Tennessee Medical Laboratory Board Meeting October 16 .

Tennessee Medical Laboratory Board MeetingOctober 16, 2014MinutesDate:October 16, 2014Time09:00AM CST/CDTLocation:Tennessee Department of HealthDivision of Health Licensure and RegulationMetro Center Complex, Iris Room, Ground Floor665 Mainstream DriveNashville, TN 37243Members Present:Stephanie Dolsen, Medical Technologist, Supervisor, Vice ChairKathleen Kenwright, Medical Technologist, EducatorPatti J. Walton, Hospital/Lab Manager/Adm. Dir.Jason S. Nolan, MD, Pathologist Non EducatorCarla M. Davis, MD, PathologistRoyce Joyner, MD, Pathologist EducatorTereyo M. Cox, Medical Technologist, GeneralJerry Lee Miller, MD Non-Pathologist PhysicianMark A. Calarco, DO Independent Lab Manager/AdministratorMembers Absent:Cheryl Arnott, S.A.-Cytotechnologist, ChairmanVACANT: Citizen RepresentativeVACANT: Hospital AdministratorVACANT: Medical Technologist GeneralistStaff Present:Lynda S. England, Medical Technologist Consultant, Director, TMLBJerry A. Gowen, Medical Technologist ConsultantMollie Gass, Advisory Attorney, Office of General CounselJulia Daniels, Medical Technologist Consultant/ Surveyor, EastTennessee Regional OfficeTaylor Carpenter, Medical Technologist Consultant/Surveyor, EastTennessee Regional OfficeRichard Carroll, Medical Technologist Consultant/Surveyor, MiddleTennessee Regional OfficeMary Hamblen, Medical Technologist Consultant/Surveyor, WestTennessee Regional OfficeStaff Absent:Onezean Otey, Jr., Medical Technologist Consultant/Surveyor,Middle Tennessee Regional OfficeKaron Hathcoat, Medical Technologist Consultant/ Surveyor, WestTennessee Regional OfficeCLIA Manager/Representative:Sandra Bogard, CLIA ManagerPresiding Officer:Stephanie Dolsen, Medical Technologist, Supervisor, Vice ChairCall To Order:The meeting was called to order at 9:00 AM CST/CDT by StephanieDolsen, Medical Technologist, Supervisor, Vice ChairPage 1 of 13

Introductions of Board Members:The Board and staff made their introductions to the public inattendance.Quorum:Seven members of the Board constitute a quorum. A sufficientnumber of Board members were present establishing a quorum ofthe Board.Approve Minutes:P & E CommitteeMeetingA motion to approve the July 17, 2014, Personnel & EducationCommittee minutes was made by: Dr. JoynerSecond: Ms. KenwrightMotion approvedFull Board MeetingA motion to approve the July 18, 2014, Board meeting minuteswas made by: Dr. MillerSecond: Dr. NolanMotion approvedBoard Reports:Ratification of Initial Determinationsof the P&E Committee Meeting:Ms. Kenwright reported the actions of the Board’s Personnel &Education Committee meeting, October 15, 2014.Motion to ratify: Ms. WaltonSecond: Dr. CalarcoThe actions of the Board’s P&E Committee were ratified aspresented.No Contested Cases were presented.Contested CasesConsent, Agreed, Compliance Orders& Letters of ReprimandConsent OrdersJeff C. Wagner, Medical Technologist - GeneralMadison, TNLicense #21165Violation of Continuing Education RequirementsLicense reprimanded, Must complete all delinquent continuingeducation and any other continuing education required by policydue to the delinquency, must pay actual and reasonable costs ofprosecuting the case which is due within six (6) months from theissuance of the Assessment of CostsMotion to accept Consent Order: Ms. KenwrightSecond: Dr. JoynerConsent order accepted by the BoardAgreed OrdersNo Agreed Orders were presentedPage 2 of 13

Compliance OrdersNo Orders of Compliance were presentedLetters ofReprimandNo Letters of Reprimand were presentedPresentations to the Board:Tennessee ProfessionalPeer Assistance Program(TNPAP):Mr. Mike Harkreader, Executive Director of TnPAP presented theTNPap Report.For the period July 1, 2013, through June 30, 2014, there was one(2) individuals being monitored. There were four (4) referrals, one(1) from an employer, two (2) referrals from the TDOH and one (1)self referral. The reasons for these referrals were due to anarrest/conviction or from a workplace positive UDS . Oneindividual declined services (TDOH Notified), One was evaluatedand declined recommendations (TDOH Notified), One and wasevaluated and monitoring was not recommended, and the otherwas in monitoring noncompliance (TDOH Notified). Thosedeclining services or recommendations were reported to theTennessee Department of Health, as indicated.Move to accept the TnPAP report as presented: Dr. DavisSecond: Ms. KenwrightReport accepted.Note: Review of TNPAP materials via internet counts as clock hours towardcontinuing education credits. A certificate of completion documenting reviewof these materials can be completed at the end of the internet session. Internet site:www.TNPAP.orgFinancial ReportVanessa CrutcherDiscussionNo Report. The year-end statistics have not been released.(Ms. England, having made the financial report asked the chair to allow theDirector’s report, Tab S, to be given at this time. The chair recognized Ms. Englandto give the Director’s report)Board Director’s ReportMs. England gave a verbal report from the Director’s Office. Ms.England also imparted information learned regarding the Ebolaguidelines from a phone meeting with Commissioner Dreyzehner.Presently, there are no confirmed cases of Ebola Virus inTennessee. General guidelines are the Central Point of Contact isthe Tennessee Department of Health. Follow best practicesguidelines and sentinel events protocol. Utilize PPE and use itcorrectly. Not using PPE is to be treated as a violation oflaboratory practice and is to be addressed aggressively by thelaboratory administration as well as the Medical Laboratory Board.Have POC needs addressed for Ebola before the need presentsitself. Other information was given as far as presentation in theEmergency Department, symptomology and handling of thepatient, but this was general information and not necessarilypertinent to medical laboratory practice or intervention. A webnarPage 3 of 13

to be conducted the next day was announced for those interestedand in attendance. It is up to medical professionals to provide andact from factual information. There is no place for rumor, panic orother non-factual information or actions. Any direct testing of theEbola Virus must be directed and approved by the TDOH and CDC.Motion to accept Director’s Report: Ms. KenwrightSecond: Dr. NolanReport accepted.(Copy of report is on file in the Administrative Office)(The chair resumed the correct agenda order)Ratifications: The following itemswere presented to board membersfor ratification per staff, state surveyor orfacility request:Exemptions for point of caretesting procedures (POCT) in alicensed Facility1:Roane Medical Center8045 Roane Med Ctr. Dr.Harriman, TN 37748Requests a new exemption to allow Cardiac Catheterization LabRegistered Nurses to perform and report ACT levels using theAbbott I-Stat with an ACT Celite Cartridge in the CardiacCatheterization Laboratory.Motion to approve exemption: Ms. WaltonSecond: Dr. JoynerExemption approved2:Jackson Madison County (1) Exemption to allow State Licensed Perfusionist to perform andreport heparin assays and heparin dose response assays, utilizingGeneral Hospitalthe Medtronic Hemostasis Management Plus Instrumentation,Jackson, TN 38301facility wide.Motion to approve exemption: Dr. MillerSecond: Ms. KenwrightExemption approved(2) Request for an extension to a previous exemption to allowState Licensed Perfusionist to perform and report activatedclotting times (ACT) assays, utilizing the Medtronic ACT Plus andwhole blood samples, facility wide.Motion to approve exemption: Dr. NolanSecond: Ms. WaltonExemption Extension approved3.Methodist Medical CenterOak Ridge, TN 37830Exemption to allow licensed Respiratory Therapists to perform andreport pH analysis of plural fluid using the ABL Radiometer 800.Page 4 of 13

Move to send exemption request to the table. On return theexemption request should address whether the ABL 800 has thecorrect module to perform pH on body fluids and thatcorrelations are conducted using plural fluid utilizing a pH meterfor those measurements. Ms. WaltonSecond: Dr. JoynerMove to send to the table approved4.Vanderbilt UniversityMedical CenterNashville, TN 37232(1) Request modification to previous exemption to approveinstrument change from the IL GEM 3000 to the IL GEM Premier4000 for all existing VUMC IL GEM 3000 Point of Care (POC)exemptions.Move to approve modification: Dr. DavisSecond: Dr. JoynerModification approved.(2) Request exemption to allow Licensed Respiratory Therapistsand Technicians (both ABG Endorsed) to perform and report ILGEM Premier 4000 testing procedures in any POC testing locationpreviously approved.Move to approve exemption: Dr. NolanSecond: Ms. WaltonExemption approved.(3) Request modification to previous exemption allowingRegistered Nurses to perform and report INR point of care testingprocedures in the VUMC Emergency Department utilizing theRoche Coaguchek XL Pro System. The extent of this modification isa location extension on the exemption granted January, 2013.Move to approve modification: Ms. KenwrightSecond: Dr. DavisModification approved.Ms. England asked that Tab 17, Section Q #D be addressed at thistime since representatives from Vanderbilt were present at thepodium.Q17D: Letter from Dr. Pampee Young requesting Boarddetermination whether individuals performing processingconsisting of storing, shipping and thawing of hematopoietic stemcell products are required to be licensed under the TennesseeMedical Laboratory Act.Move to affirm that the described individuals must be licensed:Ms. KenwrightSecond: Dr. JoynerAffirmation of Licensure approved5.Tri-Star Southern Hills(1) Request exemption to allow Registered Nurses to perform andreport lactate levels, utilizing the Abbott i-STAT, in the EmergencyPage 5 of 13

Nashville, TN 37211DepartmentMotion to approve exemption: Ms. KenwrightSecond: Dr. NolenExemption approved(2) Request modification to previous exemption to approveinstrument change for the performance of O2 Saturations in theCatheterization Laboratory by Registered Nurses from the Abbott iSTAT to the AVOX . There were no correlation studies submitted.Motion to send exemption request to the table until such time ascorrelation studies are ready to submit: Ms. KenwrightSecond: Dr. JoynerMove to send to the table approved6.Tri-Star Stone CrestSmyrna, TN 37167Request exemption to allow Registered Nurses to perform andreport lactate levels, utilizing the Abbott i-STAT, in the EmergencyDepartment and the ICU.Motion to approve exemption: Dr. CalarcoSecond: Ms. WaltonExemption approved7.Region One HealthMemphis, TN 38103(1) Requesting modification of previous exemption to allowRespiratory Therapists (ABG endorsed) to perform and report pH,pCO2, pO2, TC02, 02 Saturation, BE, Lactate, Na, K, Glucose, andIonized Calcium utilizing the GEM 4000 rather than the GEM 3000,an instrument change, facility wideMove to approve modification: Ms. WaltonSecond: Dr. JoynerModification approved.(2) Request name change from EMT to MCT. This Board has nosuch authority and suggests Region One Health Care to presentthis request to the EMT Board.Move to suggest change in venue: Dr. DavisSecond: Dr. JoynerMove to change venue approved.(3) Request modification of previous exemption granted July,2014, for Registered Nurses, Licensed Practical Nurses, Parametics(EMT), Radiology Technicians, and Respiratory Therapists (ABGEndorsed) to perform and report lactate levels, utilizing theAbbott i-STAT, facility wide.Move to approve modification: Dr. NolanSecond: Dr. CalarcoModification approved.Page 6 of 13