PUBLIC HEALTH COUNCIL

A regular meeting of the Massachusetts Department of Public Health’s Public Health Council was held on Tuesday, August 29, 2006, 10:00 a.m., at the China Trade Center, John Daley Conference Room, 5th floor, Boston, Massachusetts.  Members present were:  Chair Paul J. Cote, Jr., Commissioner, Department of Public Health, Clifford Askinazi, M.D., Ms. Soo J. Kim, Atty. Jennifer A. Nassour, Ms. Maureen Pompeo, Mr. Albert Sherman (arrived late at 10: 21 a.m.), Mr. Gaylord Thayer, Jr., and Martin J. Williams., M.D.  Atty. Michael C. Hanson was absent.  Also in attendance was Deputy General Counsel Donna Levin, Department of Public Health.  

Chair Cote announced that notices of the meeting had been filed with the Secretary of the Commonwealth and the Executive Office of Administration and Finance.  Chair Cote announced further that there was New Business docketed as 3b (Request to Promulgate Amendments to 105 CMR 130.000:  Hospital Licensure and 105 CMR 170.000: Emergency Medical Services System, for medical control service).

The following members of the staff appeared before the Council to discuss and advise on matters pertaining to their particular interests:  Ms. Sally Fogerty, Associate Commissioner, Center for Community Health Services, Dr. Lois Keithly, Director, Massachusetts Tobacco Control Program, Dr. Paul Dreyer, Associate Commissioner, Center for Quality Assurance and Control, Ms. Joan Gorga, Director, and Mr. Jere Page, Senior Program Analyst, Determination of Need Program, and Deputy General Counsels Melissa Lopes and Carol Balulescu, Office of the General Counsel.

RECORD OF THE PUBLIC HEALTH COUNCIL MEETING OF JULY 25, 2006:

A record of the Public Health Council meeting of July 25, 2006 was presented to the Public Health Council for approval.  After consideration, upon motion made and duly seconded, it was voted unanimously (Mr. Sherman not present to vote) to approve the Record of the Public Health Council Meeting of July 25, 2006, as presented.  For the record, the minutes were taken up after the staff presentation below.

STAFF PRESENTATION:  “CHANGES IN NICOTINE YIELD 1998-2004”, by Assistant Commissioner Sally Fogerty, and Dr. Lois Keithly, Director, Massachusetts Tobacco Control Program:

Ms. Sally Fogerty, Associate Commissioner, Center for Community Health Services, made introductory remarks.  She said, “We are delighted to be here today to tell you about the analysis of this data which we have received from the tobacco companies, and talk about the importance of the information.  What we do know in Massachusetts is that the number of individuals who are smoking has continued to decrease, as well as the percentage of the individuals who report, according to our Behavioral Risk Surveillance Survey, that they are smoking twenty or more cigarettes.  What we are talking about today, though, is whether or not the exposure of those individuals, even if they are smoking less cigarettes, has changed and, from our findings, what we have found is that, even though individuals are smoking less cigarettes, their actual exposure to nicotine is at least the same as it was before.”

Lois Keithly, PhD., Director, The Massachusetts Tobacco Control Program, made a slide presentation to the Council.  She said in part, “…Massachusetts General Law, Ch. 94,§307B and DPH regulation 105 CMR 660.000 require that all cigarette manufacturers must file an annual report about nicotine to the Department of Public Health for each brand of tobacco products that is sold in the Commonwealth that has a market share above 1.5 percent.  The Massachusetts testing method mandates one puff of two second duration for every thirty seconds, with a volume of forty-five milliliters of smoke per puff, and that 50% of the filter vents must be blocked.  For this analysis, we tested 116 brands in which we got data from the tobacco companies in 1998, and received continuous data through 2004.  This included data from the three major cigarette manufacturers, including Lorillard, Philip Morris, RJ Reynolds, who now owns Brown & Williamson.”

Dr. Keithly said further, “The type of data that we collected is the manufacturer’s name, and that would be Philip Morris, Lorillard, RJR, the brands and the sub-brands.  Brands would be Marlboro or Salem, Newport and sub-brands would be dictated by the type of cigarette, be they full-flavored, light, ultra-light, mentholated, whether they have a filter, their length, and whether it is a hard pack or a soft pack.  Three particular variables that we looked at were:  the total nicotine content, that is the raw amount of nicotine in the raw tobacco before it is smoked; the percent of filter ventilation, which is the amount of air that is drawn through the holes in the tobacco filter, and would dilute the smoke that the smoker would inhale; and the nicotine yield, which is based on the Massachusetts testing method.  The nicotine yield is the nicotine that goes into the oral cavities and the lungs.  It is a measure of the nicotine that enters the body.”

Nictotine Yield Testing Results:

•	For all brands tested in both 1998 and 2004 (N = 116), the total amount of nicotine delivered to the smoker has increased significantly:  1:72 mg in 1998 compared to 1.89mg in 2004.  These data were also evaluated by manufacturer.  For each of the major manufacturers (i.e., Brown & Williamson, Lorillard, Phillip Morris, and RJ Reynolds), the increases in nicotine delivered were significant.

•	Each manufacturer markets many brands of cigarettes and this data was analyzed by brand.  Once again, the increases in nicotine delivered were significant.  With the exception of Winston cigarettes, all brands that were tested in both 1998 and 2004 had significant increases in nicotine delivered to the smoker.  This includes Basic, Camel, Doral, Kool, Marlboro, and Newport cigarettes.

•	Cigarette brand families (e.g., Marlboro) with a U.S. market share of greater than 1.5% were required to submit nicotine yield information.  In 2004, a total of 179 brands were tested from the four major cigarette manufacturers – Brown & Williamson (now owned by RJ Reynolds), Lorillard, Philip Morris, and RJ Reynolds.

•	For over 30 years, nicotine yields have been reported from tests using smoking machines.  The operation of the machine was an attempt to mimic the smoking behavior of a typical smoker.  However, these historical methods have been found to be inadequate because the machine’s puff duration is too short, too little smoke is inhaled, and none of the filter ventilation holes is covered.  The MDPH testing method better stimulates the smoking behavior of the typical smoker under typical smoking conditions.  Using the Massachusetts’ method, the amount of smoke inhaled with each puff is increased and the amount of time between puffs is reduced.  In addition, 50% of the cigarette filter is covered.

•	Testing for nicotine yield using the MDPH method revealed levels that are more than twice as high as those found by the historical method.  For the typical smoker, ‘low yield’ cigarettes in almost every case deliver moderate to high doses of nicotine.  These levels are sufficient to cause and maintain heavy dependence.  For all brands tested in both 1998 and 2004 (N=116), the average from using the historical method was 0.90 mg/cigarette while the average from the Massachusetts method was 1.89mg/cigarette.

•	Ninety-three percent of the cigarettes tested in 2004 fell into the highest range.  This compares to 84% in 1998.  Of 179 cigarette brands tested in 2004, 166 were rated as high nicotine.  This includes 59 brands that the manufacturers label as ‘light’ cigarettes, 12 brands labeled as ‘mild’ or ‘medium’, and 14 labeled as ‘ultra-light’.  All remaining brands fell into the moderate range.  Cigarettes with moderate and high yields can cause heavy dependence on nicotine.

•	For all brands tested in both 1998 and 2004, there were no significant differences in the total nicotine content between ‘full flavor’, ‘medium’, ‘mild’, ‘light’, or ‘ultra-light’, cigarettes.

•	Whether a cigarette is classified by the manufacturer as being ‘full flavor’, ‘medium’, ‘mild’, ‘light’, or ‘ultra-light’, it is likely to contain similar amounts of nicotine in the unsmoked tobacco.  Smokers who switch to ‘lower yield’ cigarettes to reduce their intake of nicotine are faced with similar levels of nicotine content.

•	For all brands tested in 2004, cigarettes ranged from 0% to 83% filter ventilation, emphasizing the extreme differences in cigarette design.  When smokers place their lips and fingers over the vents, they keep outside air from diluting the smoke.  As a result, they take in higher levels of tar and nicotine.  Based on information provided by the manufacturers, there is a strong correlation between the percent of filter ventilation and total nicotine content for ultra-light cigarettes.  When the nicotine content is low, there is relatively little filter ventilation.  When it is high, there tends to be much more ventilation.  Under typical smoking condition, the amount of filter ventilation reduces the amount of nicotine delivered to the smoker.  Despite lower nicotine content for some ultra-light cigarettes, these same cigarettes tend to have correspondingly low levels of filter ventilation.  This means that a much higher proportion of the nicotine in the cigarette enters a smoker’s lungs.

In closing, Dr. Keithly said in part, “…The main implication for this data is that we, in Public Health, have spent a lot of time trying to figure out why people aren’t quitting and, in fact, this data would provide a very parsimonious explanation.  It is more difficult to quit when there is a higher amount of nicotine in the cigarette.  This data would indicate that those who prescribe nicotine replacement therapy for their patients should look closely at the amount of nicotine that is believed to be in the cigarette.  It may affect the way that they would prescribe medications.  Nicotine is also associated with low birth weight babies.  This becomes especially problematic when we look at low birth weight rates in this state.  Secondhand smoke is associated with cognitive deficits and developmental delays in young children and the fact that their parents might have a harder time quitting means that young children would be exposed to increasing nicotine and an increasing amount of secondhand smoke.  And lastly, nicotine interferes with the absorption of insulin, and it also reduces the effectiveness of many medications, including medications for cardiovascular disease, for diabetes and for depression….”

No Vote/Information Only

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State Representative Peter Koutoujian from Waltham, representing Waltham, Newton and Watertown was heard out of turn (prior to the DoN applications being heard). He spoke in favor of Determination of Need applications No. 4-3B11 of FSQ, Inc. and FS Commonwealth LLC; and Project Application No. 4-3B12 of FSQ, Inc. and FS Patriot LLC.  He stated in part, “…These two hospitals provide an essential service to the members of the surrounding communities, collectively housing almost four hundred inpatient beds and dozens of outpatient services throughout the Commonwealth.  On top of high quality care, these two hospitals also provide much needed jobs in our health care sector for approximately 1100 employees…”

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PROPOSED REGULATION:  INFORMATIONAL BRIEFING ON AMENDMENTS TO LONG TERM CARE REGULATIONS 105 CMR 150.001:  NURSING HOME FAMILY MEMBER SATISFACTION SURVEY:

Dr. Paul Dreyer, Associate Commissioner, Center for Quality Assurance and Control, briefed the Council on the Nursing Home Family Member Satisfaction Survey.  He said, “We conducted our first survey of Family Member Satisfaction in 2005.  At that time, participation by facilities was voluntary.  What is necessary for the survey is the provision of family member contact information to our contracted survey agency.  Roughly two-thirds of facilities did provide the contact information, which we thought was remarkable cooperation on a voluntary basis, but, in order to get full participation from all the nursing facilities in the Commonwealth, we thought it was incumbent upon us to require cooperation.  Essentially these facilities will be required, if this regulation is promulgated, to provide family member contact information to the contracted survey agency.  All family members will be contacted, and then, we will get the family members to choose to volunteer to participate in the survey or not.  We did get about a two-thirds participation rate from family members, as well.  Two thirds of those contacted did participate.  We need huge sample sizes because we need to get enough folks, family members from each facility to be able to draw valid statistical conclusions about their responses.  This proposed regulation will go out for a public hearing, and we will bring it back for final promulgation with any proposed changes.  This has been discussed extensively with the nursing home industry and we have their support.  I would be happy to answer any questions at this time.”

In response to Council Member Thayer’s question, Dr. Dreyer said, “The purpose of this survey is to provide another source of information to consumers about making choices with respect to nursing home placements for their family members and the results of the survey are published on the web.”

No Vote/Information Only

REGULATIONS:

REQUEST FOR FINAL PROMULGATION OF 105 CMR 960.000:  BIOTECHNOLOGY REGULATIONS:

Attorney Melissa Lopes, Deputy General Counsel, Department of Public Health.  I am before you today to request final promulgation of 105 CMR 960.000, which interprets and implements Chapter 27 of the Acts of 2005, which was passed on May 31, 2005, otherwise known as the Biotechnology Statute.

Attorney Lopes noted the following:

•	The Department sent notice 90 days prior to the public hearings, as required by the statute.  Notice was published in several newspapers, The New England Journal of Medicine and the Mass. Biotechnology Council’s On-Line Newsletter.

•	The public hearings were held on May 11, 2006 in Boston and May 12, 2006 in Worcester.  No oral or written testimony was received at the hearings.  Written comments were accepted through May 26, 2006.  Partners Health Care (Harvard University, Beth Israel Deaconess Medical Center, MGH, Brigham & Women’s Hospital, McLean Hospital, Joslin Diabetes Center, Children’s Hospital, Boston, and the Dana Farber Cancer Institute).  A second letter was received on May 26, 2006 from Dana Farber Cancer Institute (Harvard University, Children’s Hospital, Boston, and Beth Israel Deaconess Medical Center).  “Both letters of written testimony are largely the same in substance and focus on the Department’s interpretation of Section 8B of the Biotechnology Statute and in the regulations under 105 CMR 960.005A and 960.006C3 and called for the deletion of these sections.  Their comments said that the Department lacked the authority to pass and promulgate these regulations and that the Department’s interpretation contravenes the Biotechnology Statute and its legislative history and that the Department’s interpretation may inhibit Massachusetts scientists from participating in important aspects of stem cell research to be carried out throughout the country”, stated Attorney Lopes.  Staff maintains that the Department has the authority to promulgate these regulations (section 10A of the statute) and the Department’s interpretation is implicit in section 8B of the Statute.

•	The regulations had been presented to the Biotechnology Research Advisory Council twice, prior to the public hearings and after the public comments were received.  The Biotechnology Research Advisory Council made only minor editorial changes, which are reflected in the drafts of the regulations presented to the Council on August 29, 2006.   The Advisory Board was concerned that institutional investigators not be placed at greater liability in the future without proper notice.  

After consideration, upon motion made and duly seconded, it was voted (unanimously) to approve the Request for Final Promulgation of 105 CMR 960.000:  Biotechnology Regulations; that a copy be attached and made a part of this record as Exhibit No. 14,863 and that a copy of the approved regulations be forwarded to the Secretary of the Commonwealth for promulgation.

NEW BUSINESS:  REQUEST TO PROMULGATE AMENDMENTS TO 105 CMR 130.000:  HOSPITAL LICENSURE, AND 105 CMR 170.000:  EMERGENCY MEDICAL SERVICES SYSTEM, FOR MEDICAL CONTROL SERVICE:

Attorney Carol Balulescu presented the request for promulgation of amendments to 105 CMR 130.000 and 170.000.  Atty. Balulescu said in part, “…Currently, the EMS regulation requires an ambulance service that provides ALS (Advanced Life Support) to have an affiliation agreement with the hospital for medical control. The amendments to the Hospital Licensure Regulation create a new section that will establish Medical Control Service, meaning the organized provision of medical control, by a hospital to an EMS service, as a new service for which a hospital may seek to be licensed.  The amendment sets forth standards for licensure, including a designation of an affiliate hospital medical director.  The amendments also define the duties of an affiliate hospital medical director, establish qualifications for the affiliate hospital medical director and on-line medical control physicians, and require hospitals to ensure compliance with these requirements.  The amendments to 105 CMR 170.000, the Emergency Medical Services regulation, primarily make changes to existing sections of that regulation to align them with the new hospital licensure standards.”

Atty. Balulesu indicated that a public hearing and comment period was held in which the Mass. Hospital Association (MHA) submitted comments.  Several of MHA’s comments were incorporated into the draft regulations submitted to the Council in May.  MHA recommended the following:

1.	MHA recommended that the Department extend the requirement for affiliation agreement to ambulance services that provide Basic Life Support (BLS).  The Department decided against this because many BLS services are publicly-funded volunteer services and the added cost would be burdensome to cities and towns.

2.	MHA requested that all affiliate hospital medical directors across the region be notified of any disciplinary action taken by the Department against an EMT or EFR certification.  Presently DPH notifies every regional council of the final agency action and expects the regional councils to provide notice to parties in their region.  In response to this comment, DPH plans to add notice of final agency actions against any EMT or EFR to its web site so that any hospital or ambulance service will be able to access this information.

3.	MHA asked DPH to convene a formal committee to advise the Department on the notification process.  DPH currently has EMCAB and its subcommittees available to provide expert advice not only on medical control but all aspects of EMS.  The Department finds no need to convene an advisory committee on this limited topic.

After consideration, upon motion made and duly seconded, it was voted (unanimously) to approve the Request to Promulgate Amendments to 105 CMR 130.000:  Hospital Licensure, and 105 CMR 170.000:  Emergency Medical Services System, for medical control service; that a copy be attached and made a part of this record as Exhibit No. 14,864; and that the amendments be forwarded to the Secretary of the Commonwealth for promulgation.

DETERMINATION OF NEED PROGRAM:  ALTERNATIVE PROCESS FOR TRANSFER OF OWNERSHIP APPLICATIONS:

PROJECT APPLICATION NO. 4-3B11 OF FSQ, INC. AND FS COMMONWEALTH LLC: 

PROJECT APPLICATION NO. 4-B12 OF FSQ, INC. AND FS PATRIOT LLC:

Mr. Jere Page, Senior Program Analyst, Determination of Need Program, presented project application 4-3B11 to the Council.  He said, “FSQ, Inc. and FS Commonwealth LLC collectively the applicant, is before the Council, seeking a transfer of ownership of Health South New England Rehab. Hospital, Woburn and its two inpatient satellites located in Lowell and in Danvers, as well as a number of outpatient satellites located in Billerica, Danvers, Melrose, Woburn, Framingham and North Dartmouth.

The applicant is a wholly-owned subsidiary of Five Star Quality Care, Inc., which currently operates seventy-four skilled nursing facilities, 102 assisted living/independent housing sites, four institutional pharmacies, and 22 outpatient rehabilitation/wellness centers throughout the United States.  Five Star reports that there will be no immediate changes in services and no capital expenditures in either New England Rehab Hospital or its satellites in association with this transfer.

Based on review of the Five Star Application, staff has determined that the applicant satisfies the required five standards for this kind of application:  (1) individuals residing in New England Rehab Hospital service area will comprise the majority of the individuals responsible for decisions regarding borrowings, changes in service, and capital and operating budgets (2) The applicant consulted with MassHealth concerning the access of medical services to Medicaid recipients at the hospital and its satellites, and comments from MassHealth indicate that it is not aware of any specific access problems for MassHealth members that may result from this transfer, and anticipates that the hospital will continue to make access to Medicaid providers and primary care for Medicaid patients a priority (3) DHCQ found that the applicant and any health care affiliates have not engaged in a pattern or practice in violation with the provisions of Mass. General Laws regarding discrimination against Medicare recipients in discharge planning and (4) the Department has determined that the applicant is not subject to a condition of approval to increase or maintain its level of free care as defined at MGL C11G, and (5) The applicant is an affiliate of the existing licensee, Health South, as it has been assigned certain of the landlord’s surviving rights and benefits under Health South’s terminated lease, which includes the transfer of the hospital’s operating assets, rights, licenses and permits to the applicant.”

Mr. Page noted that a public hearing was held on the proposed transfer on June 28th in Winchester.  All speakers at the hearing spoke in support of Health South New England Rehab Hospital’s proposed acquisition by Five Star.  All 16 speakers were managers of Five Star facilities.  Staff recommended approval with conditions.

Ms. Gorga, Director, Determination of Need Program, presented Project Application No. 4-3B12 of FSQ, Inc. and FS Patriot LLC to the Council.  Ms. Gorga stated, “FSQ, Inc. and FS Patriot LLC are before the Council today, seeking transfer of the ownership of Health South Braintree Rehabilitation Hospital in Braintree and its inpatient satellite facility located in Natick, and 19 outpatient satellites.  The applicant is a wholly-owned subsidiary of Five Star Quality Care, Inc., and currently operates 74 skilled nursing homes, continuing care retirement communities, assisted living, independent housing sites, institutional pharmacies and outpatient rehabilitation and wellness centers throughout the United States.  Five Star reports that no immediate changes in services and no capital expenditures in either the hospital or its satellites are contemplated in association with the transfer.  The application was reviewed using the alternative process for change of ownership.  The standards applied included required residents in the applicant’s service area for a majority of individuals involved in decision making for the facilities.  There was no access problems identified by the Division of  Medical Assistance.  There was a determination by the Department that the applicant and its health care facility have not been found to engage in a pattern of practice in violation of the provision of MGL Ch.111, S.51D.  The applicant is not subject to a condition of approval relative to its level of free care because it is not an acute care facility.  Finally, in relation to the fifth standard, the applicant is an affiliate of the existing licensee, Health South, and it has been assigned certain of the landlord’s surviving rights and benefits under the terminated lease, which includes the transfer of the hospital’s operating assets, licenses and permits to the applicant.”

Ms. Gorga noted further that a public hearing was held on June 20, 2006 on the application in Boston.  The hearing was attended by 20 people, and 16 people testified, including Evrett Benton, President of Five Star and 14 other representatives of Five Star.  The attorney representing the landlord REIT also testified.  All spoke in favor of the acquisition by Five Star.  Staff recommended approval with conditions.

Mr. Evrett Benton, President, Five Star Quality Care Inc. addressed the Council.  Mr. Benton noted that Five Star is a public and profitable company with over eight million in revenue.  Five Star has 17,000 patients in 153 facilities in 20 states across the country.  Five Star has 70 inpatient rehabilitation units and now 30 outpatient clinics. Mr. Benton noted, “…Our goal is clearly to continue and improve upon the health care that has been given to the citizens of the Commonwealth.  Secondly, we are reaching out to all the employees that are presently employed at these facilities, at these two hospitals, and the reality is that we hope to be able to employ over 99.9 percent of present staff as we have in other operations.  That is what we have been able to retain.  And third, that we recognize the four conditions which the Department is suggesting be included with this recommendation and we are more than happy to work with them, with regard to that…” 

Attorney for Five Star, Andrew Levine, Donoghue, Barrett & Singal, stated that the current licensee is Health South and the physical assets belong to the Real Estate Investment Trust (REIT).  With Council’s approval today, the license will go from Health South to Five Star.  Five Star already leases other properties from REIT.

After consideration, upon motion made and duly seconded, it was voted unanimously [Ms. Kim, Atty. Nassour, Ms. Pompeo, Mr. Sherman, Mr. Thayer, Jr., and Dr. Williams, in favor; Atty. Hanson absent] (Council Members Chair Cote and Dr. Askinazi recused themselves) to approve Project Application No. 4-3B11 of FSQ, Inc and FS Commonwealth LLC for transfer of ownership and original licensure of Health South New England Rehabilitation Hospital in Woburn, and its two inpatient satellites located in Lowell and Danvers to FSQ, Inc. and FS Commonwealth, LLC.  A copy of the staff summary is attached and made a part of this record as Exhibit No. 14, 865.  This Determination is subject to the following conditions:

1.	The applicant shall complete any  items in the Operations Tranfer Plan that are still in progress and uncompleted as of August 29, 2006, including but not limited to the following:  existing patient records, payroll records, Medicaid contracts, third party payer contracts and pharmacy records.

2.	The applicant shall submit written monthly reports to the Division of Health Care Quality regarding progress toward completion of all tasks set forth in the Operations Transfer Plan.

3.	With regards to its interpreter service, the Applicant shall:

•	Maintain its capacity to ensure the availability of timely and competent interpreter services

•	Update policies and procedures to include:

o	The use of only trained interpreters in clinical situations with patients who have limited English proficiency and

o	The use of telephonic services as a last resort.

•	Adapt data collection system to include self-reported race and ethnicity information from patients as per the DPH guidelines.

•	Post signage at all points of contact and public points of entry informing patients of the availability of interpreter services at no charge.

•	Develop a detailed plan for training staff on the appropriate use of telephonic interpreters’ services.

•	Develop a detailed plan for training staff providing logistical support on the ethics, skills, and techniques of interpretation.

•	Establish a formal plan identifying the systemic support to conduct outreach to non-English speaking communities throughout HSA IV

A plan to address these interpreter service elements shall be submitted to the Office of Multicultural Health (OMH) within 120 days of the DoN approval, and the Applicant shall notify OMH of any substantial changes to its Interpreter Services Program.  Also, the Applicant shall follow recommended National Standards for Culturally and Linguistically Appropriate Services (“CLAS”) in Health Care.  In addition, the Applicant will provide annual progress reports to OMH on the anniversary date of the DoN approval.

4.	The applicant will not authorize any employee or agent of the REIT to represent the Applicant in any future dealings with the Department.

After consideration, upon motion made and duly seconded, it was voted unanimously [Ms. Kim, Atty. Nassour, Ms. Pompeo, Mr. Sherman, Mr. Thayer, Jr., and Dr. Williams, in favor; Atty. Hanson absent] (Council Members Chair Cote and Dr. Askinazi recused themselves) to approve Project Application No. 4-3B12 of FSQ, Inc and FS Patriot LLC for transfer of ownership and original licensure of Health South Braintree Rehabilitation Hospital, and its inpatient satellite located in Natick to FSQ, Inc. and FS Patriot LLC.  A copy of the staff summary is attached and made a part of this record as Exhibit No. 14, 866.  This Determination is subject to the following conditions:

1.	The applicant shall complete any  items in the Operations Transfer Plan that are still in progress and uncompleted as of August 29, 2006, including but not limited to the following:  existing patient records, payroll records, Medicaid contracts, third party payer contracts and pharmacy records.

2.	The applicant shall submit written monthly reports to the Division of Health Care Quality regarding progress toward completion of all tasks set forth in the Operations Transfer Plan.

3.	With regards to its interpreter service, the Applicant shall:

•	Maintain its capacity to ensure the availability of timely and competent interpreter services

•	Update policies and procedures to include:

o	The prohibition of the use of children and 

o	The use of only trained interpreters in clinical situations with patients who have limited English proficiency.

•	Adapt data collection system to include self-reported race and ethnicity information from patients as per the DPH guidelines.

•	Post signage at all points of contact and public points of entry informing patients of the availability of interpreter services at no charge.

•	Develop a detailed plan for training staff on the appropriate use of telephonic interpreters’ services.

•	Develop a detailed plan for training staff providing logistical support on the ethics, skills, and techniques of interpretation.

•	Establish a formal plan identifying the systemic support to conduct outreach to non-English speaking communities throughout HSA IV

A plan to address these interpreter service elements shall be submitted to the Office of Multicultural Health (OMH) within 120 days of the DoN approval, and the Applicant shall notify OMH of any substantial changes to its Interpreter Services Program.  Also, the Applicant shall follow recommended National Standards for Culturally and Linguistically Appropriate Services (“CLAS”) in Health Care.  In addition, the Applicant will provide annual progress reports to OMH on the anniversary date of the DoN approval.

4.	The applicant will not authorize any employee or agent of the REIT to represent the Applicant in any future dealings with the Department.

The meeting adjourned at 10:50 a.m.

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LMH/lmh					Paul J. Cote, Chair