Proposed amendments to Section 405.1 (Introduction) specify that the requirements of Part 405 relating to patient care and services will apply to patients of all ages, including newborns, pediatric and geriatric patients.

Proposed amendments to Section 405.3 (Administration), which currently requires hospitals to provide to the State Education Department (“SED”) a written report whenever enumerated professionals licensed by SED lose hospital employment or privileges for certain reasons, will require similar reporting to the Department of Health for certain individuals licensed by such Department.

Proposed amendments to Section 405.6 (Quality Assurance Program) will require hospital quality assurance processes to include a determination that the hospital is admitting only those patients for whom it has appropriate staff, resources and equipment and transferring those patients for whom the hospital does not have the capability to provide care, except under conditions of disasters or emergency surge that may require admissions to provide care to those patients.

A new subdivision (d) is added to Section 405.7 to require hospitals to post and provide a copy of a Parent’s Bill of Rights, setting forth the rights of patients, parents of minors, legal guardians or other persons with decision-making authority to certain minimum protections required under other provisions of these regulations. In particular, the Parent’s Bill of Rights would advise that patients may not be discharged from the hospital or the emergency room until any tests that could reasonably be expected to yield “critical value” results – results that suggest a life-threatening or otherwise significant condition such that it requires immediate medical attention – are reviewed by a physician, physician assistant (PA), and/or nurse practitioner (NP) and are communicated to the patient, his or her parents or other decision-makers as appropriate.

Proposed amendments to Section 405.9 (Admission/Discharge) specify that a hospital will be required to admit pediatric patients consistent with its ability to provide qualified staff, space and size appropriate equipment necessary for the unique needs of pediatric patients. If the hospital cannot meet these requirements, it will be required to develop criteria and policies and procedures for transfer of pediatric patients. This section also requires hospitals to develop policies and procedures permitting at least one parent/guardian to remain with a pediatric patient at all times, to the extent possible given the patient’s health and safety. Proposed amendments will also require hospitals to develop and implement written policies and procedures pertaining to review and communication of laboratory and diagnostic test/service results to the patient and, if the patient is not legally capable of making decisions, the patient’s parent, legal guardian, health care agent or health care surrogate, as appropriate and subject to all applicable confidentiality laws and regulations. Such policies and procedures must ensure that no discharge will occur while the results of a test that reasonably could be expected to yield a “critical value” are pending so as to assure appropriate care is provided to the patient. Further, all communication with the patient, parent, legal guardian, etc. must be clear and understandable to the recipient. In addition, the hospital must ask the patient or the patient’s representative for the name of the patient’s primary care provider, if known, and forward lab results to such provider.

This proposal also updates Section 405.12 (Surgical Services), which currently requires hospitals to develop and implement effective written policies and procedures, to provide that such policies and procedures include the performance of surgical procedures, the maintenance of safety controls and the integration of such services with other related services of the hospital to protect the health and safety of the patients in accordance with generally accepted standards of medical practice and patient care. The amendments will also require hospitals to assure that the privileges of each practitioner performing surgery are commensurate with his or her training and experience. Precautions must be clearly identified in written policies and procedures specific to the surgical service and post anesthesia care unit (“PACU”) including appropriate resuscitation, airway and monitoring equipment including a resuscitation cart with age and size appropriate medications, equipment and supplies.

Updates to Section 405.13 (Anesthesia Services), which currently require hospitals to develop and implement effective written policies and procedures on matters such as the administration of anesthetics, the maintenance of safety controls and the integration of such services with other related services of the hospital. Under the amendments, such policies and procedures will have to be reviewed and updated at least biennially. In addition, hospitals will have to establish clinical competencies that are relevant to the care provided and, at a minimum, include instruction in safety precautions, equipment usage and inspections, infection control requirements and any patients’ rights requirements pertaining to surgical/anesthesia consents. The amendments further provide that all equipment and services provided must be age and size appropriate.

Updates to Section 405.14 (Respiratory Care Services) will provide that orders for respiratory care services, in addition to specifying the type, frequency and duration of treatment, and as appropriate, the type and dose of medication, the type of diluent, and the oxygen concentration, must be consistent with generally accepted standards of care. The amendments further provide that all equipment and services provided must be age and size appropriate.

Updates to Section 405.15 (Radiologic and Nuclear Medicine Services) will specify that care must be provided in accordance with generally accepted standards of practice. The amendments will also require that policies and procedures regarding imaging studies for newborns and pediatric patients must include standards for clinical appropriateness, appropriate radiation dose and beam collimation, image quality and patient shielding. In addition, a policy and procedure must be developed to ensure that the practitioner’s order for an imaging study is specific to the body part(s) that are to be imaged. Quality improvement audits must verify that these policies and procedures are being followed and must include a review of the adequacy of diagnostic images and interpretations. Radiation safety principles must be adequate to ensure compliance with all generally accepted standards of practice as well as pertinent laws, rules and regulations. The amendments also provide that the chief of radiology, in conjunction with the radiation safety officer, must ensure that all practitioners who utilize ionizing radiation equipment within the hospital are properly trained in radiation safety procedures for patients of all ages.

The amendments to Section 405.15 also will update the megavoltage (“MEV”) requirements for therapeutic radiology or radiation oncology services to provide that they utilize six or more MEV unit with a source-axis distance of 100 or more centimeters as the primary unit in a multi-unit radiation oncology service. In addition, as amended, the regulations will require each therapeutic radiology service to have full time New York State licensed radiation therapists sufficient to meet the needs of the service and also a New York State licensed radiation therapy physicist who will be involved in treatment, planning and dosimetry as well as calibrating the equipment. The amendments will also change a reference to an MEV unit so that it instead refers to a linear accelerator. A computed tomography (“CT”) scanner must be available within the radiation therapy program that is equipped for radiation oncology treatment planning or arrangements must be made for access to a CT scanner on an as needed basis. Provisions must be made for access to a magnetic resonance imaging (“MRI”) scanner for treatment planning purposes on an as needed basis.

Updates to Section 405.17 (Pharmaceutical Services) will require hospital pharmacy directors, in conjunction with designated members of the medical staff, to ensure that for patients of all ages, weight must be measured in kilograms and that resources relating to drug interactions, drug therapies, side effects, toxicology, dosage, indications for use, and routes of administration are available to the professional staff. Pediatric dosing resources must include age and size appropriate fluid and medication administration and dosing. Dosing must be weight based and not exceed adult maximum dosage, or in emergencies, length based, with appropriate references for pediatric dosing available. The amendments will further require the director to ensure that the pharmacy quality assurance program include monitoring and improvement activities to identify, measure, prevent and/or mitigate adverse drug events, adverse drug reactions and medication errors in accordance with generally accepted standards and practices in the field of medication safety and quality improvement. All drugs and biologicals must be controlled and distributed in accordance with written policies and procedures to maximize patient safety and quality of care.

Updates to Section 405.19 (Emergency Services) provisions will require at least one clinician on every shift to have the skills to assess and manage a critically ill or injured pediatric patient and be able to resuscitate a child. The director of the hospital’s emergency service, attending physicians, supervising nurses, registered professional nurses (“RNs”), physician assistants (“PAs”) and nurse practitioners (“NPs”) must satisfactorily complete and be current in Pediatric Advanced Life Support (“PALS”) or have current training equivalent to PALS. Hospitals with less than 15,000 unscheduled emergency visits per year do not need to have the supervising or attending physician present, but such supervising or attending physician must be available within 30 minutes of “patient presentation” provided that at least one physician, NP, or PA is on duty in the emergency service 24 hours a day, seven days a week.

In addition, the amendments will require hospitals to develop and implement protocols specifying when supervising or attending physicians must be present. In no event shall a patient be discharged or transferred to another hospital, unless evaluated, initially managed, and treated as necessary by an appropriately privileged physician, PA or NP. Specifically, no discharge should occur while the results of a test that reasonably could be expected to yield a “critical value” are pending so as to assure appropriate care is provided. The amendments will also require hospitals to develop and implement written policies and procedures pertaining to review and communication of laboratory and diagnostic test/service results ordered for a patient receiving emergency services to the patient and, if the patient is not legally capable of making decisions, the patient’s parent, legal guardian, health care agent or health care surrogate, as appropriate and subject to all applicable confidentiality laws and regulations. Further, policies and procedures must ensure that all communication with the patient, parent of a minor, legal guardian, etc. must be clear and understandable to the recipient. In addition, the hospital must ask the patient or the patient’s representative for the name of the patient’s primary care provider, if known, and lab results must be forwarded to such provider.

Section 405.20 (Outpatient Services) requires outpatient services, including ambulatory care services and extension clinics to be provided in a manner which safely and effectively meets the needs of all patients. Written policies must be in place for admission of patients whose postoperative status prevents discharge and necessitates inpatient admission to a hospital capable of providing the appropriate level of care.

Section 405.22 (Critical Care and Special Care Services) adds new provisions regarding Pediatric Intensive Care Unit (PICU) Services. A “PICU” is defined as a physically separate unit that provides intensive care to pediatric patients (infants, children and adolescents) who are critically ill or injured. It must be staffed by qualified practitioners competent to care for critically ill or injured pediatric patients. “Qualified practitioners” are practitioners functioning within his or her scope of practice according to State Education Law and who meets the hospital’s criteria for competence, credentialing and privileging practitioners in the management of critically ill or injured pediatric patients. PICUs must be approved by the Department and the governing body must develop written policies and procedures for operation of the PICU in accordance with generally accepted standards of medical care for critically ill or injured pediatric patients. The PICU must have a minimum average annual pediatric patient number of 200/year. It must provide medical oversight for interhospital transfers of critically ill or injured patients during transfer to the receiving PICU.

The PICU must be directed by a board certified pediatric medical, surgical, anesthesiology or critical care/intensivist physician who must be responsible for the organization and delivery of PICU care and has specialized training and demonstrated competence in pediatric critical care. Such physician in conjunction with the nursing leadership responsible for the PICU must participate in administrative aspects of the PICU. All hospitals with PICUs must have a physician, notwithstanding emergency department staffing, in-house 24 hours per day who is available to provide bedside care to patients in the PICU. PICU physician and nursing staff must successfully complete and be current in pediatric advanced life support (PALS) or have current training equivalent to PALS.

The hospital must have an organized quality performance improvement program for PICU services and include monitoring of volume and outcomes, morbidity and all case mortality review, regular multidisciplinary conferences including all health professionals involved in the care of PICU patients. Failure to meet one or more regulatory requirements or inactivity in a program for a period of 12 months or more may result in actions, including, but not limited to, withdrawal of approval to serve as a PICU. No PICU can discontinue operation without first obtaining written approval from the department and must give written notification, including a closure plan acceptable to other department at least 90 days prior to planned discontinuance of PICU services. A hospital must notify the department in writing within 7 days of any significant changes in its PICU services, including, but not limited to: (a) any temporary or permanent suspension of services or (b) difficulty meeting staffing or workload requirements.

Section 405.28 (Social Services) is updated to current standards that care be provided under the direction of a qualified social worker who is licensed and registered by the New York State Education Department to practice as a licensed master social worker (LMSW) or licensed clinical social worker (LCSW), with the scope of practice defined in Article 154 of the Education Law.

Statutory Authority:

The authority for the promulgation of these regulations is contained in Public Health Law (“PHL”) Sections 2800 and 2803 (2). PHL Article 28 (Hospitals), Section 2800 specifies that “Hospital and related services including health-related service of the highest quality, efficiently provided and properly utilized at a reasonable cost, are of vital concern to the public health. In order to provide for the protection and promotion of the health of the inhabitants of the state. . . , the department of health shall have the central, comprehensive responsibility for the development and administration of the state's policy with respect to hospital and related services. . . .”

PHL Section 2803(2) authorizes the Public Health and Health Planning Council (“PHHPC”) to adopt and amend rules and regulations, subject to the approval of the Commissioner, to implement the purposes and provisions of PHL Article 28, and to establish minimum standards governing the operation of health care facilities.

Legislative Objectives:

The legislative objective of PHL Article 28 includes the protection of the health of the residents of the State by assuring the efficient provision and proper utilization of health services, of the highest quality at a reasonable cost.

Needs and Benefits:

These amendments are promulgated to update various Part 405 pediatric and general hospital provisions including surgical, anesthesia, radiology and pharmacy and emergency services. Pediatrics is a unique, distinct part of medicine which is very different than adult medicine. Historically, children have often been seen as small adults. This has changed over time and it is now recognized that certain areas of pediatric care such as emergency, critical care and medication dosing require specialized knowledge, skills and equipment.

Part 405 of Title 10 NYCRR sets forth general hospital minimum standards. In 2010, the New York State Emergency Medical Services for Children (“EMS-C”) Advisory Committee recommended and the Department determined that Part 405 needed to be updated to address the unique needs of children. A comprehensive approach was necessary to make sure that hospitals are admitting children for whom it has appropriate staff, resources and equipment and that policies and procedures are in place for transferring those patients for whom the hospital does not have the capability to provide care, except under conditions of disasters and emergency surge situations. Many facilities that once had dedicated pediatric units have closed or reduced their units, resulting in a reduced focus on pediatric care. Currently, the pediatric provisions need strengthening as they do not specifically address minimum standards for pediatric critical or emergency care. Pediatric care has become much more sophisticated and requires highly trained staff with expertise in the particular requirements for caring for children. In addition, various Part 405 subdivisions have been updated for all patients including surgical, anesthesia, radiologic and nuclear medicine, pharmaceutical and emergency services to reflect current practice.

The Department, in conjunction with the EMS-C Advisory Committee, carefully reviewed Part 405 of Title 10 and proposes numerous updates and amendments. In particular, significant changes have been made to the Emergency, Radiology and Pharmacy provisions and new provisions are added regarding standards for Pediatric Intensive Care Units (PICUs). New provisions will require age appropriate equipment and supplies. The new provisions assure that personnel in the emergency department and pediatric intensive care unit have the skills to access and manage a critically ill or injured pediatric patient, including resuscitation. Changes in technology and equipment for diagnostic medical imaging and appropriate use of such equipment are addressed. Policies and procedures regarding imaging studies for newborns and pediatric patients are updated to include standards for clinical appropriateness, appropriate radiation dosage and beam collimation, image quality and patient shielding. Pharmacy and equipment requirements for pediatric patients are revised to assure age and size appropriate dosing. The regulations clarify that pediatric dosing must be weight based and all patients must be weighed in kilograms. Current regulations require Advanced Cardiac Life Support (“ACLS”) training or current training equivalent to ACLS for adults but do not require Pediatric Advanced Life Support (“PALS”) or current training equivalent to PALS for appropriate staff that will be caring for children within the hospital. These regulations address this inequity. This regulatory proposal attempts to strengthen minimum standards for the care of children that are flexible enough to fit the large tertiary care facilities as well as rural and community hospitals. This measure also requires that if laboratory and other diagnostic tests/services are ordered for a patient while receiving emergency services, the hospital must develop and implement written policies and procedures pertaining to the review and communication of the laboratory and diagnostic test/service results to the patient, the patient’s parent, legal guardian or health care agent, or surrogate, if known, and the patient’s primary provider, if known.

These regulations, requiring hospitals provide patients and their parents or other medical decision makers with critical information about the patient’s care and to provide and post a Parent’s Bill of Rights, and another set of regulations requiring hospitals to adopt protocols to identify and treat sepsis, were inspired by the case of Rory Staunton, a 12-year old boy who died of sepsis in April of 2012. Both sets of regulations, together known as “Rory’s Regulations,” will help New York State set a “gold standard” for patient care.

Costs for the Implementation of and Continuing Compliance with these Regulations to the Regulated Entity:

Costs that may be incurred by the regulated parties could include PALS training, accommodations for parent(s) to stay with their child at all times, review and update of various policies and procedures, pharmacy requirements regarding weight based dosing and the requirement of a board certified pediatric medical, surgical, or anesthesiology critical care/intensivist physician who has demonstrated competence in pediatric critical care to direct PICU services. The cost of providing and posting the Parent’s Bill of Rights should be minimal. Regulated parties must also ensure that their equipment is age and size appropriate.

PALS certification costs can range from $0-$300. Currently there are grant funded opportunities for PALS certification. Accommodations for parents may be able to be arranged with existing resources, but could also require additional furnishings. What accommodation costs would be incurred depends on the hospital involved. Review and update of the various policies and procedures and the pharmacy requirements could be accomplished with existing staff imposing little or no additional cost to the regulated parties. The “average” salary of a board certified medical, surgical, pediatric, or anesthesia intensivist to direct the PICU would be approximately $187,192. Hospitals will need to inventory their equipment and supplies to ensure that they are size and age appropriate and provide accordingly. Pediatric dosing resources must include age and size appropriate fluid and medication administration dosing information if not already currently provided.

Cost to State and Local Government:

There is no anticipated fiscal impact to State or local government as a result of these regulations, except that hospitals operated by the State or local governments will incur minimal costs as discussed above.

Cost to the Department of Health:

There will be no additional costs to the Department associated with the implementation of this regulation. Existing staff will be utilized to conduct surveillance of the regulated parties and monitor compliance with these provisions.

Local Government Mandates:

Hospitals operated by State or local governments will be affected and be subject to the same requirements as any other hospital licensed under PHL Article 28.

Paperwork:

This measure will require facilities to develop various written policies and procedures with respect to: transfers of pediatric patients when unable to appropriately and safely care for them, enabling parents/guardians to stay with pediatric patients, assurance that staff privileges are commensurate with training and experience, assurance that various equipment is age and size appropriate, imaging studies and orders. In addition, monitoring and improvement activities to identify, measure, prevent or mitigate adverse drug events, and for a hospital that provides PICU services policies and procedures for the operation of the PICU in accordance with generally accepted standards of medical care for critically ill or injured pediatric patients.

For hospitals with less than 15,000 unscheduled emergency visits per year, the hospital must develop and implement protocols specifying when supervising or attending physicians must be present. (Such facilities must have at least one physician, nurse practitioner, or licensed physician assistant on duty in the emergency service 24 hours a day, seven days a week).

Duplication:

These regulations will not conflict with any state or federal rules.

Alternative Approaches:

There are no viable alternatives to this regulatory proposal. All general hospitals must be able to admit pediatric patients consistent with its ability to provide qualified staff, size and age appropriate equipment necessary for the unique needs of pediatric patients. If the hospital cannot meet these requirements, it will be required to develop criteria and policies and procedures for transfer of pediatric patients.

Consideration was made when developing the Pharmaceutical Services provisions in Section 405.17, that for pediatric patients only weight must be measured in kilograms. Upon further consideration it was determined that it was more appropriate to require that weight be measured in kilograms for patients of all ages.

When developing the Critical Care and Special Care Services for provisions for Pediatric Intensive Care Unit (PICU) services in Section 405.22 the Department initially considered a minimum bed standard of six beds. Upon further consideration it was determined that a minimum standard would not be a bed standard but instead require that a PICU must have a minimum average annual pediatric patient number of 200/per year.

Federal Requirements:

These regulations will not conflict with any state or federal rules.

Compliance Schedule:

These regulations will take effect upon publication of a Notice of Adoption in the New York State Register, but general hospitals will have 90 days from such date to comply with these provisions.

Effect of Rule:

These regulations will apply to the 228 general hospitals in New York State. A recent survey conducted by the Department determined that 32 hospitals in New York State currently have a pediatric intensive care unit (“PICU”). The proposed amendments will apply Statewide, including 18 general hospitals operated by local governments. These hospitals will not be affected in any way different from any other hospital. The operation of a PICU is not mandated by the State but is at the option of the hospital.

Compliance Requirements:

The literature supports the regulatory changes made to general hospital minimum standards with respect to pediatric care. These provisions specify that general hospitals in New York State must ensure that at least one clinician on every shift in the emergency department has the skills to assess and manage a critically ill or injured pediatric patient and be able to resuscitate a child. This standard is supported by the American Academy of Pediatrics (see Pediatrics 1995; 96:526). This measure also states that policies and procedures regarding imaging studies for newborns and pediatric patients must include standards for clinical appropriateness, appropriate radiation dosage and beam collimation, image quality and patient shielding. Medical imaging policies must provide age and weight-appropriate dosing for children receiving studies involving ionizing radiation as supported by the American Academy of Pediatrics and the American College of Emergency Physicians (Pediatrics 2009; 124:1223). Pediatric pharmacy resources must include age and size appropriate fluid and medication administration and dosing. Dosing must be weight based and weight must be measured in kilograms as recommended by the American Academy of Pediatrics; (Pediatrics 2003;111:1120). Pediatric Advanced Life Support (PALS) or equivalent training will be required for appropriate staff that will be caring for children in the hospital, a practice supported by the American Academy of (Pediatrics 1995;96:526).

The PICU shall have a medical director who has received special training and has demonstrated competence in pediatric critical care as recommended by the American Academy of Pediatrics and Society of Critical Care Medicine (Pediatrics 2004; 114: 1114). PICU medical and nursing directors shall be responsible for promoting and verifying pediatric qualifications of staff, overseeing pediatric quality assurance and developing and reviewing PICU care policies consistent with recommendations of the American Academy of Pediatrics, Society of Critical Care Medicine, Pediatrics 2004; 114: 1114. PICUs must have a minimum average annual patient number of 200/year. This is consistent with the recommendation made in the American College of Surgeons’ Resources for Optimal Care of the Injured Patient, 2006.

Cure Period:

Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other opportunity for ameliorative action to prevent the imposition of penalties on the party or parties subject to enforcement when developing a regulation or explain in the Regulatory Flexibility Analysis why one was not included. This regulation creates no new penalty or sanction. Hence, a cure period is not necessary.

Professional Services:

The majority of facilities have in-house staff that could make any required changes to the policies and procedures. Small facilities may contract with outside professional staff from the various disciplines to assist them.

Compliance Costs:

A hospital that wants to provide PICU services must have an intensivist who has received special training and has demonstrated competence in pediatric care to direct the PICU. Currently, the majority of PICUs in New York State already have an intensivist in their employ. According to Jobs-Salary.com, the average pediatric intensivist salary is $187,712, with a range from $100,651 to $280,000. PALS training ranges from $0-300.

Economic and Technological Feasibility:

This proposal is economically and technically feasible.

Minimizing Adverse Impact:

General hospitals will have 90 days from the effective date of these regulations to implement these provisions In addition, at present; grant funding is available for PALS certification.

Small Business and Local Government Participation:

This proposal has been discussed and reviewed by the EMS-C Advisory Committee, the Greater New York Hospital Association (“GNYHA”), the Healthcare Association of New York State (“HANYS”), the Iroquois Hospitals Association and the State Hospital Pharmacy Association.

Changes made to the last published rule do not necessitate revision to the previously published RAFA.

Nature of Impact:

These provisions will not have a significant impact on jobs. A PICU in any New York State general hospital must be directed by a board certified pediatric medical, surgical, anesthesiology or critical care/intensivist physician who must be responsible for the organization and delivery of PICU care. Such intensivist must have specialized training and demonstrated competence in critical care. Hospitals that want to provide PICU services may already have an intensivist to direct their unit.

Categories and Numbers Affected:

There are 32 hospitals in New York State the report that they have a PICU.

Regions of Adverse Impact:

There are no regions of adverse impact.

Minimizing Adverse Impact:

Hospitals will have 90 days from the effective date of these regulations to implement the provisions. In addition, at present, there is grant funding available for PALS certification.

The Department received 8 comments during the public comment period. They came from: Institute for Safe Medicine Practices (ISMP), Jacobi Medical Center (Jacobi Clinical Laboratory Director), Orange Regional Medical Center (Orange County), Greater New York Hospital Association (GNYHA), Healthcare Association of New York State (HANYS), Rory Staunton Foundation, New York American College of Emergency Physicians (NY ACEP), and the New York State American Academy of Pediatrics, District II (AAP, District II).

Patients’ Rights (Section 405.7)

COMMENT: Proposed rules regarding the Parent’s Bill of Rights do not define circumstances where parents’ rights are applicable.

RESPONSE: The intent of this regulation is that the Parent’s Bill of Rights applies to the parents/guardians of minors. Regulatory language was changed to reflect that intent.

COMMENT: Add requirement that Parent’s Bill of Rights be presented to the parent/guardian at triage/intake.

RESPONSE: The regulation has been changed to require that the Parent’s Bill of Rights be provided to a pediatric patient’s parent or other medical decision maker.

COMMENT: The requirement to allow at least one parent or guardian to remain “at all times” should include an exception for when it may not be safe, clinically appropriate or in the best interests of the child.

RESPONSE: Regulatory language was changed to reflect the same language used in similar provisions set forth in 405.9(b)(7)(v).

COMMENT: The requirement that all test results completed during admission or emergency room visit be reviewed by a physician, physician assistant (PA) or nurse practitioner (NP) familiar with the patient’s presenting condition could result in significant discharge delays if the treating clinician is not present when the test results are returned. If it is intended to allow clinicians other than the treating clinician to review the test results, it should be stated explicitly in the regulation. Allowing results to be reviewed by a physician, PA, or NP “familiar” with the patient’s presenting condition, could lower the standard of meaningful review required.

RESPONSE: It is intended that a practitioner involved with the patient’s diagnosis and treatment – who is, thus, “familiar” with the patient’s condition – be responsible to review the patient’s test results. The Department does not view this requirement as lowering the standard of review. Rather, it emphasizes that a practitioner treating the patient should be reviewing this information.

COMMENT: Some tests are appropriately done to inform the patient’s future plan of care and may not need to be completed before the patient can be safely discharged. Critical results are always called to the ordering physician, but routine results go to the chart pending review before the chart is closed. Those routine results get forwarded to the primary care physician. Putting the onus on the laboratory of insuring review prior to submitting to the primary physician would be cost prohibitive to the hospital.

RESPONSE: The ordering practitioner will need to consider the overall condition of the patient upon evaluation and use his or her best clinical judgment to determine which tests are relevant to the patient’s presenting condition. It is recognized that in some situations some tests will not be completed during the patient’s stay in the Emergency Department. Other practitioners (physician, PA, NP) can follow-up with the patient’s plan of care as long as they are familiar with the patient’s presenting condition.

COMMENT: The requirement that patients may not be discharged from the hospital or emergency room until any tests that could reasonably be expected to yield critical value results are completed and reviewed by medical staff should be revised to allow the treating clinician to use professional judgment in determining what lab tests are of such a critical nature that they would require holding a patient until they are completed and reviewed. The definition of critical lab result should be based on industry standards and be used consistently.

RESPONSE: The regulation includes a “reasonableness” component that allows for clinical judgment. The Department has reviewed the definition of “critical result” and has determined that it is clear as written.

COMMENT: Review the definitions and terms used by the Joint Commission and/or the College of American Pathologists.

RESPONSE: The Department has reviewed and considered these terms.

COMMENT: The provision that requires the communication of critical value results and the discussion of the discharge plan be accomplished in a manner that assures the patient, the parents and other medical decision makers have the capacity to obtain, communicate, process and understand the health information provided sets a high bar for the hospital and is inconsistent with the hospital’s obligation to guarantee a certain level of capacity to understand information provided to patients at discharge. A requirement that patients be informed of specific test results may not contribute to the patient’s understanding and increases documentation and notification issues surrounding critical values.

RESPONSE: The regulation has been revised to clarify that information must be communicated in a manner that reasonably assures a patient or a patient’s parent/guardian understands.

COMMENT: The provision that requires hospitals to provide all lab results to the patient’s primary care provider (PCP) is reasonable if the Department understands that hospitals are often provided inaccurate and/or incomplete information. This requirement could be difficult to operationalize because of patient preference, legal and confidentiality concerns. Language could specify that forwarding such results to the PCP may be done in a manner determined by the hospital medical staff. In the event that a patient’s primary care provider is unknown or not practicing in the local area, a reasonable attempt should be allowed to be made to communicate the information. Requiring that all test results from an entire admission be transmitted en-masse to a PCP is an unworkable process. For those labs already part of an Electronic Medical Records system, “meaningful use” regulations already require that a patient be provided on request with a Continuity of Care Record which includes all test results.

RESPONSE: The regulation has been revised to clarify that information must be provided to the PCP, if known – i.e., when the patient has provided sufficient information that the transfer of information can occur. Hospitals must develop their own policies and procedures establishing how information will be provided.

Admission/Discharge (Section 405.9)

COMMENT: On discharge, the patient/parent, legal guardian, or health care agent should receive a checklist including: (1) a highlighted telephone number to call should complications or questions arise, (2) information about diagnoses that have been considered, (3) information about possible complications, (4) a discussion about tests ordered while in emergency care, and (5) a discussion of any contact with a PCP including when the PCP will receive lab results.

RESPONSE: The regulation has been revised to state that (i) a patient, his or her parent or medical decision maker has the right to request information about the diagnosis, possible diagnoses that were considered, possible complications and any contact with the patient’s primary care provider and (ii) on discharge, a hospital must provide a phone number that could be called if complications/questions arise.

COMMENT: The language in 405.9(b)(7)(v) whereby the parent/guardian may stay with pediatric patients to the extent possible given the patient’s health and safety should be used in 405.7(d)(iii).

RESPONSE: This language has been incorporated into section 405.7(d)(iii).

COMMENT: The requirement stating that, “If patient lacks decision making capacity, communication shall be to the patient’s medical decision maker,” should be amended to add “if known and can be contacted within a reasonable period of time prior to or after discharge.”

RESPONSE: The regulation was not revised to include language. If a patient lacks decision making capacity, the hospital/provider should be communicating with some medical decision maker on discharge following admission to the hospital.

COMMENT: The requirement that all information be understood may be beyond the capability of even the most conscientious provider.

RESPONSE: The regulation has been revised to clarify that the information must be communicated in a manner that reasonably assures a patient or a patient’s parent/guardian understands.

Pharmaceutical Services (Section 405.17)

COMMENT: Section 405.17 should reflect the broader designation of “metric” weights as the standard of practice instead of kilograms. Also, nursing personnel should be included in the requirement where the pharmacy director, in conjunction with designated members of the medical staff, must ensure that patients’ weight must be measured in kilograms. The regulation should also include a definition of weight-based dosing as well as the final total calculated patient-specific dose.

RESPONSE: These changes have been made.

Emergency Services (Section 405.19)

COMMENT: Many of the comments on proposed revisions to Sections 405.7 and 405.9 also apply to Section 405.19.

RESPONSE: Any revisions to Sections 405.7 and 405.9 of Title 10 have been incorporated into 405.19.

COMMENT: For the requirement that practitioners be current in Advanced Trauma Life Support (ATLS), Advanced Cardiac Life Support (ACLS), and Pediatric Advanced Life Support (PALS), those practitioners who are board eligible or certified in emergency medicine already meet these requirements by virtue of such board eligibility or certification. Training in a non-emergency based specialty, however, should require additional training in these critical areas.

RESPONSE: The regulation was not changed. The Department intends that all practitioners, regardless of whether they are board-eligible or board-certified or have training in a non-emergency based specialty, be current in ATLS, ACLS and PALS.

COMMENT: Patients who lack decision-making capacity may present for emergency services without their decision maker. Language should be added stating that a “reasonable attempt must be made to contact a decision maker.”

RESPONSE: The regulation has been changed to clarify that, for patients presenting for emergency services, decision makers are to be contacted “if known.”

COMMENT: A policy and procedure requiring all “critical” laboratory/diagnostic tests/service results (rather than all results) be reviewed upon completion by a physician, physician assistant or nurse practitioner familiar with the patient’s presenting condition would afford patients the protection they require. In the emergency department, other tests are often ordered that will be followed by practitioners in other areas, including inpatient units, of the hospital. In some situations, test results will be quite delayed and requiring real-time transmission of non-critical tests will result in delayed care.

RESPONSE: Clinical judgment must be used to determine which tests are pertinent to the patient’s presenting condition. It is recognized that in some situations some tests will not be completed during the patient’s stay in the Emergency Department. It is the Department’s intent that other practitioners (physician, PA, NP) can follow-up with the patient’s plan of care as long as they are familiar with the patient’s presenting condition.

COMMENT: Lengthy discharge instructions are ineffective in communicating with patients, because critical information may be lost in a large volume of information.

RESPONSE: It is the intent of these provisions that patients be given what information is necessary for proper follow-up/post-care.

COMMENT: Staffing requirements for emergency services attending physicians should be amended to allow physicians who focus on teaching or administration to qualify.

RESPONSE: This issue is beyond the scope of this regulatory package.

COMMENT: Language in Section 405.19 regarding hospitals with less than 15,000 unscheduled emergency visits per year that specifies that an attending physician need not be present, but shall be available within 30 minutes of patient presentation should be amended to allow this physician response to be handled via telemedicine. Language in 405.19 (d) (2) (iii) should also be amended to update the qualifications for registered nurses working in Emergency Departments.

RESPONSE: The issues of telemedicine and nurse qualifications are beyond the scope of this regulatory package. Such issues need to be thoroughly reviewed by the medical community in light of their overall impact on the hospital system.

Critical Care Services (Section 405.22)

COMMENT: Pediatric Intensive Care Unit (PICU) Services provisions that require a 24-hour physician presence will force the closure of PICUs for economic reasons. The regulation should allow clinical coverage to be provided by properly trained and credentialed physician assistants and pediatric nurse practitioners acting under the direct supervision of a PICU attending.

RESPONSE: These provisions do not require the physician be directly in the PICU 24 hours a day, but available (excluding the ED physician) in the hospital 24 hours a day.