Quality Management of the Pre-Analytical Phase Errors: Monitoring and Way Forward
Abstract:
Inadequate
quality management during laboratory analysis can increase errors, specimen rejection,
and economic resources wastages. A
laboratory quality management system (QMS) helps to streamline and coordinate all
the processes and operations within the lab, ensuring that each step is well planned,
controlled, and correctly performed. Quality management ensures that results are
accurate, reliable, and obtained under a traceable process that can easily detect
errors. The study aimed to investigate quality practice among laboratory workers during pre-analytical
phase activities. Unexpected
deviation from quality procedures consequently compromise laboratory test results,
leading to patient mismanagement and patient safety risks. Analysis of results showed
that 97.1% (340 respondents) were knowledgeable on quality management of pre-analytical
phase, and 2.9% (10 respondents) were not. 99.1% (347respondents) agreed to availability
of quality management materials and 0.9% (3 respondents) had no resources. 4.6%
(16 respondents) do not practice quality management system at pre-analytical phase
and 94.5% (334 respondents) practiced quality improvements. 3.4% (12 respondents)
agreed that quality improvement is the responsibility of phlebotomist and field
staff. 96.6% (338 respondents) agreed that quality management is the responsibility
of everyone at the facility. There was maximum knowledge of quality management at
the facility. Availability of quality management resources at the facility was standard.
The practice of quality management was below standard. Facility requires training
in quality management. It is recommended that quality management system be integrated
into the curriculum of school of health technology to guide graduates at work.
References:
[1] Barak M, Jaschek R. (2014). A new and effective way for
preventing pre-analytical laboratory errors. Clin Chem Lab Med. 52(2): e5-8.
[2] Cornes MP, Atherton J, Pourmahram G, et al. (2016). Monitoring
and reporting of pre-analytical errors in laboratory medicine: the UK situation.
Ann Clin Biochem. 53(Pt 2):279-284.
[3] Sciacovelli L, Panteghini M, Lippi G, et al. (2017).
Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a
consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient
Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical
phases”. Clin Chem Lab Med. 55(10):1478–1488.
[4] Lippi G, Chance JJ, Church S, et al. (2011). Pre-analytical
quality improvement: from dream to reality. Clin Chem Lab Med. 49(7):1113–1126.
[5] O’Kane M. (2009). The reporting, classification, and
grading of quality failures in the medical laboratory. Clin Chim Acta. 404: 28 –
31.
[6] Atay A, Demir
L, Cuhadar S, Saglam G, Unal H, Aksun S, et al. (2014). Clinical biochemistry laboratory
rejection rates due to various types of preanalytical errors. Biochem Med 24(3):
376-382.
[7] Holman JW, Mifflin TE, Felder RA; Demers LM. (2002).
Evaluation of an automated preanalytical robotic workstation at two academic health
centers. Clin Chem. 48:540–548.
[8] Renshaw AA, Gould Ew. (2006). Measuring the value of
review of pathology material by a second pathologist. Am J. Clin Pathol. 125: 737–739.
[9] Wallin O, Söderberg J, Van Guelpen B, Stenlund H, Grankvist
K, Brulin C. (2008). Preanalytical venous blood sampling practices demand improvement:
a survey of test-request management, test-tube labelling, and information search
procedures. Clin Chim Acta. 391:91–97.
[10] Lippi G, Fostini R, Guidi GC. (2008). Quality improvement
in laboratory medicine: extra-analytical issues. Clin Lab Med. 28: 285–294.
[11] Sciacovelli L, Secchiero S, Zardo L, D’Osualdo A, Plebani
M. (2007). Risk management in laboratory medicine: quality assurance programs and
professional competence. Clin Chem Lab Med. 45: 756 –765.
[12] Begum F. A
study of pre-analytical errors in a hospital-based clinical biochemistry laboratory.
IntJ Bioassays, 2014; 3(9): 3270-3275.
[13] Vacata V, Jahns-Streubel G, Baldus M, Wood WG. (2007).
Practical solution for control of the pre-analytical phase in decentralized clinical
laboratories for meeting the requirements of the medical laboratory accreditation
standard DIN EN ISO 15189. Clin Lab. 53: 211 – 215.
[14] Clinical and Laboratory Standards Institute (CLSI). Procedures
for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard,
GP41-A6. Wayne, PA: CLSI; 2013.
[15] Howanitz PJ. (2005). Errors in laboratory medicine: practical
lessons to improve patient safety. Arch Pathol Lab Med.129:1252–1261.
[16] ISO 15189:2007: Medical laboratories: requirements for
quality and competence International Organization for Standardization Geneva, Switzerland.
[17] Rin G Da. (2009).
Pre-analytical workstations: A tool for reducing laboratory errors. Clin Chim Acta,
404(1): 68-74.
[18] Simundic A,
Lippi G. (2012). Preanalytical phase - a continuous challenge for laboratory professionals.
Biochem Med, 22(2): 145-149.
[19] Sciacovelli L, Lippi G, Sumarac Z, et al. (2017). Working
Group “Laboratory Errors and Patient Safety” of International Federation of Clinical
Chemistry and Laboratory Medicine (IFCC). Quality Indicators in Laboratory Medicine:
the status of the progress of IFCC Working Group “Laboratory Errors and Patient
Safety” project. Clin Chem Lab Med. 55(3):348-357.
[20] The Joint Commission. 2014 national patient safety goals.
Available at http://www.jointcommission.org/standards_information/npsgs.aspx. Accessed
April 2, 2014.
[21] Kellerman PS,
Thornbery JM. (2005). Pseudohyperkalemia due to pneumatic tube transport in a leukemic
patient. Am J Kidney Dis. 46(4):746-748.
[22] Lippi G, Becan-McBride K, Behúlová D, et al. (2013).
Pre-analytical quality improvement: in quality we trust. Clin Chem Lab Med. 51(1):229-2.
[23] American Clinical Laboratory association (ACLA). The
value of lab testing. Available at http://www.acla.com/value-of-lab-testing/. Accessed
April 2, 2014.
[24] Cao L, Chen M, Phipps RA, Del Guidice RE, Handy BC, Wagar
EA, Meng QH. (2016). Causes and impact of specimen rejection in a clinical chemistry
laboratory. Clin Chim Acta. 458: 154-158.
[25] Saleem S, Mani V, Chadwick MA, et al. (2009). A prospective
study of causes of haemolysis: tourniquet time should be kept to a minimum. Ann
Clin Biochem. 46(Pt 3):244- 246.
[26] Kaushik N,
Green S. (2014). Pre-analytical errors: Their impact and how to minimize them. MLO
Med Lab Obs 46(5): 22, 24, 26.
[27] Lippi G, Guidi GC. (2007). Risk management in the preanalytical
phase of laboratory testing. Clin Chem Lab Med. 45: 720 –727.
[28] Howantiz PJ, Steindel SJ, Heard NV. (2002). Laboratory
critical values policies and procedures: a College of American Pathologists Q-Probes
Study in 623 institutions Arch Pathol Lab Med 126: 663–669
[29] Al-Ghaithi
H, Pathare A, Al-Mamari S, Villacruris R, Fawaz N, Alkindi S. (2017). Impact of
educational activities in reducing pre-analytical laboratory errors. Sultan Qaboos
Univ Med J, 17(3): 309-313.
[30] Nichols JH, Bartholomew C, Brunton M et al. (2004). Reducing
medical errors through barcoding at the point of care. Clin Leadersh Manag Rev.
18: 328 – 334.
[31] Dighe AS, Rao A, Coakley AB, Lewandrowski KB. (2006).
Analysis of laboratory critical value reporting at a large academic medical center.
Am J Pathol. 125:758–764.
[32] Ofaka CE, Nafarnda WD, Sonika RG. (2022). Quality improvements
measures on pre-analytical errors in the laboratory. Texila International Journal.
[33] NCCLS. Application of a quality management system model
for laboratory services; Approved Guideline: Third Edition. NCCLS document GP26-A3.
NCCLS. Wayne, Pennsylvania. 2004.
[34] ISO 15189:2007. Medical laboratories: requirements for
quality and competence. Geneva, Switzerland: International Organization for Standardization;
2007.
[35] Verónica Valdivieso-Gómez and Rocío Aguilar-Quesada (2018).
Quality Management Systems for Laboratories and External Quality Assurance Programs,
Quality Control in Laboratory, Gaffar Sarwar Zaman, IntechOpen, DOI: 10.5772/intechopen.73052.
[36] Guide to Quality in Analytical Chemistry and Aid to Accreditation.
2002 CITAC and Eurachem publishing.
[37] Roberta B. Carey, Sanjib Bhattacharyya, Sue C. Kehl,
Larissa M. Matukas, Michael A. Pentella, Max Salfinger, and Audrey N. Schuetzg (2018).
Implementing a Quality Management System in the Medical Microbiology Laboratory.
Clinical microbiology reviews. doi 10.1128/CMR.00062-17.