May/June 2001

EDITOR'S NOTES

I would like to share a poem with you about the glories of summer. To me this poem provides a mental vacation, and leaves me feeling refreshed and smiling. We often think, if only we could have those precious days back, being kids again with out any worries. While that may not be physically possible, we can always be kids at heart. Take the time walk barefoot through the freshly mown grass, play in the sand, eat an ice cream cone, or go to a playground and swing on the swings. It truly is the simple things in life that provide the most enjoyment and it puts life back into perspective. Let the child in you come out! 

Come with me, no shoes allowed, let's go barefoot in the grass.
Hold my hand, as we remember, all the summers of the past.
Eating ice cream in the sunshine, as it dribbles down our arms.
Playing hopscotch and singing songs, like "Old McDonald had a farm"
Orange soda and Kool-Aid pops and cooking hotdogs on the grill.
Trying to see who the strongest was, who would be King of the Hill.
Sitting by the lakeside, squishing sand between our toes.
Chasing fireflies in the night sky, never knowing why they glowed.
Summer rains that gently fell and washed my little face. 
Sitting down at supper time, with family saying grace. 
Thank you Lord for giving me these precious memories.
Older now but remembering, with every summer breeze.

Written by Linda Edge 1998

Have a wonderful summer!!
Lori Murray

The principle for the erythrocyte sedimentation rate (ESR) is based on anticoagulated blood that when allowed to stand undisturbed, the red blood cells settle out to the bottom of the tube. Various factors will affect the ESR, such as red blood cell size and shape, plasma fibrinogen, and globulin levels, as well as mechanical and technical factors.

Red blood cells in normal whole blood do not form rouleaux. Therefore the red blood cell mass is small and the ESR is decreased (cells settle out slowly). Red blood cells in an abnormal condition can form rouleaux, increasing the red cell mass, thus increasing the ESR (cells settle out faster). Large red cells settle faster than small red cells, while fewer cells settle faster than a high concentration of red cells. 

Sedimentation rates are most increased in macrocytic anemia, moderately increased in anemias with low red cell counts, and slow to normal in polycythemia. Sickle cell anemia, thalassemia, and spherocytosis have variations in cell shape which will retard the sedimentation rate because the cells are unable to form rouleaux.

Plasma viscosity will also influence the sedimentation rate. Increased concentrations of plasma proteins (inflammation, multiple myeloma, hyperfibrinogenemia) increase rouleaux thus increasing the ESR. Increased levels of albumin will reduce the ESR. The increased plasma viscosity is the basis of using the ESR as a screening test for inflammation (increased gamma globulins).

The physical environment may affect the ESR. An increase of either tube diameter, angle of tube sides to vertical, temperature, and the presence of vibration may increase the ESR. Standardized tubes held at a specified angle (usually vertical) at room temperature for a specified time period (usually 1 hour) are used in the procedure.

The sedimentation rate may be useful in differentiating among diseases with similar symptoms or to monitor the course of an existing disease. The ESR can be an index to the severity of the disease.

C-reactive protein and erythrocyte sedimentation rate have good correlation, but CRP appears and disappears earlier than changes in the ESR. Therefore, CRP is more likely to be elevated in an acute phase and decreased in an chronic phase, while ESR will be more likely to be decreased in an acute phase and increased in a chronic phase of disease. 

Powers, Lawrence W., Diagnostic Hematology Clinical and Technical Principles, The C.V. Mosby 
Company, ST Louis, Philadelphia, Baltimore, Toronto, 1989

Harmening, Denise M., Clinical Hematology and Fundamentals of Hemostasis, F.A. Davis Company, Philadelphia, 1992, Roche Regeant Insert C-Reactive Protein


HCFA PREVIEWS NEW, SLIMMED-DOWN DRAFT OF LAB ABN
The Health Care Financing Administration continues to inch ahead toward establishing its first standardized format for a Medicare advance beneficiary notice (ABN) for laboratory use. The latest draft, along with a separate one for other Part B services, met with generally favorable reaction when previewed at a Mar. 26 meeting of the Practicing Physicians Advisory Council in Washington, DC. HCFA official Denis Garrison presented the drafts to the panel, which advises the HHS Secretary on Medicare matters. Garrison is director of the consumer protection division of HCFA's Center for Beneficiary Services.

The ABN helps beneficiaries make an informed choice about whether to receive a service, knowing they might have to pay for it because it is not covered or because there is genuine doubt that Part B will pay for it. Among the key features of the latest version of the draft: 

• It has been shortened to a single page. To achieve this, many of the statements from a previous draft have been condensed into two option boxes: "Option 1: Yes, I want to receive these laboratory tests" and "Option 2-No, I have decided not to receive [them]."
• It's up to the beneficiary, not the lab, to let the  physician know that the testing ordered has been declined. When choosing Option 2, the beneficiary agrees to be responsible for notifying the doctor.
• Space is provided for listing the lab tests affected by non-coverage, by frequency limits, or by experimental or research use. While the draft does not include a preprinted list of such tests, as the American Clinical Laboratory Association had recommended, Garrison said the format allows labs to create their own preprinted list of up to 40 tests.
• There is room at the top for a lab to imprint its logo, name, address, and telephone number.

Still at issue: Who has ultimate responsibility for getting the ABN signed? During the PPAC meeting, one member said this should remain with the lab since it likely knows more than the physician about which tests typically require an ABN. Critics retort that labs in many settings don't have contact with the beneficiary before the test is performed, if at all.

Providing the estimated test cost on the form is another sensitive point. Few dispute that a beneficiary should be apprised of the potential financial liability. But from an implementation standpoint, it could prove tricky to nail down the estimated cost. And if the actual cost billed is higher than the estimate, the stage is set for dispute over who should be responsible for the difference.


CLMA Special Alert
THOMPSON ANNOUNCES EFFECTIVE DATE FOR HIPAA PRIVACY RULE WILL NOT BE DELAYED

In an unexpected move, Department of Health and Human Services (HHS) Secretary Tommy Thompson has announced today that the Bush Administration will not delay the effective date for the privacy rule mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 beyond April 14, 2001. Entities will have until April 2003 to be in full compliance with the rule, while smaller facilities will have an additional year to comply. 

This decision comes despite the fact that HHS extended the comment period 30 days until March 31, 2001 and has received more than 24,000 written comments. It also follows 2 months of meetings between HHS, the White House, and a diverse group of lawmakers, interest groups, health-care leaders, and private citizens.

Thompson stated "President Bush wants strong patient privacy protection in place now" and that Bush considers this "a tremendous victory for American consumers." Nonetheless, Thompson stated that HHS will "keep the comments in mind" as HHS "continues to make sure patients receive the highest quality care and begins the process of issuing guidelines on how the rule should be implemented."

To read a copy of the Press Release containing Secretary Thompson's announcement, visit www.os.dhhs.gov .

CLMA will continue to monitor this issue closely. For a detailed guide on HIPAA and what clinical laboratories need to know to comply, please refer to your special HIPAA issues of Vantage Point from April 9 (Vol 5, No 7) and April 23 (Vol 5, No 8).

Contact: Katharine I. Ayres, Director of Health Care Policy, kayres@clma.org <mailto:kayres@clma.org>.

CLMA
989 Old Eagle School Road, Suite 815, Wayne, PA 19087
610/995-9580, 610/995-9568 (FAX)


CASE STUDY 

This patient is a 63 year old female. Initial CBC results were as follows:

WBC 3.08 x 10 3cells/ uL
RBC 2.09 x 10 6cells/ uL
HGB 10.3 g/dL
HCT 18.9 %
MCV 90.3 fL
MCH 49.5 pg
MCHC 54.8 g/dL
CHCM 37.9 g/dL
RDW 30.5 %
PLT 129 x 10 3 cells/uL

Automated results showed two red blood cell populations and very abnormal indices. Smear showed very clumped RBC's. Specimen was warmed and ran again through automated analyzer. Results as follows:
WBC 3.42 x 10 3cells/ uL
RBC 3.40 x 10 6cells/ uL
HGB 10.4 g/dL
HCT 29.0 %
MCV 85.4 fL
MCH 30.5 pg
MCHC 35.7 g/dL
CHCM 37.2 g/dL
RDW 14.5 %
PLT 108 x 10 3cells/uL

The warmed specimen shows only one red cell population and subsequently normal indices, except for the increased MCHC depicting spherocytes. 

Pathology examination reveals laboratory data WBC 2,400 with an automated differential of 69% 
segmented neutophils, 22% lymphocytes, 6% monocytes, 1% eosinophils, 1% basophils. RBD 3.5 
million, hemoglobin 10.4 gm/dL and hematocrit 29%. Indices MCV 85, MCH 39 and MCHC 35. The platelet count is 105,000.

The specimen was analyzed both by warming and the sample and native unwarmed sample. The unwarmed sample shows a biphasic red cell population, and the warmed sample shows a uniphasic red cell population. This study would suggest cold agglutinins where the agglutinated cells form a separate cell population on the histogram. Examination of blood smear made from a warm sample reveals normocytic to microcytic red blood cells. The platelets appear decreased in numbers. The white blood cells show a slight decrease in numbers with a manual differential of 57% segmented neutrophils, 11% bands, 20% lymphocytes, 12% monocytes. Red cell morphology shows 4+ rouleaux and 3+ spherocytes. Examination of unwarmed peripheral blood smear shows red cell clumping that is extremely marked. Findings suggestive of mild pancytopenia and red cell agglutination compatilble with cold agglutinin.


BILL WOULD BAR PATHOLOGY TC BILLING CHANGE

Legislation has been introduced in the House and the Senate to preserve indefinitely the ability of independent laboratories to bill Medicare globally for anatomic pathology services to hospital inpatients and outpatients.

Under a "grandfather" exception enacted late last year and expiring on Jan. 3, 2003, an independent lab may continue to bill Medicare directly for the technical component (TC) of pathology services if the hospital used an independent lab for these services as of July 22, 1999. The Health Care Financing Administration had proposed requiring such labs to bill the TC to the hospital, as of last Jan. 1. The agency argued that the TC reimbursement is included in hospital prospective payments.

The president of the College of American pathologists, Paul Bachner, MD, praised the new bills as especially helpful "to small hospitals in rural areas that depend on independent labs for high-quality, timely pathology services." CAP had lobbied hard to prevent HCFA from changing TC billing policy. Making the "grandfather" exception permanent is a key legislative priority of the College (NIR, XXII, 10/Mar. 12, '01, p.3). Capitol Hill observers say the bills are not likely to move on their own, but would have to be attached to broader legislation, as was the case with the "grandfather" exception which was nested in last year's omnibus Medicare "giveback" package.

In approving the "grandfather" provision, Congress also directed the General accounting Office to conduct a study of its impact on the Medicare program and on beneficiary access and whether it should be extended to more hospitals. The recently introduced bills would render that study moot.


OSHA SET TO ENFORCE NEEDLESTICK ACT IN JULY, 2001

Early last month, the U.S. Occupational Health and Safety Administration announced that the revised Bloodborne Pathogens Standard would take effect April 18, 2001. The agency also announced that a 90-day education period was being launched, pushing the enforcement date to July 17. The revision is mandated by enactment of the Needlestick Safety and Prevention Act signed into law on November 6, 2001. The legislation adds two definitions and modifies a third, increases reporting requirements, adds an entire new section and inserts an additional requirement for exposure control plans.

The definition of "engineering controls" reads "controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace." The legislation also adds two new definitions. The term "sharps with engineered sharps injury protection" is to be defined as "a nonneedle sharp or a needle device used for 
withdrawing body fluids, accessing a vein or artery, or administering medication or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk or an exposure incident."

The term "needleless systems" is defined as "a device that does not use needles for (1) the collection of bodily fluids or withdrawal of bloody fluids after initial venous or arterial access is established; (2) the administration of medication or fluids; or (3) any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps."

The revised standard also requires that sharps injury logs include the type and brand of device involved, the department or area where exposure incidents occur an explanations of how incidents occur. A new section the act adds to standard provides that employers solicit the input of frontline healthcare workers in the selection of safety devices and increases the reporting requirements for accidental needlesticks. 

In addition to the existing requirements for exposure control plans, the standard now mandates that an employer's review and update of their plan must "reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens" and "document consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure."


CLIENT SERVICE SPOTLIGHT

Bonnie Fuerst has been employed with Avera Queen of Peace for 24 years. She is the Chief Laboratory Technologist. Bonnie attended Dakota Wesleyan University and received her AA degree in Medical Laboratory Technology in 1977, and received her Bachelor of Arts degree in 1980 with a double major in Biology and Chemistry. 

Bonnie's hometown is Mitchell. Her husband Gary works at Cablela's. She has a 20 year old daughter, Katie, who is attending DWU, and a 5 year old daughter, Tatum, who will enter kindergarten in the fall of this year. They have a Sharpei puppy named Yogi Bear and a cat named Whiskers. Her hobbies include working with the Parish Nurse Council at church, reading, shopping, and acting in area Community Theater productions. 

When asked about her favorite aspects of her job, Bonnie comments that supervising the lab and being involved in the "total picture" of management has been very challenging and rewarding. She was micro supervisor for 18 years, and now supervises all areas of the laboratory on a daily basis. 

Bonnie goes on to state, " I have loved the opportunity to grow and develop my career and life with the Sisters' organization, and would like to thank them from my heart for all they have done for me." 


NOTABLE 2001 CPT CODING CHANGES FOR POCT

CPT Code 82465-Cholesterol code added the term "whole blood"

CPT Code 82945-New code for glucose which differentiates between blood and body fluids

CPT Code 82947-Glucose code revised to reflect a quantitative blood glucose other than by reagent strip

CPT Codes 83012, 83014-Codes for Helicobacter pylori. Description deleted "breath testing" 
terminology. By deleting I, the procedures either allow for breath or blood specimens to be tested.

CPT Code 87072-Many tests can be coded with this number including cultures, bacterial identifications, 
commercial kits (except urine), etc. The code is now deleted from CPT in 2001 and as of April 1, 
can no longer be used. Laboratorians should delete this code from their billing records and 
move it over to the cross-referenced CPT codes of 87076 or 87077 for a definitive identification.

CPT Code 88400-A new code for bilirubin identified in a new section called "transcutaneous testing"

Taken from: Brother, Can You Spare a Dime? 
Advance for Medical Laboratory Professionals, 
April 2, 2001, Volume 13, Number 7.

NEO BILIRUBINS OFFERED AT AVERA MCKENNAN

Beginning April 18, Avera McKennan instituted a new method for performing neonatal bilirubin testing. The analysis is based on a reaction with a diazonium salt to produce a highly colored dye. The color intensity is proportional to the amount of bilirubin present. The test code is Total Neonatal Bilirubin or Fractionated Neonatal Bilirubin. For further information contact Avera McKennan Regional Laboratory client services.