SETTLEMENT AGREEMENT

BETWEEN

THE UNITED STATES OF AMERICA

AND

BIO-MEDICS

DJ # No. 202-77-45


 

A.BACKGROUND

Parties:

1.   The parties to this Settlement Agreement ("Agreement") are the United States of America and Bio-Medics ("Bio-Medics").

2.   Bio-Medics is incorporated under the laws of the state of California. Bio-Medics owns and operates plasma donation centers and it pays its donors a fee in exchange for their plasma.

3.   This matter was initiated by a complaint filed by the American Council of the Blind on behalf of Dennis Stapley ("Mr. Stapley") with the United States against Bio-Medics. The complaint alleges that Mr. Stapley was prohibited from donating his plasma at a Bio-Medics donation center because he is blind.

4.   The United States contends that Bio-Medics' refusal to permit Mr. Stapley to donate his plasma because he is blind violated Mr. Stapley's rights under Title III of the Americans with Disabilities Act of 1990 ("ADA"), 42 U.S.C. §§ 12181-12189, and its implementing regulation, 28 C.F.R. Part 36.

5.   Bio-Medics' position is that at the time that Mr. Stapley came in to donate, it did not have procedures in place to accommodate persons with disabilities and that this had never been an issue in the past. Bio-Medics also stated that it is governed by the Food and Drug Administration ("FDA") and thus it had to consult them prior to permitting individuals with disabilities, including those with sight impairments, to donate their plasma for a fee. However, soon after they became aware of Mr. Stapley's complaint Bio-Medics contends that it developed procedures so individuals with disabilities could donate their plasma for a fee.

6.   The Attorney General is authorized to investigate alleged violations of title III of the ADA, and to bring a civil action in federal court if the United States is unable to secure voluntary compliance in any case that involves a pattern or practice of discrimination or that raises issues of general public importance, 42 U.S.C. § 12188(b).

7. The parties enter into this Agreement in order to avoid unnecessary and costly litigation and hereby agree as follows:

8.  The United States asserts that Bio-Medics is a private entity that owns five plasma donation centers in California, Idaho, Utah, Washington, and West Virginia. Bio-Medics is a public accommodation pursuant to 42 U.S.C. § 12181(7)(F ) and its implementing regulation, 28 C.F.R. § 36.104(6).

9. Dennis Stapley is blind and is therefore a person with a disability within the meaning of 42 U.S.C. § 12102(2)(A) and 28 C.F.R. § 36.104.

B. LEGAL STANDARDS

10. The ADA provides that "[n]o individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation." 42 U.S.C. § 12182(a); 28 C.F.R. § 36.201(a).

11. The ADA and its implementing regulation require public accommodations to make reasonable modifications in policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities, unless the public accommodation can demonstrate that making such modifications would fundamentally alter the nature of such goods, services, facilities, privileges, advantages, or accommodations. 42 U.S.C §12182 (b)(2)(A)(ii); 28 C.F.R. §36.302(a).

12. Under the ADA, "[i]t shall be discriminatory to subject an individual or class of individuals on the basis of a disability or disabilities of such individual or class, directly, or through contractual, licensing, or other arrangements, to a denial of the opportunity of the individual or class to participate in or benefit from the goods, services, facilities, privileges, advantages, or accommodations of an entity." 42 U.S.C. § 12182(b)((1)(A)(i); 28 C.F.R. § 36.202(a).

C. TERMS OF AGREEMENT

In order to take steps to make sure that qualified individuals with disabilities, including those who are deaf or hard of hearing and/or blind or have low vision, are not discriminated against, Bio-Medics agrees to the following:

13. Bio-Medics agrees to continue to use its new policies for Acceptability of Blind Donors and Acceptability of Hearing Impaired Donors ("New Policies") attached to this agreement as Appendix B and Appendix C respectively . Also, Bio-Medics agrees to post a copy of its New Policies in the waiting areas of all of its plasma donation centers. In addition, Bio-Medics agrees to distribute copies of its New Policies to its employees and donors, upon request. Bio-Medics further agrees not to modify its New Policies without the consent of the Department.

14. Bio-Medics agrees to permit individuals with disabilities, including those who are blind or have low vision or are deaf or hard of hearing, to donate their plasma for a fee as long as they pass the physical examination that all donors are required to pass.

15. Within thirty (30) days of the effective date of this Agreement, Bio-Medics will post a sign in a conspicuous location, in each of its offices, where it can be seen by both patients and staff, stating:

In compliance with the Americans with Disabilities Act of 1990, Bio-Medics will permit individuals with disabilities, including individuals who are blind or have low vision or deaf or hard of hearing, to donate their plasma for a fee provided that they pass the mandatory physical that all donors are required to take and pass. For assistance, please contact Bio-Medics' Administrative Office at (714) 363-0843.

16. Within sixty (60) days of the effective date of this Agreement, Bio-Medics agrees to provide mandatory training to all of its employees on its new policies. Thereafter, Bio-Medics agrees to train its employees, annually, on its policies.

17. Bio-Medics hereby agrees to pay to Mr. Stapley a total of Five Hundred Dollars ($500.00) as full and final settlement of the Complaint filed in this case. This sum shall be paid to Mr. Stapley in full and final satisfaction of all ADA claims arising out of the Complaint and the facts set forth therein.

18. Mr. Stapley agrees to execute and mail the Release attached to this Settlement Agreement as Appendix A to Bio-Medics prior to receiving any monetary amount from Bio-Medics.

19. Within fifteen (15) days of Bio-Medics' receipt of Mr. Stapley's fully executed Release, Bio-Medics shall mail to the undersigned counsel for the United States a check made payable to Dennis Stapley in the amount of Five Hundred dollars ($500.00).

D. REPORTING AND MONITORING

20. In order to assess whether the modifications to Bio-Medics' practices are effective, six months after this Agreement is executed, and continuing once a year for the two years this agreement is in effect, Bio-Medics will provide to the Department copies of written or e-mail complaints that Bio-Medics received from donors who are blind or have low vision or who are deaf or hard of hearing, and documentation that reflects whether and how the complaint was resolved.

E. IMPLEMENTATION AND ENFORCEMENT OF THIS AGREEMENT

21. The Attorney General is authorized, pursuant to 42 U.S.C. § 12188(b)(1)(B), to bring a civil action under Title III, enforcing the ADA in any situation where a pattern or practice of discrimination is believed to exist or a matter of general public importance is raised. In consideration of the terms of this Agreement, the Attorney General agrees to refrain from filing a civil suit under title III in this matter, except as provided in paragraph 23.

22. If at any time Bio-Medics desires to modify any portion of this Agreement because of changed conditions making performance impossible or impractical or for any other reason, it will promptly notify the United States in writing, setting forth the facts and circumstances thought to justify modification and the substance of the proposed modification. Until there is written agreement by the United States of the proposed modification, the proposed modification will not take effect. The approval shall not be unreasonably withheld or delayed.

23. The United States may review compliance with this Agreement at any time. If the United States believes that Bio-Medics has failed to comply in a timely manner with any requirement of this Agreement without obtaining sufficient advance written agreement with the United States for a modification of the relevant terms, the United States will so notify Bio-Medics in writing and it will attempt to resolve the issue or issues in good faith. If the United States is unable to reach a satisfactory resolution of the issue or issues raised within thirty (30) days of the date it provides notice to Bio-Medics, it may institute a civil action in federal district court to enforce the terms of this Agreement or title III and may, in such action, seek any relief available under law.

24. For purposes of the immediately preceding paragraph, it is a violation of this Agreement for Bio-Medics to fail to comply in a timely manner with any of its requirements without obtaining sufficient advance written agreement with the United States for an extension of the relevant time frame imposed by the Agreement.

25. Failure by the United States to enforce this entire Agreement or any provision thereof with regard to any deadline or any other provision herein shall not be construed as a waiver of the Department's right to enforce other deadlines and provisions of this Agreement.

26. A copy of this document or any information contained in it will be made available to any person by Bio-Medics or the United States on request.

27. This Agreement shall be binding on Bio-Medics, its agents and employees. In the event Bio-Medics seeks to transfer or assign all or part of its interest in any facility covered by this Agreement, and the successor or assign intends on carrying on the same or similar use of the facility, as a condition of sale Bio-Medics shall obtain the written accession of the successor or assign to any obligations remaining under this Agreement for the remaining term of the Agreement.

28. This Agreement constitutes the entire Agreement between the parties on the matters raised herein, and no other statement, promise, or Agreement, either written or oral, made by either party or agents of either party, that is not contained in this written Agreement, (including its Attachments), shall be enforceable. This Agreement does not affect Bio-Medics' continuing responsibility to comply with all aspects of the ADA.

29. This Agreement will remain in effect for 2 years from the effective date of this Agreement, or until the parties agree that full compliance with this Agreement by Bio-Medics has been achieved, whichever is later. The effective date of this Agreement is the date of the last signature.

30. The person signing for Bio-Medics represents that he or she is authorized to bind Bio-Medics to this Agreement.

 

For BIO-MEDICS:

 

FOR THE UNITED STATES:

______________________
Gary C. Crandall
Authorized Official
1892 No. Tustin
Orange, CA 92865
714-363-0843

Loretta King
Acting Assistant Attorney General
for Civil Rights

 

________________________
John L. Wodatch, Acting Deputy Assistant Attorney General
Allison J. Nichol, Deputy Chief
Philip L. Breen, Special Legal Counsel
Felicia L. Sadler, Trial Attorney
Disability Rights Section
Civil Rights Division
U.S. Department of Justice
950 Pennsylvania Ave., NW
DRS, 1425 NYA
Washington, D.C. 20530

 

 

 

 

 

APPENDIX A

RELEASE

For and in consideration of the acceptance of the relief offered to me by BIO-MEDICS in Orange, California, pursuant to a Settlement Agreement between the United States of America and BIO-MEDICS:

I, Dennis Stapley, release and discharge BIO-MEDICS in Orange, California and its current, former, and future agents, employees, officials, and designees, of and from all legal and equitable claims known or unknown arising out of the facts described in paragraphs 1 through 5 above. I further agree that I will not exercise my right to institute, against BIO-MEDICS any civil action alleging discrimination on the basis of any of the facts alleged in my complaint.

I acknowledge that a copy of the Settlement Agreement between Bio-Medics in Orange, California and the United States of America resolving the matter between them has been made available to me.

I HAVE READ THE RELEASE AND UNDERSTAND THE CONTENTS THEREOF AND I EXECUTE THIS RELEASE OF MY OWN FREE ACT AND DEED.

Signed this ___th day of April, 2009.

By: _________________________
Dennis Stapley


 

APPENDIX B

BIO-MEDICS
STANDARD OPERATING PROCEDURE MANUAL

ACCEPTABILITY OF BLIND DONORS

GENERAL

A person who is blind or has low vision is not prevented from donating plasma, as long as he or she meets all other set requirements needed to donate. However, there are several items that need to be addressed so that the donor will be afforded a pleasant experience and will be given whatever assistance they need to safely complete the process. An alert tag is to be placed in the donor record file stating the specific assistance that the donor will need while at the center.

Service Animals can be brought into the center and taken onto the donor floor. Service animals include any animal individually trained to do work or perform tasks for the benefit of an individual with a disability. The donor is to be assigned to a bed where the service animal can be beside the donor bed without blocking other donors or staff.

PROCEDURE

One employee will be assigned to the donor to assist them during the donation.

1.   Employees may assist the donor in moving about the center in a safe, comfortable atmosphere. Employees shall talk with the donor and make a notation on the alert tag as to how the donors prefers to walk through the center. For example, does the donor prefer to be assisted by his/her service animal or by an employee? If the donor prefers to be escorted by an employee does the donor want the employee's arm to loop around the donor's? Does the donor want the employee to walk in front of the donor, etc.?

2.   While walking throughout the donor floor, the employee will make a verbal description of each area to the donor. For example: "You will now need to step onto the weight scale. It is to your left." (Take the donor's hand and place it on the middle part of the stand). Tell the donor that he/she will need to step up approximately 4 inches. Give assistance if requested. The same applies when stepping off the scale.

3.   When interviewing the donor in the booth, familiarize him/her with where things are located.

4.   If the donor has to use the bathroom, he or she may need to be assisted and guided to where all items in the bathroom are located. The employee then can stand outside the door and give further assistance if it is requested.

5. When signing documents the donor will need guidance as to where they are to sign. They must freely sign the document. (The employee is not to hold the pen or guide their hand).

6.   All consents, dear donor letters, informational packets, and questionnaires are to be read to the donor by an employee in a private setting (e.g. physician's office). On the New Donor Quiz, when the questions are read to the donor, a verbal response can be marked on the quiz by the employee. On all forms a notation is to be made: "All contents of this form, read to the donor by _________ on this ________ day of __________."

7.   During a physical exam, the main emphasis should be that the donor meets all requirements to donate and that he/she fully understand the procedure and the risk involved with donating. The donor also needs to be able to give an Informed Consent. Refer to #5 above for signing of documents.

8.   Donors are to be given a guided tour of the donor floor, so they comprehend their surroundings. They need to be told what possible noise and sounds they will be hearing. Assist the donor to assigned bed, and make sure that the donor is resting on the bed in a comfortable position. If the person who has been assisting the donor is not going to be doing the venipuncture, introduce the phlebotomist.

9.   Thoroughly explain each step as it is being performed. Explain what the donor needs to do during the process. This is the general explanation given to all donors. (For Example: the inflation of the cuff, squeeze hand or grip. Deflation of the cuff, stop squeezing and relax). Tell the donor that if they hear any noises or beeps from the machine to notify his/her "Assigned Employee" or Phlebotomist, immediately.

10. Explain to the donor if they experience any abnormal symptoms, such as, being lightheaded, nauseated, or any other type of discomfort to ring the bell that is provided. (An employee will closely monitor the donor during the process).

11. When the plasmapheresis process is completed, assist the donor to the payment area.

12. Donor is to be thanked for his/her donation and should make his/her next appointment.

MISCELLANEOUS

1.  Employees need to make sure that they always introduce themselves to the donor.

2.   All prospective new donors should have a tour of the facility and be given descriptive explanations of what they are hearing and how the furniture, equipment, etc. is positioned. Employees need to make sure that information about the facility is given to the donor as this information is observed.

3.   Patience and Understanding is the Key Element for the donor to have a pleasant experience.

4.   No friends or relatives can accompany the donor during the procedure. Only a member of the staff and/or a service animal can accompany the donor.

 

APPENDIX C

BIO-MEDICS
STANDARD OPERATING PROCEDURE MANUAL

ACCEPTABILITY OF HEARING IMPAIRED DONORS

GENERAL

A person who is deaf or hard of hearing is not prevented from donating plasma, as long as he or she meets all other requirements for being a donor. However, there are several items that need to be addressed so that the donor will be afforded a pleasant experience and will be given whatever assistance that may be needed to safely complete the process. Notations can be made in the Donor Record File ("DRF") for any specific assistance the donor might require. The donor will be required to make appointments to donate, so that the center can have extra personnel available to assist the donor, especially if they need the assistance of a qualified sign language interpreter ("QSLI") or an oral interpreter ("OI").

PROCEDURE

One employee will be assigned to the donor to assist them during the donation. If the donor needs a QSLI to fill out required paperwork, to understand instructions, and to give responses, the center will make every attempt to have this person available.

1.   Employees are to assist the donor in going through the donation process in a safe comfortable atmosphere.

2.   If the donor is able to read lips and speak with ease, the employee is to converse with the donor in a slow, clear speech. The employee is to be focused on this donor and this donor only. They are to avoid distraction by other things that may be happening in a particular area.

3.   When interviewing the donor in the booth, make sure that the donor has a clear view of the employee's face. Repeat questions if the donor does not seem to comprehend what was asked. If the donor can read lips and does not need a QSLI or OI, a Flip Chart of the Medical History questions may be used to have the donor read and then verbally respond or give a written response.

4.   If using a QSLI or OI, make sure that there are no distractions and that the QSLI or OI is aware of the importance of receiving concise and complete answers to all questions.

5.   Make sure that when signing any documents that the donor is thoroughly aware of what and why they are signing. Example: when a QSLI or OI asks Medical History Questions in the booth, the QSLI or OI should ask questions in order and should not change the order in which they are asked.

6.   All consents, dear donor letters, informational packets, and questionnaires are to be read by the donor or the QSLI or OI. On all forms a notation is to be made: "All contents of this form were read by the donor or the QSLI or OI and all questions were answered by the donor or the QSLI or OI. Have donor sign and date if a QSLI or OI was used. If a QSLI or OI was used, place the following statement at the bottom of the form, "All contents of this form were read by the donor and all answers were obtained by the use of _________________ QSLI or OI on _________________ date. Have the QSLI or OI sign and date the form.

7.   During a physical exam, the main emphasis should be for the donor to meet all requirements to donate and to fully understands the procedure and the risk involved with donating. The donor also needs to be able to give an Informed Consent. For Signing of documents, refer to #5 and #6 above.

8.   Donors will need to be given a guided tour of the donor floor, so they comprehend their surroundings. Assist the donor to the assigned bed, and make sure that the donor is resting on the bed in a comfortable position. If the person who has been assisting the donor is not going to be doing the venipuncture, introduce the phlebotomist.

9.   Thoroughly explain each step as it is being performed. Explain what the donor needs to do during the process. Tell the donor that if they feel any discomfort around the venipuncture site to indicate this by blowing the whistle or ringing the bell that has been provided to them.

10. Explain to the donor, if he or she experiences any abnormal symptoms, such as, being lightheaded, nauseated, or any other type of discomfort, to blow the whistle or ring the bell that has been provided. (An employee is to closely monitor the donor during the process).

11. When the plasmapheresis process is completed, assist the donor to the payment area.

12. Thank the donor for the donation and make the next appointment.

MISCELLANEOUS

1. Employees need to make sure that they always introduce themselves to the donor.

2. All prospective new donors should have a tour of the facility and given descriptive explanations of what they are observing.

3. Patience and Understanding are Key Elements for the donor to have a pleasant experience.

4. Friends or relatives cannot accompany the donor during the procedure. Only a member of the staff and/or a QSLI or OI.

 


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