Sacred Heart Hospital, Queen of Peace Hospital, McKennan Hospital and St. Luke's Midland Hospital are a few of the more than 95 hospitals, nursing homes, physician clinics and associated services that are part of the Sioux Falls-based organization.

The Presentation Health System was formed in 1978 as an umbrella for the health ministries of the Presentation Sisters. Since then, the system has grown to include health services sponsored by the Benedictine Sisters of Yankton, community-owned hospitals and nursing homes, physician clinics, and other services such as medical equipment suppliers. There are currently 7,500 Presentation Health System employees in South Dakota, Iowa, Minnesota and Nebraska.

In keeping with the Presentation Health System name change to Avera Health, the PHS Lab newsletter will soon be undergoing a name change as well. Please be watching for these changes in upcoming editions of the laboratory newsletter.

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Compliance Plans:

An important document for your organization.

Corporate and laboratory compliance programs are aimed at preventing and detecting violations of law and other employee misconduct. Sentencing guidelines afford organizations up, to 95% reduction in fines if the organization had an effective compliance program in place before the offending conduct occurred. An effective program will focus on the true risks facing an organization given its size, resources, history, culture, and nature of its business. To have a successful compliance program, it must be practical. Elements that must be included in a compliance plan are

• Written standards of conduct
• Commitment to compliance
• High-level compliance officer
• Education and training of all personnel
• Earnest implementation and enforcement of the plan, including periodic audits of lab operations, sales and marketing, billing _ and coding, pricing, requisition forms and disclosures to physicians
• Procedures to investigate and correct compliance problems
• Open line for employee communication
• Retention of records

To get started on a compliance plan:

1. Enlist support and commitment of management

2. Assemble a compliance team led by the compliance officer

3. Discuss confidentiality issues

4. Protect attorney-client privilege

5. Evaluate and prioritize risk

6. Develop components of the compliance program

7. Communicate and educate

8. Audit and adjust

9. Document, document, document

The advantages of having a voluntary compliance program in place at your organization include-

• The reduction of fines imposed on an organization convicted of certain crimes
• Avoid prosecution for employee misconduct
• Audits, hot lines, and training sessions will help management prevent or detect violations early, possibly in time to correct the problem or limit the damages
• Preparing for an external audit, an organization can protect its legal rights and ensure its preparedness
• Avoid a forced compliance program by the federal government
• Educate the employees to understand the responsibilities and obligations of institutions under federal and state law
• The board of directors are protected when there is an effective compliance program in place
• Protect an organization's reputation
• Improve employee morale within the organization

Along with the advantages there are always disadvantages. These may include such issues as the time, money and managerial resources to put the program in place, as well as the sometimes difficult issue of employee discipline. A compliance plan creates a record of improper behavior, and voluntarily disclosing information from internal investigations can result in fines and penalties, criminal convictions and government investigations. It is also important to prepare a compliance program with care, as a poorly designed or implemented program may result in litigation.

Please contact your PHS Lab network representative for addition information regarding corporate and laboratory compliance plans.

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April 12-18: National Medical Laboratory Week.

This year the nation's medical laboratory workers will be recognized April 12-18, National Medical Laboratory Week. The theme for this year is "Laboratory Professionals: Making the World a Healthier Place", which emphasizes the laboratorian's role as a vital team member in the healthcare and wellness fields.

The laboratory staff of the Presentation Health System would like to recognize their fellow lab workers' contributions to patient care, and wish them some well-deserved recognition during National Medical Laboratory Week.

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Gel Technology - Blood Banking in the 90's.
by Patrick McMahon, McKennan Laboratory

In April of 1997, McKennan Hospital blood bank began using a new method for detecting and identifying red cell related antibodies. This method, called the "ID-MTS Typing System", utilizes gel technology, a new technology in the detection of red cell antibodies. McKennan blood bank is the first facility in South Dakota to use the gel technology procedure.

Advantages of the gel technology compared to the traditional test tube systems are:

• Fewer procedural steps minimize hands-on time
• Standardized procedures simplify interpretation, reducing repeat and/or unnecessary testing
• Clear-cut endpoints promote uniform interpretation among technologists
• Use of precise measurements decreases test performance variability
• Minimal handling of reagents and samples increases biosafety
• Elimination of false-positive reactions due to clinically insignificant cold-reactive antibodies
• Use of specimens collected in EDTA eliminates time delays due to clotting problems in anticoagulated patients
• Completed gel test reactions are stable, allowing for review or observation over an extended period of time

The gel test was developed and patented in 1985 by Dr. Yves Lapierre of Lyon, France. In the United States, the gel test is distributed by Ortho Diagnostic Systems Inc., under the name "ID-Micro Typing System." The gel test uses a plastic card with microtubes instead of test tubes. A gel card is approximately 5x7 cm and consists of six microtubes, each containing predispensed gel, diluent, and, if applicable, reagent. The top of the gel card is sealed with a foil strip, preventing spillage or drying of the microtube contents. This compact card allows ease in labeling multiple tests and minimizes the number of test tubes manipulated by testing personnel.

Each microtube is comprised of an upper reaction chamber that is wider than the tube itself, and a long narrow portion called the column. Test reactants are added to the reaction chamber and incubated at 37 C for 15 minutes. After incubation, the card is centrifuged for 10 minutes and read. The gel particles are porous and serve as a reaction medium and filter. Large agglutinates trap in the gel and are not allowed to travel through during centrifugation, while unagglutinated red cells may travel unimpeded through the length of the microtube, forming a pellet at the bottom. Any agglutinated red cells present remain fixed or suspended in the gel. The actual agglutination reactions in the gel test are graded similar to test tube hemagglutination. Unlike agglutination observed with traditional test tube hemagglutination methods, the gel test reactions are stable, allowing for observation or review over an extended period of time.

Institutions are required to demonstrate that any new procedure or test system can obtain comparable results to the process being replaced, in terms of result accuracy and reliability. Staff at the McKennan blood bank ran comparison tests for the ID-MTS gel system and the previous LISS (AES) system. Acceptable sensitivity and specificity levels were set at greater than 95%. 100 serum samples and 73 plasma samples were selected for this study. 16 of the serums and 11 plasma samples had previously identified antibodies. One of these previously identified serum samples reacted so weakly in AES that it would probably have been interpreted as negative without the previous history. The gel results for this specimen were 1+ and identified the previously known antibody. All plasma samples reacted in gel with the same strength as their corresponding serum samples, and all gel reactions were equal to or greater in strength than the corresponding AES test. Approximately 20 crossmatches were done with the gel method and all correlated with the known crossmatch results. The sensitivity and specificity of the gel tests were 100%, as all previously known antibodies were detected by this method using both serum and EDTA samples.

The excellent sensitivity, specificity, and numerous advantages make the gel method a very acceptable replacement for the AES procedure. Since switching to the gel method, the McKennan blood bank staff have been very pleased with its performance.

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SDSCLS Spring Convention Planned.
The 50th Annual SDSCLS Spring Convention will be held April 22-24 at the Crossroads Hotel in Huron, SD. An SDSCLS/CLMA spring meeting will be held in conjunction with the convention. A variety of programs covering many areas of laboratory work will be offered during the three-day period, including management issues and Internet training. An exhibit hall will also be featured, with an exhibit hall night and prizes as part of this year's line-up of activities. There will also be a special 50th anniversary celebration and awards program.

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Question of the Quarter.

A: Compliance 2000 is a term used to describe the movement companies are taking to ensure that the computers they are using will work without problems in the year 2000. The problem stems from the way computers store and calculate the year. Back in the mid-1960's, when computers were first making their way into the working world, storage space on the hard disk was very expensive. Computer programmers minimizes date data storage by storing the year as a two-digit number instead of a four-digit number. This means the year 1999 will be stored as "99" and the year 2000 as "00" (which may be recognized as the year 1900.) This creates a negative change in date and may cause the software program to fail. Early programmers also did not use all the calculations necessary to calculate leap years. The three rules which the Gregorian calendar uses to determine leap years are as follows:

1. If the year is divisible by 4 it is a leap year, unless

2. The year is also divisible by 100, then it is not a leap year, unless

3. The year is also divisible by 400, then it is a leap year.

So computers that calculate days may not recognize the year 2000 contains 366 days instead of 365 days.

How serious is the problem? The problem is very widespread because it affects hardware (BIOS, real-time clocks). Think of all the information systems that you use today that include date data storage, such as banking systems, phone system, the federal government, etc. The list of systems that affect your daily life is almost endless. The cost of checking all the systems and correcting their date data storage problems will be significant. Companies that do not prepare for the new millennium may find themselves paralyzed come the year 2000.

So how does this affect my lab? Most automated laboratory instruments have internal clocks to record the date and time diagnostic testing is performed. All of these diagnostic instruments should be checked to see if they will operate past 23:59, December 31, 1999, and preparations for this coming event should be done now.

Here are some questions you may want to ask your equipment vendors:

1. Are there any date fields used by the instrument? Are those date fields two or four digits? Does it accept any dates directly from the user? How does the user specify the year?
2. How does the instrument calculate leap years? Does it use all three Gregorian rules?
3. Are dates stored internally as a specific "date" data type? Is this done using a base year or with an offset of the number of seconds/minutes/hours/days/weeks since that base date?
4. Are two-digit years allowed/used for input, internal processing, data storage, and or input?
5. Are any special values for date fields used?
6. Does the instrument directly import or export date data to any other application and/or system? If so, can these applications and/or systems handle leap year, 2 digit dates, and dates after the year 2000?
7. When will solutions for any identified date-related problems be made available? Will maintenance be required? Will there be a charge for the update?

Requesting this information from vendors of any equipment you are currently using in your laboratory as well as any new instrumentation you may purchase in the near future will give you a good idea of how your laboratory instrumentation will perform upon the arrival of the year 2000.

Editors note: Our thanks to Warren Erickson, lab director of Sacred Heart Hospital in Yankton, for providing the answers to this "Question of the Quarter".