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

ST LOUISE REGIONAL HOSPITAL 9400 NO NAME UNO GILROY, CA 95020 Jan. 18, 2012
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review the hospital failed to obtain a signature from the ordering practitioner in accordance with State law for 4 medications and a blood transfusion ordered for 1 of 8 sampled patients (5).

Findings:

State regulation indicate verbal medication orders need to be countersigned within 48 hours. (Refer to California Code of Regulations, Title 22, Section (g)).

On 1/17/12 at 2 p.m. a review of Patient 5's medical record was conducted. Patient 5's medical record did not have a practitioner's signature for three medications ordered on [DATE] at 9 a.m. and one medication ordered on [DATE] at 2:15 p.m. Further review of Patient 5's medical record contained a blood transfusion order written on 1/13/12 at 6:40 a.m. that lacked a practitioner's signature.

The intensive care unit director confirmed the above findings were correct during an interview on that same day and time.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on documentation, the hospital failed to implement policies for the control of infections by allowing contracted patient care personnel to work without meeting all the health requirements as dictated by policy.

Findings:

The hospital policy on management of contracted patient care services, was reviewed on 1/17/12. Under subsection Policy, 4., personnel provided by a contract entity are subject to the same expectations for qualifications, orientation and assessment of competence as staff employed by SLRH (Saint Louise Regional Hospital) working in the same capacity.

The health requirement for SLRH under policy (IC EH-7-1) indicates that staff vaccinations are required for Rubella, Rubeola, Varicella and Hepatitis B. Contract RN A's health file was reviewed on 12/22/11. During the review it was noted that RN A did not have evidence of the vaccinations required by hospital policy.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on interview and record review, the hospital failed to consider data at the time of reappointment regarding the quality of specific work beyond the absence of peer review activity in 3 of 5 sampled credentials files (Practitioners 3, 4, and 5). The deficient practice eliminated a mechanism by which the hospital could assess the current competence of its medical staff.

Findings:

Review of the credentials files for Practitioners 3, 4, and 5 indicated all were nephrologists. Practitioner 3 was reappointed to the hospital's medical staff on 11/3/11; Practitioners 4 and 5 were reappointed on 7/7/11. The files indicated Practitioners 3 and 4 had no cases which had been sent to peer review; Practitioner 5's file did not specify whether or not any cases had been sent to peer review. Three peer references and an evaluation by the department chair were present in each of the files, but there was no data measuring the quality of each physician's work at the hospital.

In an interview on 1/18/12 at 9:24 a.m., Staff B stated credentials files were reviewed by the department chairs who checked whether or not cases had been sent to the performance improvement committee or whether there were any other red flags. In an interview on 1/18/12 at 11:49 a.m., Staff D stated the hospital had not had quality data for credentialing in the past and that the hospital was working on getting the information included in the credentials files.

In an interview on 1/18/12 at 2:05 p.m., Staff E stated that a report summarizing the hospital's quality data for the nephrologists had blank entries indicating they did not have medical records suspensions and had not given blood transfusions. She stated that the data on "core measures" (common measurements of hospital quality) and mortality rate were blank because the patient's primary attending physicians were the ones assigned credit rather than consulting physicians such as nephrologists. Staff E stated the data did show whether or not each physician had cases sent to peer review.

Review of the hospital's medical staff bylaws (approved 7/8/10) indicated, "Requests for clinical privileges shall be evaluated on the basis of... the documented results of patient care and other quality review and monitoring which the medical staff deems appropriate."
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
Based on interview and record review, the hospital failed to have a doctor of medicine or osteopathy or dentist serve as the chief of the medical staff. Instead, the hospital had a podiatrist serving as chief of staff.

Findings:

Review of the hospital's undated roster of "2011 MEDICAL STAFF LEADERS" indicated Staff A was a podiatrist and served as the "Chief of Staff"; Staff F was a doctor of medicine and served as the "Vice Chief of Staff".

Review of the hospital's medical staff bylaws approved 7/8/10 indicated, "If a podiatrist is elected to serve as the Chief of Staff, then the Vice Chief of Staff shall be a doctor of medicine or osteopathy and shall be responsible for the organization and conduct of the medical staff during the podiatrist's term and for reporting to the Chief of Staff and the Medical Executive Committee [MEC] on the medical staff's organization and conduct." The bylaws, however, also stated that the chief of staff's duties included, "enforcing the medical staff bylaws and rules and regulations, implementing sanctions... calling, presiding at, and being responsible for the agenda of all meetings of the medical staff... serving as chair of the [MEC] and calling, presiding at, and being responsible for the agenda and all meetings thereof... interacting with the President/CEO and Board of Directors in all matters of mutual concern... appointing, in consultation with the [MEC], committee members for all standing committees other than the [MEC] and all special medical staff, liaison, or multi-disciplinary committees..."

In an interview on 1/18/12 at 9:24 a.m., Staff A stated that he represented the hospital's medical staff to the governing body and to the community, prepared agendas for medical staff and MEC meetings and ran the meetings. Staff A stated he did not vote at MEC meetings, but convened and chaired them. He stated that the vice chief of staff was, however, responsible for the organization and conduct of the medical staff. He stated the organization of the medical staff was as stated in the bylaws and the conduct of the medical staff was under the purview of the credentials committee and MEC.

In an interview on 1/18/12 at 10:15 a.m., Staff F stated the chief of staff requested his involvement in physician conduct issues, and that he worked closely with the chief of staff at MEC, the bylaws committee, the surgery committee, and the governing body. He stated he had been under the impression that a podiatrist chief of staff was OK as long as a physician was also involved.

In an interview on 1/18/12 at 12:38 p.m., Staff G stated the vice chief of staff was intimately involved in the conduct of the medical staff and the chief of staff facilitated but that the organization and conduct of the medical staff was not his sole responsibility.

Review of the hospital's binder of medical executive committee (MEC) meeting minutes indicated they were signed by the chief of staff. Review of two letters to a physician dated 2/7/11 and 6/30/11 regarding MEC concerns over the physician's competence indicated they were signed by both the chief of staff and vice chief of staff. Review of the MEC agenda for 11/30/11 indicated the chief of staff would lead discussions regarding peer review, standards of conduct, dues, the medical staff's role in emergencies, the budget, new policies, and lead the executive session. Review of the MEC agenda for 12/21/11 indicated the chief of staff would lead discussions regarding peer review, standards of conduct, credentialing, interdisciplinary practice, new policies, and lead the executive session.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, document review and interview, the hospital governing body failed to ensure that contracted services were provided in a safe and effective manner. Furthermore, the governing body failed to ensure that policies and procedures regarding staff competencies and oversight for dialysis patients were implemented.

Findings:

The hospital governing body failed to ensure that a dialysis service, providing care to hospital patients, was done in a manner consistent with national standards (refer to A-084).

In addition, the governing body failed to ensure the contracted dialysis staff were competent to perform their duties consistent with hospital policy (refer to A-386).

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver quality health care in a safe environment.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on documentation, the hospital governing body failed to ensure that a contracted dialysis provider performed services in a manner that was safe and effective for patient care.

Findings:

Renal dialysis treatment involves microbiological test for the dialysis water purification system. The results must meet the standards as set by AAMI (Association for the Advancement of Medical Instruments). Failing to provide oversight for this standard can potentially effect the quality of care for dialysis patients.

On 12/22/11 it was noted that patients requiring dialysis were to be given the treatment by a contracted entity and not by hospital staff. A review of the entity's contract with the hospital on [DATE] indicated the dialysis provider was a private physician's group operating under a limited liability company (LLC). There was no evidence the hospital provided any oversight to the physician's group water testing procedures or that the testing results met AAMI standards.

In addition, the competencies and performance evaluations for current staff performing dialysis treatments were reviewed on 1/17/12 (Staff RN A, B, C, and D). Four of 4 of the staff did not have current competencies or evaluations. It was noted in their personnel files, that the last evaluations were done in 2007. The hospital policy references that competencies and performance evaluations be done on an annual basis (see A-386).
VIOLATION: MEDICAL STAFF RESPONSIBILITIES Tag No: A0358
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to maintain a requirement that each patient have a medical history and physical examination (H&P) when the medical staff rules and regulations provided an exception for obstetric patients. The deficient practice had the potential to avoid creating an up to date summary of each patient's health for use in the hospital.

Findings:

Review of the hospital's medical staff rules and regulations approved 2/4/10 indicated, "In the case of an obstetrical admission, the entire prenatal record can be utilized as the History and Physical, provided it is legible and updated to reflect the patient's condition upon admission."

In an interview on 1/18/12 at 9:24 a.m., Staff A agreed that the rules and regulations contained an exception to the H&P requirement for obstetric patients.

Review of Patient 9's medical record indicated she was an obstetric patient admitted on [DATE]. The prenatal record consisted of a 3 page flowsheet faxed from the obstetrician's office with entries dated from 8/26/11 through 12/26/11 as well as two nursing assessments from obstetric triage dated 11/15/11 and 1/16/12. The obstetric flowsheet contained the elements of an H&P, including multiple obstetric exams, but the general physical exam was dated 8/26/11 (more than 30 days prior to admission) and the history portion of the flowsheet was not dated.
VIOLATION: MEDICAL STAFF RESPONSIBILITIES Tag No: A0359
Based on interview and record review, the hospital failed to maintain a requirement that updates to a patient's medical history and physical examination (H&P) be completed prior to surgery. The deficient practice had the potential to eliminate an assessment of the patient's fitness for surgery.

Findings:

Review of the hospital's medical staff rules and regulations approved 2/4/10 indicated, "When the-medical [sic] history and physical examination are completed within 30 days before admission, an updated entry documenting an examination for any changes in the patient's condition must be completed. This updated examination must be completed and documented in the patient's medical records within 24 hours after admission." The rules and regulations did not specify that the H&P update also needed to be completed prior to any surgical procedure if the 24-hour deadline had not yet occurred.

In an interview on 1/18/12 at 10:43 a.m., Staff B stated she thought the requirement for the H&P update prior to surgery was elsewhere but she could not find it and only saw the requirement that the update occur within 24 hours of admission.
VIOLATION: AUTOPSIES Tag No: A0364
Based on interview and record review, the hospital failed to have a system for notifying the attending physician when an autopsy was being performed. The deficient practice had the potential to limit participation in an important quality assurance activity.

Findings:

Review of the hospital's policy "Autopsies" (last approved 9/8/11) indicated there was no mechanism of notifying the attending physician when an autopsy was being performed.

In an interview on 1/17/12 at 1:59 p.m., Staff C stated "We can put it in there... autopsies are few and far between... I communicate significant findings... many physicians don't want to attend."
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on documentation, a contracted dialysis nurse was not supervised by a nurse who had experience in dialysis. There also lacked evidence of current nurse competencies in providing dialysis care.

Registered nurse A (RN A) provided acute care dialysis to Patient 10 on 10/21/11. A review of her personnel file on 1/17/12 indicated her last competency for dialysis was done on 6/20/07. At that time she was precepted by a physician. There was no evidence the physician was qualified to evaluate the nurse for dialysis care. In addition, RN A lacked any performance evaluations, thus nursing failed to provide oversight for her dialysis practice.
VIOLATION: SUPERVISION OF CONTRACT STAFF Tag No: A0398
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on documentation, the hospital failed to ensue that non-employed licensed nurses were supervised in a manner that was compliant with hospital policy regarding the use of personal cell phone devices.

Findings:

Review of hospital policy and procedure on "Business Telephones and Personal Cell Phone Devices" dated 09/09 indicated "personal cellular phones/PDA devices may only be in associate lounges, hospital lobby, or cafeteria on the hospital premises".

A review of Patient 1's medical record on 11/22/11 at 1 p.m. indicated the patient was admitted on [DATE] for a right hip fracture. During the course of his stay, he received hemodialysis treatment in his room by registered nurse A (RN A) on 10/21/11.

During an interview with RN A on 11/23/11 at 1 p.m., RN A stated she was using her cell phone for non-work related business during patient care. RN A further stated, "I understand I should not use the phone".
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on interview and record review the hospital failed to monitor and evaluate annual tuberculosis (TB) testing compliance for 5 of 18 sampled healthcare providers.

Findings:

Review of the hospital's Exposure Control Plan for "Aerosol Transmissible Diseases with focus on Tuberculosis" dated 2010 indicated all healthcare providers "are to report to Employee Health Services annually during the month of their birthday month for TB screening.

On 1/18/12 at 11 a.m. a review of RN H's employee file was conducted. Review of the file indicated RN H was not current with her annual (TB) screening. RN H was last tested for TB on 7/22/10.

On 1/18/12 at 11:05 a.m. during an interview with the hospital's occupational nurse, the occupational nurse confirmed RN H was missing her 2011 TB screening.

On 1/18/12 at 1 p.m. a review of RN B's employee file was conducted, although RN B was tested for tuberculosis there were no TB screening results for the past two years.

On 1/18/12 at 3 p.m. a review of TB screening information provided by the hospital indicated three of the five sampled practitioners were not up to date with their TB screening. Practitioner 1 and Practitioner 4 were last tested for TB on 2010 (missing 2011 TB screening). Practitioner 5 had no information regarding his last TB screening.