| References Burtis, CA. & Ashwood, ER. Tietz Textbook of Clinical Chemistry 2nd ed. W. B. Saunders. 1994.Harmening, DM. Clinical Hematology and Fundamentals of Hemostatis 5th ed., F.A. Davis, 2008Lotspeich-Steininger, Stiene-Martin and Koepke, Clinical Hematology Principles, Procedures, Correlations, Lippincott 1992McKenzie, SB., Textbook of Hematology 2nd ed., Williams and Wilkins 1996.Miale, JB, Laboratory Medicine Hematology 6th ed., Mosby 1982.Nouwens, J and Spahn, M. Hemoglobin H Disease: A self-instructional unit 3rd ed., Educational Materials for Health Professionals, Inc. 1991.Doig, K. Rodak's Diagnostic Hematology 3rd ed. W.B.Sunders Co., 2007. | View Page |
| Review 2 Griego RD. Rosen T. Orengo IF. Wolf JE.:
Dog, cat, and human bites: a review.
Journal of the American Academy of Dermatology. 33:1019-29, 1995It is estimated that half of all Americans will be bitten by an animal or another human being during their lifetimes. The vast majority of the estimated 2 million annual mammalian bite wounds are minor, and the victims never seek medical attention. Nonetheless, bite wounds account for approximately 1% of all emergency department visits and more than $30 million in annual health care costs.Infection is the most common bite-associated complication; the relative risk is determined by the species of the inflicting animal, bite location, host factors, and local wound care. Most infections caused by mammalian bites are polymicrobial, with mixed aerobic and anaerobic species.The clinical presentation and appropriate treatment of infected bite wounds vary according to the causative organisms. Human bite wounds have long had a bad reputation for severe infection and frequent complication. However, recent data demonstrate that human bites occurring anywhere other than the hand present no more of a risk for infection than any other type of mammalian bite.The increased incidence of serious infections and complications associated with human bites to the hand warrants their consideration and management in three different categories: occlusional/simple, clenched fist injuries, and occlusional bites to the hand. This article reviews dogs, cat, and human bite wounds, risk factors for complications, evaluation components, bacteriology, antimicrobial susceptibility patterns, and recommended treatments. Epidemiology, clinical presentation, and treatment of infections caused by Pasteurella multocida, Capnocytophaga canimorsus, Eikenella corrodens, and rhabdovirus (rabies only) receive particular emphasis.
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| What is the HIPAA Security Regulation? The HIPAA Security Regulation:
Defines how to protect electronic health information.
Went into effect April 20,2005 | View Page |
| Case Study: Physical SafeguardsYou are a supervisor of a health clinic. During orientation of a new employee, you instruct him to keep the door leading from a patient area to a computer work area locked at all times. On several occasions, he forgets to make sure the door is locked as he leaves. Which of the following are true regarding this situation? | View Page |
| What is the HIPAA Privacy Regulation: The HIPAA Privacy Regulation went into effect April 14, 2003. It protects the confidentiality of individuals' health data by:Regulating how Protected Health Information (PHI) is used,
whom it is disclosed to, and
how and where it is maintained.
The HIPAA Privacy Regulation:Requires reasonable security measures to protect individuals' health information.
Establishes accountability for use and release of this information.
Gives individuals rights regarding their health information. | View Page |
| What Information is Protected? HIPAA protects ALL information related to an individual's physical or mental health, including demographic and payment information, whether oral, written, or in computer format.
All such information is referred to as Protected Health Information or PHI.
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| Limiting Use and Disclosure of PHI A covered entity may use or disclose PHI, without getting an individual's authorization, in order to:Perform requested tests and treatments.Bill for the services performed.Perform essential operations, including quality assessment, accreditation, and compliance.Meet legal reporting requirements, including those mandated by public health departments, workers' compensation, law enforcement agencies, and the US Department of Health and Human Services.
Other uses and disclosures require written authorization. | View Page |
| De-Identified Health Information Health information is considered de-identified, if it cannot be used to identify an individual. Other terms for de-identified health information are: Anonymous, Aggregated, and Scrubbed.The Privacy Regulation details the specific individual information which needs to be removed from PHI for it to qualify as de-identified.When PHI is de-identified, it is no longer considered protected.De-identified health information should be used whenever individual patient identification is unnecessary. | View Page |
| Case Study: Minimum Necessary Use & Disclosure
You are a phlebotomist at a specimen collection center. A patient arrives with an order for a blood glucose test, and a lipid profile. You get the patient's address, phone number, health insurance coverage, and ask how long ago he ate his most recent meal. You then ask him about his recent auto accident, his wound infection, and his family. You write down all the extra information. Under the HIPAA Privacy Regulations, which of the following information requests is acceptable? | View Page |
| Authorization The privacy regulations give covered entities permission to use and disclose PHI for treatment, payment, and health care operations (TPO), without obtaining specific authorization.A covered entity may disclose PHI to other covered entities such as reference laboratories, and homecare services, which are providing services to the primary covered entity.The service that the other covered entity is providing must fall within treatment, payment or health care operations (TPO).If the service being provided does not fall within TPO, an authorization is generally required.An authorization form must state the specific disclosures of PHI to be made, what the information will be used for, and must be signed and dated by the patient. | View Page |
| Case Study: De-identified Health Information. You work in a laboratory microbiology department which provides a local nursing home with information about the effectiveness of various antibiotics it uses to treat infections. You print the requested information, including complete patient identification, bacterial organisms identified, and their sensitivity to various antibiotics. What information should you provide to the nursing home? | View Page |
| Business Associate Agreement A Business Associate is a separate organization, providing services to a covered entity, which require the exchange of PHI.An agreement must be in place between covered entities and their business associates.This agreement defines the processes that will be implemented to ensure the privacy and security of PHI.Examples of Business Associates may include collection agencies, attorneys, consultants, and accountants, requiring access to PHI.Business Associate agreements are not generally required between two covered entities involved in treatment, payment, or health care operations. | View Page |
| Privacy is Your Responsibility.
As a health care worker, you are required by HIPAA to protect the privacy and security of the personal health information to which you have access. | View Page |
| HIPAA Enforcement The penalties for HIPAA violations are substantial:
Fines could range from $100 to $250,000.
Knowingly and wrongfully receiving or disclosing protected health information could also result in a maximum 10 year prison sentence.
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| Which of the following entities are covered by HIPAA? | View Page |
| Importance of Privacy - An Example You will have many opportunities to avoid disclosing protected health information. Here is one simple example: Your best friend asks you to look up her mother's laboratory results. Knowing the HIPAA privacy regulation and your own departmental policies and procedures, you do not disclose the protected health information which she is requesting. You politely tell your friend that your are not allowed to give her the laboratory results. | View Page |
| What is HIPAA? HIPAA is a federal law passed by Congress in 1996 to help protect the privacy and security of health information.
It is short for Health Insurance Portability and Accountability Act. | View Page |
| Who does HIPAA apply to? HIPAA applies to:
Health Plans (such as health insurance companies)
Healthcare Clearinghouses (such as billing companies), and
Healthcare Providers (including doctors, hospitals, laboratories, and pharmacies).
HIPAA refers to these 3 groups as covered entities. | View Page |
| A person commits a misdemeanor of the first degree by: | View Page |
| Informed Consent Informed consent must be obtained first before a HIV antigen or antibody test can be ordered.Informed consent must be preceded by: Explanation of the test subject's right of confidentiality. Notification that a positive HIV test result will be reported to county health department with enough information to possibly identify the test subject. Availability and location of sites where anonymous testing is performedInformed consent can be given by a legal guardian or other person authorized by law when the test subject is: not competent incapacitated a minor | View Page |
| Reporting results Each laboratory that performs a test indicative of HIV or AIDS shall report to the county health department in less than 2 weeks.To assure the confidentiality of the patient, reporting of HIV infection and AIDS must be conducted using a system developed by CDC or equivalent system.Each person who violates reporting rules may be fined $500 per offense. | View Page |
| Legislative Intent The Florida Legislature finds that the public health will be served by facilitating informed, voluntary, and confidential use of tests designed to detect HIV infection. | View Page |
| References Panlilo AI, Cardo DM, Grohskopf LA, Heneine W, Ross, CS. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis, 2005. MMWR Recomm Rep 2005 Sep 30; 54:RR-9.The 2005 Florida Statutes, Chapters 381, 384,456. Available at www.leg.state.fl.us.MediaLab Course "HIV: Structure and Replication," Garland Pendergraph.MediaLab Course "OSHA Blodborne Pathogens," Terry Jo Gile MT(ASCP),Ma Ed. | View Page |
| Category A Those agents in Category A are highest-priority because they: Can be easily disseminated or transmitted person-to-person Cause high mortality, with potential for major public health impact Might cause public panic and social disruption Require special action for public health preparedness | View Page |
| Category C Agents in the third highest priority, Category C, include emerging pathogens that could be engineered for mass dissemination at some future date because of: Availability Ease of production and dissemination Potential for high morbidity and mortality and major health impact | View Page |
| Biological agents that are the easiest to disseminate, or that pass most easily from person to person are found in Category: | View Page |
| Disadvantages of using Biological Agents They are not immediate. The delayed effect, for example, the long incubation period for some agents, may detract and limit their tactful usefulness as a political statement.They are hazardous to all who come in contact.There is the possibility that the biological agents could also affect the health of the aggressor forces. They are hard to control.The dependence of prevailing winds and other weather conditions such as temperature, sunlight, and desiccation may make it difficult to control distribution of the biological agent. Potential long term effects beyond the initial attack.The persistence of some agents such as spore-forming anthrax in the environment may make an area uninhabitable to aggressor forces for long periods. Results are unpredictable.Morbidity secondary to a biological attack is unpredictable since casualties will be related to the quantity and manner of exposure plus the preventive and treatment measures available. | View Page |
| 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. | View Page |
| The LRN Pyramid The LRN is a multilevel system designed to link frontline clinical microbiology laboratories and hospitals and other institutions to state and local public health laboratories in supporting advanced capacity public health, military, veterinary, agricultural, water and food testing laboratories at the federal level. Laboratories within the LRN are divided into 3 levels: Sentinel Labs, Reference Labs, and National Labs. | View Page |
| Laboratory Response - Chemical Currently there are over 60 territorial and metropolitan public health laboratories that are members of the chemical component of the LRN. A designation of Level 1, 2, or 3 defines their network participation. | View Page |
| Laboratory Response - Chemical, Level 3 Level 3 laboratories are responsible for: Working with hospitals and private laboratories in their jurisdiction Knowing how to properly collect and ship clinical specimens Ensuring that specimens, which can be used as evidence in a criminal investigation, are properly handled and that chain-of-custody procedures are followed Being familiar with chemical agents and how they can affect health and well-being Training on anticipated clinical sample flow and shipping regulations Working to develop a coordinated response plan for their respective state and jurisdiction | View Page |
| 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. | View Page |
| Your Role As a clinical laboratory worker, your role is vital in the health care process. You provide information to doctors, nurses, and healthcare organizations that is vital to proper patient care.
Because your role is so important, you must be properly qualified, trained, and licensed for your position. You must also keep up with the latest laboratory techniques and developments by fulfilling continuing education requirements. And you are bound by a code of ethics, which ensures that patient results are accurate, reliable, and free from error and bias. | View Page |
| Public health laboratory scientists Public health laboratory scientists are also regulated by the Board.
The table below outlines the various requirements for applicants to receive licensure for a public health laboratory.
Public Health Laboratory RequirementsDirectorFulfill the same requirements as a clinical laboratory directorSupervisorBe certified by National Registry in Clinical Chemistry or American Society for MicrobiologyBe licensed as a technologistHave five year's relevant experiencePass the state examTechnician (microbiology)Have a Bachelor's degree in one of the biological sciencesObtain American Society for Microbiology or the National Registry in Microbiology Certification in Public Health Microbiology
Technician (chemistry)Have a Bachelor's degree in one of the chemical, biological, or physical sciencesObtain National Registry of Clinical Chemistry Certification in Public Health ChemistryTechnician (conditional)Have a Bachelor's degree in one of the chemical or biological sciencesPerform tests only under the direct supervision of a licensed pathologist, director, supervisor, or technologist.Receives a conditional two-year license, which may be renewed only once
A license from the Board of Clinical Laboratory Personnel allows you to work in a public health laboratory at the same level and specialty. | View Page |
| CEBroker CEBroker is the Florida Department of Health's online system for tracking continuing education requirements. Companies and colleges that provide continuing education, whether through online programs, lectures, seminars, or other methods, will report your completed credits to CEBroker. All courses you complete through MediaLab that carry Florida credit will be reported to CEBroker and automatically credited to your license. For that reason, make sure you keep your license number up-to-date with MediaLab.
Even though CEBroker tracks your credits, keep copies of all Certificates of Completion that you receive in case of an audit. You are responsible for maintaining proper documentation of your completed courses.
CEBroker's website is www.cebroker.com. | View Page |
| Kickback and Inducement Violations Offering or taking a bribe, kickback, bonus, commission, or inducement is against the rules of the Board and against the law.
Many companies give away small promotional items, such as pens or note pads, to promote their products. This is legal, but be cautious about accepting more valuable items. This could be seen as a bribe.
All of the following are serious violations of Board, state, and federal rules:Participating in any commissions, bonuses, kickbacks, inducements, or split-fee arrangements from physicians, health care providers, suppliers, hospitals, nursing homes, other clinical laboratories, pharmacies, and other facilities.Exploiting or influencing a patient for financial gain, including promoting, selling, or withholding services, drugs, or referrals. | View Page |
| Which statement describes an Adverse Event? | View Page |
| Medical Errors in the United States Most medical interventions produce positive outcomes. Everyone expects to give and receive effective medical care. These expectations are routinely met by the healthcare community.
However, a 2000 publication from the Institute of Medicine, the IOM, To err is human: Building a safer health system, reports that medical errors cause as many as 98,000 deaths every year in the United States. | View Page |
| JCAHO Patient Safety Goals
JCAHO adopted national patient safety goals for laboratories and many other healthcare organizations.
2006 Laboratory Services National Patient Safety
Goals
These goals are directly quoted. | 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 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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| Medical Errors The health community describes medical errors several ways:
Failures of planned actionsMistakes of executionUse of wrong plans to achieve outcomes
Sometimes peoples' plans and actions fail, and this create medical errors.
Sometimes people make mistakes performing their duties, and this creates medical errors.
Sometimes people use wrong plans and actions, and this creates medical errors.
Medical errors are mistakes medical professionals make in patient testing, care, or treatment.
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| Adverse Events Medical errors lead to adverse events--unintended injuries or other negative health consequences. These unfortunate events are caused by medical mismanagement, not underlying patient diseases or conditions.
Adverse events may or may not be preventable.
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| Introduction The government believes that fraud, abuse and waste exist in the healthcare industry today because of cases it has settled and prosecuted.All healthcare providers, including laboratories, make billing errors.The Office of Inspector General (OIG) believes that honest members of the healthcare community can police themselves if they receive guidance.The OIG has published Compliance Program Guidance documents for health care providers, including laboratories. | View Page |
| Element 5 Element 5:
Every employee must understand that the standards, policies and procedures associated with the compliance program must be adhered to at all times.
Employee will be disciplined up to terminations for violations.
Employee can be disciplined or terminated for failing to report a problem or suspect activity.
All employees are screened prior to being hired for previous actions against them by any law enforcement or government agency regarding any health care prosecution or exclusion from the Medicare or Medicaid program.
Adherence to the compliance program's policies and procedures will be a component of every employees annual evaluation and performance review.
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| Laws and regulations that govern laboratories Social Security Act:
Medicare and Medicaid laws are in this act.
Medicare rules and regulations come under this act.
Antikickback laws:
Provide criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs.
False Claims Act:
Provides criminal penalties for knowingly or willingly filing a false claim to a government program.
Self Referral (Stark) laws and regulations:
Identify financial relationships that have the potential to result in directed referral to one or both of the individuals or entities involved.
Prohibit the referral of patients or tests between related entities unless certain conditions are met.
Health Insurance Portability and Accountability Act (HIPAA)
Prohibits health care providers and payers from improper or inappropriate use of a patient's confidential health information
Requires health care providers to insure that a patient's confidential information is kept secure
Provides for standardized electronic formats for all health care transactions
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| HCPCS and CPT coding The HCFA (Health Care Financing Administration) Common Procedural Coding System (HCPCS) and the CPT (Current Procedural Terminology) codes are used to describe specific tests or services.
The amount of payment for a test is dependent on the HCPCS or CPT code.
HCPCS or CPT codes should be assigned under the supervision of the laboratory technical staff.
Billing department employees should never change a HCPCS or CPT code without the approval of a manager or compliance officer.
If a billing department clerk notices that a particular HCPCS or CPT code is being rejected by a payer they should report it to their manager.
It is against the law to use the wrong HCPCS or CPT code for the purpose of causing or increasing payment for a test.
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| Communication with physicians and patients It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients.
Never guess at the answer to a question; ask if you are unsure.
Do not speculate or express personal opinions.
When requesting diagnosis information from the physician office staff be careful to not lead them to give a billable code:
The code must come from the patient's medical record.
There is an incentive program for patients to find and report fraud and abuse by health care providers, including laboratories, so:
Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings.
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| Client contracts A laboratory that receives referrals from a nursing home or Skilled Nursing Facility (SNF) should have a written agreement with that facility:
The Agreement should define billing and documentation responsibilities.
The facility should be responsible for determining the payment status of its patients and is liable for submitting incorrect payment information to the laboratory.
Fees should be consistent with other similar customers.
A laboratory that provides services to a Home Health Agency treating Medicare/Medicaid beneficiaries should have a written agreement with that agency:
The Agreement should define billing and documentation responsibilities.
The Agreement should place the responsibility on the Home Health Agency to establish that all patients receiving laboratory services are "homebound" as defined by Medicare.
Fees should be consistent with other similar customers.
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| What is a phlebotomist’s role in a health care facility? The phlebotomist collects blood & other specimens which ultimately provide doctors and nurses with laboratory test information critical to patient care.He or she therefore plays a vital role in any health care system.
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| What is a phlebotomist’s role in health care facility? [continued] Phlebotomists work in a variety of settings including:
Hospitals
Physician Offices
Nursing Homes
Home Health Care
Clinics, and
Military facilities.
A well trained phlebotomist will therefore have a variety of job opportunities available.Other medical professionals, including nurses, respiratory therapists, and medical assistants may also be trained to collect blood specimens.
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| What is a phlebotomist? A phlebotomist is a medical professional who:Collects blood and other specimens.Prepares specimens for testing.
Interacts with patients & health care professionals.
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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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