Q

Are you aware of a POCT for intraoperative PTH, or do you know if there is one in development?

A

Parathyroidectomies are generally considered a minimally invasive surgical procedure for many patients. Performing an intraoperative parathyroid hormone (PTH) assay as an adjunct to imaging and surgical exploration during this procedure can help contribute to promoting better patient care by decreasing anesthesia time and requring less surgical dissection. It may be done as an outpatient procedure, improve recovery time, minimize surgical complications, and in some instances, offer cost savings.^1,2,3PTH half-life is generally less than five minutes; thus a rapid decrease in blood levels at timed intervals during and post-surgery indicates that the hyperactive parathyroid tissue has been successfully removed.⁴

Key to this process is the ability to obtain accurate PTH values in a timely manner. In one study, 71% of hospitals used a central laboratory for the analysis, 23% used point-of-care facilities, and 6% used a satellite laboratory.⁵ Early assays were somewhat cumbersome and time-consuming. Today, immunometric assays have provided significant improvement in accuracy and turnaround times (TAT).

Testing times vary greatly depending on the assay methodology and location of the testing facility, i.e., central laboratory or point-of-care site. In one comparative study involving 32 central laboratories and 34 POCT sites, the mean TAT was 30.7 ± 4.5 minutes for the former, and 14.4 ± 2.8 minutes for POCT.² While TATs may be better when using POCT, the cost-benefit of setting up and maintaining POCT must be considered. One Canadian study⁶ favored use of a central laboratory showing only slightly longer TATs.

The main consideration is one of methodology and the ability to provide accurate and timely results. A number of FDA-approved PTH devices/kits are listed at the following FDA website: www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Carter and Howanitz¹ also reviewed a few available PTH methods.

Advances in technology have significantly improved clinical laboratory testing in accuracy, sensitivity, and even the size of the equipment footprint. While the multi-test analyzer of central laboratories remains the mainstay for clinical laboratory testing, there are a number of bench-top immunoassay analyzers that might be considered when establishing near-patient testing.⁷ Mounting a bench-top analyzer on a mobile cart that is wheeled into the surgical area can be done on an as-needed basis.⁶

While handheld devices are most often associated with POCT, they are limited to only a few analytes. PTH is currently not one of the approved tests. However, a handheld device has been developed in The Netherlands, called the Philips Handheld Magnotech System.⁸ It utilizes a self-contained cartridge using magnetic nanoparticles coated with specific antibodies directed against PTH. It provides an answer in 10 minutes or less, correlates well with standard assays (r=0.93), and measures down to the picomolar levels.⁹ Thus the technology is available, but its availability in the United States may be a few years away.

References

Byrne A, Howanitz PJ. Intraoperative testing for parathyroid hormone. A comprehensive review of the use of the assay and relevant literature. Arch Pathol Lab Med. 2003; 127(11):1424-1442.
Terris DJ, Weinberger PM, Farrag T, et al. Restoring point-of-care testing during parathyroidectomy with a newer parathyroid hormone assay. Otolaryngol Head Neck Surg. 2011; 145(4):557-560.
Riddle ND. College of American Pathologists Newspath. Intraoperative parathyroid hormone level evaluation during parathyroidectomy. June 1, 2010. http://www.cap.org/apps/cap.portal_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&cntvwrPtlt%7BactionForm.contentReference%7D=newspath%2F1006%2Fparathyroidectomy.html&_pageLabel=cntvwr. Accessed March 11, 2014.
Seybt MW, Loftus KA, Mulloy AL, Terris DJ. Optimal use of intraoperative PTH levels in parathyroidectomy. Laryngoscope. 2009;119(7):1331-1333.
Hortin GL, Carter AB. Intraoperative parathyroid hormone testing: Survey of testing program characteristics. Arch Pathol Lab Med. 2002;126:1045-1049.
O’Connell DA, Seikaly H, Harris JR. Central laboratory versus point of care testing in intraoperative monitoring of parathyroid levels: Cost comparison. J Otolaryngol – Head and Neck Surg. 2008; 37(1):91-97.
CAP Today. June 2011. http://www.cap.org/apps/docs/cap_today/0611/0611_CAPTODAY_ImmunoanalyzersGuide.pdf. Accessed March 11, 2014.
Royal Philips Electronics of the Netherlands. http://www.newscenter.philips.com/main/standard/about/news/press/20081120_magnotech.wpd. Accessed March 11, 2014.
Jarrige V, Nieuwenhuis JH, van Son JPHF, et al. A fast intraoperative PTH point-of-care assay on the Philips handheld magnotech system. Langenbecks Arch Surg. 2011;396:337-343.

Q

Is there a way to calculate the workload for staffing on a clinical laboratory of a general hospital of 247-license bed? I have been researching, but the only way I’m finding out is through CAP, and a fee is required. Is there a formula or a site I can go and do it on my own?

A

There is no one simple formula that can be universally applied to calculate productivity and staffing needs. Clinical laboratory benchmarking standards can vary considerably by type of institution (teaching hospital vs. community hospital; rural vs. urban), by bed size, by mission (cancer institution vs. heart institution), by instrumentation, by funding availability, and by staff competencies. With the advances in technology, benchmarking your laboratory has become a complex business.

Years ago, the College of American Pathologists (CAP) addressed this issue by creating the “Workload Recording” [WLR] program,”¹ in which timed studies were performed on individual laboratory tests, from start to final results. This was at a time when test menus were smaller, many tests were done manually, and instrumentation was limited to a few vendors. In today’s laboratory, clinical testing involves more automation, a greater number of instrument vendors, and an increased number of new laboratory tests. Due to this expansion of technology/methodology, it became extremely difficult to continue maintaining current measurements in a uniform manner. CAP’s last WLR manual was published in 1992, and it has since been replaced with the Laboratory Management Index Program (LMIP) using Q-probes, an external peer-comparison program.²

Benchmarking the clinical laboratory has expanded into a niche business due to the lack of publicly available industry standards.³ Similar to the way proficiency testing is handled, a number of companies will recruit laboratories to participate in benchmarking programs for a fee. By collecting data from many types of laboratories, comparisons can be made between your laboratory and others, but more specifically laboratories similar to yours. A few examples of the kind of data collected may include:

Total # of billable tests
Total # of tests by CPT code
Total # of accessions
Total # of slides (by section); # paraffin blocks; units transfused; etc.
Total # of technical FTEs
Total # of non-technical FTEs
Total # of paid hours
Total # of worked hours
Total # of stat & routine tests.

Once these data are collected and merged with the pool of all other laboratory participants, your laboratory then can be compared through various ratios:

# of billable tests per full-time equivalent (FTE); or per technical FTE; or per non-technical FTE
# of tests per paid hour
# of tests/worked hour
# of tests by CPT/technical FTE
# of slides/technical FTE (by section—hematology, cytology, microbiology, etc.)
# of paraffin blocks/FTE

While the WLR method focused on the minutes of effort (1 minute = 1 unit) needed to complete a specific test, data from CAP’s Q-probe evaluations look at output productivity that can be compared with peer groups. This avoids the inter-laboratory time differences that would be observed using the WLR method, which is dependent on instrumentation, methodology, technical skills, or other time-influencing factors.⁴

A variety of parameters can be examined based on the needs of the laboratory. This information can be very useful but is highly dependent on the accuracy of the information collected and the total number of participants within the group of a laboratory like yours. In addition, consistency in defining the collection parameters is critical. For example, in a Q-probe study by CAP,² data were segregated into four laboratory sections based on labor intensity, automation, and other eclectic functions within that section. They were: (1) anatomic pathology, (2) chemistry/ hematology/ immunology, (3) microbiology; and (4) transfusion medicine.

Other factors this study considered in ensuring consistency included the following:

Management (>50% time supervising) vs. non-management
FTE = 40 hrs/week (2080 hrs/year)
Doctorial staff (Time used in supervising only was included; other professional activities were not.)
Billable tests were used in counting test volumes.
Chemistry panels were unbundled for tabulation; CBC hemogram was not.
Reference testing was excluded.
Time spent for couriers, clerical, point-of-care, phlebotomy was excluded.

Data from each area were analyzed and ranked within percentiles (10%, 50%, 90%). Individual scores could then be compared. Inaccurate accounting of data and inconsistent definitions of data sources could skew productivity results, making your laboratory look more or less productive than it really is.

Similar studies have been published looking at histology⁵ and peripheral blood smear reviews.⁶ While these studies may offer some insight into what the average (median) productivity values are, they do not provide specifics with respect to the uniqueness of a single laboratory type. Similar peer comparison programs are offered by other providers for a fee.

As an alternative to external benchmarking, it is possible to look within your own laboratory to make appropriate comparisons over a period of time. By selecting specific metrics you want to measure similar to those above, you can compare each parameter for past years. For example, you can collect data for each quarter and compare the various parameters, remembering to be consistent in collecting the information.⁷ To get a more comprehensive look, you can expand the data collection to a five-year period. Entering this information into a spreadsheet and applying simple math to determine key performance ratios can be used to show volume increases per FTE, revenue increases per FTE, and other metrics that can address questions about staffing and productivity needs.

Another useful analysis to consider when making decisions about staffing is to look at the number of billable tests (or accessions, or requisitions) per day of the week. Knowing what days are the busiest allows one to staff accordingly.⁸ In a similar fashion, identifying test volume hour by hour shows how workload is distributed throughout a 24-hour period. Plotting this information on run charts visually shows where scheduling adjustments or the addition of full-time or part-time staff may be needed.

References

College of American Pathologists. Workload Recording Method & Personnel Management. CAP: Northfield, IL. 1992.
Nakhleh RE. Quality management tools. College of American Pathologists. http://www.cap.org/apps/docs/proficiency_testing/2014_qmt_catalog.pdf Accessed March 4, 2014.
Jones BA, Darcy T, Souers RJ, Meier FA. Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-probes study of laboratory staffing at 98 institutions. Arch Pathol Lab Med. 2012;136:140-147.
Soderman TM. Assessing laboratory operating performance: The Laboratory Management Index Program, in Snyder JR, Wilkinson DS, eds. Management in Laboratory Medicine, 3rd ed.1998. Lippincott: Philadelphia. 451-458.
Kohl SK, Lewis SE, Tunnicliffe J, et al. The College of American Pathologists and National Society for Histotechnology Workload Study. Arch Pathol Lab Med. 2011;135:728-736.
Novis DA, Walsh M, Wilkinson D, St. Louis M, Ben-Ezra J. Laboratory productivity and the rate of manual peripheral blood smear review. A College of American Pathologists Q-probes study of 95,141 complete blood count determinations performed in 263 institutions. Arch Pathol Lab Med. 2006;130:596-601.
Hermansen JM. Benchmarking: your laboratory by the numbers. Presentation at CLMA KnowledgeLab 2013, Orlando, FL.
Daley AT. Laboratory staffing analysis—getting started. Chi eNews, Chi Solutions, Inc. March 2011. http://www.chisolutionsinc.com/enews/2011-03.html. Accessed March 4, 2014.