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How Long Should it Take to Get a Pathology Diagnosis?
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Quality Analysis of Molecular Turnaround Times and Process Completion Times for In-House Testing
Background: Many laboratories restrict their definition of turnaround time (TAT) to intra-laboratory activities. However, such an approach will underestimate TAT since nonanalytical delays may be responsible for up to 96% of total TATs. With this in mind, we aimed to conduct a quality analysis on the impact on turnaround times since in-house testing of EGFR, BRAF, NRAS, KRAS, HPV, and CT/NG, as well as a quality analysis of completion times for sequential process steps for FFPE tissue mutational testing from order to result generation to account for possible non-analytical delays.
Objective: This quality analysis focused on three main objectives: (1) Study the TAT for current in-house molecular tests vs prior TAT for molecular test send outs; (2) Study completion time processes for main steps in FFPE tumor mutation testing for current in-house testing; (3) Gauge clinicians’ satisfaction since the introduction of in-house molecular testing.
Methods: Turnaround time points are defined as the time the order is placed to result generation, whether in laboratory section in CPRS, anatomic pathology supplementary report (APS), or cytology integrated report. Analysis of sequential steps of laboratory completion times of order-tomolecular accession to testing analysis to release of lab result to CPRS to APS report results integration for FFPE tissue mutation testing was conducted. Lastly, hematology/oncology clinicians and clinicians involved with HPV testing were surveyed on their satisfaction with TATs.
Results: Comparing prior vs current TATs, there was a decrease in mean TAT of 31.6% for EGFR, 56.4% for KRAS, 54.6% for BRAF, 61.5% for NRAS, 42.1% for CT/NG, 82.6% BCR-ABL, and 29.3% for HPV. Completion time process analysis revealed the longest completion time was order-tomolecular accession. Survey showed that clinicians reported greater satisfaction with TATs since in-house testing for FFPE mutation testing and HPV testing.
Conclusions: We noted marked improvement in TATs since in-house molecular mutational testing with greater clinician satisfaction. Future endeavors may include quality analysis of the order-to-molecular accession step to elucidate ways to improve completion times to further improve TATs.
Background: Many laboratories restrict their definition of turnaround time (TAT) to intra-laboratory activities. However, such an approach will underestimate TAT since nonanalytical delays may be responsible for up to 96% of total TATs. With this in mind, we aimed to conduct a quality analysis on the impact on turnaround times since in-house testing of EGFR, BRAF, NRAS, KRAS, HPV, and CT/NG, as well as a quality analysis of completion times for sequential process steps for FFPE tissue mutational testing from order to result generation to account for possible non-analytical delays.
Objective: This quality analysis focused on three main objectives: (1) Study the TAT for current in-house molecular tests vs prior TAT for molecular test send outs; (2) Study completion time processes for main steps in FFPE tumor mutation testing for current in-house testing; (3) Gauge clinicians’ satisfaction since the introduction of in-house molecular testing.
Methods: Turnaround time points are defined as the time the order is placed to result generation, whether in laboratory section in CPRS, anatomic pathology supplementary report (APS), or cytology integrated report. Analysis of sequential steps of laboratory completion times of order-tomolecular accession to testing analysis to release of lab result to CPRS to APS report results integration for FFPE tissue mutation testing was conducted. Lastly, hematology/oncology clinicians and clinicians involved with HPV testing were surveyed on their satisfaction with TATs.
Results: Comparing prior vs current TATs, there was a decrease in mean TAT of 31.6% for EGFR, 56.4% for KRAS, 54.6% for BRAF, 61.5% for NRAS, 42.1% for CT/NG, 82.6% BCR-ABL, and 29.3% for HPV. Completion time process analysis revealed the longest completion time was order-tomolecular accession. Survey showed that clinicians reported greater satisfaction with TATs since in-house testing for FFPE mutation testing and HPV testing.
Conclusions: We noted marked improvement in TATs since in-house molecular mutational testing with greater clinician satisfaction. Future endeavors may include quality analysis of the order-to-molecular accession step to elucidate ways to improve completion times to further improve TATs.
Background: Many laboratories restrict their definition of turnaround time (TAT) to intra-laboratory activities. However, such an approach will underestimate TAT since nonanalytical delays may be responsible for up to 96% of total TATs. With this in mind, we aimed to conduct a quality analysis on the impact on turnaround times since in-house testing of EGFR, BRAF, NRAS, KRAS, HPV, and CT/NG, as well as a quality analysis of completion times for sequential process steps for FFPE tissue mutational testing from order to result generation to account for possible non-analytical delays.
Objective: This quality analysis focused on three main objectives: (1) Study the TAT for current in-house molecular tests vs prior TAT for molecular test send outs; (2) Study completion time processes for main steps in FFPE tumor mutation testing for current in-house testing; (3) Gauge clinicians’ satisfaction since the introduction of in-house molecular testing.
Methods: Turnaround time points are defined as the time the order is placed to result generation, whether in laboratory section in CPRS, anatomic pathology supplementary report (APS), or cytology integrated report. Analysis of sequential steps of laboratory completion times of order-tomolecular accession to testing analysis to release of lab result to CPRS to APS report results integration for FFPE tissue mutation testing was conducted. Lastly, hematology/oncology clinicians and clinicians involved with HPV testing were surveyed on their satisfaction with TATs.
Results: Comparing prior vs current TATs, there was a decrease in mean TAT of 31.6% for EGFR, 56.4% for KRAS, 54.6% for BRAF, 61.5% for NRAS, 42.1% for CT/NG, 82.6% BCR-ABL, and 29.3% for HPV. Completion time process analysis revealed the longest completion time was order-tomolecular accession. Survey showed that clinicians reported greater satisfaction with TATs since in-house testing for FFPE mutation testing and HPV testing.
Conclusions: We noted marked improvement in TATs since in-house molecular mutational testing with greater clinician satisfaction. Future endeavors may include quality analysis of the order-to-molecular accession step to elucidate ways to improve completion times to further improve TATs.
Clinical Characteristics of Lung Cancer Patients With Driver Mutations at the Minneapolis VA HCS
Background: EGFR and ALK gene mutations differ in frequency in various populations, are more common in young, non-smoking women, and are predictors for response to targeted therapy. The objective of this study was to analyze the clinical characteristics of patients with these mutations, and to compare them to other lung cancer patients.
Methods: We identified 154 lung adenocarcinoma cases diagnosed from 2009-2015, here we present interim data on 100 patients. Baseline demographics, smoking history, exposure to agent orange, pathologic diagnoses, AJCC stage, treatment, and survival data were collected.
Results: At diagnosis, median age was 67 (46-90) years; 96 were male. AJCC stage was 1a (n = 3), 1b (n = 1), 2a (n = 3), 2b (n = 6), 3a (n = 16), 3b (n = 10), 4 (n = 61). 92 were white, 6 African American, and 2 Native American. 95% were smokers; 25 had multiple malignancies and, 22 were exposed to Agent Orange. 84 tumors were tested for EGFR; 78% were negative, 7.5% were positive, and 15% had insufficient material. None of 54 tumors tested for ALK had rearrangement. 68 received chemotherapy. Average survival was 20.7 (range 0-90) months; 16 patients remain alive.
EGFR positive patients includes 4 males and 2 females. 5 were smokers. None was exposed to Agent Orange or had other malignancies. Average age was 66 years (54-79). 3 were AJCC stage IV, 2 stage IIIb and 1 stage IIa. EGFR inhibitor treatment was given to 4 patients, 1 received conventional chemotherapy, and 1 declined treatment. Average survival was 19.6 ( 6-35)months; 2 remain alive.
Conclusions: In our population only a low percentage of patients has EGFR mutation and even fewer have ALK rearrangement. However, a greater proportion of patients with EGFR positive tumors are women (33% vs 4%). Smoking history should not exclude patients from evaluation for targeted therapy. While no difference in survival was observed, this may be due to the small number of patients in the EGFR-inhibitor treated group. A larger study using The National VA Tumor Registry may provide more information to help guide testing and treatment of these patients. Updated data will be presented at the AVAHO Annual Meeting.
Background: EGFR and ALK gene mutations differ in frequency in various populations, are more common in young, non-smoking women, and are predictors for response to targeted therapy. The objective of this study was to analyze the clinical characteristics of patients with these mutations, and to compare them to other lung cancer patients.
Methods: We identified 154 lung adenocarcinoma cases diagnosed from 2009-2015, here we present interim data on 100 patients. Baseline demographics, smoking history, exposure to agent orange, pathologic diagnoses, AJCC stage, treatment, and survival data were collected.
Results: At diagnosis, median age was 67 (46-90) years; 96 were male. AJCC stage was 1a (n = 3), 1b (n = 1), 2a (n = 3), 2b (n = 6), 3a (n = 16), 3b (n = 10), 4 (n = 61). 92 were white, 6 African American, and 2 Native American. 95% were smokers; 25 had multiple malignancies and, 22 were exposed to Agent Orange. 84 tumors were tested for EGFR; 78% were negative, 7.5% were positive, and 15% had insufficient material. None of 54 tumors tested for ALK had rearrangement. 68 received chemotherapy. Average survival was 20.7 (range 0-90) months; 16 patients remain alive.
EGFR positive patients includes 4 males and 2 females. 5 were smokers. None was exposed to Agent Orange or had other malignancies. Average age was 66 years (54-79). 3 were AJCC stage IV, 2 stage IIIb and 1 stage IIa. EGFR inhibitor treatment was given to 4 patients, 1 received conventional chemotherapy, and 1 declined treatment. Average survival was 19.6 ( 6-35)months; 2 remain alive.
Conclusions: In our population only a low percentage of patients has EGFR mutation and even fewer have ALK rearrangement. However, a greater proportion of patients with EGFR positive tumors are women (33% vs 4%). Smoking history should not exclude patients from evaluation for targeted therapy. While no difference in survival was observed, this may be due to the small number of patients in the EGFR-inhibitor treated group. A larger study using The National VA Tumor Registry may provide more information to help guide testing and treatment of these patients. Updated data will be presented at the AVAHO Annual Meeting.
Background: EGFR and ALK gene mutations differ in frequency in various populations, are more common in young, non-smoking women, and are predictors for response to targeted therapy. The objective of this study was to analyze the clinical characteristics of patients with these mutations, and to compare them to other lung cancer patients.
Methods: We identified 154 lung adenocarcinoma cases diagnosed from 2009-2015, here we present interim data on 100 patients. Baseline demographics, smoking history, exposure to agent orange, pathologic diagnoses, AJCC stage, treatment, and survival data were collected.
Results: At diagnosis, median age was 67 (46-90) years; 96 were male. AJCC stage was 1a (n = 3), 1b (n = 1), 2a (n = 3), 2b (n = 6), 3a (n = 16), 3b (n = 10), 4 (n = 61). 92 were white, 6 African American, and 2 Native American. 95% were smokers; 25 had multiple malignancies and, 22 were exposed to Agent Orange. 84 tumors were tested for EGFR; 78% were negative, 7.5% were positive, and 15% had insufficient material. None of 54 tumors tested for ALK had rearrangement. 68 received chemotherapy. Average survival was 20.7 (range 0-90) months; 16 patients remain alive.
EGFR positive patients includes 4 males and 2 females. 5 were smokers. None was exposed to Agent Orange or had other malignancies. Average age was 66 years (54-79). 3 were AJCC stage IV, 2 stage IIIb and 1 stage IIa. EGFR inhibitor treatment was given to 4 patients, 1 received conventional chemotherapy, and 1 declined treatment. Average survival was 19.6 ( 6-35)months; 2 remain alive.
Conclusions: In our population only a low percentage of patients has EGFR mutation and even fewer have ALK rearrangement. However, a greater proportion of patients with EGFR positive tumors are women (33% vs 4%). Smoking history should not exclude patients from evaluation for targeted therapy. While no difference in survival was observed, this may be due to the small number of patients in the EGFR-inhibitor treated group. A larger study using The National VA Tumor Registry may provide more information to help guide testing and treatment of these patients. Updated data will be presented at the AVAHO Annual Meeting.
PAP Test/HPV Co-test: Quality Improvement Initiative to Identify Approaches for Integrative Clinical Care Management
Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.
Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.
Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.
Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.
Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.
Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.
Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.
Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.
Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.
Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.
Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.
Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.
Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.
Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.
Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.
Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.
Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.
Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.
Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.
Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.
Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.