYING AN ABNORMAL LABORATORY TEST RESULT

  Agreement is required between all stakeholders on what constitutes a markedly abnormal laboratory test result. A failsafe method is required within the laboratory to help biomedical scientist staff (BMS) to identify results that fall within the agreed abnormal category. Junior BMS staff should be able to contact senior members of the department (medical staff or clinical scientists) out of hours and pass to them the responsibility for communicating a markedly abnormal result to the relevant primary care physician.

5.  COMMUNICATING AN ABNORMAL LABORATORY TEST RESULT

  Primary Care Centres should inform the laboratory of specific arrangements for making telephone contact with a GP out of hours. Laboratories should collate this information into a formal document and display it in a prominent place. Senior members of the laboratory department should be able to access this information at all times.

  When reporting a markedly abnormal result out of hours, laboratory staff are required to give the following information:

    —  the name and date of birth of the patient together with any unique patient identifier;

    —  the abnormal test result (and reference range if requested);

    —  the date and time of the request;

    —  the name of the requesting physician and/or the practice number;

    —  as much clinical history as is available; and

    —  contact details for the patient, including address and telephone number.

  Where appropriate they may also advise on a recommended course of action.

  Laboratories should maintain records of all abnormal results communicated out of hours. The record should include the information specified above together with the name of the person to whom the result was communicated and the date and time of the communication, and any advice given.

6.  PROVIDING ADEQUATE PATIENT INFORMATION WITH THE REQUEST

  General Practitioners who fill in request forms for the laboratory should always consider the possibility that the request may generate an abnormal result that may have to be communicated out of hours to another doctor. Therefore, GP request forms should be designed to accommodate the information specified in the above section and GPs should provide all the necessary details in a legible fashion.

7.  TAKING ACTION ON AN ABNORMAL LABORATORY RESULT

  The doctor receiving the markedly abnormal laboratory test result must decide how to act in the best interests of the patient (or the community in the event of an infectious disease). Each case should be treated according to it's individual circumstances. Action may include the following:

    —  contact with the GP who made the request;

    —  direct contact with the patient;

    —  generation of a follow-up request; and

    —  liaison with Health Protection staff.

8.  STAKEHOLDERS

  The following are stakeholders in facilitating the effective communication of markedly abnormal laboratory test results out of hours:

    —  Laboratory staff (BMS, medical staff and clinical scientists).

    —  General Practitioners and Community Midwives.

    —  Primary Care Trusts (PCT) or Operating Divisions (Scotland).

    —  GP co-operatives.

    —  GP deputising services, including NHS Direct, and NHS24 (Scotland).

    —  Health Protection Teams.

    —  Professional bodies (RCPath, RCGP).

    —  Patient representatives.

9.  RECOMMENDATIONS FOR FURTHER ACTION

  1.  PCTs and GPs should have an explicit agreement to ensure that a markedly abnormal test result can be received out of hours and, if necessary, acted upon. In practice PCTs are likely to negotiate a deputising service to cover several Primary Care Centres and this should be one function of that deputising service.

  2.  PCTs and GPs should have an agreement on the handover of responsibility to any out of hours GP deputising service and ensure that the laboratory is informed of the key elements of that agreement.

  3.  It is the responsibility of the requesting GP (or Community Midwife) to complete the request form with sufficient patient details and clinical information to permit effective out of hours communication between the laboratory and any deputising service. Consideration needs to be given to confidentiality and data protection issues relating to the inclusion of the patient's telephone number on the request form.

  4.  Responsibility for communicating the markedly abnormal test result to the GP or Midwife or deputising service out of hours should be handed from a junior BMS staff member on call to the designated senior member of the department who is on call.

  5.  Laboratory staff should maintain detailed records of all abnormal test results communicated out of hours.

  6.  GPs should examine practical ways to assist deputising services to obtain access to patient records out of hours.

Annex

ABNORMAL LABORATORY TEST RESULTS—TRIGGERS FOR CONTACTING PRIMARY CARE SERVICES OUT OF HOURS

1.  CLINICAL BIOCHEMISTRY

  Typical action limits for contacting GPs out of hours. These limits are based on the first abnormal set of results for an individual patient with no known history that could explain the results. Each laboratory is advised to agree specific action limits and procedures with local primary care services.

Analyte (Serum/Plasma)   Action Limits
Below Above

Sodiummmol/L120 160
Potassiummmol/L2.5 6.5
Ureammol/L-30
Creatinineumol/L- 500
Glucosemmol/L2.5 20
Calcium adjmmol/L1.8 3.5
Magnesiummmol/L0.4 -
Phosphatemmol/L0.3 -
ASTU/L- 750
ALTU/L- 750
Total CKU/L- 5000
AmylaseU/L- 1000
Carbamazepine mmol/L -100
Digoxinmmol/L- 3.5
Theophyllineumol/L- 250
Phenytoinumol/L- 150
Phenobarbitone umol/L -300
Lithium mmol/L- 1.5


2.  HAEMATOLOGY

  The focus of the guidelines is those few tests where urgent contact with GPs is required. Action required may include (i) immediate medical intervention, including admission to hospital or change in the patient's treatment or (ii) urgent referral for assessment during the next working day. While the decision to contact the primary care team will be based solely on the numerical values obtained, the assessment and clinical decision will depend on the clinical context. This is dependant on the input and knowledge of the attending clinician.

  Contact outside normal working hours often involves a deputising service when access to the patient can be difficult. However, this should not influence the decision to contact that should be based on the need for urgent (ie immediate) or next day medical intervention.

  The clinical context is crucial in the ultimate decision making and will not always be known to the laboratory and in these circumstances it is best to err on the side of caution. If the patient is known to the department and has had a similar result within the previous seven days then urgent contact is not necessary and the report can be processed as normal, whereas a "de novo" finding should always be responded to.

  If there is not an electronic link to the requesting clinician there should be a set of triggers for contact with the practice during the next working day.

2.1  Haemoglobin

  Lower limit would depend on the type of anaemia.

  < 5.0 microcytic and hypochromic

  < 5.0 macrocytic

  < 7.0 normochromic and normocytic (suggestive of bleeding)

  There must be separate criteria for renal patients.

  Upper limit (only require urgent referral if there are compounding medical problems)

  > 19.0 (or Hct > 54)

2.2  White Blood Cell count

  Lower limit—Neutropenia < 0.5

  Any presence of blast cells

  Upper limit (requires urgent but not immediate referral)

  Neutrophilia > 50

  Lymphocytosis > 50

2.3  Platelets

  Lower limit < 30

  Upper limit (only require urgent referral if there are compounding medical problems)

  > 1,000

2.4  Clotting Studies

  INR > 6.5 (on Warfarin)

2.5  Positive Malaria screen

3.  MICROBIOLOGY AND VIROLOGY

  Some Microbiology and Virology results may need to be reported urgently, particularly over a weekend or bank holiday, but also when GP surgeries are closed during the working week. Microbiology or Virology results may have additional implications for the public health of a community, as well as the individual patient, and would then need to be communicated to the local Health Protection Team, as well as the Primary Care Team. Results may be of particular significance if they relate to an outbreak of infection, possible deliberate release or have been obtained from the investigation of patients from an institutional setting, such as a school, prison or care home, where there is a significant infection risk.

  Increasing diversity of healthcare provision and patterns of care will require inclusion of clear arrangements within service specifications.

  It is the responsibility of the biomedical scientist who becomes aware of new results for primary care patients out of hours in the following categories to inform the senior virologist or microbiologist on call.

  The acute infections with outbreak potential (1) and acute hepatitis A or B (3) would also be notifiable to the local Health Protection team out of hours, depending on local arrangements with Health Protection Units. This would be a responsibility of the senior virologist/microbiologist on call.

  The following list is not exhaustive, but includes the most frequent or important infections requiring urgent contact with the primary care teams.

3.1  Acute infections with outbreak potential in close community or residential setting

    —  influenza;

    —  measles;

    —  mumps;

    —  norovirus;

    —  RSV;

    —  rubella;

    —  SARS;

    —  TB;

    —  diphtheria;

    —  Legionnaire's Disease;

    —  typhoid;

    —  paratyphoid;

    —  E coli O157; and

    —  cholera.

3.2  Acute infections in pregnancy that pose risk to pregnant/neonatal contacts

    —  parvovirus B19;

    —  rubella;

    —  varicella-zoster virus; and

    —  acute bacterial infections in pregnancy and the post partum period, for example Group A Streptococcus in a high vaginal swab.

3.3  Acute viral hepatitis (A, B) and any newly diagnosed hepatitis B for prophylaxis (HNIG/vaccine or HBIG)in some contacts.

3.4  Susceptibility to varicella in pregnant or immunocompromised contact for prophylaxis with VZIG for significant exposure

3.5  Significant positive blood culture results from patients who have been sent home for example from A&E or the Medical Assessment Unit

3.6  Antibiotic assay results from patients who are self-administering in the community.

June 2004





 
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Prepared 6 August 2004