By
Laurel W. Christensen, MLS, CLC (AMT)
 Laurel
Christensen, MLS, CLC (AMT) is President of Laurel Christensen and Associates,
Inc., a laboratory compliance and management consulting firm located in the
Farmington, NM area. She received her Master’s in Environmental Microbiology and
Laboratory Management from the University of Oklahoma in 1996. Her dissertation
focused on chlorine stressed E. coli in the Farmington Wastewater Treatment
Plant. Her research resulted in the issuance of municipal bonds for improvements
at the wastewater facility. Laurel worked for the Scientific Laboratory Division
of New Mexico Department of Health as a clinical and environmental
microbiologist in the Farmington Branch Laboratory for 25 years. Upon the
closing of the branch laboratory, she was contracted to the Public Health
Division of New Mexico Department of Health in 1995 to bring 101 public health
office laboratories in New Mexico into CLIA compliance for a moderately complex
certificate. She retired from government service in 1999 after 30 years. Laurel
has published several articles for industry journals on education of nursing
staff in point of care and data management. She received her certification as a
Certified Laboratory Consultant from American Medical Technologists (AMT)
earlier this year. Laurel is an adjunct professor at San Juan College in
Farmington. Currently she represents San Juan College on the Statewide Small
Business Development Center Network Advisory Committee. She is active in AACC,
CLMA, AMT San Juan Regional Science Fair and Toastmasters.
Laurel is a founding director and treasurer for the Southwest Regional
Point-of-Care Group, Inc. This group was founded to assist individuals in
the Southwestern states, Arizona, Colorado, New Mexico, West Texas and Utah to
network and meet once a year for continuing education activities.
Graduation. The day so long dreamed of has arrived and nursing
school is complete. A goal and aspiration are accomplished. For the newly
graduated nurse, days of intense labor and love lie ahead as a career begins of
caring for patients in various settings. The new employee reports to her new
place of employment for orientation, anxious and ready to join the nursing force
in healing arts. The skills of nursing have been learned well. A hard stark
reality of laboratory testing done by nurses soon sets in as the new job
requirements are learned. This part of nursing care is not addressed in nursing
schools.
In the health care arena nurses are trained in the skills of assessing the
clinical picture of the patient. Interpersonal relationship with their patient
is very important to these angels of mercy. They are trained to look at the
overall picture of the patient, not just a test result. On the other end of the
spectrum is the laboratorian taught the skills of assessing the components of
laboratory testing. A primary responsibility of laboratory technologists and
scientists is a quality laboratory result from a patient specimen. To these
watchdogs of quality, testing is not just a test result. It includes monitoring
of temperatures, equipment, storage conditions, testing personnel competency,
procedure manuals, quality control, quality improvement, data management, and
regulatory requirements for the laboratory testing process. Bringing these two
cultures together in the arena of patient care is the field of Point-of-Care or
near patient testing. The cultures are entirely different in their approach to
patient care, yet each must work together as clinical laboratory testing comes
permanently to the patient’s bedside. One key to the solution is education. Both
professions bring to the arena of patient care skills that are very necessary
for quality patient care. Efforts must be made by both parties to understand the
views and approach of the other party to the problem. This article will address
the need for educational criteria in nursing curricula equipping the nursing
professional with the necessary tools to determine if the results of a
Point-of-Care test are valid or needs further assessment.
When the U.S. Congress passed the Clinical Laboratory Improvements Amendments,
1988, (CLIA 88) laboratory testing regulation compliance became a requirement
for anyone performing a laboratory test on a patient in a clinical setting. CLIA
is very generous in testing personnel educational requirements for moderately
complex and waived testing. Moderate complexity testing requires, at a minimum,
a high school education with documented appropriate training and orientation to
do testing. Most non-laboratory personnel meet this requirement. Waived testing
has no educational requirements to qualify to perform laboratory testing.
However, Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
and College of American Pathologists (CAP) have stricter requirements for
testing personnel performing waived testing. A minimum of a high school
education is allowed but documented training and yearly assessment of employee
testing skills is a requirement.
Laboratory testing began as an academic exercise of the basic sciences only
performed by physicians. Early testing was done manually and was labor
intensive. As the field of laboratory testing expanded and procedures became
more complex, the duties of testing were passed on to trained non-physicians to
assist in performing diagnostic tests. With the advancement of technology,
laboratory testing has moved from the clinical laboratory to the patient’s side,
now known as Point-of-Care.
With the introduction of the Ames reflectance meter in 1970 for the measurement
of glycemic levels in diabetic patients Point-of-Care was born. As the 20th
century came to a close, the direction in patient care steered toward a more
patient focused delivery system in health care. Both physicians and patients
like Point-of-Care because of the immediacy of response. Point-of-Care brings
the tools of laboratory medicine to the patient bedside and the physician. This
technology empowers the patient to be more involved in his care. Point-of-Care
gives the provider and patient an almost immediate response to a question that
requires an answer. The question may be related to diagnosis of disease,
screening for disease, therapy monitoring, or treatment outcomes. The testing
process allows the patient the answer while in the treatment facility without
having to return for follow-up on test results.
Most Point-of-Care testing is considered in the waived category of testing.
Waived tests are considered by the Food and Drug Administration to be laboratory
tests so simple that error is negligible. An incorrectly performed test would
cause no harm to the patient. Since there are hardly any educational
requirements, almost anyone with minimal training can do Point-of-Care testing.
The major bulk of laboratory testing in the Point-of-Care arena has become the
responsibility of the nursing staff. Nurses are the staff that draw the
specimens, run the tests and record the results. The sentiment exists that “I
can’t remember a time when I didn’t do urine dipsticks.” Nurses have been doing
them forever. We’re taught how to do them in nursing school . . . Essentially
what happened is the lab people came up and trained us to do something we’d been
doing for 20 years, “It was redundant-a waste of time, effort, money and
salaries.” Nursing does not like quality control or personnel competency. In the
ten years I have been training and assessing personnel competency in the
Point-of-Care field, I have seen this resistance first hand. More than once I
have been told: “You, and who else is going to make me do this?” The answer is
simple, it is the law and it is required if the staff person is going to do
Point-of-Care testing.
In most institutions, multi-disciplinary committees oversee the Point-of-Care
Testing. Actual laboratory oversight of the program is assigned to a
Point-of-Care Coordinator. This individual must meet the requirements in the
CLIA regulations for a technical consultant. Most Point-of-Care Coordinators are
Medical Technologists certified by the American Society for Clinical Pathology
(ASCP) or American Medical Technologists (AMT). Some are clinical laboratory
scientists. All must have at least two years of laboratory experience in a
clinical laboratory. Nursing staff doing laboratory testing will have direct
contact with the Point-of-Care Coordinator.
Most Point-of-Care Coordinators are responsible for the oversight of
approximately 50,000 tests a year in their institutions. They must review all
records pertaining to Point-of-Care Testing. Their responsibilities also include
personnel competency and accurate testing techniques. In a recent small survey
of four Point-of-Care programs, two in Texas and two in Arizona, I asked the
coordinators if education and training of nursing staff in laboratory testing
procedures brought more cooperation from the nursing staff. Bob Newberry, MT
(AMT) Point-of-Care Coordinator for Yuma Regional Medical Center in Yuma,
Arizona had this to say about education of nursing staff and Point-of-Care, “I
agree that EDUCATION is the answer to 99% of the compliance issues I have in
POCT. However, more time up front may NOT be the answer, at least not here. My
take on what happens to a new RN, LPN, CNA and others when they go through
“NURSING PROCESS” is a disservice to the employee. These folks are put through
INTENSE training for three (3) days in a classroom. This is a MASSIVE amount of
new/hospital specific information on how to take care of patients. It is NO
WONDER to me that these individuals remember little or nothing of my one hour
class. The REAL education of the employees in POCT occurs in the unit with
dedicated educators with whom I have built an outstanding working relationship.”
Near patient testing is not a small business. In the four institutions I
surveyed four Point-of-Care Coordinators were overseeing a staff of 5,394 non
laboratory personnel. When queried concerning the average amount of time
required to perform one laboratory test at a patient’s bedside, the answer was
27 minutes. This included all phases of testing, pre-analytical, analytical, and
post-analytical. The average salary paid to members of the nursing profession is
$25.00 per hour. When nursing staff performs a Point-of-Care test it costs the
institution an average of $11.25 in labor. This cost is for one test. Taking the
average number of tests done per institution and multiplying that cost, it will
average out to $562,500 for the institution to pay for labor for this testing
process.
The nurse quoted in the CAP article on nursing and Point-of-Care struck an
interesting chord heard repeatedly by folks involved in Point-of-Care oversight.
Yes, the nurse did learn to perform urine dipsticks in nursing school twenty
years ago, but in time sloppy work habits develop. As technology evolves,
manufacturers’ instructions change on how to do a test. CLIA requires two things
of testing personnel. One is to follow manufacturers’ instructions for a test.
The other is to maintain competency to continue to test patient specimens.
Competency must be tested at least once a year. An improperly performed urine
dipstick can yield wrong information to the clinician treating the patient.
Sloppy procedure can result in erroneous results. Not following manufacturers’
instructions on the product insert can be just as harmful. A simple task such as
not placing the lid firmly back on the container of dipsticks can ruin the
entire contents of the container. In the many surveys I have done, this is a
common practice among non-laboratory personnel.
Education is a valuable tool in the arena of healthcare. Education is defined in
Webster’s Dictionary as “the process of training and developing the knowledge,
skill, mind, character, etc., by formal schooling”. While Mr. Webster defines
training to be “to instruct so as to make proficient or qualified”, if a basic
course in laboratory procedures were interwoven in the educational curricula in
nursing programs, the stress of laboratory testing by nurses would be reduced.
In the survey, I asked the question “Do you think that if it were possible,
nursing students and medical assistants receive education in laboratory
practices as it pertains to the Point-of-Care arena during their professional
training that it would assist you to do a better job and deliver better quality
care for patients?” Mr. Newberry responded, “YES! In fact, after six years of
crying to the local college nursing program director, I will present an
“Introduction to POCT” at nurse-extern orientation this week.” Pam Green of the
Mayo Clinic in Scottsdale Arizona stated “Absolutely! Especially if basic
quality control and quality assurance practices are included in the education.”
Deanna Bogner, 2003 American Association Clinical Chemistry (AACC) Point-of-Care
Coordinator of the Year and of Christus Santa Rosa Hospital in San Antonio
commented, “If lab training is included in a training program, it should
probably be general knowledge type laboratory information. So many parameters
are different in each institution that the information is probably better coming
from each institution.” Also from San Antonio, Sheila Coffman of the University
Hospital held the sentiment, “Education is always the key and more time to it
makes more sense.”
If education is the process of training and developing the knowledge, skill,
mind, character, etc., by formal schooling, then it makes sense to incorporate
into formal education for nurses the very basic laboratory skills of quality
control, quality assurance, basic understanding of regulations and proper
testing procedures. This does not mean every test on the market would be
covered. The basic way routine testing would be done on the common procedures in
use in most institutions, i.e., following manufacturers’ instructions on how to
do a test.
Institutions spend vast amounts of money on salaries, instruments and
expendables for Point-of-Care testing. With the advent of basic laboratory
testing education in nursing programs, error in testing would be reduced
significantly. If one institution is spending approximately $562,500 a year in
salaries for nurses to do testing, education would reduce the amount of repeat
testing in quality control and erroneous patient test results and yield a
savings to the hospital in repeated tests and failed quality control. The salary
would be spent in other areas of nursing care. It would result in a nursing
staff that had basic knowledge of how laboratory testing is performed. The nurse
would understand why things are done the way they are. She would begin to view
these procedures that have invaded her world of patient care as another tool to
give her patients quality care. Ms. Bogner further added in her comments, “When
I first started this job, a nurse told me I ‘made her do QC because I just
wanted make her life harder.’ Two years later, in a training class with a new
grad and a veteran nurse, the same statement was made by the new grad. The
veteran nurse essentially gave the new grad a chapter and verse explanation of
why QC is absolutely necessary for quality patient care. I sat there…grinned and
never said a word…” That is what nursing is all about.
The author gratefully acknowledges the help of Robert Newberry MT(AMT) of Yuma
Regional Center, Yuma, AZ, Pamela Green, MT (ASCP) Mayo Clinic, Scottsdale, AZ,
Deanna Bogner, MT(ASCP) Christus Santa Rosa Hospital, San Antonio, TX and Sheila
Coffman MT(ASCP) University Hospital, San Antonio, TX.
References Cited
Krosnick, Arthur, MD
2002 Five Decades of Diabetes Patient Care: The Time of My Life. Clinical
Diabetes 20(4 November 4):173-78.
Demers, Laurence M., and Ehrmeyer
2004 Regulatory Issues Regarding Point-of-Care Testing. In Point-of-Care
Testing, Second Edition. Christopher Price, PhD, ed. Pp. 163-69. Washington, DC:
AACC Press.
Kurec, Anthony S., MS
1995 The CLMA Guide to Managing a Clinical Laboratory. Malvern, PA: Clinical
Laboratory Management Association.
Price, Christopher P., St. John
2004 Point-of-Care Testing: What, Why, When, and Where? In Point-of-Care
Testing, Second Edition. Christopher Price, PhD, ed. Pp. 3-9. Washington, DC:
AACC Press, 05/07/26.
Titus, Karen
2000 From Nurses, POC Testing Gems. CAP Today, August.
Department of Health and Human Services, Center for Medicaid and Medicare
Services
2004 Federal Regulations. CLIA Regulations.
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