| 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 |
| References Burtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry 2nd ed. WB Saunders; 1994.Doig, K. Rodak's Diagnostic Hematology. 3rd ed. WB Saunders Co; 2007.Harmening DM. Clinical Hematology and Fundamentals of Hemostatis. 5th ed. FA Davis; 2008Hoffman R, Benz EJ Jr., Shattil SJ, Furie B, Cohen HJ, Silberstein LE. Hematology Basic Principles and Practice, 2nd ed. Churchill Livingstone; 1995.McKenzie SB. Textbook of Hematology, 2nd ed. Williams and Wilkins; 1996.Miale JB, Laboratory Medicine Hematology, 6th ed. Mosby; 1982.Stiene-Martin EA, Lotspeich-Steininger CA, Koepke JA, Clinical Hematology Principles, Procedures, Correlations, 2nd ed. Lippincott; 1998. | View Page |
| Specimen Handling and Storage The stability of the CSF sample varies depending on the procedures ordered.
Cell counts are ALWAYS STAT and should be performed within 30 - 60 minutes for best results.
Samples should be left at room temperature for no longer than one hour and refrigerated following testing.
Refrigeration is not recommended for culture specimens since fastidious organisms such as Haemophilus influenzae and Neisseria meningitidis may not survive the cold temperature.
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| Turbidity Spinal fluid samples are either clear or turbid. Some sources use the following rating system for turbid CSF specimens: 0 = crystal clear fluid 1+ = faintly cloudy, smoky, or hazy 2+ = turbidity clearly visible but newsprint read easily through tube 3+ = newsprint not easily read through tube 4+ = newsprint cannot be seen through the tubeTurbidity may be caused by leukocytes, erythrocytes, fungi, bacteria, amoebae, contrast media, or aspiration of epidural fat during puncture.200 leukocytes/mm3 will cause slight turbidity (1+); increased numbers of WBCs will cause increased turbidity. At least 400 erythrocytes/mm3 are needed to produce 1+ turbidity.Occasionally CSF will have an oily appearance due to the presence of substances remaining in the CSF after radiologic (x-ray) procedures have been performed. | View Page |
| Increased numbers of the cells shown at the right are indicative of what condition? | View Page |
| Manual Urine Reagent Strip Procedure Use a fresh, well-mixed uncentrifuged urine. Hold the reagent strip by the opposite end from the test areas and dip the stick into the specimen so that all test areas are immersed in the specimen. Remove the stick immediately. Prolonged immersion in the sample may wash out the test reagents. Hold strip in a horizontal position and run the edge of the strip against the rim of the urine container or touch the long edge of the strip to absorbent toweling to remove excess urine (do not blot the strip). Maintain the strip in a horizontal position to prevent mixing of reagent chemicals. Observe the reagent pads at the specified time periods. Color changes that occur after the stated maximum read time are not valid. Hold the strip close to the chart and compare the colors to read the results. A good light source facilitates accurate reading. Quality control procedures should be performed with each new lot of reagent strips and as often as required by the laboratory's procedure | View Page |
| Quality control procedures should be performed with each new lot of reagent strips, and as often as required by the laboratory's procedure. | View Page |
| Confirmatory Testing for Protein Semiquantitative tests are used in some laboratories to confirm the presence of protein in the specimen when the result is positive on the urine dipstick. Tests that are used for confirmation include: sulfosalicylic acid (SSA); heat and acetic acid; nitric acid ring test; and Roberts' Ring Test. Any one of these procedures may be used for confirmation of the presence of protein. A protein dipstick result that is greater than a trace may be an indication of proteinuria. | View Page |
| False Positive Results A false positive result for blood on the reagent strip can occur when oxidizing contaminants, such as hypochlorite (bleach), remain in collection bottles after cleaning. Contamination of the urine with provodine-iodine, a strong oxidizing agent, used in surgical procedures can result in a false positive reaction. Microbial peroxide found in association with urinary tract infections may also cause false-positive results. Capoten® (Captopril) can cause decreased reactivity. The muscle tissue form of hemoglobin, myoglobin is a well-known cause of false-positive reactions on the blood portion of the reagent strip. When tissue hemoglobin is present, the urine specimen has a clear red appearance. Patients suffering from muscle-wasting disorders or muscular destruction due to trauma, prolonged coma, or convulsions or individuals engaging in extensive exertion may have myoglobin in their urine. Specific tests for myoglobin, such as immunodiffusion techniques or protein electrophoresis, are needed to confirm the presence of this substance in a urine specimen. Levels of ascorbic acid normally found in urine do not interfere with this test. | View Page |
| The Ictotest® False positive results can occur in screening procedures for bilirubin due to color interference from large amounts of blood in the urine, very concentrated urine or drugs that discolor the urine such as Pyridium. Because of this it is important to verify positive bilirubin results with a confirmatory test such as the Ictotest®. | View Page |
| Limitations of the Procedure The product profile for Ictotest® points out that bilirubin is very light sensitive, so urine specimens should be protected from excessive light exposure and examined as quickly as possible when received in the laboratory. On standing, bilirubin, which has a goldish color, is oxidized to biliverdin, which is a green color. Many of the procedures used to detect bilirubin will not react with biliverdin, so false-negative results may occur if urine is not fresh when tested. | View Page |
| Reasons for Performing Confirmatory or Secondary Macroscopic Urine Tests Urine reagent strips are normally adequate for urine screening, but occasionally, it may be necessary to perform a secondary procedure to ensure the accuracy of the test result. Confirmatory or secondary procedures are usually performed for one or more of these reasons: To confirm a result that has been obtained on the reagent strip. To obtain a result from a highly pigmented urine that masks the result on the reagent strip. To test for a specific analyte (or analytes) that are not included in the specificity of the reagent strip test. For example, the glucose reagent strip test is specific for glucose, but you want to test for other reducing substances. | View Page |
| Detection of Ketone Bodies “Ketone bodies” is a generic term which refers to acetoacetic acid (diacetic acid), acetone, and beta-hydroxybutyric acid. Screening procedures used to detect ketonuria do not react with all ketone bodies. Since all three of the ketone bodies will be present in the urine and are equally significant, it is sufficient to detect an increase in any one or two of the ketone bodies. Most procedures, including Acetest®, measures acetoacetic acid and acetone but not beta-hydroxybutyric acid. | View Page |
| Overview Specimen collection and handling in molecular based methodologies will differ based on the target of interest and the specific testing protocol. Each individual procedure will require specific specimen collection and handling procedures. It is imperative that the collection and handling instructions are followed to decrease the possibility of introducing interfering substances. | View Page |
| Pre-analytical Variables Pre-analytical variables are those that affect the specimen before the actual testing begins. Some of the pre-analytical variables to consider with molecular testing include those that are applicable to all clinical specimens but should be emphasized when discussing molecular methodologies; some of these include but are not limited to: Receipt of valid order Proper patient identification Proper venipuncture procedure for blood collection Use of correct anticoagulant Collection of correct specimen type (i.e.- plasma, serum, whole blood) Order of draw Proper storage Proper transport Procedures if there is a delay in testing and/or transport | View Page |
| Specimen Collection and Handling Some global specimen collection and handling issues to consider include: Specimens that contain nucleated cells will be of interest in DNA methodologies while specimens lacking nucleated cells are more useful in RNA methodologies. rRNA is more stable than mRNA, which is labile and sensitive to contamination. DNA is relatively stable and can be obtained from nonviable sources. Serum or plasma obtained by standard routine venipuncture procedures can be used as long as proper site selection and decontamination occur. Standard anticoagulants such as Ethylenediaminetetraacetic Acid (EDTA) and Acid Citrate Dextrose (ACD) can be used; however avoid the use of heparin as an anticoagulant as it interferes with some polymerase chain reaction (PCR) methodologies. When using fluorescence, fasting serum or whole blood specimens should be used to decrease the interference by lipids. | View Page |
| Resources It is imperative to follow the individual package insert procedures when collecting and handling specimens. Reference labs provide specimen requirements as well as collection, handling and transport guidelines.The Clinical and Laboratory Standards Institute (CLSI) formerly known as NCCLS: National Committee for Clinical Laboratory Standards has published procedures for collection including those specific to molecular diagnostics. | View Page |
| Transport Many clinical laboratories utilize reference laboratories for molecular methodology testing. Transport and shipping of biological specimens must follow laws and regulations governing these types of specimens. Consult your laboratory’s accrediting agency and reference lab for specific polices and procedures. | View Page |
| Administrative Safeguards Administrative Safeguards include the policies, and procedures that your facility uses to manage and protect ePHI. Although there are probably many such policies and procedures at your institution, a few examples might include:
Active review and audits of IS activity.
Employee confidentiality agreements.
Employee security clearance policies and procedures.
Employee disciplinary policies.
Data backup and disaster recovery plans
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| Technical Safeguards: System Access Control Technical Safeguards refers to technical policies and procedures that control access and use of computer systems.
Computer system access must be regulated:Level of access to computer system must be controlled.Only minimum and necessary access is granted based on job responsibility.System may log users off if there is no activity after a certain period of time.Users may be required to log off when leaving workstations. | View Page |
| email Security Standard Internet email provides no security for PHI. Many facilities would choose not to allow transmission of PHI via email at all.
Some facilities may allow transmission of PHI via secure encrypted email, or as password protected email attachments.
You must of course comply with your facilities' policies and procedures regarding any use or disclosure of email for PHI. | View Page |
| Physical Safeguards: Storage and Disposal of Media Additional physical safeguards must be in place with regard to storage and disposal of electronic storage media such hard drives, tapes, and CDs. You must of course follow your own facilities' specific policies and procedures regarding electronic media.
Examples may include:
Storing ePHI on network hard drives only.
Storing portable media such as CDs and tapes in a locked cabinet or room.Properly disposing of electronic media, by wiping or shredding data on hard drives, or physically destroying portable media such as tapes and CDs. | View Page |
| Technical Safeguards: Passwords Access to computer systems must be password protected. Please read and understand the password recommendations below, but remember, you must follow your own facility's specific password policies and procedures.
Keep passwords secret; do not share them with others.Memorize passwords to avoid having to write them down.Create strong passwords which:Are at least 7 characters long.Are not dictionary words or easily recognizable proper nouns.Include upper and lower case letters, numbers, and special characters.Change passwords regularly. Never select "remember my password" if prompted by Windows to do so. | 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 |
| Case Study: Technical Safeguards You are given several sets of logins and passwords to access various information systems. The login is your own first initial and last name, but you have difficulty remembering the passwords, so you write them down on a sticky pad which you keep on your desk.This is not a good idea, because: | View Page |
| Case Study: Limiting Use & Disclosure of PHI
A nurse from the Winterhaven Outpatient Facility calls requesting an HIV test result on a patient, concealing the fact that she had received a needle stick injury from that same patient. You provide the nurse with the HIV test result. The nurse's request was appropriate. | View Page |
| Case Study: Limiting Use & Disclosure of PHI
You are the customer service representative in a clinical laboratory. You get a call from someone at a local gastroenterologist's office, with whom you are personally familiar, requesting that you fax results on a patient, which the referring physician's office had failed to provide. The doctor needs the test results immediately. Under the HIPAA Privacy Regulations the you can comply with this request, without getting written authorization from the patient. | View Page |
| Case Study: Accessing PHI: You are answering the office phone today. A person claiming to be a patient, whose voice you do not recognize, calls demanding all his test results for the past 6 months. He threatens to complain to the government if you won't immediately read him the results over the phone.
Under the HIPAA Privacy Regulations, you must immediately give the patient the requested information over the phone, regardless of your office policy as it pertains to release of patient results. | View Page |
| Fax Machines Fax Machines may be used to transmit PHI, provided that you are in compliance with your own institution's policies and procedures. To minimize the risk of misdirected faxes: Preprogram fax machines with frequently used destination numbers. Double check accuracy when faxing to numbers which are not preprogrammed. Always include a Confidentiality Statement on the cover page. Check transmittal confirmation after each fax, to ensure that the information was sent to the correct number. Do not leave the original report on the fax machine. Report fax errors to your supervisor or other designated person. | View Page |
| Follow your own Facilities' Policies and Procedures. This course has covered basic aspects of HIPAA Privacy and Security Regulations that you need to know.
Your facility has its own detailed policies and procedures to enforce these regulations in your workplace, and it is your responsibility to follow these policies and procedures. | View Page |
| Relevant Components of HIPAA The remainder of this course will cover what you need to know about the: HIPAA Privacy Regulation, and HIPAA Security Regulation.You will, of course, also need to understand and follow your own institution's privacy and security policies and procedures. | 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 Quality Control? Quality control procedures are performed in a clinical laboratory to ensure that patients' results are reliable. Reliability refers both to accuracy (how close a test is, on average, to patients' true results) and precision (the consistency of tests performed at different times). | View Page |
| Quality Control Procedures Quality control procedures may include the following: monitoring variables within the laboratory, like water quality, glassware calibration, and instrument calibration, that may affect results defining protocols for performing quality control for each test procedure participating in proficiency testing programs graphing quality control results performing daily and periodic analysis of quality control data and charts troubleshooting quality control errors documenting quality control errors, including the steps taken to resolve the problem and verification of success performing routine maintenance of laboratory instruments keeping records | View Page |
| Use of Controls An internal quality control program must monitor results both in the normal range and in the abnormal range. For each test, there is one control in the normal range and one or two abnormal controls. Abnormal controls may be in the unhealthy but physiologically possible range, or outside what is physiologically possible, or both. Testing in many ranges ensures that the procedures are accurate for a wide range of patient results. Controls are run at least as often as specified by the instrument manufacturer. Controls should also be run whenever there is concern about the quality of results or stability of the testing system, or if the results of previous controls were not acceptable.If a problem is discovered, the samples in previous runs of the instrument may also have been affected. Once the problem(s) are corrected, it may be necessary to go back and re-run previous samples working in reverse order, until the retested results match the original results. | View Page |
| Additional Variables To ensure reliability of results, many other factors besides controls are monitored. These include: water quality analytic balance calibration glassware calibration centrifuge calibration thermometer calibration electric power stability heating bath temperatures refrigerator temperatures freezer temperatures expiration of reagents, standards, and controls instrument maintenance procedure manuals, including written step-by-step procedures of all tests performed by laboratory method selection, based on local population and clinician needs normal range verification based on the local population technical competencies of laboratory staff members | View Page |
| Record Keeping A record keeping system is a vital component of an internal quality control program. Record keeping systems include: instrument maintenance logs calibration logs temperature logs water quality logs quality control results quality control chartsEach log includes: date time name of employee performing check or maintenance results description of maintenance performed problem description problem solving and verification stepsThe record keeping system can be used to: monitor compliance with quality control procedures train employees in problem detection and problem solving help prevent instrument breakdowns evaluate service personnel performance identify topics for continuing education programs help ensure reliable patient results | View Page |
| Types of licenses Clinical laboratory personnel licenses are divided into four types: director, supervisor, technologist, and technician. Each type has different roles, responsibilities, qualifications, and continuing education requirements. When you apply for a license, you must apply for one of these four types. All licensed clinical laboratory personnel are permitted to collect, process, store, and ship specimens and perform manual pretesting procedures. Clinical laboratory personnel qualified as director (either physician director or licensed director), supervisor, technologist, or technician can perform testing within the specialty(ies) for which they are licensed. Each license is valid for one or more specialties. Directors, supervisors, and technologists are permitted to interpret and report test results. | View Page |
| Description of Specialties (1) Specialists in microbiology perform testing to diagnose and stop the spread of infectious organisms, including bacteria, viruses, and parasites. Specialists should be able to isolate and identify a wide variety of these organisms. Testing procedures include direction examination and antigen detection methods.
Specialists in serology and immunology measure antibodies to infectious organisms. Specialists should be familiar with all serology techniques (except those specific to immunohematology). This specialty includes all lab procedures performed in the specialty of histocompatibility.
Specialists in hematology must be able to identify and evaluate cells in blood and bone marrow and identify disorders of these cell. Specialists should be familiar with routine and special tests to determine the number, morphology, and function of cells in body fluid. | View Page |
| Description of Specialties (2) Specialists in immunohematology perform all testing prior to blood transfusions and work to prevent transfusion infections. They also investigate any post-transfusion reactions. This specialty includes all lab procedures performed in the specialty of histocompatibility. Specialists in clinical chemistry analyze body fluids such as blood, urine, and spinal fluid to determine the chemical makeup, including the amount of carbohydrates, proteins, enzymes, and trace elements. The special covers urine microscopics and chemical evaluation of the liver, kidneys, lungs, heart, and other vital organ systems. This specialty also covers all testing performed in the specialties of radioassay and blood gas analysis. Specialists in blood banking can perform all immunohematology testing as well as testing from the specialties of clinical chemistry, hematology and serology/immunology that relates to donor blood. Clinical laboratory personnel who are licensed in the specialties of immunohematology, clinical chemistry, hematology, and serology / immunology may perform all tests in the blood banking specialty. | View Page |
| Director Responsibilities A clinical laboratory director is responsible for the overall operation and administration of the clinical laboratory. The director can delegate responsibilities to licensed supervisors, but is ultimately responsible for the following: Ensuring the employment of personnel who have the necessary education and experience and who are competent to perform the procedures and tasks that are assigned to them. Overseeing performance and reporting of accurate test results Verifying the laboratory's compliance with federal and state laws, rules, and regulations Delegating certain administrative duties to supervisors Being available for on-site, telephone, or e-mail consultation Ensuring that test methods and procedures, quality control, and verification methods provide reliable and accurate results Ensuring compliance with quality control and quality assurance programs Ensuring enrollment and active participation of the laboratory in a proficiency testing program, monitoring proficiency testing results, and implementing corrective action when necessary Assessing laboratory staffing needs and advising management when insufficient clinical laboratory personnel are employed Selecting which tests the laboratory offers and which employees may perform them Establishing and maintaining a patient identification system for the laboratory Establishing and maintaining accurate billing practices | View Page |
| Disciplinary Violations Licensed clinical laboratory personnel are required to follow all laws and rules of the Board, orders of the Board relating to disciplinary action, and must be truthful and helpful in the event of an investigation.
The following are violations of Board rules:Violating a previous Board order relating to disciplinary action.Misrepresenting or hiding facts during licensing, renewal, or disciplinary procedures.Interfering with investigations into disciplinary violations.
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| These statements describe things related to medical error prevention. | View Page |
| Systems Problems Psychological and human factor research verifies that most medical errors are caused by systems problems--failures in the design of procedures, tasks, and working conditions.
Complexities of medical systems, difficulties accessing information, and acceptance of rote practices challenge efforts to reduce errors. Some institutions also lack effective methods for detecting and quantifying errors. | View Page |
| Systems Failure System designers sometimes fail to analyze the purposes of medical systems and how best to achieve them. Instead, they revert to traditional ways of doing things.
These failures of analysis account for many medical errors. An example is the tendency to encourage reliance on rote memory for performing procedures instead of manuals, job aids, checklists, and computerized protocols. | View Page |
| Preanalytic Medical Errors Medical errors are possible at any phase of patient care.
Preanalytic medical errors begin with the patient and the places he or she receives medical care--the bedside, chair-side, hospital, clinic-- wherever the patient is located.
The possibility for these errors continues through the ordering processes for medical tests or procedures.
Preanalytic medical errors also happen with the systems, processes, and procedures involved in the collection of test samples from patients.
These medical errors occur during the time before the laboratory is directly involved in assaying and analyzing test samples.
Examples of preanalytic medical errors:
Wrong patient
Wrong test
Wrong timing
Wrong collection procedure
Wrong tube, container, additive
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| Analytic Medical Errors Medical errors also occur in the analytic processes and systems of patient care.
Analytic errors begin with problems in the transportation of medical samples for testing. These occur between the patient's location and the testing facility. They happen during the time between specimen collection and arrival in the testing facility.
The possibility for analytic medical error continues through the analytic processes and procedures of medical testing.
Analytic medical error also includes systems, processes, and procedures involved in the transmission and reporting of test results.
These medical errors occur during the time the laboratory is directly involved in receiving, analyzing, and reporting test samples.
Examples:
Wrong transport storage or temperature
Delay in transport
Sample mixup during transport
Acceptance of unacceptable samples that are insufficient, hemolyzed, or clotted
Centrifugation, mixing, and other test sample preparation errors
Wrong test procedures
Test control errors
Sample mixup during testing
Outdated reagents
Wrong reagents
Test result mixup
Transcription errors
Data reporting process errors
Result report delays | View Page |
| Postanalytic Medical Errors Errors also occur after analyses are completed and reported. Postanalytic errors begin with the medical professionals who receive test results, and they include interpretation of the results. These errors can occur at--the bedside, chair-side, hospital, clinic-- wherever the patient and the medical professional are located. The possibility for postanalytic medical error continues through diagnosis and treatment procedures and processes. These medical errors occur during the time after the laboratory reports test results. Examples: Wrong test value associated with patient Wrong test interpretation Wrong diagnosis Wrong treatmentLaboratory professionals might believe they are not associated with postanalytic medical errors, but they can be. One deadly example is fatal hemolytic transfusion reaction involving laboratory error. | View Page |
| Factors that Contribute to Medical Errors | View Page |
| Element 7 Element 7:
The laboratory has a duty to respond to problems it detects either through its auditing or monitoring system or as reported by employees.It is required to take corrective action and review policies and procedures to ensure the problem does not occur again.It is required to discipline or retrain employees if necessary.The laboratory will report problems to appropriate government agencies and return any money to which it is not entitled. | View Page |
| Element 1 An effective compliance program includes seven basic elements.Element 1:
The laboratory has written and distributed to all affected employees standards, policies and procedures that instruct employees in the proper legal and ethical conduct expected in all areas of business the laboratory conducts.These policies must be adhered to by all employees regardless of status or position in the company. | View Page |
| Element 3 The laboratory has established a comprehensive training and education program about the laws and regulations that govern the laboratory and the standards, policies and procedures of the compliance program.
Mandatory for all employees regardless of status or position in the company.
There is additional training for those employees who work in higher compliance risk areas of the laboratory such as billing, marketing, and sales.
This interactive software is a component of that training program.
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| 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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| Element 6 Element 6:
The laboratory monitors and regularly audits compliance activities, policies and procedures to ensure they are being followed.If a problem is detected through the audit or monitoring process, it should be reported to the appropriate supervisor, manager or the CO. | View Page |
| Tests performed and ordered correctly The laboratory has a system in place to detect tests that are not performed due to a laboratory error and stop or credit the billing for these tests.
The laboratory cannot bill for tests that are not performed.
Employee aware of a test being canceled or not being performed for some reason must follow the policies and procedures associated with correcting the billing.
The laboratory only performs tests that are ordered by individuals authorized to order tests.
If an employee knows that a test has been ordered by someone other then an authorized individual, the employee should report it to their supervisor or the CO.
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| Written and verbal orders All tests must have a written order on file.
Any verbal orders for tests including tests added on to a specimen already in the lab, must be followed up by a request for a written order.
Employee who receives a verbal or add-on order must follow procedures to ensure that a follow-up written order is requested.
It is against Medicare regulations to bill extra for calculated test results. Only appropriate tests actually performed may be billed.
It is against the law to bill for the same tests or services twice (duplicate billing).
It is against the law to bill for quality control tests or tests performed multiple times to check or verify the results.
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| Documentation and test release Documentation of compliance activities is the responsibility of all employees.
All forms must be completed and properly filed.
All procedures must be followed and properly documented.
If documentation of compliance activities cannot be established during an audit or investigation, the government will assume that the compliance program is not being followed.
Release of test results by phone, fax and other non-routine methods:
Employees should release test results only to the person who ordered the test.
Never release test results to another physician or entity unless authorized by the ordering physician in writing.
Never release the results of a test to a patient unless authorized in writing by the ordering physician.
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| Medical necessity Medical necessity means that Medicare is not allowed by law to pay for any tests that are not necessary for diagnosis or treatment of disease.A laboratory may not submit a claim to Medicare or other government payers for any test it knows is not medically necessary except in certain cases:
When the patient has signed an advance notice.
When a patient has requested the lab to submit such a claim for a determination by Medicare.
Medicare does not pay for screening tests or tests that are ordered in the absence of signs or symptoms.Billing department employees are responsible to follow all policies and procedures related to the submission of claims to reduce erroneous billings. | View Page |
| 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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| Protecting the company Secure sensitive and confidential documents and materials.Follow all security procedures and never give your password or other codes to any other employee.Be aware of aberrant behavior and excessive questioning about billing or other compliance risk areas.Stay current on compliance policies and procedures, laws and regulations.Don't guess at an employee's questions. If you don't know for sure, find out before answering.Report any suspect activity by an employee to the compliance officer. | View Page |
| Case Study 9 The setting is automated chemistry department, night shift, busy core laboratory for a hospital based outreach laboratory. A medical technologist who operates the automated chemistry analyzer on third shift encounters short samples a couple of times a night. When this happens, he runs as many of the ordered tests as he can and fills in the blank results with a comment indicating that a short sample occurred. As far as he knows there isn't a policy that addresses this problem directly.The test reports out with the results and the comments. The technologist does not have to change the physician order in any way and is providing the maximum results that can be reported for the specimen in a timely fashion. This is done as a matter of patient care and quality service. There has not ever been a complaint about this practice as far as he knows. Are there any additional steps this technologist should be taking?Correct Answer: The technologist should follow the procedures that the laboratory has in place for testing and billing samples for which there is no order or for ambiguous orders. If the policies do not seem to address his particular situation, he thinks there should be a separate policy to cover this situation or has a question about it, he should talk to his supervisor or to the laboratory compliance officerDiscussion: This choice addresses the problem in the most complete manner, in that the employee fulfills his responsibility to take action when he thinks there is a problem.
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| Company Responsibility The company also carries certain responsibilities: The laboratory has a responsibility to communicate to all its employees its compliance policies, procedures, standards of conduct and the consequences of non-compliance. All employees must be able to understand the policies and standards. The laboratory has a responsibility to act on reported problems and suspect activities. The laboratory must resolve problems and ensure they don't recur. The laboratory must take appropriate and fair disciplinary actions against all involved. The laboratory must report to the appropriate government agency when necessary. The laboratory must promptly return money received from the government to which it is not entitled. The laboratory must audit its policies and procedures to ensure they are being followed and that they work. | View Page |
| Laboratory Administration's Responsibilities Laboratory administration has these responsibilities: Communicate compliance policies, procedures, standards of conduct to all employees and the consequences of non-compliance. Act on reported problems and suspect activities. Resolve problems and ensure they don't recur. Take appropriate and fair disciplinary actions against all involved. Report to the appropriate government agency when necessary. Promptly return money received from the government to which the laboratory is not entitled. Audit the laboratory's policies and procedures to ensure they are being followed and that they work. | View Page |
| Element 7 The laboratory has a duty to respond to problems it detects either through its auditing or monitoring system or as reported by employees. It is required to take corrective action and review policies and procedures to ensure the problem does not occur again. It is required to discipline or retrain employees if necessary. The laboratory will report problems to appropriate government agencies and return any money to which it is not entitled. | View Page |
| Element 1 The laboratory has written and distributed to all affected employees, standards, policies, and procedures that instruct employees in the proper legal and ethical conduct expected in all areas of business the laboratory conducts. These policies must be adhered to by all employees regardless of status or position in the company. | View Page |
| Element 3 The laboratory has established a comprehensive training and education program about the laws and regulations that govern the laboratory and the standards, policies and procedures of the compliance program. Mandatory for all employees regardless of status or position in the company. There is additional training for those employees who work in higher compliance risk areas of the laboratory such as billing, marketing, and sales. This interactive software is a component of that training program. | View Page |
| Element 5 Every employee must understand that the standards, policies and procedures associated with the compliance program must be adhered to at all times. An employee will be disciplined up to termination for violations. An 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 employee's annual evaluation and performance review. | View Page |
| Element 6 The laboratory monitors and regularly audits compliance activities, policies, and procedures to ensure they are being followed. If a problem is detected through the audit or monitoring process, it should be reported to the appropriate supervisor, manager or the CO. | View Page |
| Seven Fundamental Elements of a Voluntary Compliance Program In developing an effective compliance program, the OIG has identified these seven fundamental elements: Implementing written policies, procedures and standards of conduct Designating a compliance officer and compliance committee Conducting effective training and education Developing effective lines of communication Enforcing standards through well-publicized disciplinary guidelines Conducting internal monitoring and auditing Responding promptly to detected offenses and developing corrective action An example of a Voluntary Compliance Program based on these seven fundamental elements follows on the next several pages. | View Page |
| Issues Related to Test Ordering, Performance, and Resulting The laboratory can only perform tests that are ordered by individuals authorized to order tests. If an employee knows that a test has been ordered by someone other then an authorized individual, the employee should report it to their supervisor or the compliance officer (CO). The laboratory must have a system in place to detect tests that are not performed due to a laboratory error and stop or credit the billing for these tests. The laboratory cannot bill for tests that are not performed. An employee who is aware that a test has been canceled or has not been performed for some reason must follow the policies and procedures associated with correcting the billing. Release of test results by phone, fax and other non-routine methods Employees should release test results only to the clinical person who is authorized to receive the test results (i.e., the ordering physician). Never release test results to another physician or entity unless authorized by the ordering physician in writing. Never release the results of a test to a patient unless authorized in writing by the ordering physician. | View Page |
| Written and verbal orders All tests must have a written order on file. Any verbal orders for tests, including tests added on to a specimen already in the lab, must be followed up by a request for a written order. Employee who receives a verbal or add-on order must follow procedures to ensure that a follow-up written order is requested. It is against Medicare regulations to bill extra for calculated test results. Only appropriate tests actually performed may be billed. It is against the law to bill for the same tests or services twice (duplicate billing). It is against the law to bill for quality control tests or tests performed multiple times to check or verify the results. | View Page |
| Medical necessity The Centers for Medicare and Medicaid Services (CMS), the US agency that administers the Medicare program, defines "medical necessity" as services or items reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Medicare will not pay for any tests that CMS determines as unnecessary for diagnosis or treatment of disease.A laboratory may not submit a claim to Medicare or other government payers for any test it suspects is not medically necessary unless: The patient has signed an Advanced Beneficiary Notice, or A patient has requested the lab to submit such a claim for a determination by Medicare. Medicare does not pay for screening tests or tests that are ordered in the absence of signs or symptoms. Billing department employees are responsible for following all policies and procedures related to the submission of claims to reduce erroneous billings. | View Page |
| Documentation Documentation of compliance activities is the responsibility of all employees. All forms must be completed and properly filed. All procedures must be followed and properly documented. If documentation of compliance activities cannot be established during an audit or investigation, the government will assume that the compliance program is not being followed. | View Page |
| Laboratory Billing Department 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. Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings. | 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 |
| Health Hazard Data This is the most important section of all. It provides information on how the chemical could affect you. Is it a carcinogen? How can it enter your body? What are the signs and symptoms of overexposure to the chemical? What first aid procedures should be used in case of an accident? | View Page |
| Fire and Explosion Hazard Data Identifies any special precautions which should be taken during fire fighting procedures. This chemical is still flammable when diluted, and can be extinguished by an ABC fire extinguisher. Special fire fighting procedures included would not necessarily apply to a laboratory setting. | View Page |
| Who Must Receive Training? According to federal and international regulations, all personnel who are involved in the packaging and shipping of infectious materials are required to have training in these procedures. This includes anyone who: Packages, labels, and/or marks the package Is responsible for classifying the materials Is responsible for documenting the package contents on a shipping declaration form, air waybill, etc. Transports hazardous materials by vehicle, plane, or vessel | View Page |
| What are the Training Requirements? The training requirements that are stated in the US Code of Federal Regulations at 49 CFR 172.704 must be met by all personnel who are involved in shipping hazardous materials in the United States and training must be completed within 90 days of employment or performance of the required hazmat function (relevant documented training from a previous employer is acceptable).These requirements include: General awareness/familiarization training Function-specific training Safety training Security awareness training (Category A substances) Safety training, must be provided by the facility where the infectious materials are packaged and must include: Emergency response information Measures to protect the employee from the hazards associated with hazardous materials to which they may be exposed in the work place, including specific measures the hazmat employer has implemented to protect employees from exposure Methods and procedures for avoiding accidents, such as the proper procedures for handling packages containing hazardous materials | View Page |
| Security Awareness A category A infectious substance is in a form that is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Exposure would occur if the substance were released from its protective packaging and a human or animal came into contact with it. Therefore, it is critical that a category A infectious substance does not end up in the hands of an unauthorized individual who may purposely or unknowingly release the substance from its protective packaging and endanger humans or animals. Being aware of the people that you interact with in the process of packaging and sending category A substances is vital to the safety of the transport and prevention of a health disaster. An outsider with limited access and system knowledge could constitute a threat, but be aware that insiders could also be a threat, e.g., a disgruntled employee or a person who is angry with his or her supervisor or job or the government. Anyone desiring to do harm could potentially seize the opportunity to steal a hazardous material.Follow these precautionary procedures: When you are questioned about an infectious substance that you are packaging for shipment, it is important that you know the person that is asking AND that he or she has a need to know. If you do not know the person and if you are not aware that the person needs to know about the substance that is being shipped, do not answer the questions. You could refer him or her to your supervisor. Watch for unusual behavior. Secure the package until it is picked up. Check the identification of the courier who will be picking up the package. Use an intralaboratory chain of custody procedure if the specimens are tranferred within the facility or system. Track the package once it has been sent to be sure it arrives safely. Notify the Responsible Official or federal authority if the package does not arrive at its destination. | View Page |
| Discussion The phlebotomist should always carefully observe the patient for clues about his mental and physical condition. In this case, the patient verbally expressed her fear of needles. In other cases, such fear may be expressed on the patient’s face or through other clues. It may help to engage apprehensive patients in conversation during the venipuncture to keep their mind off the procedure.As soon as the patient stated that she felt faint, the procedure should have been terminated. If a sitting patient faints, placing her head between her knees will help to revive her. Make sure the patient does not injure herself. Ammonium (smelling) salts, if in use at your institution, should be used cautiously, since they can be irritating. Get help from the nursing staff or a physician. Stay with the patient at least 15 minutes. The patient should not leave the area for at least 30 minutes. Make sure other appropriate institutional procedures are followed after fainting.Relevant topics:Fainting, Fainting continued | View Page |
| Discussion This phlebotomist violated hospital procedures in several ways that could adversely impact patient care:
Cleaning the site only with alcohol, not iodine, could result in a false-positive contaminated blood culture. This might result in the patient receiving unnecessary intravenous antibiotics, and could prolong the patients hospital stay unnecessarily.
Drawing both cultures at the same time lessens the chance of recovering a bloodstream organism.Drawing both cultures from the same site might result in both of them being contaminated, making it very difficult for the physician to distinguish contamination from a “real” bloodstream infection.Relevant topics:Blood cultures: introduction,
Avoid skin contamination, Blood culture site preparation 1, Blood culture site preparation 2 | View Page |
| Gloves Gloves must be worn for all procedures requiring vascular access.
Non-powdered latex gloves are most commonly used;
Alternatives available for health-care workers allergic to latex include:
Latex gloves sandwiched between 2 vinyl gloves.
Latex-free glove liners.Do not use latex gloves or tourniquets when collecting blood from patients with latex allergy. | View Page |
| Sharps disposal containers All sharps must be disposed in appropriate sharps disposal containers.
These are usually available in patient rooms, but may also be available on the phlebotomy tray depending on your institution’s policies and procedures.
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| Specimem labeling Label specimens at the bedside according to your institution’s standard procedures, or apply preprinted labels.Proper labeling is the single most critical task you are asked to perform.
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| Venipuncture Standard precautions Treat all blood & body fluids as if they were infectious.Always wear gloves during vascular access procedures. | View Page |
| Heelstick - Pediatric collection procedures: Introduction Veins of small children and infants are too small for venipuncture;Safety Lancets are used to puncture the skin and collect capillary blood.Butterfly needles may be used to collect venous blood in older children.
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| Signs Be alert to signs posted on the hospital room door or above the hospital bed.Such signs may warn you to use appropriate personal protective equipment according to your institution’s isolation policies and procedures. Other signs may specify that the left of right arm should be avoided. Patients may also alert you to avoid the use of an arm.
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| Uncooperative patients If a patient is uncooperative or combative, request help from the nursing staff.
The nursing staff will assist you in an appropriate manner according to your hospital’s procedures for patient restraint.
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| Patients refusing blood work If someone hesitates to let you collect a blood specimen, explain to them that their blood test results are important to their care.However, patients have a right to refuse blood tests. If the patient still refuses, report this to the nurse or physician, and document patient refusal according to your hospital’s policies and procedures.
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| Professionalism: maintaining confidentiality Phlebotomists are ethically and legally required to keep patient information confidential.
Reveal patient information including medical history and results only to authorized individuals as defined by your laboratory’s policies & procedures.
Do not discuss test results with patients without a written order from the ordering physician.
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| Needlestick safety and prevention act continued Please keep the following in mind:
These devices must be used properly and conscientiously to prevent injury.
Carefully follow your institution’s policies and procedures to prevent needlestick injury.
Most devices require you to activate their safety features. Often, the device lets you know it is properly activated by a click or a snap.
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