Kaiser Permanente Santa Clara STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

PRINTED: 07/23/2007 FORM APPROVED
California Department of Public Health KAISER FOUNDATION HOSPITAL - SANTA CLARA 900 KIELY BLVD SANTA CLARA, CA 95051 E 000 I Initial Comments The following reflects the findings of the California Department of Public Health during a complaint validation survey conducted from 3/19/07 to 3/21/07.

Representing the California Department of Public Health were Glenn Koike, Health Facilities Evaluator Nurse, Magda Gabali, Pharmacist Consultant and Dr. Michael Bennett, Medical Consultant.

1280.1(a) HSC Section 1280

If a licensee of a health facility licensed under subdivision (a), (b), or (f) of Sections 1250 receives a notice of deficiency constituting an immediate jeopardy to the health or safety of a patient and is required to submit a plan of correction, the department may assess the licensee an administrative penalty in an amount not to exceed twenty-five thousand dollars ($25,000) per violation.

1280.1(c)HSC Section 1280

For purposes of this section "immediate jeopardy" means a situation in which the licensee's noncompliance with one or more. requirements of licensure has caused, or is likely to cause, serious injury or death to the patient.

DEFICIENCY CONSTITUTING IMMEDIATE JEOPARDY.

E 4741 T22 DIV5 CH1 ART3-70263(c) Pharmaceutical E 474 Service General Requirements

I (c) A pharmacy and therapeutics committee, or a J committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative and the administrator. or his representative.

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution; dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementations of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

Theabove regulation was not met as evidenced .

I I by:
Based on observation, staff interviews, and document reviews, the hospital failed to provide patient safety by ensuring written policies and procedures for the distribution of all drugs were developed and implemented to ensure for the safe use of all medications. Findings include:

1. On 3/19/07 at 9:30 a.m., Administrative and Clinical Pharmacy Staff were interviewed about the investigation alleging an overdose of two pharmaceutical products administered to Patient

Patient 1 was a 1-month-old neonate diagnosed with a genetic metabolic deficiency (carbamoyl phosphate synthetase deficiency) a few days after his birth on 1/6/07, and had been transferred to Lucille Salter Packard (LSP) Children's Hospital At Stanford for the stabilization of this condition.

On 2/2/07 Patient 1 returned to Kaiser Hospital for continued treatment prior to being discharged home. Patient 1 was receiving enteral feedings I and supplemental nutritional supplements i including L-citrulline (a non-essential amino I acid). Patient 1 was also receiving I phenylbutyrate to reduce high levels of ammonia I in the blood ..

I On 2/13/07, Patient 1 returned to LSP after a medication overdose and fulminant liver failure : I requiring dialysis, and liver transplant evaluation ! and the management of his metabolic deficiency. !
On 2/24/07, Patient 1 expired.

blood.

c. On 2/7/07 Pharmacy staff had repackaged the dry powder doses L-citrulline and phenylbutyrate incorrectly. The repackaging did not take into consideration the weight of the container. Citrulline was packaged as 3.77 gram (g) doses instead of 150 milligram (mg) doses, and . phenyl butyrate was packaged as 4.1 g doses instead of 450mg doses. The repackaging error was not identified by the pharmacy technician

I repackaging the dry powder or by the pharmacist I checking the accuracy of the repackaged

product prior to distribution and administration to I the patient. .

I On 3/19/07 at 9:50 a.m., the Pharmacy Director ; said corrective action was taken to ensure the : accurate measurement of dry powders, and ; stated all pharmacists and technicians 'were to be "testedfl and "oriented" to the correct use of I the dry powder scale to ensure the accuracy of I its use so as to prevent further repackaging l medication errors. The Pharmacy Director said I I new policy and procedures for the "Weighing of I Dry Powdered Substances" (policy number

! PHAR2.22 last revised 3/07) had been implemented to ensure for the improved oversight f weight-based products. The procedures identified competency testing will be done for "all pharmacists and technicians". The .\ Pharmacy Director said only pharmacists had been in-serviced on the new procedures.

By 3/21/07, approximately 5 weeks after the error was detected, the pharmacy technicians had not been inserviced to the proper usage of the scale and for accurate weight-based procedures, which was not in accordance with the facility's policies and procedures and corrective action taken.

The violation(s) has caused or is likely to cause serious injury or death to a patient(s).