Manager Quality Assurance
Resume:
DICK S. LEM **** Diamond Avenue ( South Pasadena, CA 91030
(CLS, ASCP) (cell) 626-***-**** ( (home) 626-***-****
(e-mail: acbjyc@r.postjobfree.com
GOALS: To partner with a laboratory that understands the impending
challenging healthcare environment, and along with its managerial staff,
striving to overcome all obstacles to become profitable and successful. To
be part of an environment that is or will be a premier organization able to
attract the most talented and motivated employees.
ACCOMPLISHMENTS:
. Laboratory Information Systems: setup, validation and startup of new
LIS systems (most recently Orchard Software)
. Budgets--Actively involved with budget decisions-staffing studies and
staffing adjustments to keep lab profitable, at the same time
providing stat service for the local fertility clientele
. Provided information and explanations of lab tests, fielded any client
complaints or concerns, and served as the lab's liaison to the
physicians
. Worked closely with Medical Directors to troubleshoot, audit and
create corrective actions in response to complaints or concerns.
. Managed labs that consistently delivered error rates below 0.1%
. Successfully relocated, integrated instrumentation and employees from
one site/company to a new company/facility, as well as designed new
lab layout, planned and successfully relocated staff and ensured
proper training of all.
. Successfully merged and motivated two separate and active lab staffs
into one cohesive unit.
. Able to keep morale high with minimal employee turnover, allowing for
better continuity and consistency in lab operations.
. Oversaw the validation and initiation of new assays, most recently:
Hologic HPV High Risk Screen and HPV 16/18, HIV-RNA by Roche Taqman,
autoimmune testing on the BioRad PhD, ABO/Rh by Ortho gel, new Beckman
AU680 chemistry analyzer
. Headed team preparation for multiple, successful CAP and CLIA/State
inspections, in a reference lab and hospital environment.
. Successfully maintained and improved lab services to meet the
demanding expectations of fertility testing physicians.
. Managed and successfully guided the lab through the FDA and AABB donor
testing inspection.
. Successfully manage a donor collection/manufacturing center
MANAGERIAL QUALIFICATIONS:
. Managed 50+ employees in 5 different departments, providing 24 hour, 7
days a week coverage servicing five hospitals
. Stressed Quality Assurance principles-created, enforced and
trained QA policies and programs
. Created and monitored department budgets.
. Interviewing, hiring, firing, counseling, scheduling, and
employee reviews
o Served as operations troubleshooter (QA/QI) to organize/modify
operations to maximize output and minimize errors. The goal was
to establish an efficient, error-free environment that would
require the least amount of specialized training.
. Efficiency evaluation and implementation of new policies to
improve turnaround time and service
. Developed, wrote and reviewed test procedures
. Supervised and approved new methods
. Managed client services and warehouse/supplies departments
. Extensive human resources experience
. Developed, maintained and monitored QC and QA policies
. Familiar with CAP, California state, FDA, AABB and CLIA regulations.
Lead technical teams at 2 reference labs to achieve successful CAP
accreditation
. Involved and familiar with CAL OSHA safety policies
. Directed 6 stat labs (from Fresno to Newport Beach), overseeing
budgets, staffing, leases, client relations, materials usage, CLIA
inspections and overall operations integration with the main
laboratory
. Involved in negotiating and determining the needs to make managed care
contracts profitable
. Involved with dialysis accounts and nursing home clients
. Worked closely with sales/marketing group to attain maximum
client recruitment and client satisfaction
. Managed distribution department, balancing the needs of the clients
and the transport of routine specimens to the main lab.
. Involved with outsourcing distribution department, saving at least
$4000/month
. Determined status of profitability, through expenses and collections,
of individual draw stations and stat labs, making the necessary
changes to attain profitability
. Responsible for the operating budget of stat labs and draw stations
. Familiar with FDA and ISO 9000 requirements
. Involved extensively with pharmaceutical companies-account setup,
managing lab testing for clinical trials
. Served on numerous CAP laboratory inspection teams
COMPLIANCE EXPERIENCE
Reference laboratory fined $10 million as part of a qui tam civil suit
agreement with the Office of Inspector General. As the Chief Compliance
Officer:
. Responsible for the development and implementation of the company's
new Code of Conduct and Compliance Program as required by the
company's CIA agreement;
. Planned, implemented and conducted the company's initial and annual
Compliance training programs;
. Contracted with and interfaced directly with the Independent Review
Organization (IRO)
. Monitored/audited all phases of the company's "at risk" areas of
operations to ensure compliance;
. Provided quarterly Board of Director reports;
. Created annual reports to satisfy CIA and OIG requirements;
. Maintained an active employee reporting program encouraging open
communication and reporting of any suspected non-compliant situations;
. Conducted thorough, non-partial investigations of all reported events,
summarizing these findings to the OIG;
. Conducted audits, announced and unannounced, throughout the company's
operations, including billing, phlebotomy, sales, contracting, HR and
payroll;
. Worked with the company's attorney to create initiate new policy, as
needed;
. Interfaced directly with all Federal government representatives
TECHNICAL QUALIFICATIONS:
20+ years of experience, which includes operation, method development,
preventive maintenance and extensive troubleshooting, in the following
areas:
Chemistry Hitachi 747; Ortho Vitros, Abbott Aeroset, Beckman CX-9, Olympus
AU Ananlyzers, Siemens Centaur and Immulite, Beckman DXi,
electrophoresis, HPLC and GC; GC/MS; LC-MS/MS, BioRad PhD
Hematology Coulter STK-S, LH750, Abbott Cell Dyne, coagulation systems,
Siemens Atlas urinalysis, Sysmex 2100
Microbiology Vitek, Microscan
Cytology/Histology
CYTYC, SurePath, Hologic HPV with 16/18 genotyping
Blood Bank
Immucor ECHO, Ortho Gel
Molecular Biology
HIV, HCV viral loads by Roche PCR, Cystic Fibrosis, Chlamydia/GC
using Roche Amplicor, BD Viper, Genprobe Tigris
Computer systems Antrim, CIS, MediTech, Sun Microsystems, MISYS, Triple G,
Orchard, Schuylab
EDUCATION:
Cal State Los Angeles, 1975
B.S., Medical Technology CA State License
#MTA26569
ASCP License #122941
California CLS License #MTA26569
EXPERIENCE:
HEMACARE CORPORATION April 2013 to
present
Laboratory Manager
GENX LABORATORIES December 2012 to
present
Technical Consultant/Lab Manager
CHOC MEDICAL CENTER July 2013 to
September 2013
Technical Consultant-CAP preparations
WEST COAST CLINICAL LABORATORIES, L.L.C./PATHOLOGY, INC.
Laboratory Manager /Clinical Laboratory Director
Jan 2010 to Nov 2012
BIOCORP CLINICAL LABORATORY
Laboratory Manager/Technical Consultant
2009 to present
Laboratory Manager/Compliance Officer/Safety Officer
2006 to 2009
LOS ANGELES METROPOLITAN MEDICAL CENTER
Laboratory Director
2/2006 to 12/2009
HEALTH LINE/WESTCLIFF CLINICAL LABORATORIES, INC. 3/2000
to 9/2006
Chief Compliance Officer;
Quality Assurance (QA)/Quality Control Manager
Acting Lab Manager
DIAGNOSTIC PRODUCTS CORPORATION-Los Angeles, CA
QC Laboratory Manager 1998 to
2000
MERIS LABORATORIES, INC.-Pasadena, CA
Regional Operations Manager 1991 -
1997
Director-So. Calif. Operations
Director-So. Calif. Laboratory Operations
Night Lab Manager
CDL/METWEST/UNILAB CLINICAL LABORATORIES-Tarzana, CA
Laboratory Manager, Supervisor (Chem/RIA) 1989-
1991
CLMG, INC.-Los Angeles, CA
Supervisor-Chemistry/RIA/Toxicology 1981-
1989
Medical Technologist 1977-
1984
REFERENCES
MARY ALLEN . Quality Assurance Director . CHOC, Orange County . 949-683-
0704
RAMIL GARCIA . Sales Manager . Primex Clinical Lab . 626-***-****
ANILA GURUJI, MD . Medical Director . Pathology, Incorporated . 818-419-
4885
SUMMARY / INTEREST AREAS
. Leadership skills that empower employees to make a difference
. Extensive administrative, fiscal and operational leadership
. Goal is to enable the lab to provide quality laboratory services,
including accuracy, reliability and timeliness of patient results in a
cost efficient manner
. Creates and maintains budgets
. Years of experience managing and directing Biochemical, Hematologic,
Microbiological and Blood Banking analysis.
. More than 5 years of managerial experience in a hospital and reference
setting
. ASCP certified/licensed
. Familiar with CLIA, AABB, FDA, ISO, GMP, local, Federal and State
regulations
. Managed customer service department
. Well-versed with Excel, MS Word and Outlook
. Experience with Meditech system
. Works diligently with the QA Department-has been the QA Manager at a
number of sites
. Hires, trains, develops employees, coaches and if needed, fires or
maintains communication and respect with all employees, even those
that ultimately need to be terminated.
. Manages new method validations
Dick Lem (CLS, ASCP)
1530 Diamond Ave.
So. Pasadena, CA 91030
Re: Director of Laboratory
December 8, 2013
Dear Human Resources,
My years of experience in the clinical lab environment has helped me
understand human nature and what it takes to run a successful laboratory
and to be a successful quality assurance coordinator. I have found that
lack of training, a loose or non-existent QA program, lack of respect for
the licensed and unlicensed staff, inconsistent management of the lab staff
and lack of constant communication are all characteristics that will
guarantee failure or lack of a high quality product. I feel I have the
skill set and understanding to satisfy those characteristics. I enjoy
training, nurturing, educating, developing and motivating the staff to be
efficient, accurate and always perform as a team. This has been my forte
and the part of managing that I find most rewarding. I also fell that my
background and experience has prepared me for any laboratory environment,
be it in a hospital or a reference lab.
A concern may be my apparent instability in regards to job retention.
Because reference labs have been so unstable, it has unfortunately left me
in this situation. I am looking to switch to a hospital environment that
will allow me to get established and make a difference.
I am currently the Laboratory Manager at Hemacare, Inc. which is a
plateletpheresis manufacturing facility. I have many years of experience
managing laboratory operations from a staff of 6 all the way to a staff of
50, from high volume labs (up to 4000 accessions per day) to smaller
private laboratories. Sadly, Hemacare is also having financial
difficulties and is closing the plateletpheresis part of the business-
again another situation of instability.
I have also served as Technical Consultant for CHOC Medical Center in
Orange, helping to prepare the lab for it's initial, and successful CAP
inspection, for Universal Diagnostics Laboratory in Van Nuys and for GenX
Laboratories, Inc. in Los Angeles. All of these labs have successfully
passed their inspections with minimal deficiencies.
I have a very good understanding of AABB, CAP, CLIA and FDA requirements
and have interfaced directly with auditors, as well as a thorough
understanding of workflow in the lab. Even though I have this knowledge
and experience, I have discovered that managing is not only involved with
the knowledge of regulations, budgets, and technical knowledge, but that
the employees morale and motivation are a significant part of a successful
business.
I look forward in hearing from you.
Sincerely,
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