The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services. While few of the proposed changes appear to be substantive, the proposal includes changes that could require GACHs in California to materially alter their current operations. This On the Subject summarizes those material changes in advance of CDPH’s public hearing on the proposed regulations, scheduled for September 12, 2024, from 2:00 pm to 3:00 pm PST via Microsoft Teams.

In Depth

CLINICAL LABORATORY SERVICES

CDPH’s proposed regulations would involve the following changes to GACH licensing requirements:

New Requirement to Designate Director of Transfusion Services

CDPH proposes to require GACH clinical laboratories to ensure that consultative and support services related to the care and safety of blood donors and transfusion recipients are directed by an individual licensed to engage in the production of human whole blood or human whole blood derivatives. While this requirement already technically exists under the California Health and Safety Code for transfusion services more broadly, the addition of the obligation under GACH licensure provisions for GACH clinical laboratories imposes greater consequences for noncompliance.

Requirement That Clinical Laboratory QAPI Program Meets Federal Conditions of Participation

The proposed regulations would require GACH clinical laboratories to develop, implement, and maintain a quality assessment and performance improvement (QAPI) program consistent with the federal hospital conditions of participation. The clinical laboratory QAPI program would need to be integrated into the hospital-wide QAPI program. For hospitals that do not have a distinct clinical laboratory QAPI program, this requirement would entail establishing such a program and integrating it with the hospital-wide program.

New Requirement for Outside Blood Bank Policies and Procedures

Under the proposed regulations, when a GACH depends on outside blood banks for its transfusion services, the GACH must have an agreement in place describing how blood will be procured, transferred, and made available. The blood bank and transfusion service also must have written policies and procedures that:

• Require the evaluation of the ability of suppliers to meet the GACH’s blood bank and transfusion service needs;
• Require the blood bank and transfusion service to participate in the evaluation and selection of suppliers prior to the acceptance of an outside blood bank agreement; and
• Require written agreements with blood bank and transfusion service suppliers to delineate the expectations of the GACH blood bank and transfusion service and the outside blood bank, including an explanation of how those expectations are met.

These requirements may trigger a need to amend existing agreements.

Requirement That Clinical Laboratory Directors Fulfill Duties in Compliance With CLIA

CDPH appears to require directors of clinical laboratory services at GACHs to be licensed physicians who are board-certified or eligible to be certified in anatomic pathology or clinical pathology, and to fulfill their duties in accordance with federal Clinical Laboratory Improvement Amendments (CLIA). While a requirement to comply with federal law already exists, the proposed change would tie state licensure to CLIA compliance. Notably, under CLIA rules, a laboratory director may be, but is not necessarily required to be, a board-certified physician.

New Requirement for Laboratory Workspace Equipment

Instead of requiring “adequate laboratory space” as the existing regulations do, CDPH’s proposed regulations would add specificity by requiring GACH clinical laboratory space to have laboratory workspace, refrigerated blood storage space, and hand washing fixtures, plus space to store specimens and equipment and sufficient space for laboratory staff to work without injuring themselves or damaging specimens. While some of these requirements may reflect existing life safety or other building use requirements, the specificity in the proposed regulations could require GACHs to renovate existing clinical laboratory space.

PHARMACEUTICAL SERVICES

Inclusion of Drug-Therapy Management in Pharmaceutical Services Definition

CDPH proposes to update the definition of pharmaceutical services in the regulations to allow GACH pharmaceutical services to include participation in drug-therapy management by licensed pharmacists who have been granted privileges by the governing board.

Requirement for Director Approval of Procedures

Under the proposed regulations, the director of pharmaceutical service at a GACH would be required, in consultation with relevant administrators and other healthcare professionals, to approve all procedures relating to pharmaceutical services.

Establishment of a Pharmacy and Therapeutics Committee

Under the proposed regulations, a GACH must formally establish a pharmacy and therapeutics committee consisting of one physician, the director of pharmaceutical services or their representative, the director of nursing or their representative, and the GACH administrator or their representative. Compliance may currently be met by establishing a committee of equivalent composition, but the proposed regulations appear to require the specific title and membership in the committee.

Governing Body Policy Approval

The proposed regulations would require the GACH’s governing body to approve all policies developed by the pharmacy and therapeutics committee established pursuant to the regulations. The director of pharmaceutical services must approve procedures. This proposed change may require GACHs to revise their existing processes for approval of policies and procedures.

New Requirements for Verbal and Telephone Drug Orders

CDPH discourages the use of verbal and telephone drug prescriptions but, when necessary, proposes requiring verbal and telephone orders to be “recorded promptly in the patient’s medical record, noting the name of the prescriber, the name of the lawfully authorized individual calling in the order (the agent of the prescriber), and the name and the signature or electronic signature of the individual receiving the order.” An oral or telephonic order may only be received by an individual who is licensed and authorized to receive orders, and such person would be required to sign the order, which the prescriber or practitioner must countersign within 48 hours. When verbal or telephone orders are placed, the person receiving the order must read the order back to the person making the order to ensure accuracy. This read-back should be recorded in the patient’s medical record. Verbal or telephone orders for chemotherapeutic drugs would not be permitted. These proposed requirements reflect alignment between California’s requirements and the requirements set forth in the Centers for Medicare and Medicaid Services conditions of participation for hospitals and would establish a standardized time period for countersigning of verbal or telephone orders.

Standing Orders Permitted Without Patient-Specific Order From a Physician

The proposed regulations differentiate standing orders from pre-approved order sets and detail the compliance requirements for both. While many of the proposed regulatory requirements for use of these order types reflect current requirements and simply mirror them for both order types, the proposed regulations include important differences that, if adopted, would require GACHs to evaluate the compliance of existing processes and update policies and procedures accordingly. As proposed, pre-approved order sets would require an authorized prescriber to sign the order at the time it is given for a specified patient, and to include the order in the patient’s record. The proposed regulation for standing orders also would require documentation of the order in the patient’s medical record at the time of initiation or as soon as possible thereafter, as well as a retrospective review of the order’s execution and attending or authorized practitioner documentation of the medical necessity (or lack thereof) in the patient’s medical record. These proposed changes may seem minor but, if not reflected in current GACH policies, would require shifts in workflows and recordkeeping, and potentially additional practitioner resources to ensure reviews are completed.

New Requirement to Record Drug Orders and Pharmacist Review

The proposed regulations would require pharmacists to review drug orders for appropriateness before the drug is first administered or automatically dispensed. If an emergency prohibits this prior review, the pharmacist would be required to retrospectively review all emergency drug orders in accordance with hospital policies and procedures. While this step may already be standard operating procedure in many GACHs, this requirement would formalize the need for that procedure.

Requirement to Maintain a Controlled Substance Record System for All Scheduled Drugs

Under the proposed regulations, CDPH would require that the GACH’s controlled substance record system be immediately retrievable by hospital staff when requested by a surveyor. The pharmacy record system also would be required to facilitate the identification and extent of loss or diversion of controlled substances. This new requirement suggests that CDPH has encountered issues with GACHs immediately retrieving such records and timely utilizing the pharmacy record system to identify controlled substance loss or diversion.

New Requirement to Develop a Pharmaceutical QAPI Program

CDPH would require GACH pharmaceutical services to maintain a QAPI program consistent with the GACH’s QAPI program that covers both the pharmacy and drug use processes throughout the hospital. The pharmaceutical service would also be required to develop and assess performance indicators for all contracted pharmaceutical services. The amended rules would require the pharmaceutical service to conduct periodic audits assessing drug therapy protocols for high-risk/high-alert drugs, which have a greater chance of causing harm to patients if used in error. For hospitals that do not have a distinct pharmacy-focused QAPI program, this requirement would entail establishing such a program and integrating it with the hospital-wide program, as well as identifying and establishing performance indicators for contracted pharmacy services that align with the contracted services requirements in the conditions of participation and accrediting organization standards.

Adopting California Building Code Section 1224.19 and New Requirements Governing the Pharmaceutical Space

The proposed regulations would adopt Section 1224.19 of the California Building Code for GACH pharmaceutical services. Section 1224.19 generally requires facilities to accommodate the services and equipment associated with the drug distribution system used and the number of patients to be served and lays out the basic pharmaceutical services and space requirements for hospitals with fewer than 100 licensed beds. The proposed regulations would also specifically require that the pharmaceutical service provide space for drug storage, packaging, labeling, and dispensing, as well as sterile and non-sterile compounding.

DIETETIC SERVICES

New Requirements for a Registered Dietitian to Administer and Direct the Dietetic Service

CDPH proposes to require that a hospital’s dietetic service be administered and directed by a registered dietitian (RD). Under the proposed regulations, menus must be specific to each patient in accordance with healthcare providers’ orders and, to the extent practicable, patient preferences. Where a dietetic services supervisor is used, there must be oversight by and regular consultations with the RD to make informed decisions. If the hospital does not employ the RD full-time, the dietetic service must have enough part-time or consultant RDs on the premises to administer the service and meet patient needs. CDPH would further require that the RD provide nutrition care services upon referral and make nutrition recommendations to the medical staff. Finally, the RD would be required to develop a QAPI program in accordance with the federal conditions of participation and participate on hospital committees relevant to the dietetic service. These proposed requirements would bolster existing requirements, and they suggest that GACHs may need to increase the availability of employed or contracted RDs if the proposed regulations are adopted.

HOSPITAL-WIDE QAPI PROGRAM

New Requirement for Governing Body to Create Hospital-Wide QAPI Program

Under the proposed regulations, the GACH’s governing body would be required to develop, implement, and maintain a hospital-wide QAPI program in compliance with federal conditions of participation. This proposed requirement aligns with the conditions of participation and demonstrates CDPH’s continued focus on governing body involvement in quality aspects of hospital operations.

KEY TAKEAWAYS

CDPH’s proposed changes to the GACH licensing regulations could have material impacts on certain operational components of California hospitals. GACHs with questions or concerns regarding the proposed regulations can participate in the CDPH’s public hearing on September 12, 2024. The public hearing provides a forum for any interested parties and their representatives to present statements, arguments, or contentions regarding the proposed regulations.

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