| Patient Identification Patient safety when performing a capillary blood collection includes positive patient identification prior to performing the procedure. The accepted policy in most healthcare 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. | View Page |
| 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. | View Page |
| 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 Reminder Reason Comment Gloves are always necessary Blood 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 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 injury Often, capillary procedures are performed on very young children who are curious and may grab something that could cause injury. | View Page |
| 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 may be required when performing a successful dermal puncture.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 healthcare 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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.
| View Page |
| Factors that Contribute to Medical Errors | View Page |
| Employer Responsibility Your employer has a responsibility to educate you about chemical hazards, and safety procedures. | View Page |
| Your Responsibility Read the manufacturers' labels and MSDS sheets and follow the instructions and warnings. Access pertinent safety information through your supervisor. If you detect any potential hazards either in the facility or in your work procedures, contact your supervisor as soon as possible. | View Page |
| Handling and Storage Data Information concerning the eye, skin, and respiratory protection required while using the chemical. Safety goggles are the minimum eye protection and rubber or nitrile gloves must be worn when handling any chemical. Any special ventilation that might be needed. | View Page |
| 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. | View Page |
| 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 MSDS 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, safety goggles and rubber or nitrile gloves (not necessarily utility gloves) are necessary parts of your personal protective equipment. | View Page |
| Monitoring Certain chemicals in use in the laboratory, such as formaldehyde, are hazardous if your exposure to them is too 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. | View Page |
| 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. | View Page |
| 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 | View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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. | View Page |
| 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. | View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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. | View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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. | View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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.
| View Page |
| 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 | View Page |
| 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.
| View Page |
| 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. | View Page |
| 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 | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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#T2BAccessed June 23, 2010.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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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 | View Page |
| 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. | View Page |
| 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. NCCLS. 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. NCCLS. 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-A3. NCCLS. Wayne, PA: 2004.Ernst DJ. Applied Phlebotomy. Baltimore, MD: Lippincott Williams & Wilkins: 2005.Lowe B. Reinforcing safety sticklers. Advance for Medical Laboratory Professionals. May 2004; 16:2A-3A.The Joint Commission. Patient Safety-2009 National Patient Safety Goals. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. Accessed July 18, 2009. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. For the phlebotomist, gloves are required during every 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. | View Page |
| 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? | View Page |
| Literature and online resources Literature Dutton RP, Shih D, Edelman BB, Hess J, Scalea TM. Safety of uncrossmatched type-O red cells for resuscitation from hemorrhagic shock. J Trauma. 2005 Dec;59(6):1445-9. 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. Urgent requirements for blood (Calgary Laboratory Services, Calgary,Alberta, Canada) Online resource for laboratory's clients Why is there never enough O Rh negative blood? (American Red Cross) Advice for physicians on how to help prevent shortages of O Rh negative blood Transfusion reactions: Transfusion complications (Canadian Blood Services) Education website for CBS's hospital customers REACT (Sunnybrook HSC, Toronto, ON, Canada) Pocket reference card for nurses on signs and symptoms of transfusion reactions Quick 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) | View Page |
| 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). | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |
| 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. | View Page |