MEDICAL TECHNOLOGY LICENSURE EXAM REVIEW - HTMLE

INTERNATIONAL LABORATORY STANDARDS LABORATORY ACQUIRED INFECTIONS:

LABORATORY MANAGEMENT & OPERATIONS ●

●
To be achieved by the laboratory; to know if it follows minimum protocol for
specimen safety and specimen result quality
Assess and Measure performance against International Quality Standards
DISEASE PROBABLE SOURCE
MAXIMUM
DISTANCE FROM
SOURCE
Lecturer: Jayson B. Sanchez, RMT, MLS (ASCPi)CM, MSMTc
● Laboratory Standard Organization: Brucellosis Centrifugation (cover) Basement to 3rd Floor
Notes by: Xiao - The Conqueror of Demons, The Vigilant Yaksha, & Alatus, the Golden-Winged King
○ ISO – International Organization for Standardization Coccidioidomycosis Culture transfer, Solid Media 2 building floors
 Movement of papers and documents in the lab Coxsackie Virus Spilled tube of infected 5 feet estimate
LABORATORY MANAGEMENT ● Paths of Workflow
 Quality and competence of employee mouse tissue on floor
● Over-all handling of the Clinical Laboratory ○ entire set of operations that occur in testing begins with the PATIENT
 Speed + accuracy in the lab Murine Typhus Intranasal Inoculation of 6 feet estimate
○ ends with the REPORTING, INTERPRETATION
● Requires LEADER - provide direction, and MANAGER to get things done ○ CLSI – Clinical and Laboratory Standards Institute formerly, National Mice
● Organization – good only as its people – guided by LEADERS and Committee for Clinical Laboratory Standards (NCCLS) Tularemia 20 petri-plates dropped 70 feet
MANAGEMENT  Specific performance in the lab Venezuelan 9 lyophilized ampoules 4th floor stairs to 3rd or
● Qualities of Leader and Manager Encephalitis dropped 5th floor
● ISO Standards: (Geneva)
LEADER MANAGER ○ ISO 15189: 2007 PERSONAL PROTECTIVE EQUIPMENT (PPE)
Administrator Implementer  Medical Laboratories: Particular Req. for Quality and Competence
 Major Routes of Inoculation
Organizer and Developer Watches Bottom Line ○ ISO/IEC 17025: 2005
o Percutaneous
Risk-Taker Maintains Control  General Req. for the Competence of Testing and Calibration
o Contact between Mucus Membrane and Contaminated Material
Inspiration Is Good Soldier
o Accidental Ingestion
Thinks Long Term Thinks Short Term ● CLSI Standards: (Wayne)
 Access, Trainings, Habitual use (Self-Discipline)
Asks WHAT and WHY Asks HOW and WHEN ○ HSI-A2 (2004)
 Quality Management System Model for Health Care, 2nd Ed.  Types of PPE
Challenges status quo Accepts status quo o Gloves: remove when leaving lab, never reuse (porous)
Does the Right Thing Does Things Right  Product: Path of Workflow
○ GP26-A3 (2004) o Masks: face shield glass, FFP2, US NIOSH-N95 (respirator) certified
 Application of a Quality Management System Model for Lab o Body Coat: required in Biosafety Level 2 laboratories, BSL3 is required
● Administrator
Services, 3rd Ed to use a disposable coat
○ Assign and perform tasks
○ Coach team members
II. FACILITIES & SAFETY EMERGENCY MANAGEMENT
● Organizer and Developer
○ Transform an ordinary work to an extraordinary one
○ Helps colleague succeed ● Major Concern Person: LABORATORY MANAGERS (responsible for CHEMICAL SPILLS:
● Maintains Control reinforcing safety in the lab)  Minor Spill – person is familiar with the chemical and its hazard
○ “I’m the boss, you have to follow what I’m going to say” ● Responsible for Safety in the Laboratory o Recommended Steps:
○ Laboratory Director: participate in planning and assessment  Alert Co-workers, Clean Spill
LEADERSHIP ○ Quality Manager: conduct regular laboratory safety audits  Place a cloth on the spill and wet it with disinfectant (indirectly)
● Pattern of behaviors used to engage other to complete tasks in a timely and ● Overview of Quality Management System Model ○ Laboratorian: be aware and understand safety protocols; responsible  Free Liquid and Appropriate Absorbent
productive manner ○ Organized (understandable, workable) Structure for safety in the lab  Caustic Liquid – Propylene Pad or Diatomaceous
○ Timely and productive: employee is learning while doing the tasks ○ Ensures appropriate management ● Laboratory Design  Oxidizing Acid – Diatomaceous Earth
● Leadership Styles: ○ Model Developed by CLSI ○ Most Efficient Design = Related Activities, Place in Close Proximity  Mineral Acids – Baking Soda or Propylene Pads
○ Supportive Leader: helps in doing the task ○ Compatible with ISO Standard ○ Access: separate access of patient and staff  Flammables – Propylene Pads, Sand
○ Directive Leader: instructs / follows up ○ Quality Manager ○ Circulation Pathways: collection, processing, post-exam
○ Delegating Leader: believes that if work is distributed, it will be done in ● Geographic Organization  Major Spill – beyond minor, needs expert assistance
a timely and productive manner QUICK CONCEPTS: ○ Delineation of Laboratory Activities o Recommended Steps;
○ Coaching Leader: teaches the step-by-step procedure, demonstrates ○ Location of Service Rooms  Alert Co-workers
TERM DESCRIPTION ○ Location of Activities with Specific Requirements:  Move to Safe Location
Organization  Structure and management of the Laboratory ■ Molecular Biology: separate, at least 2 rooms  Call authorities to Report Situation
MANAGEMENT
 Establishment of Policies, Implementation, Monitoring ● Room 1: DNA Extraction (very sensitive to contamination; very
● Uses the human, financial, physical, and information resources available to
Personnel  Most important sterile) BIOLOGICAL SPILLS:
an organization in the MOST EFFICIENT and EFFECTIVE manner ● Room 2: Reagent and Amplification (organism is dead; it’s ok
 Competent and motivated (excellent productivity / output)
● Types of Management:  Apply absorbent towel to Spill
 Encouragement and Motivation not to wear face mask)
○ Operations Management  Disinfect Towel - 20 minutes
Equipment  Choose the RIGHT EQUIPMENT (1 machine for multiple ■ Fluorescence Microscopy: dark room, proper ventilation
■ Management of day to day operations  Clean surface – Alcohol or soap and water or notify supervisor and other
tests, follow minimum dimension), Proper Maintenance ■ UV Illumination for DNA gel photography: appropriate eye
■ From beginning to the last hour of shift authorities
Purchasing and  Manage Reagents and Supplies; Cost Savings; Ensure protection and dark room
○ Human Resource Management  Disinfectant:
Inventory availability of supplies ● Spatial Provision for Equipment
■ In-charge of recruitment o Most Spills: 1:50 NaHOCl (50 g/L Chlorine)
 Quality organization = ability to follow minimum standard ○ Access to Equipment for ENTRY and MAINTENANCE
■ Develops and evaluates employee o Large amount of Organics Spills: 1:10 (5g/L)
Process Control  Quality Control, Sample Management, Verification and ○ Power Supply: stable with backup
■ Provides training o Alcohol is NOT RECOMMENDED
Validation of Methods ○ Liquid Disposal from Equipment: awareness and compliance
○ Financial Management  Evaporates Quickly; Shorten Contact Time (should be 30 secs – 1
Information  Product of Laboratory: INFORMATION ■ Ex: waste container with sensor
○ Marketing Management min)
Management  Accuracy, Confidentiality, Accessibility  Facilities and Benches
■ Most important  70% alcohol – due to water concentration
Documents  Inform how to do things o High Ceiling
■ Effective marketing is needed for a product to be sold
Records  Meticulously maintained: accurate and accessible o Walls and Ceiling: painted with GLOSSY PAINT
LABORATORY FIRE:
Occurrence  “occurrence” – an error that should not have happened o Floor: easy to clean, no edge between walls and floor;
STRATEGIC PLANNING o Work Benches:  Liquids with low flash points may ignite when near to heat
Management  Handle, Learn, Take Action= NOT HAPPEN AGAIN
● Continuous REASSESSMENT of goals and services and adjust to market  Ceramic Tiles: good for benches o Ex. if sodium azide preservative is used, don’t process near a metallic
Assessment  Tool to examine: PERFORMANCE (machine, personnel,
forces like staffing shortage, stricter regulatory mandates, and new  Grout: caution taken, may harbor contaminants material = burst
system)  Small Lab Fire:
sophisticated technologies to survive competitive settings.  Steel: disadvantage: RUST when cleansed with Chlorine
 Benchmark (copying practices which are efficient /
○ Reassessment: re-evaluate plan from time to time = is output good/ o Cleaning: o Extinguishable – if within 1-2 minutes
helpful);
bad? → if bad → plan again  Weekly: Ceilings and Walls o Cover fire with Inverted Beaker or Wet Paper Towel
 Internal and External Assessment Tool
● Techniques in Strategic Planning:  Monthly: Storage areas, Refrigerators o If failed: USE FIRE EXTINGUISHER
Process  Systematic Process Improvement
○ Histogram/Graph/Scattergram  Procedures and Exercise o Fire Extinguisher – CHECK ANNUALLY
○ Brainstorming Involvement
Customer  Understand who the customers are. o Fire Drills: Evacuation Procedures, Basic Security Precautions
○ Fishbone Diagram: cause and effect relationship  Waste Management III. EQUIPMENT
Service  Assess needs and feedback
○ Storyboarding: timeline Wastes must be COLOR CODED  Calibration and Maintenance – train everyone who uses it
○ Analysis: Pareto, Delphi, SWOT Facilities and  SECURITY – prevent unwanted risk and hazards o

Safety  CONTAINMENT – minimize and keep away from o Special Attention: BREAKAGE, SHARPS, NEEDLES  Day-to-Day maintenance – responsibility of technical operator
community o Use INTERNATIONALLY RECOGNIZED LABELS  Proper Selection of Equipment (consider the following):
I. LABORATORY QUALITY
 SAFETY – policies and procedures; prevent harm o Necessities, Performance of Machine, Required Cost, Reagents Readily
 Accuracy, Reliability, Timeliness of Reported Results (according to CLSI) FIRST STEP IN SAFETY: IDENTIFICATION OF HAZARDS
 ERGONOMICS – safe and healthy working conditions, Available, Easy Operation, Warranty and Maintenance, Safety Issues
o Quality is an A-R-T address facility and equipment adaptations  Types of Hazards:  Equipment Installation:
 Consequences of Laboratory Errors Physical o Change package content contains all parts
o less occurrence of hazard o
○ Unnecessary Treatment Chemical and Radio Chemicals o Make a copy of software that is part of the system
o arrangement of specific things in the lab that o
○ Treatment Complications Needles and Sharps o Performance is verified and testing personnel are trained by the
prevents possibility of occurring hazard o
○ Delay in Correct Diagnosis o Biological manufacturer
○ Additional and Unnecessary Diagnostic Test  Material Safety Data Sheet – available, kept close to hazardous material
 Biosafety: minimum health standards that will prevent you from acquiring
● Quality Management System: coordinated activities to direct and control an
infection  MAIN SOURCE OF CONTAMINATION - Specimen
organization with regard to quality.
 Biosecurity: protect hazardous samples from theft; to prevent bioterrorism
 Designate those who are authorized to use the specimen INTERNAL AUDIT VIII. CUSTOMER SERVICE RECORDS
 Done by staff in one area of the lab conduct of another area  Customer satisfaction is one of the goals of the laboratory  Printed (hand or computer); NOT REVISED or MODIFIED
 Provide quick information ON PERFORMANCE & COMPLIANCE  To address Customer Satisfaction:  Complete, Legible, Carefully Maintained
 Information Gathered in an Audit: o Good Planning  Uses:
o Processes and operating procedures o Development of Appropriate Monitoring Tools (feedback forms) o Continuous Monitoring
o Staff competence and training o Knowledge to apply the tools to Gain Useable Information o Tracking of Samples
o Equipment  Customers: Physician, Health Care Providers, Clinic Staff, Patients and their o Evaluation of Problems
o Environment families, Public Health Officials, General Community o Management
o Handling of samples  Primary Resource: STAFF TIME  Never Change the Record – not addition (date, signature or initials)
o Quality control and verification of results  “TIP OF THE ICEBERG” - may only be the received complaints  Storage System:
o Recording and reporting practices  Received complaints may not be the sole source of customer satisfaction PAPER SYSTEM ELECTRONIC SYSTEM
 Internal Auditor/ Quality Manager: assessment Permanence Permanent ink, with Pages Needs good BACK UP
o Develop a formal plan (Table of Contents) SYSTEM
o Prepare a checklist based on selected guideline or standards IX. OCCURRENCE MANAGEMENT Regularly Maintained
 Post Installation: o Meet with all staff and explain the audit process  Deal with Laboratory Errors Accessibility Poor retrieval Good Retrieval
Equipment Calibration o Select staff to serve as auditors  Occurrence – any event that has negative impact on organization
o Security People within the lab People within the lab
Performance Evaluation o Collect and analyze information  Occurrence Cycle:
o Keep from SPILLS
o Function Check o Share results with staff o Perform Investigation
o Prepare a report Traceability GOOD IN TERMS OF Poor if user is not
o Preventive Maintenance o Early Detect Occurrence Chronological updates with knowledgeable enough
o Maintenance Plan o Present the report to management o Root Cause Analysis
o Retain the report as a permanent laboratory record. signature
o Equipment Plan  Occurrence Management Process:  Ensure Good Retention of Records
 Who can perform Internal Audit: ANY KNOWLEDGEABLE STAFF
o Equipment Inventory o Establish process to detect problems
o Inventory of Spare Parts o Keep a log of all problems: errors, date, time, action taken
ACCREDITATION 12. INFORMATION MANAGEMENT
 Machine Operation o Take Necessary Action – REMEDIAL or CORRECTIVE
o Trouble Shooting  Basic Terms: o Monitor and Observe for any RECURRENCE (if systematic)  Include Identifier:
o Service and Repair o Normative Document o Provide Information to: o Patient Identifiers
o Retiring and Disposing  Provides rules, guidelines, or characteristics and their results  All those who need it o Sample Identifiers
 Equipment Record of Maintenance  Standards, Technical Specifications, Code of Practice, Regulation  All who are affected  One Data = One Unique Identifier
o Documentation o Standard Document  Keep good records – Problems, Investigations, Action Taken  Information Management
 Established by CONCENSUS o System that incorporates all the processes needed for effectively
IV. PURCHASING AND INVENTORY  Approved by RECOGNIZED BODY that provides common and
X. PROCESS IMPROVEMENT managing data – both incoming and outgoing patient information
repeated use to achieve OPTIMUM (QUALITY/ STANDARD)  Effects of Good Information Management;
 GOAL: Ensure AVAILABILITY QUANTITY; Prevent WASTAGE  Deming’s PLAN-DO-CHECK-ACT (PDCA)
 Appointed Responsible Person
DEGREE OF ORDER in a given context o Ensure that all data – the final product of laboratory – is well managed
 New Tools:
o Regulation o Consider all the ways laboratory data will be used when planning a
o Analyze Needs of the Lab
 Standard that is mandated by a governmental agency or o Lean – Optimizing space, time, activity to improve physical path or
Establish minimum stock needed for a period system
o
authoritative body workflow;
Appropriate Logs and Forms o Ensure the accessibility, accuracy, timeliness and security of data
o
 Accrediting Body: IMPROVED LAB FLOOR PLAN
o Ensure confidentiality and privacy of information
o Procedure for Receiving, Inspecting, Storing
o ISO - International Organization for Standardization o Six Sigma – Define, Measure, Analyze, Improve, Control
 Effect of well Managed Inventory:
o CLIS - Clinical Laboratory Standard Institute  Quality – CONFORMANCE TO REQUIREMENTS; not goodness or
o Uninterrupted Flow of Needed Materials elegance XIII. ORGANIZATION
o CEN - European Committee for Standardization  Management and the supporting organizational structure of the laboratory
o Ensure Availability of Products
o WHO - World Health Authorization  Developing Successful Indicators:
o Ensure Patient Needs are Met o Objective – measurable, not subjective  Function of Organization: IMPLEMENTATION
 Types of Standardization:
o Certification – Independent body gives “written assurance” o Methodology Available – available necessary tools o Commit
V. PROCESS CONTROL o Accreditation – Authoritative body gives “formal recognition o Limits – acceptable value; upper/lower limit o Prepare to Implement in Stages
 SAMPLE MANAGEMENT o Licensure – granting of ability to practice o Interpretation – know in advance before anything o Determine Resource Requirements
o Handbook for Sample Management o Limitation – what is being identified and not o Engage all staff
 Collecting, Processing, Testing Information o Presentation – how to fully display the values  Roles:
VII. PERSONNEL
Systematic Sample Tracking within the Laboratory (F.I.F.O) o Action Plan – How, Who, & How long to collect data o Provide resources
Job Description – reflect all skills needed, accurately describe tasks, roles
o

o Established policy for specimen Storage and Disposal o EXIT Plan – when to STOP, replace if stable/working o Monitor basics
and authorities
Maintain Sample Integrity  Characteristics of Good Indicators (page 176) o Establish Monitoring Program
Competency of Personnel – evaluate at the time of hiring, and on regular,
o
  Organizational Steps
o Directly Affect Patient Care and Outcome o Measurable: the evidence can be gathered and counted;
recurring basis o Assign responsibility for implementation
 QUALITY CONTROL o Achievable: the laboratory has the capability of gathering the evidence
 Management Role: o Allocate resources
o Used to monitor ANALTICAL PHASE it needs;
o ATTRACT QUALIFIED PERSONNELS o Develop and Distribute Quality Manual
o Goal: ENSURE ACCURACY AND RELIABILITY o Interpretable: once it is gathered, the laboratory can make a conclusion
o Provide motivation and appropriate benefits o Begin Implementation
o Purpose: DETECT, EVALUATE AND CORRRECT ERRORS due to about the information that is useful to the laboratory;
o Provide appropriate WORKING CONDITIONS o Monitor Compliance
system failure environmental conditions o Actionable: if the indicator information reports a high or unacceptable
 Successful Personnel Management = INCREASED RETENTION
o QC for varying methods: level of error, it is possible to do something about the problem identified;  Successful Implementation
 Personnel Records:
 Quantitative Exam: End-Point Value o Balanced: consider indicators that examine multiple aspects of the total o Planning
o Policy – Store information that is integral only to laboratory work-related
 Qualitative Exam: Presence or Absence testing cycle in the pre-examination, examination, and post- o Management Commitment
information
 Semi-quantitative Exam: Expressed in Estimates examination phases; o Understanding the Benefits
 WHAT
o Poor Quality Control: Do not Report Result o Engaging: indicators should examine the work of all staff, not just one o Engaging Staff at all levels
o Employment details o Settling Realistic Time Frame
group;
o Original application and resume o Looking for Ways to Continually Improve
VI. ASSESSMENT o Timed: consider indicators with both short-term and long-term
o Tests the employee is authorized to perform
 PURPOSE: Identify Problem, Improve Process and Procedure implications.
o Conditions of continued employment
 Find Root Cause and Take Corrective Actions  MOST IMPORTANT – GENERATE SOLUTIONS
o Job description
o Both original and subsequent competency assessments
EXTERNAL AUDIT XI. DOCUMENTS AND RECORDS
o Continuing education programs attended;
 Done by groups or agencies outside the laboratory o Personnel actions – corrective, disciplinary
 PURPOSE: ACCREDITATION, CERTIFICATION, LICENSURE o Leave records  Procedures: should be seen visually
 Types of EQA: o Health information, including records of work injury or exposure to  Processes: only the staff of the laboratory knows
o Proficiency Testing occupational  Policies: CMT, lab managers, section heads,
 External provider of unknown sample o Hazards, vaccine status, skin test (if any) pathologist/ administrative positions know
 Cost effective, gives good, objective measure of laboratory testing o Performance appraisals  Document Hierarchy
o Rechecking or Retesting o Emergency contact information  Importance of Document Keeping:
 Re-reading of slide by reference lab  WHERE o Quality Manual – overall guiding document
 Expensive and uses considerable time o Secure Site to Protect Confidentiality for quality system
o On-Site Evaluation o SOPs - contains step-by-step instructions;
 Done when proficiency testing and rechecking are difficult to ensure consistence
conduct  CRUSH OUT ONCE, put the date, and affix signature; If there is a
 Can give true picture of lab’s overall performance mistake.
o Reference Material – good scientific & clinical info about disease
 DO WHAT YOU WROTE AND FOLLOW WHAT YOU ARE WRITING
 Accessibility – accessible to staff and laboratory person only with direct
relation to the process
LABORATORY OPERATIONS Tourniquet > 1min.  INCREASED: K+, Total Protein, Lactic NORMAL GAUSSIAN DISTRIBUTION CURVE Systematic Error  Recurring error inherent in test procedure
(Hemoconcentration) Acid Normal  The Gaussian bell-shaped curve:  Causes:
PHASES OF ANALYSIS IV Fluid contamination  INCREASED: Glucose, Electrolytes Distribution o 68% of values fall w/in ± 1 SD of mean o dirty photometer
Pre-  Test order by physician, test order by nursing/clerical (Depending on IV) o 95% of values fall w/in ± 2 SD of mean o faulty ISE
Analytical staff, patient preparation, patient ID, specimen Expired Collection tubes  DECREASED: Vacuum, Failure to o 99.7% of values fall w/in ± 3 SD of mean o evaporation/contamination of standards or
collection, specimen transport, specimen processing obtain specimen reagents
Analytical  Test Analysis, QC, reagents, calibration, preventive Incorrect Anticoagulant or  K2 EDTA before serum or heparin tube:  CV = 68%, 95%, 99.7%  Westgard Rule: affects all results 22s, 41s or 10x
maintenance Order of Draw ↓Ca2+, Mg2+, ↑K+  The lesser the CV, the better the precision  Remedy: requires investigation to determine cause
Post-  Verifications of calculations and reference ranges,  Contamination of Citrate Tube with clot  Most precise: ± 1 SD, CV is 68% False Rejection  Rejection of run because QC results indicate problems
Analytical review of results, procedures for notification of critical activator: Erroneous Coagulation  If it has exceeded 99.7% or ±3SD, it means that there is a when none is present.
values, result reporting, test interpretation by physician, Failure to Hold Bottom of tube  Carryover problem in the machine  Use of Westgard rules minimizes false rejections
follow-up patient care lower than top during collection  Additive Contamination  ±3SD: used for any SD computation
Short Draw  Incorrect Blood:Anticoagulant Ratio  ±2SD: used for clinical samples WESTGARD CONTROL RULE
QUALITY ASSURANCE vs. QUALITY CONTROL (e.g. Coagulation test) Gaussian
RULE EXPLANATION TYPE OF ERROR COMMENTS
QUALITY ASSURANCE QUALITY CONTROL Inadequate mixing of  Micro-Clots, Fibrin, Platelet Clumping Curve
12s 1 control >±2s WARNING Initiates testing of other
(acceptable error: <1%) anticoagulant from mean. rules. If no violation of
Pre-Analytical, Analytical, Analytical Hemolysis form Alcohol  ↑K+, Mg2+, LD, Iron also “Milking” Site Warning flag of other rules, run is
Post-Analytical Contamination of Capillary Puncture, Probing with possible change in considered in control.
Needle, Vigorous Shaking of Tubes, accuracy or
SPECIAL SITUATIONS IN PHLEBOTOMY Exposure of Samples to Extremes of precision.
IV  Use opposite arm or perform fingerstick, if possible; Temperature 13s 1 control >±3s Random Rejection Rule
otherwise, have nurse turn off IV for 2 min., applying from mean
tourniquet below IV, use different vein (if possible). GUIDELINES FOR SPECIMEN HANDLING AND PROCESSING 22s 2 consecutive Systematic Rejection Rule
 Document location of IV & venipuncture, type of fluid 1. Careful Blood Transport – avoid hemolysis controls >2s from
Fistula  Draw from opposite arm 2. Maintain tubes in VERTICAL POSITION – promote complete clotting mean on the same
Indwelling lines &  Usually not drawn by lab 3. Allow serum & gel separator tubes to clot for 30-60 min. before centrifugation  Normally observed / only occur when mean = mode = side
catheters, heparin  First 5 mL drawn should be discarded. Lab may draw to avoid fibrin strands median R4s 2 consecutive Random Rejection Rule
locks, cannulas below heparin lock if nothing is being infused 4. Centrifuge within 2 hours of collection. Separate serum or plasma from cells  Gaussian frequency distribution with 95% limits indicated. controls differ by
Sclerosed veins  Select another site within 2 hrs. of collection (exception: centrifuged gel tubes) QUALITY CONTROL STATISTICS 4s
Hematoma  Draw below 5. Spin most tubes at 1,000-1,300 RCF for 10-15 mins. Control  Range where control values must fall to consider test valid 41s 4 consecutive Systematic Rejection Rule
Streptokinase/  Minimize venipunctures. Hold pressure until 6. Spin Citrate tubes at 1,500 RCF for 15 mins. To produce platelet-poor Limits  Commonly used mean (clinical samples): + 2SD controls >1s from
tissue bleeding has stopped plasma  1 determination in 20 will fall outside + 2SD - anticipated part mean on same
plasminogen 7. Keep tubes capped during centrifugation to avoid loss of CO2, change of pH, of normal variation side
activator (TPA) evaporation or aerosol formation o accepted: 1 SD exceeded + 2SD 10x 10 consecutive Systematic Rejection Rule
Edema, Scar,  Select another site 8. Don’t re-spin primary tubes. Can cause hemolysis. If re-centrifuging is o not accepted: >1 exceeded + 2SD controls on same
Burns, Tattoos  Median cubital = preferred site; most stable vein necessary, transfer serum/plasma to another tubes side of mean
(well anchored by the cephalic and basilic vein) 9. Don’t re-spin SST. Serum in contact with RBCs under gel can be expressed * ALL systematic are even numbers: 22s, 41s, 10x
Mastectomy  Draw from opposite arm &↑K+
Patient Refuses  Try to persuade. If unsuccessful, notify the nurse. 10. When transferring samples to secondary containers, aspirate to avoid TYPICAL STEPS TAKEN WHEN CONTROL IS OUT OF ACCEPTABLE
 Never draw without consent; could lead to charges cellular contamination. Don’t pour RANGE
of assault or battery 11. Lipemic specimens can be ultracentrifuged at 105 x g to remove STEP REASON
 Levey-Jennings Chart showing in-control results
 chylomicrons (triglycerides)
Unidentified Ask nurse to ID before drawing Levey-  Normal distribution curve lying on its side, marked with 1. Hold until problem is solved  Inaccurate control = inaccurate result
Patient 12. Separated serum/plasma may be kept at RT for 8 hrs. or at 2-8oC for 48 hrs.
For longer storage, freeze at 20oC. Avoid repeat freezing & thawing Jennings mean, ± 1SD, ± 2SD, ± 3SD 2. Rerun control once  Maybe due to expected random error
13. Don’t freeze whole blood (RBC = consumes nutrients) Chart  Used to plot SD computed in the previous days  1 in 20 results will be outside ±2SD
SPECIAL TEST REQUIREMENTS 3. Unresolved?  Control might have been outdated,
REQUIREMENT EXAMPLES NOTES Outlier  Definition: A control result outside established limits o Run a new vial of control improperly stored, contaminated
QUALITY CONTROL
Fasting  FBS, TAG, Lipid  Nothing to eat or drink  Cause: Chance or test system problem or another lot number
Panel, Gastrin, (except water) for at QA  Lab ensures quality results – closely monitor test analytical
stage 4. Unresolved?  Consider reagents (low, outdated,
Insulin least 8 hours o Look for & correct any improperly stored, contaminated,
QC  Part of analytical phases; monitor results from control
Chilling  ACTH, Acetone,  Place in slurry or problems, then run change in lot number), preventive
Ammonia, Gastrin, crushed ice & water. samples
 For machine and reagents control maintenance (overdue), mechanical
Glucagon, Lactic  Don’t use ice cubes problems, clots, etc.
Control  Chemically & Physically similar samples to unknown
Acid, Pyruvate, PTH, alone because RBCs 5. Unresolved?  Calibration may have shifted
Renin may lyse specimen & is tested in exactly the same manner
 Purpose: Monitors precision, CLIA requires at least 2 levels  If it occurs more than once in 20 successive runs, o Recalibrate, then run
Warming  Cold Agglutinins,  Use 37oC heat block, control
Cryoglobulins heel warmer, or hold in of controls each day test is performed investigation must be carried out.
External  Controls NOT BUILT into test system. Shift  6 consecutive control values on same side of mean 6. Unresolved?  Supervisor or service rep may be
hand o Get assistance! able to determine problem
QC  e.g. Proficiency Testing
Protection from  Bilirubin, Carotene,  Wrap in Aluminum Foil
Internal  Controls that ate BUILT into test system 7. Resolved?  Provides a record for future
Light RBC,  Photo-oxidation – when o Document corrective
Monitoring reference, points out repetitive
Protoporphyrin, exposed to light action problems
Vitamin A & B12
QUALITY CONTROL STATISTICS 8. Repeat tests & issue  Ensure accuracy of reported results
Chain of  Any test as evidence  Chain of custody form.
Measure of  Statistical parameters describing spread of data about corrected reports, as needed
Custody in legal proceedings;  Lock Box may be
Dispersion mean, Trend  Control values increasing or decreasing for 6 consecutive
e.g. blood alcohol, required
 Example: Standard Deviation (SD), Coefficient of Variation runs. CALIBRATION
drug screen, DNA
Analysis (CV), Range, Measurements of Precision Calibration  Testing & Adjusting analyzer’s readout
*Follow Laboratory’s Established Procedures Range  Difference between highest & lowest values in data set  Establish correlation between measured & actual
Mean  Sum of all observations divided by number of observations concentrations
PHLEBOTOMY SOURCES OF ERROR Standard  Statistical expression of dispersion of values around mean. Calibrator  Reference material with known concentration of
Misidentification of patient  Treatment errors, possibility of Deviation  Requires a minimum of 20 VALUES analyte.
Transfusion Fatality Random  Error that doesn’t recur in regular pattern  Formerly known as Standard
Drawing at Incorrect Time  Treatment errors (TDM, Analytes Error  Most common  Mixture of different analytes
exhibiting diurnal variations)  Causes: o Standard = colorless
Improper skin disinfection  Infection at site of puncture. Where: o dirty glassware o Control = colored-like-serum
Contamination of Blood C/S and  Σ = sum o wrong pipette Calibration verification  Test 3 Levels = High, Normal, Low
component.  x = individual value o voltage fluctuation  Required every 6 months, when lot # of reagents
 Alcohol contamination in blood alcohol  x̄ = mean o sampling error changes, following preventive maintenance or
level (False Increase)  n = number of values repair, & when controls are out of range
o Anticoagulant / drug interference
Drawing from Edematous Site  Sample dilution with Tissue Fluid Coefficient  Expresses standard deviation as percentage.  Westgard Rule: 13s or R4s  Recalibrate/recondition the machine
of Variation  Formula: CV% = (SD ÷ mean) x 100
Fist Pumping during  INCREASED: K+, Lactic Acid, Ca2+,  Usually ONE-TIME ERROR (if it occurs more than once, it
venipuncture (Hemolysis) Phosphorus (CV)  The ↓ the CV, the ↑ the Precision is not a random error)
 DECREASED: pH  Remedy: controls and samples can be rerun with success
 POINT-OF-CARE TESTING B. HAZARD COMMUNICATION STANDARD FIRE SAFETY
POCT  Testing performed at site of patient care. Aka “Right to Know” Law; “HAZCOM” CLASS COMBUSTIBLE EXTINGUISHER
 a.k.a. Decentralized, Bedside, or Near-Patient Testing Purpose INFORM employees on chemical hazards in workplace & A Cloth, wood, paper Pressurize water (A)
Goal  Provide rapid test results where immediate medical protective measures Dry chemicals (A,B,C)
action is required, e.g., emergency department, Primary 1. Written hazard communication plan B Flammable/ Dry chemical (ABC)
intensive care units. Requirements 2. Inventory of hazardous chemicals on site “Basa” Combustible Liquids CO2 (BC)
Common POCT  Urine reagent strips, glucose, electrolytes, blood 3. Hazard labeling C Electrical Equipment Dry chemical (ABC)
tests gases, activated clotting time (ACT), PT, APTT, 4. Material safety data sheet (MSDS) for each chemical “Curyente” CO2 (BC)
hemoglobin. readily accessible to employees on each shift. D Combustible Metals Leave to professional firefighters
Optimal staffing  Point-of-Care Coordinator (POCC) 5. Training on initial assignment & when new hazard E Arsenal Fire Do not extinguish
o Oversees testing & responsible for compliance, introduced.
training, QC, proficiency testing (if required) C. CHEMICAL HYGIENE STANDARD MATERIAL SAFETY DATA SHEET (MSDS)
 Testing Personnel: Aka Laboratory Standard Content 1. Health effects of exposure to the product
o Qualifications determined by test complexity of Purpose LIMIT employee exposure to hazardous chemicals to levels 2. Hazard evaluation related to the product’s handling,
testing. Usually phlebotomists, lab assistants, at or below permissible exposure levels (PELs) storage, or use
nurses, respiratory therapists. Primary 1. Written chemical hygiene plan 3. Measure to protect workers at risk of exposure
Considerations  Cost, Specifications, Ease of Use, TAT, Quality & , Requirements 2. Designation of chemical hygiene officer emergency procedures
data management/connectivity/interface capabilities. 3. Hazard identification & labeling Purpose  Supplement the alert information provided on labels
4. Material safety data sheet (MSDS) for each chemical Every 3 yrs.  MSDS Required Revision Period
CREDENTIALING readily accessible to employees on each shift.
Accreditation  Institution; Meet certain Standards; Voluntary. 5. Use of personal protective equipment PERSONAL PROTECTIVE EQUIPMENT (PPE)
Certification  Voluntary; Person; Meet Education Requirements & 6. Proper maintenance of fume hoods & other PPE Application  Shall be provided, used, and maintained in a
Demonstrate Entry-Level Competency by Passing 7. Monitoring of employee exposure to hazardous sanitary and reliable condition wherever it is
Exam. chemicals encountered in a manner capable of causing injury
Licensure  Permission to engage in certain 8. Medical exams at no cost in cases of suspected or impairment in the function of any part of the
professions/businesses. overexposure body through absorption, inhalation, or physical
 Mandatory, Illegal to practice/operate in that state 9. Training on initial assignment & before assignments contact
without license PPE Provider  Employer: assure adequacy, maintenance,
HAZARD CATEGORIES OF CHEMICALS sanitation
AGENCIES FOR COMPLIANCE AND REGULATIONS CLASSIFICATION EFFECT Hazard Assessment  Identify which type of PPE shall be used
AABB  Blood Bank Standards and Accreditation Corrosives  Tissues Destruction (visible) by exposure Employer  Assess, Provide, Train, and re-train, maintain
 Association for the Advancement of Blood & Biotherapies (contact/Inhalation) Responsibilities
 Formerly: American Association of Blood Banks Toxic Substances  Interfere Metabolism (Ingestion, Inhalation, NOT Employer  Steel boots, everyday clothing, weather protection
CDC  Infection Control & Safe Work Practices; Standard & Guidelines Absorption, through Intestine) Responsibilities (sun screen, raincoat)
 Centers for Disease Control and Prevention Carcinogens  Capable of Causing Cancer
CLSI  Standards on All Aspects of Lab Practice Mutagens &  Induce Genetic Mutation EMERGENCY PRACTICES
 Clinical and Laboratory Standards Institute Teratogens  Cause Defect in Embryo Needle Stick  Post-exposure prophylaxis (PEP), Testing of Patient
ISO  Standard to facilitate international exchange of goods & Ignitable/s  Fire Injury Samples
services. Reactive/s  Explosions Fire Emergency  Cover Fire with Inverted Beaker or Wet paper towel
 International Organization for Standardization  If NOT EFFECTIVE: Use FIRE EXTINGUISHER
NFPA HAZMAT DIAMOND (annually checked)
FEDERAL REGULATIONS (Mnemonics: You Were Born Right; Y – yellow, W – white, B – Blue, R – Red)  RACE – Rescue, Alarm, Contain, Extinguish
Hazard Communication Standard  Requires employers to inform  PASS – Pull, Aim, Squeeze, Sweep
(OSHA 1983) employees about hazards & educate  Extinguishable Fire: if w/in 1-2 minutes Fire Out
“Right to Know Law”
in safe handling. Chemical Spill  Minor Spill – person is familiar with chemical and its
Clinical Laboratory Improvement  Regulates all lab testing (except hazard
Amendments of 1988 research) performed on humans in  Major Spill – needs expert assistance
Biological Spill  Apply Absorbent towel to spill
U.S administered by CMS.
“CLIA ’88’’  Disinfect Towel – 20 minutes
Occupational Exposure to  Requires Chemical Hygiene Plan to  Clean Surface – alcohol or soap and water or Notify
Hazardous Chemicals in minimize personnel exposure to supervisor and other authorities
Laboratories hazardous chemicals in labs.  Disinfectant:
(OSHA 1990)  Most Spills: 1:50 NaHOCl (50g/L Chlorine)
 Large Amount of Organic spills: 1:10 (5g/L)
“Laboratory Standard”
 Alcohol is NOT RECOMMENDED (evaporates
Bloodborne Pathogens Standard  Mandates work practices & quickly shorten contact time)
(OSHA 1991) procedures to minimize worker
exposure to bloodborne pathogens.
PACKAGING AND TRANSPORT OF SPECIMEN/MICROORGANISM
Formaldehyde Standard  Requires monitoring of formaldehyde
Primary  Test tube, vial, etc. containing etiologic agent.
(OSHA 1992) exposure HAZARD HEALTH FLAMMABILITY Container  Must be securely closed, watertight, surrounded by
Health Insurance Portability and  Regulates use & disclosure of COLOR Blue (Left) Red (Top) absorbent material & placed in secondary container
Accountability ACT of 1996 protected health information (PHI) 0 No Hazard Will not Burn Secondary  Must be watertight, sealed & placed in approved mailing
“HIPAA” 1 Significant Irritation Pre-heated for ignition to occur Container container
2 Temporary Incapacitation Heated or increase ambient temp. Mailing  Must be made of fiberboard
SAFETY IN THE LABORATORY to burn Container
3 Serious of permanent injury Ignited in Almost all Temperatures Labeling  Biohazard label required on primary & mailing containers
SAFETY PROGRAMS AND PRACTICES 4 Lethal Will vaporize & burn at normal Training  Employees must be trained & retrained every 2-3 yrs. or
A. BLOOD BORNE PATHOGEN STANDARD temp when regulations change
Purpose To protect health-care workers from occupational exposure to
bloodborne pathogens (BBP; e.g., HIV, HBV, HCV) HAZARD INSTABILITY SPECIAL HAZARD
Primary Requirements in Blood Borne Standard: COLOR Yellow (Right) White (Bottom)
1. Exposure Control Plan 0 Stable
2. Universal Precautions 1 Increase Temp. makes unstable W = unusual reactivity with
3. Engineering Controls 2 Violent chemical change at water
4. Work Practice Controls (order = manner that decreases hazard) increase temp. or pressures
5. Personal Protective Clothing & Equipment OX = oxidizer
6. Housekeeping 3 Explode from increase temp. or
7. Training shock
8. Medical Surveillance 4 Explode at normal temp &
9. Hepatitis B vaccine pressures
10. Hazard Communication
11. Sharps Injury Log