Avera LabNet - Newsletter

November 2000

FAA: Properly label and pack specimens

If you ship specimens by air, you better be sure that your staff members know how to properly label and pack these parcels because federal investigators may cite or fine you if they suspect that something is amiss.

In addition to the Department of Transportation (DOT) and the Environmental Protection Agency conducting unannounced inspections of hospitals and labs that handle biohazardous materials and waste, you now can add the Federal Aviation Administration (FAA) to the list. The FAA has cited hospitals and labs that can’t provide the relevant documentation to prove that their hazardous materials shippers are properly trained and certified.

“The FAA does what are called ‘haz-strikes’ in which we go back to the shippers and make sure they’re properly labeling and packaging (shipments)…and make sure their employees go through proper training.” says FAA spokesperson Rebecca Trexler.

The samples

If the samples are considered infectious, you need proper shipping and packaging, says Trexler. Infectious substances are specimens known or thought to contain pathogens and that are capable of spreading disease when a person is exposed to them, according to ARUP Laboratories, an independent reference lab based in Salt Lake City, UT. Shippers must identify these specimens as infectious, such as blood possibly infected by HIV.

Diagnostic specimens - which include human and animal materials being shipped for purposes of determining the nature of a disease—that are not known to be infectious do not fall under hazardous materials shipping regulations.

Documentation of training and certification becomes key proof to FAA inspectors that your lab is staying within the boundaries of government regulations. “The first thing that (FAA inspectors are) coming to look for is that you have training records on file,” says Andy McQuinn, director of business operations at Partners in Compliance, a Morrisville, NC, firm that specializes in shipment training and regulations, McQuinn says.

The regulations

The FAA references laws from the DOT as published in the federal Code of Regulations (CFR).

CFR Title 49 governs the transportation of hazardous materials in the United States. Under

49 CFR 171.11, you must ship hazardous materials under the guidelines of the International Civil

Aviation Organization, which is a United Nations technical agency for aviation.

The DOT says that hazardous shipping employees must have a general awareness of the job dangers and receive adequate training within 90 days of starting their job, according to McQuinn.

What is certification?

Certification of training generally means documentation that training took place. According to ARUP, infectious shipments must be packed by employees who have received training in accordance with DOT and/or International Air Transportation Association (IATA) regulations.

The DOT and the IATA state that a record of the training should include the employee’s name, the most recent training date, a description of training materials used, the name and address of the organization providing the training, and a copy of the certification issued that shows that the employee completed the training satisfactorily.

Enforcement

More than likely, hospitals and labs in violation of the regulations will first get a sanction from the FAA

inspector asking for corrective action to fix the problem. You can also get a warning letter for minor infractions.

Having a written policy and checklist on shipping is a good way to show the FAA that any violations are a one-time event, McQuinn suggests. A source in the DOT says that bigger problems can lead to civil and criminal penalties. Inspectors can issue tickets for serious violations that don’t risk safety, while those that do threaten safety can result in civil penalties.

NOTE: When sending those specific etiologic agents listed in 42 CFR 72.3 (f) by mail, refer to the US Post Office’s guidelines as these agents must be sent by registered mail. If sending by UPS, you must adhere to their specific guidelines as well.

Visit the website, www.gpo.gov for details of the Code of Federal Regulations.

FROM THE EDITOR...

We have been busy with HazMat training here. Anyone who handles/processes “infections” materials is required to be HazMat trained and must be able to show documentation that they have been HazMat trained in the event of DOT or FAA inspection. See relating article in newsletter for details. I must say, I have learned an immense amount of information on this matter in the past two months. If anything, my vocabulary has dramatically increased! (but nothing that I can bring up casually at the dinner table with my husband and kids!) If you have any questions on this subject, please call us and we will try to help.

Enjoy the upcoming holidays with your family and friends. Try to fill your Christmas with LOVE and GIVING (giving of yourself, your time, and your attention). As children get older, they will remember the gatherings and traditions, NOT the different gifts they received each year. Have a blessed Christmas. Pam Hegge

it’s a mystery

A 26-year-old female, 8 months pregnant, was admitted to the hospital after a motor vehicle accident.

A Kleihauer-Betke stain was performed to establish the presence or absence of a feto-maternal bleed. The initial stain indicated a bleed of approximately 70 ml.

A Kleihauer done two days after admission indicated a bleed of 205 ml. At this time preparations were made for an intrauterine transfusion. A cord blood specimen obtained had a hematocrit of 40.4 %. No blood was administered to the fetus. The patient was discharged the next day. A hemoglobin electrophoresis performed on this admission revealed the presence of fetal hemoglobin (Hg F). Quantitative HgA2 was 3.1% and quantitative Hg F was 2.1%. These levels were not high enough to suggest a diagnosis of heterozygous B-thalassemia. The amount of Hg F was not elevated enough to indicate persistent fetal hemoglobin. The patient delivered a healthy baby 1 month later. No post partum hemoglobin electrophoresis was performed.

QUESTION: What caused the elevated Hg F in this patient?

Client medicare compliance reminder

Test Add-Ons: Medicare Patients

We have noted increasing problems with clients calling in to “add-on” tests to a previously submitted specimen (Medicare patient) and the “add-on test” is covered under a Local Medical Review Policy (LMRP). The only time this might be permissible is if the “add-on test” is covered under the diagnosis provided on the original requisition. If there is any question that the test may be denied based on diagnosis medical necessity and/or frequency, it will not be allowed to be added to the original request.

The following excerpt from our ALN catalog will be followed at all times when determining if “add-on testing” will be allowed:

The Client Service Department can arrange additional testing on specimens previously submitted for testing providing the following conditions apply:

• Sufficient volume is available

• Original specimen type is acceptable for additional

testing requested

• Specimen stability guidelines have not been exceeded

• Additional testing requested does not require

documentation that is not available and is required

by federally funded programs (i.e. covered by Local

or National Coverage Policy)

Verbal orders received to request additional testing will required “Verbal Order Written Authorization” protocol be followed.

Primary Diagnosis Documentation in the Patient Records:

1. The ordering physician and/or authorized individual is responsible for maintaining

documentation of medical necessity (the primary diagnosis/reason why a specific test

is being ordered on a specific date of service) in the patient (beneficiary’s) medical record.

2. This documentation must be available in an accessible and retrievable format and must be

available at the time the laboratory service will be provided to the patient.

3. It is not acceptable to determine “reason/diagnosis for testing completion” after the

patient has had the laboratory service provided. It is also not acceptable to review

an entire patient medical record and/or old diagnosis information to try and determine the

“assumed reason” for the laboratory test order.

4. Our test requisition must have the ICD-9/Diagnosis Information” section filled out

completely. Primary diagnosis must be assigned to each test ordered and must be

the same as the medical necessity documentation in the patient medical record.

FDA REVISING WAIVED TESTING CRITERIA

The Food and Drug Administration is revising the criteria for waived testing status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Both American Clinical Laboratory Association (ACLA) and American Society for Clinical Laboratory Sciences (ASCLS) gave their views and concerns regarding waived testing at FDA workshop on August 14th and 15th.

The CLIA statute initially identified waived tests as “simple laboratory examinations and procedures which...have an insignificant risk of erroneous result,” including those which-

(A) have been approved by the Food and Drug

Administration for home use;

(B) employ methodologies that are so simple and accurate

so as to render the likelihood of erroneous results

negligible, or

risk of harm to the patient if performed incorrectly

Waived tests are exempt from the CLIA health and safety standards including personnel, patient test management, quality control, proficiency testing, quality assurance, and routine inspection requirements.

In 1997 the Food and Drug Administration Modernization Act amended the Public Health Service Act. This changed the CLIA statue by modifying the definition of waived test to include:

....examinations and procedures . . . approved by the FDA for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that

A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous

results by the user neglible, or

B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.

C) 24 USC.263a(3). This change allowed manufacturers to submit tests for home use clearance, and upon approval, automatically obtain waived status under CLIA.

To ensure test quality and the public health all tests should be safe, reliable, and accurate whether they are performed in a patient’s home, a physician office, or a moderate or high complexity laboratory. ACLA believes that no test should be approved for home use unless the test is subject to the same criteria for accuracy and precision as a test performed in a professional laboratory. The test should include mechanisms to assess both the accuracy of the test and the untrained user’s ability to correctly perform and interpret the test.

The FDA will review all comments and testimony and decide what the criteria will be for waived classification.

For more details see ASCLS Today August 2000,

Volume XIV, Number 8; and FDA website www.fda.gov/.

Foods and Medications Associated with Altered

Urinary HIAA Results

Serotonin (5-hydroxytryptamine), a derivative of the amino acid tryptophan, is produced by the argentaff

in cells of the gastrointestinal tract. 5-HIAA is excreted in large quantities by individuals with carcinoid tumors,

particularly of mid-gut (ie. ileal) origin. Carcinoids from other sites produce serotonin and 5-HIAA significantly

less frequently or not at all.

Patients should be carefully instructed to abstain from foods rich in serotonin and other indoles, and all

medications, if possible, for 72-96 hours prior to and during the collection period.

Foods and Medications Associated with Altered Urinary HIAA Results*

The following substances can cause interference in the measurement of urinary 5-HIAA:

Decreased HIAA:

Aspirin, Chlorpromazine(Thorazine), Corticotropin, Dihydoxyphenylacetic acid, Ethanol, Gentisic acid,

Homogentisic acid, Hydrazine derivatives, Imipramine(Tofranil), Isocarboxazid(Marplan), Keto acids,

Levodopa, MAO inhibitors, Methenamine, Methydopa(Aldoclor), Phenothiazines(Compazine),

Perchlorperazine, Promazine, Promathazine (Mepergan)

Increased HIAA:

Acetaminophen, Acetanilid, Caffeine, Coumaric acid, Ephedrine, Flourouracil, Glycerol

Guaiacolate(Guaifenesin), Melphalan(Alkeran), Mephenesin, Methamphetamine(Desoxyn), Methocarbamol,

Naproxen, Nicotine, Phenacetin, Phenmetrazine, Phenobarbital, Pentolamine, Rauwolfia, Reserpine,

Robaxin, Valium(Diazepam)

Increased HIAA, Foods:

Avocados, Bananas, Eggplant, Plums, Pineapple, Tomatoes, Walnuts

Foods rich in serotonin and medications which may affect metabolism or serotonin must be avoided

for at least 72 hours before and during collection of urine for HIAA.

*ARUP Interpretive Data Guide

Please put this information in your test catalog, so that information is readily available for instructing

your next patient.

Presentation College MLT Program

The Medical Laboratory Technology (MLT)

Program at Presentation College has offered a two-year Associate’s Degree to future laboratorians since 1968. Last year, the program was awarded continuing accreditation status with the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) for seven years. This is the longest length of accreditation granted from NAACLS.

Ms. Terry Dunkel, M.S.,MT(ASCP) was named the new Program Director in September 2000. She replaces Dr. Roberta Kervin, who had served in the position for sixteen years. Dr. Kervin continues to teach at Presentation College in general biology.

Avera-St. Lukes Laboratory has given the MLT program continual support, serving as the program’s clinical affiliate. The students attend clinical two days per week, rotating through the different departments of the laboratory. Ms. Bernie Reddy MT(ASCP)is beginning her second year as clinical supervisor for the MLT students. Currently, the program has three sophomore students and seven freshmen. The sophomores anticipated graduation date is May 2001.

If you have any questions about the MLT program at Presentation, please contact Terry Dunkel: tdunkel@presentation.edu or 605-229-8526.

President Cliniton signed the Needlestick Safety and Prevention Act into law on Monday November 6, 2000. Hospitals regulated by federal OSHA will be required to comply with the amended standard 90 days after it is published in the Federal Register, which is expected within 6 months. In states regulated by their own OSHA,

the law will go into effect six months after the federal revised standard goes into effect. If the state OSHA has stricter needle safety rules, the state rule will apply. If the state rule is weaker, the federal rule will apply. With

the addition of New York on November 1, 17 states have adopted needle safety legislation.

“Infection Prevention is Sticky Business”

If you are not providing safer needles and devices to prevent bloodborne pathogen exposures, you need to read this. OSHA revised its bloodborne pathogen compliance directive on November 5, 1999. This was put out to help minimize serious health risks faced by workers exposed to blood and other potentially infectious materials. Among the risks are HIV, Hepatitis B and Hepatitis C. This guideline actually helps OSHA compliance officers to enforce the standard that covers occupational exposure to bloodborne pathogens and assures consistent inspection procedures be followed. It updates the earlier directive issued in 1992 and reflects the availability of improved devices, better treatment following exposures and OSHA policy interpretations. The compliance directive states where engineering controls reduce employee exposure either by removing, eliminating or isolating the hazards, they must be used. The compliance officers are empowered to cite not only facilities that are not using safety devices, but also those facilities that are using safety devices in which there are better alternatives to be used for that procedure. The directive also emphasizes the importance of an annual review of the employer’s bloodborne pathogens program and the use of safer medical devices to help reduce needlesticks and other sharps injuries. OSHA does not advocate the use of one particular medical device over another. The directive also highlights basic work practices, personal protective equipment and engineering administrative controls. Listed below is a summary of some of the key revisions:

• Annual Review of Exposure Control Plan - employers must ensure that their plans reflect consideration

and use of commercially available safer medical devices.

• Engineering Controls and Work Practices - emphasizes the use of effective engineering controls, to include

safer medical devices, work practices, administrative controls and personal protective equipment.

• Emphasizes that employers should rely on relevant evidence in addition to FDA approval to ensure

effectiveness of devices designed to prevent exposure to bloodborne pathogens.

• Multi-Employer Worksites - focuses on employment agencies, personnel services, home health,

independent contractors, and physicians in independent practice.

• Adds most recent guidelines from the Centers for Disease Control on vaccinations against the Hepatitis B

virus. Incorporates CDC’s guidelines on post exposure evaluation and follow-up for HIV and the

Hepatitis C virus.

• Requires effective training and education for employees whenever safer devices are implemented.

Stresses “interactive” training sessions rather than just the use of films or videos that do not provide the

opportunity for discussion with a qualified trainer.

• Replaces and updates appendices. Including the following: examples of committees in health care

facilities; sample engineering control evaluation forms; Internet resource list; “fill-in-the-blank” sample

exposure control plan; and CDC guidelines pertaining to HIV exposure, control and prevention of hepatitis C,

and hepatitis B vaccinations.

Avera Health is committed to employee healthcare worker safety. Each exposure is evaluated to identify ways that it could have been prevented. Employees are retrained after the exposure. Each exposure is

analyzed for safety devices. Many safety devices have been implemented. These include needleless IV

system, safety Lancets, safety vacutainers, sharps containers, and most recently IV safety catheters. The Value Analysis Team at each of the four regional sites evaluates devices that can be utilized for patient care and employee safety. The trial and evaluation of these devices are completed by a team of professionals from a wide range of areas including Laboratory, Orthopedics, Neonatal Intensive Care, Pediatrics, Anesthesia, the Emergency Department, GI Lab, Ambulatory, and Clinics. Evaluation forms from OSHA were utilized. Staff were asked to provide input relating to the devices. This information was compiled and presented to the Value Analysis Committee, which is comprised of Infection Control, Nursing, Laboratory, Central Sterile, Long-Term Care, and Materials Management. The decisions were recorded by the committee. Documentation of training is very important and it needs to incorporate manufacturer’s specifications regarding the device. While changing multiple products can be stressful, the goal is to provide for the safety and well being of employees and patients.

It is a common misconception that since South Dakota does not have a state OSHA program that we do not have to worry about OSHA guidelines. OSHA guidelines are federal laws that are put into place to protect the healthcare worker no matter where they live within the United States. South Dakota is covered by the federal OSHA Regional Office in Bismarck, ND.

Examples of questions that should be included on an evaluation form are listed below. These questions can be rated by staff on a scale of 1-5, with 1 meaning agree and 5 meaning disagree.

1) The safety feature can be activated easily without interfering with the standard blood drawing technique.

2) The safety feature does not obstruct vision of the tip of the needle.

3) The safety feature does not interfere with the ability to penetrate the skin

4) The product does not require more time to use than a non-safety product.

5) The device works well with a wide variety of hand sizes, and is comfortable to handle while wearing

gloves.

6) The safety product does not require any additional sticks to patients.

7) The safety device is activated easily and operates reliably.

8) There is a clear, audible indicator that occurs when the safety feature is activated.

9) Patients report no increase in pain with this product

10) The inner vacuum tube needle (rubber sleeved needle) does not present a danger of exposure.

11) The safety needle is not more difficult to dispose of after use than a non-safety product.

12) Bio-Hazard waste is not increased.

13) The user does not need extensive training for proper operation of this safety system.

References:

OSHA Directives CPL 2-2.44D - Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, Occupational Safety and Health Administration US Department of Labor, November 5, 1999.

Safety Engineer Peripheral Intervenous Catheters, I Can Prevent, August 31, 2000.

CDC; International Conference on Nosocomial and Health Care Associated Infections, Atlanta, GA, Atlanta, Georgia, April, 2000.

Influenza 2000-2001

Influenza is an acute viral disease of the respiratory tract characterized by fever, headache, myalgia, prostration, coryza, sore throat and cough. The infectious agents, Influenza A, B, and C, are RNA viruses of the orthomyxovirus group. A is the most common and associated with widespread epidemics and pandemics. It has been the predominant agent of influenza in the Central Plains in the last several years. Influenza B can be associated with regional or widespread epidemics. Influenza C is rare.

Laboratory diagnosis of influenza can be provided through rapid test kits. These rapid tests are FDA approved and are CLIA classified as “moderately complex”. DFA and culture are “highly complex”. A list of tests with sensitivity and specificity are listed below.

TEST SENSITIVITY SPECIFICITY

TAT = Turn around time NP aspirate NP swab NP aspirate NP swab

Directigen Flu A, B (BD)

Influenza A&B A 96% 89% 91% 90%

(distinguishes the two)

TAT: 1 hour B 88% 71% 98% 100%

Flu OIA (Biostar)

A&B, does not distinguish 88% 83% 69% 76%

the two

TAT: 1 hour

Quick-Vue Influenza (Quidel)

A&B, does not distinguish

the two 81% 73% 99% 96%

TAT: 10 min. AND test

must be performed within

1 hour of specimen

collection

Direct Immunofluorescence(DFA)

Referral: USD-SM

Virology; distinguishes 92% NA 99% NA

A&B

TAT: 2 hours

Culture

All respiratory viruses 100% NA 100% NA

TAT: days

Confirm clinical diagnosis of influenza using a rapid test to avoid inappropriate use of antibiotics and antiviral agents. Specimen choice is the NP aspirate from infants, children AND adults. The throat specimen is only slightly better than flipping a coin. During many flu seasons, Influenza and RSV coincide. In-lab validation studies, which are required by CLIA/CAP, must rule out cross reactivity.

Do not use influenza kits out of season. Predictive value theory supports high false positive rates when influenza is not in the community. Watch for news releases and information from SD Dept of Health for timely use of rapid test kits. Use of DFA Respiratory Battery testing and/or Culture if DFA is Negative should be considered for patients with negative rapid influenza tests and remain symptomatic for viral disease or for patients hospitalized with their illness. Treatment for Influenza is with Rimantidine (A only), Oseltamivir (or Tamiflu-A and B), or Zanamivir (Relenza-A and B).

*This information was provided by the Sioux Falls Task Force on Antimicrobial Resistance (TFAR)

Influenza 2000-2001

TEST SENSITIVITY SPECIFICITY

TAT = Turn around time NP aspirate NP swab NP aspirate NP swab

Directigen Flu A, B (BD)

Influenza A&B A 96% 89% 91% 90%

(distinguishes the two)

TAT: 1 hour B 88% 71% 98% 100%

Flu OIA (Biostar)

A&B, does not distinguish 88% 83% 69% 76%

the two

TAT: 1 hour

Quick-Vue Influenza (Quidel)

A&B, does not distinguish

the two 81% 73% 99% 96%

TAT: 10 min. AND test

must be performed within

1 hour of specimen

collection

Direct Immunofluorescence(DFA)

Referral: USD-SM

Virology; distinguishes 92% NA 99% NA

A&B

TAT: 2 hours

Culture

All respiratory viruses 100% NA 100% NA

TAT: days

*This information was provided by the Sioux Falls Task Force on Antimicrobial Resistance (TFAR)

Prevention of Cytomegalovirus Infection from Transfused Blood Products

The Ad Hoc Committee on Prevention of CMV Transmission of the American Associtation of Blood Banks issued guidelines in 1998 regarding the effectiveness and use of leukoreduction in the prevention of CMV infection. They conclude that “leukoreduction, by any method capable of achieving a residual leukocyte count of <5 x 10⁶ , allows for the reduction of transfusion transmitted CMV to a level at least equivalent to the level occurring with the use of CMV-seronegative components transfused to CMV-seronegative recipients.” CMV-seronegative products and leukoreduced products are termed CMV-safe.

Based on available information and the guidelines of the American Association of Blood Banks, the following recommendations are made:

1. Leukoreduced blood products be used in place of CMV-seronegative products

for those individuals at risk for developing CMV infection.

2. The guidelines listed below be used when deciding whether or not CMV-safe

blood be used for a patient.

Recommended* Use of CMV-Safe Blood Products

Clinical Category CMV Status Need for CMV-safe Blood

General hospital patients and

general surgery patients

(including cardiac surgery; CMV (+) patient Not indicated

patients receiving chemotherapy

not intended to produce CMV (-) patient Not indicated

severe neutropenia;

patients receiving steroids)

Patients receiving chemotherapy

intended to produce severe CMV (+) patient Not indicated

neutropenia; pregnant patients;

HIV infected patients CMV (-) patient Indicated

Solid organ allograft patients CMV (+) recipient Not indicated

who do not require massive CMV(-) recipient of

transfusion support CMV (+) donor Not indicated

CMV (-) recipient of

CMV (-) donor Indicated

Patients receiving allogenic and CMV (+) recipient Not indicated

autologous hematopoietic CMV (-) recipient of

progenitor cell transplants CMV (+) donor Indicated

CMV (-) recipient of

CMV (-) donor Indicated

Infants, whether full term CMV (+) patient Indicated

or premature CMV (-) patient Indicated

* Recommendations of the AABB as modified by Avera McKennan Medical Staff