QUALITY MANAGEMENT (QM) PROGRAM

Laboratory of Pathology: 2015

Purpose:

                The Quality Management (QM) program is designed to continually evaluate the quality of clinical services generated throughout the Laboratory of Pathology (LP). This is accomplished by monitoring and evaluating quality improvement indicators for the LP and by assisting each individual laboratory with the QM plan. The LP QM Committee oversees the program.

Method of Implementation: 

General Requirements

The QM program is an LP-wide initiative and quality indicators and reports cover all clinical areas.  A list of indicators is provided below. Some clinical sections can opt to devise additional QI plans to monitor and document a set of relevant indicators based on their section’s regulatory standards (e.g. College of American Pathologists (CAP) standards for turnaround times).  Indicators for individual sections’ quality reports should include pre-analytical, analytical, and post-analytical variables. LP areas that will devise a section-specific 2015 plan to complement the LP-wide QM quality indicators’ to present at QM Committee are:

 1. Clinical Cytogenetics Section

 2. Flow Cytometry Unit

-   All clinical sections are given the opportunity to report their section specific quality plans and     subsequent end-of-year reports to QM Committee to share quality initiatives across clinical sections.

-   In addition to the annual report for these sections, General Anatomic Pathology (AP): Autopsy  and Histology Laboratory’s QA Sheets will be reviewed during each QM Committee meeting.   (Histology is the primary clinical processing laboratory, therefore monthly monitoring of quality issues are important to report to QM committee).       

 -  This quality monitor has been recommended to address the 2014 Customer Satisfaction Survey, identifying customer complaints or incidents that can affect patient care timely in QM Committee      to impact all LP sections; and also addresses the CAP’s most current checklist items for 2014 COM.04000 (Documented QM/QC Plan), GEN.20100 (QM Extent of Coverage all LP Services), GEN.20316 (QM Indicators of Quality),  the 2012 CAP  Laboratory Patient Safety Goal (most current) – Improve identification, communication, and correction of errors in a timely manner. Specific criteria approved by QM Committee require that all sections establish and define any incidents/complaints to address, monitor and report to QM Committee on a monthly basis. The objective is to identify and resolve consistent or recurrent complaints or incidents that affect all LP clinical laboratories. Action items will be addressed by

QM Committee.

   The LP QM program will be devised and monitored by the QM committee.  Indicators to be monitored and reported include: pre-analytical (number of cases without requisitions), analytical (turnaround time for SI and SB cases), and post-analytical (number of revised reports). Detailed specifications for the LP QM program and AP QI plan are listed below. The QM committee recommends that each laboratory/section/unit devise and monitor quality indicators specific to their discipline.  The section’s QM plan should improve patient safety and the quality of services provided by LP. Although a formal written and verbal report will not be required, updates on individual efforts to improve patient safety and quality of services will be requested by the QM committee.

     The QM committee will monitor the process related to patient safety (CAP and JCAHO Laboratory Patient Safety Goals) on an annual basis. The committee will utilize several parameters in this process including the annual QM reports from the required LP laboratories/units/sections; outcomes of events reported to the QM committee via QI tracker/QI log or directly to either the QM committee chair or Clinical Lab Manager; participation of QM committee chair in the Surgical Administrative Committee (SAC); and reporting of relevant LP QM findings to Clinical Center/NIH office(s) involved in patient care and safety.

      The QM committee will monitor the process related to occupational injury/illness in the LP at least on a quarterly basis. Each Unit/Section/Laboratory will submit all OMS reports to the Clinical Laboratory Manager. The OMS reports must not contain any personal identifiers. The OMS reports will be reviewed by the Clinical Laboratory Manager and reported to the QM committee to identify any common issues that could potentially impact other LP Units/Sections/Laboratories.

        The QM program for 2015 will continue address issues raised during the 2012 and 2014 customer satisfaction surveys, in which physicians and other healthcare providers in the Clinical Center were polled on quality issues relevant to LP’s mission: clinical, research, and academia.  The QM Chair and LP Medical Director have recommended (based on the survey):  to continue to improve turnaround time for all clinical sections; to implement a mechanism for addressing external submitted complaints or incidents; and Infectious Diseases physicians have been added to the autopsy notification list, as well as implemented turnaround time monitoring for post-mortem services with documentation of reasons for outliers in compliance with CAP and JCAHO recommendations.

General Requirements of the QM Committee

The QM Committee will meet to review the effectiveness of the QM program and to follow-up on any corrective actions taken.  Minutes of each QM Committee review will be generated to document the effectiveness of the QM program and to include any recommendations made to improve the QM program.

The QM Committee will include: (1) the Chief of the Laboratory of Pathology; (2) the QM Committee Chairman, (3) the Clinical Laboratory Manager, (4) the LIS Administrator, (5) a representative from each LP laboratory/unit/section, and (6) an AP resident.

A pathology resident will attend QM committee meetings as a “resident member” on a rotational basis for the purpose of providing an educational experience and an opportunity to contribute to the ongoing improvement efforts of the QM committee. Other residents are encourage participating at the meetings and will attend the meetings as “guests”. Hematopathology and Cytopathology fellows will attend the QM committee meetings as “guests” with the purpose of providing an educational experience with issues related to quality assurance, quality improvement and quality management.

PROCEDURE FOR IMPLEMENTATION OF QM PROGRAM

Laboratory of Pathology: 2015

Specific Requirements

The LP QM program also incorporates the AP QI plan to review and discuss the quality reports of at least 10 indicators chosen by the committee. The plan for each indicator is listed on the monthly reports and updated as necessary by the committee. Actions taken if goals are not met will be documented in the minutes. Quality indicators are reviewed for relevance by the QM committee at least annually. The following quality indicators have been approved by the QM committee as the 2015 Quality Indicators will be in effect from January 1 through December 31, 2015. The indicators relating to the CAP Laboratory General Checklist¹ are marked with (***) and are also the components of the AP QI plan:

                Analytic:               1. Medical Cytology Turnaround Time (TAT)

                Analytic:               2. GYN Cytology TAT

                Analytic:               3. Small Biopsy TAT***

                Analytic:               4. Complex Cases TAT***

                Analytic:               5. Intraoperative (Frozen Section) TAT***

                Analytic:               6. Autopsy TAT (Final Autopsy Report)***

                Pre-Analytic:         7. Immunohistochemistry Patient Identification Events

                Post-Analytic:       8. Intraoperative Correlation (Frozen Sections)***

                Post-Analytic:       9. Revised (Corrected) Reports***

                Pre-Analytic:        10. Patient Identification Error, Unlabeled Cases or Missing Patient Information

                Pre-Analytic:        11. Requisitions Not Submitted***

                Analytic:              12. Molecular Diagnostics Turnaround Time

                Pre-Analytic:        13. Molecular Diagnostics Specimen Adequacy

                Pre-Analytic:        14. Chromosome Pathology Unit Specimen Adequacy

                Analytic:               15. Chromosome Pathology Unit Turnaround Time (TAT)

                Pre-Analytic:        16. Flow Cytometry Bone Marrow (BM) Specimen Adequacy

                Analytic:               17. Immunohistochemistry Requests for Repeat Stains

              In addition to these quality indicators, the QM Committee engaged the in-training pathology physicians (residents and fellows) in 2014 to implement three projects and involve the in-training pathology physicians in quality management and improvement. These projects were selected because they involve recurring quality issues affecting LP and required monitoring. These projects will continue through 2015, and include:

Clotted Bone Marrow Aspirates:

                A collaborative QM project by the Hematopathology fellow(s), Flow Cytometry, and

               Cytogenetics aimed to decrease the number of clotted aspirates received by LP sections  

               due to collection techniques.

CAP Cancer Protocols Review:       

               To address CAP Anatomic Pathology Checklist requiring that all data elements required

               in applicable CAP Cancer Protocols are included in the surgical pathology report.

Final Autopsy Report Turnaround Time:      

              CAP- and Joint Commission-regulated turnaround time requirements for final autopsy

              diagnosis has been a long-standing issue for LP due to its education program and research

              missions. 

1. Medical Cytology Turnaround Time

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. A recent study collected data on TAT for medical (non-gynecological) cytology from 180 laboratories. Results showed that labs in the top 50 % of participants would have 90% of medical cytology cases with TAT (receipt to report) of 3 calendar days.2 It was not mentioned what types of laboratories participated in the study; however, it is likely that a large portion of participants were nonacademic labs. LP provides anatomic pathology services for the Clinical Center as well as 21 different Institutes of the National Institutes of Health (NIH). NIH is a large clinical/research institution where all patients participate in protocol studies for various diseases and disorders including rare syndromes and cancers.  Only a minority of patients requires a primary diagnosis. A significant number of medical cytology cases require additional ancillary studies and/or further workup to confirm primary diagnosis exclude secondary malignancy/disorder or include additional studies mandated by protocol. Therefore, the process involved in signing out medical cytology cases at the NIH is more complex and does not reflect the medical cytology cases seen at more “conventional” cytology labs where primary diagnosis is often the main concern. In addition, the NIH LP is a teaching department with accredited residency and fellowship programs in anatomic pathology. These facts must be taken into consideration when defining a threshold for medical cytology TAT. As reported by ADASP for TAT in surgical pathology cases, extra time should be allowed for cases requiring recuts, immunohistochemistry, etc.3 The same principal is valid for medical cytology cases. The threshold established for medical cytology TAT was based on the above information and also in accordance with expectations of SAC.

Threshold: 90% of medical cytology cases signed out within 5 working days.

2. GYN Cytology Turnaround Time

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. A prospective study on the TAT for gynecologic cytology specimens including 371 laboratories showed that half of the participating labs were able to sign out 90% of the cases within 8 calendar days.4 Typically these labs have a large volume of gynecologic cytology specimens. The number of gynecologic cytology cases seen at LP is low. Based on this observation and also in accordance with SAC expectations, the TAT for gynecologic cytology established by the committee is within the expected TAT for our patient population.

Threshold: 95% of gynecologic cytology cases signed out within 5 working days.

3. Small Biopsy Turnaround Time

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. A recent study collected data on TAT for routine biopsy specimens (small biopsy) from 157 small private and public hospitals in the U.S. (153) and abroad. Results showed that approximately 86% of cases were signed out within 2 working days.5 LP provides anatomic pathology services for the Clinical Center as well as 21 different Institutes of the National Institutes of Health (NIH). NIH is a large clinical/research institution where all patients participate in protocol studies for various diseases and disorders including rare syndromes and cancers.  Only a minority of patients requires a primary diagnosis. A significant number of biopsy cases require additional ancillary studies and/or further workup to confirm primary diagnosis, exclude secondary malignancy/disorder or include additional studies mandated by protocol. Therefore, the process involved in signing out biopsy cases at the NIH is more complex and does not reflect the biopsy cases seen at more “conventional” surgical pathology labs where primary diagnosis is often the main concern. In addition, the NIH LP is a teaching department with accredited residency and fellowship programs in anatomic pathology. These facts must be taken into consideration when defining a threshold for small biopsy TAT. As reported by ADASP for TAT in surgical pathology cases, extra time should be allowed for cases that needed recuts, immunohistochemistry, etc.3 Therefore, the threshold established for small biopsy TAT was based on the above information and also in accordance with expectations of SAC.

Threshold: 90% of small biopsy cases signed out within 7 working days.

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4. Complex Cases Turnaround Time

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. A study collected data on TAT for complex surgical pathology cases from 489 laboratories in the U.S. and abroad. Results showed that 60 % of complex special-handling cases were signed out within 2 working days. The median TAT was 2.6 days with a range of 0-13.5 days.6 LP provides anatomic pathology services for the Clinical Center as well as 21 different Institutes of the National Institutes of Health (NIH). NIH is a large clinical/research institution where all patients participate in protocol studies for various diseases and disorders including rare syndromes and cancers.  Therefore, the LP surgical pathology complex cases are considered special handling complex cases. In addition, a significant number of complex cases require additional ancillary studies and/or further workup to confirm primary diagnosis, exclude secondary malignancy/disorder or include additional studies mandated by protocol. The NIH LP is also a teaching department with accredited residency and fellowship programs in anatomic pathology. These facts must be taken into consideration when defining a threshold for complex cases TAT. As reported by ADASP for TAT in surgical pathology cases, extra time should be allowed for cases requiring overnight fixation, resubmission, recuts, immunohistochemistry, etc.3 The threshold established for complex surgical pathology cases was based on the above information and also in accordance with expectations of SAC.

Threshold: 90% of complex cases signed out within 10 working days.

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5. Intraoperative (Frozen Section) Turnaround Time

Frozen Section (IOC) is an essential tool for patients undergoing surgery to aid the surgeon with a rapid diagnosis; therefore, IOC turnaround time (TAT) might have direct impact on patient’s therapy and safety during and after surgery.  This indicator results from the CAP’s Anatomic Pathology checklist question ANP.11820, supported by a CAP Q-Probe study of 32,868 frozen sections in 700 hospitals (Archives of Pathology Lab Medicine, 1997; 121:559-567) which suggests that 90% of frozen sections should be completed within 20 minutes. Twenty minutes is intended to apply to the typical single frozen section, and cases involving multiple sections on a single specimen or case (e.g., resection margins) should expect longer TATs.  The threshold is established in accordance with the CAP standard and all outliers will be evaluated by the QM committee and recurring reasons will be addressed with the residents and faculty.

Threshold: 90% of frozen sections will be completed within 20 minutes average

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6. Autopsy Turnaround Time

Autopsy reporting is an important part of the quality management of medical care. It may be the only tool for answering questions and is the gold standard for determining the cause of death. Autopsies serve to identify diseases that were unknown at the time of death. The NIH Clinical Center Medical Records Department, in line with JCAHO standards has set a goal for all final autopsy reports to be returned within 60 calendar days of the autopsy. The CAP’s standard is set at 60 working days and requires ongoing review of cases failing to meet this deadline. Accordingly, the QM committee will review the TAT on all final autopsy reports, and assess possible resolutions to prevent similar future outliers.

Threshold: All autopsy Final Autopsy Diagnosis (FAD) must be signed out within 60 calendar days of the performance date of the autopsy. Outliers must have documentation to identify the reason for the delay, and an evaluation by the chief medical officer to determine future corrective actions to prevent similar delays.

7. Immunohistochemistry Patient Identification Events

In laboratory medicine, typical quality control acceptable range is a +/- 2 std. deviation. Statistically, this allows for a 95% confidence interval for 2 s.d. and 99.5% confidence for 1 s.d. Because of laboratory medicine quality control range, we will use the 2 s.d. confident interval of 95% threshold for allowable errors for patient identification events against total IHC cases stained for the month. CAP checklists (GEN.40490), (ANP. 11950), (ANP. 11950) establish a standards for Patient Identification..

Threshold: 95% of all IHC stains ordered per month will have no identification errors (this is a preliminary threshold, and will be reassessed for possible 97% confidence mid-year).

8. Intraoperative Correlation (Frozen Sections)

Discrepancies between frozen section and final diagnosis that significantly impact on patient’s treatment and/or management (major discrepancies) will be tracked and reported to the committee.  The QM committee will address major discrepancies and compliance with IOC review during each QM meeting.

Threshold: < 2% of major discrepancies

9. Revised (Corrected) Reports

The number of revised reports for reasons that significantly impact on patient’s care (major reasons) will be tracked for AP as well as for all other LP sections/units/labs and reported to the committee.  In accordance with the CAP’s 2008 National Laboratory Safety Goals, all inaccuracies will be documented and communicated as soon as an inaccuracy becomes known.  Significant impact to patient care will be assessed by a pathologist, and in accordance with the CAP Safety Goals, the pathologist should discuss the matter with the physician who ordered the consultation to determine how best to communicate the result to the patient. Compliance of this quality indicator will be assessed by reviewing all corrected reports and documentation.

Threshold: 0 with significant negative impact to patient care

10. Patient Identification Errors, Unlabeled Cases or Missing Patient Information

Another relevant CAP National Laboratory Safety Goal is to improve patient and sample identification at specimen collection, analysis, and reporting.  LP staff documents identification errors with mislabeled specimens, slides, unlabeled cases, or reports and records with missing or inaccurate patient information.  For 2010 quality indicators, SB (small biopsy) and SI (complex cases) for surgical pathology specimens will be tracked and system improvements addressed by QM Committee in partnership with section chiefs. 

Threshold: ≤ 5% of total SB/SI cases.

11. Requisitions Not Submitted for SB/SI cases

The number of small biopsy cases and complex cases that are submitted to the Surgical Pathology Section without a requisition will be tracked. The requisition should accompany the cases or should be forwarded to Surgical Pathology to prevent processing delays. 

Threshold: < 5% of cases without a requisition for more than 24 hours.

12. Molecular Diagnostics Turnaround Time

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. The Molecular Diagnostics laboratory continues to strive to improve and maintain satisfactory report time from specimen receipt through final report. There are currently no industry standards or norms for the turnaround time of Molecular tests.  Based on our patient population (research based) and expectations of our medical staff, eleven working days is established as the initial threshold. As this indicator is monitored, future consideration to decrease the threshold will be considered.

Threshold: 90% of cases reported within 11 working days of receipt.

13. Molecular Diagnostics Specimen Adequacy

The quality of services provided by the laboratory is related to the condition of the sample received and the receipt of correct documentation.   The molecular diagnostics laboratory assesses the adequacy and documentation of all specimens received.  Blood and bone marrow samples must be received with adequate anticoagulation and should not be clotted.  All blood and bone marrow specimens must have at least 1 ml of sample.  Unstained slides and paraffin blocks must contain sufficient tissue for analysis.  The sample must be labeled with the patient’s name or other clear identifier, and must be accompanied by a CRIS or Softpath order specifying the specific test.

Threshold: 0 specimen submission and processing errors

14. Chromosome Pathology Unit Specimen Adequacy

The quality of services provided by the laboratory is related to the condition of the sample received and the receipt of correct documentation. The Chromosome Pathology Unit assesses the adequacy and documentation of all samples received. In most cases, one H&E stained and four unstained slides per patient/sample are required. H&E stained should be reviewed by a pathologist who may designate tumor area(s) for analysis. Unstained slides must contain sufficient tissue for analysis. The sample must be

labeled with the patient’s name or other clear identifier, and all cases must be accompanied by a CRIS or Softpath order specifying the specific test.

Threshold: 0 specimen submission and processing errors

15. Chromosome Pathology Unit Turnaround Time (TAT)

The quality of services provided by a laboratory may be measured by the TAT of tests done by the lab. The Chromosome Pathology Unit (CPU) continues to make every effort to improve and maintain satisfactory report time from specimen receipt through the final report. The current industry standard for the turnaround time of FISH tests for formalin fixed paraffin-embedded (FFPE) tissues is 7 days [8]. Based on this observation, the TAT for the FFPE FISH established by the QM committee is within the expected TAT for our patient population.

Threshold: 90% of cases reported within 7 working days of receipt

16. Flow Cytometry Bone Marrow (BM) Specimen Adequacy

Optimal specimen quality is vital for successful flow cytometric immunophenotyping. Clotted specimens may result in loss of the cells of interest and may compromise test result accuracy. The technologist performs gross inspection on all specimens to detect non-optimal specimen conditions. Clots in all specimens are noted upon specimen receipt in the Softpath Specimen Source Modifier field during accessioning on in the Gross Section of the Final Report. The QM committee will monitor the number of clotted specimens received by Flow Cytometry.

Threshold: < 5% of BM specimens received with clots

17. Requests for Repeat IHC Stains

Whether an IHC request for repeat is due to technical, clerical, or procedural error, the reasons torepeat stain requests should be reviewed for trends to determine if there is/are system errors that could/should be implement to prevent recurring quality failures that result in repeat stains. The IHC laboratory has developed a tracking sheet to document. CAP checklist (ANP.21450) Special Stain quality, all histochemical stains are of adequate quality, and daily controls are demonstrated on each day of use for the tissue components or organisms for which they were designed

In laboratory medicine, typical quality control acceptable range is a +/- 2 std. deviation. Statistically, this allows for a 95% confidence interval for 2 s.d. and 99.5% confidence for 1 s.d. Because of laboratory medicine quality control range, we will use the 2 s.d. confident interval of 95% threshold for allowable errors for patient identification events against total IHC cases

Threshold: ≤ 5% of IHC stains will be repeated.

2014/ 2015 RESIDENT & CLINICAL FELLOW PROJECTS

                The LP QM program will also incorporate “projects” that will address specific CAP checklist requirements and areas that need further monitoring and improvement based on the results of indicators monitored in 2013 and 2014. Areas identified as potential projects to be adopted by the QM committee include: >10 day outliers, delays in autopsy, CAP cancer report criteria, switch of residents, and clotted bone marrow samples. The QM committee chair decided that initially three of these areas were be adopted as projects for the 2014 QM plan, and will continue in the 2015 QM program: clotted bone marrow samples, delays in autopsy and CAP cancer report criteria. Each of these projects will be design, implemented and monitored by an attending and a fellow(s) and/or a resident(s); and reported to the QM committee on time intervals specified in the project plan (See Attachements).

Clotted Bone Marrow Aspirates

CAP Cancer Protocols Reporting Project

Autopsy FINAL Turnaround Time QM Project

References

1.             Laboratory general checklist. Commission on Laboratory Accreditation. CAP, 2013. UPDATE Checklists #s and dates

                 4/21/2014

2.             Jones BA, Novis DA. Nongynecologic cytology turnaround time: a College of American

                Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med 2001;125:1279-84.

3.             Association of Directors of Anatomic and Surgical Pathology. Recommendations on Quality Control and Quality

                Assurance in Anatomic Pathology. Am J Surg Pathol 1991;15:1007-9.

4.             Jones BA, Valenstein PN, Steindel SJ. Gynecologic cytology turnaround time. A College of

                American Pathologists Q-Probes study of 371 laboratories. Arch Pathol Lab Med 1999;123:682- 6.

5.             Novis DA, Zarbo RJ, Saladino AJ. Interinstitutional comparison of surgical biopsy diagnosis

                turnaround time: a College of American Pathologists Q-Probes study of 5384 surgical biopsies

                in 157 small hospitals. Arch Pathol Lab Med 1998;122:951-6.

6.             Zarbo RJ, Gephardt GN, Howanitz PJ. Intralaboratory timelines of surgical pathology reports.

                Results of two College of American Pathologists Q-Probes studies of biopsies and complex

                Specimens. Arch Pathol Lab Med 1996;120:234-44.

7.             Nakhleh, R.E., Fitzgibbons, P.L: Quality Management in Anatomic Pathology, Promoting Patient Safety Through Systems Improvement and Error Reduction. College of American Pathologists (CAP); 2005.

8.             American College of Medical Genetics, E.6.5.3.2 (2009).