Quality knobhead here - details are required on reports, not SOPs. ISO 15189 states that docuements need to have:
a) All documents are identified to include:
— a title;
— a unique identifier on each page;
— the date of the current edition and/or edition number;
— page number to total number of pages (e.g. "Page 1 of 5," "Page 2 of 5,");
— authority for issue.
Information for users (ie lab handbook)
The laboratory shall have information available for patients and users of the laboratory services. The information shall include as appropriate:
a) the location of the laboratory;
b) types of clinical services offered by the laboratory including examinations referred to other laboratories;
c) opening hours of the laboratory;
d) the examinations offered by the laboratory including, as appropriate, information concerning samples required, primary sample volumes, special precautions, turnaround time, (which may also be provided in general categories or for groups of examinations), biological reference intervals, and clinical decision values;
e) instructions for completion of the request form;
f) instruction for preparation of the patient;
g) instructions for patient-collected samples;
h) instructions for transportation of samples, including any special handling needs;
i) any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed);
j) the laboratory’s criteria for accepting and rejecting samples;
k) a list of factors known to significantly affect the performance of the examination or the interpretation of the results;
I) availability of clinical advice on ordering of examinations and on interpretation of examination results;
m) the laboratory’s policy on protection of personal information;
n) the laboratory’s complaint procedure.
o) The laboratory shall have information available for patients and users that includes an explanation of the clinical procedure to be performed to enable informed consent. Importance of provision of patient and family information, where relevant (e.g. for interpreting genetic examination results), shall be explained to the patient and user.
Reports however need to include:
a) a clear, unambiguous identification of the examination including, where appropriate, the examination procedure;
b) the identification of the laboratory that issued the report;
c) identification of all examinations that have been performed by a referral laboratory;
d) patient identification and patient location on each page;
e) name or other unique identifier of the requester and the requester’s contact details;
f) date of primary sample collection (and time, when available and relevant to patient care);
g) type of primary sample;
h) measurement procedure, where appropriate;
i) examination results reported in SI units, units traceable to SI units, or other applicable units;
j) biological reference intervals, clinical decision values, or diagrams/nomograms supporting clinical decision values, where applicable;
k) interpretation of results, where appropriate;
l) other comments such as cautionary or explanatory notes (e.g. quality or adequacy of the primary sample which may have compromised the result, results/interpretations from referral laboratories, use of developmental procedure);
m) identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available;
n) identification of the person(s) reviewing the results and authorizing the release of the report (if not contained in the report, readily available when needed);
o) date of the report, and time of release (if not contained in the report, readily available when needed);
p) page number to total number of pages (e.g. “Page 1 of 5", "Page 2 of 5”, etc.).
These are the basic ISO requirements - Other standards may require further info ie JACIE/CLIA