Guidelines Information and Courses from MediaLab, Inc.

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

Fortunately, the great majority of collections are uneventful, but from time to time problems or the unexpected occur. This section will discuss a few examples of special situations that may take place during a collection and what the response of the collector should be. Obviously, not every special situation can be envisioned or discussed. It is strongly recommended that the collector be very familiar with the Department of Transportation publication: Urine Specimen Collection Guidelines dated August 25th, 2008.

Deciding how many classes to use for grouping the data is a compromise between the extremes of too much detail (each observation in its own category) and not enough detail (only one category). Most frequency tables are constructed according to the following guidelines: For most data, 6 to 15 classes are enough Class intervals (lengths) should be equal. Intervals such as 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, etc are desirable. The starting point for each class should be divisible by the interval, For example, in the class 15 - 20, the starting point, 15, is divisible by the interval, 5. Each observation must fit into only one class. When a large number of points falls around a certain value, make this value the approximate center of the frequency distribution.For the data in our example, the minimum is 65 and the maximum is 114, a range of about 50. We can therefore choose intervals of size 5, and have ten of them. Our classes are 65 - 70, 70 - 75, etc.

How do physicians interpret risk marker results? Assuming the laboratory offers, and physicians order, cardiovascular risk marker tests, how are these results used? The National Cholesterol Education Program periodically assembles scientists and physicians to create lipid treatment guidelines for patients. These panels are referred to as the Adult Treatment Panel (ATP). The third assembly of the ATP did not give specific guidelines regarding risk marker use in patients but they did acknowledge their potential utility. The general consensus is that novel cardiovascular risk markers should be used in selected patients, such as those who already have significant risk factors (hypertension, smoking, obesity, etc.) or in patients who have family histories of cardiovascular disease. The value in using risk markers is that they will not only uncover cardiovascular risk but they can also be used to motivate patients to alter lifestyle and diet. It is expected that as these emerging cardiovascular risk markers continue to be validated in clinical studies, they will become very useful and perhaps even be part of a new standard of care for patients.If risk marker levels can be correlated to treatment strategies, physicians will find them especially useful in tracking patient success.

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.

Transferrin saturation (TS) is usually reported along with the SI and TIBC. TS indicates the percent of iron binding sites on transferrin that are carrying iron. TS is derived from a calculation using the formula:TS =(SI/TIBC) x 100TS results are reported as percentages. Typical reference intervals for TS are 20% to 55% for males and 15% to 50% for females. TS is generally considered to be the most sensitive laboratory test for detecting altered iron metabolism in hereditary hemochromatosis (HH). It may be elevated prior to significant deposition of tissue iron. TS levels increase as additional iron is accumulated.A drawback to using the TS is that it is dependent on performing both the SI and TIBC. The UIBC (see section below) may be a lower cost alternative.The optimal TS criterion for detecting HH is controversial. Using a TS of >60% for males and >50% for females has been found highly accurate in detecting abnormal iron metabolism in persons with HH. Others studies suggest using lower TS levels, e.g. 45%, as a criterion indicating further testing is warranted. Current guidelines from the American College of Physicians include a TS cutoff level of >55% for identifying iron overload. (11)Patients with initially increased TS should be followed by performing a second TS from a fasting morning specimen. The patient should also be advised not to take vitamins supplemented with iron or oral contraceptives for several days prior to the repeated test. TS levels may be affected by diurnal variation, dietary factors, and co-existing disease states such as inflammation and hepatitis. Patients with HH may have falsely normal TS if chronic blood loss or inflammatory disease is present.

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.

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

Here are some guidelines for the order in which control sample testing should occur: Controls and calibration materials should not come from the same lot number. Controls should not routinely follow calibration material. Random placement of controls among patient specimens is preferred. Random placement of duplicate patient specimens, rather than consecutive, monitors reliability within the batch.

A. Computer monitors should be approximately 18" - 24" away from the eyes. The top of the monitor is best set at eye level so that the eyes gravitate toward the center of the screen. B. Try to avoid glare from the light. C. Computer monitors should be set directly in front of the user D. Keep forearms 90° from your spine and keep elbows in close to the body. E. If seated, thighs should be parallel to the floor and about a 90° angle with the calves. F. Use an adjustable chair, preferably with padded arms. Adjust the chair or work surface (if possible) to the correct position. Avoid leaning forward or to the side. Do not lean on work surfaces. Do not lean on elbows or armrests. Keep neck and shoulders in a relaxed position.G. Place keyboard in a comfortable position (preferably on an adjustable keyboard tray) and use a wrist/palm rest. H. Place feet flat on the floor or on a footrest and do not crowd the legs or body into a cramped or cluttered work space. Use a document holder to keep working documents at eye level with the screen. To avoid eyestrain, follow the 20/20/20 rule. Every 20 minutes, take a 20 second break to focus on a spot 20 feet away.

Laboratory discussion meetings help to prevent medical errors. The staff can meet periodically to discuss recent averted adverse events and ones that might have been averted.Discussion should not be about blame. Privacy must be protected, so real names should not be identified. Management can provide guidelines for discussion and analysis.A suggested format for discussion:1. Briefly describe each adverse event.2. Identify its possible causes.3. Discuss relevant guidelines.4. Suggest possible preventive actions.Discussion can include actions that do and do not work to prevent medical errors.

All sales offerings and/or written proposals must be in compliance with policies or guidelines or pre-approved by the sales manager or compliance officer.The manner in which a sales or marketing person presents a discount of special price is as important as the amount of the discount.Sales and marketing employees must be very aware of the language used during the sales process to insure the customer understands exactly what is being offered.The offering of an illegal discount is the same as actually giving it.If a client solicits a questionable or illegal discount, it should be reported to the sales manager or compliance officer.

All healthcare providers, including laboratories, could potentially submit erroneous claims for Medicare reimbursement. These billing errors can trigger an investigation. The creation of a voluntary compliance program, using the guidelines provided by the Office of Inspector General (OIG), can assist healthcare institutions and laboratories to audit themselves, thereby preventing submission of erroneous claims and a possible fraud and abuse investigation.

All sales offerings and/or written proposals must be in compliance with policies or guidelines or pre-approved by the sales manager or compliance officer.The manner in which a sales or marketing person presents a discount of special price is as important as the amount of the discount.Sales and marketing employees must be very aware of the language used during the sales process to insure the customer understands exactly what is being offered.The offering of an illegal discount is the same as actually giving it.If a client solicits a questionable or illegal discount, it should be reported to the sales manager or compliance officer.

International Civil Aviation Organization. Technical instructions for the safe transport of dangerous goods by air. Doc 9284; 2005 - 2006 ed with amendment. National Laboratory Training Network. Packaging and shipping Division 6.2 materials. Georgia Public Health Laboratory; 2008. Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorism. Available at: http://www.asm.org/ASM/files/LeftMarginHeaderList/DOWNLOADFILENAME/000000001202/Packing&Shipping11-18-05.pdf Accessed on February 13, 2009.US Department of Transportation Pipeline and Hazardous Materials Safety Administration. Transporting Infectious Substances Safely. Guide to changes effective October 1, 2006. Washington, DC; 2006.

Initial analysis of the peripheral blood picture is made in most clinical laboratories with an automated instrument. Samples are selected for further analysis when quantitative or qualitative abnormalities beyond a defined standard are found. The following are examples of quantitative RBC abnormalities that may prompt a blood smear review. Each laboratory, however, should develop its own guidelines: Hgb: < 8 or >18 g/dL (<10 or > 21g/dL in a newborn)Hct: <20% or > 60% in adults (<40% or >65% in a newborn)MCHC: <29 g/dLMCV: <69 femtoliters (fl) or >110flFlags generated by the hematology analyzer that indicate possible red cell abnormalities or spurious resultsAny of these findings should be followed up with a peripheral blood smear review.

Any review of a peripheral smear is highly subjective; therefore, each laboratory must establish its own guidelines for quantitating observations and issuing reports in a consistent format. The key question for the laboratory is "How will the clinician use the terms of qualitative results in the reports issued to decide on the next course of action with this patient?" Formats for reporting have been geared more toward the needs of instrumentation facilitation and computer management than toward needs of access and understanding by clinicians working to improve patient care outcomes. Evidence based medicine (EBM) is the formal term used for the process by which research evidence, collective clinical experience, and the user friendly rendering of testing results are integrated to evaluate patient care outcomes.

A tourniquet is used by the phlebotomist to assess and determine the location of a suitable vein for venipuncture. Single-use, latex-free tourniquets are preferred but reusable tourniquets are acceptable. However, if the reusable tourniquet becomes contaminated with blood or body fluid, it must be discarded immediately to avoid the spread of harmful contaminants to other patients. Follow the guidelines established by your facility for cleaning reusable tourniquets.Proper application of a tourniquet will partially impede venous blood flow back toward the heart and cause the blood to temporarily pool in the vein so the vein is more prominent and the blood is more easily obtained. The tourniquet is applied three to four inches above the needle insertion point and should remain in place no longer than one minute to prevent hemoconcentration. If the tourniquet is used during preliminary vein selection, it is best to release the tourniquet after assessing the vein and while you are assembling your supplies. Reapply the tourniquet just before starting the venipuncture; it should then be released soon after the needle has been inserted into the vein and the blood flows into the first tube. If collecting multiple tubes, the tourniquet may remain in place until blood enters the last tube.

Safety precautions should be observed when handling seminal fluid. The following guidelines should be followed:If non-disposable items are used, soak contaminated items(e.g.hemacytometers and coverslips) in 70% alcohol or Wexide®.All disposable items should be placed in a biohazard bag for autoclaving.Gloves must be worn and hands thoroughly washed when the examination is completed.Seminal fluids that are to be discarded should be placed in biohazard bags for autoclaving.

The Centers for Disease Control (CDC) issued Guidelines for Prevention of Tuberculosis in Healthcare Settings in 2005.These guidelines have broader applications than the Guidelines for Prevention of Tuberculosis in Healthcare Facilities issued by CDC in 1994.

Pratt R, Robison V, Navin T. Trends in tuberculosis. MMWR/57(11);281 - 285; Centers for Disease Control and Prevention: March 21, 2008. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5711a2.htm Last accessed on May 23, 2008.Respiratory Protection in Health-Care Settings Fact Sheet. Available at http://www.cdc.gov/niosh/99-143.html. Last accessed May 23, 2008. Slide set - Guidelines for preventing the transmission of M. Tuberculosis in Healthcare settings, 2005. Available at http://www.cdc.gov/tb/pubs/slidesets/InfectionGuidelines/program.htm Last accessed on May 23, 2008.Tuberculin Skin Testing Fact Sheet. Available at http://www.cdc.gov/TB/pubs/tbfactsheets/skintesting.htm Last accessed on May 23, 2008.

The following are suggested guidelines directed toward white blood cell data necessitating a hematologist's review:Total white blood cell count <3000/cumm or >12,000/cummNeutrophils >85%Lymphocytes >43% or <10%Monocytes >8%Eosinophils >6%Basophils >4%,.Mixed cells >8% on a 3-part automated differentialA morphology review may also be indicated if the platelet count is <100,000/cumm or >650,000/cumm.Thus, if the granulated cells illustrated in the photograph exceed 6% of the total WBC on a five-part differential or, in combination with monoctytes and basophils, exceed 8% of the total WBC on a three-part differential, a flag would alert the operator that a morphology review or manual differential is needed.