LAB MUST TO KNOWS

Allergy to latex
>>decreasing among health-care workers because of the availability of other types of gloves
>> allergies patches of dry, itchy irritation on the hands; delayed hypersensitivity reactions
resembling poison ivy that appear 24 to 48 hours following exposure
>>true immediate hypersensitivity reactions often characterized by facial flushing and
respiratory difficulty
>>Hand sanitizing immediately after removal of gloves and avoiding powdered gloves may aid
in preventing the development of latex allergy
>>Any signs of a latex reaction should be reported to a supervisor because a true latex allergy
can be life-threatening

Postexposure Prophylaxis (PEP)

1. Draw a baseline blood specimen from the employee and test it for HBV, HCV, and HIV.
2. If possible, identify the source patient; collect a blood specimen; and test it for HBV, HCV,
and HIV. Patients must usually give informed consent for these tests, and they do not become
part of the patient’s record. In some states, a physician’s order or court order can replace
patient consent because a needlestick is considered a significant exposure.
3. Testing must be completed within 24 hours for maximum benefit from PEP

Source Patient Tests Positive for HIV

1. Employee is counseled about receiving PEP using antiretroviral medications.
2. Medications are started within 72 hours.
3. Employee is retested at intervals of 6 weeks, 12 weeks, and 6 months.
4. Additional evaluation and counseling is needed if the source patient is unidentified or
untested.

Source Patient Tests Positive for HBV

1. Unvaccinated employees can be given hepatitis B immune globulin (HBIG) and HBV vaccine.
2. Vaccinated employees are tested for immunity and receive PEP, if necessary.

Source Patient Tests Positive for HCV

1. No PEP is available.
2. Employee is monitored for early detection of HCV infection and treated appropriately.
Any exposed employee should be counseled to report any symptoms related to viral infection
that occur within 12 weeks of the exposure.

LAB CONTAINERS
Primary container
>>glass, metal, or plastic must be watertight with a positive screw-on cap
>> must be wrapped with enough absorbent material to be capable of absorbing all its contents.
Multiple specimens must be wrapped individually before placing them in the leakproof
secondary container

Secondary container
>>must be placed in a sturdy outer container made of corrugated fiberboard, wood, metal, or
rigid plastic
>>An itemized list of contents in a sealed plastic bag is also placed in the outer container
>>Ice packs are placed between the secondary and the outer container
>>Additional measures must be taken when using ice and dry ice

CHEMICAL SPILLS
>>When skin or eye contact occurs, the best first aid is to immediately flush the area with water
for at least 15 minutes and then seek medical attention
>>Laboratorians must know the location of the emergency shower and eyewash station in the
laboratory, Do not try to neutralize chemicals spilled on the skin

The Globally Harmonized System (GHS)

>> is an international effort to standardize both the classification of hazardous chemicals and
the symbols used to communicate these hazards on labels and in SDS documentation
>>includes criteria for the classification of health, physical, and environmental hazards
>>Labels of pictograms, signal words, and a GHS hazard statement
>>SDS under GHS provides a clear description of the data used to identify hazards and has 16
sections in a specified order
>>OSHA aligned its Hazard Communication Standard with the GHS and requires that all
employees be trained on the new label elements and SDS format
>>The adoption of the GHS in the United States has increased awareness and understanding of
hazards in the workplace.

Chemical Spills
>>SDS gives specific information for the appropriate action to be taken for a chemical spill
>>A chemical spill kit must be available in every laboratory and contains appropriate PPE
(gloves and goggles), absorbent pads, disposable bags, and waste tags. Liquids are absorbed
using a neutralizer, such as a sodium bicarbonate and sand mixture, or ground clay
>>After the liquid is absorbed, it is scooped up and placed into a waste bag and labeled
appropriately for disposal

QUALITY MANAGEMENT
>>overall process of guaranteeing quality patient care
>> is the continual monitoring of the entire test process, from test ordering and specimen
collection through reporting and interpreting results
>>Written policies and documented actions as they pertain to the patient, the laboratory,
ancillary personnel, and the health-care provider are required
>> written remedial actions mandating the steps to take when any part of the system fails are
essential to a QM program

Clinical Laboratory Improvement Amendments (CLIA)

>> are regulations that specify required components for QM, including patient test management
assessment, quality control (QC) assessment, proficiency testing assessment, comparison of
test results, relationship of patient information to patient test results, patient confidentiality,
specimen identification and integrity, personnel competency, personnel qualifications and
evaluations, communication protocols, complaint investigations, review with staff, and
maintenance of records for 2 years
>>Documentation of QM procedures is required by all laboratory accreditation agencies,
including TJC, the College of American Pathologists (CAP), the American Association of Blood
Banks (AABB), the American Osteopathic Association (AOA), the American Society of
Histocompatibility and Immunogenetics (ASHI), the American Association for Laboratory
Accreditation (A2LA), and the Commission on Office Laboratory Assessment (COLA)< it is also
required for Medicare and Medicaid reimbursement. >>Guidelines published by CAP and the
Clinical and Laboratory Standards Institute (CLSI) provide very complete instructions for
documentation and are used as a reference for the ensuing discussion of the specific areas of
immunology QM
>>Documentation in the form of a procedure manual is required in all laboratories

Variable
>>defined as anything that can be changed or altered
>>Identification of variables throughout the testing process provides the basis for development
of procedures and policies within the immunology department that are located in the procedure
manual

Preexamination variables
>>occur before the actual testing of the specimen and include test request orders, patient
preparation, time of specimen collection, specimen collection, handling and transport, and
specimen storage
>>Health-care personnel outside the immunology department control many of these factors,
such as ordering tests and collecting specimens; however, communication between
departments and adequate training on the correct procedures for ordering a test, collecting a
specimen, and transporting the specimen improves the turnaround time (TAT) of results, avoids
duplication of test orders, and ensures a high-quality specimen

TAT
>>defined as the amount of time required between the point at which a test is ordered by the
health-care provider and the results are reported to the healthcare provider
>>The laboratory can monitor the TATs for both stat and routine tests to determine areas in the
process that need improvement

Specimen Collection and Documentation

>> the patient’s first and last name
>>the patient’s identification number
>>the patient’s gender
>> the patient’s age or date of birth
>> the name of the person requesting the test
>> the name of the person to contact with critical results
>> the name of the test ordered
>> any special handling requirements
>>the time and date of specimen collection
>>the time the specimen was delivered to the laboratory
>> fasting or elimination of interfering medications
>> type and volume of specimen required must be included in the specific procedure

"The criteria for specimen rejection for both physical characteristics and labeling errors must be
present. If a specimen is rejected, the criteria for rejecting that specimen must be documented
and available to the health-care provider and nursing staff."

Examination Variables
>> reagents, instrumentation and equipment, testing procedure, QC, preventive maintenance
(PM), access to procedure manuals, review and interpretation of results, and the competency of
personnel performing the tests

Reagents
>>The name and chemical formula of each reagent used, any necessary instructions for
preparation or company source of prepared materials, storage requirements, and procedures for
reagent QC are all found in the procedure manual
>>The type of water used for preparing reagents and controls must be specified

Distilled or deionized water or clinical laboratory reagent water (CLRW)

>>must be available, with bold-type statement of any safety or health precautions associated
with reagents should be present
>>All reagents must be properly labeled with the date of preparation or opening, purchase and
received date, expiration date, and appropriate safety information
>>Reagents should be checked against two levels of commercial control solutions on each shift,
or at a minimum of once a day and whenever a new reagent is opened, Results of all reagent
checks are properly recorded

Instrumentation and Equipment

>>The procedure manual must clearly provide instructions regarding the operation,
performance, frequency of calibration, and limitations of the instrumentation and equipment
>>The procedures to follow when limitations or linearity are exceeded, such as dilution
procedures, must be included in the manual, as well as instructions detailing the appropriate
recording procedures.
Deionized water
>>used for reagent preparation is quality controlled by checking its pH and purity meter
resistance on a weekly basis, as well as the bacterial count on a monthly schedule
>>All results must be recorded on the appropriate forms

Testing Procedures
>>Detailed and concise testing instructions are written in a step-by-step manner
>>Instructions should begin with specimen preparation, such as time and speed of
centrifugation, and include types of glassware needed, time limitations and stability of
specimens and reagents, calculation formulas and a sample calculation, health and safety
precautions, and procedures
>>Additional procedure information, including reasons for special precautions, sources of error
and interfering substances, helpful hints, clinical situations that influence the test, alternative
procedures, and acceptable TATs for stat tests are listed under the title of Procedure
>>Reference sources should be listed
>>The manufacturer’s package inserts may be included but cannot replace the written
procedure. The laboratory director must sign and date new procedures and all modifications of
procedures before they are used

Quality Control Quality control

>>refers to the materials, procedures, and techniques that monitor the accuracy, precision, and
reliability of a laboratory test
>>QC procedures are performed to ensure that acceptable standards are met during the
process of patient testing
>> Specific QC information regarding the type of control specimen, preparation and handling,
frequency of use, tolerance levels, and methods of recording should be included in the step-by-
step instructions in the procedure manual for each test
>>QC is performed at scheduled times, such as at the beginning of each shift or before testing
patient samples, and it must always be performed if reagents are changed, an instrument
malfunction has occurred, or test results are questioned by the health-care provider
>>Control results must be recorded in a paper or electronic log
>>Patient test results may not be reported until the QC is verified

External Controls
>> verify the accuracy or ability to obtain the expected result and precision ability to obtain the
same result on the same specimen of a test
>>Reliability is the ability to maintain both precision and accuracy
>>The control material is tested in the same manner as the patient samples
>>Analysis of at least two levels of control material is required
>>One of these is a high-level control and the other is a low-level control
>>The concentrations of the controls should be at medically significant levels and should be as
similar to the human specimen as possible
>> Documentation of QC includes dating and initialing the material when it is first opened and
recording the manufacturer’s lot number and the expiration date each time a control is run and a
test result is obtained

Food and Drug Administration

>>require that control material test negative for HIV and HBV
>>External controls are tested and interpreted in the laboratory by the same person performing
the patient testing
>>The control data are evaluated before releasing patient results
>>Data obtained from repeated measurements have a Gaussian distribution or spread in the
values that indicate the ability to repeat the analysis and obtain the same value
>> The laboratory, after repeated testing, establishes the value for each analyte and calculates
the control mean (the average of all data points) and the standard deviation (SD) (a
measurement statistic that describes the average distance each data point in a normal
distribution is from the mean)

Cefficient of variation (CV)

>> the SD expressed as a percentage of the mean
>>indicates whether the distribution of values about the mean is in a narrow versus a broad
range and should be less than 5%
Confidence intervals
>>are the limits between which the specified proportion or percentage of results will lie
>>Control ranges are determined by setting confidence limits that are within ±2 SD or ±3 SD of
the mean, which indicates that 95.5% to 99.7% of the values are expected to be within that
range
>>Values are plotted on Levey–Jennings control charts to visually monitor control values
>> Immediate decisions about patient results are based on the ability of control values to remain
within a preestablished limit
>>Changes in the accuracy of results are indicated by either a trend, a gradual change in the
mean in one direction that may be caused by a gradual deterioration of reagents or deterioration
of instrument performance, or a shift, an abrupt change in the mean that may be caused by a
malfunction of the instrument or a new lot number of reagents
>> Changes in precision are shown by large amount of scatter about the mean and an uneven
distribution above and below the mean that are most often caused by errors in technique
>>When control values are outside the tolerance limits, corrective action that includes the use of
new reagents or controls and the verification of lot numbers and expiration dates must be taken
and documented
>> designated supervisor reviews all the QC results
>>Some laboratories may participate in a commercial QC program run by the manufacturer of
the QC material
>>The results from the same lot of QC material are returned to the manufacturer for statistical
analysis and comparison with other laboratories using the same methodology
Internal Controls
>> Internal controls, also called procedural controls, consist of internal monitoring systems built
into the test system
>>monitor the sufficient addition of a patient sample or reagent, the instrument’s and reagent’s
interaction, and for lateral flow test methods, whether the sample migrated through the test strip
properly

Electronic Controls
>>use a mechanical or electrical device in place of a liquid QC specimen
>>This type of QC can be an internal or an external component inserted into a point-of-care
(POC) instrument
>>Electronic controls verify the functional ability of a testing device but do not verify the integrity
of the testing supplies
>>Many test systems use a combination of external and internal controls to verify that the entire
test system is working properly

Proficiency Testing-External Quality Assessment

>> the testing of unknown specimens received from an outside agency
>> It provides unbiased validation of the accuracy, and thus quality, of patient test results.
Several commercial vendors, such as the CAP, provide proficiency testing programs
>>Laboratories subscribing to these programs receive lyophilized or ready-touse specimens
>>The results are returned to the proficiency testing vendors, where they are statistically
analyzed with those from all participating laboratories
>>The laboratory director receives a report from the vendor, which enables the director to
evaluate the laboratory’s accuracy and compare it with other laboratories using the same
method of analysis
>>The director ensures that the laboratory takes action to correct unacceptable results
>>The CLIA mandate comparison testing for laboratory accreditation

Personnel and Facilities QC

>> is only as good as the personnel performing and monitoring it
>>Personnel assessment includes education and training, continuing education (CE),
competency assessment, and performance appraisals
>>Each new employee must have documentation of training during his or her orientation to the
laboratory
>>This documentation is a checklist of procedures and must include the date and initials of the
person doing the training as well as the employee being trained

Postexamination Variables
>> processes that affect the reporting of results and correct interpretation of data

Reporting Results
>>Standardized reporting methods minimize health-care provider confusion when reporting
results
>>Electronic transmission is now the most common method for reporting results
>>The telephone is frequently used to convey results of stat tests and critical values. Personnel
on hospital units and from health-care providers’ offices often call requesting additional results
>>When telephoning results, confirm that the results are being reported to the appropriate
person. The time of the call and the name of the person receiving the results must be
documented according to the facility’s policy
>>Written procedures should be available for the reporting of critical values, which are
significantly abnormal results that are life-threatening
>>Laboratorians must be familiar with the critical values for each test and the processes for
notification of attending staff in a timely manner

Result Errors
>>Errors may be discovered in the laboratory through a QM procedure known as the delta
check that compares a patient’s test results with the previous results
>>Variation outside the established parameters alerts laboratory personnel to the possibility of
an error that occurred during the testing procedure or in patient identification
>>Automated comparison of patient results with predetermined preapproved criteria
(autoverification) is often programmed into many laboratory analyzers to expedite result delivery
>> manual must contain a written procedure for reporting, reviewing, and correcting errors.

Summary of Quality Management Errors Preexamination

• Patient misidentification
• Wrong test ordered
• Incorrect specimen type collected
• Insufficient specimen volume
• Delayed transport of specimen to the laboratory
• Inadequate processing of specimen
• Delayed separation of serum or plasma from cells
• Incorrect storage of specimen

Examination
• Sample misidentification
• Erroneous instrument calibration
• Reagent deterioration
• Poor testing technique
• Instrument malfunction
• Interfering substances present
• Misinterpretation of QC data

Postexamination
• Patient misidentification
• Poor handwriting
• Transcription error
• Poor quality of instrument printer
• Failure to send report
• Failure to call critical values
• Inability to identify interfering substances

Interpreting Results
>>The specificity and the sensitivity for each test should be included in the procedure manual
for correct interpretation of results

Clinical Laboratory Improvement Amendments

>> governmental regulatory standards administered by the Centers for Medicare and Medicaid
Services (CMS) and the FDA
>>CLIA stipulate that all laboratories that perform testing on human specimens for the purposes
of diagnosis, treatment, monitoring, or screening must be licensed and obtain a certificate from
the CMS
>>Laboratories with CLIA certification are inspected to document compliance with the
regulations. The inspections may be performed by CMS personnel or an accrediting agency
recognized by the CMS, such as the CAP, the TJC, COLA, AABB, A2LA, ASHI, or AOA

CLIA Test Classifications Waived Testing

>>Tests considered easy to perform by following the manufacturer’s instructions
>>These tests have little risk of error
>>No special training or education is required
>>Whole blood infectious mononucleosis test (Monospot)

Provider-Performed Microscopy Procedures (PPMPs)

>>Microscopy tests performed by a physician, midlevel practitioner, or dentist
>>Microscopic urinalysis

Nonwaived Tests
>>Moderate-complexity tests
>>Tests that require documentation of training in test principles, instrument calibration, periodic
proficiency testing, and on-site inspections
>>Automated immunoassays
>>High-complexity tests
>>Tests that require sophisticated instrumentation and a high degree of interpretation
>>Proficiency testing and on-site inspections are required
>>Immunofixation electrophoresis (IFE)

CLIA classifies laboratory tests into three categories

>>waived testing
>>provider-performed microscopy procedures (PPMPs)
>>nonwaived testing
Nonwaived testing
>>separated into the categories of moderate and high complexity with regard to requirements
for personnel performing the tests
>>Laboratories must obtain the correct certification for the level of testing complexity performed
>>For each category, there is a description of the educational level necessary for personnel
who may perform the test, as well as the type of quality assessment procedures that must be in
place

Clinical and Laboratory Standards Institute or CLSI

>> nonprofit organization that publishes recommendations by nationally recognized experts for
the performance of laboratory testing
>> considered the standard of care for laboratory procedures—attention, caution, and prudence
that a reasonable person in the same circumstances would exercise
>>In a legal situation, the CLSI standards would be considered the standard of care that should
have been met

The Joint Commission or TJC

>>TJC is an independent, not-for-profit organization that accredits and certifies more than
21,000 health-care organizations and programs in the United States.
>>The mission of TJC is to continuously improve the safety and quality of care provided to the
public through the provision of health-care accreditation and related services that support
performance improvement in health-care organizations
>>To maintain accreditation, organizations must pass an on-site inspection by a survey team
every 3 years
>>Laboratories are surveyed every 2 years
>>published National Patient Safety Goals
1. Improve the accuracy of patient identification. Use at least two ways to identify patients
who are using laboratory services. For example, use the patient’s first and last name, an
assigned identification number, and date of birth. The patient’s room number or
physical location is not used as an identifier. Label containers used for blood and
other specimens in the presence of the patient.
2. Improve the effectiveness of communication among caregivers. Get important test
results to the right staff person on time. Report critical results of tests to the appropriate
health-care worker on a timely basis.
3. Reduce the risk of health-care–associated infections (HAIs). Use the current hand-
hygiene guidelines from the CDC or the World Health Organization (WHO). Set goals for
improving hand cleaning. Use these goals to improve hand cleaning.

College of American Pathologists (CAP)

>> organization of board-certified pathologists that advocates high-quality and cost-effective
medical care
>> The CAP provides laboratory accreditation and proficiency testing for laboratories
>>For accreditation purposes, CAP-trained pathologists and laboratory managers and
technologists perform on-site laboratory inspections on a biennial basis
>> Inspectors examine the laboratory’s records and QC of procedures for the preceding 2 years
>>Inspection also includes the qualifications of the laboratory staff, including CE attendance,
and the laboratory’s equipment, facilities, safety program, and laboratory management
>>CAP accreditation is accepted by both the CMS and TJC and fulfills Medicare and Medicaid
requirements
>>As previously described, laboratories that subscribe to this proficiency program receive
periodic samples to analyze and return their results to the CAP
>>The laboratory receives a report on how its results compared with other laboratories
performing the procedures in a similar manner
>>Failure to perform satisfactorily on a proficiency test can result in a laboratory losing its CLIA
certificate to perform the failed test

Quality Management Systems

>>incorporates many of the objectives of total QM and continuous quality improvement to
ensure quality results, staff competence, and efficiency within an organization
>>utilizes the concepts of the International Organization for Standardization (ISO 151189) and
the Lean and Six Sigma methods
>> The requirements of TJC and the CAP accreditation organizations are included in a QMS
>> QMS coordinates activities to direct and control an organization with regard to quality and
the reduction of medical errors
>The first step in a laboratory QMS is to determine the pathway of workflow through the
laboratory, as discussed previously under the preexamination, examination, and
postexamination phases of testing
>>In each area of the pathway, all the processes and procedures that occur are determined and
analyzed so that everyone knows what they are supposed to do, how they are supposed to do
it, and when they are supposed to do it. Instructions must be available for each activity

Quality System Essentials Quality system essentials (QSEs)

>>form the basis of a QMS
>>The 12 QSEs describe the management information needed for a laboratory to perform
quality work
>> They were developed by the former National Committee for Clinical Laboratory Standards
and the current CLSI and include the methods to meet the requirements of regulatory,
accreditation, and standard-setting organizations

Quality indicators
>>are the measurements developed by each laboratory to determine if the QSEs are being met
>>They may include such items as appropriateness of the testing, correct patient identification,
timely reporting of laboratory results, and correct proficiency testing results

The Lean System

>> originated with the automobile manufacturing industry in Japan
>>Its concepts have been adopted by many American industries, including the health-care
industry
>>Lean utilizes a tool called “6S,” which stands for sort, straighten, scrub, safety,
standardize, and sustain
>>Lean focuses on the elimination of waste to allow a facility to do more with less and, at the
same time, increase customer and employee satisfaction
>>In the health-care environment, the ability to decrease costs while providing quality health
care is of primary importance
>> The use of the Lean tools enhances efficiency and proficiency

Six Sigma
>>statistical modification of the original Plan-Do-Check-Act (PDCA) method adopted by TJC as
a guideline for health-care organizations
>> focuses on minimizing variability in process outputs that lead to wasted time and resources
>> Reducing variation will potentially reduce costs, improve performance, and increase
profitability
>>The primary goal of Six Sigma is to measure, to quantify errors, and then to reduce
variables and decrease errors to a level of 3.4 defects per 1 million opportunities
>>Attaining this goal indicates that the laboratory is addressing factors critical to customer
satisfaction and quality care

The Six Sigma methodology is represented by the acronym DMAIC:

1. Define goals and current processes

2. Measure current processes and collect data
3. Analyze the data for cause-and-effect information
4. Improve the process using the data collected
5. Control the correction of concerns displayed in the data

Root Cause Analysis

>> Similar to Lean, root cause analysis (RCA) has roots in the manufacturing industry
>> tool widely used in the investigation of adverse events in the health-care setting
>>TJC mandates the use of RCA to investigate “sentinel events,” which are defined as an
unexpected occurrence involving death or serious physical or psychological injury or the risk
thereof
>> An RCA protocol begins with the investigation and reconstruction of the adverse event to
determine how the event occurred
>>RCA focuses on the process failures, not on the individual mistakes of personnel