The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RIDEOUT MEMORIAL HOSPITAL 726 4TH ST MARYSVILLE, CA 95901 Nov. 13, 2014
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that met the needs of all the patients as evidenced by:

1. The hospital failed to ensure it proactively monitored post-anesthesia care unit (PACU-receover area after surgery) patient care areas for scheduled drug (medications with a potential for diversion (theft) and abuse) diversion. The hospital, from 1/14-8/14, did not proactively monitor PACU patient care areas for potential scheduled drug diversion. This failure resulted in the potential for undetected diversion of scheduled medications. (See A 494)

2.The hospital failed to ensure pharmaceutical services were provided in accordance with State law. Hospital 2 failed to have a pharmacy license. Hospital 2 provided patient care and pharmacy services to patients from 2/12/14-7/17/14. Pharmacy is an area, place, or premises licensed by the California Board of Pharmacy (the board) in which the profession of pharmacy is practiced and where prescriptions are compounded (mixed). Pharmacy includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances (medications with a potential for diversion and abuse), dangerous drugs, or dangerous devices are stored, possessed, and dispensed) . Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14. Hospital 2 provided care to 1,694 patients, from 2/12/14-7/17/14, without the required pharmacy license. (See A 500 #1)

3.The hospital failed to ensure pharmaceutical services were provided in accordance with Federal law. Hospital 2 failed to register with the Drug Enforcement Administration (DEA, enforces controlled substances (scheduled medications) laws and regulations). Hospital 2, from 2/12/14-8/5/14, received, stored, and dispensed, scheduled medications (medications with the potential for diversion (theft) and abuse). Hospital 2, from 2/12/14-8/5/14, did not have a controlled substance registration certificate. Hospital 2, from 2/12/14-8/5/14, provided care to 1,912 patients without the required controlled substance registration. (See A 500 #2)

4. The hospital failed to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in accordance with State law. The hospital failed to ensure the cancer center pharmacy was licensed by the California Board of Pharmacy (Ca BoP) to compound sterile intravenous (IV, directly into a vein) medications. The hospital compounded sterile hazardous (chemotherapy, used to treat cancer) IV medications. The hospital did not have the required Ca BoP sterile compounding license. The cancer center pharmacy, from 7/1/14-11/11/14, compounded 3,830 IVs without a sterile compounding license. (See A 501)

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0020
Based on observation, interview, and record review, the hospital (with two campuses, Hospital 1 and 2) failed to ensure it was compliant with Federal and State laws, which affected all patients and all hospital campuses, when it failed to ensure that:

1. Hospital 2's pharmacy was registered with the Drug Enforcement Administration (DEA, enforces controlled substances (scheduled medications) laws and regulations).

2. Hospital 2 had a State pharmacy license.

3. Hospital's Cancer Center campus had a State sterile compounding (mixing medications) license.

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Compliance with Federal, State, and Local Laws.
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0021
Based on observation, interview, and administrative record review, the hospital (with two hospital campuses, Hospital 1 and 2,) failed to ensure that:

1. Hospital 2's pharmacy was registered with the Drug Enforcement Administration (DEA, enforces controlled substances (scheduled medications) laws and regulations). Hospital 2, from 2/12/14-8/5/14, received, stored, and dispensed, scheduled medications (medications with the potential for diversion (theft) and abuse). Hospital 2, from 2/12/14-8/5/14, did not have a controlled substance registration certificate. Hospital 2, from 2/12/14-8/5/14, provided care to 1,912 patients without the required controlled substance registration. This failure had the potential for theft and abuse of medications which could result in harm, including death.

Findings:

1. During a group interview, on 11/12/14 at 2 pm, Hospital 2's pharmacy leadership was asked to describe the controlled substance registration certificate (DEA registration) history for the past 1 year. The leadership group included: Director of Pharmacy (DOP), Pharmacist (Pharm 1), and Pharmacist (Pharm 2). The group stated Hospital 2 did not have a controlled substance registration certificate from 2/12/14-8/5/14. DOP and Administrator (Admin 1) were asked if Hospital 2, from 2/12/14-8/5/14, required a DEA registration. DOP and Admin 1 stated Hospital 2 required a DEA registration from 2/12/14-8/5/14. The hospital was asked to provide the number of patients admitted to Hospital 2 from 2/12 - 8/5/14.

During an interview, on 11/13/14 at 8:30 am, in Hospital 2's pharmacy, Pharm 2 was asked to describe the medication distribution process (pharmacy services) for the past year. Pharm 2 stated that medications were stored in four automated dispensing cabinets (ADC, automated drug dispensing cabinet) in Hospital 2.

During a concurrent tour and interview, on 11/13/14 at 9:07 am, on the 1 north nursing unit, Pharm 2 identified an ADC. Inspection of the ADC showed it contained 10 mg (milligram) morphine (pain medication, a controlled substance) for injection. Pharm 2 confirmed the ADC contained 10 mg morphine for injection.

During a concurrent interview and administrative record review, on 11/13/14 at 3:20 pm, Administrator (Admin 2) identified a census report. Review of the census report showed Hospital 2, from 2/12/14-8/5/14, admitted 1,912 patients.

An administrative record review, on 11/19/14 at 9:42 am, of the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion control website at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm#3 <http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm> showed, Section III-Registration Requirements, New Pharmacy Registration, "Every pharmacy that dispenses a controlled substance must be registered with the DEA. First a state license must be obtained." Hospital 2, from 2/12/14-8/5/14, was not registered with the DEA.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A. "The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed B. Federal:, 1. "The hospital will comply with all laws, regulations and requirements of the Drug Enforcement Administration (DEA), 2. The hospital will maintain current and valid registration with DEA ..."

Hospital 2, from 2/12/14-8/5/14, did not maintain current and valid registration with the DEA.
VIOLATION: LICENSURE OF HOSPITAL Tag No: A0022
Based on interview and administrative record review, the hospital failed to ensure that:

1. Hospital 2 had a pharmacy license. Hospital 2 provided patient care and pharmacy services to patients from 2/12/14-7/17/14. Pharmacy is an area, place, or premises licensed by the California Board of Pharmacy (the board) in which the profession of pharmacy is practiced and where prescriptions are compounded (mixed). Pharmacy includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances (medications with a potential for diversion and abuse), dangerous drugs, or dangerous devices are stored, possessed, and dispensed). Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14. Hospital 2 provided care to 1,694 patients, from 2/12/14-7/17/14, without the required pharmacy license.

2. Pharmaceutical sterile (germ free) compounding (mixing) services were provided in accordance with State law at the hospital Cancer Center. The hospital failed to ensure the cancer center pharmacy was licensed by the California Board of Pharmacy (Ca BoP) to compound sterile intravenous (IV, directly into a vein) medications. The hospital compounded sterile hazardous (chemotherapy, used to treat cancer) IV medications. The hospital did not have the required Ca BoP sterile compounding license. The cancer center pharmacy, from 7/1/14-11/11/14, compounded 3,830 IVs without a sterile compounding license.

These failure had the potential for non-compliant pharmacy processes to negatively impact patient health status for all patients at both Hospital Campuses.

Findings:

California Code of Regulations, Title 22, Division 5, Chapter 1, Article 3, Paragraph (a) read: "All hospitals having a licensed bed capacity of 100 or more beds shall have a pharmacy on the premises licensed by the California Board of Pharmacy. Those hospitals having fewer than 100 licensed beds shall have a pharmacy license issued by the Board of Pharmacy pursuant to Section 4029 or 4056 of the Business and Professions Code."

During a group interview, on 11/12/14 at 2 pm, Hospital 2's pharmacy leadership was asked to describe the pharmacy licensure history for the past 1 year. The pharmacy leadership group included: Director of Pharmacy (DOP), Pharmacist (Pharm 1), and Pharmacist (Pharm 2). The group stated Hospital 2 did not have a California Board of Pharmacy issued pharmacy license from 2/12/14-7/17/14. DOP and Administrator (Admin 1) were asked if Hospital 2 required a pharmacy license. DOP and Admin 1 stated Hospital 2 required a pharmacy license from 2/12/14-7/17/14. The hospital was asked to provide the number of patients admitted to Hospital 2 from 2/12/14-7/17/14.

During an interview, on 11/13/14 at 8:30 am, in Hospital 2's pharmacy, Pharm 2 was asked to describe how medications were stored and dispensed (medication distribution process (pharmacy services)) for the past year. Pharm 2's description included that medications were stored in four automated dispensing cabinets (ADC, automated drug dispensing cabinet) in Hospital 2. Pharm 2 stated that nurses removed medications from the ADCs for administration to patients.

During a concurrent tour and interview, on 11/13/14 at 9:07 am, on the 1 north nursing unit (patient care area), Pharm 2 identified an ADC. Inspection of the ADC showed it contained vials of 10 mg (milligram) morphine (pain medication) for injection.

During a concurrent interview and administrative record review, on 11/13/14 at 3:20 pm, Administrator (Admin 2) identified a census report. Review of the census report showed Hospital 2, from 2/12/14-7/17/14, admitted 1,694 patients.

An administrative record review, of the hospital's Board of Pharmacy, Hospital Pharmacy Permit (State of California), showed "License No. HSP ...Issue Date ...July 17, 2014 ...Hospital 2." Hospital 2's pharmacy license issue date was July 17, 2014.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A."The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed 1. State of California:,"Pharmacy Services will be provided according to the regulations of the Department of Public Health as stated in Title 22 for licensed acute care hospitals." Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14.

2. During a concurrent tour and interview, on 11/13/14 at 9:15 am, in the cancer center pharmacy, three personnel were observed compounding hazardous IV medications. Pharmacy Manager (PM 1) identified the three personnel as a pharmacist and two pharmacy technicians. PM 1 stated they were compounding IV doxorubicin (chemotherapy medication) and dacarbazine (chemotherapy medication). PM 1 stated that the cancer center pharmacy compounded sterile IV medications for patients being treated at the cancer center. PM 1 said "Currently we do not have a sterile compounding license but we have applied for it."

During an interview, on 11/13/14 at 9:40 am, the DOP acknowledged that he was aware the cancer center pharmacy did not have a sterile compounding license.

An administrative record review, on 11/18/14, at 1:30 pm, of the California Board of Pharmacy website at http://www.pharmacy.ca.gov/applicants/index.shtml#sterile_injectable_compounding <http://www.pharmacy.ca.gov/applicants/index.shtml> showed, Sterile Injectable Compounding Pharmacy License, "A pharmacy may not compound injectable sterile drug products in California unless it is specially licensed with the board as a sterile compounding pharmacy ..."

An administrative record review, on 11/18/14 at 1:30 pm, of the California Board of Pharmacy website at <http://www2.dca.ca.gov/pls/wllpub/WLLQRYNA$LCEV2.ActionQuery>, did not show the cancer center pharmacy was licensed to compound sterile intravenous medication.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A. "The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed 1. State of California:, b. "All laws, regulations and licensure requirements of the California State Board of Pharmacy will be met and followed." The cancer center pharmacy did not have a sterile compounding license.

An administrative record review, of the hospital's policy and procedure for Improving Organizational Performance (IO))-Pharmacy (Last Reviewed/Approved: 2/12/2014) showed, II. Objectives;, C. "To meet regulatory, licensing and certification requirements of the state Department of Health, Joint Commission on the Accreditation of Hospitals and California Medical Review, Inc."

An administrative record review, of the hospital's Cancer Center Stats (7/1/14-11/11/14) showed the cancer center pharmacy mixed 3,830 IVs.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, and record review, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe, quality care to all patients as evidenced by:

1. Failure to ensure it proactively monitored post-anesthesia care unit (PACU- recovery area after surgery) patient care areas for scheduled drug (medications with a potential for diversion (theft) and abuse) diversion. The hospital, from 1/14-8/14, did not proactively monitor PACU patient care areas for potential scheduled drug diversion. This failure resulted in the potential for undetected diversion of scheduled medications. (See A 490 and A 0494)

2. Failure to ensure pharmaceutical services were provided in accordance with State law. Hospital 2 failed to have a pharmacy license. Hospital 2 provided patient care and pharmacy services to patients from 2/12/14-7/17/14. Pharmacy is an area, place, or premises licensed by the California Board of Pharmacy (the board) in which the profession of pharmacy is practiced and where prescriptions are compounded (mixed). Pharmacy includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances (medications with a potential for diversion and abuse), dangerous drugs, or dangerous devices are stored, possessed, and dispensed) . Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14. Hospital 2 provided care to 1,694 patients, from 2/12/14-7/17/14, without the required pharmacy license. (See A 20, A 22, A 490, and A 500 #1)

3. Failure to ensure pharmaceutical services were provided in accordance with Federal law. Hospital 2 failed to register with the Drug Enforcement Administration (DEA, enforces controlled substances (scheduled medications) laws and regulations). Hospital 2, from 2/12/14-8/5/14, received, stored, and dispensed, scheduled medications (medications with the potential for diversion (theft) and abuse). Hospital 2, from 2/12/14-8/5/14, did not have a controlled substance registration certificate. Hospital 2, from 2/12/14-8/5/14, provided care to 1,912 patients without the required controlled substance registration. (See A 20, A 21, A 490, and A 500 #2)

4. Failure to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in accordance with State law. The hospital failed to ensure the cancer center pharmacy was licensed by the California Board of Pharmacy (Ca BoP) to compound sterile intravenous (IV, directly into a vein) medications. The hospital compounded sterile hazardous (chemotherapy, used to treat cancer) IV medications. The hospital did not have the required Ca BoP sterile compounding license. The cancer center pharmacy, from 7/1/14-11/11/14, compounded 3,830 IVs without a sterile compounding license. (See A 20, A 22, A 490, and A 501)

These failures resulted in a potential for patient harm, to all patients in the Hospital, related to non-compliant processes that had no regulatory oversight.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on observation, interview, and administrative record review, the hospital failed to ensure it proactively monitored post-anesthesia care unit (PACU) patient care areas for scheduled drug (medications with a potential for diversion (theft) and abuse) diversion. The hospital, from 1/14-8/14, did not proactively monitor PACU patient care areas for potential scheduled drug diversion. This failure resulted in the potential for undetected diversion of scheduled medications.

Findings:

During an interview, on 11/13/14 at 8:30 am, in Hospital 2's pharmacy, Pharmacist (Pharm 2) was asked to describe the medication distribution process (pharmacy services) for the past year. Pharm 2's description included that medications were stored in four automated drug dispensing cabinets (ADC) in Hospital 2.

During a concurrent tour and interview, on 11/13/14 at 9:07 am, on the 1 north nursing unit, Pharm 2 identified an ADC. Inspection of the ADC showed it contained 10 mg (milligram) morphine (pain medication (scheduled substance)) for injection. Pharm 2 confirmed the ADC contained 10 mg morphine for injection.

During a concurrent tour and interview, on 11/3/14 at 9:30 am, in the Surgery Center's PACU, Pharm 2 identified an ADC. Pharm 2 was asked to describe the process for dispensing a scheduled medication from the ADC through the documentation of the medication administration. Pharm 2's description included that the nurse documented the administration of the medication on a paper medication administration record (MAR, record of medication administration). Pharm 2 stated all of the PACUs in the hospital documented medication administration on a paper MAR.

During an interview, on 11/13/14 at 12:55 pm, Pharmacy Technician (Pharm Tech 2), in the presence of the Director of Pharmacy (DOP), was asked to describe the scheduled substance diversion monitoring process in the PACUs. Pharm Tech 2 stated that if an unusual event happened (retrospective-after the incident occurred), then the pharmacy would investigate the corresponding ADC and MAR records. Pharm Tech 2 was asked if the pharmacy had a process, from 1/14-8/14, to proactively (before the incident occurs) review the PACU ADC and MAR records for inaccuracies. Pharm Tech 2 stated that the hospital did not have a process during that time period.

An administrative record review, of the hospital's policy and procedure for Investigation and Reporting of Drug Diversion-Hospitalwide (Last Reviewed/Approved: 11/08/2011) showed, I. Purpose:, C."To standardize the methods and steps for identifying potential drug diversion ..." Continued review showed, IV. Procedure:, A. Proactive Diversion Monitoring:,"A Proactive Diversion Report (or anomalous usage report) will be printed in Pharmacy and reviewed by a member or the Pharmacy Management, or designee, as a screening tool for ADC users ..." The pharmacy did not proactively monitor for potential PACU scheduled drug diversion.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation, interview, and administrative record review, the hospital failed to ensure pharmaceutical services for all patients, were provided in accordance with Federal and State law as evidenced by:

1. The hospital failed to ensure Hospital 2 had a pharmacy license. Hospital 2 provided patient care and pharmacy services to patients from 2/12/14-7/17/14. Pharmacy is an area, place, or premises licensed by the California Board of Pharmacy (the board) in which the profession of pharmacy is practiced and where prescriptions are compounded (mixed). Pharmacy includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances (medications with a potential for diversion and abuse), dangerous drugs, or dangerous devices are stored, possessed, and dispensed) . Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14. Hospital 2 provided care to 1,694 patients, from 2/12/14-7/17/14, without the required pharmacy license.

2. The hospital failed to ensure Hospital 2 was registered with the Drug Enforcement Administration (DEA, enforces controlled substances (scheduled medications) laws and regulations). Hospital 2, from 2/12/14-8/5/14, received, stored, and dispensed, scheduled medications (medications with the potential for diversion (theft) and abuse). Hospital 2, from 2/12/14-8/5/14, did not have a controlled substance registration certificate. Hospital 2, from 2/12/14-8/5/14, provided care to 1,912 patients without the required controlled substance registration.
These failures put all patients at risk for harm.

Findings:

1. During a group interview, on 11/12/14 at 2 pm, Hospital 2's pharmacy leadership was asked to describe the pharmacy licensure history for the past 1 year. The pharmacy leadership group included: Director of Pharmacy (DOP), Pharmacist (Pharm 1), and Pharmacist (Pharm 2). The group stated Hospital 2 did not have a California Board of Pharmacy issued pharmacy license from 2/12/14-7/17/14. DOP and Administrator (Admin 1) were asked if Hospital 2, from 2/12/14-7/17/14, required a pharmacy license. DOP and Admin 1 stated Hospital 2 required a pharmacy license from 2/12/14-7/17/14. The hospital was asked to provide the number of patients admitted to Hospital 2 from 2/12/14-7/17/14.

During an interview, on 11/13/14 at 8:30 am, in Hospital 2's pharmacy, Pharm 2 was asked to describe how medications were stored and dispensed (medication distribution process (pharmacy services)) for the past year. Pharm 2's description included that medications were stored in four automated drug dispensing cabinets (ADC) in Hospital 2. Pharm 2 stated that nurses removed medications from the ADCs for administration to patients.

During a concurrent tour and interview, on 11/13/14 at 9:07 am, on the 1 north nursing unit (patient care area), Pharm 2 identified an ADC. Inspection of the ADC showed it contained vials of 10 mg (milligram) morphine (pain medication) for injection.

During a concurrent interview and administrative record review, on 11/13/14 at 3:20 pm, Administrator (Admin 2) identified a census report. Review of the census report showed Hospital 2, from 2/12/14-7/17/14, admitted 1,694 patients.

An administrative record review, of the hospital's Board of Pharmacy, Hospital Pharmacy Permit (State of California), showed "License No. HSP ...Issue Date ...July 17, 2014 ...Hospital 2." Hospital 2's pharmacy license issue date was July 17, 2014.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A."The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed 1. State of California:,"Pharmacy Services will be provided according to the regulations of the Department of Public Health as stated in Title 22 for licensed acute care hospitals." Hospital 2 did not have a pharmacy license from 2/12/14-7/17/14.

2. During a group interview, on 11/12/14 at 2 pm, Hospital 2's pharmacy leadership was asked to describe the controlled substance registration certificate (DEA registration) history for the past 1 year. The leadership group included: Director of Pharmacy (DOP), Pharmacist (Pharm 1), and Pharmacist (Pharm 2). The group stated Hospital 2 did not have a controlled substance registration certificate from 2/12/14-8/5/14. DOP and Administrator (Admin 1) were asked if Hospital 2, from 2/12/14-8/5/14, required a DEA registration. DOP and Admin 1 stated Hospital 2 required a DEA registration from 2/12/14-8/5/14. The hospital was asked to provide the number of patients admitted to Hospital 2 from 2/12/14-8/5/14.

During an interview, on 11/13/14 at 8:30 am, in Hospital 2's pharmacy, Pharm 2 was asked to describe the medication distribution process (pharmacy services) for the past year. Pharm 2 stated that medications were stored in four automated drug dispensing cabinets (ADC) in Hospital 2.

During a concurrent tour and interview, on 11/13/14 at 9:07 am, on the 1 north nursing unit, Pharm 2 identified an ADC. Inspection of the ADC showed it contained 10 mg (milligram) morphine (pain medication (controlled substance)) for injection. Pharm 2 confirmed the ADC contained 10 mg morphine for injection.

During a concurrent interview and administrative record review, on 11/13/14 at 3:20 pm, Administrator (Admin 2) identified a census report. Review of the census report showed Hospital 2, from 2/12/14-8/5/14, admitted 1,912 patients.

An administrative record review, on 11/19/14 at 9:42 am, of the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion control website at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm#3 <http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm> showed, Section III-Registration Requirements, New Pharmacy Registration,"Every pharmacy that dispenses a controlled substance must be registered with the DEA. First a state license must be obtained." Hospital 2, from 2/12/14-8/5/14, was not registered with the DEA.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A."The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed B. Federal:, 1."The hospital will comply with all laws, regulations and requirements of the Drug Enforcement Administration (DEA), 2. The hospital will maintain current and valid registration with DEA ..." Hospital 2, from 2/12/14-8/5/14, did not maintain current and valid registration with the DEA.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview, and administrative record review, the hospital failed to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in accordance with State law. The hospital failed to ensure the cancer center pharmacy was licensed by the California Board of Pharmacy (Ca BoP) to compound sterile intravenous (IV, directly into a vein) medications. The hospital compounded sterile hazardous (chemotherapy, used to treat cancer) IV medications. The hospital did not have the required Ca BoP sterile compounding license. The cancer center pharmacy, from 7/1/14-11/11/14, compounded 3,830 IVs without a sterile compounding license. This placed all patients receiving cancer treatment at risk for harm due to potential contaminated medications.

Findings:

During a concurrent tour and interview, on 11/13/14 at 9:15 am, in the cancer center pharmacy, three personnel were observed compounding hazardous (dangerous) IV medications. Pharmacy Manager (PM 1) identified the three personnel as a pharmacist and two pharmacy technicians. PM 1 stated they were compounding IV doxorubicin (chemotherapy medication) and dacarbazine (chemotherapy medication). PM 1 stated that the cancer center pharmacy compounded sterile IV medications for patients being treated at the cancer center. PM 1 said "Currently we do not have a sterile compounding license but we have applied for it."

During an interview, on 11/13/14 at 9:40 am, the Director of Pharmacy (DOP) acknowledged that he was aware the cancer center pharmacy did not have a sterile compounding license.

An administrative record review, on 11/18/14, at 1:30 pm, of the California Board of Pharmacy website at http://www.pharmacy.ca.gov/applicants/index.shtml#sterile_injectable_compounding <http://www.pharmacy.ca.gov/applicants/index.shtml> showed, Sterile Injectable Compounding Pharmacy License, "A pharmacy may not compound injectable sterile drug products in California unless it is specially licensed with the board as a sterile compounding pharmacy ..."

An administrative record review, on 11/18/14 at 1:30 pm, of the California Board of Pharmacy website at <http://www2.dca.ca.gov/pls/wllpub/WLLQRYNA$LCEV2.ActionQuery>, did not show the cancer center pharmacy was licensed to compound sterile intravenous medication.

An administrative record review, of the hospital's policy and procedure for Competency, Licensure & Professional Standards-Pharmacy (Last Reviewed/Approved: 2/12/2014), showed I. Policy:, A. "The Pharmacy Services Department will operate within all applicable state and federal laws, regulations and licensure requirements." Continued review showed 1. State of California:, b. "All laws, regulations and licensure requirements of the California State Board of Pharmacy will be met and followed." The cancer center pharmacy did not have a sterile compounding license.

An administrative record review, of the hospital's policy and procedure for Improving Organizational Performance (IOP)-Pharmacy (Last Reviewed/Approved: 2/12/2014) showed, II. Objectives;, C. "To meet regulatory, licensing and certification requirements of the state Department of Health, Joint Commission on the Accreditation of Hospitals and California Medical Review, Inc."

An administrative record review, of the hospital's Cancer Center Stats (7/1/14-11/11/14) showed the cancer center pharmacy mixed 3,830 IVs.