This is a business plan for Quality Clinical Lab Solutions, a laboratory consulting agency. The business plan includes the mission, vision, nature of business, customers, stakeholders, competitive environment, regulations, marketing strategies, HR plan, and one-year budget plan.
Below is the transcript of the presentation:
QUALITY CLINICAL LABORATORY SOLUTIONS
BUSINESS PLAN
Sergiy Neverov
Healthcare Administration – University of Arizona Global Campus
MHA 690 – Health Care Capstone
Dr. Ashley Tennessee
July, 5, 2022
QCLS - Mission & Vision
Strategic planning is intentional, methodical effort to produce important decisions that form and guide the organization’s action plan and the reasons behind it (Kools and George, 2020). To establish a comprehensive strategic plan for the organization, a mission and vision statement must be developed. These statements provide a clear definition of the purpose and goals of the organization. The mission statement of a healthcare organization is believed to be an essential strategic tool. It is the foundation on which the organization plans and establishes its role and purpose (Cronin & Bolon, 2018). It is a means by which the organization communicates its priorities and purpose to the community they serve. At Quality Clinical Lab Solutions our mission is to provide clinical laboratories with technical expertise and support in developing robust quality management and compliance programs and to assist laboratories in preparing for accreditation and certification by the accrediting agencies.
QCLS Vision
According to Stevens and Silver (2015), a healthcare organization must have a clearly defined vision statement because it communicates to stakeholders the direction of the organization. The vision of QCLS is to deliver accuracy and excellence in laboratory medicine through quality management and compliance programs while implementing best practices and standardized processes.
QCLS - What We Do
Based out of Sacramento, California, Quality Clinical Laboratory Solutions (QCLS) is a full-service laboratory consulting firm that offers expertise in laboratory operations, standardization and best practices, regulatory compliance, and accreditation. Our team of professionals provides steps to improve laboratories and ensure quality and compliance.
QCLS - What We Offer
QCLS will provide expert advice and technical expertise to its clients as well as prepare the laboratory for accreditation and certification. This includes providing consultation regarding the CLIA requirements for the laboratory, supporting during the state and federal application submission for accreditation and certification, drafting standard operating procedures, assisting with developing the laboratory quality management program consistent with the standards of the regulatory agencies, reviewing and updating standard operating procedures, instrument validations, and verifications, competencies, performing periodic audits of the laboratory to prepare for the CAP inspections, and participate in all laboratory inspections. Additionally, the company offers a post-inspection follow-up to rectify any deficiencies and ensure compliance. These services will be negotiated and agreed upon during contracting.
QCLS - Our Customers
The QCLS customers are mainly hospitals and reference laboratories. Additionally, QCLS offers services to small medical office laboratories that require Commission on Office Laboratory Accreditation (COLA).
QCLS - Other Stakeholders
Stakeholder engagement is being increasingly endorsed across the board, as an important pathway to achieving improvements (Boaz et al., 2018). There are several stakeholders associated with the QCLS including laboratory personnel, laboratory medical directors and pathologists, accrediting and regulatory agencies, laboratory inspectors and auditors, technical specialists, laboratory equipment manufacturers and vendors, and more.
QCLS - Competitive Environment
There are several consulting agencies available throughout the United States, and QCLS will need to be able to compete with these organizations. Due to the challenges with compliance and the increased number of standards, there is a demand for laboratory consulting agencies in California and surrounding states. Because QCLS is a small organization, we will be able to provide a personalized approach to each client. To stay competitive, QCLS will need to employ certified laboratory consultants. The CLC certification can be obtained through certifying agencies such as American Medical Technologists. Additionally, QCLS consultants will need to be board-certified Clinical Laboratory Scientists by the American Society of Clinical Pathologists (ASCP), and licensed by the California Department of Public Health Laboratory Field Services. In the future, QCLS will seek experts such as Specialists in Blood Banking and Specialists in Hematology certified by the ASCP.
QCLS - Regulations to Consider
There are many guidelines that apply to clinical laboratories, including federal and state regulations for certification, licensure, and accreditation (Mazer, 2018). Laboratories must ensure compliance with all applicable federal, state, and local requirements. Implementing a quality assurance program can directly assist labs in achieving their quality goals (Selvi & Ankanagari, 2019).
All clinical laboratory testing performed on humans in the United States is regulated by the Centers for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). CLIA covers approximately 330,000 laboratory entities (Centers for Medicare & Medicaid Services: CLIA, 2022). The College of American Pathologists grants accreditation to laboratories that perform testing on human and animal specimens. When required by law, the laboratories must have the relevant licenses to perform lab testing (College of American Pathologists, 2022). There are 21 discipline-specific accreditation checklists offered by the College of American Pathologists. These checklists provide not only a roadmap for accreditation, but also help establish a high-quality laboratory (CAP, 2022). The Joint Commission is another accrediting agency that accredits hospitals and laboratories. Currently, the Joint Commission accredits over 1500 organizations nationwide (Joint Commission, 2022).
QCLS - Marketing Strategies
To market QCLS several marketing strategies will be employed. The QCLS brand will be created to advertise the company on the company’s website, social media platforms, other advertising companies, and search engines. A website will be developed to broadcast the company’s services and contact information. Furthermore, the company will be advertised in the periodic publications of professional organizations such as CAP Today.
QCLS - HR Plan
During the first year of the company, there will only be one employee (myself). As the business grows, the needs of the company will be reevaluated, and more consultants will be contracted as needed. In addition, the consulting agency plans to expand its expertise by hiring specialists in blood banking, specialists in hematology, and other lab expertise. Because the consultants will be independently contracted, they will be responsible for providing their own medical benefits and retirement. The terms of the contract will be negotiated.
QCLS - One-Year Budget Plan
The biggest cost of the QCLS is the salary of the consultants. The salary will be comparable to a laboratory manager’s salary of $180,000 per year. The travel expenses will be expensed to the client, and as such will not be included in this budget. According to the American Medical Technology website, the CLC Certification is $190 initially, and $90.00 annually thereafter (American Medical Technologists, 2020). There is an annual professional ASCP membership fee of $90.00. $10,000 is budgeted for office supplies. The office space will be approximately $19,200. The miscellaneous expenses are projected to be between $500 – $10,520. The estimated total first-year budget is $220,000. QCLS will need to contract 11 clients at $20,000 to reach a break-even point.
Thank you for your time and consideration.
QCLS - delivering accuracy and excellence in laboratory medicine through quality management and compliance programs, while implementing best practices and standardized processes.