Texas Pain



PROCEDURE ROOM GUIDELINES: A SYNOPSISWe have attempted to formulate a basic outline of general requirements for putting together an office based Interventional Pain Procedure Room. This is by no means an exhaustive list, nor is it intended to be a definitive authoritative document. The performance of Interventional Pain procedures in an office based setting can be a convenient, less expensive choice for appropriately chosen patients; however not all patients should undergo such procedures in an office-based setting. Increasingly reduced facility reimbursements may tempt physicians to consider the use of an office-based suite to off-set revenue loss; thereby, placing inappropriate patients well out of the appropriate venue for supportive care.The decision whether to use sedation for interventional procedures should be undertaken only after careful consideration of the patient’s co-morbid condition, the intensity of the procedure, an honest assessment of the need for sedation, and the available resources should a complication arise. We cannot stress enough that the use of sedation for interventional procedures is hazardous when performed without the proper indications and care. Catastrophic outcomes are the dreaded consequence of poor patient selection, planning, sedation, monitoring and technique. The decision to supply and staff an Interventional Procedure Suite requires considerable planning, certification and expense. Physicians with Anesthesiology backgrounds may already be familiar with Guidelines published by the American Society of Anesthesiology (ASA); yet, additional regulations and guidelines exist and pertaining to other aspects of patient safety such as the use and maintenance of radiation equipment, knowledge of complication management, Cardiac Life Support certification, etc. We have included what we believe to be a useful document to assist our members to safely care for patients during office based Interventional Pain procedures. The Texas Pain Society urges individuals to seek medical-legal advice when planning a Procedure Room. The suggestions and information outlined here do not in any way substitute for individual judgement and circumstances. General suggested resources include:Abram, S. Hazards of Sedation for Interventional Pain Procedures. APSF Newsletter. Fall, 2012Abram, S. Pain Clinic Manual, 2nd Ed. Lippincott Williams and WilliamsBaheti, et al. Interventional Pain Management: A Practical Approach 2nd Ed.Johnson, S. Sedation and Analgesia in the Performance of Interventional ProceduresRanson, M.et al., Reducing Risks and Complication of Interventional Pain Procedures. Elsevier SaundersO’Conner. How to Equip your Facility for Pain Management. Outpatient Surgery June 2012 (13): 6Patel, VB. Pain Clinic: Anatomy and Physiology – The Structure and Function for an Interventional Pain Practice. Tech Reg Anesth and Pain Mgmt, 2010 (14): 159-165Anson, J. Anesthesia and Sedation for Interventional Pain Procedures; Out of Operating Room Anesthesia: A Comprehensive Review. Springer, 2017 pp. 261-270Texas Medical Board Rules: Office Based Anesthesia Services, Title 22, Part 9; Chapter 192IMPORTANT DEFINITIONS PERTAINING TO OFFICE BASED SEDATIONLEVEL 1 anesthesia services: oral analgesics and/or anxiolytics prescribed to the patient by a physician at a dose level low enough to allow the patient to remain ambulatory. LA DOSELEVEL 2 anesthesia services: oral analgesic or anxiolytics in dosages greater than allowed at Level 1 and tunescent anesthesia, as prescribed for the patient on order of a physician. LA DOSELEVEL 3 anesthesia services: delivery of analgesics or anxiolytics rectally or parenterally. LA DOSELEVEL 4 anesthesia services: general anesthesia including regional anesthetics and monitored anesthesia care. All ASA (American Society of Anesthesiology) applicable standards and guidelines apply. In – office criteria for general anesthesia will not be further discussed in these GuidelinesDANGEROUS DRUGS: ALL drugs requiring a prescription. This includes all drugs OTHER THAN Scheduled Drugs, which of course are dangerous.SCHEDULED DRUGS: All drugs defined by the Texas Controlled Substances Act (Schedule 2-5 medications)MAC: Monitored Anesthesia Care. Considered appropriate in situations where a patient undergoes diagnostic or therapeutic procedures whereby medication is administered that creates the potential for loss of airway or protective reflexes. If at any time during MAC, the patient becomes unconscious the care is now considered to be general anesthesia.“LICENSED PROVIDERS”The term “licensed provider” as used in the TMB Rules for Office Based Anesthesia is vague. CRNAs, APNs, RNs and LVNs are all licensed providers. Nurses such as RNs and LVNs have Regulatory Boards; yet an RN and higher level APN/CRNA are the only nurses who, by their training and licensure, are capable of making patient assessments. MAs also have licenses and associations but they do not have a Regulatory Board. Surgical assistants fall under the purview of the Texas Medical Board, and as such, the physician. When choosing personnel for an office based procedure room the Texas Pain Society recommends that the physician honestly assess his/her practice style, areas of individual expertise, sedation needs, staffing requirements and patient condition. OFFICE BASED ANESTHESIA RULES (Chapter 192, TMB Rules)While these are likely to change, we strongly recommend familiarization with this document. A summarization is provided below.All Physicians who provide anesthesia services must register with the Texas Medical Board pursuant to Rule 192. A Fee will be assessed. The registration period is two yearsFailure to register risks disciplinary action WHEN THE RULES DO NOT APPLY TO OFFICE BASED SEDATION FOR PROCEDURES:Office settings where only local anesthetics are used at doses less than 50% of the Maximum Safe Dose per visitOutside TexasWhen the procedure is performed in an accredited hospital, outpatient clinic or surgery center (JCAHO, AAAASF, AAAHC, AHA, etc)Clinics located on military bases, government institutions or tribal landsClinics/Offices are subject to inspection by the TMB.REQUIREMENTS FOR ANESTHESIA SERVICES BY LEVEL:LEVEL 1:At least 2 personnel present, one of which is the physician. Physician MUST be BCLS certified at a minimum.EQUIPMENT: Bag valve mask with oxygenLEVEL 2:At least 2 personnel present including physician. Physician MUST be ACLS or PALS certifiedSecond person must be at least BCLS certifiedA licensed BCLS or ACLS provider must monitor the patient until dischargeEQUIPMENT:Crash cart with age-appropriate equipment including airway suppliesAED or other defibrillatorBag/valve mask with oxygenPre-measured doses of first line ACLS/PALS drugsIV equipmentO2 saturation monitorEKG monitorBenzodiazepines for IV or IM administrationLipid emulsion if administration of local anesthetic dosages are greater than 50% of maximum safe dosage per outpatient visitReversal agents: flumazenil and naloxone IF BENZOS AND OPIOIDS ARE USED FOR SEDATIONLEVEL 3:At least 2 personnel present including physician. Physician MUST be ACLS or PALS certifiedSecond person must be at least BCLS certifiedA licensed BCLS or ACLS provider must monitor the patient until dischargeLicensed BCLS or ACLS/PALS provider to monitor the patient during the procedurePatient must have a working IV line for the procedureEQUIPMENT:Crash cart with age-appropriate equipment including airway suppliesAED or other defibrillatorBag/valve mask with oxygenPre-measured doses of first line ACLS/PALS drugsIV equipmentO2 saturation monitorEKG monitorBenzodiazepines for IV or IM administrationLipid emulsion if administration of local anesthetic dosages are greater than 50% of maximum safe dosage per outpatient visitReversal agents: flumazenil and naloxone IF BENZOS AND OPIOIDS ARE USED FOR SEDATIONAdherence to the ASA standards for Post-Anesthetic careAny physician delegating anesthesia services to a CRNA MUST comply with ASA standards and guidelines. This includes:Appropriate AHA certification: BCLS, ACLS, (PALS if appropriate)Knowledge of ASA standards for NPO guidelines, monitoring and post anesthetic carePre-anesthesia assessmentInformed consent for anesthesia including expectations for the technique, risks and benefitsAppropriate pre-anesthetic diagnostic testing and consultsKnowledge of appropriate monitoring determined by the type of anesthesia and individual patient needsMinimum monitoring: O2 saturation, ventilation, EKG, blood pressure measured at least every five minutes and MUST BE DOCUMENTEDBack up measures for monitoring in the event of a power failurePost-procedure, the patient must be continuously monitored until deemed stable by a licensed providerAll anesthesia related equipment must be checked, maintained and the same must be documentedRADIATION There must be a designated and qualified Radiation Safety Officer who has undergone the appropriate radiation safety training. Training will depend on whether or not the RSO is a physician, radiology technician or nurse. Annual inspections of your fluoroscope and facility by a licensed medical physicist. Periodic State inspections may also occur as necessary or requested by personnel. Medical radiation equipment must be registered with the State. Lead and protective devices must be provided as well as a Notice to Employees.While a comprehensive list of obligations for the use of Medical Radiation is beyond the scope of this document, we recommend development of and maintenance of office Policy and Procedures, including credentials of the Operator(s). Dose monitoring and recording of providers will be necessary, as will provision of safety instruction for employees participating in the care of patient for which medical radiation is utilized. Memorialization of procedurally- related fluoroscopic images must be maintained for medical-legal purposes. The Procedure Room table must be able to support the appropriate weight patient, be able to be positioned for PA, lateral and oblique saved images without obstruction.The following contacts will prove useful and should be reviewed:Texas Department of State Health ServicesRadiation Safety Licensing BranchMail Code 2003 P.O. Box 149347Austin, Texas 78714-9347Registration:https.//dshs.radiation/x-ray/edical.aspxTAC Title (25): Rule 289.2Notice to EmployeesFees, Licenses, Emergency PlanningSafety Standards and ProvisionsHearings and Enforcement Medical Board Rules: Chapter 604INFECTION CONTROL ISSUESREFRIGERATORS: Medication and Employee refrigerators must be kept separately and clearly marked. No food should be allowed in medical refrigerators. Do not mix potentially infectious items with medications. STERILIZATION EQUIPMENT:Should your practice use an autoclave, the physician should be familiar with the manufacturer’s’ instructions for operation. The physician must be familiar with appropriate autoclave times, test strip interpretation and principles for sterilization. Log books must be kept for each load of supplies sterilized. Samples must be sent and documented for spore testing at regular intervals (weekly). Sterilized equipment should be labeled with expiration dates.MEDICAL WASTE:A marked Biohazard container must be available for sharps. A vendor contract with a registered medical waste disposal service should be in place for prompt removal once the container is full and the container should never be allowed to become more than ? full, such that sharps that don’t fit can potentially extend past the container door. Most companies will not accept medication vials that are not empty (still have medications such as controlled substances). The re-capping, bending or breaking of needles should be avoided. Under no circumstances should sharps containers be placed where children can access them. Biohazard bags should be available for items marked for medical waste disposal. Logs (such as disposal receipts) should be kept for all waste disposal. Small amounts of human biohazard waste, such as blood or vomit may be poured into toilets, pending local municipality sewer requirements.Non-infectious waste: Exam rooms, clinic areas, and laboratories should have trash cans lined with heavy-duty plastic trash bags, so as not to break. POLICY AND PROCEDURES:The following issues must be considered. We highly recommend development of Policies and Procedures as well as education for Employees to address the following issues:Handwashing protocols and provision of appropriate handwashing locationsUniversal Precaution educationA plan to handle exposure to blood-borne pathogens, including needle sticks A plan for First Aid in the event of Employee exposure to blood-borne pathogensThe use of gloves and protective barriers, which should be provided by the Provider’s officeRoutine cleaning and disinfectionSpill, contamination clean upMedical waste disposal planRecord-keeping requirementsEmployee immunizations (TB, hepatitis, tetanus etc.)Possible Workers Compensation issuesThe Reader is referred to the following resources:Infection Control Manual for Ambulatory Care Clinics: Texas Department of State Health Services. Box 149347 Mail Code 1960Austin, Texas 78756-3199Municipal Solid Wastes and Permitting Division, Texas Commission on Environmental Quality. RCRA Docket (5305)?U.S. Environmental Protection Agency?401 M Street, S.W.?Washington, D.C. 20460?TAC 30 Part 1, Chapter 330, Subchapter Y) TAC 25 Part 1, Chapter 1, Subchapter K ?Occupational Safety and Health Administration Department of Labor 29CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other Sharps Injuries; Final rule. Federal Register/Vol. 66, No. 12/January 28, 2001: standards.htm Texas Department of State Health Services TAC Chapter 96 Bloodborne Pathogen Rules revised effective July 2006: idcu/health/bloodborne_pathogens/reporting 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infections Agents in Health Care Settings, HICPAC, CDC, and United States Department of Health and Human Services OTHER ISSUES TO CONSIDER:ADA accessibility of the office settingPatient entrance/exit locations and strategyWheelchair availability as needed for dischargeStaffing needs for pre-procedural assessment and monitoring during and after procedurePatient HIPAA compliance strategy during high volume procedure daysMedications and cost: Single dose versus multi-dose vials? Given the issues of preservatives and neuraxial injections, some carriers including CMS are moving to mandate only preservative-free single dose vialsVendor quality, responsiveness and compliancePaper gowns, sheets, etc. versus cloth: Laundry contracts, etc.Ability and staff available to manage medical issues that arise such as spurious glucose measurements, NPO status, hypertension, fevers, plication management plan during or after procedures and the ability to realistically manage themMalpractice coverage may require additional coverage for office-based Interventional Pain procedures ................
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