(1)Existing law requires the State Department of Public Health to license and regulate general acute care hospitals. Existing regulations require a hospital with a capacity of 100 or more beds to have a pharmacy on the premises that is licensed by the California State Board of Pharmacy. Existing regulations require a hospital having fewer than 100 beds to comply with other licensing requirements enforced by the California State Board of Pharmacy. Existing law requires general acute care hospitals to comply with specific statutory provisions for standards of care and regulations promulgated by the department, and a violation of these provisions or regulations is a crime.

This bill would require a general acute care hospital licensed by the department to employ, at a minimum, one full-time pharmacist for every 100 licensed beds, and for additional licensed beds, employ additional pharmacists on a pro rata basis. The bill would require a general acute care hospital that is licensed for less than 100 beds to employ one pharmacist on at least a part-time basis.

(2)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 1373

SUBJECT: General acute care hospitals: minimum levels of pharmaceutical staff

SUMMARY:

Requires general acute care hospitals to employ at least one full-time pharmacist for every 100 licensed beds, or at least one part-time pharmacist for hospitals with fewer than 100 licensed beds.

Existing law:

1. Licenses and regulates health facilities by the department of public health (DPH), including general acute care hospitals (GACHs). [HSC §1250 et seq.]
2. Defines a GACH, in part, as a health facility that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary services. [HSC §1250 (a)]
3. Permits a licensed hospital that contains 100 beds or fewer, and that does not employ a full-time pharmacist, to purchase drugs at wholesale for administration, under the direction of a physician, or for dispensation by a physician, to persons registered as inpatients of the hospital, to emergency cases under treatment in the hospital, or, under specified conditions, to persons registered as outpatients in a rural hospital, as defined. Requires these hospitals to retain the services of a pharmacist consultant to monitor and review the pharmaceutical services provided by the hospital. This provision for pharmaceutical services in smaller hospitals is known as having a “drug room,” and the hospital needs to obtain a license for the drug room from the Board of Pharmacy. [BPC §4056]
4. Requires DPH to adopt regulations that establish minimum, specific, and numerical licensed nurse-to-patient ratios, by licensed nurse classification and by hospital unit, for hospitals, and requires these ratios to constitute the minimum number of registered and licensed nurses that must be allocated. [HSC §1276.4]

Existing regulations:

1. Require all hospitals having a licensed bed capacity of 100 or more beds to have a licensed pharmacy on the premises. [22 CCR §70263]
2. Requires those hospitals with fewer than 100 licensed beds to have a licensed “drug room,” as described in existing law 3) above.

This bill:

1. Requires a GACH to employ, at a minimum, one full-time pharmacist for every 100 licensed beds, and for additional licensed beds, to employ additional pharmacists on a pro rata basis.
2. Requires a GACH that is licensed for less than 100 beds to employ one pharmacist on at least a part-time basis.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, this bill seeks to ensure that all acute care hospitals in California, regardless of size, employ at least a part-time pharmacist. Where nurses currently have bed ratios that require a minimum number of nurses to patients, pharmacists do not. Pharmacists need the protection of minimum ratios to keep the work place balanced and to avoid stressful conditions that lead to mistakes in dispensing controlled substances. This bill seeks to do just that, by providing minimum staffing guidelines for hospitals to follow when staffing pharmacists, California pharmacists can finally get the protections afforded to other occupations that are guided by ratios.
2. Small hospitals currently without a pharmacist. As noted in existing law, existing law permits hospitals with fewer than 100 beds to provide their required pharmacy service through utilization of a “drug room” licensed by the Board of Pharmacy. A drug room does not require an on-site licensed pharmacist, and is allowed to purchase drugs at wholesale to be administered or dispensed by a physician to patients at the hospital. Hospitals with drug rooms are required to contract with a pharmacist consultant to monitor and review the pharmaceutical services provided by the hospital, but there is no requirement that this pharmacist be on site. According to the Board of Pharmacy, there are 27 GACH’s with licensed drug rooms, many of them in rural areas, such as 17-bed Jerold Phelps Community Hospital in Garberville, 25-bed Plumas District Hospital in Quincy, and 25-bed Colorado River Medical Center in Needles. Should this bill pass, each of these hospitals would be required to hire a pharmacist on a part time basis.
3. Nurse to patient ratios and patient classification systems. In 2004, regulations implementing nurse-to-patient ratios in California hospitals pursuant to AB 394 (Kuehl, Chapter 945, Statutes of 1999) went into effect. However, long before California had specific nurse-to-patient ratios, hospitals were required by regulation to establish a patient classification system. This patient classification system is a method by which hospitals establish staffing requirements by unit, patient, and shift, and includes a method by which the amount of nursing care needed for each category of patient is validated for each unit.
   
   The regulations implementing the AB 394 nurse-to-patient ratios law set the minimum ratio of nurses to patient by unit, including one-to-one in operating rooms, one-to-two in intensive care units, and one-to-five in general medical-surgical units. These regulations also incorporated the patient classification system requirement. In essence, the specific nurse-to-patient ratios establish the minimum number of nurses by unit, while the patient classification system determines whether there needs to be a higher level of staffing beyond the minimum ratio after taking into consideration factors such as the severity of the illness, the need for specialized equipment and technology, and the complexity of clinical judgment needed to evaluate the patient care plan, among other factors. The nurse-to-patient ratio regulations require that the minimum ratios must be met at all times.
4. Staffing ratios other than nurse-to-patient ratios. Generally speaking, other than nurses, there are few instances of California law establishing a minimum provider-to-patient ratio. Skilled nursing facilities are required to have a minimum of 3.5 “direct care services hours per patient day.” For purposes of meeting this requirement, a “direct caregiver” could be a registered nurse, a licensed vocational nurse, or a certified nurse assistant. In crisis stabilization units, which provide intensive behavioral health treatment for a period of less than 24 hours, the Department of Health Care Services requires that these facilities be staffed at a ratio of one licensed mental health professional on-site for every four patients receiving crisis stabilization services at any given time.
5. Guidelines on minimum standards for pharmacies in hospitals. In 2013, the American Society of Health System Pharmacy (ASHP) published a guideline entitled “Minimum Standard for Pharmacies in Hospitals.” ASHP stated that these guidelines were intended to serve as a basic guide for the provision of pharmacy services in hospitals, and outlined a minimum level of services that most hospital pharmacy departments should consistently provide. According to this guide, the pharmacy “shall employ an adequate number of competent, legally qualified pharmacists to meet the specific medication-use needs of the hospital’s patients.” The guidelines also state that “there shall be a written departmental staffing plan that addresses how patients’ needs will be met during periods of staff shortages and fluctuation in workload and/or patient acuity, and that remote medication order processing may be employed to help address staff shortages or workload fluctuations.”
6. Related legislation. SB 1288 (Leyva) requires periodic inspections of hospitals by DPH to include reviews of compliance with nurse staffing ratios, and establishes administrative penalties for nurse staffing ratio violations of between $2,500 and $25,000 for a first or second violation, $75,000 for a third violation, up to $100,000 for a fourth violation, and $125,000 for each subsequent violation. SB 1288 is set for hearing on April 18, 2018 in the Senate Health Committee.
7. Prior legislation. SB 493 (Hernandez, Chapter 469, Statutes of 2013) authorized pharmacists to perform certain functions according to specified requirements; established advanced practice pharmacist (APP) recognition; and authorized the Board of Pharmacy to set the fee, not to exceed $300, for the issuance and renewal of APP recognition.

AB 394 (Kuehl, Chapter 945, Statutes of 1999) required DPH to adopt regulations specifying nurse-to-patient ratios, by unit, for general acute care hospitals, acute psychiatric hospitals and special hospitals. Required hospitals to adopt written policies and procedures for nursing staff training. Provided that the ratios shall constitute the minimum number of registered and licensed nurses that must be provided; requires hospitals to assign additional staff in accordance with a documented patient classification system.

1. Opposition. This bill is opposed by the California Hospital Association (CHA), which states that this bill is unnecessary and would adversely affect access to care for patients. According to CHA, this bill would infringe upon long-standing pharmacy licensing rules that allow small hospitals to operate with a simpler pharmacy by utilizing a drug room. CHA states that these small hospitals would be challenged both financially and practically to employ a part-time pharmacist. CHA states that with respect to hospitals with more than 100 beds, there is no evidence to support the bill’s determination that one pharmacist for every 100 beds is an appropriate standard. According to CHA, hospitals are complex and diverse organizations, and hospitals determine pharmacy staffing based on a variety of factors including service intensity and number of doses administered. CHA states that tying staffing to number of beds makes no sense when a hospital licensed for 250 beds may serve 150 patients on one day and 225 patients a few days later.
   

The Association of California Healthcare Districts (ACHD) also opposes this bill, stating that hospital pharmacies are primarily regulated by the Board of Pharmacy, which has adopted numerous regulations to implement laws pertaining to pharmacy oversight. ACHD states that DPH provides secondary oversight, including a thorough review of pharmacy operations during triennial surveys. According to ACHD, assuming genuine patient safety concerns exist, current law provides various avenues of redress, including the often-used complaint processes through DPH or the Board of Pharmacy. ACHD states that this bill is simply unnecessary and could threaten access to care in smaller hospitals.

1. Policy comment.
   1. Adding a new challenge to small, rural hospitals. As noted in existing law, the pharmacy law provides a way for smaller hospitals to meet their required pharmacy service without having to hire a pharmacist on site. This bill removes that option, and would require some very small and rural hospitals to hire a pharmacist to continue operating as a hospital. Given the challenges facing small, rural hospitals in meeting staffing requirements generally, the committee may wish to consider whether an additional obligation on these hospitals is warranted in this case.
   2. Is the number of licensed beds a good metric for level of pharmacy service needed? The nurse staffing ratio law, rather than being based on the number of licensed beds, is based on the number of patients who are in a given hospital unit at any one time. A hospital is often licensed for more beds than are occupied on a regular basis, and the number of doses of medication dispensed or administered at a hospital is likely to vary based on the acuity of the patients served at that hospital, and how busy that hospital is on any given day.

SUPPORT AND OPPOSITION:

Support: None received

Oppose: Association of California Healthcare Districts

California Hospital Association

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