Vol. 72 • No. 6

BRIEF SCIENTIFIC REPORTS

step in the patient's care. When a doctor orders a reticulocyte count, he must send his patient to a clinical laboratory to have the test done, an inconvenience for both the doctor and his patient. Using this method, the physician can prepare the reticulocyte smears in his office and send the slide to the laboratory instead of the patient. Another use for the kit is foreseen. It is well known that during extended time in orbital missions astronauts become anemic. To study this "astronaut anemia," a simple method for preparing reticulocyte smears during orbital missions is needed. The conventional method, requiring transfer of liquids,

1013

cannot be used in the weightless state. This new method is compact, rapid, and prevents the blood from drifting about in weightlessness; there is nothing to spill. The method has been accepted by NASA for use in Spacelab Missions. References 1. Brecher G: New methylene blue as a reticulocyte stain. Am J Clin Pathol 19:895-896, 1949 2. Brecher G, Schneiderman M: A time-saving device for the counting of reticulocytes. Am J Clin Pathol 20:1079-1083, 1950

LOUIS R. PRYOR, PH.D., AND V. DEAN FREEMAN, M.M.E.

Pryor, Louis R., and Freeman, V. Dean: An archival system for clinical laboratory data. Am J Clin Pathol 72: 1013-1017, 1979. A magnetic tape-based archival system that provides for generation of computer-output microfiche has been developed. Data from magnetic tapes written on a turnkey laboratory system are used as the basis for generating the archival tapes. Programmed searches of the tapes allow retrieval directly by name or test(s). Accessing the computer-output microfiche allows retrieval by name and is being used to supplant a traditional file system. (Key words: Computeroutput microfiche; Computers; Clinical data processing; Information retrieval.) CLINICAL LABORATORY ARCHIVES are subject to legal requirements. Federal regulations promulgated on the basis of the Clinical Laboratory Improvement Act of 196712 require attention of each laboratory report for at least two years. 1617 Further, it is required that a copy be filed in the laboratory "in a manner which permits ready identification and accessibility." 10 Records retention requirements of the College of American Pathologists for accreditation are similar to the foregoing.2 Further information is available. 8 Other reasons for maintaining an easily referenced archive system include (1) access to historical test data 7 when the medical record is unavailable and (2) retrieval for research purposes. 1315 Maintaining Received October 10, 1978; received revised manuscript and accepted for publication September 18, 1979. Address reprint requests to Dr. Pryor: Clinical Laboratory—Slot 502, University of Arkansas for Medical Sciences, 4301 West Markham, Little Rock, Arkansas 72201.

University of Arkansas for Medical Sciences, Little Rock, Arkansas

archives in machine-readable format has been indicated as the basis for generating data bases for various studies. 1318 Analysis for quality control purposes can also be aided. 15 For the reasons described above, a magnetic tapebased archival system that provides computer-output microfiche has been developed. This system, which is described below, provides for facile accession of laboratory records via computer-output microfiche and permits programmed searches of the taped cumulative data base. The particular merit of this system is its compatibility with one of the most widely used turnkey laboratory computer systems. Materials and Methods In the Clinical Laboratory, University of Arkansas Medical Sciences Campus (UAMSC), Little Rock, Arkansas, a turnkey laboratory computer system is utilized in conjunction with the campus' central computer. A turnkey system is one which is easily started, as by the turning of a key, and is not usually programmed by the end-user. The turnkey system at UAMSC includes a Digital Equipment Corporation (DEC, Maynard, Mass.) PDP-12/20 computer mainframe with 28,000 12-bit (28K) words of memory, three fixed-head disks of 250K words each, 24 com-

0002-9173/79/1200/1013 $00.75 © American Society of Clinical Pathologists

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An Archival System for Clinical Laboratory Data

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PRYOR AND FREEMAN

munications lines, instrument interfaces and other peripherals, which cost a total of approximately $250,000. The software (programs) used on this mainframe was supplied by Dr. G. Philip Hicks and associates, Laboratory Computing Inc. (LCI), Madison, Wisconsin, at an initial cost of approximately $96,000. The basic software is in use on PDP-12s and PDP-1 Is (a more sophisticated DEC computer) in about three dozen sites in the United States and Canada. At UAMSC this system is used for reporting approximately 500,000 tests per year.

The third drive is to allow reading the current month's old data (data generated prior to the preceding Tuesday) and the current week's data and writing a concatenated file on the third drive. A tape containing all the current month's data is produced. Appropriate program measures care for transition between months. Elapsed time for the processing is 0.3-2 hours. Elapsed time for the commercial processing is approximately 8-12 hours. Since this time is minimal, filing discharge reports is obviated. Since paper copy is provided by the LCI system, copy is available for use until the microfiche are delivered. The format of the microfiche encompasses 210 frames per microform (32 x reduction). Most of the frames have 56 lines of 132-column arrays of patient data. The patients' data are recorded in alphabetical order, as are the tape sets. In a given frame the patient's demographic data are presented first. Included are name, identification number, ward or clinic and room number, race/sex, birthdate, and the dates of admission and discharge. The test data are subsequently presented in three horizontal fields, one test per field (see Fig. 1). The last three to five frames are used for tables of normal values, a cross reference, and an alphabetical index. The cross reference indexes patients by number versus name. Access to the patient data on computer-output microfiche is had by conventional microfiche readers. Accession of the archival tapes is via a program' developed for that purpose. This program allows patient, test- or test group-oriented searches using a single tape drive, terminal, and (optionally) a disk drive. The following data are presented to enable estimation of time-sharing costs for those not having their own computer. The processor time for production of the archival tapes and the tapes for transmission of copy is approximately 200,000 kilocore seconds/ month. A kilocore second (KCS) is 1,000 words of memory obligated for 1 second, a typical accounting unit in a time-sharing environment. The charges associated with 1 KCS range from $0,003 to $0,015. The processor time for searching a tape and writing the results into a disk file is less than 2,000 KCS for results of two types of tests for all patients. Less than 200 KCS are needed to return all values on a single patient. The charges for computer-output microfiche are $2.10/master microform and $0.13/copy. Monthly charges have been approximately $60. These charges have been incurred as follows. Processing the most recent seven days' data five times each week generates one or two master microforms each oc-

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The basic software provides data-base management for patients' demographic data, laboratory requisitions, and test data. Accession can provide reports presenting patient data in chronologic or hierarchical order, quality control information (including some statistics), and test tallies. A variety of options is available. 10 For the UAMSC system, LCI's "Magnetic Subroutine" option was purchased ($1,600). This provides the ability to write to magnetic tape all patient data as they are purged from the data base. The purging may occur either at discharge or at some other time specified by the user. The tape written in the discharge sequence is processed on the campus' central computer, a DEC System-10, via a series of FORTRAN 4 - 5 and COBOL 3 programs developed at UAMSC. These programs generate archival tape(s) and a tape for generation of computer-output microfiche. Operations accomplished by the software include (1) selection of tapes to be used, (2) sorting and merging of appropriate data, (3) writing a new archive tape when appropriate, and (4) writing a tape for processing by a commercial microfilm service (COM-Microfilm Systems, 900 West Capitol, Little Rock, Arkansas). Computer resources utilized by the software for generating the archives include a disk, magnetic tapes, and tape drives. The disk is used for sorting the current day's patients' data in a scratch file. Twelve tapes are cycled under program control to collate the data for (1) the most recent seven days (eight tapes) and (2) the most recent month (four tapes). Another tape is used for transmittal of copy to COM-Microfilm Systems for generation of computer-output microfiche. Bimonthly the most recent two months' data are collated on a tape. The number of tapes provides redundancy, thereby precluding catastrophic loss of data. Four days per week the processing requires two tape drives. This permits merging the daily data with the current week's data and writing the tape for generation of computer-output microfiche. On the other weekday, Tuesday, three drives are needed.

A.J.C.P. • December 1979

Vol. 72 • No. 6 DATE

TINE

BRIEF SCIENTIFIC REPORTS ACCt TEC (BTRY) TEST

RESULT MOD

STYP

TEC (BTRY) TEST

RESULT HOD

1015 STYP

TEC (BTRY) TEST

RESULT HOD

SMITH JANE • 479994 WARD/ROOM! 2A-12 01/14 1030R 9704 027 (ELEC) NA I 14S 027 (ELEC) C02 1 23

y/F

BIRTHDATEI 05/31/1931 ADMITTED: 01/14/79 DISCHARGED: 01/17/79 027 (ELEC) K : 4.7 027 (ELEC) CL ! 99 044 ( ) ALDO: 5.1

SHITH JOSEPH • 408214 WARD/ROOM: 2A-08 01/14 1400R 9894 09B ( ) HCT ! 54.8

W/M

BIRTHDATE! 07/13/1929 ADMITTED: 01/14/79 098 ( ) WBC : 9.2

• 178440 WARD/ROOM: 3B-14 : 7.4 ((PT >) UBC PAT : 38.3 NEG (UA ) UG : TR (UA > UPR : 1.014 (UA > s.o.: 1+ (UMIC) UWBC: HYAL (UHIC) OCAS:

W/M

SMITH RALPH 01/14 1440R 9857 028 9858 048 0348 033 033 033 012 012

BIRTHDATE: 09/05/1889 04B 053 053 012 012 012

CONT! UPH ! UBIL: UTYP: GCAS: UMI8:

D I S C H A R G E D : 01/17/79

ADMITTED! 01/14/79

10.1 S.O NEG UNCT NONE EPIT

053 053 012 012 012

DISCHARGED: 01/17/79 (UA > (UA > (UMIC) (UMIC) (UMIC)

BIRTHDATE: 03/05/1937 ADMITTED: 12/31/78 FOR MORPHINEF CODEINE. METHADONE 007 007 040 040 040 040 040 014

(CBC ) (CBC > (DIFF) (DIFF) (DIFF) (DIFF) (DIFF) (PT >

RBC : HCV ! BASO: BAND: MONO: SHAP: PLTE: CONT!

3.94 87 0 0 4 NORM ADO 11.0

044 ( > ESR 1 027 (SMA4) K : 027 (SHA4) BUN :

30.0 4.9 15

UKET: UHGB: URBC1 CRTS! UCOM!

NEG NEG 2+ NONE NONE

DISCHARGED: 01/17/79

007 (CBC > HGB ! 007 (CBC ) MCH ! 040 (DIFF) EOS i

11.9 30.2 3

'.

43

040 (DIFF) OTHR! 040 (DIFF) COLR!

0 NORH

014 (PTT ) PATT:

24.5

040

(DIFF) SEG

027 (SHA4) CL 027 (SHA4) CR

! !

105 1.0

ABBREVIATIONS. ACRONYMS. AND CODES 4323 007 (CBC ) WBC : 9.3 007 (CBC > HCT : 34.7 007 (CBC ) .NCHCt 34.4 040 (DIFF) META: 0 040 (DIFF) LYH : 28 MIXD SLT 040 (DIFF) SIZE: 040 (DIFF) POLY: ABS 11.0 4324 014 (PT ) PAT : 014 (PTT ) CTL : 27.0 32.9 028 (CBC > MCHC: 141 01/14 1130* 9832 027 (SMA4) NA : 27 027 (8HA4) C02 : 9.3 042 ( )CA :

(PT ) (UA ) (UA ) (UMIC) (UMIC) (UMIC)

STYP

1016

PRYOR AND FREEMAN

characteristics include type of search (name or test) and the identifiers) {name(s) or test code(s)}. A search of a bimonthly tape can be completed in less than 5 minutes' elapsed time. Discussion

The first alternative seemed likely to suffer from the basic limitations inherent in manual systems, including space requirements for file cabinets, filing time, filing errors, and transcription errors upon retrieval. Even if the final hard-copy reports were microfiched as generated, editing the sequence of such reports, if keeping them in patient name or number order, would be tedious and would not allow machine-readable accession. Such a system has been used for laboratory purposes. 9 To circumvent some of the difficulties of this first alternative, it is possible to index chronologically generated microfilm files for automated retrieval. 6 Automated retrieval would soon become necessary in such a system, due to the increased numbers of frames attendant to not having compressed the format prior to the manual microfilming. The second alternative, an on-line retrieval system, is now available for the PDP-11 based version of the LCI system" for approximately $30,000. For reasons of cost and lack of immediate availability as an option for the on-site PDP-12, this course was not judged a feasible embellishment for our laboratory's mainframe. An on-line retrieval system utilizing a central computer in conjunction with an LCI system has been described. 14 In this implementation a weekly discharge tape is read and the data therefrom are incorporated in a disk file. The file structures described should be very effective for archiving and accession. Therefore, this system has great potential. Since a disk pack or a significant portion thereof could not be obligated on the local DEC System-10 for a laboratory archive, this approach was not attempted at UAMSC. For the foregoing reasons the third alternative, the tape-based archives and computer-output microfiche,

was implemented at UAMSC. It is our belief that there are other applications for this approach. For example, a recent paper has described implementation of a computer-output microfiche-based archive for anatomic pathology data. 1 This reported implementation did not, however, include computerized retrieval. A year's experience has indicated some opportunities for enhancement of the archival system. These include (1) obtaining a horizontal guide for the fiche reader to prevent parallax error while reading the computeroutput microfiche, (2) writing more efficient programs, (3) developing semiannual and annual computer-output microfiche files, and (4) providing diagnosis-oriented patient or test searches, or both. The first version of the archival system was implemented exclusively in FORTRAN. Rewriting all the programs in COBOL (except those that direct tape and program selection) has increased the speed fivefold. This was due to more efficient data exchange with COBOL. Being able to search the archives to secure test results obtained in work-ups on patients with a diagnosis of interest can be of value for research or teaching purposes. Hence, it is our intent to include a diagnosis as a test result whenever possible. Summary The archival system for clinical laboratory data that has been developed as described above has proven advantageous for the following reasons. All completed test results can be transferred from a turnkey laboratory system to archive tapes, with redundant copies. Human intervention is required essentially only to carry the tapes between machines and to verify that all has gone well. Rapid retrieval for single patient test results can be had via computer-output microfiches. More comprehensive searches to provide machine-readable files can be had via the retrieval package. In addition to these advantages, there are efficiencies associated with elimination of manual filing problems and opportunities for enhancement of patient care through analysis of a significant data base. References 1. Allen PW, Angus BV: Computer output microfilm in an anatomic pathology laboratory. Am J Clin Pathol 68:537-543. 1987 2. Clinical Laboratory Improvement Seminar. Inspection Checklist. Section I. Laboratory General. Item 1.403. College of American Pathologists, Skokie. Illinois. 1976 3. Digital Equipment Corporation: COBOL Language Handbood. Second edition. Document No. DEC-10-KCID-D. Maynard. Massachusetts. 1973 4. Digital Equipment Corporation: FORTRAN-10 Programmer's

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Our original interest in developing an archival system for laboratory test data was based on: (1) legal requirements, (2) needing to respond to requests for "old" information when patient charts were not available, and (3) the possibility of collating machine-readable data for research and quality control. To accomplish this, three approaches seemed possible. These were (1) improve the manual system in use at the time, (2) implement an on-line computerized retrieval system, or (3) develop a magnetic tape-based system to generate computer-output microfiche and allow searches of the archival tapes.

A.J.C.P. • December 1979

Vol. 72 • No. 6

5. 6. 7. 8. 9. 10. 11.

Reference Manual. Document No. DEC-I0-LFORA-C-D. Maynard, Massachusetts, 1975 Digital Equipment Corporation: Addendum to the FORTRAN-10 Language Reference Manual. Document No. DEC-I0-LFORAB-DI. Maynard, Massachusetts, 1975 Eastman Kodak Co.: The Management of Information. Bulletin A-I724 30 M972. Markets Division, Rochester, New York 14650, 12 pp Grams RR, Pastor EL: New concepts in the design of a clinical laboratory information system (LIS). Am J Clin Pathol 65: 662-674, 1976 Halper HR, Foster HS: Laboratory Regulation Manual. Aspen Systems Corporation, Germantown, Maryland 10767, 1976 (plus updates) Krieg AF: Personal Communication. Clinical Laboratory, Hershey Medical Center, Hershey, Pennsylvania 17033, 1976 Krieg AF, Shearer LK, Israel M: Operational Aspects of the LABCOM System. Clinical Laboratory, Hershey Medical Center, Hershey, Pennsylvania 17033, 1977 Laboratory Computing, Inc.: Laboratory Inactive Storage. Bulletin L-1000. LCI, 3301 Kinsman Blvd., Madison, Wisconsin 53701, Feb. 1978 Partners for Health Amendments of 1967: Section 5-Clinical Laboratories Improvement Act of 1967. Public Law 90-174. U. S.

13. 14. 15. 16.

17.

18.

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Congress, House of Representatives, 90th Congress. 5 Dec. 1967 Seligsen D: Current trends in laboratory automation, Computers in Laboratory Medicine. Edited by D Enlander. New York. Academic Press, 1975, pp 166-182 Soffer S, Entine S, Wolfe T. et al: Archival storage of clinical laboratory data. Clin Chem 24:436-441, 1978 Spraberry MN, Fretz P, Gascho T. et al: A computerized data management system for the clinical laboratory. Am J Med Technol 42:201-208, June 1976 Title 20—Employees' Benefits, Code of Federal Regulations. Chapter III — Social Security Administration. Part 405—Conditions for Coverage of Services of I ndependent Laboratories. Subpart M — Personnel. Section 405.1316. Condition—Clinical Laboratory management. Code of Federal Regulations, 1976, pp 631-632 Title 42—Public Health. Code of Federal Regulations. Chapter I — Public Health Service, DHEW. Subchapter F—Quarantine, Inspection, Licensing. Part 74—Clinical Laboratories. Subpart G—General Provisions. Section 74.54—Laboratory report and record. In: Federal Register, 33:15586, 31 Dec. 1968 Young DS: Databases for laboratory medicine. Hum Pathol 5: 619-620, 1974

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12.

BRIEF SCIENTIFIC REPORTS

An archival system for clinical laboratory data.

Vol. 72 • No. 6 BRIEF SCIENTIFIC REPORTS step in the patient's care. When a doctor orders a reticulocyte count, he must send his patient to a clinic...
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