HospitalInspections.org

Based on interview and record review, the hospital failed to ensure that state licensure standards were met as follows:

1. The California Department of Public Health (CDPH) was not notified of a relocation of outpatient services to a new, unlicensed off-campus location at 2450 Oro Dam Boulevard, Oroville. This failure prohibits CDPH from providing the required oversight for patient safety and quality of care.

2. The hospital failed to review and update their policy and procedure for Infant/Child Security within the last two years. This failure had the potential to negatively impact the protection and safety of infants and children in the hospital.

3. The hospital failed to ensure that 49 medical records were completed within two (2) weeks following the patient's discharge. This failure had the potential to adversely impact the patient's continuing care, since copies of reports are routinely shared with the post-hospital team.

Findings:

1. The California Code of Regulations, Title 22, Division 5, Chapter 1, Article 4 70301(a) reads, "Any licensee desiring to establish or conduct, or who holds out, represents or advertises by any means the provision of a supplemental service, shall obtain prior approval from the Department..."

The California Code of Regulations, Health and Safety Code, Section 1253 (a) reads:

(a) No person, firm, partnership, association, corporation, or political subdivision of the state, or other governmental agency within the state shall operate, establish, manage, conduct, or maintain a health facility in this state, without first obtaining a license therefor as provided in this chapter, nor provide, after July 1, 1974, special services without approval of the state department. However, any health facility offering any special service on the effective date of this section shall be approved by the state department to continue those services until the state department evaluates the quality of those services and takes permitted action....
1253.6 (c) Upon determination by the department that an application for an outpatient clinic service as a supplemental service is complete pursuant to subdivision (b), the department shall investigate the facts set forth in the application and, if the department finds that the statements contained in the application are true, that the establishment of the operation of the supplemental service are in conformity with the intent and purpose of this chapter, and that the applicant is in compliance with this chapter and the rules and regulations of the department, the department shall approve the additional or modified outpatient clinic service, add it to the hospital license, and issue a new license. However, if the department determines in the course of the investigation that additional information is needed to determine whether the statements contained in the application are true or that the establishment or the continued operation of the supplemental service are in conformity with the intent and purpose of this chapter, or that the applicant is in compliance with this chapter and the rules and regulations of the department, the applicant shall provide the additional information to the department upon request. If the department finds that the statements contained in the application are not true, or that the establishment of the outpatient service as a supplemental service is not in conformity with the intent and purpose of this chapter, or if the applicant fails to provide any additional information to the department within 30 days of the request, the department shall deny the outpatient clinic services application. The department shall either grant or deny the application for the outpatient clinic service as a supplemental service within 100 days of the filing of a completed application.
(d) If a licensed general acute care hospital has previously been approved for an outpatient clinic service within 30 days after receipt of a completed application for an additional outpatient clinic service, the department shall approve the additional or modified outpatient clinic service, add it to the hospital license, and issue a new license, unless the applicant does not meet the requirements of this section. Notwithstanding any other law, the department shall not be required to conduct an onsite inspection prior to approval of an outpatient clinic service pursuant to this section. However, nothing shall preclude the department from conducting an onsite inspection at any time, or denying an application, in accordance with subdivision (c). If the department determines that the applicant does not meet the requirements of this section, the department shall provide the hospital, in writing, the particular basis for this determination.

The CDPH All Facilities Letter (AFL) 10-28, dated 3/17/11, that was sent to all general acute care hospitals, read, "Legislation which became effective January 1, 2009,...requiring general acute care hospitals... to provide at least 30 days advance notice before closing or eliminating or relocating supplemental services to a different campus... Documentation of the required advance notice to CDPH advising of the facility closure or the elimination or relocation of a supplemental service to a different campus and the date of notification.
· Documentation of the required advance notice to the local county Board of Supervisors advising of the facility closure or the elimination or relocation of a supplemental service to a different campus and the date of notification.
· Documentation of the public postings notating the date of relocation, closure or elimination of the supplemental service."

On 8/6/15, the hospital's website listed the following services available at the above location:
-Multi-specialty Practice, including Internal Medicine, Cardiology, Nephrology, and Urology
- Golden Valley Outpatient Rehabilitation Center
- Dove's Landing Pharmacy

Two other services, Aesthetic Medicine and Urgent Care Clinic, were listed on the website as "OPENING SOON."

CDPH sent the hospital a letter regarding the Dove's Landing site, dated 3/19/15, that read, "Please inform this office, in writing, when you will be ready for an inspection and a visit will be scheduled. It is the Department's policy that, in except in unusual circumstances, only one inspection visit will be made; and that failure of the service to be in substantial compliance with the requirements for approval at the time of visit, will result in the denial of the application." CDPH records further indicated that the last contact with the hospital contact was on 6/10/15 in which the hospital informed CDPH that the new outpatient location was hoping to be ready for CDPH inspection by the beginning of July 2015.

On 8/5/15, the job description for the Clinic Manager, dated 4/12/12, indicated direct reporting relationship to the CEO. The job description read, "Collaboratively with the Director of Nurses, upholds and implements the goal of the hospital and works toward meeting current ...Title 22 standards

On 8/4/15 at 3:45 pm, the Chief Executive Officer (CEO) indicated that the Clinic Manager was responsible for coordinating the licensing visit with CDPH but he, the CEO was responsible to oversee that it was done. CEO stated the above services moved into the new location and began seeing patients on 7/27/15. The CEO reviewed their records and confirmed that CDPH had not been notified. The CEO was asked for the policy or guidelines the hospital uses to open new services, and he responded that they did not have one.

CDPH received a a fire safety inspection clearance form, dated 7/29/15, two days after patient services began at the above location.


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2. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70738 reads, "Written policies and procedures shall be adopted and implemented to accurately identify infants and to protect infants from removal from the facility by unauthorized persons. The policies and procedures shall be reviewed and updated by the facility every two years."

During an interview and document review on 8/5/15 at 1:30 pm, Perinatal Clinical Nurse Specialist A confirmed the Policy and Procedure titled, "Infant/Child Security" was last reviewed 3/2011. She confirmed the policy was overdue for review.



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3. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70751(g) reads, "Medical records shall be completed promptly and authenticated or signed by a physician, dentist or podiatrist within two weeks following the patient's discharge..."

The "HIM (Health Information Management ) Chart Deficiency Data Collection-2nd Quarter" report was reviewed with HIM Staff A on the morning of 8/6/15. She explained that as of 8/3/15, there were 263 delinquent records (those that were still incomplete two weeks (14 days) following the patient's discharge. Of these, 49 records required the physician's completion of a discharge summary.

Based on interview and record review, the hospital failed to ensure that personnel evaluations were done annually for nine of 17 employees. This failure had the potential for competency to not be assessed which could negatively impact a patient's health status. (Physical Therapy Assistant A, Human Resources Staff 1, 2, 3, and 4 and Pharmacist 1(RPH 1), and 3 (RPH 3), Pharmacist Manager 1 (RPH MGR 1), and Director of Pharmacy (DPH) )

Findings:

On 8/6/15, the hospital policy, titled, "Employee Performance Evaluation," last reviewed 8/2015 was reviewed. The first sentence stated: "All employees of Oroville Hospital will receive a Performance Evaluation at least annually."

1. Physical Therapy Assistant A's file was reviewed and contained no evidence of a performance evaluation since 8/7/13, approximately two years prior.

On 8/5/15 at 2:50 pm, Human Resource Staff A acknowledged that an annual performance evaluation was not performed.



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2. Beginning at 1:10 pm on 8/5/15, the human resources files of four employees (Human Resource Staff 1, 2, 3 and 4) in the Health Information Management department were reviewed. None of the files contained an annual performance evaluation for every year since 2013 to present date (8/5/15). This finding was confirmed concurrently by Human Resource Director.



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3. The facility failed to assure four of eight sampled pharmacists (RPH 1, RPH 3, RPH MGR 1, and DPH) were evaluated annually to determine if each had met published professional standards as they related to pharmaceutical services provided (e.g. ASHP standards) to prevent harm for adverse outcomes as a result of preventable mediation errors as evidenced by the following:

Definition: The American Society of Health System Pharmacists (ASHP) develops official professional policies, in the form of policy positions and guidance documents (statements and guidelines), for the continuum of pharmacy practice settings in integrated systems. [Reference: www.ashp.org]. These standards include six domains: Leadership and Practice Management, Drug Information and Education, Optimizing Medication Therapy, Medication Distribution and Control, Facilities, Equipment, and Information Resources, and Research. [Reference: Am J Health-Syst Pharm 1995; 52:2711-7.]

A review of the hospital's policy, titled, " Employee Performance Evaluation, " dated 8/15, showed, " All employees of Oroville Hospital will receive a Performance Evaluation at least annually."

On 8/6/15 at 10:15 a.m., in an interview the Director of Human Resources and Privacy Officer (DHRPO) DHRPO was asked to provide documentation that a performance appraisal was conducted for each of the sampled pharmacists within the past year. The DHRPO gestured to personnel files for RPh 1, RPh 3, RPH MGR 1 and the DPH, and said, "I don't think we have these."

On 8/6/15 a review of the human resources files review of personnel files for RPh 1, RPh 3, RPH MGR 1 and the DPH showed no documentation that a performance evaluation had been conducted within the previous year as required for four pharmacists as follows:

*The last performance evaluation on file for RPh 1 was dated 6/17/13;
*The last performance evaluation on file for RPh 3 was dated 4/10/13;
*The last performance evaluation on file for RPH MGR 1 was dated 8/17/10; and
*No performance evaluation was available for the DPH since he was hired in 2004.
The DPH was unavailable to interview about his direct reports as he was on an excused absence.

The ADPH was unavailable to interview.

A review of the hospital's policy, titled, "Job Description for Director of Pharmaceutical Services", dated 7/23/08, showed the Director of Pharmaceutical Services reports to the Chief Operating Officer. The job description showed provisions for supervision and coordination with ancillary professional departments; however, it showed no requirement, based on the needs of the patients, to set goals for the pharmacy, to develop plans and schedules for meeting goals, to direct the implementation of the plans, to determine whether the goals and schedules are met, or to institute corrective actions. A review of the job description showed no reference for professional standards outside the employee's job description; however, the job description required, "Maintains a level of service which is consistent with modern concepts and advances in the delivery of institutional based pharmaceutical service."

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard I ,"Leadership and Practice Management", showed, "The director of pharmacy shall be responsible for setting the short- and long-term goals of the pharmacy based on the needs of the patients served, the specific needs of the hospital ...and developments and trends in health care and hospital pharmacy practice, developing plans and schedules for achieving these goals, directing the implementation of the plans and day-today activities associated with them, determining whether the goals and schedule are being met, and instituting corrective actions where necessary." [Reference: Am J Health-Syst Pharm 1995; 52:2711-7.] The section for Standard I also described: education and training standards under the following headings: the [pharmacy] Director, a pharmacy mission, support personnel, work schedules and assignments, education and training, recruitment and selection of personnel, performance evaluation, position descriptions, operations manual, drug expenditures, workload and financial performance, committee involvement, quality assessment and improvement, 24 hour pharmaceutical services, after hours pharmacy access, practice standards and guidelines, laws and regulations, and patient confidentiality.

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard II "Drug Information and Education" described standards under the following headings: drug information requests, mediation-therapy monographs, patient education, and dissemination of drug information.

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard III "Optimizing Medication Therapy" described standards under the following headings: medical record documentation, medication histories, medication orders, mediation-therapy monitoring, therapeutic purpose, pharmacist consultations, medication use evaluations, medication use policy development, documentation of pharmaceutical care and outcomes, continuity of care, work design initiatives, clinical care plans, microbial resistance, mediation therapy decisions, immunization programs, and substance abuse programs.

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard IV, "Medication Distribution and Control" described standards under the following headings: medication orders, formulary, prescribing, extemporaneous compounding, sterile products, unit dose packaging, medication storage, adverse drug reactions, medication errors, drug product recalls, patient's own mediations, vendor's representatives, samples, manufacturers and suppliers, cytotoxic and hazardous drug products, controlled substances, nondrug substances, medication storage area inspections, floor stock, disaster services, medical emergencies, and drug delivery systems, administration devices, and automated dispensing machines."

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard V, "Facilities, Equipment, and Information Resources" described standards under the following headings: medication storage, packaging and compounding, cytotoxic and hazardous drug products, drug information, consultation space, office and meeting space, automation, record maintenance, and computerized systems."

The ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" section, Standard VI, "Research "described standards under the following headings: policies and procedures, distribution and control, institutional review board, and drug information.

On 8/6/15 at 1:45 p.m., in an interview, the Chief Operating Officer said, "I don ' t supervise [DPH]. The COO indicated he had never conducted a performance evaluation. He indicated he was not in a position to know what standards were used to evaluate the DPH. The COO explained that the CEO was the DPHs supervisor.

On 8/6/15 at 2:30 p.m., in an interview, the Chief Executive Officer (CEO) indicated he was the immediate supervisor for the DPH. The CEO indicated he had evaluated the DPH on several occasions in discussions where he authorized pay raises. The CEO said, "There is nothing in writing." The CEO indicated criteria existed for evaluating performance of professional staff assigned.

A review of the hospital's undated Employee Performance Evaluation Form for "Pharmacy Department" showed a section, "Area of Responsibility as Listed in Appropriate Job Description" with a check boxes for each of 35 evaluable areas which included: observance of working hours, attendance, observance of safety rules, quality of work, amount of work, ability to organize own work, initiative, cooperation, adaptability, relation to others, judgement, ability to learn, dependability, appearance, maintains confidentiality of medical information ..., fosters an environment that nurtures collaboration ..., participates in orientation ...staff meetings ..., maintains compliance with ...all regulatory agencies requirements, interprets physicians orders ..., may be responsible for scheduling the administration of medication to provide optimal effect if the physician did not specify times for administration, provides clinical drug information, may present clinical conference to nurses, maintains a patient record system, may participate in the decision making process of drug selection, may be a team member of cardiac resuscitation team, participates in teaching pharmacy students, supervision of pharmacy assistant, compounds prescriptions, dispensed prescriptions using accepted, good pharmaceutical technique, responsible for control of drug inventory, supplies and floor stock, participates when needed in pharmacy drug information service, responsible for correct preparation of patient charge documents, participates in professional association activities, and responsible for following department policies and procedures." Instructions on the form indicated that checking a box under one of four columns to the right of each of the 35 areas corresponded to "Does not Meet Standards", "Meets Standards", "Exceeds Standards" or "Outstanding."

A review of the hospital's policy, titled, " Employee Performance Evaluation, " dated 8/15, showed, "Performance evaluations will be based on criteria set forth in the job description ...The Performance appraisal process is separate from the company's pay increase process. All pay increases will be processed separately from the performance appraisal."

Based on staff interview, record review, and document review, the hospital's Governing Body (GB) failed to effectively govern the hospital and ensure compliance with federal regulations, as evidenced by the following:

1. The GB failed to ensure that Medical Staff Members and Distant-Site physicians were fully and properly credentialed prior to being granted clinical privileges. Refer to A 51; A 52 & A 343.

2. The GB failed to ensure that contracted services had provided services which were safe, effective and permitted the hospital to comply with all applicable conditions of participation. Refer to A 83; A 84; A 85 & A 343.

3. The GB failed to ensure that the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement program. Refer to A 263; A 308; A 83; A 84; A 85, A 273, and A 343.

4. The GB failed to ensure adequate resources were allocated for measuring, improving, and sustaining the hospital's performance. Refer to A 315.

5. The GB failed to ensure that nursing services were furnished or supervised by a registered nurse and were consistent with nationally accepted standards of practice. Refer to A 405, findings 1-3, A 412, A 395, and A 396.

6. The GB failed to have a pharmaceutical service, with demonstrated competency, that stored and distributed medications in a safe and effective manner. Refer to A 490, A 491, findings 1-5, A 492, findings 1-6, A 501, findings 1-3, A 502, and A 505.

7. The GB failed to ensure an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases. Refer to A 747, A 748, findings 1-4, A 749, findings 1-15, A 713, and A 724, findings 1-3.

8. The GB failed to ensure surgical services were well organized and in accordance with nationally recognized standards of practice, in order to ensure safe and high quality surgical care to all patients. Refer to A 940, findings 1-5, A 952, findings 1 and 2, A 749, findings 4, 5, 6, 9, 10, 12, and 13.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Governing Body.

Based on staff interview and document review, for 20 of 20 distant-site radiologists (physician who perform X-rays) (TRad 1 thru TRad 20), the hospital's Governing Body (GB) failed to enforce hospital credentialing protocol by permitting members of the Distant-Site Telemedicine Entity's (DSTE) medical staff to exercise clinical services in the hospital, without prior credentialing and based solely upon their membership in a specialty body and employment by the DSTE. This failure allowed patients to receive medical care provided by essentially unknown radiologist with unknown qualifications or training, and without the required certification and credentialing mandated by this hospital's medical staff bylaws and rules, potentially exposing patients to risk of harm.

Findings:

On 8/3/15 the hospital's medical staff bylaws, rules and policies pertaining to Medical Staff (MS) credentialing were requested and provided. The hospitals contract(s) with any DSTE(s) and any related documentation showing related actions taken by the GB were requested; these documents were provided and reviewed on 8/4/15 and 8/5/15.

On 8/4/15 at 4 p.m., during an interview, the hospital's Administrator (Admin) stated that the hospital had very recently (7/17/15) entered into an agreement with a Distant-Site Telemedicine Entity (DSTE-1) which was currently providing tele-radiology (radiologists located in cities and other locations away from the hospital, who reviewed via computer transmission and interpreted X-ray study data for X-ray studies performed by the hospital's radiology department) services for the hospital. Admin acknowledged that the hospital had not requested nor obtained from DSTE-1, the entity's By-laws, Rules and Credentialing Standards which specified the policies, procedures or protocols detailing the manner in which DSTE-1 radiologist were credentialed and reviewed for ongoing professional proficiency review. Admin also stated that although the hospital had already begun using the services of these distant-site tele-radiologists, the GB had not reviewed the written contracts with DSTE-1 and had not formally documented the hospital's intent to rely on the credentialing information provided by DSTE-1. Admin stated that he was unsure of the extent to which the Medical Staff Coordinator had done credentialing review of the DSTE-1 radiologists.

On 8/5/15 at 3:45 p.m., during an interview and concurrent credential file review, the Medical Staff Coordinator stated that she had not assembled individual credential files for any of the 20 DSTE-1 radiologists (TRad-1 thru TRad-20) that were currently providing services. MS Coordinator stated she was the recognized custodian of all the MS Credential Files, and the only credentialing process that she performed for these Tele-Radiologists was to verify that each was currently listed by the California Medical Board to have a current California state medical license.

On 8/6/15 at 10:10 a.m., during an interview and after reviewing the information from MS Coordinator, Admin stated that to his knowledge the only credentialing evidence which the hospital presently had for the 20 Tele-Radiologists (TRad-1 thru TRad-20) was that each was currently on staff and employed by DSTE-1.

Based on staff interview and document review, for 20 of 20 tele-radiologists (physicians who perform X-rays) (TRad 1 thru TRad 20) the hospital's Governing Body (GB) failed to perform the required prerequisite review of the Distant-Site Telemedicine Entity's (DSTE) governance and credentialing processes before utilizing the services of DSTE tele-radiologists. This failure allowed patients to receive medical care provided by essentially unknown radiologist with unknown qualifications or training, and without the required certification and credentialing mandated by this hospital's medical staff bylaws and rules, potentially exposing patients to risk of harm.

Findings:

On 8/4/2015 at 4:00 p.m., during an interview, the hospital's Administrator (Admin) stated that the hospital had very recently (7/17/15) entered into an agreement with a Distant-Site Telemedicine Entity (DSTE-1) which was currently providing tele-radiology services for the hospital. Admin acknowledged that the hospital had not requested nor obtained from DSTE-1, the entity's By-laws, Rules and Credentialing Standards which specified the policies, procedures or protocols detailing the manner in which DSTE-1 radiologist were credentialed and reviewed for ongoing professional proficiency review. Admin acknowledged that as a result the Governing Body (GB) had failed to ensure, through the written contract dated 7/17/215, that each of the required provisions from the federal regulations [at CFR 42 §482.22 (3)] had been met:
" (i) The distant-site telemedicine entity's medical staff credentialing and privileging process and standards at least meet the standards at §482.12(a)(1) through (a)(7) and §482.22(a)(1) through (a)(2).
(ii) The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity providing the telemedicine services, which provides the hospital with a current list of the distant-site physician's or practitioner's privileges at the distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance of these privileges and sends the distant-site telemedicine entity such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients, and all complaints the hospital has received about the distant-site physician or practitioner."

On 8/6/15 at 10:10 a.m. Admin reiterated that the GB and hospital had failed to fulfilled the prerequisite regulatory steps to assure compliance for CFR 42 §482.12, in utilizing distant-site tele-radiologists services.

Based on staff interview and document review, for 386 of 386 known contracts, the hospital's Governing Body (GB) failed to ensure that contracted services were monitored to ensure that each contracted service was furnished in a manner which permits the hospital to comply with all applicable conditions of participation and standards for the contracted service(s). The GB failed to maintain an accurate list of all the contracts and failed to develop a mechanism designed to ensure that all services furnished under contracts are provided safely, effectively and in a manner that would always permit the hospital to comply with all applicable standards and conditions of participation.

Findings:

On 8/4/15 at 4 p.m. and again on 8/6/15 during interviews, the hospital Administrator (Admin) acknowledged that:

1. The hospital's current list of contracted services was incomplete and did not contain the scope and nature of the services provided. Refer to A 85 for details.

2. Quality Indicators (QI) and/or Performance Indicators (PI) had not yet been identified for each service. Refer to A 84 for details.

3. The hospital had not yet developed a mechanism designed to ensure that all services furnished under contracts are provided safely, effectively and in a manner that would always permit the hospital to comply with all applicable standards and conditions of participation. Refer to A 84 for details.

Based on document review and staff interview, for 386 of 386 known contracts, the hospital's Governing Body (GB) failed to ensure that contracted services were performed in a safe and effective manner when an effective quality oversight system to objectively measure and evaluate the performance of contracted service vendors, on a periodic basis, was not documented in a plan or policy to hold the governing body responsible to ensure that vendor services were continuously safe and effective. This failure put patients at risk for unsafe, ineffective or poor quality care and services.

Findings:

On 8/3/15 the hospital's list of all contracted services, the Quality Assessment and Performance Improvement (QAPI) Program Plan and any Policies or Procedures which governed any aspect of services utilized under contract and/or review of contracted services was requested.

On 8/4/15 the list of contracted services and the current QAPI Plan had been provided and was reviewed. The list of contracted services contained 386 line entries, but did not contain all services which were utilized in the hospital and did not contain the scope and nature for each service. The QAPI plan contained 3 pages and was titled "Oroville Hospital Quality Improvement Plan 2015." The plan did not contain any information concerning a mechanism for review of contracted services.

On 8/4/15 at 4 p.m. during an interview, the hospital Administrator (Admin) acknowledged that the hospital's current list of contracted services (386 of 386) was incomplete and did not contain the scope and nature of the services provided. He also acknowledged that Quality Indicators (QI) and/or Performance Indicators (PI) had not yet been identified for each service or contract which could be utilized to monitor the contracted services, in a manner which could reasonably determine the service(s) was/were safe, effective and delivered quality. He also stated that he was unsure if all contracts contained language which required of each provider that services would be delivered in a manner that could facilitate the hospital's compliance with all applicable conditions of participation and standards for the contracted services.

On 8/6/15 at 10:10 a.m., Admin was again interviewed. He repeated his statement that the hospital's list of contracts was incomplete and that QI's or PI's had not been identified which could help the hospital assure that contracted services were safe, effective and provided in a manner that could facilitate the hospital in being compliant with all applicable federal regulations. He agree that the hospital did not have in place sufficient mechanisms to ensure that all services were safe, effective and assisted the hospital in complying with all applicable standards and conditions of participation.

Based on document review and staff interview, for 386 of 386 known contracts, the hospital's Governing Body (GB) failed to maintain a list of all contracted services, including the scope and nature of the services provided. The list did not include:

1. Distant-Site Telemedicine Entity (DSTE 1) which was currently providing tele-radiology (X-ray services) services; and

2. The transcription/dictation company.

This failure to have a full and detailed list of all contrated services, could cause a failure to review one or more contracted services and thus put patients at risk for unsafe, ineffective or poor quality care and services.

Findings:

On 8/3/15 the hospital's list of all contracted services was requested. On 8/4/15 at 10:30 a.m. the list was provided and reviewed. The list contained 386 line items, each one with the name of the vendor (company) that provided the services. The names of several vendors appeared multiple times on the list, each for a separate service. The list did not clearly list the scope and nature for each service.

On 8/4/15 thru 8/6/15, review of the list showed the following services were not included:

1. The list did not contain information about the DSTE-1 which was currently providing tele-radiology services for the hospital.



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2. The master list of contracted services did not include the medical transcription/dictation company. The agreement was reviewed on the morning of 8/4/15; it was effective in June, 2011.

During an interview with Health Information Management Staff A on 8/5/15, she confirmed the service is used regularly.

On 8/4/15 at 4 pm during an interview, the hospital Administrator (Admin) acknowledged that the hospital's current list of contracted services was incomplete and did not contain the scope and nature for each of the services utilized.

Based on observation, interview and policy review, the hospital failed to ensure one of 30 sampled residents' electronic medical records was secure, when the mobile computer work station was left unattended, unsecured, and visible in the hall of Unit 1.

Findings:

During an initial tour of Unit 1 on 8/3/15 at 9:45 am with Administrative (Adm) Nurse C, a mobile charting station was observed in the hallway by the nurse's station. The mobile charting station was unattended and opened to Patient 12's record. Patient 12's record was clearly and easily visible to passers by. Adm Nurse C concurrently confirmed that the mobile charting station was left unsecured and the screen should have been minimized to eliminate visibility.

On 8/4/15, the hospital's Confidentiality of Protected Health Information policy, dated 8/14, showed that leaving a computer work station unsecured (especially with personal health information displayed onscreen) was a "Violation/Breach of Patient confidentiality" and that appropriate levels of protection of confidentiality must be afforded to all computerized personal health information.

The hospital's Information Systems Confidentiality and Security Policy, dated 4/20/15, showed that failure to log off the computer when finished can result in unauthorized individuals being able to view the information left on the screen and was a security violation.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement, as evidenced by the following:

A. The Quality Assessment and Performance Improvement (QAPI) Program did not contain review of all department and services, including Contracted Services and nor utilized specific Quality Indicators (QI) and/or Performance Indicators (PI) selected to ensure each service was safe, effective and provided services and which facilitated the hospital's compliance with all applicable conditions of participation and standards for the service and care provided. Refer to A 83, A 84, A 85, A 273, findings 1-4, and A 308.

B The GB failed to fulfill its responsibility to review the written contract with the Distant-Site Telemedicine Entity (DSTE), so that all of the required provisions for the federal regulation at CFR 42 §482.22 (3) had been met prior to allowing Tele-radiologists to provide services without a credentialing process (QAPI process) within the hospital. Refer to A 51 & A 52.

C. The GB failed to provide adequate resources for measuring, improving, and sustaining the hospital's performance. Refer to A 315.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Quality Assessment and Performance Improvement.

Based on interview and record review, the hospital failed to ensure that the hospital had a comprehensive quality program to assess the effectiveness and safety of services and quality of care, as follows:

1. The hospital quality plan failed to identify indicators reflective of all services and care provided.

2. Failure to adequately monitor the adequacy of pharmaceutical storage.

3. Failure to monitor the completion of annual performance evaluations.

4. Failure to monitor the accuracy and adequacy of health information management processes.

These failures had the potential for ineffective and unsafe services and care practices to persist and negatively impact patients' health status.

Findings:

1. On 8/6/15 the hospital's 2015 Quality Improvement Plan (QIP) was reviewed. The QIP read, "The Administration shall be accountable to the Board for the quality of patient care.... They shall receive reports from and assure the appropriate performance of all Hospital Departments and Committees as it relates to the Quality Projects."

On 8/6/15 at 10:30 am, Quality Director (QD) reviewed the QIP and acknowledged that it did not contain quality indicators and/or data collection that represented all the departments and services that provided service and care, including contracted services.

2. On 8/3/15, 27 of 35 sampled routine pharmacy inspection reports (to ensure proper medication storage) were incomplete or not performed for the fifteen patient care areas administering medications. Refer to A 491 for further details.

On 8/3/15 at 3:11 pm. the Director of Pharmacy acknowledged the monitoring was not complete and actions had not been documented to correct identified problems.

3. On 8/6/15 at 10:30 am, QD was asked if the completion of employee performance/competency evaluations was monitored. Refer to A 23, findings 1-4. QD acknowledged completion of employee performance evalations was not reported to the Quality Assurance Committee.



11389

4. During an interview with Staff Health Information Management Staff (HIM) A on the afternoon of 8/4/15, the quality assessment and improvement activities were discussed. There was no formal measuring and analyzing of quality indicators for the services provided by contracted companies/individuals (including release of patient information, medical transcription, and coding). Nor was the quality of work of the health information department employees monitored and reported through the quality program channels. HIM A acknowledged that the only monitoring reported to the medical staff Quality Assessment and Improvement Committee was regarding the number of delinquent records.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the hospital's organization and services. The QAPI Program did not review all hospital departments and each of the services, including 386 of 386 listed contracted services. The GB failed to identify Quality Indicators (QI) and/or Performance Indicators (PI) which had been selected to ensure each contracted service was safe, effective and provided services which facilitated the hospital's compliance with all applicable conditions of participation and standards for the contracted services.

Findings:

On 8/6/15 thehospital's 2015 Quality Improvement Plan (QIP) was reviewed. The QIP read, "The Board (of Trustees, GB) will also receive and evaluate reports from the Administration and Medical Staff who have responsibility to address the quality of patient care and safety through the organization."

On 8/3/15 the hospital's list of all contracted services was requested. On 8/4/15 at 10:30 am, the list with 386 contracts was provided and reviewed.

Medical staff bylaws, rules and policies pertaining to Medical Staff (MS) credentialing were requested and provided. The hospitals contract(s) with any Distant Site (DSTEs) and any related documentation showing related actions taken by the GB were requested; these documents were provided and reviewed on 8/4/15 and 8/5/15.

On 8/4/15 at 4 pm, during an interview, the hospital Administrator (Admin) acknowledged that the hospital's current list of contracted services was incomplete and did not contain the scope and nature of the services provided. (Refer to A 84 for further details). Admin also acknowledged that Quality Indicators (QI) and/or Performance Indicators (PI) had not yet been identified for each service or contract which could be utilized to monitor the contracted services, in a manner which could reasonably determine the service(s) was/were safe, effective and delivered quality. Admin also stated that he was unsure if all contracts contained language which required of each provider that services would be delivered in a manner that could facilitate the hospital's compliance with all applicable conditions of participation and standards for the contracted services.

On 8/6/15 at 10:10 am, during an interview and after reviewing the information from MS Coordinator, Admin stated that to his knowledge the only credentialing evidence which the hospital presently had for the 20 Tele-Radiologists (physicians who provide X-ray services) (TRad-1 thru TRad-20) was that each was currently on staff and employed by DSTE 1.

Based on interview and document review, the hospital failed to ensure that adequate resources for measuring, improving, and sustaining the hospital's performance were in place. This failure has resulted in a quality program that was not comprehensive to address all areas of care and service, unable to effectively evaluate non-compliance, does not design action plans to improve performance, and does not ensure sustained compliance with regulatory statutes and professionally accepted standards of practice. This failure had the potential to lead to adverse patient outcomes and ineffective patient care.

Findings:

On 8/6/15 at 10:20 am during a review of the quality plan and other quality monitoring documents, the Quality Director (QD) explained that she was responsible for the oversight of the quality program with the assistance of one non-clinical specialist. QD further explained that she was responsible for the utilization review oversight (appropriateness of care and services), including case management (assists patients with post hospitalization concerns), and served as the corporate compliance officer. When asked about the lack of a comprehensive quality plan that included all areas of care and service (refer to A 273 and A 308), QD stated that the quality program had been larger (more indicators) in the recent past but she had been directed by the Chief Executive Officer (CEO) to reduce the number of indicators. QD further stated that she was unable to do more with the resources she had available.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to fulfill its regulatory obligations prior to: 1) utilizing tele-radiological services (X-ray services) under a service contract with a Distant-Site Telemedicine Entity (DSTE), and 2) relying upon the credentialing and privileging decisions made by the DSTE under a credentialing agreement.

Under 42 CFR §482.12, in order to properly utilize these contracts, the hospital's governing body must first "ensures, through its written agreement with the distant-site telemedicine entity, that the distant-site telemedicine entity furnishes services that, in accordance with §482.12(e), permit the hospital to comply with all applicable conditions of participation for the contracted services.
The hospital's governing body must also ensure, through its written agreement with the distant-site telemedicine entity, that all of the following provisions are met:
(i) The distant-site telemedicine entity's medical staff credentialing and privileging process and standards at least meet the standards at §482.12(a)(1) through (a)(7) and §482.22(a)(1) through (a)(2).
(ii) The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity providing the telemedicine services, which provides the hospital with a current list of the distant-site physician's or practitioner's privileges at the distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance of these privileges and sends the distant-site telemedicine entity such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients, and all complaints the hospital has received about the distant-site physician or practitioner."

In failing to perform these regulatory obligations prior to granting clinical privileges to the distant-site radiologists, and also failing to conduct credentialing on these tele-radiologists in accordance with the hospital's Medical Staff Bylaws, Rules and credentialing standards, the GB allowed those professional privileges, dependent solely upon the fact they were members of the (DSTE) medical staff. These failures allowed patients to receive medical care provided by essentially unknown radiologists, with unknown qualifications or training, and without the required certification and credentialing mandated by this hospital's medical staff bylaws and rules, potentially exposing patients to risk of harm.

Findings:

On 8/3/15 the hospital's medical staff bylaws, rules, and policies pertaining to Medical Staff (MS) credentialing were requested and provided. The hospitals contract(s) with any DSTE(s) and any related documentation showing related actions taken by the GB were requested; these documents were provided and reviewed on 8/4/2015 and 8/5/2015.

On 8/4/15 at 4 p.m., during an interview, the hospital's Administrator (Admin) stated that the hospital had very recently (7/17/15) entered into an agreement with a Distant-Site Telemedicine Entity (DSTE-1) which was currently providing tele-radiology (radiologists located in cities and other locations away from the hospital, who reviewed via computer transmission and interpreted X-ray study data for X-ray studies performed by the hospital's radiology department) services for the hospital. Admin acknowledged that the hospital had not requested nor obtained from DSTE-1, the entity's By-laws, Rules and Credentialing Standards which specified the policies, procedures or protocols detailing the manner in which DSTE-1 radiologist were credentialed and reviewed for ongoing professional proficiency review. Admin also stated that although the hospital had already begun using the services of these distant-site tele-radiologists, the GB had not reviewed the written contracts with DSTE-1 and had not formally documented the hospital's intent to rely on the credentialing information provided by DSTE-1. Admin stated that he was unsure of the extent to which the Medical Staff Coordinator had done credentialing review of the DSTE-1 radiologists.

On 8/5/15 at 3:45 p.m., during an interview and concurrent credential file review, the Medical Staff Coordinator (MS Coordinator) stated that she had not assembled individual credential files for any of the 20 DSTE-1 radiologists (TRad-1 thru TRad-20) that were currently providing services. MS Coordinator stated she was the recognized custodian of all the MS Credential Files, and the only credentialing process that she had done for these Tele-Radiologists, was to verify that each was currently listed by the California Medical Board to have a current California state medical license.

On 8/6/15 at 10:10 a.m., during an interview and after reviewing the information from MS Coordinator, Admin stated that to his knowledge the only credentialing evidence which the hospital presently had for the 20 Tele-Radiologists (TRad-1 thru TRad-20) was that each was currently on staff and employed by DSTE-1.

Based on observation, interview, and record review, the facility failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice as evidenced by:

1. Failure to ensure registered nurses, who prepared immediate use compounded (combined) sterile products and administered them to six of six sampled patients (Patients 2, 3, 4, 5, 6, and 7) over a five day period had completed training or had competency verified in annual inservices. Refer to A 405, finding 1.

2. Failure to follow medication administration policies for three of 30 sampled patients. (Patients 1, 11 and 28). Refer to A 405, fnding 2-3, and A 412.

3. Failure to have a care plan that directed nurses on isolation procedures for multi-drug resistant organisms (MDROs are bacteria that many antibiotics cannot treat because they have built up resistance against them) for one of 30 sampled patients. (Patient 13) Refer to A 396.

4. Failure to ensure intravenous (IV, into the vein) sites were labeled with date and time for 13 of 30 sampled patients to prevent associated complications including infection. (Patients 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28) Refer to A 395.

The cumulative effect of these systemic problems had the potential to compromise the health of patients, cause injury or harm to patients due to inaccurate patient assessments, cross contamination, infection, and improper medication preparation and administration; and resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.

Based on observation, interview, and policy review, the hospital failed to ensure patients' IV (intravenous, tube that accesses the vein for medication administration) dressings were labeled for 13 of 30 sampled patients. This failure had the potential for a healthcare -acquired infection. (Patients 16, 17, 18, 19, 20, 21, 23, 24, 25, 26, 27 and 28)

Findings:

On 8/3/15, the hospital's "Dressing for Peripheral IV site" policy, dated 6/15, showed the "Date and time of IV insertion will be documented on the dressing..."

During an initial tour of the hospital's medical surgical units on 8/3/15 between 9 am and 10:45 am, the following patients' IV dressings were not labeled:

Patients 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28.

On 8/3/15 at 9:40 am, Administrative Nurse C confirmed that the patients' IV dressings should be labeled with the dates.

Based on observation, interview, and record review, the hospital failed to ensure one of 30 sampled patients' care plans were developed to address isolation to prevent the spread of infection, typically of multi-drug resistant organisms (MDROs are bacteria that many antibiotics cannot treat because they have built up resistance against them) . (Patient 13) This failure had the potential for patient exposure to infectious diseases.

Findings:

During an initial tour of the hospital on 8/3/15 at 10:22 am, Patient 13 was observed in Room 108, designated as an isolation room. Administrative (Adm) Nurse C confirmed that the patient in that room was in isolation for Vancomycin Resistant Enterococcus (VRE, a multi-drug resistant organism resistant to potent antibiotics).

On 8/4/15, Patient 13's record was reviewed showed he had a history of VRE and was put on isolation precautions. Patient 13's record listed isolation as a problem but there was no care plan present. The problems of preventing transmission of infection, potential for social isolation, education of staff and visitors for wearing personal protective equipment associated with Patient 13's isolation status, were not identified and care planned.

On 8/5/15 at 9 am, Adm Nurse C stated that the hospital's current electronic health record system was not set up to care plan isolation patients. She stated that the hospital had to contact the electronic health record system administrators to customize it and add care plans for isolation patients.

On 8/5/15, the hospital's "Daily Nursing Assessment - Plan of Care" policy, dated 6/15, showed that a plan of care was to be developed for patients' educational, psycho-social (emotional) and safety needs when identified.

Based on observation, interview, and record review, the hospital failed to ensure patient safety and continuity of care in accordance with hospital policies and accepted standards of practice for eight of thirty sampled patients (Patients 1, 2, 3, 4, 5, 6, 7 and 28) when:

1. A registered nurse Night Supervisor (RN SUPV) prepared immediate use compounded (combined) sterile products (IUCSPs) and administered them to five of thirty sampled patients (Patients 2, 3, 4, 5, and 7) over a five day period prior to completing training or having competency verified in annual inservices in accordance with hospital policies or standards of practice (e.g. United States Pharmacopeia Chapter 797) as adopted by the hospital. Hazardous drugs (chemotherapy, for cancer treatment) were administered by nurses in a manner not consistent with standards of practice (e.g. United States Pharmacopeia Chapter 797) adopted by the hospital as reflected in written policies.

2. A registered nurse (RN 1) in the Post Anesthesia Care Unit (PACU) did not perform hand hygiene prior to administering hydromorphone (a controlled substance schedule II opiate mediation used to treat moderate to severe pain) to one of thirty sampled patients (Patient 1) in accordance with the hospital's policies. RN 1 did not waste a partial dose of hydrocodone prior to administration to Patient 1, as required by the hospital's policy.

3. RN G failed to administer medication required for an elevated blood pressure according to physician's orders for one of 30 sampled patients. (Patient 28)

The hospital's failure to ensure nurses were competent to prepare, administer and use IUCSPs (as compounding personnel) in accordance with the hospital's adopted standards of practice placed patients at risk for adverse outcomes of fever and blood born infection complications related to medication errors associated with intravenous (IV, into the vein) administration of compounded sterile preparations. The hospital's failure to ensure a nurse performed hand hygiene and controlled substance waste procedures during a medication pass placed a patient at risk for infectious complications and contributed to the loss of control of the drug supply. The failure to respond to Patient 28's elevated blood pressure may have contributed to a decline in her condition that lead to resuscitative efforts and eventually her demise (death).

Definitions:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. [Reference: www.usp.org]

The U.S. Pharmacopeial - National Formulary (USP-NF) is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients (ingredient in medications that make it stick together), medical devices, and dietary supplements. [Reference: www.usp.org]

Pharmaceutical Compounding-Sterile Preparations- (USP Chapter 797) provides procedures and requirements for compounding sterile preparations. It describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins (toxins inside bacteria), and variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. [Reference: www.usp.org]

Compounded Sterile Products (CSPs) are "Compounded biologics, diagnostics, drugs, nutrients, and radio-pharmaceuticals (radio-active drugs)... that must be sterile when they are administered to patients ...," and "Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers' approved labeling... or prepared differently than published in such labeling." [Reference: www.usp.org]

Immediate Use Compounded Sterile Products (IUCSP) relates to the "immediate-use provision" of USP-NF Chapter 797 intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. IUCSPs are not intended for storage ...and unless complete administration is witnessed ...the CSP shall bear a label listing the exact 1-hour BUD and time...and ... if administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safety discarded. [Reference: www.usp.org]

Beyond Use Date (BUD) for the purpose of USP Chapter 797 is the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded.

The term ''controlled substance schedule II" refers to a drug included in schedule II of the subchapter of the Controlled Substance Act of the Food and Drug Administration enforced by the Department of Justice. The schedule II drug hydromorphone has a high potential for abuse and has a currently accepted medical use with severe restrictions. [Reference: www.fda.gov].

The term ''opiate'' means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. [Reference: www.fda.gov ].

BOP refers to the California State Board of Pharmacy, a regulatory agency that licenses hospitals to conduct sterile compounding activities.

Findings:

1. On 8/3/15 at 12:51 pm, during an interview, the Director of Pharmacy (DPH) indicated that a California (State) Board of Pharmacy inspector (BOPI) visited the pharmacy in order to renew the hospital's compounding license on 7/30/15.

A review of the BOP Inspection Report, dated 7/30/15, showed the hospital was cited for maintaining "drugs lacking in quality and strength" which were "staged for dispensing to patients" ... and, "The stability of these drugs was compromised." [Reference: Health and Safety Code 111295]. The report instructed the DPH to "Complete all NEW process validation and documentation for all compounding staff." The report instructed, in bold capital letters as indicated, "PHARMACY SHALL CONTINUE WITH IMMEDIATE USE COMPOUNDING.... Destroy OR RETURN ALL ADULTERATED (made impure or weaker) POWDERED DRUGS IN REFRIGERATOR. "

On 8/3/15 at 12:51 pm, during an interview, the DPH indicated BOPI renewed the license upon the condition that only Immediate Use Compounded Sterile Products (IUCSPs) would be prepared in the hospital past 7/30/15 until conditions changed. The DPH indicated the hospital used USP 797 standards related to compounding activities. The DPH said, "Pharmacists and technicians compound during the hours when pharmacy is open. Nurses compound after hours when the pharmacy is closed." The DPH said, "Since 7/30/15, "Pharmacy staff had been compounding only immediate use CSPs ... and after-hours nurses do it." The DPH indicated that prior to the restrictions on the hospital's compounding license the hospital routinely prepared CSPs with "longer expiration dates." He said, "Now, everything we compound expires within one hour." The DPH indicated the hospital had conducted extensive testing of the pharmacy staff to ensure competency. The DPH said, "I don't know if the nurses have been trained."

On 8/4/15 at 9:13 am, during an interview, the Director of Pharmacy said, "From eleven pm, on 7/3/15 to 7 am, on 7/4/15 nurses compounded these emergent meds." The DPH indicated that all of the medications were prepared and administered by Registered Nurse Night Supervisor (RN SUPV). The DPH said, "I don't believe we have documented competencies for her to compound IUCSPs." The DPH indicated he was unaware that USP 797 standards state under the section, Immediate-Use CSPs, " ...antineoplastics (cancer drugs) shall not be prepared as immediate-use CSPs because they are hazardous drugs." [Reference: www.usp.org] The DPH said the hospital's pharmacists had prepared and that nurses had administered, "about eleven chemo treatments as immediate use compounded sterile products since 7/30/15." The DPH indicated that to his knowledge none of the nurses were fully aware of the standards adopted by the hospital and that none of them had been trained.

On 8/4/15 at 3:04 pm, during an interview, the Chief Nurse Executive (CNO) indicated that the hospital's medical staff approved policies which ensure compliance with USP 797. The CNO indicated nurses in the hospital compounded IUCSPs after hours when a pharmacist was not available. The CNO said, "Nurses have been doing these the last few weeks." The CNO said, "I do not have any training for nurses to do CSPs.. [that are] current ...we used to." The CNO indicated that, other than training "at nursing school," nurses had not been trained by the hospital to check for clarity of IUCSPs before administering IUCSPs. With regard to the hospital ensuring that nurses were skilled, instructed, and trained prior to being assigned to compound IUCSPs, the CNO said, "They do not have a completed competency in their file." The CNO indicated that she could not say for certain if nursing had been trained in a process such as "specific release criteria" or "sequencing" to ensure accuracy, completeness, and sterility of IUCSPs prior to administration. In the same interview, the DPH said, "All the pharmacists accomplish these processes as part of using master compounding formulas." The CNO indicated the nurses did not have access to nor used master compounding formulas. The DPH indicated that one nurse, RN SUPV, had done all the compounding after hours since the hospital was restricted to, "immediate use" on 7/30/15, by agreement with the Board of Pharmacy, as a condition of their compounding license. He clarified that the hospital's policy allowed, "nurses" to compound and it was not restricted to night supervisor registered nurses. The CNO and DPH indicated that RN SUPV did not receive training to ensure standards for IUCSPs were maintained according to USP 797, including, "training to ensure the compounding procedure is a continuous process not to exceed one hour" ..."training to ensure aseptic (no germs) technique is followed, and if not immediately administered, the finished CSP is under immediate supervision" ..."training to ensure administration begins not later than one hour following the start of the preparation of the CSP" ..."training to ensure that unless immediately and completely administered by the person who prepared it and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, that name or initials of the person who prepared the CSP, and the exact-hour Beyond-use-date (BUD) and time" ...and "training to ensure that if the IUCSP is not administered within one hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded."

On 8/4/15 at 3:04 pm, during an interview, the CNO, Director of Medical Services & Patient Safety (MD 2) a physician, Chair, Pharmacy and Therapeutics (MD 1) a physician and the Chief Executive Officer (CEO), indicated they were aware they had adopted USP Chapter 797 as a standard for compounded sterile pharmaceutical products. The CEO and MD 1 indicated they had been provided with a copy of the BOP report which restricted the hospital to compounding only immediate use products. The CEO, MD 1, the CNO and MD 2 indicated they were not consulted by the DPH on the complexities and did not fully realize the potential impact on hospital processes or patient care that came with an environment restricted to immediate use compounding.

A review of the hospital's policy, titled, "I.V. 9intravenous) AFTER HOURS COVERAGE", dated 8/14, "PROCEDURES" section for the hospital's "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "The Pharmacy Department is open daily from 0700 to 2300 [7:00 am to 11:00 pm], Monday through Friday; Saturday, Sunday and Holidays from 0700 to 1900 [7:00 pm]. The policy showed, "In case of emergency during the hours the Pharmacy is closed, the nurses can: prepare I.V. solution using drugs from the floor stock I.V. solution or prepare I.V. solution using laminar flow hood (enclosed bench designed to prevent contamination) in Pharmacy." The policy showed, "Records are kept on all items removed from the pharmacy" ...and ..."Nursing personnel that mix I.V. preparations after pharmacy hours will be inserviced annually on the proper procedures and sterile techniques for admixture preparation."

A review of the "POLICY" section for the hospital's "COMPOUNDED STERILE PHARMACEUTICAL PREPARATION: IMMEDIATE USE CSPs, dated 1/14, showed as the first sentence, "For the purposes of emergency or immediate patient care, CSPs are exempted from the risk levels described above when the following criteria are met ..." There was no mention of risk levels "described above" in the policy.

On 8/4/15 at 3:04 pm, during an interview and concurrent policy review, a physician and Pharmacy and Therapeutics Chair said of the policy, "There is no description of risk levels in our policy."

A review of USP 797 requires, "Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical (radioactive drug) products from the manufacturers' original containers and not more than two entries into any one container or package (e.g. bag, vial) of sterile infusion solution or administration container/device. For example, antineoplastics shall not be prepared as immediate use CSPs because they are hazardous drugs." [Reference: www.usp.org]

A review of the "POLICY" section for the hospital's policy, titled, "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "It is critical that compounding personnel maintain high standards for the quality and control of processes, components and environments and for the skill and knowledge of personnel who are assigned to prepare compounded sterile products. The Director of Pharmacy or supervisory designees shall ensure that the following occur in compliance with the most recent version of the USP0-NF, Chapter 797: Before being dispensed or administered, the clarity of solutions is visually confirmed ...Beyond-use-dates are assigned based on extrapolation (estimate) from reliable literature sources ...Procedures for dilution, mixing, packaging and labeling conform to the correct sequence and quality established for the specific compounded product ...Deficiencies in compounding, labeling, packaging and quality testing/inspection can be rapidly identified and corrected ...and ...When time and personnel availability permit, compounding manipulations (treatments) mentioned clarity of solution."

A review of the "PROCEDURES" section for the hospital's policy, titled, "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "A written quality assurance procedure that includes appropriate in-process checks in place ...Compounding personnel are adequately skilled, educated, instructed and trained to correctly perform and document the following activities in their sterile compounding duties" to include, "...Perform antiseptic hand cleansing and disinfection of non-sterile compounding surfaces" ... "select and appropriately don gloves, goggles, gowns, mask, hair covers, and shoe covers ...Use laminar flow clean air hoods ...identify and measure additives ...manipulate sterile products aseptically ...label and quality inspect final products ... remove air bubbles and ...check correct volume ...if possible use a filter needle to inject the contents of the syringe into the solution if the contents of the syringe were removed from a glass ampoule (vial) or a reconstituted (restored by adding water) powder ...wipe the port of the solution with an alcohol swab prior to each entry and allow to dry ...discard all used ampoules and needles into the sharps containers ...IV's prepared from a reconstituted vial /drug in solution must be discarded after 24 hours if stored at room temperature or sooner if the manufacturer indicates stability less than 24 hours ...clean up the work area with a germicidal (kills germs) cloth ...and multidose vials may be used up to the expiration date assigned by the manufacturer."

On 8/3/15 at 12:51 pm, during an interview, the DPH indicated the hospital was cited on 7/30/15 by a California Board of Pharmacy inspector (BOPI) for maintaining adulterated (to make something unpure or weaker) antibiotics in stock in a pharmacy refrigerator, failure to maintain sterile compounding competencies, and failure to maintain recordkeeping associated with compounding. The DPH indicated that the BOPI renewed the hospital's compounding license on the condition that the hospital discarded all adulterated (made impure or weaker) products and restricted compounding activities to "immediate use only." The DPH said, "Since 7/30/15 pharmacy staff had been compounding only immediate use CSPs ... and after-hours nurses did it." The DPH indicated that prior to the restrictions on the hospital's compounding license the hospital routinely prepared CSPs with "much longer expiration dates." The DPH said, "Now, everything we compound expires within one hour." The DPH indicated the hospital had conducted extensive testing of the pharmacy staff to ensure competency. He said, "The nurses do compounding after hours. I don't know if they've been trained." The DPH said, "The hospital's policy is to follow USP 797 standards. That hasn't changed."

A review of a list of medication administration summaries provided by the DPH showed all patients who received IUCSPs compounded by RN SUPV 1 after hours when the pharmacy was closed between 7/31/15 and 8/4/15 as follows:

On 7/31/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Chloride 10 milliequivalents (mEq) in Dextrose 0.2% Normal Saline 500 milliliters (mL), a potassium supplement, to Patient 2.

On 8/2/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams (mg), an antiviral, to Patient 3.

On 8/2/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 millimoles (mM), a CSP phosphate supplement, to Patient 4.

On 8/3/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams to Patient 3.

On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 mM to Patient 5.

On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Chloride 40 mEq in Normal Saline to Patient 7.

On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 mM to Patient 5.

On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams to Patient 3.

On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams.

2. On 8/3/15 at 3:48 pm, during a medication pass observation in PACU, RN 1 obtained a dose of hydromorphone 1mg/1ml syringe from a Pyxis machine (an automated dispensing system) in PACU. RN 1 administered hydromorphone 0.5 milligrams to Patient 1 without first performing hand hygiene.

On 8/3/15 at 4 pm, during an interview, RN 1 was asked what her usual procedure was for performing hand hygiene related to medication administration. In response, RN 1 said, "I only have to wash between patients. I only have one patient."

A review of the hospital's policy, titled, MEDICATION ADMINISTRATION, revised 6/15, showed, "Hand washing is required before and after medication administration."

On 8/3/15 at 3:48 pm, during a medication pass observation in PACU, RN 1 administered a dose of hydromorphone 0.5 milligrams in 0.5 mL from a 1 ml syringe to Patient 1 without first wasting (disposing of) the portion of medication in the syringe not ordered for that administration. RN 1 held the medication in her hand continuously for 12 minutes and never made an attempt to waste the partially used syringe or ask available registered nurse colleagues (RN 2 and RN 3) to assist her in wasting the remaining 0.5mg/0.5 ml dose.

On 8/3/15 at 4 pm, during an interview, RN 1 was asked what her usual procedure was for administering a partial dose of a syringe of a controlled substance. RN 1 said, "I give them the first part and if they need more I give it to them." RN 1 indicated it was her usual practice to use the same syringe to administer multiple doses. RN 1 said, "I never waste it first. They need more doses. They have orders. It would cost patients a fortune to get a new one every time."

A review of the hospital's policy, titled, DESTRUCTION OF PARTIALLY USED CLASS II, III, and IV DRUGS, revised 5/12, showed, "When partially used Class II, III and IV drugs, of the Federal Comprehensive Drug Abuse and Prevention and Control Act of 1970 as amended, are to be destroyed, one of the following steps must be adhered to" ..."Two registered nurses must take part, one performing destruction, the other witnessing, and both signing the Narcotic or Hypnotic (sedative) disposition record via paper or electronic signature when automated mediation dispensing systems are used" ..."Two licensed nurses, one registered nurse and the other an LVN [Licensed Vocational Nurse]: the policy for the destruction and witnessing as in 1. Above is to be followed" ..."A pharmacist and a licensed nurse following 1. Is carried out" ... and "Two pharmacists following 1. Above." The policy also showed, "Signature will be defined as signature rendered in indelible (permanent) ink or through electronic signature as designated by the internal security system."

On 8/3/15 at 5 pm, during an interview, the DPH said, "We have a policy and procedure they have to follow. They have to waste ...first ...no exceptions."



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3. On 8/6/15, Patient 28's record was reviewed. Patient 28 was admitted on 7/23/15 with weakness, a slow heart rate, and changes in her cardiac (heart) rhythm. Patient 28's record contained physician's order for Hydralazine (for high blood pressure) 10 mg (milligrams) every six hours for systolic blood pressure (top pressure number) greater than 160 mmHg (millimeters of mercury). Patient 28's record contained a medication administration record that indicated Patient 28 had received this medication on 7/24/15 at 7:25 pm for a blood pressure of 206/87 (normal is below 120/80). Patient 28's record contained vital signs record that recorded a blood pressure of 170/82 at 7:53 am on 7/25/15 and 85% (percent)oxygen saturation on her pulse oximetry (measures oxygen saturation - normal is greater than 90%.)

Patient 28 was had a large emesis (vomit) and became unresponsive. A code (resuscitation team) was called on 7/25/15 at 9:25 am (approximately 1.5 hours after high blood pressure reading.) Patient 28 was not able to be revived.

On 8/6/15 at 1:30 pm, RN G stated that she could not recall being notified of Patient 28 having to be medicated for high blood pressure on the previous shift. RN G further stated that she had not been made aware of Patient 28's high blood pressure reading (taken by a certified nurses assistant) at 7:53 am. RN G recalled Patient 28 had a change of condition and seemed more confused so she asked the charge nurse about moving her closer to the nursing station. RN G stated she was busy with another patient and returned to Patient 28 to witness the Patient's emesis and called the code. RN G stated that had she known about the blood pressure reading at 7:53 am on 7/25/15, she or the charge nurse would have administered the blood pressure medication.

On 8/6/15 at 2 pm, Admin Nurse C acknowledged that Patient 28 did not receive blood pressure medication when it was indicated.

Based on observation, interview, and record/policy reviews, the hospital failed to ensure that one of 30 sampled patients were safely allowed to self administer medication when Patient 11's inhaler was left on his bedside table and he used it unsupervised. This failure resulted in the wrong dose of medication and had the potential to negatively impact Patient 11's health status.

Findings:

Patient 11 was admitted on 8/3/15 for abdominal pain.

During initial tour of Unit 1 on 8/3/15 at 9:48 am with Administrative (Adm) Nurse C, Patient 11's ProAir (albuterol inhaler help clear lungs for breathing) was observed on his bedside table. There was no hospital label attached to indicate it had been sent to the hospital's pharmacy for labeling. Patient 11 stated he brought the ProAir inhaler from home. Patient 11 stated that he used two puffs of the inhaler 10 to 12 times daily. The recommended dosing according to the drug manufacturer, is two puffs every 4 to 6 hours (maximum 6 times daily). Adm Nurse C was concurrently asked to check Patient 11's medication administration orders. Adm Nurse C stated that the ProAir was not labeled by the hospital's pharmacy and the medication had not been entered on his current physicians orders by the hospital's pharmacy. There was no documentation for how much ProAir was administered to Patient 11.

The hospital's Bedside Medications policy, dated 6/2015, showed patients were not to keep medications at the bedside unless ordered by the physician, and were to be secured. It showed that approved bedside medications were to be labeled by the pharmacy with directions for use and administration must be documented.

The hospital's Medication Reconciliation policy, dated 6/2015, showed home medications were to be accounted for and disposition documented and it should be completed as soon as possible in the admission process and faxed to the pharmacy.

On 8/5/15 at 9:45 am, the hospital's Director of Pharmacy (DPH) was interviewed about Patient 11's ProAir inhaler. The DPH stated the hospital was an "inhalerless" facility and that Patient 11 had an order for albuterol to be administered by the Respiratory Therapist (RT). Patient 11's Medication Reconciliation Physician Order, dated 8/3/15, was concurrently reviewed with the DPH who stated it had not been completed correctly in the Emergency Room (ER). DPH stated that Patient 11's home medications (inhaler) should have been bagged in the ER and the form completed for the medication either sent home with someone or to the pharmacy. DPH further stated that it was not safe for Patient 11 to be receiving both the inhaler albuterol and the RT administered albuterol ordered by his physician. DPH confirmed that the hospital's Medication Reconciliation policy was not followed.

Based on observation and staff interview, the facility failed to ensure that adequate personnel were employed to ensure prompt processing (scanning) of medical records. This failure had the potential for miscommunication and could negatively impact patients' health status.

Findings:

A tour of the Health Information Management (HIM) Department with HIM Staff A was done on the afternoon of 8/4/15. A file cabinet with several stacks of paper portions of medical records was observed.

In a concurrent interview, HIM Staff A said that that these papers needed to be scanned into the electronic medical record and they dated back to 7/10/15; and that this backlog was more than usual due to unfilled vacant positions within the department.

Based on document review and staff interview, the facility failed to ensure that all medical record entries were complete, dated and timed in five of 30 records reviewed. (Patients 11, 51, 52, 54, and 55)

Findings:

1. Patients 51, 52, 54, and 55's records were reviewed on 8/6/15. The Conditions of Admission form was pre-printed with "AM/PM" after the lines where the time was to be entered when signed by the patient/responsible party and the witness. The appropriate choice of AM or PM was not indicated in these records. In addition, in Patient 54's record, the Consent to Surgery form did not indicate either AM or PM when the patient signed the consent.

The facility's policy was requested and reviewed early afternoon on 8/6/15. The policy #R002, "Pt. Interview," was last reviewed/revised on 8/2005 (ten years ago). The procedure contained no instruction about the proper documentation of the time the form was signed.



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2. The hospital's Medication Reconciliation policy, dated 6/2015, showed home medications were to be accounted for and disposition documented, and medication reconcilliation should be completed as soon as possible in the admission process and faxed to the pharmacy.

During initial tour of Unit 1 on 8/3/15 at 9:48 am with Administrative (Adm) Nurse C, Patient 11's ProAir (albuterol inhaler help clear lungs for breathing) was observed on his bedside table.

On 8/4/15, Patient 11's record was reviewed. Patient 11 was admitted on 8/3/15 for abdominal pain.

On 8/3/15 at 11 am, Adm Nurse C stated that Patient 11's Admission Nursing Assessment, dated 8/3/15, incorrectly showed the "Disposition of Home Medications" as "Did Not Bring Medication" entered on 8/2/15. Adm Nurse C stated that is was entered incorrectly in the Emergency Room (ER).

On 8/5/15 at 8:45 pm, Patient 11's record contained a Medication Reconciliation Physician Order, dated 8/3/15, was concurrently reviewed with the Director of Pharmacy (DPH), who stated the order had not been completed correctly in the ER. Pharmacist stated that Patient 11's form was not completed for whether his medication was either sent home with someone or to the pharmacy. Pharmacist confirmed that the hospital's Medication Reconciliation policy was not followed.

Based on interview and record review, the facility failed to ensure the required medical history and physical examinations had been performed for two of three sampled patients prior to their endoscopic procedures. (During an endoscopy procedure, a slender, tubular optical instrument used as a viewing system for examining an inner part of the body, with an attached instrument, for biopsy(removal of tissue) or surgery). This failure placed patients at risk for surgical complications. (Patients 1 and 2).

Findings:

1. On 8/6/15, the records of three patients that underwent an endoscopic procedure was reviewed. Two of three patients did not have a current medical history and physical examination (H&P).

Patient 1 underwent an endoscopy procedure on 8/4/15. The date of the most current medical history and H&P was dated 6/30/15, thirty-five days prior to the endoscopy.

2. Patient 2 underwent an endoscopy procedure on 8/4/15. The date of the most current H&P was dated 6/23/15, forty-two days prior to the endoscopic procedure.

On 8/6/15 at 2:10 pm, a concurrent interview and record review was conducted with the Ambulatory Care Services Nurse Manager (ACS Nurse Manager). Copies of the most recent patient H&Ps and the physician's pre-procedure interval notes for endoscopy Patients 1 and 2 were reviewed. The ACS Nurse Manager acknowledged that both patients should have had a new H&P performed. ACS Nurse Manager stated if it has been longer than 30 days since an H&P was performed, a new H&P is needed.

Page 4 of a 33 page document titled, "Oroville Hospital Medical Staff Rules", was reviewed. Under section F. ii) For outpatient procedures not performed in the operating room and requiring only moderate sedation, a pertinent medical history and physical examination shall be documented no more than thirty days before the procedure is performed. When done more than thirty days before the procedure, a pertinent updated medical history and physical examination must be documented before the procedure is performed.

Based on interview and record review, the hospital failed to ensure that one of ten sampled surgical/procedural patients had an updated examination documented in the medical record prior to their surgery. This failure placed patients at risk for surgical complications. (Patient 52)

Findings:

1. On 8/6/15, Page 4 of a 33 page document titled, "Oroville Hospital Medical Staff Rules", was reviewed. Under section F. ii) For outpatient procedures not performed in the operating room and requiring only moderate sedation, a pertinent medical history and physical examination shall be documented no more than thirty days before the procedure is performed. When done more than thirty days before the procedure, a pertinent updated medical history and physical examination must be documented before the procedure is performed.

Patient 52's record was reviewed on 8/6/15 at 1:15 pm. This record contained a history and physical examination done eight (8) days prior to the outpatient surgery performed under general anesthesia. There was no documentation of an updated exam of the patient prior to surgery. This finding was confirmed concurrently by Information Technology (IT) Staff A.

The hospital failed to ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to ensure:

1. A pharmacist supervised and coordinated with healthcare professionals related to the provision of pharmaceutical services and activities related to use of Immediate Use Compounded Sterile Products (IUCSPs) throughout the hospital. Refer to A 0492, findings 1-6.

2. Training for all compounding(combining medications) personnel was conducted prior to assignment when a registered nurse night supervisor (RN SUPV 1) prepared immediate use compounded sterile products (IUCSPs) and administered them to five sampled patients (Patients 2, 3, 4, 5, and 7) over a five day period. As a result, there was a potential for patients to experience adverse outcomes of fever and blood born infection complications related to medication errors associated with intravenous administration of compounded sterile preparations. Refer to A 0405, finding 1.

3. Compounding and dispensing of drugs was performed under the supervision of a pharmacist and performed consistent with State and Federal law when pharmacists dispensed IUCSPs without a Beyond Use Date (BUD) and a registered nurse night supervisor (RN SUPV) compounded and administered eight IUCSPs prior to receiving training for these activities. As a result, there was a potential for expired or contaminated medications to be administered after the BUD had passed. Refer to A 0501, findings 1-3.

4. Medication storage areas were administered (maintained) in the hospital in accordance with accepted professional principles as defined in publications by the U.S. Pharmacopeial Convention (USP), the American Hospital Society of Hospital Pharmacists (ASHP), and the California Health and Safety Code related to maintenance of medication storage temperatures, segregation (separation) of expired, outdated, mislabeled, unusable medications, and routine inspection of storage areas by pharmacists throughout the survey period. Refer to A 0491, findings 1-4.

5. Expired and mislabeled antibiotic and insulin (for diabetes) medications were not available for patient use when four products were reintroduced into pharmacy stock after dispensing. As a result, there was a potential for expired or medication lacking potency (strength) to be administered. Refer to A 0505.

6. Four pharmacists (RPh 1, RPh 3, the Assistant Director of Pharmacy (RPH MGR 1) and the Director of Pharmacy (DPH)) received a performance evaluation at least annually in accordance with hospital policies. Refer to A 23, finding 3.

7. An unlabeled multidose vial of blood pressure medication was available for use. Refer to A 491, finding 5.

8. Unauthorized medication (an inhaler) was at Patient 11's bedside. Refer to A 502.

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver pharmaceutical services in a safe manner to be in compliance with the Condition of Participation for Pharmaceutical Services.

Based on observation, record review, and interview, the hospital failed to ensure all medication storage areas were administered (maintained) in the hospital in accordance with accepted professional principles as defined in publications by the U.S. Pharmacopeial Convention (USP) and the American Hospital Society of Hospital Pharmacists (ASHP) and the California Health and Safety Code. The hospital failed to provide oversight of mediation storage areas and conditions (e.g. outdated, expired and unusable medications were not segregated from pharmacy stock, pharmacists did not inspect medication areas monthly as required to identify irregularities with medication storage, and medications were not stored within predetermined required temperature ranges) in 14 of 14 sampled patient care areas (Emergency Department (ED), Same Day Surgery (SDS), Intensive Care Unit (ICU), Medical Surgical Unit 1 (Unit 1), Medical Surgical Unit 2 (Unit 2), and Medical Surgical Station 3 (Unit 3), Pediatrics (childrens unit), Obstetrics (laboring women and babies), High Acuity Medical Surgical Unit (HAMS), Cardiology (heart specialty), CAT Scan (type of X-Ray images), Post Anesthesia Care Unit (PACU), Pharmacy, POD [POD is not an acronym, Dept after surgery]) as evidenced by the following:

1. The pharmacy stored powdered antibiotic medications in a refrigerator in the pharmacy in a manner not in accordance with USP standards to store these under conditions of Controlled Room Temperature. On 7/30/15 the California State Board of Pharmacy (BOP) determined the pharmacy's refrigerated stock of antibiotics was "adulterated (make impure or weaken)" ..."lacking in quality or strength" ... and "the stability of these drugs was compromised." The hospital was directed to "Destroy or return all adulterated powdered drugs in refrigerator." After the inspection by the BOP, the pharmacy destroyed 238 vials of 39 types of antibiotics available for patient use. The hospital's investigation indicated 12,438 patients had the potential to receive dispensed antibiotics which were previously stored in the refrigerator (rather than Controlled Room Temperature as required) between 8/1/14 and 7/30/15. The hospital's failure to ensure antibiotics were maintained under temperatures to preserve potency and quality placed 12,438 patients at risk for treatment failure of infections.

2. Four expired medications ( two of which were mislabeled) compounded under Immediate Use (only) conditions were observed in stock in the Unit Dose Preparation Area of the pharmacy and not promptly discarded as required by standards of practice. Unusable medications were not segregated from pharmacy stock in a pharmacy refrigerator when they were awaiting disposition(being given) (subsequent to reports of temperature excursions (out of range) in a Post Anesthesia Care Unit (PACU) refrigerator which exceeded USP standards).

3. Daily medication refrigerator logs were maintained by the Engineering Department with no oversight by the pharmacy. Between 1/4/15 and 7/25/15, in six of nine patient care areas (Emergency Department (ED), Same Day Surgery (SDS), Intensive Care Unit (ICU), Medical Surgical Unit 1 (Unit 1), Medical Surgical Unit 2 (Unit 2), and Medical Surgical Station 3 (Unit 3), temperatures were noted 178 times to be out of range. Refrigerators were not maintaining conditions cold enough to meet refrigerated medication storage standards.

4. The hospital's failure to document unit inspections by a pharmacist was noted in 27 of 35 sampled inspection reports maintained by the pharmacy for 14 of 14 sampled patient care areas (ED, SDS, Pediatrics, Obstetrics, ICU, HAMS, Unit 1, Unit 2, Unit 3, Cardiology, CAT Scan, PACU, Pharmacy, POD) between 8/1/12 and 7/31/15 in accordance with state regulations and ASHP standards.

5. An unlabeled multidose vial of blood pressure medication was available for use.

The hospital's failure placed the patients in the hospital (census 110) at risk for treatment delay and adverse outcomes as a result of preventable mediation errors related to loss of potency or quality of medications. The hospital's failure to store antibiotics in accordance with the manufacturer's labeled USP standards during the survey period (August 1, 2012 to Aug 1 2015) potentially placed an additional 12,438 patients at risk for treatment failure of an infection.

Definitions:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP General Chapter 659 describes Packaging and Storage standards. USP General Chapter 797 describes Pharmaceutical Compounding Sterile Products standards. [Reference: www.usp.org]

According to the USP website, in the Frequently Asked Questions section, it showed, "Can a USP Reference Standard [medication] be stored at a different temperature other than what is provided on the label?" The response was, " ...we do not have data to support the continued suitability of the item stored at an alternate storage condition. For this reason, we are unable to comment on the storage of a USP Reference Standard at an alternate temperature. It is the responsibility of the user to determine if a material remains suitable for use when handled differently than the provided instructions."

The American Society of Health System Pharmacists (ASHP) develops official professional policies, in the form of policy positions and guidance documents (statements and guidelines), for the continuum (range) of pharmacy practice settings in integrated systems. The section, Standard IV, "Medication Distribution and Control" of the ASHP publication, titled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals", describes guidance for aspects of pharmaceutical care in hospital (e.g. sterile products, medication storage, and medication storage area inspections. [Reference: Am J Health-Syst Pharm 1995; 52:2711-7.]

The California Health and Safety Code (H&SC) section 111260 states, "Any drug or device is adulterated if the methods, facilities, or controls used for its ...holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.

The H&SC section 111295 states, "It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is adulterated."

Findings:

1. On 8/3/15 at 1:15 pm during a tour of the pharmacy, the Director of Pharmacy (DPH) provided a report, dated 7/30/15, signed by himself and an investigator from the California State Board of Pharmacy (BOPI). The report indicated the California State Board of Pharmacy (BOP) cited the hospital on 7/30/15 for stocking "drugs lacking in quality or strength ... in that, drugs in powdered form were to be stored at Room Temp were in fact stored in bulk in the refrigerator ... In addition, the same drugs were staged for dispensing to patients. The stability of these drugs was compromised ... As pertains to H&SC [California State Health and Safety Code] 111295."

On 8/3/15 at 1:30 pm, in an interview, the DPH said, "We stored 39 products - lyophilized powder (unreconstituted) antibiotics - in the refrigerator because we were having some problems with infections." He said, "We moved the vials to the refrigerator ... we assumed they were stable." He said, "I have not checked our references yet for stability sterility." The DPH indicated he had not begun an investigation on the potential scope or impact on patients who may have received improperly stored antibiotics because he had not had time." During the interview, the DPH indicated he called an antibiotic drug manufacturer. After a brief conversation, the DPH hung up the phone and indicated the manufacturer would not comment on stability or potency of an antibiotic stored outside the labeled temperature range.

On 8/3/15 at 2:09 pm, in an interview, the DPH said, "We assumed cold storage would deter bacterial growth ... we had no standard or reference based on that." The DPH provided no literature source, policy and procedure, or source of scientific judgment upon which to base his prior decision as to whether or not to use antibiotics stored under refrigeration.

A review of a report emailed to the surveyor from the DPH on 8/4/15, titled, "IV Piggyback (a second IV) Waste", dated 8/4/15, included an Excel spreadsheet which detailed by drug name, lot number, manufacturer, expiration date, destruction record, quantity and NDC number [a unique identifier for a drug package] the "number of doses dispensed" ..."for the survey period." The report indicated that 12,438 patients had the potential to receive 83,846 prepared doses of antibiotics stored under refrigeration in the pharmacy (36-46 degrees F) when instructions on the label required storage at USP Controlled Room Temperature (68 -77 degrees F) as follows:

*Between 8/12/12 and 12/12/12, a total of 7,482 doses of antibiotics were dispensed to 607 patients.
*Between 1/1/13 and 12/31/13, a total of 27,577 doses of antibiotics were dispensed to 4,762 patients.
*Between 1/1/14 and 12/31/14, a total of 34,346 doses of antibiotics were dispensed to 5,695 patients.
*Between 1/1/15 and 7/30/15, a total of 14,441 doses of antibiotics were dispensed to 1,410 patients.

On the above email, in addition to the Excel spreadsheet, the DPH indicated this report reflected the number of doses dispensed for patients during the survey period between 8/12/12 and 12/12/12.

A review of the manufacturers' labels available in the pharmacy [package inserts] for six of 39 types of antibiotics determined by the BOP to be "adulterated" showed the following:

*Ceftriaxone 1g manufactured by Hospira, had on the label, "Ceftriaxone for Injection, USP sterile powder should be stored at 20°to 25°C (68° to77°F) [See USP Controlled Room Temperature]." [Reference: Product Package Insert Hospira, July 2011]
*Ceftazidime for injection, manufactured by Hospira, had on the label, "Tazicef (brand name for ceftriaxone) in the dry state should be stored at 20 to 25°C (68 degrees to 77 degrees F) [See USP Controlled Room Temperature]."
*Piperacillin / Tazobactam for injection, manufactured by Hospira, had on the label, " Piperacillin and Tazobactam for injections USP vials should be stored at controlled room temperature (20 °C to 25°C [68° to 77° F]) prior to reconstitution. [Reference: Product Package Insert Hospira, 1993.]
*Meropenem for injection, manufactured by Hospira, had on the label, "The dry powder should be stored at controlled room temperature 20 to 25°C (68 degrees to 77 degrees F) [See USP Controlled Room Temperature]." [Reference: Product Package Insert Hospira, 4/2013]
*Vancomycin manufactured by Hospira, had on the label, "Prior to reconstitution, store dry powder at 20 to 25°C (68 degrees to 77 degrees F). [See USP Controlled Room Temperature.]" [Reference: Product Package Insert Hospira, September 2010.]
*Ampicillin manufactured by APP Pharmaceuticals, had on the label, "Store at 20° to 25°C (68 degrees to 77 degrees F). [See USP Controlled Room Temperature.]" [Reference: Product Package Insert APP Pharmaceuticals, November 2007.]

A review of all the hospital's written policies showed no policies or procedures or written quality assurance processes related to identification or correction of storage conditions when medications were observed to be stored outside defined temperature ranges.

A review of unit inspection reports for pharmacy showed pharmacists did not identify for the past three years (August 1, 2012 through 8/3/15) that 39 antibiotic product types were stored outside the recommended temperature range of Controlled Room Temperature.

A review of the hospital's policies and procedures showed there were no written policies or procedures related to what actions were expected when medications were discovered stored out of range.

On 8/4/15 at 10:05 am, in an interview, the DPH said, "I don't believe there is a written procedure for when or what conditions staff are supposed to notify for temperature excursions (out of range)." The DPH indicated he was responsible for ultimate oversight to ensure mediations were stored within USP standards or as labeled by the manufacturer. The DPH said, "Engineering is supposed to notify me. We have a policy." The DPH said he was familiar with USP standards for maintenance of temperature of medications. The DPH indicated that "for years" the hospital has not stored unreconstituted antibiotics under conditions of "controlled room temperature" as defined by USP. The DPH said, "We had a problem with infections in the hospital." He indicated the hospital had been storing powdered antibiotics in the refrigerator throughout the survey period since 7/30/15.

A review of the USP standard for controlled room temperature (CRT) shows the acceptable temperature range for mediation storage is between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). [Reference: General Chapter 659 Packaging and Storage Requirements in the USP-NF publication]

According to the USP website, in the Frequently Asked Questions section, it showed, "Can a USP Reference Standard [medication] be stored at a different temperature other than what is provided on the label?" The response was, " ...we do not have data to support the continued suitability of the item stored at an alternate storage condition. For this reason, we are unable to comment on the storage of a USP Reference Standard at an alternate temperature. It is the responsibility of the user to determine if a material remains suitable for use when handled differently than the provided instructions." [Reference www.usp.org]

According to the USP website, in the Frequently Asked Questions section, it showed, "Is a USP Reference Standard still suitable for use if a temperature excursion occurs?" The response was, "USP does not comment on storage deviations and the potential effect of temperature excursions on the USP Reference Standard material. The user should consult their own internal policies & SOPs (standards of practice) and use their best scientific judgment to make the decision on whether or not to use the material(s). [Reference www.usp.org]

A review of the ASHP Standard IV, section "Sterile Products" showed, "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ... for inpatient and ambulatory patients. Policies and procedures governing these functions shall be developed by the pharmacy with input from other appropriate hospital staff and committees."

A review of the ASHP Standard IV, section "Sterile Products" showed, "All sterile medication shall be prepared and labeled in a suitable environment by appropriately trained personnel in accordance with applicable practice standards and regulations (e.g. FDA [Food and Drug Administration] state board of pharmacy. Adequate quality assurance procedures for the preparation of sterile products shall exist."

2. Four expired sterile medications compounded for "Immediate Use only" were observed in the Unit Dose Preparation Area of the Pharmacy Department as follows:

*On 8/3/15 at 12:51 pm, during a tour of the pharmacy, with the Director of Pharmacy (DPH), two bags of unusable Compounded Sterile Products (CSPs) antibiotic medications (e.g. ceftriaxone 1 gram (g) in Normal Saline 0.9% 50 milliliters (mL) and ceftriaxone 2 g in Normal Saline 0.9% 50 mL) were observed in the pharmacy stock in the unit dose preparation area without required labels. The ceftriaxone 2 g in Normal Saline 0.9% 50 mL bag had handwritten annotations in a black marker "8/1" and "JA" in the upper margin of the bag. Neither bag had Beyond Use Dates (BUDs) on the label.

*On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two expired and mislabeled insulin syringes (e.g. Insulin Glargine 8 units and Insulin Glargine 25 units) were observed in the pharmacy stock with missing label components or a Beyond Use Date (BUD). The syringe of Insulin Glargine 25 units was labeled with patient-specific information for Patient 8 but it did not have a complete date when the year was missing. The syringe of Insulin Glargine 8 units was labeled with patient-specific information for Patient 9 but it did not have a complete BUD date when the date and year were missing.

On 8/3/15 at 12:51 pm, in an interview, the DPH said, "These four products should not be in stock. The DPH acknowledged that there was no risk to Patient 7 and Patient 8 to receive these mediation products (they were discharged), rather, they posed a risk to all patients in the hospital who had the potential to receive ceftriaxone or insulin.

Expired and unusable medications were not segregated (separated) from pharmacy stock in a pharmacy refrigerator when they were removed from a Unit 1 B (U1B) refrigerator awaiting disposition (being given) subsequent to reports of temperature excursions which exceeded USP standards as follows:

On 8/6/15 at 10:05 am, an empty medication refrigerator was observed in the second of two medication refrigerators in U1B.

On 8/6/15 at 10:30 am a plastic bin of medications was observed in the pharmacy bulk refrigerator. The medications and the container were not segregated from stock and not marked as to location where they were from or include instructions not to use them until evaluated. The bin contained the following items:

*An antibiotic, ceftriaxone 1 gram / 50 mL in Normal Saline, quantity one;
*Insulin Lispro 100 units per milliliter, 3 mL vial, quantity three;
*Humalog Insulin, Regular, 100 units per milliliter, 3 mL vial, quantity three;
*An antiarrhythmic used to treat irregular heart rhythms, Diltiazem HCL 25 milligrams 25 milligrams per mL, 5 ml vial, quantity four;
*An antihistamine medication used to reduce gastric secretions, Famotidine 20 mg, 2 ml vial, quantity six; and
*An anxiolytic medication used to treat anxiety, Lorazepam, 2 mg per 1 mL vial, quantity 20.

On 8/5/15 at 10:30 am, in an interview, a pharmacy technician (Rx Tech 2) said, " I brought these back from Unit one fifteen minutes ago. I was just told to get these meds and I'm waiting for instructions."

On 8/5/15 at 10:30 am, in an interview, a pharmacist (RPh 4) was asked if she would use the medications for other patients. The RPh 4 said, "If it was from our med refrigerator it would be okay to dispense." In the same interview, a pharmacy technician ((Rx Tech 3) interjected and said, "I wouldn't pull from there." When asked, "Why not?" Rx Tech 3 said, "Those medications are in Pyxis [automated dispensing cabinet] bins. I wouldn't use them because I recognize the Pyxis containers inside the plastic bin." The RPh 4 indicated she changed her mind and would never use any medication pulled from a Pyxis bin. When asked if there were written policies or procedures regarding storage, use, or segregation of medications that were identified as stored under conditions not supported by USP standards or the manufacturer, Rx Tech 2, a pharmacy technician (Rx Tech 3) and the RPh 4 all indicated "No."

A review of the ASHP Standard IV, section "Medication Storage" showed, "Medications shall be stored and prepared under proper conditions of sanitation, temperature, light , moisture, ventilation, segregation, and security to ensure medication integrity and personnel safety."

On 8/4/15 at 1:55 pm, during an interview, a registered nurse Perioperative Services Nurse Manager (RN MGR 1) indicated she removed medications from a "sterile core" refrigerator in PACU after determining that the "refrigerator is out of order." She indicated that, to her knowledge, a housekeeper from the Environmental Services Department (EVS 1) had performed daily checks on the refrigerator for years and had documented temperatures which may indicate the refrigerator was maintaining refrigerated medications in temperatures out of range. RN MGR 1 indicated it was her opinion that EVS 1 recorded temperatures which only appeared out of range (too high) because of a series of decimal error. She indicated that a temperature recorded as "55" really meant 5.5 Celsius. By that logic, she explained that a temperature of 55 degrees Fahrenheit would be nine degrees too high whereas a temperature of 5.5 degrees Celsius would correspond to between 41 and 42.6 degrees Fahrenheit, within an acceptable range. RN MGR 1 said, "I think [EVS 1] did not see the decimal point when he was checking these temps." RN MGR 1 demonstrated that the digital refrigerator temperature monitor was permanently set to Celsius and that all readings had a decimal point in between readings. She explained that the temperature in the refrigerator should be maintained between 36-46 degrees Fahrenheit which corresponded to between 2 and 8 degrees Celsius. As the housekeeper had not been trained, RN MGR 1 was returning the medications to Pharmacy to await disposition. RN MGR 1 was unsure what pharmacy would do with the medications. She indicated that if written policies and procedures to segregate medications existed, she was unaware of them.

3. A review of the USP standard for refrigeration temperature (CRT) shows the acceptable temperature range for mediation storage for the above medications is between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit). [Reference: General Chapter 659 Packaging and Storage Requirements in the USP-NF publication]

A review of the logs with the inclusive dates between 1/4/15 and 7/25/15 showed the following documentation by the Engineering Department, of 178 instances of measured out of range temperatures in refrigerators in six of nine patient care areas (e.g. ED, SDS, ICU, Unit 1, Unit 2 and Unit 3) where medications were stored above the acceptable standard of 8 degrees Celsius (C) with no evidence of followup to ensure safe medication use as follows:

*On 1/5/15 at 6:45 am, an ED refrigerator temperature was 10.2 C
*On 1/5/15 at 6:45 am, a SDS refrigerator temperature was 8.7 C
*On 1/5/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 1/6/15 at 7:00 am, an ED refrigerator temperature was 8.2 C
*On 1/7/15 at 7:30 am, an ED refrigerator temperature was 10 C
*On 1/8/15 at 7:00 am, an ED refrigerator temperature was 8.2 C
*On 1/9/15 at 7:00 am, an ED refrigerator temperature was 9.1 C
*On 1/12/15 at 7:00 am, a Unit 2 refrigerator temperature was 12.8 C
*On 1/12/15 at 7:00 am an ED refrigerator temperature was 8.9 C
*On 1/13/15 at 7:00 am, an ED refrigerator temperature was 8.5 C
*On 1/13/15 at 7:00 am, an ED refrigerator temperature was 8.9 C
*On 1/13/15 at 7:00 am, a Unit 2 refrigerator temperature was 14.3 C
*On 1/17/15 at 8:00 am, an ED refrigerator temperature was 9 C
*On 1/30/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 2/1/15 at 8:00 am, an ED refrigerator temperature was 9.2 C
*On 2/2/15 at 7:00 am, an ED refrigerator temperature was 8.1 C
*On 2/3/15 at 7:00 am, an ED refrigerator temperature was 10.7 C
*On 2/4/15 at 7:00 am, an ED refrigerator temperature was 8.7 C
*On 2/4/15 at 7:00 am, a Unit 1 refrigerator temperature was 9.7 C
*On 2/5/15 at 7:00 am, an ED refrigerator temperature was 9.3 C
*On 2/5/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.6 C
*On 2/5/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.6 C
*On 2/6/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.2 C
*On 2/6/15 at 7:00 am, an ED refrigerator temperature was 8.1 C
*On 2/6/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.5 C
*On 2/6/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.2 C
*On 2/7/15 at 7:00 am, an ED refrigerator temperature was 9.0 C
*On 2/7/15 at 7:00 am, an ED refrigerator temperature was 8.6 C
*On 2/8/15 at 7:00 am an ED refrigerator temperature was 8.4 C
*On 2/8/15 at 7:30 am, a Unit 1 refrigerator temperature was 8.3 C
*On 2/8/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.5 C
*On 2/9/15 at 7:00 am, a Unit 1 refrigerator temperature was 9.1 C
*On 2/10/15 at 6:45 am, a Unit 1 refrigerator temperature was 8.6 C
*On 2/11/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.6 C
*On 2/12/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 2/14/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 2/15/15 at 9:00 am, an ED refrigerator temperature was 8.3 C
*On 2/16/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.2 C
*On 2/17/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.5 C
*On 2/18/15 at 7:00 am, a Unit 1 refrigerator temperature was 9.5 C
*On 2/19/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 2/23/15 at 7:00 am, a Unit 2 refrigerator temperature was 8.9 C
*On 3/5/15 at 7:30 am an ED refrigerator temperature was 8.1 C
*On 3/8/15 at 10:00 am, an ED refrigerator temperature was 8.2 C
*On 3/17/15 at 7:00 am, a SDS refrigerator temperature was 8.1 C
*On 3/17/15 at 7:00 am, a Unit 2 refrigerator temperature was 8.5 C
*On 3/21/15 at 7:30 am, an ED refrigerator temperature was 8.5 C
*On 3/19/15 at 7:00 am, a SDS refrigerator temperature was 8.3 C
*On 3/22/15 at 7:00 am, an ED refrigerator temperature was 8.1 C
*On 3/24/15 at 7:00 am, an ED refrigerator temperature was 9.1 C
*On 3/27/15 at 7:00 am, an ED refrigerator temperature was 8.8 C
*On 3/28/15 at 8:30 am, an ED refrigerator temperature was 8.3 C
*On 3/29/15 at 10:00 am, an ED refrigerator temperature was 9.1 C
*On 3/30/15 at 7:00 am, a Unit 2 refrigerator temperature was 8.5 C
*On 4/3/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 4/5/15 at 7:30 am, an ED refrigerator temperature was 8.5 C
*On 4/5/15 at 7:30 am, a Unit 1 refrigerator temperature was 8.7 C
*On 4/8/15 at 7:00 am, an ED refrigerator temperature was 8.9 C
*On 4/9/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 4/11/15 at 9:00 am, a Unit 1 refrigerator temperature was 8.8 C
*On 4/12/15 at 7:30 am, an ED refrigerator temperature was 9.2 C
*On 4/12/15 at 7:30 am, the Unit 1 refrigerator temperature was 8.1 C
*On 4/13/15 at 8:30 am, a Unit 1 refrigerator temperature was 8.9 C
*On 4/14/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.2 C
*On 4/15/15 at 7:15 am, an ED refrigerator temperature was 8.5 C
*On 4/16/15 at 7:150 am, an ED refrigerator temperature was 8.5 C
*On 4/18/15 at 7:10 am, an ED refrigerator temperature was 8.2 C
*On 4/18/15 at 7:10 am, a Unit 3 refrigerator temperature was 9.0 C
*On 4/21/15 at 7:15 am, an ED refrigerator temperature was 8.3 C
*On 4/23/15 at 7:00 am, an ED refrigerator temperature was 8.3 C
*On 4/23/15 at 7:00 am, a SDS refrigerator temperature was 11.8 C
*On 4/23/15 at 7:00 am, a Unit 2 refrigerator temperature was 10.2 C
*On 4/26/15 at 7:15 am, a Unit 2 refrigerator temperature had a notation "broke"
*On 4/26/15 at 7:30 am, a Unit 1 refrigerator temperature had a notation "broke". A dash was recorded for this refrigerator temperature for 4/27/15, 4/28/15, 4/29/15, 4/30/15, 5/1/15 and 5/2/15.
*On 4/27/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.1 C
*On 4/27/15 at 7:00 am, an ED refrigerator temperature was 8.4 C
*On 4/27/15 at 7:00 am, an ED refrigerator temperature was 8.1 C
*On 4/30/15 at 7:00 am, an ED refrigerator temperature was 11.2 C
*On 5/2/15 at 9:00 am, an ED refrigerator temperature was 9.2 C
*On 5/4/15 at 7:00 am, an ED refrigerator temperature was 8.3 C
*On 5/5/15 at 7:00 am, an ED refrigerator temperature was 8.5 C
*On 5/6/15 at 7:45 am, a Unit 2refrigerator temperature was 9.8 C
*On 5/10/15 at 8:30 am, an ED refrigerator temperature was 9.4 C
*On 5/11/15 at 7:00 am, an ED refrigerator temperature was 8.4 C
*On 5/12/15 at 7:00 am, an ED refrigerator temperature was 8.4 C
*On 5/13/15 at 7:00 am, an ED refrigerator temperature was 9.4 C
*On 5/14/15 at 7:00 am, an ED refrigerator temperature was 8.4 C
*On 5/14/15 at 7:00 am, an ED refrigerator temperature was 8.4 C
*On 5/17/15 at 7:15 am, an ED refrigerator temperature was 9.2 C
*On 5/17/15 at 7:15 am, a Unit 2 refrigerator temperature was 8.3 C
*On 5/17/15 at 7:15 am, an ICU 1 refrigerator temperature was 9.2 C
*On 5/18/15 at 7:15 am, an ICU 1 refrigerator temperature was 9.6 C
*On 5/21/15 at 7:00 am, an ICU refrigerator temperature was 9.1 C
*On 5/22/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.6 C
*On 5/23/15 at 10:00 am, an ED refrigerator temperature was 8.6 C
*On 5/23/15 at 10:00 am, a Unit 1 refrigerator temperature was 9 C
*On 5/24/15 at 7:00 am, an ED refrigerator temperature was 8.6 C
*On 5/24/15 at 7:00 am, a Unit 1 refrigerator temperature was 9.2 C
*On 5/25/15 at 9:30 am, a Unit 1 refrigerator temperature was 9.6 C
*On 5/25/15 at 9:30 am, a Unit 3 refrigerator temperature was 9.1 C
*On 5/26/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.3 C
*On 5/26/15 at 7:00 am, a Unit 1 refrigerator temperature was 9.4 C
*On 5/27/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 5/28/15 at 7:00 am, a Unit 3refrigerator #2 temperature was 8.6 C
*On 5/29/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 5/29/15 at 7:00 am, a Unit 3 refrigerator temperature was 9 C
*On 5/31/15 at 7:15 am, a Unit 3 refrigerator temperature was 9.6 C
*On 6/1/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.4 C
*On 6/2/15 at 7:00 am, an ED refrigerator temperature was 8.1 C
*On 6/2/15 at 7:00 am, an ED refrigerator temperature was 8.2 C
*On 6/3/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.2 C
*On 6/4/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.1 C
*On 6/4/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 6/5/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.1 C
*On 6/6/15 at 7:15 am, a Unit 3 refrigerator temperature was 8.3 C
*On 6/7/15 at 7:15 am, a Unit 3 refrigerator temperature was 8.9 C
*On 6/8/15 at 7:00 am, an ED refrigerator temperature was 11 C
*On 6/10/15 at 7:00 am, a Unit 3 refrigerator temperature was 9.8 C
*On 6/11/15 at 7:00 am, an ED refrigerator temperature was 8.2 C
*On 6/11/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.7 C
*On 6/12/15 at 7:00 am, an ICU refrigerator temperature was 9.1 C
*On 6/13/15 at 9:00 am, a Unit 3 refrigerator temperature was 8.8 C
*On 6/14/15 at 7:15 am, a Unit 3 refrigerator temperature was 9.5 C
*On 6/15/15 at 7:00 am, an ED refrigerator temperature was 11.6 C
*On 6/15/15 at 7:00 am, a Unit 3 refrigerator temperature was 8.4 C
*On 6/16/15 at 7:00 am, a Unit 3 refrigerator temperature was 9.2 C
*On 6/26/15 at 7:15 am, a Unit 2 refrigerator temperature was 8.4 C
*On 6/23/15 at 7:00 am, a Unit 1 refrigerator temperature was 9 C
*On 6/24/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.9 C
*On 6/25/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.7 C
*On 6/26/15 at 7:15 am, a Unit 1 refrigerator temperature was 8.9 C
*On 6/27/15 at 7:15 am, a Unit 1 refrigerator temperature was 8.8 C
*On 6/28/15 at 7:15 am, a Unit 1 refrigerator temperature was 8.5 C
*On 6/28/15 at 7:15 am, an ED refrigerator temperature was 8.5 C
*On 6/30/15 at 7:00 am, an ED refrigerator temperature was 8.3 C
*On 7/3/15 at 7:00 am, an ED refrigerator temperature was 8.8 C
*On 7/3/15 at 7:00 am, a Unit 2 refrigerator temperature was 8.3 C
*On 7/4/15 at 10:00 am, a Unit 2 refrigerator temperature was 8.4 C
*On 7/5/15 at 9:00 am, a Unit 2 refrigerator temperature was 8.3 C
*On 7/5/15 at 9:00 am, a Unit 1 refrigerator temperature was 8.5 C
*On 7/6/15 at 7:00 am, a Unit 1 refrigerator temperature was 8.2 C
*On 7/6/15 at 7:00 am, a Unit 2 refrigerator temperature was 9.1 C
*On 7/6/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/7/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/8/15 at 7:15 am, a Unit 2 refrigerator temperature was 8.5 C
*On 7/8/15 at 7:15 am, an ICU refrigerator temperature was 8.7 C
*On 7/9/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/10/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/11/15 at 8:30 am, an ICU refrigerator temperature was 8.7 C
*On 7/12/15 at 9:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/13/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/14/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/15/15 at 7:00 am, an ICU refrigerator temperature was 8.7 C
*On 7/16/15 at 7:00 am an ICU refrigerator temperature wa

Based on interview and record review, the hospital failed to ensure a pharmacist supervised and coordinated activities with staff (e.g. nurses, pharmacists, administrators, engineers, and medical staff) to provide pharmaceutical services related to safe medication storage conditions and use of Immediate Use Compounded Sterile Products (IUCSPs) throughout the hospital. The hospital's failure placed 110 patients at current risk for adverse events from preventable mediation errors when IUCSPs and medications stored under refrigeration did not meet quality standards to promote patient safety. The hospital's failure placed 12,438 patients at risk for adverse events of treatment failure resulting from past non-compliance related to storage of 83,846 doses of adulterated (made impure or weakened) antibiotics during the survey period.

Definitions:

The California Health and Safety Code (H&SC) section 111260 states, "Any drug or device is adulterated if the methods, facilities, or controls used for its ...holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.

The American Society of Health System Pharmacists (ASHP) describes minimum practice standards for hospital pharmacies. Under Standard I, the "Leadership and Practice Management", is a section, "Laws and Regulations" which showed, "The practice standards and guidelines of the American Society of Health System Pharmacists and the Joint Commission on Accreditation of Healthcare Organizations or other appropriate accrediting body should be viewed as applicable, and the hospital should strive to meet these standards regardless of the particular financial and organizational arrangements by which pharmaceutical services are provided to the facility and its patients."

Findings:

1. On 8/3/15 at 12:51 pm, during an interview, the Director of Pharmacy (DPH) indicated that he had not supervised nursing staff performing compounding activities after receipt of a citation from the California Board of Pharmacy for storing adulterated antibiotics. The DPH indicated he had not attempted to coordinate training of nursing staff with the Chief Nursing Officer (CNO). (Refer to A 405)

On 8/4/15 at 3:04 pm, during an interview, the CNO, Director of Medical Services & Patient Safety (MD 2) a physician, Chair, Pharmacy and Therapeutics (MD 1) a physician, and the Chief Executive Officer (CEO) indicated they were aware they had adopted USP Chapter 797 as a standard for compounded sterile pharmaceutical products. The CEO and MD 1 indicated they had been provided with a copy of the BOP (Board of Pharmacy) report which restricted the hospital to compounding only immediate use products. The CEO, MD 1, the CNO and MD 2 indicated they were not consulted by the DPH on the complexities and did not fully realize the potential impact on hospital processes or patient care that came with an environment restricted to immediate use compounding. (Refer to A 405)

2. The DPH did not coordinate with the engineering department to identify or respond to 178 reports of out of range temperatures in medication refrigerators over a seven month period which involved six patient care units. (Refer to A 491).

3. On 8/3/15 at 12:51 pm, during an interview, the DPH indicated that pharmacists had been trained to assign a Beyond Use Date (BUD) of 1 hour on all IUCSPs but he had not coordinated to develop an audit process or supervise to ensure this was actually being done by pharmacists and nursing staff. The DPH indicated the hospital did not have written quality assurance procedures developed to ensure IUCSPs were dispensed with required label elements. (Refer to A 505)

On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two expired and mislabeled insulin syringes (e.g. Insulin Glargine 8 units and Insulin Glargine 25 units) were observed in the pharmacy stock with missing label components and a Beyond Use Date (BUD). The syringe of Insulin Glargine 25 units was labeled with patient-specific information for Patient 8 but it did not have a complete date when the year was missing. The syringe of Insulin Glargine 8 units was labeled with patient-specific information for Patient 9 but it did not have a complete BUD date when the date and year were missing. (Refer to A 505)

4. On 8/3/15 at 12:51 pm, in an interview, the DPH indicated he had not coordinated to develop an audit process or written quality assurance procedure to ensure expired IUCSPs were promptly, safely discarded. The DPH said, "These four products [two antibiotics and two syringes of insulin] should not be in stock. The DPH indicated that Clerk 1, a pharmacy clerk who placed the expired products in stock in error, had not been trained to promptly and safely discard and not store expired IUCSPs in accordance with practice standards.

On 8/3/15 at 1:08 pm in an interview, Clerk 1 said, "I usually credit the IVs [intravenous solutions] and take them to the IV room sink or the sink here in the pharmacy." Clert 1 indicated she had not been trained to segregate expired mediations from stock. A review of Clerk 1's competency records showed she had not received training in handling IUCSPs, segregating stock, or handling pharmaceutical waste. (Refer to A 505)

5. The DPH did not maintain oversight of unit inspections that were not performed by pharmacists. (Refer to A 491)

6. A review of three of eight sampled pharmacist's personnel files showed the DPH had not conducted an annual performance evaluation as part of supervision for two staff pharmacists (RPh 1 and RPh 2) or the Assistant Director of Pharmacy as required by hospital policies. (Refer to A 23)

Based on observation, interview and record review the hospital failed to ensure all compounding (combining drugs) and dispensing of drugs was performed under the supervision of a pharmacist and performed consistent with State and Federal law and hospital polices as evidenced by:

1. A registered nurse Night Supervisor (RN SUPV) compounded and administered eight Immediate Use Compounded Sterile Products (IUCSPs) to six patients (Patients 2, 3, 4, 5, 6, and 7) prior to receiving training for these activities.

2. Pharmacists dispensed IUCSPs without a Beyond Use Date (BUD) for two patients (Patient 8 and Patient 9).

3. Quality assurance procedures were not developed to ensure BUD assignment and prompt discarding of IUCSPs.

The hospital's failure placed six sampled patients (the census was 110 patients) at risk for adverse outcomes of fever and blood borne (in the blood) infection complications related to medication errors associated with intravenous administration of compounded sterile preparations. (Patients 2, 3, 4, 5, 6 and 7)

Definitions:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. [Reference: www.usp.org]

The U.S. Pharmacopeial - National Formulary (USP-NF) is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. [Reference: www.usp.org]

Pharmaceutical Compounding-Sterile Preparations- (USP Chapter 797) provides procedures and requirements for compounding sterile preparations. It describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, and variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. [Reference: www.usp.org]

Compounded Sterile Products (CSPs) are "Compounded biologics, diagnostics, drugs, nutrients, and radio-pharmaceuticals... that must be sterile when they are administered to patients ...," and "Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers' approved labeling... or prepared differently than published in such labeling." [Reference: www.usp.org]

Immediate Use Compounded Sterile Products (IUCSP) relates to the "immediate-use provision" of USP-NF Chapter 797 intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. IUCSPs are not intended for storage ...and unless complete administration is witnessed ...the CSP shall bear a label listing the exact 1-hour BUD and time...and ... if administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safety discarded. [Reference: www.usp.org]

Beyond-Use-Date (BUD) for the purpose of USP Chapter 797 is the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded.

BOP refers to the California State Board of Pharmacy, a regulatory agency that licenses hospitals to conduct sterile compounding activities.

Findings:

1. On 8/3/15 at 12:15 pm, in an interview, the Director of Pharmacy (DPH) indicated competencies for all pharmacy staff that performed compounding in the hospital was in the process of being validated (ensuring it is correct). He said he noticed the tests needed to be re-accomplished because he bumped a dial in an incubator in his office which potentially invalidated the results of a Media Fill test (a test that ensures operator competence during activities associated with compounding sterile products).

On 8/4/15 at 9:30 am, during an interview, the DPH said no one in the hospital had a valid competency test for Media Fill (negative result) because results would not be available for, "another ten days." [The Media Fill test requires 14 days of incubation to determine a pass or fail evaluation]. The DPH said the pharmacy was revalidating the tests, "to get a clean slate" but they were, "not required because everyone had a current competency validation on file."

A review of the California (State) Board of Pharmacy inspector's (BOPI) report, dated 7/30/15, showed the hospital's compounding license was conditionally renewed for "Immediate Use Compounding" and that the hospital was instructed to, "Complete all NEW process validation and documentation for all compounding staff."

A review of the hospital's policy, titled, I.V. [intravenous] AFTER HOURS COVERAGE, dated 8/14, "PROCEDURES" section for the hospital's "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "Nursing personnel that mix I.V. preparations after pharmacy hours will be inserviced annually on the proper procedures and sterile techniques for admixture preparation."

On 8/3/15 at 12:51 pm, during an interview, the DPH stated, "Since 7/30/15, pharmacy staff had been compounding only immediate use CSPs ... and after-hours, nurses do it." The DPH indicated the hospital had conducted extensive testing of the pharmacy staff to ensure competency. The DPH said, "I don't know if the nurses have been trained." The DPH indicated that he had not supervised nursing staff performing compounding activities. The DPH indicated he had not attempted to coordinate training of nursing staff with the Chief Nursing Officer (CNO).

A review of the hospital's policy, titled, I.V. [intravenous] AFTER HOURS COVERAGE, dated 8/14, "PROCEDURES" section for the hospital's "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "The Pharmacy Department is open daily from 0700 to 2300 [7:00 am to 11:00 pm], Monday through Friday; Saturday, Sunday and Holidays from 0700 to 1900 [7:00 pm]. The policy showed, "In case of emergency during the hours the Pharmacy is closed, the nurses can: prepare I.V. solution using drugs from the floor stock I.V. solution or prepare I.V. solution using laminar flow hood (enclosed bench used to prevent contamination) in Pharmacy." The policy showed, "Records are kept on all items removed from the pharmacy" ...and ..."Nursing personnel that mix I.V. preparations after pharmacy hours will be inserviced annually on the proper procedures and sterile techniques for admixture preparation."

On 8/4/15 at 9:13 am, during an interview, the DPH indicated that all of the medications were prepared and administered by registered nurse night supervisor (RN SUPV). The DPH said, "I don't believe we have documented competencies for her to compound IUCSPs." The DPH indicated he was unaware that USP 797 standards state under the section, Immediate-Use CSPs, " ...antineoplastics (cancer drugs) shall not be prepared as immediate-use CSPs because they are hazardous drugs." [Reference: www.usp.org] The DPH said the hospital's pharmacists had prepared and that nurses had administered "about eleven chemo treatments as immediate use compounded sterile products since 7/30/15."

On 8/4/15 at 3:04 pm, during an interview, the Chief Nurse Executive (CNO) indicated that the hospital's medical staff approved policies which ensure compliance with USP 797. The CNO indicated nurses in the hospital compounded IUCSPs after hours when a pharmacist was not available. The CNO said, "Nurses have been doing these the last few weeks." The CNO said, "I do not have any training for nurses to do CSPs ... [that are] current ...we used to." The CNO indicated that, other than training "at nursing school" nurses had not been trained by the hospital to check for clarity of IUCSPs before administering IUCSPs" ... "They do not have a completed competency in their file."

A review of the "POLICY" section for the hospital's policy, titled, "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed, "It is critical that compounding personnel maintain high standards for the quality and control of processes, components and environments and for the skill and knowledge of personnel who are assigned to prepare compounded sterile products. The Director of Pharmacy or supervisory designees shall ensure that the following occur in compliance with the most recent version of the USP-NF, Chapter 797: Before being dispensed or administered, the clarity of solutions is visually confirmed ...Beyond-use-dates are assigned based on extrapolation (estimations) from reliable literature sources ...Procedures for dilution, mixing, packaging and labeling conform to the correct sequence and quality established for the specific compounded product ...Deficiencies in compounding, labeling, packaging and quality testing/inspection can be rapidly identified and corrected ...and ...when time and personnel availability permit, compounding manipulations (treatments) mentioned clarity of solution."

On 8/4/15 at 9:13 am, during an interview, the DPH provided an undated summary of medications administered to patients compounded by a registered nurse night supervisor (RN SUPV). The DPH said, "From 11 pm on 7/3/15 to 7 am on 7/4/15 RN SUPV compounded eight medications."

A review of a list of medication administration showed the following:

On 7/31/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Chloride 10 milliequivalents (mEq) in Dextrose 0.2% Normal Saline 500 milliliters (mL), a potassium supplement, to Patient 2.

On 8/2/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams (mg), an antiviral, to Patient 3.
On 8/2/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 millimoles (mM), a CSP phosphate supplement, to Patient 4.
On 8/3/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams to Patient 3.
On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 mM to Patient 5.
On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Chloride 40 mEq in Normal Saline to Patient 7.
On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Potassium Phosphate 24 mM to Patient 5.
On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams to Patient 3.
On 8/4/15 RN SUPV prepared and administered a CSP intravenous solution of Acyclovir 800 milligrams to Patient 6.

A review of the "PROCEDURES" section for the hospital's policy, titled, "Compounded Sterile Pharmaceutical Preparation: Sterile Compounding Process", dated 1/14, showed a requirement for "a written quality assurance procedure" that includes appropriate in-process checks in place ...Compounding personnel are adequately skilled, educated, instructed and trained to correctly perform and document the following activities in their sterile compounding duties" to include, " ...Perform antiseptic hand cleansing and disinfection of non-sterile compounding surfaces" ... "select and appropriately don gloves, goggles, gowns, mask, hair covers, and shoe covers ...Use laminar flow clean air hoods ...identify and measure additives ...manipulate sterile products aseptically ...label and quality inspect final products ... remove air bubbles and ...check correct volume ...if possible use a filter needle to inject the contents of the syringe into the solution if the contents of the syringe were removed from a glass ampoule (vial) or a reconstituted powder ...wipe the port of the solution with an alcohol swab prior to each entry and allow to dry ...discard all used ampoules and needles into the sharps containers ...IV's prepared from a reconstituted vial /drug in solution must be discarded after 24 hours if stored at room temperature or sooner if the manufacturer indicates stability less than 24 hours ...clean up the work area with a germicidal (kills germs) cloth ...and multidose vials may be used up to the expiration date assigned by the manufacturer."

On 8/4/15 at 9:13 am, during an interview, the DPH indicated that standards defined in USP 797 for IUCSPs required compounding personnel to receive, "training to ensure that unless immediately and completely administered by the person who prepared it and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, that name or initials of the person who prepared the CSP, and the exact-hour Beyond Use Date (BUD) and time.

No record to demonstrate supervision of nurses related to compounding activities, or a written quality assurance procedure, was provided by the hospital during the survey.

2. On 8/4/15 at 9:13 am, during an interview, the DPH indicated beyond use date (BUD) of all compounded sterile products prepared and administered in the hospital since 7/30/15 would be, "one hour" and, "consistent with the USP 797 standard of practice" as stated in hospital policies.

On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two bags of unusable Compounded Sterile Products (CSPs) antibiotic medications (e.g. ceftriaxone 1 gram (g) in Normal Saline 0.9% 50 milliliters (mL) and ceftriaxone 2 g in Normal Saline 0.9% 50 mL) were observed in the pharmacy stock in the unit dose preparation area without required labels. The ceftriaxone 2 g in Normal Saline 0.9% 50 mL bag had handwritten annotations in a black marker "8/1" and "JA" in the upper margin of the bag. Neither bag had BUDs.

On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two expired and mislabeled insulin syringes (e.g. Insulin Glargine 8 units and Insulin Glargine 25 units) were observed in the pharmacy stock with missing label components or a Beyond Use Date (BUD). The syringe of Insulin Glargine 25 units was labeled with patient-specific information for Patient 8 but it did not have a complete date when the year was missing. The syringe of Insulin Glargine 8 units was labeled with patient-specific information for Patient 9 but it did not have a complete BUD date when the date and year were missing.

On 8/3/15 at 9:47 pm in an interview, the Director of Pharmacy (DPH) said, "These four products should not be in stock. The unit dose preparation area of the pharmacy is considered pharmacy stock and they are sitting here." The DPH held the syringe of Insulin Glargine 8 units and said, "It should have a date and time indicating a BUD and this does not have a date." The DPH held the Insulin Glargine 25 units syringe and said, "By interpreting the label it does not have a complete date and time indicating the BUD because it is missing the year." The DPH indicated the hospital's compounding license was restricted compounding activities to "Immediate Use Only" also known as Immediate Use Compounded Sterile Products (IUCSP) limits. Requirements and definitions for CSPs and IUCSPs and BUDs are defined in the United States Pharmacopeia- National Formulary Chapter 797 (USP 797), an organization that sets standards for compounding sterile products in the United States. [Reference USP.org] The DPH indicated the hospital adopted the USP 797 standards in its policies. The DPH indicated that all CSPs compounded since 7/30/15 were required to bear the label, and assigned a BUD of one hour using a complete date and time. He held the two bags of ceftriaxone and said, "These have been mixed. They are CSPs that fall under our Immediate Use CSP policies." The DPH said, "The 8/1 on the antibiotic indicates this product was compounded August 1, 2015." He said, "These antibiotics expired a couple of days ago. I am not exactly sure when. The other one has no label or BUD, therefore it's unusable."

A review of the hospital's policy, titled, DISPOSAL OF NON-NARCOTIC PRESCRIPTION DRUGS, revised 3/15, showed, "Disposal procedure for non-narcotic prescription drugs picked up from [hospital name] Radiology Department, Emergency Department, Ambulatory Care, Intensive Care, Medical and Surgical floors and Obstetrics Labor and Delivery and all Provider Base Clinic offices ... are placed in 2-gallon or 5-gallon Pharmaceutical containers by the nursing staff."

A review of the hospital's policy, titled, COMPOUNDED STERILE PHARMACEUTICAL PREPARATION: STERIL COMPOUNDING PROCESS, showed, "The Director of Pharmacy or supervisory designee shall ensure that the following occur in compliance with the most recent version of the USP-NF, Chapter 797" ...Beyond-use-dates are assigned based on extrapolation (estimations) from reliable literature sources ...label and quality inspect final products ...IV's [intravenous solutions] prepared from a reconstituted (adding fluid) vial/drug in solution must be discarded after 24 hours if stored at room temperature or sooner if the manufacturer indicates stability less than 24 hours."

Based on observation, interview and record/policy reviews, the hospital failed to ensure that one of 30 sampled patients' medications was securely stored when left on his bedside table. This failure placed patients and visitors at risk for complications related to unauthorized access to medications. (Patient 11)

Findings:

Patient 11 was admitted on 8/3/15 for abdominal pain.

During initial tour of Unit 1 on 8/3/15 at 9:48 am with Administrative (Adm) Nurse C, Patient 11's ProAir (albuterol inhaler helps clear lungs for breathing) was observed on his bedside table. There was no hospital label attached to indicate it had been sent to the hospital's pharmacy for labeling. Patient 11 stated he brought the ProAir inhaler from home. Adm Nurse C concurrently stated that Patient 11's ProAir was not labeled by the hospital's pharmacy, and should not have been left on his bedside table. Adm Nurse C confirmed that Patient 11 had not been evaluated for medication self administration and that the ProAir was not on his physicians orders.

The hospital's Bedside Medications policy, dated 6/2015, showed patients were not to keep medications at the bedside unless ordered by the physician, and were to be secured.

On 8/5/15 at 9:45 am, the hospital's Director of Pharmacy (DPH) was interviewed about Patient 11's ProAir inhaler. The Pharmacist stated the hospital was an "inhalerless" facility and that Patient 11 had should not have had the ProAir inhaler at his bedside. DPH further stated that is was not safe for Patient 11 to be receiving both the inhaler albuterol and the RT administered albuterol ordered by his physician. DPH confirmed that the hospital's Bedside Medications policy was not followed.

Based on observation, interview, and record review, the facility failed to ensure expired (outdated) and mislabeled (two products did not have required Beyond Use Dates (BUDs) on the labels) antibiotic and insulin medications were not available for patient use when four products were reintroduced into pharmacy stock by a pharmacy clerk (Clerk 1) after dispensing. The hospital's failure had the potential to result in treatment failure or contamination and subsequent patient harm for all patients who potentially required these medications. (Census of 110 patients).

Definitions:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. [Reference: www.usp.org]

The U.S. Pharmacopeial - National Formulary (USP-NF) is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. [Reference: www.usp.org]

Pharmaceutical Compounding-Sterile Preparations- (USP Chapter 797) provides procedures and requirements for compounding sterile preparations. It describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, and variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. [Reference: www.usp.org]

Compounded Sterile Products (CSPs) are "Compounded biologics, diagnostics, drugs, nutrients, and radio-pharmaceuticals... that must be sterile when they are administered to patients ...," and "Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers' approved labeling... or prepared differently than published in such labeling." [Reference: www.usp.org]

Immediate Use Compounded Sterile Products (IUCSP) relates to the "immediate-use provision" of USP-NF Chapter 797 intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. IUCSPs are not intended for storage ...and unless complete administration is witnessed ...the CSP shall bear a label listing the exact 1-hour BUD and time...and ... if administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safety discarded. [Reference: www.usp.org]

Beyond-Use-Date (BUD) for the purpose of USP Chapter 797 is the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded.

Findings:

On 8/3/15 at 12:51 pm, during an interview, the Director of Pharmacy (DPH) indicated the hospital adopted USP 797 standards for sterile compounding (combining drugs) as reflected in the hospital's written policies. The DPH indicated that on 7/30/15, the hospital's compounding license was restricted to compounding activities for "Immediate Use" only, (as defined in USP 797) subsequent to an inspection by the California Board of Pharmacy on 7/30/15 during a compounding license renewal inspection. The DPH indicated he was familiar with the requirements and definitions for CSPs, IUCSPs, and BUDs as defined in the United States Pharmacopeia- National Formulary Chapter 797 (USP 797). The DPH indicated that all CSPs compounded, since 7/30/15 were required to bear the label and assigned a BUD of one hour using a complete date and time.

On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two bags of unusable Compounded Sterile Products (CSPs) antibiotic medications (e.g. ceftriaxone 1 gram (g) in Normal Saline 0.9% 50 milliliters (mL) and ceftriaxone 2 g in Normal Saline 0.9% 50 mL) were observed in the pharmacy stock in the unit dose preparation area without required labels. The ceftriaxone 2 g in Normal Saline 0.9% 50 mL bag had handwritten annotations in a black marker "8/1" and "JA" in the upper margin of the bag. Neither bag had BUDs.

On 8/3/15 at 12:51 pm, during a tour of the pharmacy, two expired and mislabeled insulin syringes (e.g. Insulin Glargine 8 units and Insulin Glargine 25 units) were observed in the pharmacy stock with missing label components or a Beyond Use Date (BUD). The syringe of Insulin Glargine 25 units was labeled with patient-specific information for Patient 8 but it did not have a complete date when the year was missing. The syringe of Insulin Glargine 8 units was labeled with patient-specific information for Patient 9 but it did not have a complete BUD date when the date and year were missing.

On 8/3/15 at 12:51 pm, in an interview, the Director of Pharmacy (DPH) said, "These four products should not be in stock. The DPH acknowledged that although the patients had been discharged, they posed a risk to all patients in the hospital who had the potential to receive ceftriaxone or insulin. He indicated that Clerk 1 had not been trained in the hospital's standard to promptly and safely discard and not store expired IUCSPs.

On 8/3/15 at 1:08 pm in an interview, Clerk 1 said, "I usually credit the IVs (intravenous solutions) and take them to the IV room sink or the sink here in the pharmacy." Clerk 1 indicated she had not been trained to segregate (separate) expired mediations from stock.
A review of Clerk 1's competency records showed she had not received training in handling IUCSPs, segregating stock, or handling pharmaceutical waste.

A review of the hospital's policy, titled, COMPOUNDED STERILE PHARMACEUTICAL PREPARATION: IMMEDIATE USE CSP'S, revised 1/14, showed, "CSP shall bear a label listing patient information such as name and identification number(s), the names and amounts of all products and use time and date. The policy showed, "If administration has not begun within one hour following the start of preparing the CSP, the CSP is promptly discarded. Immediate Use CSP's shall NOT be stored for later use.

Based on dietetic services observations, dietary staff interview, and departmental document review, the hospital failed to ensure comprehensive oversight of:

1. Cool down procedures for cooked foods.

2. Adherence to dress code in the kitchen.

These failures may result in patient exposure to unsafe food handling practices and/or food production systems that may compromise patients' medical status.

Findings:

1. On 8/3/15, the hospital policy, titled, "Cooling of Food," dated 9/2008, indicated the temperature of the food item is documented at the point of being removed from the heat source and documented on the log. Hourly measurements are continued to ensure that it is chilled from 135 degrees Fahrenheit (F) to 70 degrees F in two hours, and then from 70 degrees F to 41 degrees or below in the next two hours. The policy further indicated that food that does not meet these measurements must be reheated and cool down procedures restarted or the food is discarded.

On 8/3/15 at 3 pm, the cool down log, dated 6/25 to 8/1/15, was reviewed with the Administrative (Admin) Staff A. The log was incomplete, for 6/25/15, for pork which did not demonstrate an appropriate cool down temperature until 4.75 hours had passed. Also on 6/25/15, the log had broth that did not have a temperature taken at the two hour time frame. The log did not indicate the food items were discarded.

In a concurrent interview, Admin Staff A acknowledged the hospital policy for food cooling was not followed.

2. On 8/3/15, the hospital policy, titled, "Uniform Policy," dated 5/2015, read, "Hair is to be covered at all times."

On 8/3/15 at 11:50 am, Cook A was observed wearing a surgical skull cap which did not cover hair at the nape of his neck.

The Director of Nutrition and Food Service was present and acknowledged that Cook A's hair was not covered as required by policy.

Based on interview and record review, the hospital failed to ensure that one of 30 sampled patients (Patient 29) had her nutritional status evaluated according to the hospital policy. This failure had the potential for nutritional and/or medical status compromise.

Findings:

On 8/6/15, the hospital policy, titled, "Nutrition Assessments, last reviewed on 5/2014, indicated that patients with risk factors such as diabetes and non-healing wounds should receive supportive nutritional measures to facilitate effective medical treatment.

On 8/6/15, the hospital policy, titled, "Nutrition Reassessments," last reviewed 3/12, read, "Each patient will receive nutritional reassessment with 4-10 days of the initial assessment... as outlined in the Prioritization Guidelines for Nutritional Care (PGNC)." The PGNC indicated that patients with wound healing problems should be assessed every 3-5 days, and patients with diabetes should be reassessed every 5-7 days.

On 8/4/15, Patient 29's record was reviewed. Patient 29 was admitted on 7/14/15 with diagnoses including anemia (low blood cell count), diabetes, and ulcers (sores) on her heels. Patient 29's record contained a record of a dietician's evaluation on 7/14/15. Patient 29 had difficulty swallowing and was placed on a pureed diet. Patient 29's record contained a reassessment of her nutritional status on 7/26/15 (12 days later) which indicated she was not tolerating the pureed diet and continued to have wounds on both of her heels.

On 8/6/15 at 2:30 pm, the Director of Nutrition and Food Service acknowledged that Patient 29 did not receive timely nutritional reassessments.

Based on observation and interview, the hospital failed to ensure their Biohazard trash (biological substances that pose a threat to health and can include medical waste, microorganisms, and toxins) was stored safely when the doors to the storage room were propped open on Unit 1 and Unit 2.

Findings:

During the initial tour of Unit 1 on 8/3/15 at 9 am with Administrative (Adm) Nurse C, the door to the biohazard trash storage room was observed to be propped open.

During initial tour of Unit 2 on 8/3/15 at 9:43 am with Adm Nurse C, both hallway doors to the biohazard trash storage room were observed to be propped open.

On 8/3/15 at 11 am, Adm Nurse C stated that the hospital's practice was that the biohazard storage doors were to remain closed.

Based on observation and interview, the hospital failed to ensure their supplies and equipment were maintained at an acceptable level of safety and quality when:

1. Expired medical supplies and devices were found in several clinics and hospital units;

2. The temperature gauge on the medication refrigerator in Unit 1 was not operational for four months.

3. Emergency supplies for infants who were not breathing were not regularly checked to ensure adequate supplies were present.

These failures had the potential to compromise patients' health status.

Findings:

1a. During an initial tour of the hospital's Unit 1 supply room with Administrative (Adm) Nurse C, expired vacutainers (blood collection tube) and intravenous (IV, in the vein) catheters were observed available for use. Adm Nurse C confirmed they were expired.

1b. During initial tour of Unit 2, expired IV catheters and occult blood testing supplies (tests for blood in the stool/feces) were observed available for use. Adm Nurse C confirmed they were expired.

1c. During an initial tour of the hospital's Multi Specialty clinic on 8/4/15 at 8:10 am with Clinic Manager A, packages of sterile gloves, urine pregnancy testing supplies and Cidex Plus (disinfecting solution) test strips (tests the concentration of solution) were observed expired.

On 8/4/15 at 8:45 am, Clinic Manager A confirmed the above items were expired and should not have been in use.

1d. On 8/4/15 at 10 am, the hospital's Radiation/Oncology (cancer treatment) clinic was toured with Clinic Manager A. Occult blood (blood in stool/feces) testing products, bone marrow biopsy (removing tissue sample) needles and packages of sterile gloves were observed and concurrently confirmed by Clinic Manager A to be expired.

1e. On 8/4/15 at 10:46 am, the hospital's Orthopedic (bone problems) clinic was toured with Clinic Manager B. Sterile water and Betadine (antiseptic solution) were observed not labeled with the dates opened. Clinic Manager B confirmed the products should have been dated when opened to know their quality (how long they can be used).

1f. On 8/4/15 at 10:47 am, the hospital's Surgical Specialists clinic was observed to have expired packages of sterile gloves. Clinic Manager A confirmed they were expired.

2. During an initial tour of Unit 1 on 8/3/15 at 10:30 am with Adm Nurse C, the temperature gauge on the right Pyxis (pharmacy drug dispensing machine) refrigerator was observed to not be readable. Adm Nurse stated the connecting wire looked broken, the temperature was unreadable and that she called Plant Operations.

On 8/6/15 at 10:04 am the same refrigerator was observed and the temperature gauge read 8.3 degrees Celsius (C). The refrigerator to the left had a temperature gauge that read 6.6 C. The Director of Pharmacy (DPH)concurrently stated the Pyxis refrigerators were supposed to be between 2 and 8 C and that the refrigerator on the right side was not within those parameters. DPH stated that it contained insulin and Ativan (sedative).

On 8/6/15 at 10:25 am, Plant Operations Director stated that the temperature gauge on the Unit 1 Pyxis refrigerator had been broken since 4/11/15 and that only Maintenance personnel monitored these refrigerators.

On 8/6/15 the hospital's "Storage of Drugs and Bilogicals" policy, dated 10/12, showed refrigerator temperatures shall be between 2.2 and 7.7 degrees C and "drugs and biologicals must be stored in such a way as to insure that integrity, stability, and effectiveness of the product are kept intact..."



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3. On 8/3/15 at 9:25 am, during a tour of labor (for women giving birth) Room Number 1 with the Relief Charge Nurse (RCN), a stabilette (medical equipment that is equipped with oxygen, suction equipment, and emergency medical supplies that is used to support and maintain breathing and circulation for an infant who is not breathing and/or whose heart has stopped) was observed.

On the back of the stabilette was a clipboard that contained a checklist of emergency supplies and if the oxygen and suction equipment was checked to ensure it is functional. The checklist was dated July 2015. Each day of the month had a column that was to be used to check if the oxygen tank and suction equipment was functional and the necessary emergency supplies were on the stabilette.

Sixteen of the thirty-one days in July were blank. July first through July eleventh, July thirteenth and fourteenth, July twenty seventh, twenty eighth, and July twenty ninth. For July 30th, the column for checking that the oxygen tank and suctioning equipment was functioning was blank.

At 9:32 am, an 8/3/15, the RCN was interviewed. The RCN was asked why there were so many blanks on the checklist. The RCN stated that she didn't know. "They should have checked the stabilette but they didn't. We do it so we know the supplies are there."

On 8/4/15 at 10:30 am, the Nurse Manager of the Obstetrics (OB) department was interviewed. She stated the nursery nurse or the labor nurse is responsible for ensuring that the stabilettes are ready for use. The nursery nurse is responsible for delegating the responsibility if she can't get to it.

The policy for checking the stabilettes was requested. The OB Nurse Manager stated that there is no policy for checking the Stabilettes. They go by the "NRP", Neonatal Resuscitation Program. The Neonatal Resuscitation Program was developed and is maintained by the American Academy of Pediatrics. This program focuses on basic resuscitation skills for newly born infants.

According to the Neonatal Equipment Resuscitation Program, equipment needed for resuscitation should be available at every delivery area and routinely checked to ensure the equipment is functioning properly. American Academy of Pediatrics. Overview and principles of resuscitation. In: Textbook of Neonatal Resuscitation (NRP), 6th ed, Kattwinkel J (Ed), American Academy of Pediatrics, 2011.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases as evidenced by:

1. Failure to follow hospital isolation policies. Refer to A 748, finding 1.

2. Failure to update policies for cleaning isolation rooms with the hospital's approved cleaning products. Refer to A 748, finding 2.

3. Failure to provide personal protective supplies to protect employees from splashing of patient waste during the use of a hopper (a flushing sink). Refer to A 749, finding 1.

4. Failure to ensure nursing staff were able to accurately describe the proper disinfection for glucometers, used to test blood sugar. Refer to A 749, finding 2.

5. Failure to ensure safe and sanitary air handling systems in the operative (surgery) areas in accordance with nationally recognized infection control guidelines. Refer to A 749, finding 4 and 5.

6. Failure to ensure the sterility of surgical instruments and supplies. Refer to A 742, finding 3, and A 749, findings 6 and 13.

7. Failure to ensure expired supplies were made unavailable for use. Refer A 749, findings 1, 7, 9, and 10.

8. Failure to ensure used supplies, saved for future use by an outside company, were appropriately disinfected. Refer to A 749, finding 8.

9. Failure to ensure staff adhered to the standards for attire in the OR (operating room) and the kitchen. Refer to A 749, finding 12 and A 620, finding 2.

10. Failure to follow the hand hygiene policy. Refer to A 749, finding 11.

11. Failure to ensure a public restroom had soap and towels for appropriate hand hygiene. Refer to A 749, finding 14

12. Failure to ensure cooked food was cooled down in the prescribed timeframes to prevent promoting bacterial growth. Refer to A 620, finding 1, and A 749, finding 15.

13. Failure to ensure that biohazard trash was not accessible to the general public. Refer to A 713.

14. Failure of the Infection Control Practitioner to be knowledgeable of standards for the prevention of infection in the surgical services. Refer to A 748, findings 3 and 12.

The cumulative effects of these systemic problems resulted in the facilities inability to ensure an effective system-wide infection control program that failed to provide a safe environment free of transmission sources of infections and communicable disease to be in compliance with the Condition of Participation for Infection Control.

Based on observation, interview, and policy review, the hospital failed to follow their policies to prevent the transmission of infections when:

1. Personal protective equipment was not donned (put on) before entering an isolation room (rooms that separate patients from others to prevent the spread of infection, typically of multi-drug resistant organisms);

2. Policies were not updated to reflect the approved cleaning products used to clean Clostridium Difficile (C-Diff, a multi drug resistant organism) affected rooms and equipment.

3. The Infection Control Practitioner (ICP) was not knowledgable of nationally accepted standards for sterile processing of surgical supplies and instruments.

4. The Infection Control Plan was not updated annually and was not current with nationally accepted standards adopted by the hospital.

These failures had the potential for patients to acquire healthcare associated infections which could further compromise their health status.

Findings:

1. During an initial tour of Unit 1 on 8/3/15 at 10:22 am, Physician B was observed entering isolation Room 108 as she was putting a protective yellow isolation gown on. Physician B did not don (put on) gloves and was observed as she pulled the patient's bedside privacy curtain and went into the room further. Administrative (Adm) Nurse C concurrently confirmed that Physician B was a hospitalist (a hospital in-patient physician who works with many patients in house) and should have been wearing gloves before entering the room and touching things. Adm Nurse C confirmed that the patient in that room was in isolation for Vancomycin Resistant Enterococcus (VRE, a multi drug resistant organism resistant to potent antibiotics).

On 8/4/15, the hospital's Management of Patients with VRE policy, dated 3/5/14, showed that the mode of transmission read, "VRE is transmitted primarily by person to person spread, most often on the hands of staff which have been transiently (lasting a short time) contaminated by contact with infected or colonized (infected) patients....Since VRE is among the major hospital acquired infections, reducing the spread of VRE requires consistent use of appropriate hygiene policies by all staff and on all patients and throughout the hospital...Isolation policies apply to all hospital personnel and visitors entering the room at all times and for all reasons..."

2. During initial tour of Unit 1 on 8/3/15 at 9 am, several C-Diff isolation rooms were observed. Adm Nurse C was asked what the hospital was using to clean the C-Diff rooms. Adm Nurse C stated the hospital had started using a new product (Perisept 62) that was a solution of vinegar and peroxide for the C-Diff rooms.

On 8/5/15, the hospital's Management of Patients with Clostridium Difficile policy, dated 8/20/14, showed patients' rooms and equipment would be cleaned with a bleach solution.

On 8/5/15 at 2:35 pm Infection Control Practitioner (ICP) stated the hospital was going "back and forth" with the Perisept 62 product and bleach. ICP confirmed their policy to clean the C-Diff rooms had not been updated to reflect the use of Perisept 62.



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3. On 8/4/15 at 10:15 am, an interview with the ICP revealed she was not aware of the infection control practices hospital wide. The ICP acknowledged, the Hospital policy and procedures state the hospital followed "event related sterility (a package is sterile unless contaminated or until used)" guidelines in the storage of sterile supplies and sterile instruments. The ICP stated, "I am not familiar with that term." Additionally, she indicated she did not perform rounds or oversee rounds throughout the hospital campuses. The ICP further indicated that due to the reportable infections duties she is responsible for and the lack of support staff, she was not able to participate in other infection control activities. A review of storage of sterile supplies, the facility was not following the Hospital stated national recognized standard of the Association of Perioperative Registered Nurses, (AORN) in event related sterility. Refer to 749, item 10 for further information.

According to AORN Preoperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013):

"Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity ...Events that may affect the sterility of a package include, but are not limited to.

1. Multiple handling that leads to seal breakage or loss of package integrity:
2. Compression during storage;
3. Moisture penetration;
4. Exposure to airborne and other environmental contaminants;
5. Storage conditions (e.g. type of shelving, cleanliness, temperature, humidity, traffic control);
6. Type and configuration of packaging materials used; and
7. Use of sterility maintenance covers and method sealing.

Sterile packages should be stored under environmentally controlled conditions. Sterile storage area temperature should be controlled and not exceed 75 degrees Fahrenheit (F). The humidity should not exceed 70 percent. There should be a minimum of four air exchanges per hour, and the air flow should be under positive pressure in relation to adjacent areas."

3. In review of the facility policy titled, "INFECTION CONTROL PLAN," dated 08/12, the ICP indicated the plan was to be updated annually and was outdated according to the AORN standards, which the facility identified as the nationally recognized standards they were following.

In further review, the Infection Control Plan identified the ICP as responsible for managing the infection control program. "The infection Control Practitioner performs surveillance designed to identify opportunities to improve performance, develops and implements hospital-wide policies and procedures based on current theory or regulation, assist department managers in developing and implementing department-specific policies and procedures based on current theory and regulation." The ICP acknowledged the facility was not following their own policy and procedure, "INFECTION CONTROL PLAN," dated 8/12.

Based on observation, interview and record review, the hospital failed to ensure adequate methods for preventing the spread of infection when:

1. The hopper (a flushing sink used for disposing of patient waste) in the Intensive Care Unit (ICU) soiled utility room did not have a splash guard, and there were no protective face shields or gowns to protect against splashing of patient waste;

2. A Registered Nurse (RN) A was unable to describe the correct method for disinfecting glucometers (devices for testing blood sugar);

3. Staff in the Respiratory Therapy Department were not properly measuring sanitizer for cleaning equipment;

4. Room temperatures and humidity levels were not monitored in the endoscopy procedure rooms (During an endoscopy procedure, a slender, tubular optical instrument used as a viewing system for examining an inner part of the body, with an attached instrument, for biopsy(removal of tissue) or surgery).

5. Endoscopy procedure rooms were not monitored for air exchanges (the number of times outside air replaces inside air in a room);

6. Laryngoscope handles and blades (a medical instrument that is used to look deep into the patient's mouth and into the throat) were not stored in a fashion to protect them from contamination;

7. Expired supplies were available for use in the Perinatal Department (birthing unit);

8. Used disposable supplies, saved for future use by an outside organization, were not properly disinfected;

9. Cloth hats were used in the Perioperative (surgical) Department in a manner not consistent with hospital policy or nationally accepted standards;

10. Hinged instrument were sterilized in a closed position and with other instruments stacked on top of them which was not consistent with nationally accepted standards;

11. A public restroom was available for use without handwashing supplies; and

12. The cool down procedure, used to prevent cooked foods from promoting pathogen growth and causing foodborne illnesses, was not followed.

These failures had the potential for patients to develop healthcare-acquired infections and food borne illnesses which could further compromise their health status.


Findings:

1. During an observation on 8/3/15 at 9:15 am, the hopper in the ICU did not have a splash shield, nor were there any gowns or face shields in the room.

In a concurrent interview, Administrative Nurse B confirmed there was no protection for the staff against splashing of patient waste while using the hopper, and stated there should be gowns and face shields available.

During an interview on 8/5/15 at 2:15 pm, the Infection Control Practitioner stated her expectation was that there should be gowns and face shields by the hopper.

2. During an interview on 8/3/15 at 10 am, RN A described how he disinfected a glucometer between patients. He stated he wiped it with Sani-Cloth Bleach, let it dry, then returned the glucometer to its holder. RN A further stated he did not note how long it took for the bleach solution to dry.

According to the instructions printed on the Sani-Cloth Bleach container, the surface being disinfected "must remain visibly wet for a full four minutes. Use additional wipe(s) if needed to assure continuous four minute wet contact time."

3. During an observation and interview on 8/5/15 at 9:50 am, Respiratory Therapist (RT) A demonstrated and described how he mixed a bleach solution with water to disinfect patient equipment.

The instructions on the bleach container called for one tablespoon (Tbs) of bleach solution to be mixed in one gallon of water for proper disinfection.

RT A used the cap of the bleach container to measure out one Tbs. At the surveyor's request, he poured the capful of solution into a small measuring cup; it measured less than one Tbs. RT A confirmed he had not been correctly measuring the disinfecting solution.

In an interview on 8/5/15 at 10:05 am, the Director of Cardiopulmonary (heart and lung) Services confirmed the Respiratory Therapy Department had not been measuring the bleach disinfectant correctly.



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4. On 8/4/15 at 10:53 am, an endoscopy procedure was observed (a slender, tubular optical instrument used as a viewing system for examining an inner part of the body with an attached instrument, for biopsy (removal of tissue or surgery).

At 11:16 am on 8/4/15, no monitor for reading the temperature and humidity of the procedure room was observed.

On 8/4/15 at 2:40 pm, a concurrent interview was conducted with Registered Nurse (RN) 1 and Licensed Vocation Nurse (LVN) 2. When asked if the temperatures and humidity levels were being checked in the endoscopy procedure rooms, RN 1 and LVN 2 stated that none of the endoscopy rooms had a thermometer or a device to monitor the temperature and humidity levels in the rooms.

During an interview with the Ambulatory Care Services Nurse Manager, he stated that room temperatures and humidity levels were not monitored in the endoscopy procedure rooms.

According to the Guidelines for Perioperative Practice, published by the Association of periOperative Registered Nurses (AORN) 2015 (the standards used by this hospital), heating, ventilation, and air conditioning (HVAC) systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas. The HVAC system is intended to reduce the amount of environmental contaminates (eg, germs skin cells, dust, lint) in the surgical suite.

AORN indicated the temperature of an unrestricted area (endoscopy procedure room) should be between 70º F and 75º Fahrenheit and the humidity in an endoscopy procedure room should be 20% to 60%.

On 8/5/15 at 2:37 pm, an interview was conducted with the Director of Plant Operations (DPs). When asked to view his temperature and humidity logs for the endoscopy procedure rooms, he stated that nobody checks the temperature and humidity of those rooms. DPS further stated that the temperature and humidity of the endoscopy rooms have not been monitored for the last 30 years.

5. On 8/5/16 at 2:37 pm, the DPS was interviewed. The DPS was asked for logs to show that the facility was maintaining the required number of total air changes per hour (ACH) for the operating room and the endoscopy procedure rooms. (An air change is how many times the air enters and exits a room from the heating, ventilation, and air conditioning system in one hour). The DPS stated that he doesn't have a log for checking the air changes in the operating room or the endoscopy procedure rooms. When asked to see his policy and procedure, the DPS stated that he does not have a policy and procedure for monitoring the ACH.

The Guidelines for Perioperative Practice, published by the Association of periOperative Registered Nurses 2015 was reviewed. According to AORN guidelines, the ACH in the operating room should be maintained at 20 total changes per hour, with a minimum of five air changes of outdoor air per hour or at the rate that was applicable at the time of design or of the most recent renovation of the HVAC system. The ACH in the endoscopy procedure room is 6 total with 2 outdoor air changes.

The health care organization should create and implement a systematic process for monitoring HVAC performance parameters and a mechanism for resolving variances.

The HVAC system is intended to reduce the amount of environmental contaminates in the surgical suite. The HVAC system reduces the amount of environmental contamination by carrying airborne contaminates away from the sterile field and removing these contaminants through the return duct vents located at the periphery of the room.

6. On 8/3/15 at 9:25 am, three laryngoscope blades and a laryngoscope handle (a medical instrument that is used to look deep into the patient's mouth and into the throat) were observed in the top drawer of the stabilette (medical equipment used to stabilize an infant immediately after they are born). Neither the laryngoscope handle or the blades were stored in a fashion to protect them from contamination when they were not in individual packages.

The Guidelines for Perioperative Practice, 2015 Edition, published by the Association of periOperative Registered Nurses (a nationally recognized organization that publishes guidelines used by hospitals), was reviewed. According to these guidelines, laryngoscope blades and handles should be cleaned and high-level disinfected or sterilized after each use. The blades and handles should be packaged and stored in a manner that prevents contamination. Laryngoscope blades should be stored in individual packages.

On 8/6/15 at 2:35 pm, the Infection Control Nurse (IC) was interviewed. When asked if she was aware of how the laryngoscope blades were being stored in the stabilettes in the Obstetrics department (department dedicated to the care of women and babies during pregnancy and childbirth), the IC stated she was not aware.

7. On 8/3/15 at 9:25 am, a concurrent tour of the Obstetrics Department (OB) was conducted with the relief charge nurse. During the tour the following outdated supplies were observed:

a. In labor room one, a urinary catheter insertion tray had an expiration date of 1/15.

b. Twenty-four samples of diaper rash ointment had an expiration date of 3/11/13.

c. In the dirty utility room, two bottles of Seracult developer (to detect blood in stool/feces) had an expiration date of 5/15.

d. On a shelf in the nursery, a bottle of Seracult developer had an expiration date of 11/12.

e. A partial bottle containing hydrogen peroxide had an expiration date of 7/15.

The Relief Charge Nurse and Nursery RN acknowledged that these items had expired.

8. During a tour of the OB department on 8/3/15 at 10:15 am, an uncovered clear plastic box containing surgical instruments was observed in the nursery on the bottom of a shelf.

The Nursery RN was interviewed on 8/3/15 at 10:16 am. According to the Nursery RN, the surgical instruments were disposable. They were used for circumcisions. The surgical instruments were wiped with a disinfectant wipe and stored in the plastic bin. They save them for a staff member who sends them to third world countries.

On 8/4/15 at 10:36 am, an interview was conducted with the OB Nurse Manager regarding the disposable surgical instruments. She confirmed that the surgical instruments were disposable and for single patient use. When asked if there was a policy for the handling and storing of the used instruments she stated that there was not a policy in place.

The product information sheet for the disinfectant wipe staff used to wipe the disposable surgical instruments was reviewed. The disinfectant is registered as an intermediate level disinfectant. This means that the product can kill bacteria, viruses, and the bacteria that causes tuberculosis. This product does not kill spores (A small reproductive body from which a new organism can grow certain bacteria, algae, and fungi). According to the product information, the product is to be used as follows, "Use on hard, non-porous environmental surfaces". The label did not claim this product was intended for the cleaning of surgical instruments.

Surgical instruments that remain in a patient care area that have not been reprocessed or disposed of according to the manufacturer's instructions are considered contaminated and are a source of potential cross contamination.

AORN's Guideline for Cleaning and Care of Surgical Instruments, published in the 2015 edition of Guidelines for Perioperative Practice, was reviewed. Devices labeled as single-use should not be reprocessed unless the Food and Drug Administration (FDA) guidelines for reprocessing of single-use devices can be met.

During an interview with the Infection Control Nurse (IC) on 8/6/15 at 2:35 am, the IC was asked about the used disposable surgical instruments that were being stored in the nursery. The IC stated that she was not aware this was happening.

9. A concurrent observation and interview was conducted with RN 1 in the endoscope reprocessing room on 8/3/15 at 11:55 am. RN 1 explained the reprocessing procedure that staff follow after an endoscopy procedure. RN 1 explained that after the endoscope has been processed through the automated endoscope reprocessor, a test strip is used to check the concentration of the disinfectant.

On 8/3/15 at 12:17 pm, a concurrent interview and observation was conducted with LVN 2. A partial bottle of test strips used to check the concentration of the disinfectant used in the automatic endoscope reprocessor was observed. The bottle was not dated. When asked if the bottle of test strips were dated, LVN 2 stated, no but it was supposed to be dated.

10. On 8/3/15 at 12:20 pm, a container partially filled with a liquid was observed on the counter in the automated endoscope reprocessing room. According to LVN 2, the solution was used for disinfecting instruments. LVN 2 explained that the solution was checked with test strips to make sure it meets the required concentration. The partial bottle of test strips was not dated. When asked why the bottle was not dated, LVN 2 stated that it should have been dated.

The label on the outside of the test strips indicated, "Once the container
is opened, the shelf life is reduced to 120 days. Record the date opened on the bottle under "date opened" to ensure that the monitors are not used beyond the 120 days."

11. On 8/3/15 at 11:47 am, X-ray Technician 1 was observed in the recovery room. X-ray Technician 1 was wearing gloves. She removed a pillow from behind the patient that had an area about the size of a basket ball that appeared wet and bloody. After the x-ray was taken, X-ray Technician 1 removed her gloves, disposed of the gloves in a trash can, and left the recovery room pushing the portable x-ray machine.

Immediately following the observation, X-ray Technician 1 was interviewed. When asked why she didn't wash her hands after she removed her gloves, she stated, "I just didn't".

The Center for Disease Control's (CDC-the standard of practice followed by the hospital for infection control) Hand Hygiene in Healthcare Settings was reviewed. "Healthcare providers should practice hand hygiene at key points in time to disrupt the transmission of microorganisms (germs) to patients including: before patient contact; after contact with blood, body fluids, or contaminated surfaces (even if gloves are worn); before invasive procedures; and after removing gloves [wearing gloves is not enough to prevent the transmission of pathogens (germs that cause infections) in healthcare settings]."



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12. On 8/4/15 at 2:50 pm, during an observation of the sterile core (an area that encompasses operating rooms, sterile processing, sterile storage), a hat stand (a wood stick approximately 5' high, with wooden sticks approximately 3 inches long serving as arms to hang cloth surgical hats on) was found located in the women's OR (operating room) lounge. The hat stand was found with approximately 50 cloth caps hanging on the stand. In a concurrent interview, the Perioperative Director/Manager (PDM) stated, "I know they (cloth hats) are not approved according to the standards but the nurses will not stop wearing them. I require the hats be washed daily by the facility." The PDM, indicated she does not require a disposable cap over the cloth cap; acknowledging the disposable cap is the standard according to the Association of Pri-operative Registered Nurse (AORN). The PDM, stated, "The AORN standards are followed by the department".

In a concurrent interview with the ICP, she indicated she is not familiar with the AORN standards for cloth hats in the OR. ICP acknowledged the staff should be following facility policy and facility policy should be based on the AORN standards selected by the facility as national accepted standards the facility will follow.

In review of records, the policy and procedure titled, "Surgery Dress Code" dated 6/2015 indicates, surgical hats made of cloth may be worn by personnel allergic to synthetic hats. These hats must be laundered in the hospital. All personnel entering the Operating Room suite must wear a clean surgical hat that is discarded at the end of the day unless it becomes contaminated during the day. The facility is not following their own policy in limiting the cloth hats to "personnel allergic to synthetic hats".

13. On 8/5/15 at 10:10 am, in an interview of sterile processing Techs 1, 2 and 3 and observation of rigid surgical trays (a container to hold surgical instruments during sterile processing) identified as ready for surgical use; seven out of 13 hinged instruments were found with tips closed. In addition, a blue towel tightly rolled containing 12 instruments was placed on top of the hinged instruments placing the weight of the rolled instruments on the tips of the hinged instruments.

In a subsequent interview at 10:20 am, the sterile processing staff Techs 1 and 2 acknowledged the placement of the instruments was not consistent with the AORN standard, which Techs 1 and 2 identified as the standards they follow. Techs 1 and 2 indicated they did not have adequate equipment to properly process the surgical instruments. In a following interview with PDM, she indicated prior knowledge of the needs of the Techs to process the hinged instruments with tips opened. PDM further indicated knowledge of the facility's need to purchase rigid trays and stringers (devices used to keep parts of sugical instruments a part) to accommodate the surgical instruments used and processed by the facility. The ICP acknowledge she was not familiar with the sterile processing department and therefore did not know the policy and procedures nor the National Recognized Standards.

The AORN Standards and Recommended Practices, 2015 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment was reviewed. Under Recommendation XII, the following information was provided:

"Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces. Proper organization will facilitate sterilant contact on all surfaces and adequate drying.

XII.a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer. Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps. Overloading trays can cause wet packs because an increase in metal mass in the tray results in more condensate, which requires additional drying at the end of the cycle.

XII.c. Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary. Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (e.g., retractors) enables the sterilant to contact all surfaces. XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."



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14. On 8/5/15 at 3:45 pm, the public restroom in the hallway next to the laboratory contained no paper towel dispenser, and no soap dispenser. There were no means of washing or drying one's hands in this restroom. No sign was on the door indicating the bathroom was out of order.

On 8/5/15 at 4:30 pm, Adm Staff A acknowledged the lack of handwashing supplies in this restroom.

15. On 8/3/15, the hospital policy, titled, "Cooling of Food," dated 9/2008, indicated the temperature of the food item is documented at the point of being removed from the heat source and documented on the Cool Down log. Hourly measurements are continued to ensure that is chilled from 135 degrees Fahrenheit (F) to 70 degrees F in two hours, and then from 70 degrees F to 41 degrees or below in the next two hours. The policy further indicated that food that does not meet these measurements must be reheated and cool down procedures restarted or the food is discarded.

On 8/3/15 at 3 pm, the cool down log, dated 6/25 to 8/1/15, was reviewed with the Adm Staff A. The log was incomplete for 6/25/15 for pork which did not demonstrate a cool down temperature until 4.75 hours had passed. Also on 6/25/15, the log had broth that did not have a temperature taken at the two hour time frame. The log did not indicate the food items were discarded.

In a concurrent interview, Adm Staff A acknowledged the hospital policy for food cooling was not followed.

Based on observation, staff interviews, medical record and document reviews, the hospital failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice, in order to ensure safe and high quality surgical care to all patients evidenced by:

1. Failure to ensure the required medical history and physical examinations had been performed for three of ten sampled surgical and/or procedural patients prior to their procedures. (Patient 31, 32, and 52) Refer to A 952, findings 1 and 2.

2. Failure to ensure safe and sanitary air handling systems in the operative (surgical) areas in accordance with nationally recognized infection control guidelines. Refer to A 749, findings 4 and 5.

3. Failure to ensure sterility of surgical instruments and supplies. Refer to A 749, findings 6 and 13.

4. Failure of staff to adhere to the standard for OR attire in the surgical suites. Refer to A 749, finding 12.

5. Failure to ensure test strips used to ensure the concentration of the disinfectant for processing of endoscopes (tube to view the inside of the body) were not expired. Refer to A 749, findings 9 and 10.

These failures put patients at risk for adverse surgical outcomes or hospital-acquired infections. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on interview and record review, the hospital failed to ensure the required medical history and physical examinations had been performed for three of ten sampled surgical and/or procedural patients prior to their procedures. (Patients 31, 31, and 52) This failure placed patients at risk for surgical complications.

Findings:

1. On 8/6/15, the records of three patients who underwent an endoscopic procedure (during an endoscopy procedure, a slender, tubular optical instrument used as a viewing system for examining an inner part of the body with an attached instrument, for biopsy (tissue removal) or surgery) was reviewed. Two of three patients did not have a current medical history and physical examination (H&P).

Patient 1 underwent an endoscopy procedure on 8/4/15. The date of the most current medical history and H&P was dated 6/30/15, thirty-five days prior to the endoscopy.

2. Patient 2 underwent an endoscopy procedure on 8/4/15. The date of the most current H&P was dated 6/23/15, forty-two days prior to the endoscopic procedure.

On 8/6/15 at 2:10 pm, a concurrent interview and record review was conducted with the Ambulatory Care Services Nurse Manager (ACS Nurse Manager). Copies of the most recent patient H&Ps and the physician's pre-procedure interval notes for endoscopy Patients 1 and 2 were reviewed. The ACS Nurse Manager acknowledged that both patients should have had a new H&P performed. ACS Nurse Manager stated if it has been longer than 30 days since an H&P was performed, a new H&P is needed.

Page 4 of a 33 page document titled, "Oroville Hospital Medical Staff Rules", was reviewed. Under section F. ii) For outpatient procedures not performed in the operating room and requiring only moderate sedation, a pertinent medical history and physical examination shall be documented no more than thirty days before the procedure is performed. When done more than thirty days before the procedure, a pertinent updated medical history and physical examination must be documented before the procedure is performed.




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3. Patient 52's record was reviewed on 8/6/15 at 1:15 pm. This record contained a history and physical examination done eight (8) days prior to the outpatient surgery performed under general anesthesia. There was no documentation of an updated exam of the patient prior to surgery. This finding was confirmed concurrently by Information Technology (IT) Staff A.

Based on interview and record review, the hospital failed to ensure that one of 10 surgical/ procedural records reviewed had a post anesthesia (after surgery) evaluation completed and documented. This failure had the potential for anesthesia complications to persist and negatively impact patients' health status.

Findings:

Patient 52's record was reviewed on 8/6/15 at 1:30 pm. Patient 52 was admitted for an outpatient surgery. The post-anesthesia evaluation did not document the time when performed, nor was there a space on the pre-printed section of the form for noting the time of the evaluation. This finding was confirmed concurrently by Information Technology Staff A.