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Table of Contents

The Lab Management University Curriculum ............................................................................................. 3 Lab Management University Advanced Curriculum Portfolio Development ......................................... 4-5 Summary ..................................................................................................................................................6-7 Resume ...................................................................................................................................................8-11 Appendix A: Work Products(s) ..............................................................................................................12-24 Appendix B: Certification(s) ......................................................................................................................25Contributors ..............................................................................................................................................28

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Copyright ©The American Society for Clinical Pathology 2016.

The Lab Management University Curriculum Lab Management University (LMU) is a self-paced certificate program designed to improve competencies in laboratory management with customizable options for all skill levels. Developed by an impressive lineup of laboratory leaders, LMU focuses on the practical, day-to-day skills that are needed for successful careers and success in the lab. Flexible and customizable, LMU was created for everyone, including those either currently in or aspiring to be in leadership positions in the lab. Content is relevant for laboratory professionals, pathologists, and pathology residents alike. The LMU curriculum focuses on developing key skills in six major competency areas:

• Leadership • Personnel Management • Operations • Financial Management • Informatics • Compliance

For a full list of available courses, go to http://www.ascp/lmu/.

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Copyright ©The American Society for Clinical Pathology 2016.

Lab Management University Advanced Curriculum Portfolio Development

What is a portfolio?

A professional portfolio is a collection of carefully selected artifacts that represent your progress and accomplishments as a pathologist or lab professional. It is a professional tool that will help you communicate your skills, knowledge and accomplishments to your current supervisor or prospective employers.

Why do I need one?

You may be asking yourself, “Why do I need a portfolio?” I am happy with my career and not planning on changing anytime soon. This is a common misconception about portfolios. Although having a good—if not great—portfolio is imperative for a job search, a professional portfolio has other uses as well. Maintaining a professional portfolio can be a valuable personal professional assessment tool.

Application package vs. professional portfolio

When looking for a job, you will want to assemble a special form of portfolio often known as an application package. When you are trying to maintain documentation of your accomplishments for your current employer, you will want to think about work products or items that demonstrate meaningful contributions to your organization. This kind of documentation can help you have a more productive conversation with your supervisor during a performance review and in some cases it can help you get a promotion.

What should I put in a portfolio?

Application package

Various items can make up an application package and a professional portfolio and some of them may overlap. Both of these should contain your resume. A resume is typically one and not longer than two pages designed to highlight your career accomplishments and education. Other items in an application package may include letters of reference, professional goals, copies of certifications, and even transcripts.

Developing a Resume

When developing your resume, employers will be looking at the listing of positions and places you have worked and more importantly, what accomplishments you made while you were there. Think about what improvements were made by your lab or your staff due to your work? Perhaps you were able to increase the number of accurate tests performed daily due to changes that you made to a work process. What special projects did you undertake? Perhaps, you developed a new recruitment strategy that resulted in a better qualified staff. These are the kinds of things that you want to list for each position along with the qualifications that set you apart.

Here are some guidelines to keep in mind when developing your resume

1. Tell the truth 2. Make it easy and pleasing to the eye. Don’t make it difficult to read because it won’t be read!

a. Clear and concise formatting b. Use bullets whenever possible c. Avoid paragraphs (people won’t read them)

3. Get their attention:

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Copyright ©The American Society for Clinical Pathology 2016.

a. In “10 seconds” b. Focus on “what’s important to the employer.” c. Add links for additional details

4. Create an “Accomplishments” and/or “Achievements” section with results, percentages or numbers when possible, and remember to include your education.

5. Target the employer’s needs and align them with your skills, experience and accomplishments. 6. Customize each resume with a focus on the industry and position. 7. Your Objective Statement should be in a block paragraph:

a. Describe your targeted industry b. Include a very brief career summary with the skills and attributes you offer c. Restrict to about 3-5 sentences - again, be concise!

8. Prepare a cover letter that targets the employer’s needs aligned with your experience, skills and talents.

9. Rule of thumb:

a. Less than seven years of experience = one page resume. b. Greater than seven years of experience = two page resume

10. Ask people for feedback and edits before sending it out. 11. Describe “you” in your own “action” words clearly and concisely. This is not the time to be shy!

Work Products

The work products you choose for your portfolio should demonstrate your knowledge, skills and ability to execute. Items may include things like quality improvement plans for a change in process or a new piece of equipment or test, a proposal for development and implementation of a new or revised safety or compliance program or documentation for development or revision of a recruitment strategy. When thinking about these items, make sure you select the items that demonstrate your best work. You’ll find various guidelines and examples of these items in the resource folder for this course. You will also find many resources on the internet at various web sites we have listed.

How often should I update it?

The great thing about creating a portfolio is that once it is made, the hard work is done. You will just need to update it on a regular basis, for example, once or twice a year. To be sure that you don’t forget anything, keep an email folder and paper folder to collect important documents. Make sure to date paper documents.

Finishing your Portfolio

The requirements for the LMU course are to include a minimum of 5 portfolio items including your resume and certificate documentation. Once you have submitted these items, you can elect to receive feedback from one of the faculty for Lab Management University. Review the additional information that includes Frequently Asked Questions, instructions and videos on how to upload your items to the ASCP web site.

In addition to uploading these documents to the ASCP web site, we have also provided you with a list of portfolio building web sites and tools that will enable you to produce a portfolio that can be accessed by current and future employers upon your invitation.

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To Whom It May Concern: 2/11/16

I serve as the Laboratory Director for LBJTMC (Lyndon Baines Johnson Tropical Medical Center)

and one of the two pathologists here in American Samoa for the last 6 years. It is a CLIA

regulated and a hospital based clinical laboratory, the only one here in the Territory, and one of

3 among the United States Associated Pacific Islands (USAPI, the other ones are Guam and

Saipan). My primary responsibility is Management and oversight of the Clinical Laboratory and I

am also in charge of the performance of Hospital and Forensic autopsies for the territory.

I have participated in both the LMU fundamentals and LMU Advanced programs and it has

helped me tremendously in my work performance in all aspects of Laboratory Management.

Being a foreign medical graduate and foreign trained anatomic and clinical pathologist, I had to

learn laboratory management in a U.S. territory, essentially on the job. I realized that I could

only do this by gaining affiliation as an international fellow with the ASCP and CAP. I was doing

a lot of readings from their study materials available online, text books I have ordered from

them as well, and varied regulatory site documents (i.e. CLIA, OSHA etc.). When I saw the LMU

being offered from ASCP, I knew right away it would provide me the best resources I could

apply in my practice and so I jumped at the opportunity. The knowledge I have gained through

the LMU has been truly valuable to my practice here in American Samoa.

Here are some of the concrete examples how LMU has helped me:

1) In financial management- I have become aware of good budget preparation and have gained

knowledge in the billing and reimbursement process. It has helped me share this knowledge as

well with my team of laboratory staff in our laboratory management (our manager, quality

manager, and section supervisors) and even our finance department.

2) In the operations management side, it has helped me find better ways to improve our

strategic plan for the laboratory as well as do safety management.

3) In terms of personnel management, the LMU has given me valuable resources that helped

me build and implement a new career ladder and update job descriptions for all laboratory

personnel here at LBJTMC through the work I shared with our Human Resources department.

This has helped them at HR also improve how we do wage and salary determination and

administration. Last year, I was able to work with our quality manager in launching our

Competency assessment program. We have been able to establish a solid continuing education 6

plan for all of our personnel particularly as we are trying to build their local capacity. We have

been successful in our recruitment and hiring processes. I have utilized a lot of the ASCP

template resources from LMU for all these projects. it has helped me with better ways of

helping resolve conflicts in the laboratory and has helped me and our laboratory staff in gaining

better knowledge and commitment to our goals as an institution and our own personal goals in

the profession. A lot of our staff and including myself have been successful and are still working

towards additional certifications in laboratory practice.

4) In Quality Management, it has been very valuable to our continued certification and

compliance with CLIA through CMS inspections. In fact we have successfully done this for 3

consecutive times now since I started here. Our inspector himself said, that our trajectory has

been amazing when he looks at the learning curve for this aspect of management. It is also

helping us now as we move towards implementation of IQCP in some of our test systems.

I could really say more, but these are the most significant ways the LMU has helped me

improve my job performance and helped improve the culture of our laboratory here in

American Samoa.

I have e-mailed Ms. Angel Fisher my updated resume and the work product I have submitted is

our Updated Quality Assurance and Management Plan. I am attaching the same documents

here as well. It is something that will definitely improve all the processes / systems in our

laboratory.

Thank you again for this opportunity to share my experience with LMU. I'm very happy to share

that I have been saying the same great things about this awesome program to my colleagues

and friends. I have pre-registered and truly excited to attend more of the management courses

that will be offered in the Las Vegas Annual Meeting. I was in the Long beach Meeting last year

and that was really the best conference I have ever attended to date.

Sincerely,

Ma Ivy T. Clemente, MD, FASCP, CTGYN (ASCPi)

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MA. IVY T. CLEMENTE, BSPH, MD, DPSP (AP/CP), IFCAP, FASCP, CTgyn(ASCPi)CM, CPT (NHA) Objective: Forward-thinking, detail-oriented, energetic and proactive, senior laboratory professional seeking a position as a Laboratory Director or Manager in a thriving laboratory organization.

Summary of Qualifications • Local and International Experience in Hospital-based Clinical Laboratory directorship. • Professional experience and knowledge in both Clinical and Anatomic Pathology practice management. • Administrative experience and expertise in Quality, Personnel, Operations and Financial management

aspects of a laboratory. • Experience in directorship of a CLIA regulated laboratory with both waived and nonwaived testing

capability in Hematology and Coagulation, Clinical Microscopy, Clinical Chemistry, Immunology, Blood Bank and Microbiology.

• Hands-on experience and knowledge in peripheral smear evaluations; microscopic urinalysis examination; evaluation of quality control runs on automated chemistry equipment; blood typing, antibody screen and identification; transfusion reaction evaluations, generation and interpretation of antibiograms; knowledge of diagnostic algorithms and clinical interpretation of laboratory tests; microscope maintenance; best practices in pipetting techniques; shipment of diagnostic specimens; fine needle aspiration biopsy and other cytologic specimen evaluations; surgical pathology specimen processing and evaluation; hospital and forensic autopsy performance; knowledge in DNA specimen collection and interpretation of relationship testing.

Professional Experience and Accomplishments in Current Position • Responsible for the operation of a 45-employee clinical laboratory. • Successful CLIA recertification of the LBJTMC laboratory for the duration of service as laboratory director

(6 years). • Successfully created and implemented a laboratory quality assurance program. • Developed a career ladder system, revised personnel job descriptions, initiated regular laboratory personnel

training with an individualized approach for all personnel resulting in successful certifications, development and implementation of a competency assessment program for all laboratory personnel, improvement in qualified personnel recruitment and retention.

• Responsible for the development and implementation of laboratory protocols/ documentations (General Laboratory and Sections’ standard operating procedures, Laboratory safety manual)

• Responsible for automation of bacterial identification and susceptibility testing and subsequent generation of our hospital antibiograms from 2012 up to the present.

• Diminished cost of off-island referral through evaluation and implementation of automated equipment with expanded testing capacity for various laboratory sections.

• Responsible for oversight and successful participation in proficiency testing surveys with the College of American Pathologists

Work Experience Institution and Location

Dates employed Position Primary responsibilities

Lyndon B. Johnson Tropical Medical Center Pago Pago, American Samoa 96799

March 24, 2010 to present

Laboratory Director; Anatomic and Clinical Pathologist

Serves the LBJ Medical Executive Committee as Chief of the Laboratory Department. Oversee a CLIA regulated laboratory with about 40 to 45 personnel, who perform both waived and non-waived diagnostic testing (~850,000 tests annually). Perform hospital and forensic autopsies (~10 to 20 per year)

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Sacred Heart Hospital Malolos City, Philippines

April 2007 – March 1, 2010

Laboratory Director; Anatomic & Clinical Pathologist

Laboratory director of a Level 2 laboratory with about 5 to 10 personnel. Served as general anatomic pathologist responsible for sign out of all surgical pathology & cytopathology specimens.

Our Lady of Mercy General Hospital Pulilan, Bulacan, Philippines

May 2007 – March 2010

Anatomic Pathologist

General anatomic pathologist responsible for sign out of surgical pathology & cytopathology specimens.

Plaridel County Hospital Plaridel, Bulacan, Philippines

April 2007 – March 2010

Anatomic Pathologist

General anatomic pathologist responsible for sign out of surgical pathology & cytopathology specimens

Training and Education

Institution and location

Dates Position/ Program Description of training / studies

University of the Philippines- Philippine General Hospital Taft Avenue, Manila

Jan. 1, 2003- Dec. 31, 2006

Medical Officer IV Residency Training in combined Anatomic and Clinical Pathology under the Department of Pathology (University of the Philippines- College of Medicine) & the Department of Laboratories (UP-Philippine General Hospital)

Jose R. Reyes Memorial Medical Center Rizal Avenue, Metro Manila

May 1, 2000- April 30, 2001

Medical Internship One year of post-graduate medical internship training

Fatima College of Medicine Mac Arthur Highway, Valenzuela City

June 1996- April 2000

Medical Degree Four years of Medical Education including a final year of Clinical Clerkship with rotations in varied clinical departments of several affiliate hospitals

University of the Philippines- Manila, College of Public Health Pedro Gil St., Ermita, Manila

June 1992- April 1996

Pre-Med/ Bachelor’s Degree

Four years of Bachelor of Science Degree Majoring in Public Health which includes 6 months of community public health practice and hands on clinical laboratory rotations

Honors and Achievements

Program Honors and Awards Other • Honorable Mention, Olympus Bioscapes International Photomicrography 2009 Residency training program AP /CP

• Passed the certification boards ( Philippine Board of Pathology) January 27 and February 3, 2007

• Overall First ranked resident in Anatomic Pathology for national level In Service Examinations 2005 and 2006 given by Philippine Society of Pathologists

• Top ranked in Clinical Pathology (10th overall and 5th for year level IV, 2006, 3rd for year level III)

• Participant, 12th Resident's Research Forum, Departments of Pathology & Laboratories, UP-PGH, October 31, 2006; December 3, 2004; and November 27, 2003 with the following papers presented: 1. Sirenomelia Sequence associated with Craniofacial Congenital

Anomalies: A Case Report & Review of Etiopathogenesis (published in

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the Philippine Journal of Pathology 2006 :33-37) 2. Tumor & Tumor-like Lesions of the External Ear & Middle Ear Among

Philippine General Hospital Patients: A Review of 460 Cases 3. Evaluation of the Quality, Accuracy & Relevance of Combined

Intraoperative Cytologic & Frozen Section Diagnosis in the Management of the Central Nervous System Lesions Among Philippine General Hospital Patients

• 3rd place, Olympus Photomicrography contest, Philippine Society of Pathologists' Annual Convention, April 2006

• Advanced Promotion from Medical Officer III to Medical Officer IV, Jan. 1, 2005,Year level III, UP-PGH Department of Laboratories

• First place, Poster contest, Philippine Society for Pathologists' Annual Convention, April 2004

• Passed, Training for Basic Life Support , UP-PGH Department of Emergency Medicine, 2003

• Participant, Workshop on Clinical Teaching & Evaluation for Residents & Fellows, UP College of Medicine, December 2002

Post Graduate Medical Internship

• Passed the Qualifying Examination for Residency Training conducted by the Health Human Resource Development Bureau of the Department of Health, Manila, Philippines, July 7, 2002

• 12th place out of 1,263 examinees, Philippine Physician Licensure Examination, February 2002 with an average score of 84.92%

• Most Outstanding Medical Intern out of 130 Medical Interns • First place, Case Presentation, Department Of Obstetrics & Gynecology • Presented Research paper: Ovarian Pregnancy: A Case Report

Passed, Training for Basic Life Support Medical Education • Ranked 6 out of 186 medical graduates

• Most Outstanding Clinical Clerk • Full Academic Scholar 1996-2000

Presented Research paper on : Effect of Coffee on Serum Cholesterol Levels Bachelor’s Program in Public Health

• College Scholar • Presented Research paper: Carriage Rate of Malassezia furfur in Normal

Individuals Affiliations

Organization Role Date College of American Pathologists (CAP)

Member- International fellow Jan. 2011 to present

American Society of Clinical Pathologists (ASCP)

Member- International fellow, International Technologist in Gynecologic Cytology

Jan. 2011 to present; Oct 16, 2015 valid up to Oct. 31, 2018

National Healthcareer Association

Member- Certified Phlebotomy technician

Mar.31, 2011 to present

Philippine Society of Pathologists

Member- Diplomate in Anatomic and Clinical Pathology

Jan. 2007 up to present

University of the Philippines Alumni Association

Member April 1996 up to present

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Professional Licenses: Pathologist LBJ-TMC- American Samoa HSRB License # 2061-C valid until 3/16/2016 Anatomic and Clinical Pathologist- Physician PRC # 0097336 valid until 11/26/2018 U.S. Certified Phlebotomy Technician (NHA)- #4011-0817 valid until 3/31/2017 CTgyn (ASCPi)CM - ID#25398073 valid until 10/31/2018 References:

Name Contact number/s, Email address Company and Position Michael Gerstenberger, FACHE

(US)1-520-392-6929 n1297f@aol.com

Lyndon B. Johnson Tropical Medical Center Former Chief Executive Officer

Dr. Nelson T. Geraldino, M.D., FPSP

521-8450 loc. 3947

University of the Philippines College of Medicine Philippine General Hospital Department Chairman (Laboratories) Medical Consultant- Training officer for Pathology residency program (Clinical Pathology) Former President- Philippine Society of Pathologists

Dr. Jose Ma. C. Avila, M.D., FPSP

521-8450 loc. 3947

University of the Philippines College of Medicine Philippine General Hospital Medical Consultant- Former Department Chairman Former President- Philippine Society of Pathologists

Dr. Marimin A. Lapuebla, M.D., FPSP

521-8450 loc. 3202

University of the Philippines College of Medicine Philippine General Hospital Medical Consultant- Former Department Chairman (Laboratories)

Dr. Jose M. Carnate, Jr., M.D, FPSP

521-8450 loc. 3947 University of the Philippines College of Medicine Philippine General Hospital Medical Consultant- Training officer for Pathology residency program (Anatomic Pathology)

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Appendix A: Work Product(s) 1. Request for Laboratory Equipment Proposal 2. Quality Assurance and Management Program Plan

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Request for Laboratory Equipment Proposal

PRIORITY: URGENT! Immediately needed to replace outdated BacT/ Alert 3D Blood culture automated microbial detection system that has constant downtime problems and limited capabilities. TYPE OF PROJECT: Laboratory Instrument NAME OF PROJECT: BacT/ALERT 3D Combination module PURPOSE: Replace current model with a more reliable and technologically updated instrument, and expanded incubation capacity VENDOR: MedPharm Group of Companies PRODUCT NAME AND ORDER INFORMATION: bioMerieux Inc. BacT/ALERT 3D Combination module

Model: BACTEC 9120 System

JUSTIFICATION: The current instrument is more than 5 years old. Constant breakdowns have been responsible for extensive delays in the reporting of results. This has caused complaints from the medical staff and delays in more definitive antibiotic therapy for patients. Maintenance expenses will be reduced drastically with the purchase of the new instrument. This new model offers an updated technology and expanded incubator capacity (120 cells) to help address our increasing workload for blood cultures. It will help facilitate workflow and cut turnaround time through continuous monitoring and immediate result notification through audible and visual alerts, especially during days when blood culture samples exceed the current 60 cell capacity on our existing equipment. Also, it will help prevent subjective blood culture checks by using manual incubation and checking techniques, the procedure reverted to when all incubator cells are completely filled or when equipment breakdown happens.

NET PURCHASE PRICE: $53,382.00 ESTIMATED TESTING VOLUME: 6,000 blood cultures a year INCOME PER TEST: $15.00 facility fee ANNUAL INCOME GENERATED: $90,000.00 LIFE EXPECTANCY: 5 years ACQUISITION OPTIONS: The distributor offers complete package (unit, reagent starter kit, Observa workstation, UPS) and installation requirements (shipping, installation, testing and commissioning) ; outright purchase with payment of 50% upon issuance of purchase order and completion of payment upon acceptance of turnover and warranty certificate, and onsite operation training for microbiology personnel. There is a 12 month warranty on the equipment and equipment maintenance servicing will be provided onsite by the distributor’s biomedical engineer onsite. Details are attached. FINANCIAL RATIOS:

Payback Period: 7.1 months Average Rate of Return: 168% Net Present Value: ~$395,000 (Cost of Capital estimate: 13.5%)

CONCLUSION: This project will not only improve the technological performance of the microbiology section of the laboratory but also is a very attractive financial investment for the hospital.

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Quality Assurance and Management Program LBJTMC- Lyndon Baines Johnson Tropical Medical Center P.O. Box LBJ Fagaalu, Village, Pago Pago, AS 96799 December 7, 2015 Laboratory Director: Ma. Ivy T. Clemente, MD, IFCAP, FASCP Signature:________________________________ Annual Review Date:____________________________Changes made? Yes No Annual Review Date:____________________________Changes made? Yes No Annual Review Date:____________________________Changes made? Yes No Annual Review Date:____________________________Changes made? Yes No Annual Review Date:____________________________Changes made? Yes No Purpose: The purpose of our Quality Assurance and Management Program is to improve the accuracy, reliability, efficiency and quality of our laboratory activities and test results. The document supersedes all previous QA plans which are to be archived. Goals: The specific goals of the Quality Assurance and Management Plan are to:

• Evaluate the effectiveness of our laboratory’s policies and procedures by comparing our Laboratory data with published Community standard Quality Specifications for Laboratory Quality Indicators

• Identify problems and potential problems and make corrections to prevent them from happening again.

• Assure accurate, reliable and prompt performance of tests and reporting of results. • Improve and monitor the overall quality and efficiency of the LBJTMC laboratory. • Provide excellent patient care and safety.

Roles and Responsibilities: The Quality Assurance and Management plan of LBJTMC was drafted by the Laboratory director who is primarily responsible for overall laboratory quality. The director is responsible for final approval of this plan. The Laboratory director will be responsible for presenting the QI reports to the QI Medical Staff committee meetings done monthly. The plan will be reviewed annually by the Laboratory Director and The Quality Project Team (QPT) of the Laboratory headed by the Laboratory Quality Manager. The rest of the Quality project team shall comprise of selected laboratory personnel representing all laboratory sections (Phlebotomy, Clinical Microscopy, Clinical Chemistry, Hematology and Coagulation, Serology, Blood Bank, Cytology-Histopathology).The Quality Project Team will meet regularly (monthly) to provide reports on all ongoing Quality improvement projects of the laboratory. The Laboratory Quality Manager is responsible for presenting these QI projects to the hospital-wide QI meetings. The individual laboratory section representatives to the Quality Project Team will be responsible for sharing the QPT meeting minutes with their respective sections. They are also responsible for bringing quality issues encountered in their respective sections to the QPT meetings so they may be addressed appropriately. Plan Implementation: We will use this plan to meet regulatory requirements (CLIA) and our specific goals.

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We will perform quality assessment reviews of each phase of testing (general, preanalytic, analytic and post-analytic). We will think about our laboratory activities and ask how they could be better, faster, easier, and more efficient. We will be vigilant about reporting problems and potential problems, we see- even our own mistakes. We don’t want to hide what is wrong, we want to fix it. We will use problem logs and keep them conveniently located to make sure problems are easily reported and always documented. We will collect data on our laboratory activities and evaluate that data to identify problems, areas of weaknesses, and potential problems. When problems are found we will investigate them, try to uncover the root cause, make corrections, and redesign our procedures so they don’t happen again. We will perform follow up reviews to evaluate the effectiveness of the corrections and revised procedures, and to make sure that the changes do not create new problems. We will share the findings of our quality assessment activities (i.e. with the hospital-wide QI committee, Medical Staff QI committee) and will document everything. We will retain our quality assessment documentation for at least two years. Quality Assessment Reviews Our laboratory will evaluate the general, preanalytic, analytic and post-analytic phases in the path of workflow and perform and document quality assessment reviews of activities in each phase. We will perform reviews when problems are found, and also periodically review important activities in each phase because they have the potential to impact the quality of our laboratory testing and service. We will perform reviews as follows: GENERAL PHASE The general phase includes activities and policies, many administrative in nature, that relate to more than one phase in the path of workflow: Patient and Employee Safety We will maintain a safe environment for patient and employees. Standard (universal) precautions are observed, annual safety training is provided, and we properly dispose of biohazard waste. Patient Confidentiality We will maintain the privacy of patient information throughout all phases of the testing process that are under our control. LIS (Laboratory Information System) We currently have no laboratory information systems (LIS). Data from Laboratory equipment are transcribed by testing personnel into the hospital information system (Open Vista) that allows entry into the electronic health record (Carevue). We will however evaluate the accuracy of data entry, calculations, and test reports, and evaluate data storage and recovery. We have policies and procedures for security, use of the HIS laboratory module and have continuing operations when the system is down. Complaints and Communication Breakdowns We will make sure all reported complaints and problems are documented. We will investigate all complaints and take appropriate actions to resolve the complaint as well as take action to prevent the same situation from occurring again. We will establish and define appropriate communication channels

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for ordering tests, communicating with the laboratory, and reporting results and we will identify and document problems that occur as a result of communication breakdowns between the laboratory and healthcare providers that order tests and receive test results. Personnel We will hire qualified individuals and provide adequate training in job functions and responsibilities. We will encourage continuing education opportunities. We will establish and follow written policies and procedures, as described in the CLIA personnel requirements, to evaluate employee competency (and consultant competency, as applicable). We will adhere to a career ladder for laboratory employees that outline the career track for individuals employed in the LBJTMC laboratory. We will help develop local capacity by hiring qualified local personnel, helping and facilitating certification of local personnel and by prioritizing local personnel to training. Equal training opportunities will be provided in order to help maintain and retain qualified and certified contracted personnel. Proficiency testing We will enroll in Proficiency testing with CAP annually. We will perform PT in the same manner as patient testing and rotate the performance of PT among all testing personnel. We will review and evaluate proficiency testing results and verify the accuracy of both regulated and unregulated analytes, and any ungraded results. Corrective actions will be taken for unsatisfactory PT results to identify the cause and prevent a recurrence. Documentation for all PT reports, evaluations and corrective actions will be done. Vendor and Reference Laboratory Relationships We will evaluate the service we receive from our vendors (Medpharm) and reference laboratory (DLS and Hawaii Pathologists’ Laboratory). Any test that we will send out to the reference laboratory will only be referred to a CLIA- certified or accredited laboratory. General Phase Reviews At least once each year, we will select an activity in the general phase to review. We will think about which general laboratory activities, if not performed properly, will have the most significant impact on the quality of testing or the level of service we provide, make note of them below, and schedule quality assessment reviews of the activity. We will evaluate the selected activity multiple times to get a true picture of performance over time. We will evaluate our policies and procedures for general phase activities and confirm that they are being followed consistently by all staff. We will establish acceptable limits for measurable activities and compare collected data to those limits. General phase activities selected for review in our laboratory: ACTIVITIES Date for Review Patient and Employee Safety Laboratory Safety Audit Blood Borne Pathogens training Number of Needle stick injury among laboratory personnel

Patient Confidentiality Review policy on patient confidentiality. Random check of computer screens and

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conversations to ensure compliance Laboratory Information System Random check for transcription errors

Complaints and Communication Breakdowns (Include verbal, electronic and written communication channels) Incident reports Non-conformity events

Personnel Competency assessment Review of Personnel and training files Employee turnover rate

Proficiency Testing Review of PT policies, enrollment Review of PT worksheets, records, documentation and evaluation reports Review of split testing reports Number of unacceptable performance in CAP PT/ Total number of PT performances expressed in percentage Number of unacceptable performances in CAP-PT occurring as a result of a cause previously corrected per year/ Total of unacceptable performances expressed in percentage Total number of tests with CV% higher than selected target per year/ Total number of tests

Vendor and Reference Laboratory Relationships VENDORS Backorders, delivery delays Incorrect shipments, missing items Damaged shipments Customer service issues, pricing and billing REFERENCE LABORATORY Specimen pick up issues TAT reports Report interpretation Customer service issues, pricing and billing

Forms to use: (Refer to form instructions for details on the use of these forms.) 1) Problem log in each sections of the laboratory 2) General phase activity data collection forms to collect data and compile information that will be

used to perform QA reviews.

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• Patient and Employee Safety • Patient confidentiality • Laboratory Information system ( LIS) • Complaints and Communication Breakdowns • Personnel • Proficiency testing • Vendor and Reference Laboratory relationships

3) General Phase Quality Assessment review form to perform periodic reviews of the general phase activities listed and as needed reviews to resolve problems noted on the problem logs.

PRE-ANALYTIC PHASE This is the phase that comes before actually performing the testing. Because pre-analytic activities are the input to testing, problems in this phase have a significant effect on our output-the test results. Many laboratory problems and errors occur in this phase, so we will pay special attention to pre-analytical activities. Test Ordering We require written or electronic authorization for patient testing from an authorized healthcare provider. Test requests must contain essential information that identifies the ordering provider with contact information, the testing laboratory, complete patient identification with sex, age, or date of birth, the test to perform, source of the specimen, the date and time of specimen collection, and any additional information necessary to ensure accurate and timely testing and reporting of results. If we transcribe or enter test requests or authorization information into our electronic system, we will ensure the information is transcribed and entered accurately. Specimen Collection, Labeling and Handling We have written policies for specimen collection, labeling, processing, rejection, storage, and transport. If we accept specimens from other outlying clinics, DOH, VA clinic, written instructions for the above will also be provided or communicated to the facilities. Pre- Analytic Phase Reviews At least once each year, we will select an activity in the pre-analytic phase to review. We will think about which pre-analytic laboratory activities, if not performed properly will have the most significant impact on the quality of testing or the level of service we provide, make note of them below, and schedule quality assessment reviews of the activity. We will evaluate the selected activity multiple times to get a true picture of performance over time. We will evaluate our policies and procedures for pre-analytic phase activities and confirm that they are being followed consistently by all staff. We will establish acceptable limits for measurable activities and compare collected data to those limits. Pre-Analytic Phase Activities selected for review in our laboratory: Activity Date for Review Test ordering Number of unnecessary or duplicate testing

Test order accuracy Specimen collection, Labeling and Handling

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Requisition errors Number of requests without physician Identification Number of requests with errors concerning test input Customer satisfaction survey (Phlebotomy services) Number of requests with erroneous identification of physicians Surgical pathology / cytology specimen labeling errors Number of samples collected in inappropriate containers Number of samples hemolysed ( Hematology and Chemistry) Number of samples clotted ( hematology and Chemistry) Number of samples with insufficient volumes Number of samples with inadequate sample to anticoagulant ratio Number of improperly labeled samples Number of improperly stored samples Number of verbal orders with follow up written or electronic requests

Number of missing test requests Number of illegible handwritten orders Number of transcription errors on laboratory order requests Number of specimens rejected by the reference laboratory Number of specimens rejected In- house Blood culture contamination rate Overall rate Monthly contamination rate per phlebotomist

Number of rapid strep false negative tests due to improper or inadequate throat swab collection

Forms to use:

1. Problem log from each section to document identified problems 2. Pre-analytic phase activity data collection forms to collect data and compile information that will

be used to perform QA reviews • Test Ordering • Specimen Collection, Labeling and Handling 3. Preanalytic phase Quality Assessment Review form to perform periodic reviews of pre-analytic

phase activities and as-needed reviews to resolve problems noted on the problem logs. (Refer to form instructions for details on the use of these forms.)

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ANALYTIC PHASE This is the testing phase. Analytic activities are the activities that happen and the resources that are used during the actual testing of patient specimens: Procedure Manual We have a written collection of instructions for all tests performed by our laboratory. Included in these instructions are patient preparation and specimen collection requirements, how to perform quality control, calibration, and maintenance, steps for corrective action, method limitations, reportable ranges and reference values, and critical values. New procedures are signed and dated when put in use, and discontinued procedures are dated and retained for two years. The procedure manual is accessible to laboratory staff, kept up to date, and annually reviewed and approved by the laboratory director. Test Systems, Instruments, Reagents, and Supplies We have selected test systems that meet the needs of the laboratory and our clients. We follow the manufacturer’s instructions for everything used in the laboratory and ensure correct environmental conditions for all laboratory methods and supplies to ensure reliable instrument, operation and test results. We manage our inventory and purchasing to prevent shortages and wastage. Reagents are monitored for acceptable labeling (identity of substance, open or preparation dates, expiration dates, and storage). Verification of Performance Specification When our laboratory introduces any new non-waived test methods, we verify the manufacturer’s stated claims for the performance specifications of accuracy, precision, reportable range, and reference range before testing patients. For modified methods, methods that are not FDA-approved, we will establish our own performance specifications and include validation of analytical sensitivity and specificity. We will make sure our test systems continue to meet the expected performance specifications and take corrective action if they do not. Calibration and Calibration Verification We perform calibration and calibration verification procedures following the manufacturer’s instruction and at least every six months, and when certain situations occur, to ensure method accuracy. When calibration and calibration verification problems are found, we will consider the relationship of this activity to quality control, instrument maintenance, and personnel competency. Maintenance and Function Checks We understand the importance of proper instrument maintenance for optimum performance and longevity. We will perform all maintenance and function checks following the manufacturer’s directions and at the recommended frequencies. We document all maintenance and function checks and take corrective action when necessary. Quality Control For each test system, we have control procedures that monitor the accuracy and precision of the complete analytical process. We perform quality control (QC) in the manner and at the frequency recommended by the manufacturer of each waived and non-waived test method (or as established by our laboratory, if more frequent). We follow the CMS (CLIA) QC requirements for all test systems- see CLIA Sec. 493.1256-1273 for specifics. We evaluate out of control situations to ensure proper corrective action is taken and that quality control results are acceptable before patient results are reported. When

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quality control problems are found, we will consider the relationship to maintenance, calibration, and personnel competency. Comparison of Test Results If our laboratory has multiple instruments, methods, or sites that test for the same analyte, we evaluate these systems to compare the results they produce. We are aware that if a healthcare provider is following a patient and the same testing is performed on a different test system, then the laboratory and the provider need to be aware of any significant difference in results so it will be clear if fluctuating results are due to a change in the patient’s condition, or to a different test system. We evaluate test results that appear inconsistent with patient criteria (age, sex, clinical diagnosis, relationship with other test results, etc.). Corrective Actions We have policies and procedures to follow when laboratory systems do not meet our performance specifications, such as when quality control or calibration is unacceptable, or improper storage temperatures occur. We will design solutions for identified problems, implement corrective actions, and evaluate those actions for effectiveness. Test Records We maintain test records that demonstrate positive identification of the specimen and include the date and time of specimen receipt into the laboratory, the reasons for and actions taken when specimens are not acceptable, and the records and dates of all specimen testing, including the identity of the personnel who performed the test(s). When electronic system is used, we evaluate the accuracy of data entry and calculations, and evaluate data storage and recovery. All records of patient testing are retained, including worksheets, logs, and instrument printouts. Analytic Phase Reviews At least once each year, we will select an activity in the analytic phase to review. We will think about which analytic laboratory activities, if not performed properly will have the most significant impact on the quality of testing or the level of service we provide, make note of them below, and schedule quality assessment reviews of the activity. We will evaluate the selected activity multiple times to get a true picture of performance over time. We will evaluate our policies and procedures for analytic phase activities and confirm that they are being followed consistently by all staff. We will establish acceptable limits for measurable activities and compare collected data to those limits. Analytic Phase Activities selected for review in our laboratory: Activity Date for Review Procedure Manual Annual review and random check of updated SOP and manufacturer’s inserts

Test Systems, Instruments, Reagents, Supplies Test menu review and update Test volume (statistics per section) Cost per test review Random check for supply and reagent labeling, storage and expiration dates Stock card review, Inventory review

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Number of repeat testing Number of instrument downtimes, unscheduled service repairs Blood component wastage Number of reports delivered outside of specified TAT due to instrument failures per year/ Total number of reports expressed in percentage Reagent or supply shortages affecting testing Verification of Performance Specifications Validation study review

Calibration and Calibration Verification Review of Instrument list and frequency of calibration

Maintenance and Function Checks Review of Maintenance logs Review of Service records Review of temperature logs

Quality Control Regular review of Quality control in each section of the laboratory

Comparison of Test Results Review of method comparison worksheets between primary and secondary instruments

Corrective actions Number of repeat testing for discrepant results Number of unscheduled recalibration, maintenance checks, service

Test Records Delta checks Review of instrument printouts, testing logs and test worksheets

Forms to use:

1. Problem log from each section to document identified problems 2. Analytic phase activity data collection forms to collect data and compile information that will be

used to perform QA reviews • Procedure manual • Test systems, Instruments, Reagents, Supplies • Verification of performance specifications • Calibration and Calibration verification • Maintenance and Function checks • Quality control • Comparison of Test Results • Corrective actions • Test Records • Proficiency testing Results

3. Analytic phase Quality Assessment Review form to perform periodic reviews of analytic phase

activities and as-needed reviews to resolve problems noted on the problem logs. (Refer to form instructions for details on the use of these forms.)

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POST-ANALYTIC PHASE This is the phase that occurs after testing is complete. Post-analytic activities include the manual or electronic transfer of test results, result reporting and archiving, and specimen management after testing: Test Reports and Reference Laboratory Reports Test reports from our laboratory are reviewed for accuracy and turnaround times. This review includes: accurate transcription or transferal of results and the accuracy of results from calculated data. We verify that reports have all essential information, including: positive patient identification, name and address of the testing laboratory, report date, units of measurement or interpretation of results, reference intervals. Critical value notification is documented. Test reports from outside laboratories identify the testing laboratory and are not to be altered by our laboratory. If report errors are detected, we have a written protocol for report correction that includes notification of the ordering provider, how to issue a corrected report, and retention of both reports. Specimen Retention After Testing When possible, we will retain specimens after testing, maintaining their identity and integrity to allow for repeat testing and add-on tests. We will return specimens to proper storage conditions as soon as possible after testing. We will properly discard specimens that are no longer needed or no longer viable for testing. Post Analytic Phase Reviews At least once each year, we will select an activity in the post-analytic phase to review. We will think about which post-analytic laboratory activities, if not performed properly will have the most significant impact on the quality of testing or the level of service we provide, make note of them below, and schedule quality assessment reviews of the activity. We will evaluate the selected activity multiple times to get a true picture of performance over time. We will evaluate our policies and procedures for post- analytic phase activities and confirm that they are being followed consistently by all staff. We will establish acceptable limits for measurable activities and compare collected data to those limits. Post-Analytic Phase Activities selected for review in our laboratory: Activity Date for Review Test Reports Critical Value reporting (Percentage of CV results communicated/ All CV reports to be communicated during period of review) TAT review for ER, ICU, Pediatrics (Nursery) TAT for specific tests (Number of reports delivered outside specified acceptable TAT/ Total number of test reports during period of review expressed in percentage) Number or percentage of corrected reports

Reference Laboratory Reports Number of corrected or amended reports

Specimen retention after testing Number of retested specimens ( for add on tests) in storage

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Forms to use: 1. Problem log from each section to document identified problems 2. Post-Analytic phase activity data collection forms to collect data and compile information

that will be used to perform QA reviews • Test Reports • Reference laboratory reports • Specimen retention after testing

3. Post-Analytic phase Quality Assessment Review form to perform periodic reviews of post-

analytic phase activities and as-needed reviews to resolve problems noted on the problem logs.

(Refer to form instructions for details on the use of these forms.) References:

1) Best Practices for Developing a Quality Assurance and Management Program, LMU Advanced Program (APF/ ASCP 2015)

2) Laboratory Medicine Quality Indicators by Stage of the Total testing Process, American Society for Clinical Pathology (Shahram Shahahangian, and Susan R. Snyder; American Journal of Clinical Pathology 2009;131:418-431)

3) Quality Indicators in Laboratory Medicine: from theory to practice- Laura Sciacovelli et al., Clin Chem Lab Med 2011; 49(5): 835-844

4) COLA Quality Assessment Plan, A simplified Approach, 2008

Revision: February 10, 2016 _______________________________

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Appendix B: Certification(s)

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Certificate of Completion

This is to certify that

has participated in and successfully completed all prescribed requirements of Lab Management University conducted

in a joint collaboration between APF and ASCP. Lab Management University covers six core competencies in Leadership,

Personnel Management, Operations, Financial Management, Informatics, and Compliance.

Ma Ivy T Clemente, MD FASCP

Given on the 26th of June, Two Thousand Fourteen

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Advanced Certificate of CompletionThis is to certify that

has participated in and successfully completed all prescribed requirements of Lab Management University conducted

in a joint collaboration between APF and ASCP. Lab Management University covers six core competencies in Leadership,

Personnel Management, Operations, Financial Management, Informatics, and Compliance.

Ma Ivy T Clemente, MD FASCP,

CTgyn(ASCPi)

Given on the 8th of February, Two Thousand Sixteen

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Contributors

Lab Management University Faculty Acknowledgements For their peer review contributions in Portfolio Development: Anna M Moran, MD FASCP Clinical Assistant Professor of Pathology and Laboratory Medicine, University of Pennsylvania Health System Yolanda S. Garcia, MS, MLS(ASCP)CMSBB Manager, RML Blood Center Instructor, College of Health Sciences, Rush University Medical Center Amy L. Thompson, Ph.D., MLS(ASCP) Associate Professor, Austin Peay State University Lee B Springer, PhD, MLT(ASCP) Director of Laboratory Services, Glencoe Regional Health System Amy J. Wendel Spiczka, M.S. SCT, MB, HTL (ASCP)CM Manager, Anatomic Pathology, Mayo Clinic Arizona

This portfolio is made possible through The American Society for Clinical Pathology and The American Pathology Foundation. If you have questions about the content, feel free to contact: Melissa Lord-Toof, MBA Director of Operations, The American Pathology Foundation, Laguna Beach, CA Phone: 877-993-9935 | Fax: 949-376-3456 | Email: info@apfconnect.org LMU STAFF LIAISONS: Angel Fisher, MPM, PMP Program Manager, Quality Improvement Education Solutions, American Society for Clinical Pathology Karisa Munoz, M Ed Senior Instructional Designer, Education Design and Technology, American Society for Clinical Pathology Eric R. Parks, PhD Director, Educational Design and Technology, American Society for Clinical Pathology

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