Appendix 3 - final draft trt with notes from clinical design subgroup

Appendix 3 – Turnaround Times
REPORTING TIME CATEGORIES FOR TURNAROUND TIME FOR
CLINICAL BIOCHEMISTRY

This document has gone out to consultation with both the East of England Clinical
Biochemistry Professional Development Group and the Royal College of
Pathologists Speciality Advisory Committee (SAC) for Clinical Biochemistry.
Any laboratory service should be quality driven, including quality of analysis, quality
of delivery (the right result at the right time on the right patient in the right format),
innovative, flexible, cost effective and, most importantly, patient and clinical pathway
centred.
The service must support all requirements for the acute Trust.
It should not be refuted that turnaround time is a function of clinical need.

The vast majority of in-patient work is urgent and a rapid turnaround time is
essential.
Some GP work is required urgently.
Some common analytes are unstable and therefore speed is essential.
It should be noted that many aspects of a turnaround time pathway are outwith the
laboratory’s control. The biggest one having an impact on TAT is sample transport.
The other critical factor is the adequacy of the IT network.
It should be appreciated that it will be blood sciences which integrate haematology
and clinical biochemistry and, to some degree, specific areas of microbiology and
immunology.
This is precipitated by having the analytical platforms which have the ability to
analyse all these different analytes. One of the most important aspects is the
potential for having to split sample which can be even more time consuming than the
actual analytical process, namely this would be particularly relevant to paediatric
samples where one does not want to waste volume.
There needs to be mechanisms for safe pre-analytical collection and transport, e.g.
for CSF lactate/peruvate ratio, CSF neurotransmitters etc. and Gut Hormones.
Processes will become complex unless there are Region-wide investigations
protocols.
Finally, Major Incident Planning needs to be considered.
Appendix 3 – Turnaround Times
Reporting time
Category
Biochemistry test in this category
Calcium
Phosphate
Magnesium
Liver function incl Direct Bilirubin
Troponin
Therapeutic drugs (carbamazepine, phenytoin, theophylline, digoxin etc)
Paracetomol
Salicylate
Ethanol
Blood glucose
Blood gases
Quantitative HCG / pregnancy testing
Iron
Ammonia / lactate
Osmolality
Urine sodium, potassium and Osmolality
Thyroid function and Cortisol ( see below)
Toxicology (drugs of abuse, toxic alcohols) CRP High sensitivity CRP (neonatal sepsis) Gentamycin / vancomycin Urine electrolytes CSF xanthochromia Triglyceride for TPN patients Cortisol – but robust mechanism must exist to be able to deliver in < 2hrs when clinical indication dictates. Thyroid function – but must be able to deliver in < 2hrs when clinical indication dictates. Gonadotrophins Prolactin PTH Lipid profiles Gamm-GT Urate Microalbumin Immunosuppressants (cyclosporine, tacrolimus). Myeloma screening (serum and urine) Immunoglobulins Appendix 3 – Turnaround Times
HbA1c Bile acids Tumour markers – but mechanism must exist to provide in less than 8hrs when clinical indication dictates. Autoantibodies – but mechanism to provide < 8hrs must exist when clinical indication dictates. Thyroid antibodies. Oestradiol / progesterone. Testosterone. Trace metals (copper, zinc, selenium etc) Specialist endocrinology such as ACTH, growth hormone Vitamins. Metabolic studies such as organic acids, carnetine – but mechanism must exist to provide in < 24hrs. Specialist endocrinology such as 17-hydroxyprogesterone – but mechanism for < 24hr results must exist. Specialist endocrinology such as androstendione, DHEA, 11-deoxycortisol., renin, aldosterone. Immunology investigations have been in consultation with the Chair of the SAC for Immunology. Proviso: Immunology turnaround times will be very dependent on the local set up, e.g. ANA screen, ANCA screen and others. OCT 2010 DBF Appendix 3 – Turnaround Times
Cellular Pathology Reporting Time Categories:
for East of England Transforming Pathology
Services
Reporting time (adapted for cellular
Specimens in this category
pathology, excludes weekends)
Level 1 (immediate – 1 hour)
Frozen sections Intra-operative sentinel lymph node imprints One-stop FNA clinics Level 2 (1 hr – 6 hrs)
Transplant biopsies Moh’s surgery specimens Level 3 (6 hrs – 24 hrs)
Urgent/same day biopsies (without complete IHC) Urgent non-gynaecological cytology Level 4 (24 hrs – 72 hrs)
In-patient biopsy/non-gynaecological cytology (with complete IHC) Surgical resection specimens (urgent) Level 5 (72 hrs – 1 week)
Out-patient and GP biopsies Surgical resection specimens (routine) Gynaecological cytology Level 6 (>1 week)
Specialist external referrals Highly complex cases Decalcification specimens Adjunctive molecular testing Other Urgent Situations (Level 1)
Freezing fresh tissue, sampling for research No flexibility with timing of attendance as fixed by other members of team. Blood Sciences Reporting Time Categories (as proposed 17/06/2010 to be
adapted by the other pathology disciplines)
Level 1 - 7
Appendix 3 – Turnaround Times
NOTES/ CAVEATS
“Hot”/ “cold” categorisation is not straightforward in cellular pathology. Triage of
specimens may be best considered according to clinical need e.g. urgent, soon, routine.
Turnaround times do not inform where specimen is handled. Hot lab not an established
process in histopathology unlike other disciplines
Some urgency is due to logistical rather than clinical issues e.g. samples arriving late in
a cancer pathway. MDTs can lead to “artificial” pinch points in workload as they are
organised around other clinicians’ availability.
Very useful document available from RCPath around this and other parameters for safe
‘modernisation’ of pathology.
Also need to consider IT issues around availability of reports across sites, Trusts and
use of NHS number as facilitating identifier.
Reporting times above may be achievable in specialist departments but are thought too
ambitious for DGHs
Specialist external referrals may be more urgent than 1 week or more e.g. for MDTs and
may involve biopsies and small numbers of slides rather than whole resections
Turnaround times should include the final report and not encourage interim reports e.g.
without immunohistochemistry. The use of supplementary reports should be minimised
because of patient safety issues.

SS/RL July 2010
Updated September 2010 following consultation. SS


Appendix 3 – Turnaround Times
Time the sample is taken to the time the result is available at the bedside –
assessment for microbiology - DRAFT
An outline of what results (or activities) are required in what timeframe. It is accepted that logical groups of tests will follow from this - i.e. although a test may not necessarily be required in a short timescale, it is illogical to ‘split’ it off from one that is when it is being done on the same sample. An additional factor for Microbiology/Virology is that samples may need to be processed in a critical timeframe to prevent deterioration of the specimen. HBsAg, HIV antigen/antibody, HCV antibody for needlesticks/organ * gentamicin and vancomycin – dialysis, some pus, biopsy and fluid samples from normally sterile sites) ‘delicate’ organisms – culture and incubation started early – N gonorrhoeae, commencement of blood culture incubation, pernasal swabs for pertussis. VZV IgG, norovirus tests and urgent respiratory and CSF PCR AFB microscopy3 and inoculation of culture media inoculated <8 to give result in this timescale Confirmatory testing blood borne viruses Some non-urgent PCR (e.g. HBV and HCV treatment monitoring) Complex identification, typing, serology Notes
1. NICE guideline 102 – Bacterial meningitis and meningococcal septicaemia (2010)
2. Some clinical settings may require more urgent testing
3. Laboratory guidelines for the diagnosis of M. tuberculosis infection (2006)
4. Infectious Diseases in Pregnancy Screening Programme (2010)
Explanatory notes, to be read in conjunction with the table
1.
This has been prepared in consultation with colleagues in the region (through the Regional Microbiology Development Group) and the RCPath SAC. This is an initial draft proposal, providing a basic framework on which further development can be based. Further development will be required – for example users will also need to comment. For some tests there are standards and we have referred to these. Most people thought that we should state that routine microbiology samples need to be cultured within a certain timeframe: to prevent overgrowth, with all of its implications; and some samples require rapid culture to prevent loss of delicate organisms. Whilst certain tests may be required in different timescales: it is inefficient to have them performed in different places from one sample, requiring the specimen to be “split”, given infrastructure and staffing requirements there are also effectiveness and safety issues (such as timescale, deterioration, loss, mismatch, ability to go back to original sample) from a patient and user perspective around splitting samples and investigations. Natural groupings of tests will emerge. For each specimen the number of different steps in different places should be kept to a minimum e.g. for general bacteriology the microscopy and inoculation of culture plates to happen in the same laboratory. The number of transcriptions of patient data should be kept to a minimum. The ability of go back to a specimen to repeat an investigation should be maintained. Patients should not be inconvenienced e.g. by having to provide another sample because the original has been sent elsewhere. 10. Inevitably any service configuration will require ‘individualisation’ depending on many factors including patient mix, the test, the distance, originators on site staffing and infrastructure, transport and IT connectivity in place. Turnaround Times for Haematology and Blood Transfusion Laboratory
Services
Reporting time
Category (from time sample taken
to time result received by
requestor)
Haematology tests in this category
In patient INR/FBC – for care / discharge planning
decisions; chemo clinics & similar – the majority of these,
esp septic/ acutely ill patient (A&E, ITU, maternal
haemorrhage etc) are actually required in <1 hour

Blood Film for severe cytopaenia / Ac leukaemia / malaria
Coag screen – acute bleed / DIC
D-Dimer - ? VTE
Sickle screen – emergency pre-op
Urgent blood group & cross match / issue of blood & blood
products
ESR for ? polymyalgia/GCA Community FBC/INR including Lab INR check post “out of range” result on NPT Factor assay for monitoring of treatment in known haemophiliac with acute bleed or peri-operative Malarial parasites Blood film review (&? Marrow aspirate) of urgent abnormal FBC: ? ITP, Acute leukaemia, Malaria, etc antiglobulin test, Kleihauer, G6PD screen, plasma viscosity Majority primary care FBCs & blood films, coagulation screen, anti-Xa ESR, IM test Cold agglutinins Bone marrow aspirate in acute situation Immunophenotype for ? acute leukaemia reticulocytes Semi urgent (same day transfusion) cross match Routine Cross match; antenatal antibody screen B12, Folate, Ferritin Factor assays / Lupus inhibitor screen in prolonged APTT / PT Haemoglobinopathy investigation G6PD screen, Ham’s test / PNH screen Immunophenotype for haematologic malignancy Routine marrow aspirate Thrombophilia screen? Blood group / antibody screen - planned cared Molecular markers eg: JAK-2, HLA-H, BCR-ABL Serum EPO vWF multimer analysis; Thrombophilia screen? These times are from sample being taken to receipt of result. They have been derived following consultation with colleagues within the region (Haematology Professional Development group) and nationally (Intercollegiate Committee for Haematology, RCP & RCPAth). Turnaround times are significantly impacted upon by issues outwith the direct control of the laboratory, in particular transport from primary care & other distant sites. Rapid result delivery relies upon compatible integrated IT systems. Failsafe mechanisms to ensure continuity of service are crucial for all aspects of pathology provision in order to maintain safe patient care. Integration with Biochemistry and some aspects of microbiology into a “Blood Sciences” laboratory may enable easier & speedier reflex or secondary testing of some analytes, where the need for a further test only becomes apparent when the preliminary result is available. September 2010
Genetics Reporting Time categories

Reporting time
Category (from time sample taken to time
result received by requestor)


Genetics test in this category
None
Rapid Prenatal test results eg by FISH or PCR (not full
karyotype or Southern blotting) Blood spot test results eg raised IRT or tumour markers 7 National / professional reporting times

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