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Reopening Shuttered Hospitals to Expand Surge Capacity

Public Health Emergency Preparedness

This resource was part of AHRQ's Public Health Emergency Preparedness program, which was discontinued on June 30, 2011, in a realignment of Federal efforts.

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Appendix D. Legal & Regulatory Issues: Chapter 3. State Laws and Regulations Governing Hospitals (continued)

3.2.9 Complaints and Incident Reports


Complaints. Every hospital must develop a written procedure for investigating serious complaints against hospital employees or members of the medical staff.87 A senior member of the hospital staff must serve as a complaint officer and oversee the investigations. There must be a clear, written procedure for reporting and investigation of complaints. The surge hospital should comply with this requirement so that it can be made aware of serious problems that may exist within the facility.

Incident Reports. In Massachusetts, the surge hospital will be required to report immediately by telephone to MDPH any of the following serious incidents and accidents that take place on the hospital premises:88

  • Fire.
  • Suicide.
  • Serious criminal act.
  • Pending or actual strike action by its employees, and contingency plans for operation of the hospital.
  • Serious physical injury to a patient resulting from an accident or unknown cause.

In addition, a written report must be filed with the MDPH of any serious incidents occurring on the licensed premises of the hospital that seriously affect the health and safety of its patients. The surge hospital should expect to comply with this reporting requirement.

Illinois: Illinois requires that each hospital report to the Department of Public Health any incidents or occurrence that puts patients at immediate jeopardy that requires the transfer of patients to other parts of the facility or to other facilities. Each report must be filed within 2 days working days of the incident. Occurrences requiring reporting include but are not limited to fire, flood, and power failure.89 In addition, Illinois requires reporting of the death of a pregnant woman or the death of a woman within 1 year of the termination of a pregnancy90, special circumstances related to mothers and infants and discharges of children released to someone other than their natural parent,91 as communicable diseases.92 These requirements would be required of a surge facility.

Kansas: Kansas also requires hospital risk management committees review all clinical concerns raised by hospital employees, evaluate the level of risk, and report those meeting certain requirements to the licensing agency.93 For a surge facility, and acute care hospitals in the area would need to meet these standards unless the requirements are modified. Surge facilities, especially, may have difficulty meeting these standards, necessitating a waiver.

Texas: Texas regulations require reporting of fire and other safety-related incidents. In addition, Texas hospitals must develop emergency plans to be put into effect if an incident affecting patient safety were to occur.94 This plan must be tested annually, a requirement that would not be possible for a surge facility.

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3.2.10 Patient Rights

Massachusetts: MGL Chapter 111, section 70E, confers certain legal rights upon patients at hospitals and other health-care facilities, including the surge facility. The most pertinent of these rights for the surge hospital is the right of every patient to choose the facility at which the patient will be treated. Although this right is suspended in the event a patient requires emergency medical treatment, the patient ordinarily may refuse to be transferred from one health-care facility (e.g., a surge hospital) to another health-care facility (e.g., a skilled nursing facility or a hospital). Exercise of this right may interrupt the flow of patients from one facility to the other and lead to the surge hospital having a small patient population that it is not well suited to serve. Since the right to choose a health-care facility is embedded in a statute, there is no waiver available that would allow the surge facility to exercise an override of the patient's decision. 

Illinois: Section 250.260 of Title 77 of the Illinois Administrative Code "recommends" that hospitals adopt a written policy on patients' rights and that should be available to all patients. That section requires hospitals have a written plan for the provision of spiritual, emotional, and attitudinal health of the patient, patients' families, and hospital personnel. Surge facilities would likely be able to meet these requirements by adopting that of a hospital currently in operation.

Kansas: Kansas' Hospital Regulations 28-34-3b confers legal rights to inpatients and outpatients at Kansas hospitals. The regulations do not include provisions for choosing the facility at which the patient is treated. 

Texas: Texas Hospital Licensing Rules provide detailed requirements for hospitals regarding patient rights, however, these requirements do not include provisions for selecting the facility at which the patient is treated.95

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3.2.11 Medical Records

There are Federal requirements governing privacy and security of personal medical information in the Healthcare Insurance Portability and Accountability Act (HIPAA),96 with which the surge hospital must comply. These regulations apply to every State.

Massachusetts: Every licensed hospital, including the surge facility, must maintain medical records for each of its patients in accordance with MGL Chapter 111, section 70 for a period of at least 30 years. A copy of the medical record must be made available to the patient or the patient's authorized representative for a reasonable fee. The surge hospital can expect that the requirement to maintain proper medical records is unlikely to be waived since the quality of patient care often depends upon information available to caregivers through the patient's record. Responsibility for maintaining and storing patient medical records over the 30-year period once the surge hospital has closed will rest legally on the licensee. If the licensee is not the Commonwealth of Massachusetts, the Commonwealth may still assume responsibility for storage and retrieval.

Recommendation: Provision will need to be made to retain medical records (perhaps at State health departments) after the emergency eases and the surge facility closes.

Illinois: Illinois requires that every licensed hospital must maintain an "adequate, accurate, timely, and complete" medical record for each patient.97 The regulations specify that these records must be housed safely to prevent unauthorized use and to protect the records from damage by water or fire. The State requires that a registered medical record administrator or accredited medical record technician be responsible for overseeing the hospital's record department. Medical records or photographs of such records must be preserved in accordance with the American Hospital Association's recommendation and legal opinion on record retention and preservation. In addition, each licensed hospital would need to have a policy for preservation of records should the hospital close. As in Massachusetts, a surge facility would need to comply with these requirements.

Kansas: Kansas regulations require that patient records be kept on file for 10 years after the date of last discharge of the patient and a summary shall be kept on file for 25 years. The regulations further stipulate that the records are the property of the hospital and should not be removed from the premises except as authorized by the governing body of the hospital or for purposes of litigation.98 These requirements may pose a challenge for a surge facility, particularly with respect to the on-site storage of the medical records. The hospital's governing body would need to permit the removal of the records at the conclusion of the disaster.

Texas: Texas requires that patient records be kept on file for at least 10 years. Films and other image records must be retained for 5 years. The regulations specify that if the hospital should close, the hospital must notify the Department of Health about the location where the records are stored and contact information for the custodian of the records. As described above, a surge facility would need to comply with these requirements.

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3.2.12 Discharge Planning; Advocacy Office

Discharge Planning. Massachusetts requires every licensed hospital to develop a comprehensive discharge planning service for its patients.99 Since the surge facility will be a temporary placement for most patients, the discharge planning service will be key to continuity of care for the surge facility patients. Medicare rules for discharge planning are incorporated directly into the Massachusetts regulations. The regulations are unusually specific about certain requirements for the discharge planning service (e.g., for Medicare patients, the regulations set forth the minimum size of the type to be used on the front page of every individual patient discharge plan). The discharge planning service must be multi-disciplinary and responsible for coordinating the transfer of patients to either an independent living situation or another institution. As with any hospital, patients may be discharged from a surge hospital facility for a variety of reasons, including a need for a more acute level of care than is available from the surge hospital, to return home if medical care is no longer needed, or to transfer to another type of health-care facility, such as a skilled nursing facility. The surge hospital should review the discharge planning requirements and seek waivers of the requirements that do not have a direct impact on the quality of the discharge service.

Recommendation: A surge facility probably would not be able to provide multidisciplinary discharge planning; that responsibility could remain with the tertiary medical center that transferred the patient to the surge facility.

Advocacy Office. Acute care hospitals that serve Medicare patients are required to take certain steps to protect the rights of Medicare beneficiaries.100 Hospitals are prohibited from taking any discriminatory action against any patient based upon the patient's status as a Medicare beneficiary. A notice of rights must be distributed to every Medicare beneficiary. In the event a Medicare beneficiary believes a hospital engages in discriminatory behavior or provides inadequate discharge planning, the beneficiary has a right to file a complaint with the Advocacy Office within the MDPH. The Advocacy Office has the authority to investigate complaints from Medicare beneficiaries, encourage negotiated resolution of complaints and issue Notices of Final Disposition in the event negotiated resolutions cannot be achieved. Although this report does not discuss payment issues, Medicare beneficiaries are almost certainly going to be in the patient population served by the surge facility.  The surge facility should be prepared to comply with the nondiscrimination and notice requirements of this regulation.

Illinois: Illinois provides the general requirement that hospitals have written policies for admission, discharge, and referral of all patients who present themselves for care. In addition, Illinois regulations include the Medicare requirement that hospitals provide 24-hour notice to Medicare beneficiaries prior to discharge along with information concerning their right to appeal.101

Otherwise, Illinois regulations regarding patient rights do not include provisions for filing a complaint or complaint resolution.102 A surge facility would not need to comply with requirements beyond the Federal regulations.

Kansas: Kansas regulations include requirements for maternity and infant discharges but are silent with respect to other discharges. These would likely not apply to a surge facility as we envision it.

Kansas regulations require the hospital to develop a procedure for responding to patient grievances.103

Texas: Hospitals in Texas must comply with a detailed list of requirements concerning patient transfers from one hospital to another. The regulations provide definitions of patients who may be transferred, conditions under which a patient may be transferred, notification requirements regarding the transfer, and parties responsible for the patient during and after the transfer. The regulations describe transfer from one hospital to another but are silent with regard to discharges home or to another institution.104

Texas regulations also include requirements that all hospitals develop and implement policies to ensure patients' rights, including informing the patient of the hospital's policy for resolving patient complaints.105 A surge facility would need to comply with these requirements unless a waiver was sought.

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3.2.13 Clinical Laboratory

Massachusetts: The surge hospital will not have an onsite clinical laboratory. Laboratory tests will be sent to outside laboratories, although there is a possibility that bedside laboratory testing with kits may take place within the surge hospital. Hospital laboratory testing is regulated under 105 CMR 130.350 and 105 CMR 180.000. These regulations do not address directly the issue of whether bedside testing with kits is a regulated activity. Prior to commencing bedside testing, the surge facility should consult with MDPH officials and seek waivers if appropriate.

Illinois: Illinois requires hospitals to have a clinical laboratory that is certified under the Federal Clinical Laboratory Improvement Amendments of 1988.106 Section 250.510 of Title 77, Illinois specifies that laboratory services must be adequate for the individual hospital as determined by the complexity of services, nature of the hospital, and commensurate with the size of the facility. The regulations further specify the types of basic laboratory tests the facility must provide. All other tests may be conducted by an outside laboratory under contract to the hospital. If a surge facility planned to conduct bedside testing, the Illinois Department of Health would need to be consulted about whether or not that approach would fulfill the requirements of the State. A waiver may be necessary for surge facilities operating in Illinois.

Kansas: Kansas regulations require that laboratory services be performed by a CLIA-certified laboratory either on the hospital premises or by an outside laboratory. As in Massachusetts and Illinois, a waiver would likely be needed for a surge facility in Kansas related to bedside testing. 

Texas: Texas regulations also require laboratory services to be furnished by a CLIA-certified laboratory. The regulations require that each hospital have adequate laboratory services to meet the needs of its patients, including the availability of 24-hour a day emergency laboratory services, a written description of the services provided and policies for determining which tissues require macroscopic analysis and which require both macroscopic and microscopic.107 Like the other States, the department of health should be consulted about whether or not a waiver would be necessary to perform bedside testing in a surge facility.

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3.2.14 Sharps and Medical Waste Disposal


Sharps. Massachusetts hospitals are required to take reasonable precautions to protect health-care workers from exposure to sharps. Hospitals must develop written exposure control plans that include an effective procedure for identifying and selecting existing sharps injury prevention technology where at all feasible. In addition, every hospital is required to maintain a sharps injury log and report annually to the MDPH information from its sharps injury log in such form as the MDPH shall require.

Medical Waste Disposal. Storage and disposal of infectious physically dangerous medical or biological waste is addressed in the Massachusetts State Sanitary Code at 105 CMR 480.000 and incorporated by reference into the Massachusetts hospital licensure regulations. Because of the danger to health-care workers in the facility and to the public health in general, the MDPH is unlikely to waive or limit the application of the sharps or medical waste disposal requirements.

Illinois: Handling and disposal of medical or biological waste is addressed in the Illinois Administrative code at 77 Ill. Adm. Code 250.1720, the hospital licensure requirements for the State and in regulations related to environmental protection, 35 Ill. Adm. Code 1420.101-120. While the hospital licensure requirements are general, the environmental protection regulations provide detailed requirements on segregation, containment, transfer, and labeling of potentially infectious medical waste and sharps. As in Massachusetts, these regulations are not likely to be waived by the Illinois Department of Public Health.

Kansas: Kansas regulations provide instructions for the disposal of medical waste but do not address sharps.108 Compared to those in Massachusetts and Illinois, the requirements are quite general, however, it is unlikely the State would waive these requirements during a mass casualty event.

Texas: State regulations in Texas also provide moderately detailed instructions for the disposal, treatment, and transport of medical waste from health-care facilities that include provisions for sharps.109 These are unlikely to be waived during a mass casualty event.

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3.2.15 Reportable Diseases, Isolation and Quarantine


Reportable Diseases. Massachusetts health-care providers are required to report certain diseases and medical conditions to their local boards of health.110 The term "health-care providers" is broadly defined to include hospitals, physicians, registered nurses and others. The list of diseases reportable to local health authorities is published at 105 CMR 300.100. A much shorter list of diseases that are directly reportable to the MDPH by any health-care provider is set forth at 105 CMR 300.180(A)-(C). Finally, the MDPH requires that any unusual illness or any illness that is part of an outbreak or cluster be reported to the appropriate local board of health. See 105 CMR 300.133-134. Since surge hospital patients will be transferred to the surge facility from other health-care facilities, surge facility patients infected with reportable diseases usually will have been reported prior to their arrival at the surge facility. Nonetheless, each patient's medical record should be scrutinized upon admittance to the surge hospital to determine whether the patient has a reportable disease and, if the answer is yes, whether the patient has been reported. If the patient has not been reported, the surge facility must be prepared to do so.

Isolation and Quarantine. 105 CMR 300.200 authorizes isolation and quarantine for diseases identified as dangerous to the public health. Local boards of health are usually the entities charged with enforcing these provisions. The isolation and quarantine requirements, in general, focus on issues of infection control in the overall population and are not limited to, or even intended for, the hospital setting. For example, the most common restrictions are on food handlers who have contagious infections. Standard medical reasons for isolating a patient, such as the patient having an open wound or a compromised immune system, are not addressed in the isolation and quarantine regulations. However, in the event an infectious agent causes a mass casualty event, the Governor and the Commissioner of Public Health, using the governor's emergency powers, have authority to impose isolation and quarantine restrictions beyond those expressed in the regulations.

Local Authority. A series of statutes that authorize local authorities to take police action in the event of an outbreak of infectious disease remain in effect even though they are outdated and have not been enforced for many years.111 These laws allow, in part, for local authorities to break into houses to seize infected persons, to seize hotels, rooming houses and other nonpublic buildings to house infected persons, and to quarantine individuals in isolation as may be required to protect the public health. In the event of a mass casualty, some of these laws may be resurrected and enforced. Renewed enforcement is not likely, however, to affect operation of the surge facility.

Waivers. 105 CMR 300.000 does not have a waiver provision. Given that an infectious agent may cause the mass casualty event, the surge facility should not seek waiver of the requirements of this regulation.


Illinois has defined very detailed rules for reporting suspected or confirmed cases of infectious, contagious, and dangerous diseases.112 The regulations also place responsibility on an array of health-care providers and school personnel for reporting the suspected or diagnosed cases.

Isolation and Quarantine. Unlike Massachusetts, Illinois regulations refer hospital personnel to the CDC's guidelines for isolation precautions in hospitals. The regulations follow the CDC's recommendations with respect to the duration of isolation, except for a few specific diseases for which Illinois has developed different requirements. 

Local Authority. The regulations also give authority to the local health authority having jurisdiction over the area in which the suspected or carrier of a communicable disease reside. Only the local health authority may establish isolation and quarantine of contacts to a case, carrier, or suspected case of a communicable disease and terminate the isolation and quarantine period. Like Massachusetts, Illinois law gives the health authorities the right to close-off to the public private property in the event of an emergency involving communicable diseases.113 


Kansas regulations require notification of the State department of health and environment by laboratories that yield positive tests for certain diseases. The regulations define a positive test result and prescribe the information to be reported. It is unlikely that a State department of health would waive this reporting in the case of a mass casualty event, particularly one related to a biologic outbreak.

Isolation and Quarantine. Kansas regulations contain detailed provisions for isolation and quarantine of specific infections and contagious diseases, as well as general provisions for conditions of isolation and quarantine that are not specified in the regulations.114 Like Massachusetts, the regulations in Kansas do not make specific reference to isolation and quarantine in hospital settings.

Local Authority. The general provisions will be ordered and enforced by a local health officer or the secretary of health and environment. 


Texas regulations also include detailed provisions for reporting of certain conditions and suspected conditions. The regulations provide detailed instructions about who must report a condition, timeliness of reporting, information to be reported, and communication between local, regional, and State health authorities.115 These requirements are unlikely to be waived in the case of a mass-casualty event.

Isolation and Quarantine. The regulations concerning isolation and quarantine are very general. A health authority may declare a house, building, apartment to be a place of quarantine. The regulations do not provide specific requirements for particular diseases nor do they make reference to any specific rules for hospitals. The local health authority will determine the length of quarantine.

Local Authority. The local health authority has jurisdiction over any events relating to isolation and quarantine.

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3.2.16 Ambulance Transportation


In Massachusetts, emergency medical services (EMS) are organized into five regions to allow for coordination of emergency services within each region.116 Ambulance services are licensed at two levels, basic life support and advanced life support. The level of ambulance service required for a patient depends upon the acuity of the patient's illness or trauma.  Emergency medical technicians (EMTs) who staff the ambulances are also licensed by the MDPH and certified at three levels-basic, intermediate and paramedic. EMTs are required to be certified at a level consistent with the level of service offered by the ambulance service employing them. Minimum staffing requirements for each licensed level of ambulance service are specified in the regulations.117 In addition, 105 CMR 170.360 states that "[N]o ambulance service... shall transport a patient between health-care facilities who is receiving medical treatment that is beyond the training and certification capabilities of the EMTs staffing the ambulance unless an additional health-care professional with that capability accompanies the patient."

Transport of Patients with Communicable Disease. EMTs and other health-care providers who are suspected of having an unprotected exposure to either a blood borne infection or a disease dangerous to the public health (i.e., a reportable disease) while accompanying a patient in an ambulance must file an Unprotected Exposure Form with the hospital that receives the patient. Once the receiving hospital has confirmed a diagnosis of either a blood borne infection or a disease dangerous to the public health in the patient, the hospital must notify the ambulance service, which in turn must notify the EMT who suffered the exposure. See 105 CMR 172.000.

Agreements to Transfer. Massachusetts law and regulations do not address the form of, or require the existence of, a written agreement to transfer and transport patients between a hospital and an ambulance service. Immediately upon starting the process of reopening the surge facility, the director of the surge hospital should contact the local EMS Regional Council. The director should discuss with the EMS Regional Council the needs of the surge facility and receive a list of appropriate local ambulance services.  The director should work with the ambulance services to ensure that surge facility transport needs are met.

Waivers. The Commissioner of Public Health has authority under MGL chapter 111C, Section 22 to waive any regulatory provision or guidelines promulgated under chapter 111C, including 105 CMR 170.000 and 105 CMR 172.000. However, if a mass casualty event occurs and ambulance services in a particular service region of the State are overwhelmed, ambulance services from other regions can be called in to fill the need. Given the availability of backup emergency personnel, it should not be necessary to waive any of the licensure standards either of ambulance services or of EMTs to meet the increased demand for service.


In Illinois, requirements for ambulance service providers as well as the broader emergency medical system are addressed in 77 Ill. Adm. Code Section 515. In Illinois, emergency medical services (EMS) are organized into 11 regions. As in Massachusetts, ambulances are licensed to provide either basic—or advanced—life support services. Emergency medical technicians are also certified at three different levels. 

Transport of Patients with Communicable Diseases. The regulations in Illinois do not address reporting requirements of EMT personnel that transport patients with communicable diseases.

Agreement to Transfer and Waivers. As in Massachusetts, the Illinois regulations do not mention agreements to transfer. The Governor has the authority to waive waivers of licensure standards in cases in which one system is overburdened. The director of the surge facility should discuss with the Regional Ambulance Service Board the needs of the surge facility and receive a list of appropriate local ambulance services. The director should work with the ambulance services to ensure that surge facility transport needs are met.


Kansas regulations address ambulance service providers at KAR 109. In Kansas, emergency medical services are organized into six regions, however, ambulance services may be provided by municipalities. Activities are coordinated by the Emergency Medical Services Board.

Transport of Patients with Communicable Diseases. As described in a previous section, Kansas has fairly extensive requirements concerning reporting of communicable diseases, as well as authority concerning isolation and quarantine. However, Kansas regulations do not specify the role of ambulances in transporting persons with communicable diseases with respect to reporting or notifying the hospital.

Agreement to Transfer. Kansas regulations do not contain any requirements for written agreement between hospitals and ambulance companies. As in the other States above, the surge facility would need to seek approval and guidance from the Emergency Medical Services Board and local municipality.

Waivers. The most significant features of the Kansas regulations related to a mass-casualty event are that they allow for ambulances licensed in States other than Kansas to respond to a call in Kansas and for the temporary licensure of EMT personnel licensed in other jurisdictions.118


Texas regulations for EMTs allow the waiver of certain requirements if the individual applying for the license is accredited by a nationally recognized organization. The regulations do not stipulate, however, whether or not licensure can be deemed in the event of an emergency situation.119 This policy would need to be investigated with the Texas Department of Health.

Transport of Patients with Communicable Diseases. The Texas Communicable Disease Prevention and Control Act requires a licensed hospital to notify a health authority in instances when an emergency medical services, police officer, or firefighter may have been exposed to a reportable disease from a person delivered to the hospital.120   

Agreement to Transfer. Ambulance service providers in Texas are required to have written permission from the local government authority responsible for each jurisdiction, however, transfer agreements among hospitals are voluntary. All agreements must be in compliance with standards established by the Texas Department of Health and approved by the Department. Hospitals should consult with the Department of Health to determine whether or not an agreement is advisable in the case of a mass-casualty event.121

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3.2.17 Hospital Pharmacy Services

Massachusetts: Establishing a hospital pharmacy requires compliance with a complex set of requirements on the State and Federal level. First of all, the surge facility should have an area within the hospital that previously served as a pharmacy in order to assure security of the drug supply. Once this area has been renovated (if necessary) to meet current construction standards and inspected by the MDPH, the surge facility can file for registration with the Drug Control Program and the Board of Pharmacy within the MDPH. Subsequent to filing for registration with the MDPH, the surge facility should file for a Federal registration number with the Drug Enforcement Agency (DEA). The DEA prefers that State registration be pending or completed prior to filing of the Federal application. In the ordinary course, the DEA takes 30 to 60 days to issue a Federal registration number. If a hospital pharmacy is registered with State authorities, but the DEA application is still pending, the hospital pharmacy is legally authorized to fulfill prescriptions for Schedule VI medications (which include most prescription drugs). Nevertheless, wholesale suppliers of prescription drugs usually require a DEA registration number before they will sell to a hospital. The surge facility should work closely with the MDPH to expedite State registration. However, the surge hospital may have difficulty acquiring the drugs necessary to fill prescriptions until the DEA approves the hospital's application for Federal registration.

Illinois: Illinois requires all licensed hospitals to operate a pharmacy or drug and medicine service, under the direction of a pharmacist employed by the hospital. Given this requirement, a surge facility would not be able to operate in Illinois if it intended to contract with a pharmacy at another hospital, an option described previously in this report.  This requirement may need to be waived for a surge facility depending on the particular circumstances of that facility. 

Kansas: The Kansas Hospital Regulations, 28-34-10 contain general provisions for pharmacy services within hospitals, including organization and staffing, facilities, policies, medications dispensed, and use of commercial pharmaceutical services. The regulations require a hospital to establish and maintain a pharmacy and therapeutics committee to formulate and review policies about procurement, storage, distribution and use of drugs in the hospital. This group must meet at least quarterly, according to the regulations. A surge facility would be unable to meet this requirement and would need to seek a waiver related to the activities of the committee. If the surge facility were operated by another hospital, it is possible that hospital's committee could incorporate the surge facility into its purview.

Texas: Like Kansas, Texas regulations contain general provisions for pharmacy services within hospitals, including organization and staffing, facilities, policies, and medication dispensing procedures.  In many cases, Texas requires that hospital pharmacies adhere to generally accepted practices within the pharmacy profession. One particular requirement that would be difficult for a surge facility to meet is that pharmacy staff must develop programs for hospital staff concerning new drugs added to the formulary, how to resolve drug therapy problems, and other issues. This requirement might be met if the surge facility were operated by another hospital; otherwise it would need to be waived.

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