Saving laboratory records: what, how, how long?

CONTINUING EDUCATION

To earn CEUs, see test on page 18.

LEARNING OBJECTIVES

Upon completion of this article the reader will be able to:

1. Discuss the importance of accurate record keeping in the clinical laboratory.

2. Identify the different requirements

3. Identity the significant records that need to be maintained on employees.

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.

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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.

CE test on SAVING LABORATORY RECORDS: WHAT, HOW, HOW LONG?

MLO and Northern Illinois University (NIU), DeKalb, IL, are co-sponsors in offering continuing education units (CEUs) for this issue's article on SAVING LABORATORY RECORDS: WHAT, HOW, HOW LONG?. CEUs or contact hours are granted by the College of Health and Human Sciences at NIU, which has been approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.[R] program (Provider No. 0001) and by the American Medical Technologists Institute for Education (Provider No. 121019; Registry No. 0061). Approval as a provider of continuing education programs has been granted by the state of Florida (Provider No. JP0000496), and for licensed clinical laboratory scientists and personnel in the state of California (Provider No. 351). Continuing education credits awarded for successful completion of this test are acceptable for the ASCP Board of Registry Continuing Competence Recognition Program. After reading the article on page 10, answer the following test questions and send your completed test form to NIU along with the nominal fee of $20. Readers who pass the test successfully (scoring 70 percent or higher) will receive a certificate for 1 contact hour of P.A.C.E.[R] credit. Participants should allow four to six weeks for receipt of certificates.

The fee for each continuing education test will be $20.

All feature articles published in MLO are peer-reviewed.

This test was prepared by Shirley A. Richmond, PhD, MT(ASCP), CSL(NCA), Dean, College of Health and Human Sciences, Northern Illinois University, DeKalb, IL.

1. Copies of the laboratory procedure manual should be kept

a. only as long as the procedures are current.

b. two years after discontinuation of the procedure.

c. Permanently.

d. None of the above.

2. Immunohematology records need to be retained

a. one year.

b. three years.

c. minimum of five years.

d. minimum of 10 years.

3. Proficiency testing indicates

a. performance of the laboratory as compared to a group of peers.

b. performance of the laboratory as compared to previous month's testing results.

c. performance of laboratory as compared to national results banks.

d. a and c.

4. Technologist's personnel file should contain

a. evidence of appropriate education.

b. licensure or certification documents.

c. continuing education documentation.

d. All of the above.

5. JCAHO often requires documentation of

a. professional meeting Minutes.

b. continuing education records for professional and technical staff.

c. safety training records.

d. All of the above.

6. OSHA's regulations require the laboratory to have a

a. chemical hygiene plan.

b. documentation of hazardous-chemical spills.

c. personnel records.

d. a and b.

7. OSHA's rules on bloodborne pathogens require documentation of employee exposure to bloodborne pathogens.

a. True

b. False

8. In accordance with OSHA's rules, each employee must be vaccinated against hepatitis B virus, and all records of the vaccination must be kept on file.

a. True

b. False

9. OSHA records must be maintained for

a. five years.

b. 10 years.

c. 15 years.

d. 30 years.

10. Some state laboratory regulations are stricter than the CLIA rules and should be monitored by the laboratory.

a. True

b. False

11. If your laboratory performs toxicology or drug-of-abuse testing, standards that are greater than the exempt quantities must be used for quality control.

a. True

b. False

12. Laboratories performing toxicology and drug-of-abuse testing may be inspected by the Drug Enforcement Agency (DEA). Therefore, it is necessary to maintain records of

a. receipt of samples.

b. inventory.

c. use and disposition of the drugs.

d. All of the above.

13. Laboratories performing radioactive testing must

a. monitor employee exposure.

b. retain employment records for the lifetime of the employee.

c. retain employees records for 30 years.

d. a and b.

14. NRC and DEA require laboratories to retain testing records for

a. six months.

b. one year.

c. 30 years.

d. three years.

15. Regulatory agencies will allow records to be maintained electronically.

a. True

b. False

16. CAP requires serum/CSF/body fluids to be retained for

a. eight hours.

b. two days.

c. 24 hours.

d. one year.

17. Negative and unsatisfactory cytology slides should be kept for

a. 10 years.

b. one year.

c. five years.

d. six months.

18. Specimens from blood-bank donors and recipients should be retained for

a. seven days post-transfusion.

b. two days.

c. eight days post-crossmatch.

d. one day post-transfusion.

19. JCAHO requires proficiency-testing records to be held for

a. 10 months.

b. two years.

c. five years.

d. indefinitely.

20. Accurate testing and records of all tests and quality control are the laboratory's best defense in cases of liability.

a. True

b. False

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Table 1: Documents to keep in employee personnel files

* Position description              * Performance standards
* Periodic evaluations              * Employment application
* Relevant education                * Subsequent training including
                                      in-service education
* Statement of experience prior to  * Statement of health and safety
  employment in the laboratory        training

* Record of vaccination against Hepatitis B or a statement declining
  vaccination

Table 2: Summary of regulations

MATERIAL/RECORD                   CLIA               CAP         JCAHO

Laboratory service requests,       2 years Medicare   2 years    2 years
surgical pathology requests,       6 years
cytology requests, and other       (42CFR1003
laboratory test ordering           132)
documents.
Records of specimens received;     2 years            2 years    2 years
tests, including identification
of the patient, name of the
submitter, dates of receipt and
report, type of test performed;
and test results, including
instrument printouts and
original test report or exact
duplicate.
Bone marrow--reports and smears                      10 years
Records of inspection,             2 years            2 years    2 years
validation, calibration,
repair, and replacement to
ensure proper maintenance and
operation of equipment and
proper reactivity of test
materials.
Procedure manuals, card files,     2 years            2 years    2 years
flow charts
Records of quality control         2 years            2 years    2 years
procedures in use in the
various technical areas of the
laboratory, including results
on standards and reference
materials, and action limits,
when appropriate
Blood-bank records; donor and                        Forever
recipient records; records of
employee signatures, initials,
and identification
Cytology slides--negative and      5 years            5 years    5 years
unsatisfactory
Cytology slides--positive and      5 years            5 years    5 years
suspicious
Histopathology slides and fine-   10 years           10 years   10 years
needle aspiration slides
Blood films, permanently stained                      7 days
body fluid slides, and
microbiology slides
Serum/cerebrospinal fluid/body                       24 hours
fluids
Specimens from blood-bank donors   7 days post-
and recipients                     transfusion or
                                   10 days post-
                                   crossmatch
Specimen blocks                    2 years            5 years    2 years
Wet-tissue specimen                Until diagnosis    2 weeks
                                                        after
                                                        final
                                                        report
Autopsy wet tissue                                    3 months
                                                        after
                                                        final
                                                        report
Surgical pathology accession log                      2 years
Pathology reports                 10 years           10 years   10 years
Cytology reports                  10 years           10 years   10 years
Cytology records indicating the                       2 years
daily accession of specimens,
each of which is numbered, and
an appropriate cross-filing
system according to the
patient's name
Histologic or clinical            10 years           10 years   10 years
confirmation of cytologic
findings on abnormal cases and
false-negative and false-
positive results for each
category of specimens, when
such results are made
available.
Proficiency-testing records        2 years            2 years    2 years
Immunohematology records,          5 years            5 years    5 years
quality control, and test
reports
Quality-assurance records          2 years            2 years

Table provided by Robert Nakamura, MD, and the Quality Control staff at
Scripps Clinic Laboratory

Table 3: Record-retention requirements for certain of OSHA's
environmental and occupational safety and health regulations

Standard        Subject & examples           How long to retain

1910.1030       Bloodborne pathogens
                Training records             3 years from date of
                                              training
                Medical and exposure         Duration of employment,
                                              plus 30 years (1910.20)
1450.1450       Occupational exposure
                to hazardous chemicals
                in laboratories
                Medical records              Duration of employment,
                                              plus 30 years
                Environmental exposure
                 measurements                At least 30 years
1910.1048       Formaldehyde
                Exposure records             At least 30 years
                Medical records              Duration of employment,
                                              plus 30 years
                Respirator fit test          Until updated
1910.1028       Benzene
                Exposure monitoring and
                 personal protective
                 equipment                   At least 30 years
                Medical surveillance         Duration of employment,
                                              plus 30 years
1910.1001-1016  Specified carcinogens
                Listed in regulations.       At least 30 years
1904.1904       Recordkeeping and
                reporting occupational
                injuries and illnesses
                All logs and summaries       5 years following the end
                                              of the year to which they
                                              relate
1910.95         Occupational noise exposure
                Noise exposure
                 measurements                2 years
                Audiometric test records     Duration of affected
                                              employee's employment
120.120         Hazardous waste
                operations and
                emergency response
                Medical surveillance         Duration of employment plus
                                              30 years
                                             Depends upon level of
                                              exposure
1910.96 and     Ionizing radiation
10 CFR Part 20  (NRC regulations)
                Exposure records             Depends upon level of
                                              exposure

Other OSHA Standards: Most cite requirements under 1910.20, OSHA's
generic records standard entitled "Access to Medical and Exposure
Records"

References

1. American Association of Blood Banks. American Association of Blood Banks News. July 1968;4.

2. College of American Pathologists. Professional Relations Manual. 9th ed. CAP, Northfield, IL. 1988.

3. Occupational Safety and Health Administration. Occupational exposures to hazardous chemicals in laboratories: final rule (29 CFR 1910). Washington, DC. Federal Register. January 31, 1990;55:3300-3335.

4. Occupational Safety and Health Administration. Occupational exposure to blood-borne pathogens: final rule (29 CFR 1910.1030). Washington, DC. Federal Register. December 6, 1991;56:64004-64181.

5. Occupational Safety and Health Administration. Access to Medical and Exposure Records. DSHA Publication No. 3110. Washington, DC; 1989.

6. Sarewitz SJ. Queries and Comments, LAP News Section. CAP Today, February 2004; 78-80.

By Dan Baer, MD

Daniel M. Baer, MD, is professor emeritus of the Department of Pathology and Laboratory Medicine at Oregon Health and Science University in Portland, OR, and is affiliated with the Education Division of Portland's Veterans Affairs Medical Center.