REGULATIONS THAT c2-AFFECT LABORATORY PERSONNEL.docx

CHAPTER 2 ========= Safety and Compliance ===================== OVERVIEW -------- Patient safety is one of the most important concerns in every health care facility. Equally important is the safety of the employees who work with these patients. Several regulatory bodies promote the health and wel...

CHAPTER 2 ========= Safety and Compliance ===================== OVERVIEW -------- Patient safety is one of the most important concerns in every health care facility. Equally important is the safety of the employees who work with these patients. Several regulatory bodies promote the health and welfare of patients and workers alike. Among these are the Occupational and Safety Health Administration (OSHA), The Joint Commission, College of American Pathologists, Clinical Laboratory and Standards Institute (CLSI), and Centers for Disease Control and Prevention (CDC). These agencies develop protocols and regulations to help ensure that every patient receives high-quality care and accurate test results. They also work to establish guidelines that encourage health professionals to use safety measures to detect problem areas and find solutions that create positive changes in health care. Among these regulations are the Bloodborne Pathogens Standard, Clinical Laboratory Improvement Amendments (CLIA), Needlestick Safety and Prevention Act, and Good Laboratory Practice. To ensure that schools teach and adhere to current standards, the National Accrediting Agency for Clinical Laboratory Science offers program accreditation and approval, consultation, and continuing education in clinical laboratory sciences. Infections and accidents are harmful to both patients and phlebotomists. That\'s why it\'s important to be trained in first aid and cardiopulmonary resuscitation (CPR), as well as infection control methods to reduce the spread of disease. In addition to ensuring physical safety, phlebotomists must keep patients\' personal information safe and confidential. One regulation that helps promote confidentiality patient information is the Health Insurance Portability and Accountability Act (HIPAA). It is important for patients and health care professionals to be aware of regulations and adhere to established standards. Objectives ---------- Upon completion of this chapter, you should be able to: - Explain regulations regarding workplace safety. - Describe regulations regarding operational standards. - Adhere to HIPAA regulations regarding protected health information (PHI). - Describe the scope of practice and comply with ethical standards applicable to the practice of phlebotomy. - Describe quality control measures for laboratory equipment and CUA-waived tests. - Identify and dispose of sharps and biohazards according to the Bloodborne Pathogens Standard. - Follow exposure control plans in the event of occupational exposure. - List the details of transmission-based precautions. - Follow standard precautions regarding personal protective equipment (PPE). - Explain aseptic and infection control techniques throughout the phlebotomy process. - Initiate first aid and CPR when necessary. - Comply with documentation and reporting requirements. REGULATIONS THAT AFFECT LABORATORY PERSONNEL ============================================ Workplace safety ---------------- OSHA has established regulations and guidelines to direct phlebotomists to work at the highest level of safety possible. OSHA strictly regulates workplace safety-including exposure to biologic hazards and hazardous chemicals-and requires that employers and employees adhere to these regulations. The Bloodborne Pathogens Standard protects phlebotomists and other health care professionals from exposure to body fluids. The Bloodborne Pathogens Standard requires implementation of work practices and engineering controls to prevent exposure incidents. It provides guidelines for training for all employees who handle body fluids. The standard addresses use of personal protective equipment (PPE) and availability of the hepatitis B immunization for all at-risk employees. The standard also has definitions relating to engineering controls, record-keeping requirements, an exposure control plan, and provisions for employees to provide input about work practice and engineering controls. To adhere to the Bloodborne Pathogens Standard, each workplace must have an exposure control plan that determines the risk level of each employee, depending on their potential exposure to biologic hazards. Next is the implementation of guidelines to ensure employees\' safety according to their level of exposure. Finally, the standard provides plans for actions to take after accidental exposure to potentially infectious agents. All employees in health care facilities must use standard precautions, which include treating all body fluids as potentially infectious. Hand hygiene is one of the most effective ways to keep phlebotomists and patients safe from contamination. Perform handwashing before and after direct contact with every patient. Employees who handle body fluids directly must use PPE (gloves, masks, gowns, goggles, face shields, shoe covers). The type of PPE needed depends on the potential for exposure to body fluids, and OSHA mandates it accordingly. For venipuncture and capillary puncture, wear well-fitting nitrile or vinyl gloves. Replace gloves if they tear, as well as before and after each contact with patients. If there is a splash risk, goggles and a face mask or full-face shield are essential. When a patient is in isolation, use additional safety measures (mask, gown, shoe covers). When encountering patients who have tuberculosis or other airborne transmittable infections, be sure to wear an N95 or N99 respirator to reduce the risk of transmission of the pathogen. Another way that OSHA helps ensure safety is its mandate of engineering controls for handling used needles, lancets, and other sharps. Never recap, reuse, or bend used needles, even for the same patient. Dispose of used needles, lancets, and other sharps into a designated, OSHA-approved, puncture-proof, leakproof sharps container as soon as possible. Sharps containers are usually red, and should have a clearly visible biohazard symbol on the outside of the container. Keep sharps containers upright, do not fill them past the designated line on the container (typically no more than ¾ full), and properly lock them when they are ¾ full. Never reach into or empty a sharps container. OSHA requires documenting all accidental exposures to body fluids and following the required procedures. The first priority following an exposure is to administer first aid. Following first aid treatment, you must undergo a medical examination. Both you and the patient must sign consent forms to give permission for blood tests to determine exposure to HIV, hepatitis B (HBV), and hepatitis C (HCV). The patient will need testing for HIV, HBV, and HCV, unless there is documentation of infection with one or more of these pathogens. However, the patient has the right to refuse testing. You need to document accidental needlestick injuries in the sharps injury log. This log includes the date and time of the incident, type of sharps used, who was involved (patient or staff, without names), location, and a detailed description of how the incident occurred. Laboratory staff must make every effort to keep the incident and log confidential. As a part of the U.S. Department of Labor, OSHA also maintains regulatory standards for minimizing occupational exposure to hazardous chemicals in laboratories. These standards require chemical manufacturers to supply Safety Data Sheets (SDSs) for their chemicals. Each SDS bears a hazard warning label and lists information about each chemical, including protective measures to take when working with the chemical. It also includes the chemical\'s name, trade names, and synonyms; the manufacturer\'s name, address, and emergency telephone numbers; information about handling and storage; and actions to take in case of accidental exposure. Operational standards ===================== The Joint Commission -------------------- The Joint Commission accredits and certifies thousands of health care organizations in the U.S. As an independent, nongovernmental, nonprofit organization, its operational standards focus on continual improvement of patient safety and quality of care. The Joint Commission updates the standards regularly to reflect the rapid advances in health care and medicine. There are more than 250 hospital accreditation standards, which address areas such as patients\' rights and education and operational improvement. The National Patient Safety Goals (NPSGs) program increases patient safety by setting requirements for issues including accurate identification, communication of test results, and necessary training of health care professionals. The NPSGs require validating patient identification using a two-factor method. For example, confirm identification by matching the wristband to the medical record, and asking patients for their telephone number, home address, or date of birth. Always ask patients to state their name, then compare that with the name on the wristband or laboratory requisition form. Refer to the study guide addendum on the NHA website for details on CLSI guidelines for patient identification specific to specimen collection. To ensure test results are reported as quickly as possible, NPSGs emphasize the need for active communication between the health care professional performing the test and the provider ordering it. Ongoing personnel training in safety and infection control through proper hand hygiene and use of disinfectants adds an additional layer of safety. Clinical and Laboratory Standards Institute ------------------------------------------- The CLSI is committed to providing high-quality care for patients by developing standards and guidelines to help laboratories achieve accreditation. To help organizations achieve the standards, the CLSI works in coordination with industry and health care professionals to ensure they have the most up-to-date information and use the safest methods of performing blood tests. Along with accreditation for laboratories, the CLSI provides guidelines to help phlebotomists provide better patient care and achieve greater accuracy in blood testing. These guidelines cover venipuncture, dermal puncture, and phlebotomists\' safety. For venipuncture, the standards detail the use of equipment such as tubes and needles. Standards include the proper level of additives in vacuum tubes and their use for the appropriate blood test to provide the most accurate results. The CLSI also established the proper order of draw for venipuncture. All phlebotomists filling multiple tubes of blood must adhere to these standards. The CLSI order of draw includes filling yellow-top tubes (Sodium Polyanethol Sulfonate \[SPS\]) or blood culture bottles first, then light blue-top (sodium citrate) coagulation tubes, serum tubes with or without clot activator and with or without gel (red-speckled top), green-top (heparin) tubes with or without gel plasma separator, purple- or lavender-top (EDTA) tubes, and finally grey-top (sodium fluoride or potassium oxalate) tubes. There might be some variation in these tubes from different manufacturers. The CLSI further details standards for venipuncture including the proper collection (e.g., angle of insertion) and the processing and handling of venous blood. For capillary procedures, guidelines include the correct locations and depth for blood collection for both infants and adults and the order of draw for microcollection tubes. The CLSI mandates the use of disposable equipment for all capillary collections (e.g., single-use lancets). It is uncommon to use microcollection tubes for blood-gas determination. But if a provider orders it, collect blood for this test first, and then follow the usual order of draw. For phlebotomists\' safety, the CLSI sets guidelines that help prevent the transmission of disease from patients to phlebotomists by all potential routes of exposure (vapor, blood, splashes, contact with potentially contaminated laboratory equipment). The CLSI also provides guidelines that address quality control, patient care, risk reduction, and implementation of time-saving methods and cost-cutting measures. Centers for Disease Control and Prevention ------------------------------------------ The CDC is a government agency that helps identify and educate about infections, illnesses, and disease prevention. The CDC attempts to identify new diseases and work quickly to find ways to prevent their spread. It recommends standard precautions with any procedure that could result in an exposure to body fluids. The CDC provides guidelines for PPE, sharps handling, and hand hygiene. Below are a few actions the CDC recommends to improve safety and reduce the transmission of disease. - Always wear gloves when handling any bodily fluid. - Activate the needle\'s safety mechanism immediately after use. - Dispose of sharps immediately into an approved container. - Wash hands with soap and water both before and after patient care. If handwashing facilities are not readily available, use an alcohol-based disinfectant (unless hands are visibly soiled). The CDC advises phlebotomists to pay close attention to patients and procedures, especially when handling sharps. Be even more vigilant at high-risk times, such as during needle insertion and removal. Using butterfly needles or the needle and syringe method of blood collection increases the risk for accidental needlestick injuries. Needlesticks most often occur when disposing of a needle, attempting to recap a needle, or removing a needle from the adapter after use. If an accidental needlestick injury occurs, the CDC advises washing the area first with soap and water. Then notify the immediate supervisor. You will need to undergo an immediate medical examination to assess and treat the wound, determine the risk of exposure, and take appropriate measures. HIPAA regulations ----------------- It is of the upmost importance to understand and acknowledge every patient\'s right to protection of personal information. A patient\'s protected health information (PHI) is any and all information that relates to the patient\'s care in the medical record or electronic health record. HIPAA details what patient information is confidential as well as any authorized release of this information. Areas HIPAA\'s rules protect include patient demographic information and information relating to treatment, medications, and diagnostic testing. Information without any way to identify the patient it came from does not require the same protection, and researchers and those who gather public health statistics may use it. Protect all health information, whether electronic, written, or verbal. Keep this information private and protect it from other health care staff. The exception is those who have a direct need for the information and legitimate involvement in the patient\'s care (requesting provider, medical specialists, nurses, billing, accounting, health care insurance employees). The patient must sign a release before health care workers may share information with any other requestor. For example, a medical facility may release test results from a patient\'s emergency department visit with the provider the patient will see for follow-up care for the same health problem. Patients may also sign a consent form allowing a specific family member to receive their health care information. Never assume that the family member in the room with the patient should have access to the patient\'s PHI. To determine who has access, ask patients to identify who may receive their health care information, and then make sure that there is a consent form on file. Avoid discussing patients\' information with colleagues in public places or with those who have no direct involvement in the patient\'s care or treatment. It can be easy to get into the habit of discussing patients by their diagnosis or by using other personally identifying information (name, bed number, PHI) with other professionals treating the same patient. This can become an issue if the discussion takes place in an area where others can overhear the information. When discussing patient information on the phone, identify the person calling and their need for the information. Speak at a low volume to help prevent anyone else from hearing confidential information. Scope of practice and ethical standards --------------------------------------- You are responsible for the well-being of the patient before, during, and immediately after venipuncture. In addition to performing within your scope of practice, you must practice cultural competence to interact appropriately and effectively with all patients, treating everyone with respect and dignity. Before a venipuncture, correct identification is essential. Using a two- or three-point method of identification confirms that the correct patient is receiving care. If the patient is in a hospital, it is important that an identification band is in place. Although typically on the wrist, some patients might have the identification (ID) band on their ankle. If the patient does not have an identification band, do not perform the procedure until the patient has one in place. Do not use an identification band on a bed, a tray, or any location other than the patient\'s body. When working in an outpatient setting, identification that includes a photo is usually required. Examples include a driver\'s license, military identification, state ID, or employee ID badge. After identification, the patient must provide consent for procedures you will perform. For most venipunctures, the patient will provide implied consent, often by extending an arm or rolling up a sleeve. In addition, the patient might provide verbal consent. Understand that patients have the right to refuse any procedure, even right before it begins or after they have given consent. If a patient conveys a mixed message, such as extending an arm but then stating ((I do not want you to take my blood,\" ask the patient whether to continue with the procedure prior to taking any additional steps. Proceed only if the patient again gives consent and is willing to have the venipuncture. Threatening to move forward with the procedure without consent can be considered assault. Ethical treatment of patients continues even after verifying identification and consent. If a patient asks if the procedure is going to be painful, don\'t lie and say that it won\'t hurt. Pain is subjective, and the level of pain perceived varies from patient to patient. It is more ethical to tell the patient that the procedure might cause some pain, but that you will make every effort to minimize the discomfort. This will assist in gaining the patient\'s trust. If the patient has never had a venipuncture before, explain the procedure in terms they will easily understand. When palpating for a vein, do not slap the patient\'s hand or antecubital area. This activity-once a routine phlebotomy action-could constitute battery. After applying a tourniquet and not seeing a \"good\" vein, use other techniques for locating a vein (warming the area, wiping it with an alcohol wipe, lowering the limb below the level of the patient\'s heart). Careful site location for venipuncture adds another component of safety. Avoid the inside of the wrist due to potential ulnar nerve damage or inadvertent arterial access. Likewise, avoid the legs and feet of a patient who has diabetes mellitus to help prevent possible infection. The basilic vein is a last choice if all other veins are inaccessible, because it is close to the brachial artery. If you miss on the first venipuncture attempt, make only one additional attempt. After missing a vein, make the second attempt using a new sterile needle, even if the second area is very close to the first location. Although there is no rule about the number of attempts a phlebotomist should make to collect blood, the more important issue is knowing when to stop and seek assistance. As a general guideline, phlebotomists tend to consider two attempts the limit. This might vary with individual circumstances and the phlebotomist\'s confidence in obtaining the specimen with additional attempts. Regardless, the patient always has the right to refuse to have the phlebotomist perform a subsequent attempt at blood collection. Throughout the venipuncture procedure, it is important to observe patients and respond to their needs. If a hematoma develops, stop the venipuncture. If the patient shows any difficulties, including early signs of a seizure or loss of consciousness, stop the procedure. If a patient has any unexpected issues during the procedure, do not leave them alone until the situation completely resolves. In an outpatient facility, advise patients to stay until full recovery is reasonably apparent.