IX Archiving & Interlaboratory

Nongynecological Cytology Practice Guidlines

prepared by the American Society of Cytopathology, Cytopathology Practice Committee.

Adopted by the ASC Executive Board, March 2, 2004

IX Archiving and Interlaboratory Information Systems

 

IX.A. Slide Storage and Retrieval

Cytology laboratories must retain all nongynecological slide preparations, regardless of diagnosis, for five years from the date of microscopic examination, or for longer if state regulations require it.78 Fine needle biopsy glass slides must be retained for a minimum of 10 years, unless local regulations require longer retention.6 Slides may be stored on-site in the laboratory or on institutional premises, or may be stored off-site. Whether stored on-site or off-site, slides must be retrievable within a reasonable amount of time for histologic-cytologic correlation or as requested for external inspection procedures. Slide breakage and slide loss may occur on rare occasions. When breakage is discovered, there should be appropriate documentation of the incident and repair of the slide if possible.

IX.B. Records Storage and Retrieval

As is the case with storage and retrieval of slides, records may be stored on-site in the laboratory or on institutional premises, or may be stored off-site. Whether stored on-site or off-site, records must be retrievable within a reasonable amount of time if retrospective review is necessary or as requested for external inspection procedures. The storage and retrieval site should allow for appropriate patient care and quality assurance practices.

If reports are stored in a computerized information system with appropriate backup, (such as microfilm, microfiche or other electronic storage) laboratories are not required to retain paper copies of reports. Such stored report records must contain the same information (“exact copy”) that is sent to the authorized individual who orders or utilizes the test report. However, it is not required that an “exact copy” be an exact duplicate of the report. Exact copies must also contain the signatures (electronic or manual) when required.94

IX.C. Retention Requirements

Cytopathology records should be retained for an appropriate time period, allowing for optimum patient care and quality assurance practices. Laboratories must comply with local standards for retention.6,95

  • Test requisitions must be retained for 2 years from date received
  • Test reports must be retained for 10 years from date of the report
  • Logs and accession records for cytology specimens must be retained for 2 years from date of receipt.
  • Quality control records for cytology specimens must be retained for 2 years from the date that they were created/generated.
  • Documents pertaining to discontinued procedures for cytology specimens must be retained for 2 years from the date that they were discontinued.
  • Maintenance records for instruments used in processing and analyzing cytology samples must be retained for 2 years after the instrument(s) has been out of use.
  • All nongynecological cytology slides, regardless of diagnosis, must be retained for 5 years from date of examination.
  • All fine needle biopsy slides must be retained for at least 10 years from date of examination according to the College of American Pathologists.

IX.D. Loaning of Slides for Proficiency Testing Programs and Interlaboratory Slide Review

Slides may be loaned to proficiency testing programs in lieu of maintaining them for this time period. The laboratory must receive acknowledgment of the receipt of slides by the proficiency-testing program and maintain documentation of the loan of such slides thereby allowing retrieval of the slide(s) if needed. Documentation of slides that are loaned or referred for purposes other than proficiency testing (such as for interlaboratory slide comparisons, consultation, or educational purposes) also must be maintained. 96

IX.E. Discarding Slides and Records

Slides and records that are outside retention and retrieval requirements may be discarded. When discarding such materials, patient confidentiality must be insured. The disposal process must result in the inability to identify the patient. If outdated/expired materials are retained for educational or research purposes, then patient identifiers should be removed.

IX.F. Requirements for Cytology Materials Received from or sent to Secondary Laboratories (Reference or Referral Laboratories)

The laboratory in which the slides were actually examined for final interpretation must store the slides. A reference or referral (secondary) laboratory is responsible for storing slides interpreted in that laboratory for the retention period. Reports must clearly state which laboratory performed the interpretation.94 For cytological-histological correlation, the reference or referral laboratory may review previous cases stored in the laboratory’s files or may request slides from another laboratory, carefully following procedures for documenting loaned material (Section X.D ).

IX.G. Variability in Practice

 

  • Slide retention requirements for state and federal regulations and professional accreditation organizations may vary. CLIA ’88, College of American Pathologists, and state regulations should be consulted.
  • Academic and research goals may merit longer slide storage by individual laboratories.
  • Restrictive slide storage and access policies may be necessary on the basis of federal regulations mandating slide storage and custody.
  • The systems by which laboratories retain, store and retrieve slides and records vary. For example, laboratories may store these materials in accession number order, by patient name, by date received or reported, by interpretive categories or by other means.

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Bibliography/References

6     College of American Pathologists. Commission on Laboratory Accreditation Inspection Checklist 2002 edition, Northfield, Illinois.

78     Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Jan. 24, 2003; Vol. 68: 493.1274(f).

94     Appendix C-Survey Procedures and Interpretive Guideline for Laboratories and Laboratory Services.  Washington, D.C.: Department of Health and Human Services. Health Care Financing Administration; 1993; 1-296.

95     Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Jan. 24, 2003; Vol. 68: 493.1105(a)(7).

96     Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Jan. 24, 2003; Vol. 68: 493.1274(f)