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Launching quality improvement in histology.

An organized, well-defined plan can yield gratifying results in this specialized area of the laboratory.

QUALITY ASSURANCE in histology can present special challenges because it is so elusive. Instead of working with quantitative values subject to statistical evaluation, we deal with procedures that are based on interpreting subjective and qualitative characteristics of examined tissue.

When given responsibilities over quality assurance, our first task was to clarify goals and get a handle on quality control, which is measurable through the use of charts and individual studies. Only then could we tackle the more global aspects of quality assurance in measuring customer satisfaction of the product--a clinically relevant diagnostic report. So once daily process controls, such as maintenance logs, temperature charts, special stain control slides, and solution-changing records were totally adapted in all areas, we started down the road to real QA.

* Specimen receiving. The ultimate goal was to redesign the system in order to improve performance and service. Our biggest time-consumer was tracking unlabeled or mislabeled specimen containers and requisitions in the gross room. Even though specimen integrity and labeling requirements are explicitly outlined in the Laboratory Services Manual--found at all nursing stations, surgical areas, and client services--we knew that something more was necessary. After consulting with our technical assistant and members of nursing services, we settled on a Specimen Discrepancy Log.

When an incident occurs, the gross room assistant logs the details in the book and calls the area of origin. The accountable party must physically come to Pathology to correct the error and sign the log sheet, thereby assuming responsibility for the change. A Hospital Risk Management Incident Report is generated, which ultimately goes to the unit supervisor.

Compilation of the data is fairly straightforward, listing frequency, type of incident, and responsible areas. The indicators include labeling issues, requisition components, and correlation of information between the specimen container and the requisition. All thresholds are set at 100% compliance.

Our first quality assurance report statistics were abysmal; however, they were useful in getting our gears meshed and in assessing risk and targeting aberrant areas. A strict policy resulted: verbal counseling for one labeling incident, suspension without pay for two incidents, and termination for three. Our most recent quarterly report shows 99.4% compliance. As you can imagine, the amount or time that we spend tracking mislabeled or unlabeled specimens and requisitions has dropped dramatically.

* Routine slides. Our high-profile success with specimens, plus the realization by staff that time, effort, and undaunted documentation pays off, provided us with a launchpad for other studies. We began daily quality control of histology slides. We modified a log sheet originally provided by Sigma Diagnostics (St. Louis, Mo.) for listing deficiencies (Figure 2, Daily H & E Slide Quality Assessment Log). Before filing, randomly chosen slides representing all cutters are set aside daily and reviewed by the QA "Pathologist of the Month." The pathologist grades all criteria and subsequently determines the ability to diagnose.

The log lists the indicators--embedding, sectioning, processing, staining, and mounting. The threshold for slides judged "unable to diagnose" is set at 1%. Each technologist should have no more than 20% deficiencies overall--a criterion on our annual performance evaluations. The report enumerates deficiency categories to allow for the investigation of sudden shifts or slowly developing trends. It also includes complementary documentation of corrective actions taken by technologists. Ratings have improved so much that the pathologists want to discontinue monitoring!

* Special stains. The performing histotechnologist uses a daily log to grade special stains. The control slide is the process control to determine the effectiveness of the stain. The log provides a monitor for repeat workload, problem reagents, ineffective control sections, and technical competence. The corrective action column provides students and histotechnologists with an avenue for troubleshooting techniques. The report is similar to that for routine slides and provides comparable information.

* Surgical reports. The accuracy of surgical reports became our next focus. Two reports per transcriptionist are pulled weekly at random and checked for these indicators and thresholds:

* Correct spelling and grammar, 98%

* Typographical correctness, 98%

* Clear, concise, and adequate content, 100%

* Matching of gross description on report with requisition, 100%

* Matching of specimen in gross description with specimen in microscopic description, 100%

* Correct surgeon receiving report, 100%

* Grading and staging of tumor diagnoses, 100%

A pathologist assists with these reviews. Data for both the transcriptionists and for the dictating pathologist are tallied, with both identified by code letters for confidentiality. Although correcting spelling, typographical, and grammatical errors are secretarial responsibilities, these percentages are included with the pathologist's data for possible correlations and trends. (Is Pathologist A not as clear as his colleagues? Does Pathologist B make more grammatical errors?)

While most transcription and typographical errors are minor, the unintended exclusion or inclusion of words such as "No," "Present," or "Absent" could have serious consequences. Columns are tallied and results reviewed with the medical and clerical staff. Appropriate continuing education is documented as well.

* Turnaround time. Another quality assurance issue for any clinical area is turnaround time. We analyze three products for timeliness: daily distribution of slides to the pathologists, frozen section diagnoses, and delivery of surgical reports.

Our schedule demands that all slides be delivered to the pathologist by 11 a.m. A 90% threshold allows for two late days a month. We keep a daily record of the number and type of blocks cut and the time the last tray is distributed. Initial data accumulation surprisingly revealed no actual correlation between workload and completion time, yet our first study was out of compliance. Since the number and caliber of staff members had a direct effect, however, we started assessing the workloads of individual cutters. The next quarterly report found us within threshold!

The established CAP turnaround time for frozen section diagnosis is 15 minutes. Our threshold is set for 95%. We record specimen arrival time, time of verbal report, case number, and name of performing pathologist. The first quarterly accumulation was within threshold, so we delayed further studies until this year.

Another CAP inspection guideline states that the majority of surgical reports be delivered within 48 hours. We list outstanding cases (more than 24 hours old) in a gross room manual and assign a reason, such as prolonged fixation or elaborate dissection.

This tracking mechanism not only provides us with a central log but also is a help when the laboratory computer pending sheet is reviewed. Outliers are researched on a daily basis to assure that cases are not being neglected.

* CQI. Having seemingly exhausted issues of quality assurance, we began to scratch at the surface of continuous quality improvement (CQI). The need for persistent monitoring of the frequency and category of errors prompted us to design a global Incident/Discrepancy Report for use in all areas by all staff members. When warranted, based on the severity of the problem, the responsible party completes the corrective action section and returns it to the department supervisor. In addition, occasional audits are conducted to assess the "state of the state." Mini-reviews and compilations also help keep the department flowing smoothly.

Since CQI goes beyond the walls of the laboratory, we occasionally meet with members of ancillary and support services to better satisfy the needs of our customers--clinicians, surgeons, nurses, and patients. For example, when specimen containers were found to be inadequate to meet surgery's needs, we supplied them with an alternative.

The next task force will review requisitions for legibility of patient name and number, birth date and age, specimen type, and surgeon's full name (it doesn't matter how fast a report is delivered if it goes to the wrong doctor). In the future, we hope to monitor supplemental and revised reports for frequency and follow-up as well as documentation and tracking of intra- and extra-departmental consultation.

* What we have learned. Comprehensive quality assurance in histology is limitless and can be overwhelming if not approached in an organized and well-defined manner. A diagnostic report is the result of a number of processes beginning with the attending physician's consultation through the examination of tissue and the correlation of morphologic observations. Process controls must be thoroughly adapted before attempting true quality assurance. A written 10-step plan that is well documented and shared with all staff members is half the battle.

Keep in mind that there must be an end to the means. The report evaluations must be sensitive to possible trends and patterns of performance. The evaluations also should attempt to identify causes of problems and show evidence of methods by which performance can be improved. There should be documentation and assessment of each action's effectiveness, so remonitor indicators that do not fall within the threshold. Beneficial changes must be measurable, such as cost cuts, reduced errors, or shortened turnaround time. And, finally, conclusions should be reported through established channels.

Quality assurance programs in histology have to be integrated into the daily workflow just as in any area of the clinical laboratory. The mechanisms may be different, but the results--increased customer satisfaction, better patient care, more technologist/pathologist interaction, and improved levels of performance--are just as rewarding.

The author is pathology department supervisor, Presbyterian Hospital, Charlotte, N.C. She thanks former colleague Patricia B. Brown for her contribution in preparing this article.
COPYRIGHT 1993 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

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Author:Shaw, Patricia A.
Publication:Medical Laboratory Observer
Date:Mar 1, 1993
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