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Safety Information and Courses from MediaLab, Inc.

These are the MediaLab courses that cover Safety and links to relevant pages within the course.

Learn more about laboratory continuing education for medical technologists to earn CE credit for AMT, ASCP, NCA, and state license renewal and recertification. Or get information about laboratory safety and compliance courses that deliver cost-effective OSHA safety training and continuing education to your laboratory's employees.



Advances in Noninvasive Prenatal Testing For Down Syndrome and other Trisomies
Recommendations By Other Organizations

In June 2012, the California Technology Assessment Forum (CTAF) issued an independent evaluation of the cfDNA technology used for the assessment of fetal aneuploidy for Down syndrome (Trisomy 21) in high-risk women. The assessment concluded that the cfDNA technology is promising and has a high sensitivity and specificity for evaluation of fetal aneuploidy in high-risk women. Later in October 2012, CTAF recommended the use of cell-free fetal DNA as a prenatal advanced screening test for fetal aneuploidy for Trisomy 21 and Trisomy 18 in high-risk women who meet all five CTAF criteria for safety and efficacy and improvement in health outcomes.In addition, The National Society of Genetic Counselors (NSGC) issued a position paper in February 2012 indicating support for the use of NIPT as an option for patients whose pregnancies are considered to be at an increased risk for certain chromosome abnormalities. NSGC emphasizes that NIPT only be offered if there is an informed patient consent, patient education, and counseling provided by a certified genetic counselor. In addition, patients with abnormal NIPT results should receive genetic counseling and be given the option of standard confirmatory diagnostic testing.

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Basics of Lean and Six Sigma for the Laboratory
Six Sigma Level of Quality in Health Care

Is there any process in health care that can run at or above Six Sigma level? Transfusion medicine has actually achieved above and beyond Six Sigma, confirming that a Six Sigma level of quality can actually be achieved not only in aviation or manufacturing, but in health care as well. Transfusion medicine is one of the most regulated and earliest adapters of a quality system approach to quality management. Let us look at how transfusion medicine measures up when we translate this statistic into Six Sigma.Based on the FDA Center for Biologics Evaluation and Research (CBER) "Fatalities Reported to FDA Following Blood Collection and Transfusion" annual summary, there were 52 transfusion-related fatalities in the fiscal year of 2007 (October 1, 2006, through September 30, 2007). According to the National Blood Collection and Utilization Survey conducted by AABB, a total of 30,044,000 units of blood components were transfused during 2006. Three opportunities for defect (pre-analytical, analytical and post-analytical) will be used to determine transfusion safety in the United States. By using the formula from the previous page, we can determine both the DPMO and process sigma.DPO = 52/(30,044,000 x 3) = 0.0000005769DPMO = 0.0000005769 x 106 = 0.58Process Sigma = 6.36Transfusion medicine did not achieve Six Sigma level of quality overnight, and other industries who are operating at Six Sigma level, such as the aviation industry, have taken decades to achieve this level of quality.

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Example of FMEA

Here is an example of a FMEA analysis for a phlebotomy training program. This example details the purpose, team members, SOD scales (1-5), RPN score, and the recommended actions. FMEA AnalysisPurpose: Increase student and instructor safety in a phlebotomy teaching programTeam members: Phlebotomy program director, clinical instructors, phlebotomists, and phlebotomy studentsSeverity (S) rating:5-- Could threaten the life of instructors or students, require immediate actions (require medical attention)4-- Potential to cause permanent harm to instructors or students (require medical attention)3-- Potential to cause non-permanent harm to instructors or students (require medical attention)2-- Potential to cause non-permanent harm to instructors or students (does not require medical attention beyond first aid)1-- Potential to cause minor discomfort in short duration (does not require medical attention or first aid)Probability of occurrence (O) rating:5-- Probability of occurrence more than once per lab session4-- Probability of occurrence once per lab session3-- Probability of occurrence every three lab sessions2-- Probability of occurrence at least once with every group of students 1-- Probability of occurrence is minimal; may not occur with every group of studentsDetectability (D) Rating:5-- No chance of detection4-- Remote chance of detection3-- High chance of detection only if instructors are experienced and pay close attention2-- High chance of detection 1-- Close to 100% detection rate

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Blood Banking Question Bank - Review Mode (no CE)
Which of the following activities will put an employee at risk for exposure to a Bloodborne Pathogen (BBP)?View Page
What type of Personal Protective Equipment (PPE) is necessary when opening a centrifuge (chance for splashing)?View Page

Body Fluid Differential Tutorial
Peritoneal lavage Trauma STAT

Peritoneal lavage is performed in the trauma setting to evaluate the extent of a patient's injury from blunt force trauma to the chest and abdomen. Sterile physiological saline is infused into the peritoneal cavity and then retrieved. The color and clarity of the extracted fluid provides information on the extent of internal injuries if present. Bloody fluid indicates organ laceration and hemorrhage. Muddy brown fluid indicates a bowel perforation.These photos are from the peritoneal lavage specimen of a child in a motor vehicle accident who was not in a child safety seat. Her large intestine was ruptured when she hit the seat-back in front of her. Notice the variety of intra and extra cellular bacteria, and possibly small yeast forms. These organisms represent the normal intracolonic flora which seeded the peritoneal cavity when her bowel ruptured (see arrows).

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Cerebrospinal Fluid (retired 7/17/2012)
Safety Precautions

Important safety precautions must be observed when handling cerebrospinal fluid. The following guidelines apply:Semi-automatic micropipettes and disposable plastic chambers are the safest option for CSF testing. Many laboratories still use the hemacytometer with disposable pipets.If disposable materials are not used, soak contaminated reusable pipets, hemacytometer and coverslip in 70% alcohol or Wexide.All disposable items should be placed in a biohazard container for appropriate disposal.Wash hands thoroughly when the examination is completed.Spinal fluids which are to be discarded must be placed in biohazard containers for appropriate disposal.Careful attention to specimen processing and handling will help ensure that accurate results are obtained.

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Department of Transportation (DOT) Federally Regulated Urine Specimen Collection Training
Federal drug testing custody and control form (CCF)

The federal drug testing custody and control form (CCF) must be used to document every urine collection required by the Department of Transportation drug testing program. At the present time, these include the: Federal Motor Carrier Safety Administration (FMCSA) Federal Aviation Administration (FAA) Research and Special Programs Administration (Pipeline) (RSPA) Federal Transit Administration (FTA) Federal Railroad Administration (FRA) United States Coast Guard (USCG)

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Exceptions

It should also be understood that a Federally Regulated CCF need not be used in every situation involving a company regulated by the Department of Transportation. For example, if an interstate truck driver slips and falls while standing on the loading dock of a trucking terminal, and the trucking company for which the driver works requires a post-accident drug screen, a Non-Federally Regulated CCF would be appropriate for this collection. The driver was not involved in a safety sensitive assignment. On the other hand, if the driver had an accident while driving, then a Federally Regulated CCF must be used since the driver was in a safety sensitive position when the accident occurred.

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Unacceptable forms of identification

Unacceptable forms of identification include: Identification by a co-worker. Identification by another employee also working in a safety sensitive position. Use of a single non-photo identification card such as a social security card, credit card, membership card, pay voucher, or voter registration card. Faxed or photocopies of identification documents.

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Dermal Puncture and Capillary Blood Collection
Patient Identification

Patient safety when performing a capillary blood collection includes positive patient identification prior to performing the procedure. The accepted policy in most health care facilities is to use two forms of identification, including a unique number if possible, such as a hospital number or medical record number.Ideally, the patient (or the parent/guardian if the patient is a small child) should be asked to spell his/her name and state his/her date of birth. This may not always be possible, but it will aid in positive patient identification whenever it can be done.The phlebotomist should LOOK at the patient's paperwork while they LISTEN to the patient's response. For inpatients, the patient identification bracelet, which must be attached to the patient's wrist or ankle, should be used to verify patient identity. A hospital number recorded on the bracelet may be used as a second identifier in the case of an inpatient.Paying close attention to these details and correcting any discrepancy discovered will greatly reduce the risk of misidentifying a patient. Always follow the policy of your facility for identification and never shortcut the patient identification procedure.

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Introduction

A dermal (skin) puncture may be required when a venipuncture cannot be performed or may be the option of choice for some point-of-care test procedures. A dermal puncture may be a fingerstick or, in the case of small infants, may be a heelstick. Patient safety involves proper identification prior to specimen collection, care in preparing the collection site, proper technique during collection, and treatment of the puncture wound following collection. The technique that is used for collection of the specimen must also prevent the introduction of errors that could cause the specimen to be rejected and require recollection.

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Protect Yourself and Your Patient

It is important to remember that the collection of a specimen by dermal puncture may involve the potential of exposure to bloodborne pathogens as well as other safety considerations for both the phlebotomist and the patient. Some important safety reminders are listed in the table below.Safety ReminderReasonCommentGloves are always necessaryBlood contaminates the skin during a capillary blood collection. Gloves protect the phlebotomist from potential exposure to bloodborne pathogens.Gloves must remain intact to be an effective barrier against exposure to potential pathogens. Wear additional personal protective equipment (PPE), such as lab coat or gown when appropriate or required. Safety goggles and surgical mask may be needed if there is a potential for splashes or sprays of blood.May be needed to protect the phlebotomist or may be required to protect the patient from potential infection in some cases.Safety goggles and mask should both be worn to adequately protect the eyes and mucous membranes from exposure to bloodborne pathogens if there is the potential for splashes or sprays of blood. Only have the equipment needed for this procedure at hand and additional equipment out of reach of the patient. Protects the patient from accidental injuryOften, capillary procedures are performed on very young children who are curious and may grab something that could cause injury.

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Which of these pieces of personal protective equipment (PPE) is always required when a dermal puncture is performed to collect a capillary blood specimen?View Page
Miscellaneous Equipment

In addition to the puncture device, additional equipment is required to perform a safe and successful dermal puncture and to collect an acceptable specimen. This may include any of the items discussed below.Plastic microcollection devices: Plastic microcollection devices are small plastic tubes designed to collect capillary blood from a dermal puncture wound. Each small collection tube is color-coded in the same manner as blood collection tubes used for venipuncture. The color of the cap of each container tube corresponds to the type of additive inside the tube, most often an anticoagulant. The additive coats the inside of the tube. Examples of microcollection devices are shown below. Heel warmer: It is best practice to warm the heel of an infant with a warming device known as a heel warmer. The heel warmer, when activated, is designed to warm its contents to a standardized temperature. This temperature will be hot enough to effectively warm the heel and facilitate blood flow to the area without causing heat injury to the patient. It is unacceptable to warm a cloth using a microwave. There may be "hot spots" on the cloth that could potentially burn the patient. Keep in mind, what may feel warm to you, the phlebotomist, may feel hot to your patient!Plastic or Mylar-wrapped capillary tube: In some facilities blood from a capillary puncture is collected directly into a capillary tube. These tubes are very delicate and must be used with great caution. As soon as the tube is two thirds to three-fourths filled, one end is sealed to prevent blood from leaking out.Glass microscope slides: In some facilities, the person collecting the capillary specimen may also be required to prepare a blood smear for laboratory examination. A drop of blood is placed directly on a glass slide and spread to create an area for cell examination. If you are required to prepare blood smears, remember that the slide is considered infectious until fixed or stained. It is also important to remember that glass is a sharps hazard. If not used correctly, the glass may cause injury to both the patient and the phlebotomist. Be as cautious with a glass slide containing blood as you are with a contaminated needle. Dispose of glass slides that will not be used for testing in approved sharps containers.Alcohol and gauze pads: Alcohol is the disinfectant of choice for dermal puncture. The alcohol must be allowed to air dry, which will prevent hemolysis of the specimen and discomfort for the patient. A piece of clean or sterile gauze is used to wipe away the first drop of blood. Gauze is also used to apply pressure to the wound after the specimen collection is complete to stop the wound from bleeding.Iodine or other approved cleaning agents may be used as an alternative to alcohol.Bandage: It may be necessary to apply a bandage to the puncture wound on a finger or heel if the site continues to bleed. However, it is NOT recommended to bandage the finger of a child who is 2-years-old or younger since the bandage may become a choking hazard if the child puts that finger in his/her mouth.Personal protective equipment (PPE): All health care professionals that may come in contact with blood and/or body fluids while performing a laboratory procedure are required to wear intact gloves. It is against safety guidelines to alter gloves in any way that may compromise the integrity of the gloves. Eye protection, such as safety goggles, is recommended if there is the possibility of a splash of blood while collecting a capillary blood specimen. In many facilities, special gowns are required in some patient areas such as special-care nurseries. Always follow the policies of your facility in regard to PPE.

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First Aid
Introduction

An important component of safety training is a working knowledge of first aid and the medical services available to you.This program will explain several common injuries and their treatment.

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Treatment of Chemical Burns of Eye

Keep the affected eye open using your fingers. Immediately begin flushing the eyes with water and continue for 15 minutes. Use an eyewash, safety shower, or water from the sink.Assist the victim by supporting the head so that water flows across the eyeball from the inside corner of the eye (nearest the nose), outward. This will prevent chemical from getting into the unaffected eye.Get immediate medical help.

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General Laboratory Question Bank - Review Mode (no CE)
What type of protective gear must be worn as a minimum when working with hazardous chemicals:View Page

Hemoglobinopathies: Hemoglobin S Disorders
References

Afenyi-Annan, A., Kail, M., Combs, M.R., Orringer, E.P., Ashley-Kock, A., & Telen, M.J. Lack of Duffy antigen expression is associated with organ damage in patients with sickle cell disease. Transfusion. 2008;48:917-924. Ataka, K. I. et. al.Efficacy and safety of the Gardos channel blocker, senicapoc (ICA-17043), in patients with sickle cell anemia. Blood: 2008; 11(8) 3991-3997.Ballas, S.K., Sickle Cell Anaemia: Progress in Pathogenesis and Treatment. Drugs 2002: 62(8); 1143-1172.Bianchi, N., Zuccato, C., Lampronti, I., Borgatti, N., and Gambari, R. Fetal Hemoglobin Inducers from the Natural World: a novel approach for the identification of drugs for the treatment of B-thalassemia and Sickle-cell anemia. eCAM: 2009; 6(2)141-151.Centers for Disease Control and Prevention. Sickle cell disease: Symptoms and treatments. Available at: http://www.cdc.gov/ncbddd/sicklecell/symptoms.html. Accessed January 21, 2010.Harmening, Denise M., Clinical Hematology and Fundementals of Hemostatis 4th., F.A. Davis, 2001.Inati, A., Koussa, S. Taher, A., & Perrine, S. Sickle cell disease: New insights into pathophysiology and treatment. Pediatr Ann. May 2008.Kaushansky, K., Lichtman, M.A., Beulter, E., Kipps, T.J., and Prchal, J.T. Williams Hematology 8th Ed. McGraw Hill 2010.Lotspeich-Steininger, Stiene-Martin and Koepke, Clinical Hematology Principles, Procedures, Correlations, Lippincott 1992. McKenzie, Shirlyn B., Textbook of Hematology 2nd ed., Williams and Wilkins 1996. Miale, John B, Laboratory Medicine Hematology 6th ed., Mosby 1982. Niscola, P., Sorrentino, F., Scaramucci, L., de Faritiis, P., & Cianciulli, P. Pain syndromes in Sickle Cell Disease: An update. American Academy of Pain Medicine. 2009:470-480.Rodak, Bernadette, Diagnostic Hematology, W.B.Saunders Co., 1995.Yoon, S.L. & black, S. Comprehensive, integrative management of pain for patients with Sickle-Cell Disease. Journal of Alternative and Complementary Medicine. 2006: 12; 995-1001.

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Hemolytic Disease of the Fetus and Newborn
Routine Serologic Tests - Mother

Tests done routinely as part of perinatal testing programs vary from country to country and within countries. Below is one example of routine serologic tests typically done when pregnant females lack clinically significant antibodies. Other test protocols exist.Tests on Mother ABO, Rh*, and antibody screen at first prenatal visit; Test for weak D, if initial Rh typing appears to be D-negative (Optional -not mandated by blood safety standards); D-negative females: Tested again (ABO, Rh, and antibody screen) at ~ 28 weeks gestation prior to administration of RhIg (depending on the country) and again at delivery.* The mother, putative father, and fetus can be typed for D using DNA methods, if available.

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Calculating RhIg Dosage

Using the estimated volume of fetal bleed determined by the Kleihauer-Betke test or flow cytometry, the number of vials of RhIg (300 µg) to inject is calculated as follows: Number of vials of 300 µg RhIg = volume of fetal bleed/30 mLIn the interests of safety some American organizations recommend the following to deal with decimal points: If the number to the right of the decimal point is <5, round down and add 1 vial (e.g., 1.4 = 1 +1 = 2 vials) If the number to the right of the decimal point is greater than or equal to 5, round up and add 1 vial (e.g., 1.7 = 2 +1 = 3 vials) Sub-calculations: Volume of fetal bleed: % fetal cells x maternal blood volume Maternal blood volume: 70 mL/kg x weight (kg) (assume 5,000 mL if maternal information is unknown) Note: RhIg dose calculators are available (see Further Reading: Paxton A. Bringing new rigor to RhIG calculations).

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The appropriate dosage of Rh immune globulin (RhIg) to administer post-delivery to an Rh-negative mother delivering an Rh-positive child is calculated based on the estimated volume of fetal bleed.What is the value of x in the formula given below that is used to calculate RhIg dosage?Number of vials of 300 µg RhIg = volume of fetal bleed/x mLEnter the number in the box below that is represented by x in the formula; do not spell out the number.(e.g., use "5" and not "five").View Page

Histology Special Stains: Carbohydrates
Safety Precautions for Microwave Usage

While microwave use in the laboratory is considered to be relatively safe, the following safety precautions should be taken to prevent high doses of exposure to microwaves and personal injury: Periodically inspect and clean door seals and hinges. Use a microwave leakage detector to check for microwave leakage from the door seals on a regular basis. Always handle containers with potholders or thermal mitts. Never operate the microwave without a minimum volume of microwave-absorbing material inside the container. Never heat food in a microwave oven used for laboratory procedures.

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Histology Special Stains: Connective Tissue
Safety Precautions for Microwave Usage

While microwave use in the laboratory is considered to be relatively safe, the following safety precautions should be taken to prevent high doses of exposure to microwaves and personal injury:Periodically inspect and clean door seals and hinges.Use a microwave leakage detector to check for microwave leakage from the door seals on a regular basis.Always handle containers with potholders or thermal mitts.Never operate the microwave without a minimum volume of microwave-absorbing material inside the container.Never heat food in a microwave oven used for laboratory procedures.

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HIV Safety for Florida
Which of the following properly describes use of needles?View Page
Sharps

A sharp is any object which can penetrate the skin, including: needles scalpels broken glassPlace all needles and other sharps in puncture resistant sharps disposal containers as soon as possible after use.Properly use the safety devices provided with needles.

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Face and Eye Protection

Face shields, masks, and safety glasses protect your eyes and the mucous membranes of your nose and mouth.They must be worn whenever it is reasonably anticipated that splashing or spraying of blood or other contaminated materials may occur.Employees who wear prescription eyewear may be protected with a face shield, goggles, or with side shields attached to their glasses.

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Introduction to Bioterrorism
Laboratory Response

The broad base of clinical laboratories in this country is an essential component of our nation’s public health and healthcare system and is an essential link in addressing biological and chemical terrorism. In 1999 the Centers for Disease Control and Prevention (CDC) initiated the concept of a Laboratory Response Network (LRN).  The LRN is a network of local, state, federal, and military laboratories across the United States and internationally which work together in an integrated and coordinated way for a rapid response to public health emergencies. The LRN concept of operations is based on a system of safety and proficiency.

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Sentinel Labs

The frontline clinical microbiology laboratories are known as “sentinel laboratories”. The sentinel laboratories play a key role in the nation’s preparedness efforts. These laboratories perform the initial screening of clinical specimens for potential pathogens (rule-out) and refer specimens or isolates to a state or local public health laboratory at the reference level of the LRN. There are two kinds of sentinel laboratories: advanced and basic. Classification depends on their biological safety level and analytical capability.

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Your Response – At Work

Recent events, including the terrorist attacks on September 11, 2001 and the subsequent bioterrorist releases of anthrax, have been a harsh awakening that the nation’s workplaces could be terrorist targets.Traditionally laboratory safety guidelines have emphasized use of optimal work practices, appropriate containment equipment, well-designed facilities, and administrative controls to minimize risks of unintentional infection or injury for laboratory workers. Today, in addition to the above, laboratories must make a risk and threat assessment, secure data and electronic technology systems, plus develop policies regarding specimen accountability, facility security, and emergency response.The next few pages will cover a number of things that you can do to assist in making your laboratory more risk free to a terrorist attack and some things you can do in case that security is breached. You too have a role in the security of your workplace!

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Laboratory Ergonomics
Learn to Use Your "Ergonomic Eye"

Ergonomics is an important part of the overall laboratory safety program that ensures the well-being of all employees. The potential for MSDs while performing routine tasks exist in all areas of the laboratory. Laboratory workers should apply ergonomic principles to the performance of their job tasks and should report workplace design concerns. Each physical activity should be observed for opportunities to decrease physical stress and increase comfort.

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References

Cornell University. CUErgo. Available at: http://ergo.human.cornell.edu/ Accessed December 6, 2013.National Institute for Occupational Safety and Health. Ergonomics and musculoskeletal disorders. Available at: http://www.cdc.gov/niosh/topics/ergonomics/ Accessed December 6, 2013.UCLA Ergonomics. Musculoskeletal disorders: Anatomy of an injury. Available at: http://ergonomics.ucla.edu/MSD_Anatomy.html. Accessed December 6, 2013.US Department of Labor. Healthcare wide hazards module: Ergonomics. Available at: http://www.osha.gov/SLTC/etools/hospital/hazards/ergo/ergo.html Accessed December 6, 2013.

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Laws and Rules of the Florida Board of Clinical Laboratory Personnel (retired 9/1/2010)
Capability Violations

The accuracy and safety of patient testing depends on the capability and honesty of clinical laboratory personnel. If an individual's ability to perform testing is influenced by illness, injury, drug use (legal and illegal), or alcohol use, he or she may no longer practice. The Board can order a doctor's exam to determine if illness, injury, drugs, or alcohol is a factor. The individual can get his / her license back after recovery and proving that the condition is no longer a problem. If an individual commits a crime in any state relating to matters of honesty (such as filing false reports or advertising false services), that individual's Florida license may be suspended. Other licensed personnel who know that an individual is practicing despite being under the influence of drugs or alcohol, is physically or mentally incapable, has been convicted of a lab-related crime, or is not competent to perform his / her duties are required to report the individual to the Board. The following are violations of Board rules:Continuing to practice after becoming unable to safely perform testing because of illness or use of alcohol or drugs, or another mental or physical condition. Continuing to practice after being judged mentally or physically incapable.Being convicted of any crime relating to activities of clinical laboratory science or involving dishonesty or lack of morals. Failing to report to the Board that one has been convicted of a crime (as listed above), been judged mentally or physically incapable, or had a licensed revoked in another state. Knowingly allow an unqualified person to perform clinical laboratory duties.

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Medical Error Prevention (retired)
The Joint Commission on Accreditation of Healthcare Organizations promotes improved patient safety through its programs and resources. True or false?View Page
These statements describe things related to medical error prevention.View Page
Root Cause Analysis

Root causes are specific reasons that contribute to medical errors. They cause mistakes that lead to great patient harm (adverse events). Usually they can be identified. Examples: Using a wrong calculation factor Neglecting to use directions for complicated tests Reporting the wrong test result Using outdated reagents Testing clotted or partially-filled samples Diluting a test sample incorrectlyIn most cases, management has the authority and means to resolve root causes. Root Cause Analysis also recommends actions to prevent reoccurrence of an adverse event.

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Study

The Internet provides extensive, current resources for studying ways to prevent errors. Performing word searches for Medical Errors or Patient Safety or Laboratory Errors identifies a wealth of Internet resources. A Patient Safety search lists more than 93 million items.

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New Joint Commission Standards

The healthcare community uses RCA to reduce medical errors, but it is reactive in nature. For this reason, Joint Commission collaborates with recognized patient safety experts to develop and implement additional patient safety standards. These new standards charge healthcare organization leaders to create cultures of patient safety. They emphasize the need for teamwork and effective communication. They are based on well-known experiences of the aviation industry and they reflect findings from Joint Commission's Sentinel Event Database. They identify communication breakdowns as the most common underlying factor in all types of Sentinel Events.

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Joint Commission Patient Safety Goals Joint Commission adopted national patient safety goals for healthcare organizations, including specific goals for laboratories. 2009 Laboratory Services National Patient Safety Goals These goals are directly quoted.View Page
Choose the organization(s) that strive to improve patient safety.View Page
Improving Patient Safety Many other organizations strive to improve patient safety. These dedicated groups promote current information about their goals, projects, progress, publications, tools, and educational offerings in their Internet Websites.View Page
American Society for Clinical Pathology The American Society for Clinical Pathology, ASCP, promotes medical error prevention through its projects, programs, and activities. It includes this important topic in its many 400 workshops, symposia, teleconferences, and self-study programs. ASCP also promotes error prevention in the medical textbooks, reference manuals, slide atlases, audiovisual materials, and computer software it publishes. Its membership newsletters and The American Journal of Clinical Pathology and LabMedicine journal frequently address error prevention and patient safety.View Page
American Society for Clinical Laboratory ScienceThe American Society for Clinical Laboratory Science, ASCLS, joins the leadership effort to prevent medical errors and increase patient safety.View Page
Public Responsibility for Safety

People can help prevent errors in their medical care by understanding their treatment, keeping organized health records, and asking questions. They should feel comfortable talking with medical professionals when things do not seem right.

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Factors that Contribute to Medical ErrorsView Page

OSHA Bloodborne Pathogens
Methods of Control

Methods of control are ways you can protect yourself from exposure to bloodborne pathogens by using: Proper equipment Safety features Work practice controls The next few pages will acquaint you with these ways to keep yourself safe.

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Engineering Controls

Engineering controls are devices that isolate the worker from the hazard of exposure.Examples include: Self-sheathing needles (top image on the right)Sharps disposal containers (bottom image on the right) Disposable resuscitation bags Biological safety cabinets Hand washing facilitiesProper use of engineering controls in your workplace will help protect you from bloodborne pathogens.

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Sharps Safety Summary

DO...place all needles and other sharps in puncture resistant sharps disposal containers as soon as possible after use. use extreme caution or a safety device when removing a scalpel blade from its handle.DO NOT...recap, bend, shear, or break needles. remove needles from needle holders or disposable syringes.fill sharps containers above the line on the sharps container that indicates maximum fill (no more than 3/4 full).

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Needles, safety needles, and needleless systems

Most hospitals use some form of needle/holder combination that incorporates a needle safety device. This device has a mechanism that will cover the needle after use. It must be activated as soon as the task is completed. The device that is pictured here is just one of many options that are currently available. There are also needleless systems that use special adapters that can be attached to some intravenous lines and will permit blood to be obtained without the use of needles.

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Face and Eye Protection

The following protect your eyes and the mucous membranes of your nose and mouth: Face shield Mask worn with safety glasses Employees who wear prescription eyewear may be protected with a face shield, goggles, or with side shields attached to their glasses (a mask must also be worn to protect the nose and mouth).Face and eye protection must be worn whenever it is reasonably anticipated that splashing or spraying of blood or other contaminated materials may occur. A splash guard (as shown below) is an engineering control that can be used for facial protection.

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OSHA Bloodborne Pathogens (retired)
Engineering Controls

Engineering Controls are devices which isolate the worker from the hazard of exposure.Examples: Self-sheathing needles Sharps disposal containers Disposable resuscitation bags Microbiological safety cabinets Proper use of engineering controls in your workplace will help protect you from bloodborne pathogens.

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Face and Eye Protection

The following protect your eyes and the mucous membranes of your nose and mouth: Face shields Masks and safety glasses They must be worn whenever it is reasonably anticipated that splashing or spraying of blood or other contaminated materials may occur.Employees who wear prescription eyewear may be protected with a face shield, goggles, or with side shields attached to their glasses.

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Methods of Control

Methods of control are ways you can protect yourself from bloodborne pathogens using proper equipment, safety features, and work practices. The next few pages will acquaint you with these ways to keep yourself safe.

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OSHA Electrical Safety (retired 11/19/2012)
Space Heaters

Electrical space heaters are prohibited unless they are approved for use and inspected by your facility's management department. Space heaters are NOT permitted in hospital sleeping areas or in laboratories containing flammable liquids or gases.

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Electrical Hazard Awareness

Manufacturers are required to label appliances and instruments with electrical ratings including voltage, frequency, current, and/or wattage of the device and precautionary statements if applicable. Operating and safety instructions are provided with electrical equipment. It is prudent for personnel to familiarize themselves with this information before using the equipment. Personnel should be aware of the hazards associated with the use of defective electrical equipment. Defective equipment should be tagged and repaired or discarded. Keep liquids, chemicals, and heat sources away from electrical outlets and cords.

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OSHA Formaldehyde
Personal Protective Equipment

When using formaldehyde in any concentration, with the exception of placing specimens in single vials, you must wear:Protective clothing with material that is impervious to formaldehyde A face shield and chemical safety goggles Gloves If there is a risk of formaldehyde reaching the eyes, chemical safety goggles should be worn with a face shield.

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A Carcinogen

In June 2011, the National Toxicology Program of the U.S. Department of Health and Human Services officially classified formaldehyde as a human carcinogen. This classification is documented in the Report on Carcinogens-- 12th edition, available at http://ntp.niehs.nih.gov/?objectid=035E57E7-BDD9-2D9B-AFB9D1CADC8D09C1. Accessed November 1, 2012.

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Acceptable Results

If the monitoring results are below the Action Level of 0.5 ppm, no additional monitoring is required unless there is a change in procedure. However, annual monitoring is recommended as a good safety practice.

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OSHA Formaldehyde (retired)
A Potential Carcinogen

More importantly, the National Institute for Occupational Safety and Health (NIOSH) has labeled formaldehyde a potential human carcinogen.

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Acceptable Results

If the monitoring results are below the action level, no additional monitoring is required unless there is a change in procedure.However, annual monitoring is recommended as a good safety practice.

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PPE

When using formaldehyde in any concentration, with the exception of putting specimens in single vials, you must wear: A cover gown or apron A face shield or safety goggles Gloves This personal protective equipment is provided at no cost to you.

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Safety is no accident!

These rules and regulations are designed to protect YOU--our most valuable resource!

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OSHA Hazard Communication and Chemical Hygiene Updated to the Globally Harmonized System
Employer Responsibility

Your employer has a responsibility to educate you about chemical hazards and safe procedures that will prevent injuries.Employers who have hazardous chemicals in the workplace were required to train workers on the new GHS label elements and SDS by December 1, 2013.

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Your Responsibility

Read the manufacturers' labels and safety data sheets (SDS), and follow the instructions and warnings. Access pertinent safety information through your supervisor. If you are concerned that something is a potential hazard, either in the facility or in your work procedures, contact your supervisor as soon as possible.

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Handling and Storage Data

Information concerning the eye, skin, and respiratory protection required while using the chemical Any special ventilation that might be neededNote that appropriate gloves (nitrile or in some cases, rubber) should always be worn when working with a hazardous chemical. Safety goggles or other face protection should also be used when handling chemicals, especially when the procedure is not being conducted in a fume hood.

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General Laboratory Precautions

Laboratory safety includes a number of precautions designed to protect you and your coworkers. Remember that: eating drinking smoking applying cosmetics or lip balm are forbidden in areas where chemicals are present.

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Personal Protective Equipment

Personal protective equipment is an essential way to protect yourself from the dangers of chemicals. You'll find on the label or safety data sheet (SDS) exactly what kinds of clothing, gloves, and coverings you'll need to keep yourself safe. Also, the laboratory's chemical hygiene plan will include information about necessary personal protective equipment and engineering controls that will reduce your exposure to hazardous chemicals. At a minimum, chemical safety goggles and rubber or nitrile gloves (not necessarily utility gloves) are necessary parts of your personal protective equipment.

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Monitoring

Certain chemicals in use in the laboratory, such as formaldehyde, are hazardous if your exposure to them is prolonged. The amount of the chemical to which you can be exposed before possible danger is called the threshold limit value. Monitoring badges are used from time to time to measure your exposure. These are worn in the "breathing zone" for a certain period of time--often eight hours (for long-term exposure) or fifteen minutes (for short-term exposure). Based on the results of this monitoring, additional personal safety measures, such as ventilation or face-fitted masks, may be implemented for your protection.

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Packaging and Shipping Infectious Materials (retired July 2013)
Training Requirements for Packaging and Shipping Category A Substances and Dry Ice

In the United States, required training must be completed within 90 days of employment by all personnel who are involved in packaging and shipping category A infectious substances and/or dry ice (when shipped by air in quantities greater than 5.5 pounds). Relevant documented training from a previous employer is also acceptable.Training requirements, which are stated in the Code of Federal Regulations at 49 CFR 172.704, include:General awareness/familiarization training Function-specific training Safety training Security awareness training (Category A substances) Safety training, must be provided by the facility where the infectious materials are packaged and must include:Emergency response information Measures to protect the employee from the hazards associated with hazardous materials to which they may be exposed in the work place, including specific measures the hazmat employer has implemented to protect employees from exposure Methods and procedures for avoiding accidents, such as the proper procedures for handling packages containing hazardous materials OSHA bloodborne pathogens training is generally sufficient to meet this requirement for packaging and shipping infectious materials.

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Security Awareness

A category A infectious substance is in a form that is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Exposure would occur if the substance were released from its protective packaging and a human or animal came into contact with it. Therefore, it is critical that a category A infectious substance does not end up in the hands of an unauthorized individual who may purposely or unknowingly release the substance from its protective packaging and endanger humans or animals. Being aware of the people that you interact with in the process of packaging and sending category A substances is vital to the safety of the transport and prevention of a health disaster. An outsider with limited access and system knowledge could constitute a threat, but be aware that insiders could also be a threat, e.g., a disgruntled employee or a person who is angry with his or her supervisor or job or the government. Anyone desiring to do harm could potentially seize the opportunity to steal a hazardous material.Follow these precautionary procedures: When you are questioned about an infectious substance that you are packaging for shipment, it is important that you know the person that is asking AND that he or she has a need to know. If you do not know the person and if you are not aware that the person needs to know about the substance that is being shipped, do not answer the questions. You could refer him or her to your supervisor. Watch for unusual behavior. Secure the package until it is picked up. Check the identification of the courier who will be picking up the package. Use an intralaboratory chain of custody procedure if the specimens are tranferred within the facility or system. Track the package once it has been sent to be sure it arrives safely. Notify the Responsible Official or federal authority if the package does not arrive at its destination.

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References

International Air Transport Association. Guidance document: Dangerous Goods Regulations (DGR). 52nd ed. 2011.National Laboratory Training Network. Packaging and shipping Division 6.2 materials. Georgia Public Health Laboratory; 2011. Sentinel laboratory guidelines for suspected agents of bioterrorism: Clinical laboratory bioterrorism readiness plan. Available at: http://stanfordhospital.org/PDF/bioterrorism/labGuidelinesSuspectedAgentsBT.pdf. Accessed January 31, 2011.US Department of Transportation Pipeline and Hazardous Materials Safety Administration. Transporting Infectious Substances Safely. Available at http://www.phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Files/Transporting_Infectious_Substances_brochure.pdf.

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Parasitology Question Bank - Review Mode (no CE)
Which of the following safety measures must be in place when handling initial samples for parasite study?View Page

Phlebotomy
Case

Julie Smith, a newly certified phlebotomist at Northlake Hospital, entered a patient's room on the third floor for a routine blood draw. The patient was an elderly woman who had very small fragile veins. Julie therefore decided to use a safety butterfly needle attached to a Vacutainer tube in order to draw the blood. When Julie was finished with the venipuncture, she detached the butterfly needle from the Vacutainer, and approached the Biohazard needle disposal box. She noticed that the disposal box was full , but decided to try to fit the butterfly into the box anyway. Holding the butterfly by the tubing, she tried to push the butterfly into the box. The needle suddenly recoiled and stuck Julie's finger. Julie left the patient's room in a panic and headed back to the lab to report the needle stick injury.

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What should Julie have done to prevent the needle stick?View Page
Discussion

All biohazard needle disposal containers are marked with a "full" line at about ¾ of the box's volume. Therefore, needles should never be sticking out of the top of the container. Julie should never have attempted to put the needle into an overly full container. The needlestick safety and prevention act requires the use of butterflies with built in safety devices. However, they are only effective if properly activated. When disposing of a butterfly needle, hold its "wings" with one hand, and the hub at the opposite end of the tubing with your other hand to prevent the needle from recoiling. Butterflies should be used with extra caution since they are the number one cause of needle stick injuries.Relevant topics:Needle disposal, Sharps disposal containers, Butterfly needles with safety 1, Butterfly needles with safety 2, Needle-stick injuries, Built-in safety features, Angel Wing™ safety butterfly, Punctur-Guard™ safety butterfly

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Case

A phlebotomist at Memorial Hills Hospital entered the room of a 6 year old patient. The only test ordered was a CBC, so the phlebotomist decided to do a finger stick. After gathering proper supplies for the finger stick, the phlebotomist began the procedure by putting on gloves and wiping the tip and side of the patient's ring finger with alcohol. He positioned the safety lancet between the ball and the side of the finger and made a small incision. The child cried as the blood was collected.

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Butterfly needles with built-in safety features continued

Two examples of butterfly needles with built-in safety devices are shown.The Punctur-Guard™ (Bioplexus), shown above, uses an internal blunt needle which is activated after blood is drawn. The activated device showing the blunt internal needle is shown in the inset on the upper right. The Angel Wing ™ (Monoject), is activated by sliding a safety shield over the needle after venipuncture.

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Needle holders with built-in protection devices

You will be required to use appropriate safety devices with your needle holder. Various options are available. The Needle-Pro™ Needle protection device (Sims Portex) shown here is an example of a needle holder with a built-in safety device. It is activated after venipuncture by pressing the orange protection device against any flat surface so as to engage the sheath firmly on the needle.

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Multiple draw needles with built-in safety features.

You will be required to use multiple draw needles with built-in Safety features. One example is the Puncture-Guard™ (BioPlexus) needle, which uses an internal blunt needle (detail above) that is activated with forward pressure on the final blood tube prior to withdrawal of the needle from the vein. Refer to your institution's and the manufacturer's procedure manuals before using these devices.

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Needle holders, built-in protection devices contd

When the orange safety sheath is engaged, as shown on the right, it protects the user from needlestick injury, until the device is properly disposed of in an approved sharps container. Refer to the manufacturer's instructions, and your procedure manual for detailed instructions prior to use.

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Syringes with built-in safety devices

Syringes are used for injections, as well as to collect blood. There a various syringes with built-in safety features.One example is the Monoject™ (Sherwood Services AG), Safety Syringe, shown here.

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Syringes with built-in safety devices contd.

After use, a safety shield is slid over the needle, and locked into place. The safety syringe with the shield locked in place is shown here.

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Needles with built-in safety devices

You will be using needles and/or needle holders with built-in safety devices. Various such needles are on the market. Remember that you must still activate the safety device to get the protection offered. So careful attention to what you are doing is still one of the best ways to protect yourself against needlestick injury.

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Butterflies with built-in safety features

You will be using butterfly needles with built in safety features. Butterfly needles are the number-one cause of needlestick injuries, so proper use of their safety devices is critical. Their use is described in greater detail in the section on butterfly needle blood collection.

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Activation of safety device

Activate the safety device in use at your institution.Be sure to follow your institution's procedure for activating this device to protect yourself from needlestick exposure.

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Butterfly needle - Angel WingTM safety butterfly

The Angel Wing™ (Monoject), is activated by sliding a stainless steel safety shield over the needle after withdrawal from the vein.The Angel Wing™ (Monoject), is activated by sliding a stainless steel safety shield over the needle after withdrawal from the vein.

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Butterfly needle - Butterfly needles with built-in safety features

You will be using butterfly needles with built-in safety device. The safety device must be activated upon completion of the blood collection.You will be using butterfly needles with built-in safety device. The safety device must be activated upon completion of the blood collection.The Angel Wing™ (Monoject) safety butterfly is shown here.

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Finger stick - Finger stick collections

A finger-stick collection is performed by piercing the fingertip with a safety Lancet, which controls the depth of incision, and collecting capillary blood. The BD Microtainer™ Brand Safety Flow Lancet is shown here.Finger-sticks should not be performed on children under one year of age.

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Finger stick - puncture

Select a safety lancet appropriate for the size of the patient's finger.You may warm the finger prior to puncture to increase blood flow.Make the puncture perpendicular, rather than parallel, to the finger print.

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Syringe - Transferring blood to collection tubes

After collecting the blood specimen into a syringe, properly activate the appropriate safety device, and dispose of the needle in a sharps container.Attach the syringe to a blood transfer device by twisting the needle tip into the hub of the device.Push a vacuum blood collection tube into the holder of the transfer device, and let the tube fill to the appropriate level.

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Butterfly needle - Punctur-GuardTM safety butterfly

Another type of safety butterfly needle is shown to the right.The Punctur-Guard™ (Bioplexus) uses an internal blunt needle (arrow) that is activated by manually locking a small lever on the butterfly. Please refer to your facility's and the manufacturer's procedure manuals for detailed instructions.

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Activate needle safety device

After collecting the blood, activate the needle safety device according to manufacturer's instructions, and place it in a sharps disposal container. If blood was collected into a syringe, insert the syringe tip into the hub of a blood transfer device, and rotate the syringe clockwise to secure it to the device. Push the blood culture bottle into the holder of the transfer device, and draw the appropriate volume of blood into the blood culture bottles.

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Needlestick safety and prevention act continued

Please keep the following in mind: These devices must be used properly and conscientiously to prevent injury. Carefully follow your institution's policies and procedures to prevent needlestick injury. Most devices require you to activate their safety features. Often, the device lets you know it is properly activated by a click or a snap.

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OSHA bloodborne pathogens standard

The Occupational Health and Safety Administration (OSHA), of the federal government has mandated bloodborne pathogen training for all US workers who are at risk of exposure. The next few slides cover a few highlights of this training. You will receive complete OSHA bloodborne pathogens training before you begin work.

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Needlestick safety and prevention act

The Needlestick Safety and Prevention Act was passed by Congress in November 2000. This law modifies the OSHA Bloodborne Pathogens Standard to require that health-care institutions use only needles and other sharps which have engineering controls and design features to help prevent accidental sharps injury. Health care institutions must update their exposure control plans to reflect these changes.

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Needlestick safety and prevention act continued

There are many different types of needle safety devices on the market. As you go through this program, we will introduce you to some of them

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Needlestick safety and prevention act continued

The law requires that each institution gets input from employees actually involved in blood collection. So the actual safety devices you are required to use will vary depending on where you work.

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Preliminary Identification of the Primary Select Agents of Bioterrorism
Purpose of the Laboratory Response Network (LRN)

Today, the Laboratory Response Network (LRN) is a multi-level network of local, state, federal, and military laboratories across the United States and internationally which work together in an integrated and coordinated way to provide a rapid response to public health emergencies. The LRN concept of operations is based on a system of safety and proficiency.Some of the goals of the LRN are to: Establish standardized protocols used for the identification of pathogens that carry a high consequence Provide guidance for safe and effective handling of suspected threat agents Serve as a source of expert advice for agents of concern Identify threat agents using complex molecular methods

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Select Agents of Bioterrorism

The United States government has determined a list of select agents that include the bacteria, viruses, fungi, and toxins that have the potential to cause a severe threat to public health and safety if used in a bioterrorist attack.This course will primarily focus on sentinel laboratory procedures used to rule out the bacterial organisms that are part of the select agents list, as well as provide information regarding some of the viral and biological toxins.

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Sentinel Laboratory Safety Protocols

Recommendations for establishing the necessary laboratory safety protocols can be found in Biosafety in Microbiological and Biomedical Laboratories 5th Edition, available online at:http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf

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Agent Biosafety Level (BSL) Requirements and Laboratory Exposure Risk

These agents are dangerous, highly virulent organisms that should NEVER be manipulated on an open bench! Laboratory infections can occur and the use of a class II, or higher, biological safety cabinets (BSC) is critical when aerosols are likely. The importance of following facility specific safety protocols and standard microbiology practices at ALL times cannot be understated. Agent Biosafety Level Laboratory Exposure Risk B. anthracis BSL-2 Low Y. pestis BSL-2 Medium F. tularensis BSL-2/3 High Brucella species BSL-2/3 High Burkholderia species BSL-2/3 High

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A class II, or higher, biological safety cabinet (BSC) must be used when manipulating potential bioterrorism agents or if aerosols are likely.View Page
Categories of Biological Agents

The federal government has defined the pathogens or toxins that have the potential to pose a severe threat to public health or safety.The Centers for Disease Control (CDC) categorized these critical agents into three groups: Category A agents (highest priority) Category B agents (second highest priority) Category C agents (third highest priority)The biological agents are placed in one of the three groups depending on the level of risk each poses to national security.

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Quality Control
Safety and Handling of Controls

To ensure the safety of those performing patient testing, controls do not contain HIV or the hepatitis B virus. Manufacturers place the same batch of control material into small vials. This allows only a small portion of the control to be handled while the remainder is stored until needed. Storage information for controls is printed on the label. These instructions should be followed carefully in order to prevent contamination or false results.

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Rh negative female with anti-D at delivery: A case study
Calculating RhIg Dosage

Using the estimated volume of fetal bleed determined by the Kleihauer-Betke test or flow cytometry, the number of vials of RhIg (300 µg) to inject is calculated as follows: Number of vials of 300 µg (1500 IU) RhIg = volume of fetal bleed/30 mLIn the interests of safety some organizations recommend the following to deal with decimal points: If the number to the right of the decimal point is <5, round down and add 1 vial (e.g., 1.4 = 1 +1 = 2 vials) If the number to the right of the decimal point is greater than or equal to 5, round up and add 1 vial (e.g., 1.7 = 2 +1 = 3 vials) Sub-calculations: Volume of fetal bleed: % fetal cells x maternal blood volume Maternal blood volume: 70 mL/kg x weight (kg) (assume 5,000 mL if maternal information is unknown) Note: RhIg dose calculators are available (see Further Reading: "Bringing new rigor to RhIG calculations").

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Crossmatch Implications of RhIg-associated Passive Anti-D

Once again, policies vary from laboratory to laboratory since the issue is not directly addressed by blood safety standards. For example, AABB and other standards require a version of the following: When clinically significant red cell antibodies are detected or the recipient has a history of such antibodies, RBC components shall be prepared for transfusion that lack the corresponding antigen and are serologically crossmatch-compatible, where serologically is taken to be an IAT at 37oC. If no clinically significant antibodies were detected in antibody screen tests and the patient has no record of such antibodies, detection of ABO incompatibility is required, which can be accomplished by immediate spin crossmatch or an electronic crossmatch. The key issues are whether detectable passive anti-D from RhIg or a record of passive anti-D from RhIg should be considered clinically significant for crossmatch purposes. Because standards do not directly address these issues, TS laboratories are left to interpret what is required to meet the standards. Practices may be further complicated because of the transfusion service's laboratory information system (LIS).

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Blood safety standards such as AABB Standards directly specify that an electronic crossmatch cannot be done when an Rh negative female has an anti-D consistent with antenatal RhIg administration.View Page
For those facilities that in the interest of safety use a special calculation for RhIg dosage, regardless if they round up or round down, they always add one vial.View Page
Routine Serologic Tests - Mother

Tests done routinely as part of perinatal testing programs vary from country to country and within countries. Below is one example of serologic tests typically done when pregnant females lack clinically significant antibodies. Other test protocols exist.Mother ABO, Rh, and antibody screen at first prenatal visit; Optional (not mandated by blood safety standards): Test for weak D, if initial Rh typing appears to be D-negative; D-negative females: Tested again (ABO, Rh, and antibody screen) at ~ 28 weeks weeks gestation prior to administration of RhIg (depending on the country) and again at delivery. Note: The application of DNA analysis to typing blood group antigens started in the early 1990s but is not yet widely available. When available, the mother can be typed for D using molecular methods, but this is usually not done unless she is weak D. The purpose is to determine using molecular methods which D variant the mother has, weak D or partial D, since the latter can produce anti-D. (see Further Reading) Molecular typing is reviewed more fully in Refresher on Hemolytic Disease of the Fetus and Newborn and Its Prevention, a companion course that complements this one.

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For infants born to Rh negative females, a test for weak D is optional when initial D typing shows the newborn to be Rh negative.View Page

Risk Management in the Clinical Laboratory
Introduction to Risk Management

In 1999 the Institute of Medicine (IOM) published a study entitled "To Err Is Human: Building a Safer Health System." Its estimate of the number of deaths and adverse outcomes caused by medical errors sent shockwaves throughout the healthcare community as well as the general population. Perhaps for the first time members of the healthcare community began to seriously look at the way healthcare is delivered and how the process could be improved to enhance patient safety.Thus, one of the most beneficial results from the IOM study was that hospital workers and other healthcare providers realized that they urgently needed to fully and more effectively incorporate "risk" as a crucial component of their management.

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Federal Regulations for Risk Management

Several federal agencies share responsibilities for oversight of the healthcare industry in the United States. These agencies include: U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services- Responsible for regulating clinical laboratory testing through the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Food and Drug Administration (FDA)- Responsible for protecting public health through regulation of food, drugs, vaccines, blood and blood products, medical devices, and more. U.S. Department of Labor Occupational Safety and Health Administration (OSHA)- Ensures safe working conditions in healthcare as well as other industries. Some of the federal laws/regulations that affect clinical laboratories in the United States and relate either directly or indirectly to risk management include: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Health Insurance Portability and Accountability Act of 1996 (HIPAA) OSHA standards for hazard communication, chemical hygiene, and bloodborne pathogens Safe Medical Devices Act of 1990 (SMDA) The Patient Safety and Quality Improvement Act of 2005

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Occupational Safety and Health Administration (OSHA)

The Occupational Safety and Health Administration is an agency working within the United States Department of Labor. It was created in 1970 by congress under the Occupational Safety and Health Act. As the primary regulatory agency in the field of occupational safety and health, its mission is to prevent work-related injuries, illnesses, and deaths by issuing and enforcing standards for workplace safety and health. Several states have also implemented their own occupational safety and health programs. To qualify as a state plan, the state agency must promulgate regulations that are equal to or more stringent than the federal OSHA program. Some of the safety regulations brought about by OSHA that affect the laboratory are: Personal protective equipment (PPE)- primarily to prevent exposure to bloodborne pathogens. Lockout/tagout- securing energy sources in an "off" condition when performing repairs of maintenance. Hazard communications- requires developing and communicating information on hazards of chemical products used in the laboratory, such as material safety data sheets (MSDS). Bloodborne pathogens- a standard designed to prevent both employees and patients from being exposed to bloodborne pathogens.

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The Patient Safety and Quality Improvement Act of 2005

The Patient Safety and Quality Improvement Act, signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States as highlighted in the Institute of Medicine's 1999 report, To Err is Human: Building a Safer Health System, which was mentioned at the beginning of this course. The goal of The Patient Safety and Quality Improvement Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.Along with the Clinical Laboratory Improvement Amendments of 1988, The Patient Safety and Quality Improvement Act of 2005 provides a means by which confidential reports contributed by healthcare providers on patient safety events can be used to identify unsafe practices that increase risks to patients.

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Introduction to Patient Safety and Risk Exposures

Laboratory quality management and risk management plans that address processes in the preanalytic, analytic, and postanalytic phases of testing are key elements in ensuring patient safety. The preanalytic phase of testing includes all processes prior to the actual testing of a specimen. The analytic phase consists of all the processes involved in the testing of a specimen, and the postanalytic phase includes all the processes involved after test analysis.

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References and Recommended Reading

Astion ML, Shojania KG, Hamill TR, Kim S, Ng VL. Classifying laboratory incident reports to identify problems that jeopardize patient safety. Am J Clin Path. 2003;120:18.Bersch C, Clemons K. The wheel of misfortune prepare to win if disaster strikes. MLO. 2008;40:12. Berte L. Laboratory quality management: A road map. Clin Lab Med. 2007;27:771.Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48:691-698. Available at http://www.clinchem.org/cgi/content/full/48/5/691#T2B Accessed February 2, 2012.Carraro P, Plebani M. Errors in a stat laboratory: Types and frequencies 10 years later. Clin Chem. 2007;53:1338-1342.Carroll R ed. Risk Management Handbook for Health Care Organizations. 5th ed. San Francisco: Jossey-Bass; 2006.Howanitz PJ. Errors in laboratory medicine: Practical lessons to improve patient safety. Arch Pathol Lab Med. 2005; 129:1252 - 1261.Kalra J. Medical errors: Impact on clinical laboratories and other critical areas. Clin Biochem. 2004;37:1052-1062. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.Lippi G, Guidi G. Risk management in the preanalytical phase of laboratory testing. Clin Chem & Lab Med. 2007;45:720. Malone B. Risk management for clinical labs. Clinical Laboratory News. 2008;34:1.Pierangelo B, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48:691-698.Sazama K. Legal implications of laboratory errors. Lab Med. 2005;36:213.Smith TJ. Strategies for error reduction, Advance Magazine. 2009;18:25.Vidal Y. 101 Ways to Prevent Medical Errors: A 24-year Odyssey. Andrews, TX: Lara Publishing; 2002.

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Root Cause Analysis

Root cause analysis (RCA) is a structured study that determines the underlying causes of adverse events. RCA focuses on systems, processes, and common causes that were involved in the adverse event. It then determines ways to prevent recurrence by identifying potential improvements in systems and processes that should decrease the likelihood of repeating the event. Occurrences that may jeopardize patient safety must be investigated immediately and appropriate risk-reduction activities must be implemented. The most serious of these occurrences has been labeled by the Joint Commission as a sentinel event. A sentinel event is an unexpected event involving patient death or serious physical or psychological injury. A root cause analysis must be performed if a sentinel event occurs.Another serious event that also requires investigation at the level of a root cause analysis is sometimes referred to as a near miss. A near miss is a process variation that did not result in patient death or serious injury, but a significant risk of one of these adverse outcomes was present and could occur if the same process variation was repeated.

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Risk Management Accrediting Organizations: College of American Pathologists

The College of American Pathologists (CAP) is a private, non-profit accrediting organization that has been granted "deeming" authority by CMS. The goal of the CAP laboratory accreditation program is to "Improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed regulatory requirements." Though CAP inspects only clinical laboratories, there are various types such as: reference laboratories, clinics, military installations, hospital laboratories, etc. which may be accredited through this organization.Surveys are unannounced and the program uses volunteer teams of practicing laboratory professionals as inspectors, or CAP inspection specialists. Inspection specialists are CAP employees who have extensive experience in laboratory medicine. If a hospital is inspected by the Joint Commission and the laboratory chooses to seek CAP accreditation, the CAP inspection is recognized by the Joint Commission so that the laboratory will not be inspected again by the Joint Commission during the hospital inspection. In the fall of 2008 CAP launched a laboratory accreditation program based on the International Organization for Standardization (ISO) 15189:2007. This program utilizes criteria and procedures specifically developed to determine technical competence and account for quality management systems. It does not replace the CAP Laboratory Accreditation Program but is an addition to it. Participation is strictly voluntary and there is no tie to CMS for Medicare reimbursement.The table to the right depicts factors involved in determining technical competence.

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Routine Venipuncture
What is a Hidden Error?

Hidden errors are those that cannot be detected or corrected by the laboratory analyst prior to testing. Most often these errors can be prevented by the phlebotomist following correct venipuncture procedure for every procedure, every time.Hidden errors include hemoconcentration, incorrect order of draw, and (the most serious of all errors) misidentification of patient or specimens. Because these errors often are unknown, the analyst may inadvertently report erroneous patient results which could be harmful to the safety and well-being of the patient. Condition What is it? How does it happen? What is the Result? Hemoconcentration Blood pools at site of venipuncture Tourniquet is applied for a prolonged period of time Test results may be inaccurate because blood components move between blood and tissues Pouring Blood between tubes Mixing contents of two or more tubes Removing top of tube to combine contents of one tube with another Inaccurate test results due to over or under dilution or incorrect anticoagulant Clots form due to lack of mixing Patient may have to be redrawn Incorrect patient identification and incorrect specimen labeling Using the wrong name to label a specimen Failure to positively identify EVERY patient using 2 unique identifiers BEFORE beginning venipuncture Failure to label EVERY specimen in the presence of the patient Failure to concentrate fully on the task Results reported to caregiver for wrong patient Compromises patient care; may be life-threatening

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Protect Yourself

The safety of both the phlebotomist and patient is of utmost concern at all times. In the unfortunate event of an accidental needlestick or if you get blood or other potentially infectious materials in your eyes, nose, mouth, or on broken skin, immediately flood the exposed area with water and clean any wound with soap and water or a skin disinfectant if available. Report this immediately to your employer and seek immediate medical attention. It is imperative that the phlebotomist follow facility protocol for reporting the incident. This ensures prompt treatment for the injury. The facility procedure must be followed whether the accidental puncture was from a clean or contaminated needle.The single most important element to prevent an accidental needlestick is for the phlebotomist to fully concentrate during every procedure. Keeping your mind on the task at hand contributes to a successful and safe result.

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References

Clinical and Laboratory Standards Institute (CLSI). Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline. Fourth ed. CLSI document H21-A4. CLSI. Wayne, PA: 2003.Clinical and Laboratory Standards Institute (CLSI). Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard. Sixth ed. CLSI document H3-A6. CLSI. Wayne, PA: 2007.Clinical and Laboratory Standards Institute (CLSI). Procedures for the Handling and Processing of Blood Specimens; Approved Guideline. Third Edition. CLSI document H18-A4. CLSI. Wayne, PA: 2010.Ernst DJ. Applied Phlebotomy. Baltimore, MD: Lippincott Williams & Wilkins: 2005.The Joint Commission. National Patient Safety Goals. Available at: http://www.jointcommission.org/standards_information/npsgs.aspx. Accessed November 19, 2013.

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Needles and Patient Safety

All needles are single use. That is, every needle is immediately discarded in a sharps container after one insertion. If you suspect that you inadvertently touched anything with the needle prior to inserting the needle into the patient's vein, the needle cannot be used. The safety device must be activated and the needle discarded.NEVER remove a needle from a patient and reinsert into another vein; this could put the patient at risk for infection.

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Blood Collection Systems and Devices

The phlebotomist has a choice of several blood collection systems. Three that are commonly used are discussed on the following pages. Evacuated Tube SystemThe primary choice for a routine venipuncture that will be performed on an adult or an older child is a blood collection system that consists of a holder (or adapter), a needle that is pointed on both ends, and evacuated blood collection tubes. One end of the needle will pierce the vein and the other end will pierce the stopper of the evacuated tube so that blood will flow into the tube to fill the vacuum. A safety device is required on either the holder or the needle to comply with current standards for needle safety. Two examples of needle holders equipped with safety devices are shown on this page.

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Winged Device

The winged device is another popular choice for the phlebotomist. This may be chosen for pediatric venipuncture, small delicate veins on adults (particularly geriatric patients), or hand veins. The device can be used with a needle holder and evacuated tube or a syringe. A needle safety device is incorporated into the design of the winged device to prevent needlestick injury.

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Venipuncture Procedure At a Glance

Required Step Description Step #1 Wash your hands. Clean your hands with soap and water or gel cleanser. Step #2 Positively identify patient using unique identifiers. Ask the patient to state his/her first and last name; if the patient is unable to give you this information, ask the patient's caregiver to confirm the patient's name. A second unique identifier must also be used. Step #3 Special test requirements Determine if the test to be obtained has any special requirements. For example, should the patient be fasting? Is this a timed test? If any requirements are not met, consult with the caregiver to determine a course of action. Step #4 Prepare the patient Explain the procedure to the patient and obtain cooperation. Usually the patient will extend an arm. (This is a form of implied consent.) Position the arm for venipuncture; support the arm on a firm surface; the arm should be in a downward position. Step #5 Site determination The patient can make a fist, but should not pump the hand open and closed. Apply tourniquet Palpate the vein. Release the tourniquet and assemble appropriate equipment. Step #6 Aseptic technique Wear gloves that have not been altered in any way. Cleanse site with approved disinfectant. Allow the disinfectant to air-dry to avoid hemolysis of the specimen and discomfort to the patient. Step #7 Specimen collection Re-apply tourniquet about 3-4 inches above puncture site, insert needle, bevel-side up, at about a 30° angle, and collect specimens. Remove needle and immediately activate the safety device. Mix specimens by gentle inversion 5-10 times. Step #8 Patient care Apply direct pressure to stop bleeding at puncture site; do not have patient bend arm as this may cause a hematoma to form. After about 2 minutes, check the puncture site to verify that bleeding has stopped. Apply bandage if appropriate. Thank the patient for his/her cooperation. Step #9 Specimen labeling Label specimen(s) in the presence of the patient including all the information that is required by your facility. Check the labeled tubes a second time against the patient's wristband to verify labeling accuracy. A professional phlebotomist follows the procedure in the same way for every venipuncture. This ensures that none of the vital steps are omitted. The phlebotomist who is consistent in performance and who concentrates fully to obtain a quality specimen is an indispensable part of the healthcare team.

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Don't Get Stuck Without It

Current practice mandates the use of safety devices on all needles. These devices are designed for ease of use and disposal. Tampering or disabling any safety mechanism is forbidden and unprofessional. If the safety mechanism has been compromised, you are putting yourself, the patient and your coworkers at risk of injury.

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Do It Right the First Time

All sharps, including needles with safety devices activated, must be immediately placed into an approved biohazard sharps container. Containers with rigid sides must be puncture proof and leak proof. The container must be tightly closed and discarded when 3/4 full. Biohazard waste other than sharps should be properly disposed of in clearly marked biohazard bags or containers according to site protocol.

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Don't Compromise Your Safety

An important element of safety is personal protective equipment (PPE). This must be provided to phlebotomists by their facility and may include gloves, lab coats, and protective eyewear. An N95 respirator (shown in the lower image) or other respiratory protection may be required to protect the phlebotomist from Mycobacterium tuberculosis or other airborne infectious agents. Phlebotomists and other healthcare workers must be medically cleared and fit-tested to wear N95 respirators. Gloves are required during every phlebotomy procedure. The gloves must remain totally intact. The gloves cannot be altered in any way as to expose the hand or fingers to potential bloodborne pathogens. Never remove all or part of the finger tip of the glove while performing venipuncture.

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Semen Analysis
Materials Needed

The following is a list of materials needed for semen analysis. Laboratories will differ slightly in the equipment used. Use of this equipment will be described further in the later pages of this course. Materials needed include:graduated test tube or serological pipets with safety bulb to measure volumepH paper in neutral to basic range (e.g. 7.2-8.8)counting chamber and/or automated counting machineglass slides and coverslips for wet mount if motility and sperm count are to be assessed separatelyhand counterif dilution is donediluting fluid calibrated automatic pipetspositive pressure pipets and glass boreslight microscope with phase contrast objectives for sperm count and bright field objectives for morphology assessmentglass slides and fixative for morphology slidesset-up for performing Papanicolaou or other morphology stainingReference materials, such as the most current WHO laboratory manual for the examination and processing of human semen, a publication of the World Health Organization.

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Safety Precautions

Safety precautions should be observed when handling seminal fluid. The following guidelines should be followed:If non-disposable items are used, soak contaminated items(e.g., hemocytometers and coverslips) in 70% alcohol or other appropriate decontaminate.All disposable items should be placed in a biohazard bag.Non-latex or powder-free latex disposable gloves must be worn and hands thoroughly washed when the examination is completed.Seminal fluids that are to be discarded should be placed in biohazard bags.

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Special Topics in Phlebotomy
Case Study Two: Discussion

Case study:An 18-year-old male has come to the outpatient clinic for blood work. He tells you that he has not been feeling well for several days, which is obvious from his skin pallor. He also mentions being weak and fatigued. If you are the phlebotomist, what would you do?Suggested plan of action: It is important to observe and listen to the patient and assess the situation to avoid a potential adverse event. In this case, because the patient is in a weakened condition, it would be best to have him lie down for the venipuncture as a safety precaution.

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Sample Integrity

Sample integrity is critical to the safety of clinical laboratory services. If there is a problem with the sample, then test results are meaningless. Each time there is a problem with specimen integrity, patients experience wasted time in addition to anxiety and loss of faith in the expertise of the phlebotomy staff. Patients may also experience harm, if harm is defined as delay in diagnosis, therapy, hospital admission or discharge.Threats to sample integrity include:Collection of a sample from the wrong patientCollection of the wrong blood sample (eg, a blue top tube when a green top is needed)Missed venipuncture (multiple attempts)Multiple venipunctures due to improper or inadequate sample collectedMislabeled and unlabeled samplesImproperly performed venipuncture or skin puncture

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Special Tests May Mean Special Collections

Some laboratory tests are so specialized that they require the use of special collection tubes to prevent erroneous results.Some examples of special requirements include:Laboratory TestConsiderationsHeavy metalsBlood collection container material must be free of heavy metalsTissue typingSample may need to be collected in preservative solutionBlood culturesSpecimens must be collected in bottles containing nutrient media to promote growth of bacteria within the bottle. Genetic studiesSpecial tubes may be needed to preserve DNA and/or RNA It is the responsibility of the phlebotomist to be aware of special requirements for certain tests. If the correct collection tube is not known then the phlebotomist MUST refer to the specimen collection manual or ask the appropriate laboratory worker to obtain the information. It is also imperative that the phlebotomist obtain and use only the correct equipment and not substitute something that is "close". This could affect the test results and the safety of the patient.

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Geriatric Patients

Patients who are elderly may also require special considerations before, during, and after the venipuncture procedure.Mobility: Some elderly patients have difficulty walking or getting into or out of a chair. Using a chair that is an appropriate height so that the patient can safely get in and out of it will make it easier for the patient. Geriatric patients may also be unsteady on their feet. In such situations, the phlebotomist should react appropriately and walk alongside the patient, if necessary, to ensure patient safety.Veins: The veins of an elderly patient may appear to "roll" when venipuncture is attempted. The vein is not actually moving, but rather the muscles surrounding the vein have lost tone and the vein is not as stable as in a younger patient. Therefore, the phlebotomist must anchor the vein firmly and securely when attempting venipuncture. Skin: Skin may become thin and "papery" with advanced age. The phlebotomist must apply firm and prolonged pressure after venipuncture to prevent bruising. Use a bandage with a gentle adhesive to ensure stoppage of bleeding and promote skin integrity. Health concerns: Some elderly patients take medications that could affect their bleeding or their balance. Be aware that these patients may require extra attention and time. Keep in mind, not all elderly patients experience hearing loss. Thus, the phlebotomist should not assume the patient is hard of hearing and shout at the patient while speaking to them. Most often, the patient will tell you to speak louder if they are unable to hear you.

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Cultural Diversity and the Phlebotomist

It is very important for phlebotomists to recognize and respond appropriately to cultural differences they encounter during performance of their job duties. Patient-centered care includes respecting the patient. If necessary, procedures should be adjusted to accommodate cultural customs, keeping in mind that patient safety must be maintained. For example, in some cultures, the male is the spokesperson for the female members of the family. If this is the case, the female patient may not speak directly to a male health care worker. This may pose a challenge to the phlebotomist when positively identifying the patient prior to venipuncture. The male may verbalize answers to all of the phlebotomist's questions but the phlebotomist must adhere to precise identification procedures. The phlebotomist, while respecting the patient's cultural customs, must be sure that accurate patient identity is established.

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The Disappearing Antibody: A Case Study
Antibody identification checklist

To improve the quality of conclusions when identifying antibodies, a checklist is a simple quality control tool to increase transfusion safety. If a specific antibody pattern cannot be identified with acceptable confidence, or if significant serologic or non-serologic data are inconsistent and cannot be rationalized, further testing will be required.Before concluding that the investigation is complete, unless not applicable, mentally reply to each question in the checklist. If any answer is no, has it been resolved? Antibody Identification Checklist Yes/No/NA 1. For a single antibody, does the reaction pattern fit only one antibody specificity? 2. Is antibody specificity consistent with the results of the initial antibody screen? 3. Are reaction phases consistent with antibody specificity? 4. If multiple antibodies are present, can all reactions be explained by the antibody combination? 5. If the autocontrol is negative, are patient red cells negative for the corresponding antigen(s)? 6. Have additional possible antibodies been excluded by selected red cells? 7. Can all variable reaction strengths be explained? 8. If tested, are antigen-negative donor cells compatible by antiglobulin crossmatch? 9. If there are data that do not fit antibody specificity or if there are results that are improbable, are they explainable? 10. Have all results and conclusions been systematically evaluated for consistency?

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Literature and online resources

LiteratureDutton RP, Shih D, Edelman BB, Hess J, Scalea TM. [abstract]. Available at: Safety of uncrossmatched type-O red cells for resuscitation from hemorrhagic shock.J Trauma. 2005 Dec;59(6):1445-9. Accessed November 5, 2012.Johnson ST, Rudmann SV,Wilson, SM. Serologic problem solving strategies:a systematic approach. Bethesda, MD: AABB, 1996.Online resourcesThe following are online examples of good practice. The information should not be used as a substitute for technical and clinical judgment. Medical and technical information becomes obsolete quickly and current sources relevant to the user's location should always be consulted.Transfusion reactions: Transfusion complications (Canadian Blood Services)Education website for CBS's hospital customersREACT (Sunnybrook HSC, Toronto, ON, Canada) Pocket reference card for nurseson signs and symptoms of transfusion reactionsQuick cals (online calculator of p values for Fisher's exact test) Use a one-tailed test (since we would expect an antibody to react with red cells that are positive for the corresponding antigen)

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The antibody screen is positive but the transfusion of the O Rh-negative RBCs is already in progress. What are the transfusion service (TS) laboratory's priorities in this case?Place the following procedures that will be followed by the TS in the appropriate order of priority.View Page
Signs and symptoms - Job Aids

Some blood safety standards require that a list of common signs and symptoms of suspected adverse reactions be included in both nursing and transfusion service manuals. Several organizations have developed job aids to help clinical staff recognize the signs and symptoms of various suspected transfusion reactions and to suggest appropriate actions (e.g., see REACT in Online Resources).

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The Influenza A Virus: 2009 H1N1 Subtype
Laboratory Tests

A variety of tests are available for the detection of influenza A viruses, including the 2009 H1N1 strain. These tests include: rapid antigen tests, direct fluorescent antibody tests to detect the presence of virus in patient specimens, shell vial cell cultures, classical tube cell cultures, and reverse transcriptase PCR (RT-PCR), which detects influenza-specific viral genes. These tests differ in sensitivity, specificity, availability, and the ability to distinguish between different influenza strains and subtypes, such as influenza A 2009 H1N1.The rapid tests, such as the direct rapid antigen tests or immunofluorescence assays, have lower sensitivity and specificity compared to cell culture and the RT-PCR based tests. Rapid tests vary in their ability to detect the 2009 H1N1 virus. The range of sensitivity is 10% to 70% and none of the rapid tests that are currently available are specific for H1N1. However, results of rapid tests are available within 30 minutes to one hour so that a positive test will provide further information toward a diagnosis when it is coupled with a patient's symptoms. A few FDA-cleared RT-PCR kits are available for the detection of influenza A viruses. For the subtyping of influenza A viruses, such as Influenza A seasonal H3N2, and 2009 H1N1, the FDA has given the status of "Emergency Use Authorization" (EUA) to a few of the RT-PCR kits; currently available kits under this emergency status category include those made by the CDC, ELITech, Prodesse, Focus Diagnostics, and Roche. (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm)State Departments of Health have been provided with RT-PCR kits from the CDC for the subtyping of influenza A viruses. This testing has also been FDA-reviewed and given the status of EUA. State and local health department guidelines determine which specimens should be submitted to public health laboratories for RT-PCR testing. In addition, several commercial reference laboratories, academic labs, and hospital labs have been able to perform influenza A subtyping for 2009 H1N1 under the same EUA status. Any laboratory that performs an EUA method would be required to perform an internal validation process.

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Contact Precautions for Laboratorians

•Public health guidelines recommend that manipulation of samples for influenza testing be done inside a safety cabinet.If an employee has close contact with a patient with known or probable Influenza A 2009 H1N1 illness, an N95 respirator, as shown in the image below, should be worn, according to CDC guidelines. Note that if an N95 respirator is used, it must first be fit tested to ensure a complete seal around the mouth and nose.Laboratorians should always observe basic infection control procedures including equipment/counter top decontamination and Standard Precautions that include the use of engineering controls such as safety cabinets; personal protective equipment (PPE), such as gloves, fluid-resistant outer clothing, and respiratory protection; and work practice controls, such as frequent hand washing.

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H1N1 Vaccine

When vaccine first became available to protect against infection with H1N1 virus, supplies were limited and those who were in high risk groups were given priority for receiving the vaccine. However, as of late December 2009, supplies increased substantially so that sufficient vaccine was available for everyone who chose to receive it. The CDC recommends that all individuals, regardless of age or health status, receive the vaccine. Individuals, age 65 or older with no medical risk factors, are less likely to get sick with H1N1, however, severe illness and deaths have occurred in all age groups. Therefore, it is prudent for everyone to be vaccinated. The vaccine is produced in the same manner as the vaccine against seasonal influenza and has the same assurance of safety that has been proven with the seasonal influenza vaccine. One caution that should be noted is that persons with known allergies to eggs may experience allergic reactions to the H1N1 vaccine, as they would with any influenza vaccine. These individuals should consult with a physician before receiving the vaccine.

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FDA Surveillance and H1N1 Preparedness

The US Food and Drug Administration's (FDA) worked with the CDC and other health agencies, both in the United States and globally, to protect public health during the H1N1 virus outbreak. The FDA ensures the safety, effectiveness, and supply of antiviral medications and the H1N1 vaccine that is produced and/or distributed in the United States; it has the responsibility of approving medical devices for the serologic testing of the 2009 H1N1 virus. The FDA also performs other roles such as ensuring the production of an adequate supply of respiratory protection and other personal protective equipment. The FDA also monitors the safety of the blood supply, and, although no cases of transmission of H1N1 virus through blood have been reported, the guidelines for donor deferral that have been established by the FDA further ensure that this would not occur.

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Transfusion Reactions
Disease Transmission

Even though blood components are tested rigorously for certain infectious diseases, bacterial, viral, parasitic, and prion pathogens continue to evolve. If they are not detected, they can cause harm to the patient and even death. Donors must be screen to determine eligibility. Their blood samples are also tested for hepatitis B and C, human immunodeficiency virus (HIV) 1 and 2, human T-cell lymphotrophic virus (HTLV) I and II, West Nile virus and syphilis. The table to the right describes the screening tests performed on all blood donors in the United States.It is not yet possible to eliminate the risk of infectious disease transmission through transfusions. There are many other organisms that may be transmitted through transfused blood, which are not routinely tested for in the blood supply. These organisms include the Epstein-Barr virus, cytomegalovirus (CMV), bacteria, and parasites such as malaria, Babesia microti, and Trypanosoma cruzi, which is responsible for Chagas disease, and prions such as variant Creutzfeldt-Jakob disease (vCJD).Selection of eligible donors is a critical part of ensuring the safety of the blood supply. Donors with certain lifestyles, medical conditions, travel histories, immigration backgrounds, or specific physical findings are deferred, either for a specific period of time or indefinitely. This minimizes the risk that a transmittable agent will be present in the donors blood. Click here to learn more about donor eligibility criteria from the American Red Cross.Click here to learn more about Babesia microti. Click here to learn more about Chagas Disease. Click here to learn more about vCJD.Click here to learn more about malaria.

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Tuberculosis Awareness for Health Care Workers
TB Infection Control in the Laboratory

The laboratory director is responsible for the development of a risk-based infection control plan for the laboratory.The personnel are trained in methods that minimize the production of aerosols.The personal protective equipment that is specified in the infection control plan is used consistently. A respirator is used when performing procedures that can result in aerosolization outside a biological safety cabinet.Disposable gloves are worn for all laboratory procedures.

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Biosafety Levels

Laboratory workers who handle infectious materials in the microbiology laboratory should be aware of the work practices, safety equipment, and barriers that will protect them, and others in the area, from infectious agents. The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) created guidelines to assist laboratories in developing safe practices based on the infectious agents that are handled. These guidelines are referred to as Biosafety Levels 1 through 4. Each increasing number represents increased risk, requiring more stringent work practice and increasingly protective safety equipment and barriers. A copy of the Guidelines can be obtained from the CDC or accessed online on the CDC website:http://www.cdc.gov/biosafety/publications/bmbl5/index.htm. Accessed November 7, 2013.

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Biosafety Level Criteria and Requirements for Handling Specimens Suspected of Containing Mycobacterium tuberculosis

All specimens suspected of containing M. tuberculosis (including specimens processed for other microorganisms) should be handled in a Class I or II biological safety cabinet (BSC). Appropriate personal protective equipment (PPE) must be used. At a minimum, this includes gloves and fluid-resistant laboratory coat or gown. Non-aerosol-producing manipulations (eg, preparing direct smears for acid-fast staining when done in conjunction with training and periodic checking of competency) can be performed using biosafety level-2 (BSL-2) practices and procedures, containment equipment, and facilities. BSL-3 practices, safety equipment, and facility design and construction are applicable to microbiology laboratories that work with indigenous or exotic agents with a potential for respiratory transmission, and which may cause serious and potentially lethal infection. If the laboratory is propagating and manipulating cultures for M. tuberculosis, BSL-3 practices, containment equipment, and facilities are required. Barriers include controlled access to the laboratory and ventilation requirements that minimize the release of infectious aerosols from the laboratory. Secondary barriers should include self-closing double-door access and negative airflow into the laboratory. Exhausted air must not be recirculated. Work surfaces must be decontaminated, using the laboratory-approved disinfectant, upon completion of procedures, immediately following a spill, and at the end of the work shift, if the surface was recontaminated since the last cleaning. Laboratory equipment should be routinely decontaminated.Hands must be washed upon completion of work with potentially infectious materials and before leaving the laboratory.

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