Role of Clinical History in Laboratory Diagnostics
The Supreme Purpose of History is a Better World ~ Herbert Hoover
‘History’ is derived from a Greek word which means ‘investigation’. Clinical history is made up of many different pieces of information that tell the complete story about an individual’s current and past health and forms an important part of diagnostic reasoning. A doctor’s first few minutes of history-taking and physical examination subsequently determines the path of diagnosis and effectiveness of treatment given.
Bridge between Laboratory Diagnostics and Clinics
Quite often laboratory diagnostics depends on the input of physicians and surgeons who are fully aware of the potentials and limitations of the specialty. A laboratory diagnosis is a blinded outcome of an investigation done on a human sample that acquires full meaning only when the laboratory medicine professional is fully cognizant of the essential clinical data, patient history and surgical findings.
A common assumption prevails among clinicians who believe that the laboratory medicine professionals given only a piece of a patient’s tissue or a few millilitres of fluid, have the entire wherewithal necessary to produce a statement of absolute truth at the end of his report. Sometimes, it is also presumed that any additional clinical history might prejudice the laboratory into producing a biased report. However, incomplete communication between the clinician and the pathologist may make diagnosis difficult or impossible. To perform intelligently, a pathologist must know the facts that have any bearings on the specific report being sought. To render a diagnosis of an inherently puzzling bit of specimen with only vague knowledge of its source and no concept of the clinical problem is as foolhardy as to undertake an appendectomy on the basis of hearsay evidence that the patient had a pain in his belly! For example, ‘history of lymphoma’ is a vague term and may not be adequate for the pathologist to appropriately triage a specimen for ancillary studies. Ideally a thorough oncologic history includes the presumptive diagnosis, location of tumour, clinical appearance of the lesion and information from any auxiliary test already done. Additionally, it has been noticed all over the world that requests for consultation in clinical pathology i.e. hematology, clinical chemistry or immunology, hardly ever come with any relevant history e.g. drug administration, when that may be crucial to test selection and test interpretation.
History-taking: A Lost Art?
When it comes to giving the pathologists the information they need to release a diagnostic report, a growing body of literature has shown that in too many instances, critical information is nowhere to be found. Missing information is a particularly vexing problem for patients who have been hospitalized.
Unlike in many high-income settings, where advancements in medical technology have, in most cases, been complementary to understanding disease pathogenesis and acquisition of core clinical skills, emerging evidence from many low- and middle-income countries like India, point to the contrary. There are widespread concerns about doctors’ declining time-allocation in history-taking and physical examination owing to over-reliance on results of diagnostic tests. The expansion of imaging and laboratory testing has inverted the diagnostic paradigm; clinicians are seen to be bypassing the bedside evaluation (history, interview and physical examination) for immediate testing.
Those Who Do Not Know History are Destined to Repeat It! ~ Edmund Burke
Recently, several articles have highlighted the role of inadequate clinical information contributing to diagnostic errors and amended reports in surgical pathology. Failure to obtain all relevant information contributes to one-fifth of diagnostic errors. Perhaps not surprisingly, it is estimated that missing information would probably hurt patient care in 44% of all patient visits, and produce delays in care or lead to additional services nearly 60% of the time.
A CAP Q-Probes study of surgical pathology accessioning processes reported a number of accessioning deficiencies. Among the deficiencies were 40% ‘no clinical history or no diagnosis mentioned on requisition slip’; 9.4% ‘no tissue source indicated on container or requisition slip’; 6.7% ‘no name of submitting physician’. Once additional history was obtained, the information led to a substantial change in diagnosis in 6.1%, confirmed the initial diagnostic impression in 59%, and was deemed not relevant to the final diagnosis in 25%. In a subsequent Q-Probes study, which quantitated amended surgical pathology reports, it was noted that 10% of the amended reports resulted directly from additional clinical information unknown to the pathologist at the time of original sign-out. An additional 20% of cases came to the pathologist’s attention because of a clinic-pathologic discrepancy recognized by the clinician.
Diagnostic changes or report revisions were more often associated with either malignancy or therapy-induced changes in 3 organ systems (small bowel, lung, and ovary). Additional clinical data were associated with higher rates of diagnostic changes in the ovary (15%), small bowel (12%), and lung (10%), and in endoscopic biopsies (7%) and incisional biopsies (7%). In numerous conditions (eg, inflammatory bowel disease, prostate cancer, and allograft rejection), therapy has been shown to change the histologic appearance of the lesion and may lead to an improper diagnosis. Also, inadequate clinical history has a profound impact on TAT; 32% of cases experience delay.
History is a Vast Early Warning System ~ Norman Cousins
Inaccurate or misunderstood clinical history can be equally problematic as having no clinical history at all. Following are the potential consequences of inadequate clinical information and correlation:
- Inappropriate treatment or management
- Inadequately specific diagnosis
- Inappropriate specimen triage for ancillary studies
- Lack of necessary ancillary studies
- Performance of unnecessary ancillary studies or duplication of studies
- Additional time and rework for pathology and clinical staff
- Delayed case TAT
- Delayed notification of significant or unexpected results to treating personnel
- Diagnostic over-commitment based on sampling error
- Contradictory diagnoses in patient record
- Medicolegal consequences
Missing clinical information has been implicated in injurious adverse events that are likely to result in patient harm. Such harm could include otherwise avoidable drug interactions or duplications, missed or delayed diagnoses, missed immunizations, unnecessary testing and procedures, and the downstream effects of such events. Adverse outcomes range from minor inconvenience to financial hardship to actual physical injury.
Lack of sufficient clinical and clerical details is not only potentially dangerous but it also wastes the time of clerical staff and laboratory medicine professionals. Inadequate clinical information can also result in customer dissatisfaction with pathology services. Consequently, it has been the underlying cause of medical negligence claims brought against laboratories. System errors can result in patient mix-ups and legal issues when the diagnosis is given to the wrong patient. Such errors are potentially avoided with adequate clinical information.
Potential Barriers to Communication of Clinical Information: The list of potential barriers to effective communication of clinical information is lengthy and includes clinicians, pathologists, technology, logistic issues, and at times, the patients themselves.
- Minimum face-to-face interaction between clinician and laboratory.
- Poor consultation venues, overcrowded clinics with low doctor to patient ratio
- Because of their busy schedules, clinicians might delegate some of the order entry duties to non-physicians such as nurses who might not know the patient as well or just might not be aware of how important specific information is.
- Increasing mobility of patients among local healthcare systems; for e.g. a breast cancer patient may have her core biopsy performed in a radiology centre, receive non-adjuvant therapy at one hospital, and then undergo subsequent excision at a second hospital. Consequences for such a patient might include inaccurate diagnosis, multiple contradictory diagnoses, and duplication of studies.
- Stat cases are more likely to omit a condition, indicating that a time crunch can affect whether a condition is mentioned or not.
- Individuals whose health problems limit communication or reliable self-reporting viz. older adults with memory loss, children etc.
- Technology, including lab information system and electronic health records can be important source of clinical information but are limited by interfacing capabilities, ease of use, accuracy of information entered and the personnel using them.
- Lack of knowledge of laboratory medicine among newly trained clinicians; due to overemphasis on therapeutics, need for rapid institution of treatment and/or due to rapid technological advances and introduction of new biomarkers constraints
The requisition slip for a clinical laboratory test should ideally be completed by a clinician familiar with the case or by a healthcare professional under his or her direct supervision. It is recommended to enter clinical information in the clinical diagnosis or preoperative diagnosis section of the diagnostic report and if no such information is provided that fact should be documented. It is also recommended to report a differential in uncertain cases as this may prompt the clinician to provide additional information that can lead to a final diagnosis.
These principles are codified in the laboratory accreditation standards outlined by the Laboratory Accreditation Program of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Both standards require that each specimen is accompanied by pertinent clinical information and, to the degree known, by the preoperative and postoperative diagnosis, in case of surgical specimens.
Faulty diagnostic decisions resulted from a failure to gather critical data, minor clinical details, which many a times are omitted in diagnostic test requisitions, can have a positive influence on both clinician’s time and laboratory’s turn around. A full understanding of the clinical picture optimizes the medical laboratory professional’s ability to see his or her way to the most accurate diagnosis.
- Nakhleh et al. Arch Pathol Lab Med—Vol 123, July 1999
- Raouf E. Nakhleh. Error Reduction and Prevention in Surgical Pathology. Springer 2015. Chapter 6
- Gogoi G et al. J Mol Biomark Diagn 2016; 7: 301
- Verghese et al., 2011, p. 550
- The Nurse Practitioner 2014; 39 (14): 31-35
Knowledgeable information provided by this article…to a layman person.