How to Document Correctly

Appropriate, consistent and accurate medical record documentation is essential to maintaining the integrity of the medical record. Keep the following in mind regarding documentation:

• Illegible records make evaluating the level of

care difficult

• Legible and thorough documentation are

essential components to maintaining adequate

patient histories and providing a defense in the

event of a malpractice allegation. Transcribed or

computerized reports help reduce problems

of illegibility

• Reports that identify the physician by full name

or initials help provide a history of who provided

care

• The patients name or other identifier on all

sheets in the record helps to ensure that proper

care is given to the correct patient

• A method to verify the content and accuracy of

the report is a tool that can improve

documentation

• Documentation made contemporaneously with

the patient’s visit ensures better recall of the

encounter and a more accurate record

• Initialed, timed, and dated entries complete a

record and provide a history of who provided

care

FETAL FIBRONECTIN UPDATE

Re: Invalid Result

In the past few weeks we have discovered that on rare occasions the testing of a fetal fibronectin specimen results in an “Invalid” reading on the instrument (unable to determine if positive or negative for FFN).

Possible reasons for “Invalid” results included the following:

1. Atypically high concentration of fibronectin due to

amniotic fluid. (The assay is intended to be used

on women with intact fetal membranes).

2. Interfering substances

• Contaminants (Contraindications include soaps

and lubricants).

3. Sample Matrix

The ADEZA Biomedical Corporation has assured

us that these invalid results occur infrequently.

An invalid result will be reported and called to you by our laboratory as “Indeterminate” with the comment “possibly due to specimen collection or patient preparation.”

Overnight to ADEZA in Sunnyvale, CA for further testing that will result in a positive or negative determination. The result of this testing will be called to you as soon as we receive it and will be reported by our laboratory as the FFN Confirm. There will be no additional charge for this confirmation testing.

If the quantity of the remaining specimen is not sufficient for the referred testing (250 microliters is required) we will contact you with the “Indeterminate” result and request that another sample be submitted. However, you must wait 24 hours after the original collection (or since the most recent digital exam) to recollect or the test results will be inaccurate.

FROM THE EDITOR...

Thank you to all who responded to our Communication Survey. The results were very helpful to us and we will be using those results to guide future articles and content. We greatly appreciate and respect your input, and will do our best to continue to provide you with the information you are wanting and needing.

Pam and I wish to thank Becky Aman for her dedication to the Newsletter. Becky has been the editor since the inception of this Newsletter and has done a wonderful job. Pam and I hope to follow in her footsteps in providing useful and timely information. Becky is still connected to the newsletter as a reporter and we are extremely grateful for all her contributions.

The Avera Laboratory Network Booth has been on the road to South Dakota, Minnesota, and Nebraska this past month for various medical or laboratory conventions. Hopefully you have had a chance to get out to these sessions as well. June will find us getting back to our regular routine. We hope that being out of the office for these shows has not created any inconvenience to our clients.

Enjoy these wonderful first months of summer! Have fun and stay safe.....

TIDBITS

Remember to distinguish PSA screening on Medicare men over 50 vs. PSA diagnositic testing. For diagnositic testing the LMRP must be followed for coverage. Screening is only covered one time per year, and a full year must have elapsed before it will be covered again.

Magic in Mitchell, SDSCLS/CLMA Spring meeting Update: Approximately 200 persons participated in the conference which provided a wide variety of educational opportunities as well has time for fun and camaraderie.

HIPAA - at a Glance

HIPAA, or the Health Insurance Portability and Accountability Act, is intended to protect health insurance coverage for employees and their families who change or lose jobs. This law provides for “portability” between health plans.

The administrative burden created by this protection will require many changes for the health information systems and demand that healthcare providers, health plans, and others, adopt national standards for identifiers, transactions, claims, data privacy and security and medical records, as defined by Part C, Subtitle F, Administrative Simplification. Claim forms and all laboratory reports for bills will be included. HIPAA requirements under the Administrative Simplification provisions facilitate standardized,

electronic transmission of certain financial and administrative transactions now carried out in paper form. It is important to realize that this Administrative Simplification standard only applies to the transmission of data, whereas the security standard applies to all healthcare information maintained or used in electronic transmission.

The security standard may pose the greatest implementation and cost challenge. Translating health information to an electronic format poses new risks to data integrity and confidentiality. The security and privacy standards were designed to specifically

address these risks. Although it is clear that these standards apply to all electronic health information, it is unclear if this will apply to information stored on paper. HHS is currently seeking legal opinion on its authority to regulate medical records in all forms.

Both civil and criminal penalties have been proposed for noncompliance with HIPPA Administrative Simplification. Although funding is not there to create an organization to enforce compliance, it is expected that market competition will drive compliance. Both the Joint Commission on Health Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) have already incorporated HIPAA stands in their accreditation standards. The expected date for finalization of the regulations is mid-2001. The expected time frame for compliance is 26 months following publication of final rules.

Taken from Vantage Point (April 7, 2000)

For additional information visit www.hin.com/hipform.html

Computers Change Nation’s Medical Care: Workers Must Learn New Methods

The Information Age has energized clinical laboratory scientists.

“Our role in the future is to be information specialists” said Dr. Karen R. Karni, director of the medical technology division at the University of Minnesota.

Dr. Karni and other clinical laboratory scientists are happy that computers have redefined jobs that had grown limited as the field became more automated. Despite stable employment numbers, some health professionals had predicted the field was doomed to extinction. Health care’s new reliance on computers has changed all that, although lab employees will still need to evolve.

“It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change,” said Dr. Karni, quoting Charles Darwin. Machines and computers will handle more of the hands-on lab work, she said, but humans beings are still required to interpret it and to know how to apply the results.

Positioning clinical lab scientists and technicians to be computer-using problem solvers will requite retooling the profession’s educational and training programs. Schools should start emphasizing more problem-solving and teamwork skills. The traditional lab science curriculum is inadequate. The University of Texas Health Science Center at San Antonio is ahead of the pack in introducing students to new work order. Clinical laboratory science seniors are required to investigate how the tests affect what happens to patients. The students were to find out how to “most cost-effectively and effectively make a diagnosis for the patient”. All the school’s project ideas come from the pathologists, promoting the idea that physicians and clinical scientist must work together. No physician can understand all the details about the more than 4000 clinical tests available. That takes an entire clinical laboratory science team.

New web-based courses will allow laboratorians to advance their degrees over the internet. The format inherently promotes more abstract thinking. These types of programs will also help promote the field in rural areas, which are notoriously short of most lab scientists.

*CLMA 4/12/00

Reducing Medical Errors

Incidence of preventable medical errors is a hot topic. Washington has issued an executive order mandating a federal task force to develop patient safety guidelines. A report in December estimated deaths from medical errors to be close to 98,000 annually. The focus is broad and fragmented with medical records and medication administration being highlighted.

The White House recently offered a 5-pt plan designed to trim medical mistakes by 50% over 5 years.

The laboratory focus will most likely be in the pre-analytic or non-testing phase of specimens. This is probably where a significant number of errors take place. Use of barcoding has already cut down on errors with regard to labeling and handling of specimens.

Currently, specific information regarding preventable death and serious medical errors is available to patients and their families for malpractice purposes. Under the proposed plan, hospitals would have to investigate the “root causes” of the errors. That

information, with names of patients and providers removed, would be made available to the public.

JACHO already addresses these issues within its regulatory requirements. CLIA is due to release new regulations soon that clearly address quality control in each step of the analytical phase, to help pinpoint the exact cause of error. NCCLS is also getting in the act with its proposed guidelines for identifying and tracking errors in point of care testing.

So what is the big deal? This is much of what comprises a normal day for a laboratorian.

Possibly this is an area where we can be leaders and set examples for other healthcare professionals. This is our chance to assume leadership roles in our facility’s error-reduction program. Get involved!

Advance (April 10, 2000)

Hemoliance Update

Looking for something new in Hemostasis equipment or supplies for your Laboratory?

One of the benefits of being a Premier member is to gain advantages of scale for purposes such as purchase of supplies, equipment, or services. Avera Health has made a commitment with Hemoliance for hemostasis products under Premier. With this commitment, all Avera affiliates are now eligible for the same pricing with Hemoliance. Contact your Group Purchasing agent or Hemoliance representative for details.

CLIENT SERVICES STARS

Ardith Fiechtner has been an employee of Avera St. Luke’s for 24 years. She graduated from Northern State

University and did her Medical Technology internship at St. Luke’s Hospital in Aberdeen.

She works as a Medical Technologist in the lab at Avera St. Luke’s and also does technical consultation. Ardith likes the challenges that her job offers on a daily basis, and says her peers make her workplace enjoyable. Even with all the technological advances the laboratory has made in the last 20 years, Ardith feels her job as Medical Technologist is very rewarding.

In addition to her job, Ardith enjoys reading, music, movies, gardening, golf and any sports or outdoor activities. She spends her time away from work with her special friend Dave and her two cats, “Spook” and her “Shadow.”

HEMOGLOBINOPATHIES

Case Study: R.O. is a nine-month-old infant with microcytic anemia. Review of the peripheral blood smear show normal red cell morphology. Hemoglobin electrophoresis (alkaline and acid) demonstrates two hemoglobin bands. Hemoglobins A and S are present with more hemoglobin A than hemoglobin S. This patient demonstrates sickle cell trait, the heterozygous state for the hemoglobin S gene.

Discussion: Sickle hemoglobin (Hb S) mutation is due to substitution of valine for glutamic acid at position 6 on the beta chain. A patient with sickle cell trait has one abnormal gene and is usually clinically well. Growth and development proceed normally, infections occur with no greater frequency than in the general population, and there is no increased frequency of bone and joint disease is observed.

Life expectancy and overall mortality rate for persons with sickle cell trait are the same as for the general population. A homozygous patient demonstrates only hemoglobin S. Hemoglobin S is freely soluble when fully oxygenated; when oxygen is removed from hemoglobin S, polymerization of the abnormal hemoglobin occurs, forming tactoids that are rigid and deform the cell into the shape that gave the cell its name. The rigid cells are more susceptible to trauma and are readily trapped by the spleen. Small blood vessels are blocked and tissue that does not receive a normal blood flow becomes damaged. Sickling may be demonstrable in any disorder in which hemoglobin S is present and patients with sickle trait can occasionally demonstrate the complications of sickle cell disease.

Recommendations: Sickle cell disease is among the most prevalent of genetic disease in the United States.

It is estimated that 8 percent of the African American population carries the sickle cell trait, and approximately 1 African-American child in every 375 is affected by sickle cell disease. Hemoglobin S is also found with appreciable frequency among individuals whose ancestors came from the Mediterranean basis, the Arabian peninsula, the Caribbean, Central and South American.

Targeted screening may miss up to 20% of cases and at least 34 states now perform universal screening for hemoglobinopathies.

For more information see:

www.medlib.med.utah.edu/WebPath/webpath.html

http: www.l.umn.edu/hema/index.html (note case studies)

IMMUNOLOGICAL RESPONSE:

MEMORY CELLS

There are at least two types of B cells in the immune system.

One type of B cells differentiate into plasma cells which sythesize

antibodies. The second type of B cells revert to a resting state to become “memory B lymphocytes”, which are capable of surviving for years. These memory cells are responsible for the difference between the primary and the secondary immune response. The first encounter with antigen leads to a short-lived response known as a primary response. There is a relatively long lag phase, followed by a phase of exponential increase of antibody, and then a decline. The secondary, or anamnestic response has a shortened lag period, antibody rise is much more rapid, and serum levels remain higher for longer periods. This is due to the large numbers of antigen-specific memory T and B cells generated during the primary response.

Prothrombin Time, INR, and Reagent Sensitivity (ISI)

—Cheryl Wildermuth, MS, MT(ASCP)

Avera McKennan Hematology Supervisor

It is that dreaded time of year in our coagulation department. Our current lot number of Prothrombin Time (PT) reagent is about to outdate, so we must evaluate and switch to a new lot number of PT reagent.

This year our laboratory is undertaking a major change to a PT reagent (thromboplastin) with a 1.0 ISI. Some Avera Laboratory Network members have already made the change and others will follow, but we’re right in the middle of it. As a result, in addition to the normal evaluation process (normal ranges, therapeutic ranges and so on), we will soon be launching a comprehensive education campaign to our staff, physicians, and clients. This article is a brief introduction to why we decided to make the change to a PT reagent with a 1.0 ISI and the effect it will have.

The International Sensitivity Index (ISI) is a numerical ratio comparing the reactivity or sensitivity of the commercial thromboplastin to the World Health Organization’s (WHO) International Reference Preparation (IRP) which has been assigned the 1.0 ISI designation. The ISI is used in the calculation of the International Normalized Ratio (INR) which makes PT’s comparable from one laboratory to the next. The purpose of the INR is to correct for the wide variation in coagulation testing instruments and reagents. The INR reporting system provides a reliable, standardized means of reporting Prothrombin Times on patient’s receiving oral anticoagulant with minimal variability between different laboratories, thromboplastin reagents and methods of clot detection. When you change to a new Prothrombin Time reagent or new lot number of reagent always remember to change the ISI value in your INR calculations or you will be reporting erroneous INR’s.

Thromboplastins vary in their responsiveness (or sensitivity) to clotting factor deficiencies depending on their tissue of origin and method of preparation. Recent recommendations are to use a thromboplastin with an ISI of less than 1.5 (preferably 1.2 or less) when monitoring oral anticoagulant (warfarin) therapy. The development of the new recombinant PT reagents with an ISI of 1.0 makes this all the more inviting. These highly sensitive thromboplastins are prepared from recombinant human tissue factor and synthetic phospholipid. The improved sensitivity of the 1.0 ISI reagent assures better accuracy and precision of PT and INR results, and permits more optimal adjustment of warfarin dosage. A big plus to the laboratory is that these recombinant reagents have a longer open vial stability, a shelf life of greater than one year to outdate and little, if any, lot to lot variation. Diagnostic advantages of the low ISI reagents include increased sensitivity to factor deficiencies, better assessment of abnormal PT values, better assessment of liver disease, and reduced

sensitivity to heparin.

The more sensitive PT reagent, however, will result in significant change in the therapeutic range of PT’s in seconds. Using a sensitive thromboplastin (lower ISI) results in a greater prolongation of abnormal PT’s than use of an insensitive reagent (higher ISI). The more sensitive the reagent the wider the range. The table below gives examples of how different PT reagents with differing ISI values result in vastly differing PT values in seconds, but in identical INR’s.

Based on this example, the same patient analyzed with a range of ISI reagents results in a broad range of PT’s in seconds, but equivalent INR’s. Some propose that PT’s only be reported as INR’s and not in seconds for patient’s on oral anticoagulant therapy. Then this change and virtually any PT reagent change would be invisible. The problem with that approach is that INR’s are a standardization for patient’s on oral anticoagulant therapy only and PT’s in seconds would still have to be reported for all other applications. A better approach would be laboratory standardization to a 1.0 ISI reagent. Then all labs would produce equivalent Prothrombin Times.

Unfortunately, laboratory standardization does not yet exist in coagulation and the initial change to the 1.0 ISI reagent significantly widens the “abnormal” range of Prothrombin Times. That is why we must alert and educate. Those who are accustomed to treating oral anticoagulated patient’s based on Prothrombin Times in seconds will need to RE-THINK the concept of PT. Physicians, clients and staff will need to be very cognizant of the new wider therapeutic ranges, especially when treating patients.

With these advances in coagulation reagents we move toward more consistency and standardization in coagulation testing. In the perfect laboratory this will be the last time we have to make changes in our coagulation normal and reference ranges. Oh, for the perfect lab......