What is a Medical Laboratory

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Definitions, Inclusions, and Exclusions

In order to ensure comparability of results, a number of standard definitions were adopted. Four laboratory sections were defined as follows:

1. Anatomic Pathology Section.

This section was defined as a section of the laboratory that performed 1 or more of the following: gynecologic cytopathology, nongynecologic cytopathology, surgical pathology, histochemistry, immunohistochemistry, or autopsy pathology. Not included were test counts or staff related to electron microscopy, flow cytometry, or peripheral blood smear evaluation.

2. Chemistry/Hematology/Immunology Section.

This was defined as a section of the laboratory that included routine and special testing in chemistry, hematology, coagulation, urinalysis, serology, and immunology, whether done in the central (main) laboratory or an off-site laboratory. Staff associated with a central specimen-processing area or send-out area were included in this section. Send-out test counts and staff time devoted to phlebotomy were not included. Staff or test counts were not included for the following activities: athletic drug testing, heavy-metal analysis, quantitative sweat analysis, point-of-care tests, manual smear reviews initiated by the laboratory and not requested by a clinician, toxicologic confirmatory testing, and any calculated tests.

3. Microbiology Section.

This was defined as a section of the laboratory that performed 1 or more of the following: aerobic and anaerobic cultures, antimicrobial susceptibility testing, mycobacterial culture, mycology cultures, and parasitology. Not included were test counts or staff time devoted to serologic testing, virus cultures, or rapid tests for viruses.

4. Transfusion Medicine Section.

This was defined as a section of the laboratory that performed 1 or more of the following: blood type/ABO, atypical antibody identification, or holding and dispensing of blood products. Not included were test counts or staff related to collection of autologous blood; collection of heterologous blood; and any testing associated with unit collection such as viral marker testing, tissue bank functions (bone, skin, etc), or on-site apheresis (therapeutic or other).

It was of special importance that staff in each section be counted in a uniform manner to ensure comparability of results. Each employee assigned to the laboratory cost center was classified as “management” (spends more than 50% of time supervising activities of others) or “nonmanagement” (spends 50% or less time supervising others). Nonmanagement employees included medical technologists or technicians, cytotechnologists, and histotechnologists primarily performing “bench” testing or procedures, although they could also perform some nontechnical tasks.

Doctoral-level staff (physicians or individuals with PhD or other doctorate degree) may or may not supervise activities of others. Time spent by doctoral-level staff supervising activities of others was tabulated as part of this study. Time spent in research, academic time, or time spent developing esoteric tests was not included in this study.

Staff were tabulated as FTEs. One FTE = 40 h/wk (2080 h/y) of paid activity assigned to a laboratory cost center. Paid disability time was not tabulated. When staff served in both a management and nonmanagement role, their time was divided between the applicable categories. If staff were engaged in externally funded research or a training program for medical technologists, histotechnologists, or cytotechnologists, their externally funded research time was not tabulated.

When staff worked in more than 1 laboratory section (ie, when staff members were shared by anatomic pathology, chemistry/ hematology, blood bank, or microbiology), their time was tabulated according to the amount of time spent in each laboratory section. All of the activity of shared staff (except for time related to externally funded research, teaching in a training program, time spent in a nontesting section, or time that was specifically excluded from section totals, per instructions) was accounted for and assigned to 1 of the 4 laboratory testing sections. Staff from all shifts were included. Staff devoted to autopsy activities were tabulated along with histology staff.

This study did not include staff time associated with maintaining a laboratory computer system; performing phlebotomy; point-of-care testing; or nontechnical tasks such as are found in courier, clerical, transcription, marketing, or billing operations.

Source: www.archivesofpathology.org
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