Book Review: Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results

Abstract Context.—A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.—To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.—Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.—Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.—Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

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Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

Spravočnik vrača obŝej praktiki (Journal of Family Medicine) ◽

10.33920/med-10-2012-02 ◽

2020 ◽

pp. 15-22

Author(s):

Elena Vitalievna Perminova

Keyword(s):

Clinical Laboratory ◽

Medical Laboratory ◽

Laboratory Research ◽

Laboratory Diagnostics ◽

Clinical Diagnostic Laboratory ◽

Diagnostic Laboratory ◽

Iso 15189 ◽

Laboratory Service ◽

Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

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Laboratory Diagnostics Performance in Uganda: A Survey of Test Availability and Constraints Across 100 Laboratories

10.21203/rs.3.rs-842323/v1 ◽

2021 ◽

Author(s):

Noel Namuhani ◽

Suzanne N Kiwanuka ◽

Martha Akulume ◽

Simeon Kalyesubula ◽

William Bazeyo ◽

...

Keyword(s):

Clinical Laboratory ◽

Disease Diagnosis ◽

Sub Saharan Africa ◽

Essential Medicines ◽

Full Blood Count ◽

Laboratory Diagnostics ◽

Cross Sectional ◽

Laboratory Services ◽

Control And Prevention ◽

Sub Saharan

Abstract Background Clinical laboratory services are a critical component of the health system for effective disease diagnosis, treatment, control and prevention. However, many laboratories in Sub Saharan Africa remain dysfunctional. The high costs of tests in the private sector also remain a hindrance to accessing testing services. This study aimed at assessing the functionality of laboratories based on test menus and the associated constraints in Uganda. Methods This cross sectional quantitative study involved an assessment of 100 laboratories randomly selected in 20 districts from four regions of the country. Sixteen percent of the studied laboratories were regional hub laboratories. Laboratory in charges and managers in each of the selected laboratories were interviewed. A checklist for laboratory supplies adapted from the Essential Medicines and Health supplies list for Uganda, (2012) was used to assess availability of testing supplies. Data was analyzed using excel and STATA 14. Results At the point of assessment, generally, all laboratories were able to perform malaria tests and HIV tests. All the hub laboratories conducted malaria tests and TB screening. Less than half had electrolytes tests due to lack of equipment, nonfunctioning equipment and lack of reagents. Full blood count tests were missing in 25% of the hub laboratories mainly due to lack of equipment. The lack of reagents (66.7%) and the lack of equipment (58.3%) caused the majority 10/16 of the hubs to routinely referred specimens for tests that are supposed to be carried out in these laboratories due to lack of reagents (66.7%) and non-functional equipment (58.3%). Although officially recognized as an operational structure, Hub laboratories lacked a list of essential and vital supplies. Conclusions Most laboratories performed well for the common tests. However, many laboratories did not meet testing requirements especially for the advanced tests according to standard testing menus for Uganda due to non-functioning equipment, lack of equipment and reagents. Hubs lack list of essential supplies. Therefore, there is need to provide equipment to laboratories, repair the non-functional ones and develop an essential list of supplies for the hub laboratories.

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The actual aspects of the combination of theory and practice in the teaching of discipline «clinical laboratory diagnostics»

Bukovinian Medical Herald ◽

10.24061/2413-0737.xxiii.1.89.2019.21 ◽

2019 ◽

Vol 23 (1 (89)) ◽

pp. 140-144 ◽

Cited By ~ 1

Author(s):

G. I. Kshanovska ◽

L. D. Boreyko ◽

I. A. Plesh ◽

S. Yu. Karatieieva ◽

N. А. Slyvka

Keyword(s):

Clinical Laboratory ◽

Theory And Practice ◽

Laboratory Diagnostics

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Application of Nanoscale Bioassemblies to Clinical Laboratory Diagnostics

Advances in Clinical Chemistry Volume 41 - Advances in Clinical Chemistry ◽

10.1016/s0065-2423(05)41002-1 ◽

2006 ◽

pp. 23-48 ◽

Cited By ~ 2

Author(s):

Jarrod Clark ◽

Steven S. Smith

Keyword(s):

Clinical Laboratory ◽

Laboratory Diagnostics

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Herbal Remedies: Effects on Clinical Laboratory Tests

Archives of Pathology & Laboratory Medicine ◽

10.5858/2006-130-521-hreocl ◽

2006 ◽

Vol 130 (4) ◽

pp. 521-528 ◽

Cited By ~ 2

Author(s):

Amitava Dasgupta ◽

David W. Bernard

Keyword(s):

Chinese Medicine ◽

Laboratory Test ◽

Alternative Medicine ◽

Clinical Laboratory ◽

Herbal Remedies ◽

Test Results ◽

Abnormal Laboratory ◽

St John's Wort ◽

Laboratory Test Results ◽

Laboratory Results

AbstractContext.—Complementary and alternative medicine (herbal medicines) can affect laboratory test results by several mechanisms.Objective.—In this review, published reports on effects of herbal remedies on abnormal laboratory test results are summarized and commented on.Data Sources.—All published reports between 1980 and 2005 with the key words herbal remedies or alternative medicine and clinical laboratory test, clinical chemistry test, or drug-herb interaction were searched through Medline. The authors' own publications were also included. Important results were then synthesized.Data Synthesis.—Falsely elevated or falsely lowered digoxin levels may be encountered in a patient taking digoxin and the Chinese medicine Chan Su or Dan Shen, owing to direct interference of a component of Chinese medicine with the antibody used in an immunoassay. St John's wort, a popular herbal antidepressant, increases clearance of many drugs, and abnormally low cyclosporine, digoxin, theophylline, or protease inhibitor concentrations may be observed in a patient taking any of these drugs in combination with St John's wort. Abnormal laboratory results may also be encountered owing to altered pathophysiology. Kava-kava, chaparral, and germander cause liver toxicity, and elevated alanine aminotransferase, aspartate aminotransferase, and bilirubin concentrations may be observed in a healthy individual taking such herbal products. An herbal product may be contaminated with a Western drug, and an unexpected drug level (such as phenytoin in a patient who never took phenytoin but took a Chinese herb) may confuse the laboratory staff and the clinician.Conclusions.—Use of alternative medicines may significantly alter laboratory results, and communication among pathologists, clinical laboratory scientists, and physicians providing care to the patient is important in interpreting these results.

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