Archiving and Interlaboratory Slide Review

 

Cervical Cytology Practice Guideline

Approved by the ASC Executive Board November 10, 2000

 

 

X. Archiving and Interlaboratory Slide Review

 

X.A.  Slide Storage and Retrieval

 

Cytology laboratories must retain all cervical slide preparations, regardless of diagnosis, for five years from the date of microscopic examination, or for longer if state regulations require.114   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 if retrospective review is necessary (see VII.F.) or as requested for external inspection procedures (see XIV.E).  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.

 

X.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 (see VII.F.) or as requested for external inspection procedures. Again, required retention periods under CLIA ’88 or applicable state regulations, vary depending upon the type of record (see section X.C.). 

If reports are stored in a computerized information system with appropriate backup, as microfilm, or as microfiche, 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.125

 

X.C.  Retention Requirements

 

While State, local or professional requirements may require longer retention timeframes, current federal regulations mandate the following retention periods for materials related to cervical cytology specimens: 43114126

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

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

Slides that are less than five years old 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 the slide(s) if needed.  Documentation of slides less than 5 years old 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.114

 

X.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.

 

X.F. Requirements for Cervical 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.61114  A reference or referral (secondary) laboratory is responsible for storing slides interpreted in that laboratory for the 5-year retention period. For retrospective review purposes, the reference or referral laboratory must review previous cases stored in the laboratory’s files, but is not required to request previous slides from another laboratory for this purpose.  The report must clearly state which laboratory performed the interpretation.125

 

X.G.  Variability in Practice

 

  • Slide retention requirements for state and federal regulations and professional accreditation organizations may vary. Both CLIA ’88 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

43  Clinical Laboratory Improvement Amendments of 1988; Final Rule.  Federal Register.  Feb. 28, 1992; Vol. 57:  493.1105.

61  College of American Pathologists. Commission on Laboratory Accreditation Inspection Checklist 2000 edition, Cytopathology, Section 8A, Northfield, Illinois.

114  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 493.1257(g).

125  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.

126  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 493.1107.