Clin Chem Lab Med 2016; aop
Opinion Paper Michael A. Moss*
Moving towards harmonized reporting of serum and urine protein electrophoresis DOI 10.1515/cclm-2015-0937 Received September 28, 2015; accepted December 27, 2015
Why should we harmonize?
Abstract: During the last decade, surveys by questionnaire in Canada, Australia and New Zealand revealed wide variation in reporting practices by laboratories and individual practitioners in the interpretation of serum and urine protein electrophoresis (PE). Such variation has potential to adversely impact patient outcomes if report structure is inconsistent or if the messaging is incorrectly perceived by the receiving physician. Concerted efforts have been initiated to promote harmonization in the use of interpretative comments. The primary goal is to add value through clear communication with requesting physicians in the interest of quality patient care. Resistance to a harmonized approach largely reflects longstanding personal reporting habits and preferences but change can be more readily embraced if the new system is intuitive, easy to use and saves time in reporting.
As many patients have PE performed repeatedly over the years, this component of laboratory medicine practice affords the laboratorian an opportunity to not only review their own previous reports on a particular patient but also, those issued by their colleagues. Inevitably, differences in style and content become apparent in these reports. Some may comprise the single word, ‘Normal’ or the tightly worded and, arguably, inadequate, ‘Known case of paraproteinemia’, while other reports might qualify for entry in a short story contest. Could such variation impact patient care and, if so, to what extent would it be reasonable to harmonize reporting? I will make some assertions before addressing these questions. I regard a PE request as a consultation. The analysis itself is a snapshot of selected components of a patient’s biochemical profile. The laboratorian’s role is to review the gel or the scan and report any material observations that cannot be inferred from the quantitative data alone. As an example of a complex laboratory test that requires explanation [1], the report should include an interpretation of significant or potentially significant findings in the context of available clinical information and also in the context of previous PE studies, if applicable. Furthermore, I believe a PE report should be complete and stand alone; it should not ordinarily require the requesting physician to retrieve previous PE reports in order to assess the significance of current findings. Interoperability is the preservation of shared meaning when exchanging information between two parties [2] and in my experience, variation in reporting can cause confusion for the clinician with potential to adversely impact patient care. Over time, a patient’s electronic medical record will reflect a collection of laboratory reports from multiple sources, compounding the potential for error due to lack of harmonization [2]. Guidelines for the provision of interpretative comments on biochemical reports have been published [3] and state that whether a comment is required will depend on the clinical details provided, the clinical implication of the results and the likely
Keywords: harmonization; interpretative comments; protein electrophoresis; quality improvement; user adoption.
Introduction I am passionate about the issue of harmonized reporting in protein electrophoresis (PE) and am grateful to the editors for the invitation to offer this opinion article. My perspective is based on a personal experience of approximately 100,000 cases interpreted and reported in both a high volume community laboratory setting and tertiary care hospital practice.
*Corresponding author: Michael A. Moss, MB MSc FRCPC, Regional Medical Director, Laboratory Services, Interior Health, 2398 Arthur Court, Kelowna, BC, Canada V1V 2S7, E-mail: [email protected]
Brought to you by | The Flinders University Authenticated Download Date | 2/4/16 11:37 AM
2 Moss: Harmonized reporting of protein electrophoresis Table 1: Potential benefits of report harmonization. A uniform reporting practice has the potential to promote consistency and… –alignment/compliance with consensus guidelines, as they evolve –reduce the possibility of misinterpretation by clinician –comparability of serial reports through standard format and terminology –reduce typographical errors –reduce reporting time, by facilitating: –review of previous reports –uniform construction of interpretative comments –improve precision by harmonizing the use of semi-quantitative terms –e.g. slight, moderate, marked –facilitate medical peer review and research activities
familiarity of the requesting physician with the tests and their interpretation. I advocate harmonization in the firm belief that developing guidelines for reporting with reduced variation will promote completeness and consistency, thereby improving overall quality (Table 1).
Current state At least two reviews have been conducted that demonstrated large variation in reporting PE, with subsequent recommendations for a consistent approach. In 2007 the Canadian Coalition for Quality in Laboratory Medicine (CCQLM) conducted a national survey in Canada to gain information about practices in reporting PE profiles and to develop model interpretative comments. Recommendations were presented at a workshop at the American Association for Clinical Chemistry annual meeting in 2012. In 2008, two surveys were performed by questionnaire in Australia and New Zealand, under the auspices of the Australasian Association of Clinical Biochemists (AACB). About half of the laboratories in the region responded; analysis revealed extensive variation in certain reporting practices [4]. These findings led to the formation of a Working Party on Standardized Reporting of Protein Electrophoresis as a subsequent initiative of the AACB. Through a Position Paper and a subsequent consensus process this group developed comprehensive recommendations for standardized reporting of PE [5]. Some of these recommendations are summarized in Table 2. The AACB also recommended that a laboratory reporting PE should have an educational strategy in place suitable for requesting physicians. This strategy should
Table 2: AACB: some recommendations related to reporting protein electrophoresis [5]. Nomenclature: preferred terms –serum monoclonal component: paraprotein or monoclonal IgX xxxx –serum monoclonal free light chains (reserve the term ‘Bence Jones protein’ for urine) Detection and monitoring –preferable to use the same analytical method to monitor paraprotein concentration in individual patients –refer specimens requiring isoelectric focusing electrophoresis (IFE) to a reference laboratory (e.g. to classify a low concentration band newly detected in a post-stem cell transplant patient) –consistently report paraprotein(s) in the same quantitative field (e.g. in β region) –round paraprotein (PP) quantitation to nearest whole number (g/L) –report PP 5 4–5 2–4
Opinion Paper Michael A. Moss*
Moving towards harmonized reporting of serum and urine protein electrophoresis DOI 10.1515/cclm-2015-0937 Received September 28, 2015; accepted December 27, 2015
Why should we harmonize?
Abstract: During the last decade, surveys by questionnaire in Canada, Australia and New Zealand revealed wide variation in reporting practices by laboratories and individual practitioners in the interpretation of serum and urine protein electrophoresis (PE). Such variation has potential to adversely impact patient outcomes if report structure is inconsistent or if the messaging is incorrectly perceived by the receiving physician. Concerted efforts have been initiated to promote harmonization in the use of interpretative comments. The primary goal is to add value through clear communication with requesting physicians in the interest of quality patient care. Resistance to a harmonized approach largely reflects longstanding personal reporting habits and preferences but change can be more readily embraced if the new system is intuitive, easy to use and saves time in reporting.
As many patients have PE performed repeatedly over the years, this component of laboratory medicine practice affords the laboratorian an opportunity to not only review their own previous reports on a particular patient but also, those issued by their colleagues. Inevitably, differences in style and content become apparent in these reports. Some may comprise the single word, ‘Normal’ or the tightly worded and, arguably, inadequate, ‘Known case of paraproteinemia’, while other reports might qualify for entry in a short story contest. Could such variation impact patient care and, if so, to what extent would it be reasonable to harmonize reporting? I will make some assertions before addressing these questions. I regard a PE request as a consultation. The analysis itself is a snapshot of selected components of a patient’s biochemical profile. The laboratorian’s role is to review the gel or the scan and report any material observations that cannot be inferred from the quantitative data alone. As an example of a complex laboratory test that requires explanation [1], the report should include an interpretation of significant or potentially significant findings in the context of available clinical information and also in the context of previous PE studies, if applicable. Furthermore, I believe a PE report should be complete and stand alone; it should not ordinarily require the requesting physician to retrieve previous PE reports in order to assess the significance of current findings. Interoperability is the preservation of shared meaning when exchanging information between two parties [2] and in my experience, variation in reporting can cause confusion for the clinician with potential to adversely impact patient care. Over time, a patient’s electronic medical record will reflect a collection of laboratory reports from multiple sources, compounding the potential for error due to lack of harmonization [2]. Guidelines for the provision of interpretative comments on biochemical reports have been published [3] and state that whether a comment is required will depend on the clinical details provided, the clinical implication of the results and the likely
Keywords: harmonization; interpretative comments; protein electrophoresis; quality improvement; user adoption.
Introduction I am passionate about the issue of harmonized reporting in protein electrophoresis (PE) and am grateful to the editors for the invitation to offer this opinion article. My perspective is based on a personal experience of approximately 100,000 cases interpreted and reported in both a high volume community laboratory setting and tertiary care hospital practice.
*Corresponding author: Michael A. Moss, MB MSc FRCPC, Regional Medical Director, Laboratory Services, Interior Health, 2398 Arthur Court, Kelowna, BC, Canada V1V 2S7, E-mail: [email protected]
Brought to you by | The Flinders University Authenticated Download Date | 2/4/16 11:37 AM
2 Moss: Harmonized reporting of protein electrophoresis Table 1: Potential benefits of report harmonization. A uniform reporting practice has the potential to promote consistency and… –alignment/compliance with consensus guidelines, as they evolve –reduce the possibility of misinterpretation by clinician –comparability of serial reports through standard format and terminology –reduce typographical errors –reduce reporting time, by facilitating: –review of previous reports –uniform construction of interpretative comments –improve precision by harmonizing the use of semi-quantitative terms –e.g. slight, moderate, marked –facilitate medical peer review and research activities
familiarity of the requesting physician with the tests and their interpretation. I advocate harmonization in the firm belief that developing guidelines for reporting with reduced variation will promote completeness and consistency, thereby improving overall quality (Table 1).
Current state At least two reviews have been conducted that demonstrated large variation in reporting PE, with subsequent recommendations for a consistent approach. In 2007 the Canadian Coalition for Quality in Laboratory Medicine (CCQLM) conducted a national survey in Canada to gain information about practices in reporting PE profiles and to develop model interpretative comments. Recommendations were presented at a workshop at the American Association for Clinical Chemistry annual meeting in 2012. In 2008, two surveys were performed by questionnaire in Australia and New Zealand, under the auspices of the Australasian Association of Clinical Biochemists (AACB). About half of the laboratories in the region responded; analysis revealed extensive variation in certain reporting practices [4]. These findings led to the formation of a Working Party on Standardized Reporting of Protein Electrophoresis as a subsequent initiative of the AACB. Through a Position Paper and a subsequent consensus process this group developed comprehensive recommendations for standardized reporting of PE [5]. Some of these recommendations are summarized in Table 2. The AACB also recommended that a laboratory reporting PE should have an educational strategy in place suitable for requesting physicians. This strategy should
Table 2: AACB: some recommendations related to reporting protein electrophoresis [5]. Nomenclature: preferred terms –serum monoclonal component: paraprotein or monoclonal IgX xxxx –serum monoclonal free light chains (reserve the term ‘Bence Jones protein’ for urine) Detection and monitoring –preferable to use the same analytical method to monitor paraprotein concentration in individual patients –refer specimens requiring isoelectric focusing electrophoresis (IFE) to a reference laboratory (e.g. to classify a low concentration band newly detected in a post-stem cell transplant patient) –consistently report paraprotein(s) in the same quantitative field (e.g. in β region) –round paraprotein (PP) quantitation to nearest whole number (g/L) –report PP 5 4–5 2–4
