http://www.mlo-online.com/articles/0404/0404coverstory.pdf

http://www.findarticles.com/p/articles/mi_m3230/is_5_36/ai_n6077821

Saving laboratory records: what, how, how long?
Medical Laboratory Observer, May, 2004 by Dan Baer


Imagine this situation: Your laboratory has been sued for negligence in the
case of Baby Brown who is a three-and-one-half-year-old mentally retarded
child. Barbara Brown, his mother, alleges that your laboratory was negligent
in performing tests before and at the time of the baby's birth that led to
his mental retardation because of erythroblastosis.

Here are the facts of the case: Barbara Brown has group A, Rh-negative
blood. On a prenatal visit and at the time of Baby Brown's delivery, your
laboratory did not detect antibodies to Rh-positive cells. At the time of
Baby Brown's birth, his cord blood was group AB, Rh negative, he had a
negative direct Coombs test, and his total serum bilirubin was 3 mg/dL. No
tests were performed on the baby's father.

In preparing for trial, you and your attorney must assemble information that
will allow you to show the court that your laboratory performed according to
state-of-the-art testing and exercised a high degree of care and skill in
performing the tests. In court, you will want to demonstrate that:

* The test(s) was performed correctly;

* The test(s) was performed on the correct patient;

* The technologists performing the test(s) were qualified;

* The reagents and equipment used to perform the test(s) were operating
correctly; and

* The physician was given correct information, which would allow him to
correctly interpret the test results.

What do we need to show that the test was performed correctly?

The laboratory procedure manual indicates that the test methods were up to
date and that a standardized procedure was uniformly practiced by all of the
technologists in the laboratory. Since the tests in this case were carried
out three to four years ago, the test methods may have changed; and the
current procedures might be different. It is a good idea, therefore, to
retain old procedures in a file clearly indicating the time period in which
they were in use. The manual will also show the reference ranges in use at
the time the test was performed.

Test logs, including instrument printouts and observations of reactions,
such as blood typing, can demonstrate that clerical errors in transcription
of results did not occur. Test logs can also be used to identify the
technologist performing the test(s) and supervisor's review of test
results--or verification by a technologist--of the results prior to
releasing them in a computer. In Baby Brown's case, the laboratory should
have records of blood typing, grouping, and Coombs test, because
immunohematology records need to be retained, according to requirements of
most of the accrediting and regulatory agencies, for at least five years.

The records of the bilirubin test probably no longer exist. In court, you
would want to indicate that records of nonimmunohematology tests are
retained for only two years, as well as what kinds of test records are kept.
If the bilirubin test was subject to autoverification by the laboratory
information system (LIS), you should be able to produce the autoverification
rules in use at the time of testing.

Quality control (QC) records would show the results of daily QC and of
corrective actions taken when the QC limits were exceeded. As with test
records, QC records generally are retained for only two years, except in the
immunohematology lab.

Proficiency-testing results show the performance of the laboratory as
compared to a group of peers. These records also would demonstrate the
corrective actions taken when proficiency-testing acceptable results are not
obtained.

Was the correct patient's blood tested?

You need to prove to the court that you took reasonable care in identifying
the patient, labeling the patient's specimen, and carrying this
identification through all of the testing and reporting processes. Mistakes
in patient identification do occur. Consider for instance the following
report published in the AABB newsletter in 1968: "Two patients named Ruth
Rogers arrived at Greensville (SC) General Hospital's emergency room at the
same time, and both were put in room B. They had hip fractures on the same
side and were patients of the same doctor. Both were born in the same month
and year, and both received blood--but Ruth Harris Rogers had type A,
Rh-positive blood, and Ruth Smith Rogers had type A, Rh-negative blood." (1)
The court should be shown the procedures for identifying patients and
labeling specimens.

Was the technologist who performed the tests qualified to do so?

Here, you need to show:

* who performed the test(s);

* that the personnel were qualified to perform the test(s); and

* that the personnel were competent to perform the test(s).

The testing logs, if they still exist for the specific test(s) in question,
should identify the technologist who performed the test(s). If the
technologist can be identified, you would want to be able to demonstrate,
from the personnel files, that he had appropriate training and experience to
perform the test(s). This proof would require having evidence of the
technologist's education and previous work experience. If you work in a
state requiring licensure or certification of a technologist, a copy of his
license(s) or certificate(s) would be important and should be in his
personnel file(s). It is also important to show that the technologist's
knowledge and skills remained current; therefore, records of continuing
education should be part of the personnel file that is shown in court.
Evidence of current competency can be demonstrated through quality-control
data, proficiency-testing records, and the technologist's annual
performance-evaluation records. Even if the technologist performing the
test(s) cannot be identified, you can show the court what your laboratory's
requirements are for hiring a technologist.

Were the equipment and reagents operating correctly?

You will, of course, produce quality-control records for the day of testing,
if they still exist. The QC records will show that the quality-control
results were within the acceptable range and that there is a good indication
the test(s) was operating correctly.

Other records that will help establish this are:

* functional checks, showing temperatures of water baths and refrigerators;

* records showing the proper functioning of new lots of reagents; and

* maintenance records of instruments, which should be retained for the
entire life of the instrument.

Was the physician given proper information for interpretation of the test
result(s)?

You can show the court a copy of the test result(s) that includes the
reference ranges in use at the time of testing. This will indicate that the
physician was provided with information that would allow him to judge
whether the result(s) was normal or abnormal. It is a good idea to keep
lists of reference ranges when they change, so that if a question comes up
about reference range of test(s) performed a number of years ago, you will
have information showing what the range was and when it was changed.

CLIA and CAP

The kind of documentation that we have been discussing is crucial for
proving in court that good care was provided to Barbara Brown and her baby.
These very same documents are the ones required by the regulatory agencies
that inspect our laboratories: the Centers for Medicare and Medicaid
Services (CMS), Clinical Laboratory Improvement Amendments (CLIA) '88
requirements, the College of American Pathologists (CAP), the Commission on
Office Laboratory Accreditation (COLA), the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), and states that regulate
labs. Their rules may differ in detail to some extent, but the principle is
the same for all: Good records are an indication of good quality. Table 1
lists the records required by CMS and the duration during which they must be
retained. The same table also gives CAP's and JCAHO's recommendations. (2)
CAP's record-retention recommendations are listed on its website,
www.cap.org (look under Laboratory Improvement/Laboratory Accreditation
Program--Inspection Checklists and Other Accreditation Documents).

The JCAHO hospital inspection is less specific about required records and
their retention time. At the time of a JCAHO survey, this organization is
concerned with activities during the previous year. In addition to all of
the records listed by CLIA and CAP, JCAHO may want to see professional staff
meeting Minutes; records of professional and technical staff training and
continuing education; records of safety training; and data used to make
recommendations about recredentialing of professional staff members. If you
use JCAHO for your laboratory accreditation, however, this organization will
have a detailed interest in your lab's records.

Other record-retention issues

Defense of lawsuits and accreditation are not the only reasons for
maintaining records. Other regulatory agencies have record-retention
requirements, as well.

State regulations. Some states have laboratory regulations that are stricter
than the CLIA rules. For instance, California requires a three-year record
retention.

Health and safety records. The Occupational Safety and Health Agency's
(OSHA's) regulations concerning hazardous chemicals, waste disposal, and
bloodborne pathogens (references) have specific requirements that demand
documentation of a variety of activities (Table 2).

OSHA's regulations concerning hazardous chemicals require the laboratory to
have a chemical hygiene plan, a record of staff training concerning the
plan, documentation of hazardous-chemical spills and other untoward
incidents, and an inventory and record of disposition of carcinogenic
chemicals. Some of these records must be retained for a period of 30 years.
Before disposing of records required by these regulations, the Director of
the National Institute of Occupational Safety and Health must be notified.

OSHA's rules on bloodborne pathogens require documentation of employee
exposure. Each employee must be offered vaccination against hepatitis B
virus, and a record of the vaccination must be kept. If the employee
declines vaccination, his refusal must be made in writing and kept in the
employee's file. OSHA requires maintenance of these records for 30 years
past the employment termination of that employee.

Disposal of hazardous and medical wastes are regulated by the federal
government and by most states. Some of these regulations require the
laboratory to maintain a disposal history of the regulated wastes. For
example, Oregon requires manifests of hazardous-waste disposal, including an
inventory of waste generated and disposed of to be retained at least three
years (OAR Chapter 340-102-040). Legally, it is advantageous to keep such
records forever, or at least until a certificate of waste destruction is
received.

Personnel records. In reviewing the various requirements for record keeping,
we have developed a list of documents that need to be kept in each
employee's personnel folder (Table 1). Although no formal recommendations
exist for the retention of personnel records, OSHA-required records of
hepatitis B vaccination or refusal of vaccination, medical records, and
records of occupational exposure to hazardous materials must be kept for 30
years following the end of employment. Other information--such as
qualifications for employment, including education--should be available as
long as the statute of limitations exists in your state. For an infant, this
is the number of years until adulthood is attained, plus the statute of
limitations (commonly four years), or a total of 22 years. My recommendation
is to follow the OSHA rule, and keep all records for 30 years.

Controlled substances

If your laboratory performs toxicology or drug-of-abuse testing and uses
standards that are greater than the exempt quantities, it is necessary to
maintain records of receipt, inventory, use, and disposition of the drugs.
These may be inspected by the Drug Enforcement Agency (DEA), and need to be
available for a three-year period.

Radioactive materials. The Nuclear Regulatory Commission's (NRC's) rules are
similar to those of DEA. The lab must keep records for at least three years
of receipt, use, and disposition of radioactive materials above a very low
exempt quantity. In addition, records of exposure monitoring of employees
are required. These should be kept for at least the lifetime of the
employee. This is necessary because, in later life, the employee could
develop a tumor or other condition, claiming that it was due to ionizing
radiation received during employment in your lab.

Specimen retention. Although they are not records, for the sake of
completeness, we should list the requirements and recommendations for
retention of specimens, surgical pathology paraffin blocks, and pathology
and cytology slides (Table 1).

The status of electronic records. Regulatory agencies have indicated that
records need not be in hard copy form but may be in electronic or
photographic medium. Records in computers, magnetic tapes or disks, compact
disks, and microfilm or microfiche are acceptable, as long as they can be
retrieved within a reasonable length of time. For large laboratories, the
ability to store data in one of these media makes the storage of such data
manageable.

If records are downloaded, entered via a direct interface, or directly
entered into the LIS, printouts of the same data do not need to be kept. If
the record is produced first in printed form or hard copy and then manually
entered into the computer however, the original hard copy must be retained
in order to prove that transcription errors have not occurred. (6) Some
questions about electronic storage of data are not resolved, such as how
rapidly must the data be able to be retrieved, and what happens when you
change computer systems?

The rapidity of retrieval depends on the reasons for which you need the
data. If retrieval of data is for patient care or troubleshooting a problem,
it should be available within a few hours. Recent data is usually rapidly
available and most useful for troubleshooting. If the data is needed to
prove to regulatory or accreditation inspectors that it exists, recovery
from archived tapes might take a day or more. I would accept this as a
"reasonable length of time."

The other issue has to do with the retrieval of data when computer systems
are replaced by a different system. Consider, for example, what would happen
to your vinyl-record collection if you changed to a compact-disk system.
This would result in loss of data in the older system--unless the data was
translated or re-recorded, or if you retained your old system or used
another data-compatible system.

Conclusion

Laboratory regulation involving quality and safety issues is an
ever-evolving pursuit. We can expect new rules to be introduced and old ones
to be changed. It is vital for us all to remain alert to record-keeping
and -retention requirements.