CHAPTER I

INTRODUCTION

This chapter presents the introduction, background of the study,

statement of the problem, objectives, conceptual framework,

hypothesis, the significance of the study, scope and limitation, and

definition of terms.

Background of the Study

The clinical laboratory is a healthcare facility where

experiments are conducted on clinical specimens to collect

information on the patient's condition in terms of diagnosis,

recovery, and disease prevention. Generally speaking, errors

produced in the clinical setting are typically referred to as 'analytical

errors,' which are sadly misleading because the analytical step in

the total testing process (TTP) is strictly regulated. Healthcare

workers rarely acknowledge preventable mistakes, but the figures

are astounding.

A new publication by the World Health Organisation (WHO,

2015) reported that 1 in 10 patients in the developing world is at

risk of some error during hospitalization; furthermore, around 10

percent of patients in countries that make up the European Union

were thought to have suffered preventable adverse outcomes

(European Commission on Patient Protection, 2014). It cannot be

denied that pre-analytical laboratory errors play a major role in the

total risk of error in healthcare (Šimundić, 2015) because laboratory

1
medicine, like every other clinical field, is prone to error. Most of the

errors occurred during the pre-analytical process of the TTP

(Šimundić and Lippi, 2012; Šimundić, 2015), involves sample

selection, handling, and transportation.

Quality in the clinical laboratory should be described as

ensuring that any phase of the total testing process (TTP) is

performed correctly, ensuring valuable medical decision-making

and effective clinical practice. The pre-analytical process has the

highest number of failures at 40-70% of the overall research

process. The pre-analytical period covers all procedures starting

from the doctor's order for a laboratory ‘till the specimen is

examined in the laboratory (e.g. patient identification, blood

collection, specimen transportation, centrifugation, dilutions, etc).

Pre-analytical errors occur in up to 70% of all laboratory clinical

errors, most of which result from complications of patient planning,

sample selection, transportation, and preparation for analysis and

storage. Although patient preparation and sample selection are

commonly accepted as recurrent sources of error, more attention

should be given to the transportation of samples. This field needs

development programs, as there is a rising movement towards the

relocation of laboratory facilities, with a consequent need for long-

distance sample transport. The most frequently identified forms of

pre-analytical error are: (a) missing sample and/or test order, (b)

inaccurate or absent identification, (c) leakage from the infusion

pathway, (d) hemolyzed, clotted, and inadequate tests, (e)

2
improper tubes, (f) improper blood to anticoagulant ratio, and (g)

inappropriate storage and transport conditions.

Healthcare laboratory errors are of interest because they

contribute to real or possible adverse effects on patients. Given the

dynamic nature of healthcare and the uncertainty of evaluating the

impact of a single laboratory mistake on patient management, it is

difficult to determine the frequency of confirmed patient injury. Such

difficulties mean that; the present calculations are likely to greatly

underestimate the scale of the challenge, given the high number of

quantitative experiments conducted in clinical laboratories.

The pre-analytical process begins from the moment the doctor

has requested a patient examination before the sample is ready for

analysis. Any errors in these fields, especially pre-analytical ones,

can impact the overall testing process and therefore can lead to a

significant misdiagnosis of the patient. Human errors arising from

these errors are direct signs of a poor degree of knowledge among

laboratory employees of the quality control system.

Sustained improvement is an essential process for improving

laboratory consistency. It is part of the multiple mechanisms of

overall quality control. Performance metrics are an instrument used

in these procedures to calculate and track laboratory errors. Quality

metrics are characterized as the evaluation of critical areas in the

laboratory outlined by the Institute of Medicine (patient protection,

efficacy, equity, patient focus, timeliness, and efficacy). 

3
 This description specifically tests the goals of the quality

metrics as a method for performance enhancement in the

laboratory. ISO15189[4.12.4] specifies that the laboratory shall

introduce quality metrics to regularly track and measure the

contribution of the laboratory to patient care. The World Health

Organization (WHO) indicated in its Laboratory Management

Manual that the quality indicator aims to provide information on the

efficiency of the process to highlight possible quality issues.

Awareness as described is the knowledge that already exists

or a perception of a concept based on facts or experience. This is

an essential step in the strategy to upgrade the laboratory to meet

its aim of producing an accurate, consistent, and timely result. This

research also included a survey of the pre-analytical procedures

among the residents in Barangay 168, Deparo, Caloocan City,

Metro Manila, Philippines to identify the proper instructions given to

them by the Medical Technologist and to know the possible causes

of errors in their practices when it comes to specimen collection

and self-preparation before collection. Raising awareness in these

activities may play a role in reducing pre-analytical errors in routine

clinical laboratory testing to have an accurate patient diagnosis.

Statement of the Problem

This study aims to assess residents' knowledge and awareness

in the pre-analytical procedure in Clinical Laboratory, primarily in

specimen collection, handling, and patient preparation in Barangay

4
168, Deparo, Caloocan City, Metro Manila, Philippines. Specifically,

it seeks

to answer the following questions:

1. What is the profile of the resident of Barangay 168,

Deparo, Caloocan City respondents as to:

1.1 Age;

1.2 Gender;

1.3 Educational Attainment; and

1.4 Times undergo Laboratory testing in a Year?

2. What is the level of knowledge on practices of the resident

of Barangay 168, Deparo, Caloocan City, regarding the pre-

analytical procedure (specimen collection, handling, and

patient preparation) on routine testing in the clinical

laboratory in terms of:

2.1 Age;

2.2 Gender;

2.3 Educational Attainment; and

2.4 Times undergo Laboratory testing in a Year?

3. What is the level of awareness on practices of the resident

of Barangay 168, Deparo, Caloocan City, regarding the pre-

analytical procedure (specimen collection, handling, and

patient preparation) on routine testing in the clinical

laboratory in terms of:

3.1 Age;

3.2 Gender;

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 3.3 Educational Attainment; and

3.4 Times undergo Laboratory testing in a Year?

4. What is the level of knowledge on practices of the resident

of Barangay 168, Deparo, Caloocan City, regarding the pre-

analytical procedure (specimen collection, handling, and

patient preparation) on routine testing in the clinical

laboratory in terms of:

4.1 General Information;

4.2 Blood;

4.3 Urine; and

4.4 Stool?

5. What is the level of awareness on practices of the resident

of Barangay 168, Deparo, Caloocan City, regarding the

pre-analytical procedure (specimen collection, handling,

and patient preparation) on routine testing in the clinical

laboratory in terms of:

5.1 General Information;

5.2 Blood;

5.3 Urine; and

5.4 Stool?

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Conceptual Framework

A resident of Barangay 168, Deparo,

INDEPENDENTCaloocan City (Age, Gender, Educational
VARIABLE Attainment and Times proceed to
laboratory test in a year)

Level of Knowledge and Awareness

DEPENDENT on Practices of pre-analytical
VARIABLE procedures (specimen collection,
handling, and preparation)

Figure 1.1. Conceptual Framework

To conduct this research entitled “Evaluation of Knowledge and

Awareness on Quality Indicator in the Pre-analytical Phase in

Routine Laboratory testing among the Residents of Barangay 168,

Deparo, Caloocan City'', the researchers were disseminated a link

through google online survey questionnaire to the Barangay Hall.

The questionnaire comprised three parts and was answered using

the given yes or no, multiple choices, and the four (4) scale (Likert

scale) prepared by the researchers. It was composed of the

following demographic variables such as age, gender, educational

attainment, and times to undergo laboratory tests in a year. The

survey also contains the level of knowledge about some factual

and misconceptions about pre-analytical procedures (specimen

collection, handling, and patient preparation) on routine testing in

clinical laboratory answerable via yes or no and multiple choices.

The third part is the awareness of practices in pre-analytical

procedures on routine testing and answers through the four Likert

scale. The researchers formulated the questionnaire that is usually

observed and seen in the clinical laboratory and community

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 services. The questionnaire was subjected to pilot testing and was

checked by a statistician and a grammar expert to improve the

questionnaire itself. After collecting the following data, the

researchers processed the hypothesis through the distribution table

and the t-test ANOVA. It was generated through Statistical

Package for the Social Science (SPSS) version 20.

The concept of this analysis is based on the overall quality

control system for quality management in the healthcare laboratory.

Quality metrics are a method for performance development in the

laboratory and a part of the quality improvement process of the

Total Quality Management (TQM). Other components of this

system are quality preparation, quality laboratory method, quality

management, quality evaluation, and the goals, objectives, and

quality criteria of this framework. Concerning this, the researchers

were focused on Barangay 168, Deparo, Caloocan City resident’s

knowledge and awareness on practices on pre-analytical process

specifically on doings before and after blood collection, urine

collection, and fecal collection, handling, and preparation.

Objectives of the Study

In general, this research aims to assess the level of

awareness and knowledge of patients when it comes to self-

preparation for specimen collection and handling upon

submitting to the laboratory in Barangay 168, Deparo, Caloocan

City. The goal of the study is to identify the demographic profiles

8
 of the respondents, to identify the degree of the patient's

awareness and knowledge in the pre-analytical phase of the

laboratory, specifically the proper practice of specimen collection

such as urine and stool and the preparation for blood collection.

Specifically, it seeks to study and conduct a survey of the

patients' level of awareness and knowledge about the pre-

analytical procedures, the submission of their specimen in the

routine clinical laboratory tests to determine key error-prone

measures in the total testing process.

Null Hypotheses (Ho)

There is no significant difference in the level of

knowledge and awareness on practices of the residents of

Barangay 168, Deparo, Caloocan City about the pre-analytical

procedures (specimen collection, handling, and patient

preparation) on routine testing and their profile variables.

Significance of the Study

Pre-analytical procedure in the laboratory is the most crucial

procedure because most of the errors starts and occurs here. It is

the foundation or basis to accurately diagnose a patient. In this

study, the researchers aim to identify patients' awareness and

knowledge in pre-analytical procedures to determine the gap in

what aspect of their knowledge and awareness in the pre-analytical

9
phase could be improved on for a better total testing process.. The

results of this research paper will be beneficial to the following:

Patients. The result of this research will provide patients better

and timely results of their test requests and reduce the risk of

further health complications. The adaptation of this study in

information dissemination of patients’ knowledge and awareness

will also allow patients to better understand the pre-analytical

laboratory procedure, which will result for them to gain trust,

assurance, and collaboration in giving true health information.

Hospitals or free-standing laboratories. The answers on this

study will give the hospitals or laboratories the ability to improve the

system in the pre-analytical errors that will then help the facility to

provide a better quality of test results, accurate diagnosis, and

improved information dissemination in the Philippines. 

Medical technologists. The results of the study will help the

medical technologists assess and improve their skills upon giving

instructions for patients. The study will enhance the knowledge,

and attitude, thus improving and preparing globally-competitive

medical technologists.

Medical Technology Students. Data gathered will also help

the researchers to improve both their academic and clinical

performance through the assessment of pre-analytical errors. The

study will provide knowledge and awareness for the researchers on

the aspects of where they can improve in the pre-analytical

10
 procedures of the laboratory for the patients and their future

internship or job. 

Future researchers. The study will be helpful for future

researchers who plan to disseminate better awareness and

knowledge of patients in the pre-analytical procedure of the

laboratory. The content of the study can also improve the

knowledge where It can be adapted for training programs of

medical technologist practitioners.

Scope and Limitations

The scope of the study is the patients' awareness and

knowledge about the instructions in the pre-analytical procedures

of the routine test under a Clinical Chemistry, Clinical Hematology

and Clinical Microscopy in the laboratory, specifically the patients'

collection of specimens of urine and stool, and their preparation for

blood collection.

The study is limited within the area of Barangay 168 Deparo,

Caloocan City with 100 respondents, to survey about the topic via

Google form survey designated through emails, messenger, or

Facebook provided with the link. The sampling technique used is

quota sampling. The questionnaire focuses on three different parts:

demographic profile, knowledge and awareness. The study also

focuses on the pre-analytical factors that may affect the blood,

urine and stool examination results.

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 The study does not include any face-to-face patient interaction.

Data Privacy Act of 2012 will ensure the individuality and

confidentiality will be observed in getting such data information.

Definition of Terms

For a better understanding of the research, the following terms

were defined operationally by the researchers.

Clinical Chemistry - it is a branch of chemistry that is

usually concerned with the study of body fluids for medical and

medicinal purposes. Components may include blood glucose,

electrolytes, carbohydrates, hormones, fats, other metabolic

substances, and proteins.

Clinical Microscopy – Section in the laboratory that performs

the analysis of body fluids such as urine, stool, vaginal secretion,

semen, cerebrospinal fluids, synovial fluid. It analyzes body fluids

to diagnose and give a certain prognosis of the disease and can be

an indicator of physiological and pathological conditions.

Clinical Hematology – it is the study of blood that focuses on

the causes, treatment of blood disorders, malignancies, and other

blood-related diseases and prognosis.

Clinical Laboratory - a laboratory where clinical specimen

analyses are conducted to collect information about the patient's

condition to help with the diagnosis, treatment, and prevention of

diseases.

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 Freestanding laboratories - a clinical laboratory that is not a

part of any established institution

Secondary laboratory – it involves the section of Clinical

Microscopy, Hematology, Clinical Chemistry (Routine Test), and

Microbiology (Gram Stain and KOH).

Google Online Form - the method of gathering data through a

survey form that will disseminate through emails and messenger.

Knowledge – information and perception of a concept based on

facts or experience, or education. It can be a practical

understanding of the subject or topic described.

Level of Awareness - to acquire a concern and sensitivity

towards pre-analytical errors in the laboratory.

Practices - the actual application or use of an idea, belief, or

method from doctor recommendation to the last part of the pre-

analytical procedure.

Pre-analytical procedure - consists of all steps from the

preparation of the patient for the processing of the specimen to the

care of the specimen before the analytical stage.

Pre-analytical error - refers to any inappropriate output before

the specimens are assessed by analyzers, such as improper

sample selection, transport delays, illegible handwriting on order,

etc.

Quality Management - ensure that the laboratory, product, or

service is reliable. Used by the International Organisation for

13
Standardization (ISO) and the Institute for Clinical and Laboratory

Standards.

Total Testing Process- relationship to the series of 11 stages of

laboratory research, starting with a clinical question triggered by a

patient-clinician experience and ending with the effect of the test

outcome on patient treatment.

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 CHAPTER II

REVIEW OF RELATED LITERATURE AND STUDIES

This part of the research briefly shows the background of the pre-

analytical process in the laboratory and some statistical locally and

internationally being assessed in the study. The chapter contains the

concept of the Pre-analytical phase, factors affecting the pre-analytical

phase, and its potential errors corresponding with different processes

on pre-analytical as indicated in the Literature Review.

Total Testing Process

The quality standards set by the CLIA shall be upheld by the

accreditation and inspection procedures and by the proficiency

exams. Accreditation allows clinical laboratories to be accredited by

their state and CMS before the approval of human subjects for

medical tests. Enforcement, though, is driven by regular

inspections and proficiency tests. Repairing the CLIA examination

includes a commitment to the laboratory's implementation and

recording of protocols and processes that are necessary for a

successful diagnosis. Proficiency training and biennial inspections

mandated by CLIA offer a basis for the implementation of protocols

and processes that enable the laboratory to be in a continuous

state of compliance.

15
 In general, the CLIA regulations established consistency

requirements for laboratory experiments conducted on human

tissues, such as blood, body fluid, and tissue, for the diagnosis,

prevention, or treatment of illness, or the evaluation of fitness. The

CLIA rules are now arranged to follow the direction of the patient

specimen as it passes around the laboratory; i.e., specimen

obtaining (pre-analytic), processing (analytic), and reporting (post-

analytic) stages. This global analysis of the procedure allows the

laboratory worker to focus beyond the test itself and on the crucial

factors involved in achieving the best outcomes for the right patient.

It is well known that most laboratory errors occur in the pre-and

post-analytical stages, although less than 10% of all errors in

clinical laboratories occur in the experimental process.

Pre-analytical Phase

The pre-analytical phase is the most sensitive aspect of the

overall research process and is considered to be one of the most

important obstacles for laboratory professionals. Errors may occur

at the time of patient examination, entry of the test order,

completion of the application, identification of the patient, collection

of specimens, transport of specimens, or reception of specimens in

the laboratory. In a pre-analytical error analysis, 47% of the errors

were attributable to insufficient sample consistency accompanied

by inaccurate patient identity (26.8%), missed medical order (14

16
percent), inadequate sample quantity(11.6%), and inadequate

bottle.

As regards the pre-analytical process, CLIA needs the

following laboratories: Have written protocols for the pre-

analytical process; Provide data on the skills and instruction of

staff; and Track consistency metrics of the sample.

Although the care of specimens and policies in the laboratory is

not entirely standardized, sample selection, transport, and handling

guidelines are available. In addition to satisfying CLIA criteria, pre-

analytical errors can also be eliminated by automating support and

logistical processes and improving coordination between the

laboratory and healthcare providers.

Quality Indicators Rationale

General Information

The collection, labeling, transport and processing

of all specimens must take place in accordance with

established processes including sample volume, special

handling needs and the type of container. Specimen

rejection may result in failure to follow particular

procedures.

According to the World Health Organization,

Laboratories have an extensive impact on patient safety,

with laboratory tests providing 80-90% of all diagnosis.

The first objective of the 2008 Joint Commission is to

improve the "accuracy of patient identification" of the

17
National Patient Safety Goals for Labors. A life

threatening medical error may be the misidentification of

patients during the time of sample collection. At specimen

collection, there is about 1 in 1000 and 1 misidentification

in patients in 12,000. At a particular time, samples must

be collected. If the planned time frame is not followed,

wrong findings and misinterpretation of the condition of a

patient can occur.

According to 5th Edition of Susan King Starsinger

and Marjorie Schaub Di Lorenzo, Urinalysis and Body

Fluids, clean, dry, leak-proof containers must collect

specimens. Disposable containers are advised because

the risk of contamination due to unsafe washing is

eliminated.

Blood

According to the Expert Committee on the

Diagnosis for the Classification of Diabetes Mellitus as

stated in the book of Henry’s Clinical Diagnosis and

Management by Laboratory Methods, revised the criteria

for the diagnosis of diabetes, modified by American

Diabetes Association, fasting plasma glucose level or

blood sugar level should be obtained after an eight hours

fast (8-hour). Symptoms of hyperglycemia such as

polyphagia, polyuria, unexplained weight loss and

polydipsia with a glucose level of 200 mg/dL or an

18
equivalent of 11.1 mmol/L or higher, with a hemoglobin

A1c of 6.5% or higher is already a diagnosis of diabetes

for two different days of repeated laboratory results.

The primary analysis performed in the Hematology

Section of the laboratory as stated in the Phlebotomy

Textbook (S. Strasinger & M. Di Lorenzo) is the complete

blood count, it is very often ordered on a STAT basis. The

tests under Complete Blood Count are the Differential

count which determines the percentage of white blood

cells in different types, it also evaluates red blood cells

and the platelets morphology. Hematocrit determines the

amount of packed red blood cells in volume. Hemoglobin

determines the oxygen-carrying capacity of red blood

cells. Red Blood Cell Indices calculates to determine the

size, amount and weight of the red blood cells. Platelet

count determines the number of platelets circulating in

the blood. Red Blood cell count determines the number of

red cells circulating also in the blood. Red cell distribution

width determines the differences in the size of red cells.

And the white blood cell count which determines the

number of white blood cells circulating in the

bloodstream. All of these tests that are done under

complete blood count does not need to undergo fasting.

Urine

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 According to 5th Edition of Susan King Starsinger

and Marjorie Schaub Di Lorenzo, Urinalysis and Body

Fluids, the patient's name and ID number, the date and

date of collection and further information such as age and

location for the patient, as well as the name of the

physician, as required by institutional procedures must

also be appropriately labeled for all specimens. Labels

must be attached not to the lid and not to the container,

when the container is cooled or froze, should not be

released.

The clean-catch specimen provides a safer, less

traumatic method to obtain bacterial culture urine and

routine urinalysis as an alternative to the catheterized

specimen. It provides a less epithelial cell and bacterial

contaminated specimen and thus is more representative

of the actual urine than the routinely vacuumed

specimen.

Specimens should be delivered quickly and tested

within 2 hours after collection. A specimen not available

for submission and testing should be cooled within 2

hours. The first sample in the morning is a concentrated

sample, ensuring that chemicals and constituted

elements that may not be present in diluted, random

samples are detected. The patient should be directed

20
immediately to collect the specimen and to deliver the

specimen to the lab within 2 hours.

Stool

According to the NHS website in the United

Kingdom (2021), the collected stool sample must be fresh

upon submission to the laboratory; because If not, the

bacteria in it multiplies, which means that the level of

bacteria in the stool sample will not be the same as the

bacteria levels in the digestive tract, thus the outcome will

not be correct, or the result of bacteria levels does not

match. The stool sample should be sent to the laboratory

as quickly as possible. But If the sample cannot be sent

right away, the patient must know how long it should be

stored in the refrigerator from the inquired information

from the doctor or the healthcare provider who ordered

the test result.

According to WebMD corporation (2017), the stool

container should not be filled up to the top ridge because

It only needs a sample about the size of a walnut for the

examination. It should be made sure to include bloody,

slimy, or watery characteristics of the stool.

According to the study of Lasson, A., et al. (2014),

the calprotectin concentrations and variability in stool

samples that are kept at room temperature are stable for

21
 up to 3 days but decreases in value after seven days, so

they concluded that stool samples may be kept for three

days but more than three days is not recommended.

According to Strasinger, S. K., & Di Lorenzo, M. S.

(2014), stool samples should be collected in a clean bag,

such as a clean bedpan or a plastic container, and

transfer it to a corresponding laboratory container.

Containers that have preservatives for ova and parasites

should not be used to gather stool specimens for other

tests. Patients should be aware that urine or toilet water

may contain chemical disinfectants that may affect the

chemical test of the stool.

Analytical Phase

The analytical process starts when the patient specimen is

prepared for the examination and concludes when the test outcome

is interpreted and confirmed. Advances in analytical methods,

laboratory instrumentation, and automation have increased

analytical efficiency, resulting in a substantial reduction in error

rates. However, methodological consistency is also a big concern.

Improper preparation of the sample or the presence of interference

substances (e.g., hemolysis, lipids) can influence test results.

Establishing and checking the performance parameters of the test

22
 system in terms of consistency, precision, sensitivity, specificity,

and linearity is protection against unrecognized analytical errors.

As regards the analytical process, CLIA needs the following

laboratories: Establish and retain written procedure, method,

and process manuals; Provide preparation and assess the skill

of workers; Participate in a test proficiency curriculum that is

suitable for their test menu and specialties; Check instrument

output and monitor instrument configuration and repair, and

Keep notes of the laboratory climate.

Often CLIA laboratories use a pro forma—a fill-in method that

collects real-time information on reagent planning, instrumentation,

incubation times, analysts, and other elements that can improve

reproducibility or give an insight into what caused the test to fail.

Post Analytical Phase

In the post-analytical process, the findings are checked and

released to the clinician, who interprets them and makes diagnostic

and clinical decisions. Timeliness and inaccurate understanding of

medical or experimental procedures are responsible for a large

number of errors in outpatient and emergency room settings.

Important factors to post-analytical error include the inability to

register, incorrect validity of analytical results, and incorrect entry of

data.

As regards the pre-analytical process, CLIA needs the

following laboratories: Report STAT outcomes and vital values

23
 as soon as possible; Have a written program for quality

assurance; Generate Levy-Jennings or pattern QC results in

plots to detect improvements in test efficiency; Precisely relay

test findings; and Reduce human error by root cause research,

process management, and education/communication.

Every year, medical laboratories produce a huge amount of

vital data used to identify and treat patients. Their primary aim is to

offer prompt and error-free care to doctors and their patients. As

mentioned above, the importance of extra-analytical issues in the

efficiency of the laboratory is included by the CLIA Regulations.

Compliance with CLIA addresses the Complete Testing Process

(TTP), in which all steps of the evaluation cycle are measured,

tracked, and enhanced to minimize error rates and increase patient

safety.

Variables could Affect the Laboratory testing

Proper patient planning for fasting needs as well as careful

phlebotomy techniques is necessary to ensure correct laboratory

test results. A common practice is to make the patient fast 12 hours

before blood is taken, particularly when checking the lipid profile

and glucose tests. There is also evidence that fasting for creatinine

levels should be considered, particularly where high protein/meat

diets are used. Patients should also restrict smoking, cigarettes,

physical discomfort, and caffeine. It is ideal to make the patient wait

24
for 15 minutes until the blood is drawn and do it in the morning (7-

11 AM).

Although all pre-analytical factors cannot be excluded,

phlebotomists and scientific personnel need to be made aware of

the multiple variables that can impair the precision of laboratory

experiments. Up-to-date blood sampling protocols should offer

guidelines on resolving possible important results in the pre-

analytical process of study. Establishing quality assurance monitors

for selected pre-analytical mistakes will help identify opportunities

that can be resolved, minimizing the likelihood of adverse effects.

(Kurec, 2016)

There are four general areas of pre-analytical heterogeneity,

including: test ordering, patient preparing, specimen selection and

specimen handling, transport and storage. In this post, we discuss

the causes of variance, possible responses and relevant QIs for

each group.

Test Ordering

Test ordering, the first stage of the pre-analytical process,

is also referred to as the pre-analytical phase. Ordering the

incorrect test is not only costly but also potentially dangerous to

patients. Providers prescribe incorrect tests for a number of

reasons, including misunderstanding about tests with identical

names, needless repeat instructions, interpretation mistakes

during order entry, and misinterpreted verbal orders, which arise

because doctors do not position the test orders themselves.

25
 In order to resolve the issues in this step of research, the

laboratories must employ personnel to encourage effective use

of the test. This is normally achieved by a laboratory form

committee or a test use committee that relies on hospital-wide

expertise and affects the doctor's ordering actions. Institutions

that lack the capacity or structure to set up a form committee

should concentrate on areas that would have the most impact,

such as tracking costly packages and repeat requests. Labs

must ensure that such efforts are data-driven and tightly tracked

with QIs that can detect incorrect test orders, duplicate orders,

and test input errors.

Patient Preparation

Patient planning is one of the most difficult pre-analytical

stages, since it encompasses factors that usually exist when a

person arrives for his or her sample selection. Patient readiness

considerations shall include:

Fasting: Based on the book of Henry’s Clinical

Diagnosis and Management by Laboratory Methods 23rd

Edition, Fasting glucose level should be obtained after an

8-hour fast, the book of Phlebotomy Essentials McCall

5th edition suggest an 8-12 hours of fasting prior to

specimen collection for Glucose, Cholesterol and

Triglycerides and according to Ambardekar (2020), For 8-

10 hours before a fasting glucose test,it is important that

26
one individual shouldn't eat and drink anything other than

water. Fasting helps ensure a precise measure of fasting

blood sugar levels is recorded in blood tests.

Diet: Diet intake is a big cause of pre-analytical

heterogeneity. This influence depends on the analyte and

the time between the intake of the meal and the

processing of blood. For eg, after meals of high

carbohydrate and fat, glucose and triglycerides increase

dramatically. An overnight fasting cycle of 10 to 14 hours

prior to blood processing is suitable for reducing

variations. However, certain ingredients can have longer-

lasting effects and particular foods may be prohibited

before such studies.

Posture/exercise: A shift from lying to standing will

induce an average rise of 9 percent in serum protein

concentrations or protein-bound constituents within 10

minutes. Which happens when the amount of blood

decreases by around 10% and only protein-free fluid

flows into the capillary tissues. Prolonged bed rest often

sometimes has a significant effect on hematocrit, serum

potassium, and protein-bound components. As a result,

certain admitted patients should postpone such

procedures before they exit the hospital and begin daily

life.

27
 Moderate and strenuous training often deranges

analytes such as aspartate aminotransferase, lactate

dehydrogenase, creatinine kinase, and aldolase at the

other end of the activity spectrum. This is due to the

release of the skeletal muscle. Patients should be

advised to prevent mild to strenuous activity with such

analytes before the processing of specimens.

Time sampling

Blood quantities of different analytes change throughout

the day. This cyclical fluctuation can be important, so the timing

of the selection of the samples should be strictly controlled. The

timing of sample selection is highly important for the monitoring

of medicinal drugs, which involves trough thresholds for most

analytes. Protocols must determine the optimal sampling time

for each test, and the real sampling time must be properly

recorded.

Clinical Error Impact

According to Lao et al., 2017, The goal of this analysis is

to examine the possible risks of laboratory medical operations in

all systems. This research also gave worth to the effect on the

patient welfare of these threats. The Failure Model and Results

Analysis was the approach used in this research to define and

predict potential failure modes (FMEA). The actual errors were

28
 then reported according to the Failure Notification Review and

Corrective Action Mechanism methods in the same systems

(FRACAS). Also, the basis of the knowledge available in the

laboratory quality method was used.

This research article built a risk map in the medical

laboratory where It helped the researchers to define key points

and prioritize the regulation of these points in all laboratory

processes. Also, it helped to select preventive or correction

steps that could be used in preparation and risk assessment for

laboratory improvement.

Historical Perspective

In the 1970s, a new word "pre-analytical phase" was adopted

for the laboratory medicine lexicon. In the 1980s, terms such as

interference considerations for vocational training programs were

added, resulting in the publication of the first book on pre-analytical

variables in1987, which became part of the terminology used in

clinical laboratory vocabulary sciences.

In1981, the Clinical Science Laboratory Institute (CSLI)

adopted pre-analytical guidelines for the study of pre-analytical

methods, accompanied by the European Committee on Clinical

Laboratory Standards (ECCLS). The acts of these bodies meant

that the word 'pre-analytical process' was used in the training and

teaching programs in medicinal routine and laboratory medicine.

29
 Bonini et al.,(2002) were one of the first researchers to publish

that more than 60 percent of TTP errors have been produced at the

pre-analytical level. A sample form and stability guidelines were

released by the WHO in the same year, which contributed to a

greater knowledge of pre-analytical variables in laboratory

medicine. In 2012, the European Federation for Laboratory

Medicine set up a working group (EFLM-WG) with the primary

objective of raising an understanding of the value of the pre-

analytical process among laboratory personnel and other

healthcare professionals who are users of the services rendered by

the laboratory. As part of an attempt to increase awareness of the

value of the pre-analytical process, the EFLM-WG initiated a series

of biannual conferences that draw a significant number of

participants worldwide; the last meeting was held in Portugal in

2015.

Pre-analysis defines the non-laboratory processes leading to

the analytical process. The primary function of the clinical routine

laboratories is the biochemical study of blood and other body fluids

(whole blood, serum, or plasma), semen, cerebrospinal fluid, and

other effusions. Intrinsically, the collection, detection, preservation,

and transfer of samples for laboratory examination has long been

part of the analytical process.

The emergence of statistical quality assurance of analytical

methods in the first quarter of the 1970s contributed to the

understanding that other extra-analytical factors had an impact on

30
 the capacity of the medicinal routine laboratory to achieve reliable

results. It has been common knowledge for many decades that

factors such as patient planning before blood sampling, sampling

time and location, choice of anticoagulant, temperature and

storage, transport, centrifugation time, and isolation of samples

have affected clinical routine laboratory performance. Although the

analytical variables were still largely undefined, these extra-

analytical considerations could not be determined until2002, when

Bonini and co-workers were able to calculate the effect of pre-

analytical variables on total laboratory errors in clinical routine.

Other Related Literature

Foreign Literatures

Laboratory errors are categorized by time of the occurrence

in the laboratory process: pre-analytical, analytical, and post-

analytical. Pre-analytical errors are errors that arise when

pathogenic organisms enter the laboratory, during selection

and transport. Analytical errors are errors that arise in the

laboratory and during the preparation and generation of

samples. Postanalytical errors are errors that arise when

medical judgments are made based on false perception and

the use of laboratory data. Many laboratory errors are pre-

analytical(61.9%), supported by post-analytical(23.1%) then

analytical(23.1%) errors.

31
 This is the product of a study of different facets of

efficiency, cost, and pace in a broad sample of laboratory

testing in the Asia Pacific region. It is the first of its kind to be

released and is a snapshot of current performance in a vast

number of diagnostic laboratories in a wide variety of countries

in the Asia-Pacific region. The survey includes data on such

quality attributes, such as Turnaround Time (TAT) and quality

management activities. It has been the case that some of the

KPIs have changed throughout the studies, for example, by

reducing the average TAT, and this may have arisen as a

result of involvement. (Badrick, 2017)

The introduction of a clear and quick check-list, including

verification of blood collection instruments, patient preparation,

and sampling techniques is efficient in improving sample

consistency and reducing certain pre-analytical errors

associated with these procedures. The use of this instrument,

along with the introduction of objective and standardized

systems for the identification of non-compliance with unsuitable

samples, can help to standardize pre-analytical practices and

improve the quality of laboratory diagnostics, thereby helping to

reaffirm a knowledge-based "pre-analytical" culture and real

risk perception. (Giavarina, 2017).

According to Lima-Oliveira et al., 2017, the data were

published 28 years ago on the impact of posture on routine

hematological research, this pre-analytical topic has not been

32
 standardized to date. So they conducted a methodology in 19

fit volunteers by obtaining a full blood count after 25 minutes in

the supine position, 20 minutes in the sitting position, and 20

minutes in the upright position. Results show that the change

from the supine position to the sitting position caused

hemoglobin, hematocrit, and red blood cell counts to rise

noticeably. In addition, the transition from supine to standing

resulted in clinically important changes in hemoglobin,

hematocrit, red blood cell, leukocyte, neutrophil, lymphocyte,

basophil, and platelet counts, and mean platelet number, and

clinically significant increases in hemoglobin, hematocrit, and

red blood cell, leukocyte, neutrophil and lymphocyte counts

from sitting to standing. Further support for the idea that

attempts should be taken to promote universal standardization

of phlebotomy practice, particularly patient posture, is provided

by the findings of this investigation.

In Turkish public hospitals, this paper empirically

analyzes the impact of performance and structural consistency

on patient satisfaction. It also discusses, from a comparative

viewpoint, the contentious relationship between patient

performance and systemic consistency for small, medium, and

large hospitals.

The results suggest that hospital performance affects the

way the relationship between structural consistency and patient

satisfaction changes. Depending on the hospital scale, the

33
trade-off between quality and productivity is observed to be

varied. For small-size hospitals, a negative association is

observed between consistency and performance. However, as

demonstrated by the Total Quality Management (TQM)

methodology for large-size hospitals, a positive association

between performance and quality is found to be significant. This

report further gives longitudinal proof of the adverse relationship

between patient care and the scale of the hospital. In

conclusion, for inefficient small and medium-sized hospitals, the

effect of hospital quality on patient satisfaction could be

improved by taking successful large hospitals as role models.

(Gok et al., 2013)

Medica (2012) explains that the pre-analytical phase is the

most insecure aspect of the overall research process and is

perceived to be one of the biggest obstacles for laboratory

professionals. However, pre-analytical practices, management

of unsuitable specimens, and monitoring procedures are not

completely developed or harmonized worldwide. There are

many requirements for blood sampling and sample transport

and handling, but compliance with these guidelines is limited,

particularly outside the laboratory, and where blood sampling is

carried out without the close supervision of the laboratory

personnel. Moreover, for some of the most important

procedures in the pre-analytical process, globally agreed

34
 protocols and recommendations, as well as associated quality

controls, are sadly not available.

As stated in the study of Tosif et al., 2012, The best

approach for diagnostic urine collection in children is unknown.

Clean capture urine (CCU) specimens are recommended by

the National Institute of Health and Clinical Excellence to detect

urinary tract infections (UTI). CCU, suprapubic aspiration

(SPA), catheter specimen urine (CSU) and bag specimen urine

(BSU) samples have been investigated for leakage rates. This

research paper concluded that the CCU pollution

concentrations are much higher than in tests from CSU and

SPA. Ideally, for the microbiological examination of urine of

small children, SPA should be used. If the CCU is used,

selection procedures need to be efficient.

According to McLawhon, 2011, this research advocates

the use of reference standards for calibration as a means of

harmonizing laboratory findings provided with different in vitro

diagnostic methods because the case for standardization and

harmonization has been evident for over 4 decades. The subject

has been studied and debated thoroughly over the prevailing

time both within and outside the laboratory community, but a

large number of the physician and surgeon colleagues still

refuse to understand or recognize the shortcomings of current

laboratory measurements, the lack of interchangeability of

findings obtained by different analytical methods, and the

35
 subsequent effects on interpretation, decision-making in clinical

practice, and patient management. This research shows that

This study intended health workers must remain diligent in

raising consciousness that current laboratory findings are not

standardized nor harmonized and can lead to erroneous

decisions with severe implications.

According to Nigam 2011, pre-analytical variables include

specimen selection, storage, preparation, physiological

influences, and/or intervention factors. Because blood

collection is the first step, any mistake in this step will

jeopardize all test results, no matter how reliable they are

tested in the laboratory. Here, some typical mistakes in blood

processing and care in hospital patients have been illustrated

in some cases. Preanalytics shall include the patient, the

surgeon, the resident physician, the nurse, the technician, the

laboratory staff, and the transport service. Therefore, both of

them ought to know about the pre-analytical factors, their

potential origins, and their effect on the test results.

Local Literature

The focus of study in the clinical laboratory has now moved

to the pre-analytical process due to the number of errors. The

most frequently found pre-analytical errors are: incomplete

specimen or order, hemolyzed or clotted blood for EDTA,

inadequate blood volume, misidentification of the patient, and

36
incorrect transfer of the sample and storage. In a study

performed over five years, the cumulative pre-analytical error

rate was 13.54%. The errors monitored were ineffective

containers (0.08 %), insufficient sample (0.35 %), and

hemolyzed sample (8.76%). The effect of pre-analytical errors

has become immense because it will have an impact on the

whole research process, so there will be no sample to be

tested and no findings to be obtained. But the patient diagnosis

is very much affected (Balogh, 2015).

A study conducted by Cerio et al., 2015 in Quezon City it

was found out that the bulk of prescription mistakes can be

traced to the illegibility of handwriting by the clinicians. The

purpose of this study is to assess the readability of medical

handwriting in both private and public hospitals in Quezon City,

Philippines. To include generic medications, prescription

abbreviations, and symbols were compiled based on similar

literature and grouped into prescription components. The

variables greatly impacting the readability of the handwriting of

physicians were then subjected to variance analysis. It was

determined from the studies that the doctors had identical

handwriting, regardless of the specialty. Abbreviations should

be minimized to minimize uncertainty. Pharmacists are more

likely to classify prescriptions accurately in the appraisal

classes. 

37
 A categorical questionnaire on chemical risks and safe

laboratory practices was administered to laboratory technicians

in 18 laboratories at Cebu Doctors' University (CDU). This was

primarily used to assess the current CDU laboratory regime

and evaluate the performance of past workshops on good

laboratory practices (GLPs) and waste management among

laboratory technicians. On the average percentile, the following

fields were accurately observed: laboratory work procedures

(71 percent); housekeeping (68 percent); threat coordination

(62.6 percent); chemical storage (82 percent); flammable liquid

storage and processing (79 percent); waste handling (68

percent); means of an emergency evacuation (76 percent); and

protection devices. However, special issues were assessed in

the following areas: personal protective equipment (PPE) (52

percent) > marking and publishing (49 percent) > compressed

gas cylinders (30 percent). Existing areas of lesser reaction are

currently being tackled and additional surveillance will be

conducted, including students and teachers. Remember,

however, that this is the initial survey to track the laboratories

as a result of which more detailed results will be provided as

soon as further assessments are carried out (Galarpe, 2013).

In most developed nations, the accuracy of data in national

health information systems has been uncertain. However, the

reasons for error in the case recognition process are not well

known. The goal of this research was to analyze the processes

38
 of error in the case recognition process in the current routine

health information system (RHIS) in the Philippines by

calculating the probability of error on the health program

indicators used in the Field Health Services Information System

(FHSIS1996) and to classify these indicators accordingly.

(Murai, 2011)

According to Murai (2011), the findings indicate three

characteristics of meanings of indicators, such as those which

(1) are not supported by actual circumstances in the health

system, i.e. (a) data are expected from a facility that cannot

explicitly produce data and (b) definitions of indicators are not

compatible with its corresponding program;(2) insufficient or

vague, which allows for a variety of interpretations; and (3) total

but easily overlooked by health staff.

Synthesis

In compliance with point 4.12.4 of ISO15189, "Medical

Laboratories-Special Quality Competence Requirements," it is

recommended that laboratories should incorporate quality metrics

for the formal appraisal of laboratory efficacy in the delivery of

healthcare. The aim of these quality metrics set out by the World

Health Organisation (WHO) is: to identify areas for further research

and review, to highlight possible quality issues, and to assess the

quality of services. It was proposed that the laboratories should

have their standard metrics for output assessment.

39
 Laboratory personnel knowledge of the quality control system

is an essential component in achieving an efficient laboratory

service that provides precise, consistent, and timely outcomes.

Pre-analytical process operations included more human

management, and all mistakes in these fields are caused by human

error. Improving this area of the research process includes

recruitment and training of laboratory staff and other healthcare

practitioners. In the book entitled "Improving Diagnosis in Health

Care" written by the Institute of Medicine, a successful diagnosis of

patients relies on the preparation and education of healthcare

professionals. Accreditation and qualification of healthcare

practitioners for quality assurance training would increase the

quality of the laboratory system.

Theoretical Framework

40
 Figure 2.1. Theoretical Framework of Total Testing Process

and Pre-analytical Phase

According to Plebani (2004), Clinical laboratory research

requires a range of steps to guarantee high-quality laboratory

facilities. Clinical laboratories have historically based their

efforts on quality management systems and quality evaluation

initiatives concerned with methodological aspects. However, a

growing body of evidence has been gathered over the last

decades to suggest that consistency of clinical laboratories

cannot be guaranteed merely by relying on solely analytical

aspects. In particular, the Total Testing Process (TTP) is an

essential mechanism for patient safety and better laboratory

facilities. In this cyclical process, a patient or physician shall

initiate tests to answer a therapeutic or public health issue. The

laboratory examination shall be requested, the patient shall be

marked, and the specimen shall be obtained, shipped, and

prepared for review. The specimen is then examined and the

findings are translated and communicated to the physician or to

the individuals who requested the tests.

41
 A new study of errors in laboratory medicine concluded that

errors arise more often in laboratory experiments before the

laboratory conducts the test (preanalytic) than after the test has

been completed. Many of the defects in the TTP are referred

to as laboratory malfunction but are in fact due to inadequate

coordination, behavior by those participating in the research

process (physicists, nurses, phlebotomists, etc.), or improperly

constructed procedures outside the control laboratory.

Research Paradigm
INDEPENDENT VARIABLE DEPENDENT VARIABLE

Demographic
Profile
Laboratory
Sections Level of Knowledge and
Pre-analytical Awareness on Practices of the
procedure (specimen Resident of Barangay
collection, handling, and
patient preparation) on
Routine testing

Figure 2.2. Research Paradigm of the Study

The intention of this study was to know the level of

knowledge and awareness on practices of the residents of

Barangay 168, Deparo, Caloocan City, Metro Manila,

Philippines.

The participants of this study will be identified through

their Age, Gender, Educational Attainment, and the times they

undergo Laboratory testing in a year. Aside from the

42
 demographic profile, the researchers also identified the Routine

Tests under Clinical Chemistry, Clinical Microscopy, and Clinical

Hematology that were experienced by the Patients during the

Pre-Analytical procedure by specimen collection, handling, and

patient preparation to assess the knowledge and awareness of

the participants.

CHAPTER III

METHODOLOGY

This chapter contains the materials and procedures, research

design, and research locale. This chapter also includes the research

respondents, statistical treatment/ data analysis, research instrument,

and data gathering will also be included.

43
Research Design

In this study, the researchers utilize a quantitative-descriptive

survey design, a type of research undertaken that aims to describe

characteristics of variables in a situation. According to Best and

Khan (2014), descriptive survey design is concerned with

conditions or relationships that exist, opinions that are held,

processes, evident effects, or trends that are developed. According

to Kerlinger (2013), the descriptive survey design enables data

collection without the manipulation of research variables. The

nature of the descriptive survey optimized the capabilities of both

quantitative and qualitative analysis approaches. The survey

method allowed collecting data from a large sample population and

generated discoveries that presented the whole population at a

lower cost (Saunders, 2012).

Research Locale

This research entitled “Evaluation of Knowledge and

Awareness on Quality Indicator in the Pre-analytical Phase in

Routine Laboratory test among the Residents of Barangay 168,

Deparo, Caloocan City", is conducted at the Manila Central

University - City of Caloocan, Metro Manila. The study is conducted

44
 by the distribution of questionnaires to the selected participants

with the use of google online survey form due to the protocol of

Inter-Agency Task Force. The researchers’ respondents are

residents of Barangay 168, Deparo, Caloocan City.

Study Area

Caloocan City is an area located in the northern part of the

National Capital Region that is comprised of 5,333.40 hectares

of land area. It is divided into two based on the geographic

location, the southern and the northern Caloocan (Caloocan City

Office Website 2020).

Barangay 168 Deparo is one of the barangay of Novaliches,

Zone 15, Caloocan City, NCR, Philippines. It has an area of 2.16

square kilometer of scope with 32, 620 population as of August

2015 census (National Statistics Office of the Philippines and

National Statistical Coordination Board 2015). It is a densely

populated barangay, and the people participates actively in

health services offered to them based on the reports on the

Caloocan City Office page.

45
 Figure 3.1. Location and View of the Barangay 168 Deparo, Caloocan
City, NCR, Philippines.

Figure 3.2. Location and View of the Barangay Santa Monica in Quezon
City, NCR, Philippines for Pilot testing

Research Respondents

Quota sampling is a sampling technique in which data from a

homogeneous population is obtained. This involves a two-step

method where two variables can be used to filter population

information. (Mohammed et al. 2017) It can be administered quickly

and allows fast distinctions. The study is a finite element of the

statistical population where the properties are analyzed to collect

knowledge about the entire population. It is more appropriate,

especially for the online method, than quota sampling. The target

respondents of this study are the residents of Barangay 168,

Deparo, Caloocan City. The target participants are 100

respondents. Since the pandemic (COVID-19) occurs in the

Philippines, protocols are made to avoid too much contact and

gatherings. The respondents should be 21 years old above or so-

called (working employee) as a criterion. The researchers selected

46
 their participants based on the respondents' availability and their

willingness to answer the online survey sheet that the researchers

sent to them through google forms.

Research Instrument

The collected data for this study, the primary instrument that

the researchers used is online survey questionnaires. The

researchers formulated questions that are deemed essential to

know and to assess the knowledge and awareness on practices

about the pre-analytical phase on laboratory method primarily in

the collection of specimens among the residents of Barangay 168,

Deparo, Caloocan City. The questionnaire is validated by a College

of Arts and Science professor in Manila Central University, a

professor in College of Medical Technology in Far Eastern

University- Manila and a Practicing Registered Medical

Technologist.

The research questionnaire consists of 3 main parts. The first

part is the data regarding the respondents' demographic profile,

specifically their age, gender, educational attainment, and times to

undergo laboratory tests in a year.

The second part of the questionnaire measures the level of

knowledge about factual myths and misconceptions about pre-

analytical procedures on routine testing in clinical laboratory

primarily in specimen collection, with an approach of yes or no

questions and multiple choice.

47
 The third part is the awareness of practices in pre-analytical

procedures on routine testing, especially in specimen collection.

Every question was answered using a 4-Likert scale by the

respondents. The respondents chose between numbers one to

four, where one (1) means strongly disagree, two (2) means

disagree, three (3) means to agree, and four (4) means strongly

agree as to their answer, and the survey runs for about 10 minutes.

Reliability testing

The researcher formulated the questionnaire that is usually

observed and seen in the clinical laboratory and community

services. The research is based on the Ebook references such as

Henry’s Clinical Diagnosis, Strasinger Urinalysis and Other Body

Fluids, etc. The respondents must know the essence of the

questions because, in that way, the researchers can gather specific

and accurate data that is essential for the success of the study.

The survey questionnaire went through pilot testing, which

helped the researchers find questions that do not make sense to

the participants or concerns with the questionnaire, leading to bias.

This pilot testing was led by a certified statistician, and grammar

expects to improve the questionnaire itself. The respondents of the

pilot testing are from the residents of Barangay Sta. Monica,

Novaliches, Quezon City. Pilot testing was done on a smaller

number of respondents compared to the original plan of

48
 respondents. The sample questionnaire and consent form can be

seen in Appendix A.

The questionnaire survey also requires anonymity, which is

beneficial since it increases the likelihood of a 'real answer.'

Ethical Consideration

The research was accepted by the Manila Central University

Institutional Review Board. The probable participants were updated

on the research and presented in the local language's participant

information sheet. The researchers addressed the participant's

concerns about the analysis. Those persons who wanted to take

part in the analysis completed the questionnaire. A neutral

assistant was offered to those in need of assistance in responding

to the questions.

This research honors the researchers' privacy and was

ensured that the respondents' identity is kept secret and

confidential. The data that was obtained were used for analysis that

was non-maleficent. It helped the positive and was used against

the participants. Respondents would not be obligated or compelled

to engage in this survey. They have the right to withhold informed

consent, which would be disseminated to their respective groups.

Honesty and honesty was exercised in this study to ensure the

authenticity of the findings. Researchers practiced ethics

Guidelines as a duty to protect the evidence and the findings

against all potential changes.

49
Data Gathering Procedure

The researchers have presented a letter addressing the

Barangay Chairman about the research, followed by a letter of

consent to each participant through messenger or email. This letter

included all the things they need to know about this research –its

purpose, why it is conducted, the people who benefited from it, and

the things that should be done during the research span. It was

indicated in the letter that the data gathering was held with

confidentiality and for research purposes only. The researchers

were also informed that it was based on their availability and

willingness to participate.

The data was gathered using online google form survey

questionnaires. The respondents were given a list of questions with

three components from which the respondents were choosing

between numbers one to four; yes or no and multiple-choice as to

their answer for the second part. For the third part, the questions

were answered; they can choose one to four in the scale where

one means strongly disagree, and four means strongly agree as to

their answer for the third part. The researchers first explained each

question for them to have a clear understanding of the topic. The

respondents answered the questions freely and based on their

understanding and point of view.

Data Interpretation

50
 For accurate and useful data processing and interpretation,

frequency counts, ratios, means, and standard deviations were

used.

The researchers also used inferential statistics as a method to

be able to select a sample from a given population that served as

the respondents of the study. Inferences for the study variables are

the independent variable, pre-analytical phase, and level of

awareness and practices as a dependent.

Table 3.1. Description of Mean for Level of Knowledge and

Awareness
Average Mean Verbal Description
1.00-1.75 Strongly Disagree
1.76-2.50 Disagree
2.51-3.25 Agree
3.26-4.00 Strongly Agree
A 4-point scale was used to assess respondents' views of

quality metrics for awareness of residents of Barangay 168, Deparo,

Caloocan City in terms of the pre-analytical phase (specimen

collection, handling, and preparation). To simply get the average mean

the researchers used the McCall-Crabbs Test Formula in a 4-point

scale.

According to Polit and Beck (2014), Questionnaires tend to be

more acceptable for using large sampling scales and for assessing

procedures. Qualitative research, such as a questionnaire study, may

be useful in offering a better view of crucial facets of the pre-analytical

process that a quantitative approach could not accomplish. Perceptions

of collection procedures by medical and laboratory workers are useful

when designing techniques to increase the TTP's pre-analytical

51
efficiency to be able to have specific awareness and knowledge of the

residents.

Statistical Treatment

Data from the 100 respondents was analyzed using a

probability distribution table and t-test analysis (ANOVA) using the

Statistical Package for the Social Science (SPSS) version 20. A p-

value of less than 0.05 was applied as statistically significant. The

data was collected through an in-depth survey.

Due to variability among items, researchers applied scientific

probability-based designs to select the samples. This reduced the

risk of a distorted view of the population and enabled statistically

valid inferences from the sample. The final stage of the analysis

was to provide a richer or deeper meaning to the residents'

responses in the survey form. Descriptive statistics (frequency,

percentage) was used to analyze the data that was gathered.

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