Quality and Compliance

Commitment to Quality Assurance

Compliance Statement

Policy – We abides by regulations pertaining to the appropriate language for labeling non-FDA approved test methods offered.

Purpose

The U.S. Food and Drug Administration (FDA) considers many clinical laboratory tests as Class I and II medical devices and as such reviews and approves tests and methodologies for “In Vitro Diagnostic Use.” Clinical diagnostic tests without FDA approval must meet the performance specifications according to the Clinical Laboratory Improvement Amendment of 1988 (CLIA).

Compliance Statement A

For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay

Analyte Specific Reagent. This test was developed and its performance characteristics determined. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.

Compliance Statement B

For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations

This test was developed and its performance characteristics determined. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Compliance Statement C

For human genetic inheritable conditions and mutations

This test was developed and its performance characteristics determined. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Compliance Statement D

For laboratory tests using a manufactured RUO kit

This test was developed and its performance characteristics determined. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Quality

Commitment to Quality Assurance

Quality is of utmost importance. It is a process and goal that permeates every department and technical section, from client services to hepatitis and retroviral testing. Quality improvement, required by the College of American Pathologists (CAP), is used to improve patient care and to address the needs of its clients. Through constant monitoring and with a focus on continual improvement, we ensure that clients are satisfied with the service they receive.

To achieve and maintain high standards, our Quality Assurance (QA) program monitors several each month. These address the quality of our assays, as well as pre- and post-analytical aspects of testing. Example indicators include: accuracy and clarity of laboratory reports; appropriateness of samples, labeling, and transport conditions; assay precision; client interaction and consultation; compliance with policy and procedure; patient outcome; and turnaround time.

We view quality assurance as the natural cornerstone to continuous improvement. By utilizing the data generated by QA indicators, combined with internal and external customer needs assessments. Continuous improvement of our QA program uses client and employee involvement to improve critical processes. The goal is to define and meet the needs of the complex customer base. This allows us to constantly reevaluate and improve customer service.

We are committed to providing the highest quality service to its clients in full compliance with all federal, state, and local laws and regulations. This commitment applies not only to technical operations, but also to business operations, including marketing practices and billing.

HIPAA Compliance

We are is committed to comply with the Health Insurance Portability and Accountability Act (HIPAA) Standards. We have implemented policies, processes, and procedures designed to ensure compliance with these standards. Compliance to these standards is continuously monitored and audited for effectiveness. Workforce training is completed annually.

We comply with the security standards by ensuring that systems, policies, and procedures meet or exceed all required and addressable implementation specifications. Internet and interface connectivity is encrypted and/or password protected, and electronic access is limited to only those entities that have been authorized. Additionally, we have implemented secure methods for communicating protected health information (PHI) and sensitive business communications with our clients. Clients wishing to  retrieve PHI, may do so by contacting client services

Quality

Notice of Privacy Practices Statement

This notice describes how medical information about you may be used and disclosed and how you can receive access to this information. Please review it carefully.

PRIVACY PRACTICES

We are committed to protecting the confidentiality of your medical and health information (“protected health information”) as described in this notice and maintains the privacy of your protected health information as required by law. We have provided this notice to you to describe the way we may use and share your protected health information. This notice describes our privacy practices relating to protected health information, including how we may use your protected health information within our facility and how under certain circumstances we may disclose it to others outside our facility. This notice also describes the rights you have concerning your own protected health information. Please review it carefully. If you have questions about any part of this privacy notice, or if you want more information about the privacy practices, please contact the privacy officer listed at the end of this notice.

USES AND DISCLOSURES OF PROTECTED HEALTH INFORMATION PERMITTED BY LAW

The law permits us to use your protected health information for treating you and billing for services and healthcare operations, as explained below. Certain types of protected health information have additional protection under state or federal law. For example, information about genetic testing and mental health treatment or conditions may have added protection. To disclose this type of information to others, we are required to get your authorization as described below.

Your protected health information may be used and disclosed only for the following purposes:

For treatment: We may use your protected health information to provide you with medical treatment and other services. We may also disclose your protected health information to others who need information to treat you, such as doctors, physician assistants, nurses, medical and nursing students, technicians, therapists, emergency service and medical transportation providers, medical equipment providers, and others involved in your care. For example, we will allow your physician to have access to your laboratory results to assist in your treatment and for follow-up care.

For payment: We may use and disclose your protected health information to get paid for the medical services and supplies we provide to you. For example, your health plan or health insurance company may ask to see parts of your medical record before they will pay us for your treatment.

For healthcare operations: We may use and disclose your protected health information for healthcare operations, which include patient and internal education, administration, planning, and other various activities that improve the quality of care we provide to patients. We may disclose protected health information to outside companies to support administrative functions, such as data analysis or accounting or legal services, but we will only do so after they have signed an agreement stating that they will abide by our privacy policy.

To business associates:  We may provide your PHI to other companies or individuals that need the information to provide services for us. These other entities, known as “business associates,” are required to maintain the privacy and security of PHI. For example, we may provide information to companies that assist us with billing of our services.

For eligibility in Utah Medicaid or the Children’s Health Insurance Program: We may disclose your personally identifiable information to Utah state databases to determine whether you are eligible for Utah Medicaid or Children’s Health Insurance Program.

To family members and others involved in your care: We may disclose your protected health information, unless prohibited by applicable federal or state law, to a family member, another relative, a close personal friend, a person identified by you who is involved in your medical care, or someone who helps pay for your care. If you do not want us to disclose your protected health information to family members or others, please contact our privacy officer, as provided below.

For research: We may use or disclose your protected health information without your consent or authorization for research projects, such as studying the effectiveness of a treatment you received, if an institutional review board approves a waiver of authorization for disclosure. These research projects must go through a special process that protects the confidentiality of your protected health information.

As required by law: Federal, state, or local laws sometimes require us to disclose protected health information. For instance, we are required to report child abuse or neglect and must provide certain information to law enforcement officials in domestic violence cases. We also are required to give information to the State Workers’ Compensation Program for work-related injuries.

For public health activities: We may also use and disclose certain protected health information for public health purposes, such as preventing or lessening a serious and/or imminent threat to an individual’s or the public’s health or safety. We may also report information to your employer as required under laws addressing work-related illness and injuries or workplace medical surveillance. For instance, a positive communicable disease test result may be reported to the state health department. We also may need to report patient problems with medications or medical products to the Food and Drug Administration (FDA).

For public health or safety: In limited circumstances, we may disclose protected health information to prevent or lessen a serious and/or imminent threat to an individual’s or the public’s health or safety.

To law enforcement officials: We may disclose protected health information to law enforcement officials as required by law or in compliance with a search warrant, subpoena, or court order. We also may disclose protected health information to assist law enforcement officials in identifying or locating a person, to prosecute a crime of violence, to report deaths that may have resulted from criminal conduct, and to report criminal conduct.

For military, veterans, national security, and other government purposes: If you are a member of the armed forces, we may release your protected health information as required by military command authorities or to the Department of Veterans Affairs. We may also disclose protected health information to federal officials for intelligence and national security purposes, or for Presidential Protective Services.

For judicial proceedings: We may disclose your protected health information if we are ordered to do so by a court or if we receive a subpoena or a search warrant.

For health oversight activities: We may disclose protected health information to a government agency that oversees our facility or our personnel, such as the College of American Pathologists (CAP), the federal agency that oversees Medicaid and Medicare (CMS), and the Food and Drug Administration (FDA), to ensure compliance with state and federal laws.

To coroners, medical examiners, and funeral directors: We may disclose protected health information concerning deceased patients to coroners, medical examiners, and funeral directors to assist them in carrying out their duties.

For organ and tissue donation: We may disclose protected health information to organizations that facilitate organ, eye, or tissue donation or transplantation.

USES AND DISCLOSURES WITH YOUR AUTHORIZATION

We cannot use your Protected Health Information for anything other than the reasons mentioned above, without your signed “Authorization”. An Authorization is a written document signed by you giving us permission to use or disclose your Protected Health Information for the purposes you specifically set forth in the Authorization.  You may revoke the Authorization, at any time, by delivering a written statement to our Privacy Officer.  If you revoke your Authorization, we will no longer use or disclose your Protected Health Information as permitted by your Authorization.  However, your revocation of Authorization will not reverse the use or disclosure of your Protected Health Information made while your Authorization was in effect.

YOUR INDIVIDUAL RIGHTS

Right to request your protected health information: You have the right to access your protected health information (laboratory testing). You must make the request for such protected health information in writing or by calling Client Services. A notarized authorization form will be required and is available here: Patient Access Authorization Form. Within thirty (30) days after our receipt of your request you will receive a copy of the laboratory testing unless an exception applies. Exceptions include if the access is reasonably likely to endanger the life or physical safety of you or another person as determined by a licensed health care professional.  If the results cannot be produced within the thirty days, you will be notified by mail.

To request the forwarding of your protected health information to your healthcare provider, write to our privacy officer as set forth below. We may charge a fee for the costs of copying, mailing, or other supplies associated with your request, but we will let you know about the fee in advance.

Right to request amendment of protected health information you believe is erroneous or incomplete: If you examine your protected health information and believe that some of the information is wrong or incomplete, you may ask us to amend your record. We will comply with your request unless we are not the originator of the information or we believe that the information you request to be amended is accurate and complete or special circumstances apply. To ask us to amend your protected health information, write to our privacy officer as set forth below.

Right to receive an accounting of disclosures of your protected health information: You have the right to request a list of certain disclosures we make of your protected health information. If you would like to receive such a list, write to our privacy officer as provided below. Your request must state a time period desired for the accounting, which must be within six years prior to the date of your request and may not include dates before April 14, 2003. We will provide the first list to you free of charge, but we may charge you for any additional lists you request during the same 12- month period. We will tell you in advance what this list will cost, at which time you may withdraw or modify your request.

Right to request restrictions on how we will use or disclose your protected health information for treatment, payment, or healthcare operations: You have the right to request us not to make uses or disclosures of your protected health information to treat you, to seek payment for care, or to operate our laboratories. We will consider your requests carefully, but we are not required to agree to your requested restriction. If you want to request a restriction, submit your request in writing to our privacy officer and describe your request in detail. Ourprivacy officer will reply within 30 days of receiving your request.

Right to request special communications: You have the right to ask us to communicate your protected health information by alternative means of communication or at alternative locations. For example, you can ask us not to call your home but to communicate with you only by mail. To make such a request, write to our privacy officer.

Right to receive a paper copy of this notice: If you have received this notice electronically, you have the right to a paper copy at any time. You may call or write to our privacy officer.

CHANGES TO THIS NOTICE

From time to time, we may change our practices concerning how we use or disclose protected health information or how we will implement patient rights concerning such information. We reserve the right to change this notice and to make the provisions in our new notice effective for all protected health information we maintain. If we change these practices, we will publish a revised notice. You can receive a copy of our current notice at any time by calling or writing to our privacy officer.

QUESTIONS, CONCERNS, OR COMPLAINTS

If you have any questions about this notice or have further questions about how we may use and disclose your protected health information, please contact the privacy officer as set forth below. We welcome your feedback regarding any problems or concerns you have with your privacy rights or how we uses or discloses your protected health information.

MCI Diagnostic

Providing top patient care with fast results. 

7018 South Utica Avenue

Tulsa, Oklahoma 74136

Hours of Operation

Mon - Sat: 7AM-11PM

Sun: 7AM-3PM

Government Contract

Mon - Sat: 7AM-11PM

Sun: 7AM-3PM

Laboratory

Mon - Sat: 7AM-11PM

Sun: 7AM-3PM