CLINICAL LABORATORY STRATEGIES
MANAGEMENT ALERT 

LifeScan to Pay $60 Million to Settle Defective Glucose Meter Claims 
Company Says Current SureStep Products Not Affected by Defects

Washington, D.C., December 21, 2000- Last Friday, LifeScan, Inc. (Milpitas, Calif.), a subsidiary of Johnson & Johnson, pled guilty to charges that it knowingly manufactured and sold defective SureStep glucose meters in the mid-'90s. The company was ordered by the U.S. District Court for the Northern District of California to pay a criminal fine of $29.4 million and civil penalties, damages, attorneys' fees and restitution to the United States for $30.6 million. 
The U.S. Attorney's Office in the Northern District of California note in a recent press release that, "LifeScan admitted in pleading guilty to the charges that it failed to advise customers about two defects in the product and failed to file Medical Device Reports with the FDA on some of the illnesses and injuries reported. The reports LifeScan did file with the FDA contained false, incomplete or misleading information in that they failed to disclose the existence of either the error defect or incomplete strip insertion problem." 

According to the plea agreement, LifeScan's SureStep brand blood glucose monitoring systems that were manufactured and distributed between May 1996 and August 1997, had two defects that would cause the meters to display problematic readings. One, a software defect, caused the SureStep to sometimes display an error message instead of a "HI" at blood glucose levels above 500 mg/dL and to always display an error message instead of a "HI" at blood glucose levels above 600 mg/dL. The second defect arose when the monitor's test strip was almost, but not quite, fully inserted. An "Incomplete Strip Insertion" could result in the meter displaying readings that were up to 90% less than the user's actual blood glucose level.
Court documents stated that during 1996, 1997, and 1998, LifeScan received over 2,000 SureStep customer complaints of inaccurate low readings, some of which were attributable to incomplete strip insertion, and over 700 complaints regarding error messages, some of which were attributable to high blood glucose. At least 61 of the error complaints were associated with illness or injury, including some hospitalizations. In court documents, one woman reported that her SureStep had given her a reading of 160 mg/dL at 7:30 a.m., yet her physician's meter two hours later showed that her glucose level was 545 mg/dL, resulting in her hospitalization for hyperglycemia.

In addition to paying the fines, LifeScan will be on probation for three years, meaning that the Food and Drug Administration and U.S. Probation Office will oversee certain aspects of the corporation's functioning. In addition, LifeScan entered into a Civil Compliance Agreement with the Department of Health and Human Services (HHS) which provides for additional oversight of LifeScan by HHS.

Upon announcement of the settlement, the law firm of Milberg, Weiss, Bershad, Hynes & Lerach put out a press release stating that Johnson & Johnson and LifeScan still face an ongoing class-action lawsuit brought by the law firm on behalf of more than 400,000 Americans with diabetes who purchased the defective monitors and the test strips that are used with the monitors. The suit-pending in federal court in San Jose, Calif.-is seeking several hundred million dollars in damages and restitution, and also asks the court to order LifeScan and Johnson & Johnson to "disgorge profits the companies allegedly reaped through untrue and misleading advertising and fraud perpetrated on consumers," said the law firm.

In the meantime, lab directors should check all of their SureStep monitors to be certain they were manufactured after August 1997 and that they are using SureStep strips manufactured after March 1998. Also, be aware that you could experience problems with the Lifescan FastTake Meter if you use the millimoles per liter (mmol/L) setting. The company announced in early November that a small number of FastTake Meters set to "mmol/L" may display test results that show a Y-shaped, non-numeric character in the "ones" position. Please contact the company if a "Y" appears on your meter (see information about this potential problem on the Lifescan web site at <http://www.lifescan.com/lsabout/press/fasttake_letter.html>.
There are at least three web sites with information on the settlement if you would like to read more about it. The actual court documents can be found on the U.S. Attorney's Internet site at: 

The U.S. Attorney's Press Release can be found at: 

A press release from the attorneys who are pursuing the class action lawsuit can be read at:

A press release from LifeScan can be found at:

A press release from Johnson & Johnson can be found at:

This Management Alert is provided by Clinical Laboratory Strategies.


CASE STUDY

Young woman came to the emergency room with complaints of abdomen pain because she could not void. 
The dysuria started a week ago. She also had been vomiting. She has had a headache for a week with 
general malaise, and bouts of confusion. Upon examination her neck was stiff on flexion, and there were lesions on her vaginal area consistent with herpes genitalia.

Laboratory results: cbc parameters and crp were normal; slightly elevated ast. Urinalysis showed small blood, moderate leukocyte esterase with microscopic showing 15-20 wbc/hpf, 2+ bacteria, and 2-4 epithelials/hpf. Cerebral spinal fluid: clear, colorless; 532 wbc (H) 2% neutrophils and 98% lymphocytes, 25 rbc, 43 glucose, 128 total protein (H); gram stain showed few wbc, no bacteria , culture no growth; Meningitis panel negative, India ink negative, fungal culture negative; positive for herpes titer.

Her final diagnosis was herpes encephalitis, herpes genitalia, and urinary tract infection. Treatment was acyclovir and antibiotics.


TACROLIMUS AND ATOPIC DERMATITIS

Tacrolimus is an immunosuppressant that downregulates T-cell activity and proliferation, and was initially approved for prevention of allograft rejection. Since 1998, this drug has gained considerable focus after preliminary data showed promising for treatment of some dermatological conditions. Generally given intravenously, studies have shown that an ointment of 0.1% tacrolimus is an effective treatment for atopic dermatitis in adults and children. 

Rapid onset of action, minimal systemic absorption, and safe head and neck application are all of obvious benefit to the patient. Unlike corticosteroids, tacrolimus doesn't thin the skin, which can be permanent. Some people have tissue paper skin and bruise easily with chronic corticosteroid use. The face is of special consideration because it is most susceptible to steroid side effects.

Many physicians and parents of children with the atopic dermatitis hope the drug will prove valuable for pediatric use. Studies have shown already that tacrolimus is clearly more effective than placebo. Although degrees of improvement varied, all children in the study showed measurable improvement. The incidence of side-effect is low, usually marked by a burning sensation. Tacrolimus can be safely applied to the face, and systemic absorption is minimal and tends to decrease as lesions heal and normal cutaneous barrier function returns. 

Atopic dermatitis is a chronic skin condition that affects about 10% of children in the United States. It is characterized by chronic skin inflammation, redness, areas of hard, rough skin and severe itching complicated by staph bacterial infections. It significantly impacts quality of life, causing school absenteeism and 
occupational disabilities, and can hamper social interaction and disrupt sleep.


CLIENT SERVICE SPOTLIGHT

Terri Mingo is employed by Avera Sacred Heart. She is a Medical Technologist and is the supervisor of the Microbiolgy Department. She has worked at Avera Sacred Heart for 12 years. Terri grew up in Tracy, Mn. and later attended SDSU in Brookings, SD. She received her Bachelors of Science in Medical Technology and did her internship at Marion Health Center in Sioux City, Iowa. Her family includes her husband Dave and her two children, Ryan (15) and Megan (6). Their hobbies are fishing, hunting and reading books. When asked about her favorite aspect of her job, Terri says that the working in Microbiology has been rewarding and she enjoys solving problems. 


CLIENT SERVICE SPOTLIGHT

Katherine (Kay) Remily has been employed by Avera St. Lukes for 32 years. She is a Client Service Representative and is the Hematology/Coagulation Technical Specialist. Kay's undergraduate work was done at Mount Marty College and her internship was at Sacred Heart Hospital in Yankton. Her hometown is Aberdeen.

Kay and her husband Clarence have two children, Lisa and Daniel. In her free time, Kay enjoys reading books about mysteries, travel, or history (but not historical novels). She finds time for some volunteer work and is busy with do-it-yourself projects in the new home they just purchased.

Kay comments that "our profession is so varied that there is always something to learn. I have often felt fortunate that I've had the opportunity to work as a Laboratory Professional." Her favorite aspect of her job is the people she works with and the people she meets through work. Kay says " We have about "five" minutes to establish a good relationship with our patients", and Kay makes the most of those "five" minutes.


OSHA ISSUES ERGONOMICS FINAL RULE

The Occupational Safety and Health Administration (OSHA) has published their ergonomic final standards that will require most workplaces, including hospitals and health systems, to improve working conditions that put employees at risk for developing certain musculoskeletal disorders (MSDs). To read the standards in the November 14 Federal Register, go to 
www.access.gpo.gov/su_docs/fedreg/a001114c.html.


EDITOR'S NOTES

January is traditionally a time when it is difficult to recruit blood donors. January is National Volunteer Blood Donor Month and highlights the importance of giving the gift of life through the donation of blood. Every three seconds someone needs blood. Each day, patients across the country receive approximately 32,000 units of blood. The demand for blood is greater today than ever, and the nations supply needs constant replenishment. An estimated 8 million people donate in the United States each year, but many more donors are needed. Accident victims, surgical patients, patients receiving treatment for leukemia, cancer, or other diseases, all utilize blood. An auto accident or gun shot wound alone, can require up to 20 units of blood. 

We need to do what we can to promote blood donation in our communities. Do what you can to promote blood drives at your schools, churches or places of business. Encourage people to stop in at the blood collection centers on their next shopping trip to Sioux Falls. Set an example for your children or the children you know, so that they will grow up to be blood donors like you. 

Quick Blood Facts

BLOOD BANK CODING & COMPLIANCE UNDER APC'S

Since the implementation of APC's in August 2000, major changes have been made by HCFA regarding proper billing of Blood Bank procedures including the pre-transfusion workup, the Blood Product, and the administration of the Blood Product.

Information received from the Claims Processing/Billing Q&A's on the HCFA OPPS Medical Learning website: http://www.hcfa.gov/medlearn/faqclaim.htm states the following:

HCFA has changed the way blood use is to be billed. They will pay the following:

You may not bill for blood processing and storage, since those costs are captured in the payment rate assigned to the blood or blood product. If you bill for processing and storage, rather than units of blood, your claims will not be paid. Fiscal 
intermediaries were to change their revenue code edits to reflect these changes effective 12/11/00. 

Although the Fiscal Intermediary is aware of these instructions as of early January 2001 the South Dakota Fiscal Intermediary was not accepting any Outpatient claims for Blood Transfusions, regardless of what codes were used. You are encouraged to make sure your billing procedures are update to accommodate the new HCFA billing guidelines.

Listed below is an "example" of the more common Blood Products, the APC, HCPCS and Revenue codes for each of them as well as the National payment rate as published Dec. 1, 2000 in AABB Weekly Report P.2. 

GUIDELINES ENDORSE F.I.S.H. TESTS FOR PRENATAL SCREENING

The American College of Medical Genetics and the American Society of Human Genetics have endorsed the use of fluorescence in situ hybridization (FISH)-based genetics tests for prenatal screening. The endorsement comes in the form of a position paper published in the November/December 2000 issue of Genetics in Medicine.

The position statement details the circumstances in which prenatal FISH is standard practice and defines what currently available assays can and can't tell a provider about a fetus. The paper also describes the populations of pregnant women that will receive the greatest benefit from FISH testing.

Genetics in Medicine is the official journal of ACMG. For more information, visit ACMG's Web site at http://www.faseb.org/genetics/acmg/acmgmenu.htm. To see the position paper, go to the journal's web site at http://www.wwilkins.com/GIM/GIM111200toc.html.


BLOOD DEDUCTIBLE - MEDICARE PART B

Where blood is furnished on an outpatient basis, it is subject to the Medicare Part B blood deductible. 
The Part B blood deductible is applicable to the first three pints of whole blood or equivalent units of packed red cells received by a beneficiary in a calendar year. This special blood deductible applies only to charges for:

The following services are NOT subject to the blood deductible:

Charges applied toward the blood deductible DO NOT count as incurred expenses toward the annual cash deductible. The blood deductibles are in addition to any other applicable deductible and/or coinsurance amount for which the beneficiary 
is responsible.

This applies to the following states: Alaska, Arizona, Colorado, Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and Wyoming.


MEDICARE REQUIREMENTS DEALING WITH PHYSICIAN ORDERS.

Medicare does stipulate that a laboratory test or other diagnostic test must be ordered by the beneficiary's treating physician. The physician's signature on a requisition is not the only permissible way of documenting that a test has been ordered. Under CLIA rules, a lab may perform services at "the written or electronic request of an authorized person, or in the case an oral request, only if the lab requests a written authorization for the testing within 30 days."

TOP TEN LIST OF DEFICIENCIES DETECTED IN INSPECTIONS

Here is a recent list of the most often sited deficiencies identified by HCFA, JCAHO and CAP. 
Knowing these can be helpful in preparing for inspections.

HCFA

  1. QC procedures using at least 2 controls per test per day and documentation of QC activities.
  2. Compliance with manufacturer's directions.
  3. QA evaluation of total testing process.
  4. Lab director specifying the responsibilities of personnel and assuring education and training.
  5. Name, address of lab and analyst's initials on test reports.
  6. Enrollment in a proficiency testing program.
  7. Procedure manuals available that describe testing and reporting of patient results.
  8. Calibrating or checking calibration at least every 6 months.
  9. Verification at least twice a year of analytes not included in proficiency testing.
  10. Lab director assuring the competence of personnel.

JCAHO

  1. Surveillance of results daily.
  2. Remedial actions.
  3. Evaluation of analytical equipment.
  4. Review and remedial action for proficiency testing.
  5. Equipment preventive maintenance.
  6. QC of microbiology media.
  7. Adequate bench space.
  8. Compliance with legal safety requirements.
  9. Temperature documentation.
  10. Test and control records for waived tests.

CAP (1995) some may no longer apply.

  1. In absence of supervisor, review of results on next shift.
  2. Reference ranges on test report.
  3. Incomplete reagent labeling.
  4. Verification of linearity.
  5. System to document errors.
  6. QC review daily.
  7. Absence of QC.
  8. Proficiency testing.
  9. Corrective action for out of control situations.
  10. Written QC program and QC records.

Source: What's New With CLIA '88, JCAHO, & CAP by Sharon S. Ehrmeyer, Ph.D.
Complete article can be accessed at http://www.westgard.com/guest6.htm.


APPENDIX PP RETENTION OF LABORATORY RECORDS AND MATERIALS CAP APPROVED NOVEMBER 2000

The College of American Pathologists makes the following recommendations for the minimum requirements for the retention of laboratory records and materials. They meet or exceed the regulatory requirements specified in CLIA 88. The College of American Pathologists urges laboratories to retain records and/or materials for a longer period of time than specified when such would be appropriate for patient care, education or quality improvement needs. Some state regulations may require retention of records and/or materials for a longer time period than that specified in the CLIA 88 regulations; therefore any applicable state laws should be reviewed carefully when individual laboratories develop their record retention policies.

Materials/Record Period of Retention
General Laboratory

Accession log records 2 years
Maintenance/instrument maintenance 2 years
Quality control records 2 years

Surgical Pathology

Wet tissue 2 weeks after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years

Cytology

Slides (negative-unsatisfactory) 5 years
Slides (suspicious-positive) 5 years
Fine needle aspiration slides 10 years
Reports 10 years

Non-Forensic Autopsy Records

Wet tissue 3 months after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years

Forensic Autopsy Records

Wet stock tissue 3 years
Wet tissue of whole organs 3 months
Paraffin blocks 20 years
Reports Indefinitely
Slides Indefinitely
Gross photographs/negatives Indefinitely
Accession log records Indefinitely
Serum/CSF/Urine 2 years
Whole blood 6 months
Dried blood stain or frozen tissues for DNA Indefinitely
Frozen tissue for toxicology 6 months

Clinical Pathology Records

Patient test records 2 years
Serum/CSF/Body fluids (except urine) 48 hours
Urine 24 hours
Peripheral blood smears/body fluid smears 7 days
Permanently stained slides - microbiology (gram, trichrome, etc.) 7 days

Cytogenetic Records

Slides 3 years
Wet specimen/tissue Until adequate metaphase cells are obtained
Fixed cell pellet 2 weeks after final report
Final reports 20 years
Diagnostic images (digitized or negatives) 20 years

Blood Bank

Donor and recipient records Indefinitely
Records of employee signatures, initials and identification codes 10 years
Quality control records 5 years
Records of permanently deferred donors Indefinitely
Specimens from blood donor units and recipients 7 days post-transfusion

CALENDAR

Mark your calendars for April 6, 2001 Workshop

Clinically Relevant Cost Effective Community Hospital Microbiology
Location: Avera McKennan Auditorium
Speaker : Dennis Wegner Ph.D./ SM(ASCP)

Look for brochures in the mail soon.....