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Based on observation, interview, and record review, the hospital failed to ensure patient care services were provided in accordance with State laws and regulations evidenced by:

1. Failure to obtain a State license for mobile MRI (magnetic resonance imaging, x-ray) and CT (computerized tomography, x-ray) units, and outpatient services.
2. Failure to have policies for the mobile CT scan unit.
3. Failure to provide nurse staffing at 1:5 ratio.
4. Failure to implement the patient classification system.
5. Failure to have an annual meeting with the nursing staff to review and revise, if needed, the patient classification system.
6. Failure to have a Committee on Interdisciplinary Practice.
7. Failure to employ a credentialed medical records supervisor.

These failures had the potential for unsafe patient care.

Findings:

1. California Code of Regulations Title 22 70105(a)(3) stipulates, "A verified application shall be forwarded to the Department when any of the following circumstances occur: (3) Added service or change from one service to another."

On 3/18/13 at 10:30 am, a mobile CT (computerized tomography) was observed in the parking lot of the hospital.

The current hospital license did not list a mobile CT service.

On 3/21/13 at 11:50 am, Administrative (Admin) Nurse A reviewed the hospital license and discussed the services provided by the hospital. Admin Nurse A stated the following services were provided at the hospital and were not currently on the license:
- Mobile CT unit
- Mobile MRI unit
- Outpatient Services

2. California Code of Regulations Health and Safety Code 1765.160 stipulates the following: "Any licensee using mobile services pursuant to this chapter shall do all of the following: (a) Have written policies established by the governing body of the licensee, to govern the services that the mobile unit provides. The policies shall include, but shall not be limited to, policies related to patient care, personnel training and orientation, personnel supervision, and evaluation of services provided by the mobile unit. (b) Have written policies regarding patient selection criteria. (c) Develop and implement the written policies and procedures for the mobile unit in consultation with other appropriate health care professionals. (d) Ensure that the written policies and procedures are consistent with the policies and procedures of the parent facility, if any. (e) Ensure that the policies and written procedures shall be approved by the governing body, administration, and medical staff of the licensee, where appropriate. (f) Ensure that the written policies and procedures include, but are not limited to, all of the following: (1) Scope of services. (2) Procedures for the performance of the services provided. (3) Quality assurance. (4) Infection control."

On 3/21/13 at 8:20 am, Radiology Manager F acknowledged that the mobile CT unit did not have policies and procedures for the mobile unit as outlined in the above regulation.

3. California Code of Regulations Title 22 70217(a) (11) stipulates, "The licensed nurse-to-patient ratio in medical/surgical care units shall be 1:5 or fewer at all times."

On 3/18/13, the hospital's Nursing Assignment Reports were reviewed for 1/1/13 to 3/17/13 (76 days, 152 shifts). Twenty three shifts (15%) had one nurse caring for six to eight patients.

The hospital's policies were reviewed in regards to staffing. None of the policies addressed the above staffing ratio regulation.

On 3/21/13 at 9:30 am, Admin Nurse A stated she was unaware of the regulation and confirmed that the hospital had not provided the required nurse-to-patient ratio.

The hospital had been issued a program flexibility on 3/16/04 for this regulation in regards to coverage by the emergency room nurse for the medical surgical unit nurse break or lunch. The program flexibility was contingent on the following conditions:
"1. The facility will continue to call in an additional nurse, licensed vocational nurse, or house supervisor when the medical surgical census is six and there is a patient in the emergency room that requires nursing services...
3. The hospital shall implement their patient classification system in the medical surgical unit and the emergency department...
5. The hospital will continue to assess this alternative of meeting the requirement by continuing quality assurance activities."

Admin Nurse A confirmed that the conditions for the program flexibility granted in 3/16/04 had not been met.

4. California Code of Regulations Title 22 70217(c) stipulates, "A written staffing plan shall be developed by the administrator of nursing service or a designee, based on patient care needs determined by the patient classification system. The staffing plan shall be developed and implemented for each patient care unit and shall specify patient care requirements and the staffing levels for registered nurses and other licensed and unlicensed personnel. In no case shall the staffing level for licensed nurses fall below the requirements of subsection (a). The plan shall include the following:
(1) Staffing requirements as determined by the patient classification system for each unit, documented on a day-to-day, shift-by-shift basis.
(2) The actual staff and staff mix provided, documented on a day-to-day, shift-by-shift basis.
(3) The variance between required and actual staffing patterns, documented on a day-to-day, shift-by-shift basis."

On 3/21/12 at 9:30 am, Admin Nurse A was asked to provide copies of their patient classification (also known as acuity) system from 1/13 to 3/17/13. Admin Nurse A stated that they had a policy and form to measure the acuity of the patients but the nurses had not been using the form. Admin Nurse A acknowledged that the hospital was not in compliance with the above regulation.

5. California Code of Regulations Title 22 70217(e) stipulates, "The reliability of the patient classification system for validating staffing requirements shall be reviewed at least annually by a committee appointed by the nursing administrator to determine whether or not the system accurately measures patient care needs."

On 3/21/12 at 9:30 am, Admin Nurse A stated she was unaware of the regulation and acknowledged that this annual meeting regarding the patient classification system had not occurred.



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6. California Code of Regulations (CCR) Title 22 Section 70706 stipulates in part: "(a) In any (licensed hospital) ... in which licensed or certified healing arts professionals who are not members of the medical staff will be granted will be granted privileges pursuant to Section 70706.1 there shall be a Committee on Interdisciplinary Practice established by and accountable to the Governing Body, for establishing policies and procedures for interdisciplinary medical practice." "(b) The Committee on Interdisciplinary Practice shall include, as a minimum, the director of nursing, the administrator or designee and an equal number of physicians appointed by the Executive Committee of the medical staff, and registered nurses appointed by the director of nursing. Licensed or certified health professionals other than registered nurses who are performing or will perform functions as in (a) above shall be included in the Committee."

In meetings with the Director of Quality (DQ) on 3/19/13 at 10:15 a.m. and at 3:40 p.m., she stated that the hospital does not have an Inter-Disciplinary Practices Committee (IDPC) or other committee comprised of physicians, Allied Health Practitioners (AHP), nurses and administrative staff [as required by section CCR T22 Section]; and no such group of health care professional fulfills the duties required by this section of regulation.



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7. California Code of Regulations Title 22 Section 70713 stipulates: "If a hospital does not employ a qualified professional person to render a specific service to be provided by the hospital, there shall be arrangements for such a service through a written agreement with an outside resource--which meets the standards and requirements of these regulations. ... The outside resource, when acting as a consultant, shall apprise the administrator of recommendations, plans for implementation and continuing assessment through dated and signed reports which shall be retained by the administrator for follow-up action and evaluation of performance."

The facility does not employ a credentialed medical records supervisor [as required by CCR T22 Section 70747(b)]; so they contracted with a credentialed person, effective 10/1/12. The contract for Health Information Management Services was reviewed on 3/19/13. The agreement did not state how frequently the consultant was expected to visit the facility nor did it state the amount of time that was to be spent performing some of the duties remotely. Also, there was no mention of the requirement that dated and signed reports would be provided to the administrator. Administrative Staff A (Tom Hayes) was interviewed on 3/20/13 at 2:25 PM and he confirmed that the contract omitted mention of those items and that he had not received written reports from the consultant.

Based on observation and interview, the facility failed to ensure that all emergency drugs in the Emergency Department (ED) crash cart (contained supplies and drugs to be used in case of an emergency) as well as other medication storage areas had not expired. This had the potential to put patients at risk for poor clinical outcomes including infection and an ineffective response in the case of a patient emergency.

Findings:

1. During the initial tour of the ED on 3/18/13 at 10:50 am, the crash cart contained the following emergency intravenous medications, available for patient use, that had expired dates: Magnesium Sulfate two grams in 50 milliliters of D5W with an expiration date of 10/1/12; two vials of Atropine 1 milligram (mg) with an expiration date of 11/1/12 and one vial with an expiration date of 12/1/12; Narcan one vial with an expiration date of 2/1/13, Epinephrine two vials with an expiration date of 3/1/13. Other storage areas contained three vials of Dextrose 50% that had expired on 3/1/13.

During an interview on 3/18/13 at 10:50 am, Registered Nurse (RN) M confirmed the above dates. RN M stated that the pharmacy tech was responsible for checking for expired medications but the nurses should do it also. She explained that a list of the emergency medications with their expiration dates was taped to the outside of the crash cart. They used this list when the crash cart was checked to make sure none of the medications had expired.

A list of the medications taped to the outside of the crash cart was compared to a list that was taped to the inside of the crash cart and the lists had different expiration dates for some of the medications. The list on the outside had no expired medications but the list on the inside listed expired medications. RN M confirmed that the dates differed on the two lists.

During an interview on 3/18/13 at 11:45 am, the Pharmacy Tech had no explanation for why the expiration dates of the medications differed on the lists taped to the outside and inside of the crash cart.

During a subsequent interview on 3/21/13 at 9:55 am, the Pharmacy Tech confirmed it was her job as well as the nurses' to check for expired drugs.
She explained that the hospital had difficulty obtaining some of the drugs that had expired but provided no documentation regarding what the hospital did to obtain these medications.

During an interview on 3/21/13 at 2:10 pm, Administrative Nurse A was asked for documentation from pharmacy committee meetings regarding discussion about difficulty obtaining any medications but none was provided.

A hospital policy titled, "Checking Crash Carts", last revised on 2/14/13, read as follows, "The crash cart in the ER will be checked daily by the RN assigned to work in ER. When the crash cart is used, it will be restocked immediately by the pharmacy tech & central supply person."

2. During the initial tour of the ED on 3/18/13 at 10:50 am, three opened multi-dose vials of Lidocaine 1% were observed that had no open dates written on them. During a concurrent interview, RN M confirmed this and stated that multidose vials should be dated when opened.

A hospital policy titled, "Multidose Vials and Single Dose Vials", last revised in 2/2013, read as follows, "Multi-dose vials must be dated when opened."

Based on observation, interview, and record review, the hospital failed to ensure that the operating room (OR) temperature and humidity was measured to maintain the proper environment to prevent infections.

Findings:

On 3/19/13 at 2 pm, the operating room was observed with Licensed Nurse (LN) I. Temperature and humidity gauges were observed on the wall. LN I was asked about the proper temperature and humidity levels and she was unable to recall but stated she would refer to the policy. The OR temperature and humidity logs for 2/13 were reviewed (there was no log for 3/13) and only one one day had been recorded - 2/20/13, for temperature and humidity. LN I acknowledged that she had not followed the hospital policy for daily monitoring.

On 3/19/13, the hospital policy, titled, "Equipment Logs and Guidelines," reviewed on 1/13, read, "Temperature and humidity logs are monitored and recorded daily."

Based on food storage observations and dietary staff interview, the hospital failed to: 1) store the disaster food and water supply within the licensed building; and 2) ensure there was adequate food available. Failure to store foods within the hospital's footprint may result in the unavailability of the food supply in the event of a disaster. Failure to ensure a food supply within the certified hospital may compromise patient nutritional and medical status.

Findings:

During review of disaster meal planning on 3/18/13 beginning at 1:55 p.m., it was noted that the inventory list of food supplies was incorrect and one of the entree's listed did not list enough therefore the hospital did not have adequate food supplies on hand. The hospital was short one case of food which would supply one meal of the three day disaster plan for 60 people. The disaster food and water supplies were not stored within the foot print of the hospital.

In a concurrent interview, interim Dietary Manager stated it would be easier to have the supplies closer to the hospital or kitchen. It would be the expectation that all supplies, including food and water, required for disaster preparedness would be stored within the approved critical access hospital.

Based on interview and record review, the facility failed to have a governing body that assumed full legal responsibility for determining, implementing, and monitoring policies governing the hospitals total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment as evidenced by:

1. Failure to implement the Medical Staff Bylaws, Rules and Regulations, and administrative policies to evaluate data for granting clinical privileges. (Refer to C 241, Item 1)

2. Failure to have a Medical Records Committee as outlined in the Medical Staff Bylaws. (Refer to C 241, item 2)

3. Failure to have evidence of Medical Staff meeting to revise the Bylaws. (Refer C 241, Item 3)

4. Failure to have a credible review by the governing body of the the hospital's quality plan. (Refer to C 241, Item 4)

5. Failure to develop, implement, and annually review patient care policies. (Refer to C 270)

6. Failure to provide periodic evaluation and quality assurance review of all services provided directly and by contracted services. (Refer to C 330)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Organizational Structure.

Based on document review and staff interview, the governing body (Board of Directors: BOD) failed to ensure that the medical staff Bylaws, Rules and Regulations and Administrative Policies were carefully developed, implemented, administered, and monitored so as to ensure that quality health care was provided in a safe manner and safe environment. This failure permitted the hospital to operate without functional safeguards designed to ensure quality health care in a safe environment, and could contribute to patient or staff harm.

Findings:

1. The "Medical Staff Bylaws, Revised December 8, 2012" were reviewed on 3/18/13. Section 5.2-2 "Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, demonstrated professional competence and judgment, clinical performance, and the documented results of patient care and other quality review and monitoring which the medical staff deems appropriate. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions and health care setting where a member exercised clinical privileges."

Yet on 3/19 and 3/20/13, during review of eight randomly selected credential files, it was observed that each practitioner had been granted clinical privileges, and none of the eight credential files contained documentation that the six (6) determinates of privilege eligibility: 1) education, 2) training, 3) experience, 4) demonstrated professional competence and judgment, 5) clinical performance and 6) documented results of patient care and other quality review and monitoring, had been considered prior to the MEC recommending privileges and the BOD ' s approval of those privileges, as demonstrated by the following:

a - MSM (Medical Staff Member) 4: On 3/19/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges.

b - MSM 6: On 3/19/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA (American Medical Association) profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges.

c - PA (Physician's Assistant) 1: On 3/20/13, review of the Physician Assistant's (PA) credential file showed that the file did not contain primary verifications of education or training; no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the PA's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the PA exercises clinical privileges.

d - MSM 10: On 3/20/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges.

e - MSM 7: On 3/20/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges. The file contained an expired medical license and no evidence of a current license.

f - MSM 8: On 3/20/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges.

g - LCSW (Licensed Clinical Social Worker) 1: On 3/20/13, review of the psychologist's credential file showed that the file did not contain primary verifications of education or training; no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the practitioner's specific proficiency in patient care. The file did not contain a "privilege card", but did contain a letter stating nonspecific clinical privileges had been granted.

h - MSM 9: On 3/20/13, review of the physician's credential file showed that the file did not contain primary verifications of education or training; there was no AMA profile, and no official letters of completion from schools or training. The file contained no documentation of clinical performance, documented results of quality review or monitoring the physician's proficiency in patient care. There were no recent letters of reference and no documentation of pertinent information concerning clinical performance obtained from other sources, such as other institutions and health care settings where the physician exercises clinical privileges.

During an interview on 3/20/13 at 2 pm, the Medical Staff Coordinator (MSC) confirmed that there had been no review of any health care records for any of the Nurse Practitioners or Physician Assistants who work for the hospital. Also that she knew of no mechanism that was in place to collect data about the number of patient encounters or quality of care provided over time, for either the AHP staff or the MS members. MSC confirmed none of the credential files contained any data that showed evidence the practitioners' professional proficiency had been evaluated.

2. The "Medical Staff Bylaws, Revised December 8, 2012", Section 9.6 (pages 64 & 65) describe the Medical Records Committee, listing their duties and stating that they shall meet at least quarterly, maintaining a permanent record of its proceedings. During an interview, the Health Information Management (HIM) Staff B on 3/19/13 at 11 am, she stated that there was no such committee and no meetings had been held since at least April 2011, when she began working at the facility. HIM Staff B further explained that any significant medical record issues would go to the Medical Executive Committee; however they had not performed one of the primary duties of "review and evaluation of medical records....."

3) The "Medical Staff Bylaws (MS Bylaws), Revised December 8, 2012", Article XII (pages 82 & 83) describe the process by which the Bylaws may be adopted and amended. This section reads in part: " ... Such action shall be taken at a regular or special meeting (of the medical staff) provided (a) written notice of the proposed change ... If a quorum is present ... require an affirmative vote of 50%... These bylaws, together with the appended rules and regulations, shall be adopted at any regular meeting of the active medical staff ...The mechanism described herein shall be the sole method for the initiation adoption, amendment, or repeal of the medical staff bylaws." This copy of MS Bylaws was provided with the assurance that it was the current and authentic version; however it does not contain a signature page.

On 3/18/13 and 3/19/13 the minutes of the Medical Executive Committee (MEC) and Board of Directors (BOD) from 1/12 to date were reviewed and no reference was found in either set of minutes concerning a change in the MS Bylaws. On 3/19/13 at 3:40 p.m. Admit Staff A was asked for the minutes of the "regular and special meetings of the medical staff" for the calendar years of 2012 & 2013; and she responded that since the medical staff was so small, there had been not meetings of them as a group other than when they met as the MEC or one of its subcommittees. There had been no regular or special meeting of the medical staff as described in Article XII of the Bylaws. On 3/21/13 at 10:40 a.m. Administrative (Admin) Staff A was again asked about the amended MS Bylaws and she said she recalled the change had taken place late in 2012. However she knew of no other documents beyond the minutes of the MEC and BOD already provided for review. The hospital had no minutes or other documentation to show that the MS Bylaws had been amended in a manner consistent with Article XII.

4) On 3/19/13 Administrative Policy #AD066, titled "Quality and Performance Improvement" (Q/PI), was reviewed and it was noted to have been reviewed and approved by the BOD in 2/2013. On 3/19/13 at 3:40 p.m. Admin. Staff A explained the process by which this document and all of the other policies in the Administrative Policy binder was reviewed by two members of the BOD prior to the 2/28/13 regular meeting of the BOD. Each of the policies in the binder and a binder of Pharmacy Policies was read and some were edited by those board members. Then at the regular meeting the BOD, on the recommendation of the two members who had reviewed the policies, the BOD as a whole approved all of the policies as a group. Specific information found in any of the policies was not reviewed in detail at the regular BOD meeting.

On 3/20/13 review of the Q/PI policy showed that it contained language that indicated it had been written for a considerably larger hospital, which had not been modified to fit a small Critical Access Hospital. At page 2 of this document, a table indicates that the MEC will 'receive and act on reports from the "medical staff departments, divisions, committees, and assigned activity groups" and reports their action to the Governing Body and "Quality Management Board Committee" ... 10 times/year'. The hospital does not have "medical staff departments" or "divisions" or "assigned activity groups," or a "Quality Management Board Committee." On 3/18 and 3/19/13, a review of the MEC and BOD minutes did not reveal documentation of the 10 quality reports that went from the MEC to the BOD. The Q/PI policy specifies that a medical staff committee named the "Quality Management Committee" is to report to the MEC ten times per year. But according to the MS Bylaws (page 69 in section 9.12), states the medical staff committee designated to address "quality" is named the "Quality Assessment Committee" and the MEC fulfills the duty of this committee in a meeting just prior to each MEC meeting, as the MEC acting as a "committee of the whole." On page 3 of the Q/PI policy, there was a table of 25 specified activities for which the Q/PI program were to collect and organize "Quality Indicator Data," 14 or more were to be "Reported To/Through" the Quality Management Committee, an undefined committee.

On 3/20/13 beginning at 3:50 p.m. during a phone interview with the Director of Quality (Admin Staff A) she acknowledged that the BOD as a whole had never reviewed in detail the Q/PI policy and she could not say that the BOD members understood the specifics of or intent of the Q/PI plan. She also acknowledged that the Q/PI policy did originally come from another hospital and had not been modified sufficiently to fit the hospital. As a result details listed in the policy may be beyond the hospital ' s capacity. She acknowledged that few of the 25 listed specific QI data collection activities listed on page 3 of the policy had been begun. They had not yet established QI (quality indicators) for each of those activities, and had not yet established specific objective criteria to use in collecting data. She also acknowledged that MS members and BOD members may not understand the Q/PI policy because they had no training or experience related to the currently acceptable quality assessment and performance improvement methods utilized by larger hospitals.

In another interview with Admin Staff A on 3/21/13 beginning at 10:40 a.m. she indicated that over the past several years, there had been a couple of specific cases where peer review had been reviewed by entities outside of the hospital and there was one case that lead to a MS member resigning in June or July 2012. However for those few cases, and all others, any consideration or evaluation of a practitioner's (MS member or AHP staff) professional proficiency was done exclusively by the MEC and conducted in closed session for which there are no records of the proceedings, data or any corrective action. The Chief of Staff did occasionally give a verbal report to the BOD, however those were also conducted in closed session and other than the one or two sentences found in the regular minutes after the closed meeting adjourns there are no records. Admin Staff A acknowledged that the hospital had not developed a quality improvement plan that was tailored specifically to itself and had no documentation to demonstrate that the Q/PI policy (Administrative Policy #AD066) had been implemented and administered as written; or that the Q/PI policy had been monitored to assure that it was functional in improving quality and safety.

Beginning at 2 p.m. on 3/21/13, in an interview with the CEO and a member of the Board of Directors (BOD 1), it was acknowledged that the hospital had no documentation of any evaluation of quality, safety or practitioners' performance. Any considerations by the BOD or the MEC, related these quality indicators had been conducted in closed session, and there were no minutes or other recordings of the matters discussed or the action taken. The BOD, CEO and MEC had not maintained evidence to show that a system-wide evaluation of the quality and appropriateness of the diagnoses and treatments furnished at the hospital had been conducted; nor had they maintained evidence that the overall quality and safety in the hospital had been evaluated. They had no information to show these evaluations had been done within the hospital or by an outside entity, such as a quality improvement organization (QIO) or hospital.

Based on document review and interview, the hospital failed to disclose the name and address of the person responsible for medical direction. This failure could result in the public not being able to contact the appropriate person for their concerns.

Findings:

On 3/19/13 at 10:15 a.m. the Director of Quality (DQ) provided information that the hospital district's webpage, contained information about the names, titles and addresses for the Board of Directors and other key hospital administrative staff. Review of the hospital district's webpage, showed that although the names and addresses were provided for the Board of Directors and the hospital's Chief Executive Officer (CEO), there was no information concerning the person or persons responsible for medical direction at the hospital.

On 3/20/13 during a phone interview, the DQ acknowledged that the Chief of the Medical Staff was the most senior physician of the Medical Executive Committee and responsible for medical direction of the hospital. The DQ also acknowledged that she had no evidence to demonstrate that the hospital had posted the name/s or address/s for the person or persons responsible for medical direction at the hospital.

Based on interview and document review, the hospital had not established a committee that included both physicians and Allied Health Practitioners (AHP) in order to develop, execute or periodically review written policies governing the services furnished in the hospital.

Findings:

On 3/18/13, the hospital was asked to provide the minutes of the Inter-Disciplinary Practices Committee (IDPC). On 3/19/13 at 9:45 a.m., the IDPC minutes were again requested and it was learned that there were no minutes because the hospital did not have an IDPC. (Refer to C-152). At 10:15 a.m. the Quality Director verified that the hospital did not have an IDPC and there had been no committees or other meetings of medical staff and AHP members to write or reviewed any hospital policies.

Based on interview and document review, the hospital failed to ensure that its physicians and allied health practitioners (AHP) participated together in periodically reviewing patients' health records, and did not ensure that its Medical Staff (MS) Bylaws, Rules and Regulations regarding this practice were developed and implemented. This resulted in inadequate supervision of the nurse practitioners and physician assistants that could have negative patient care outcomes.

Findings:

On 3/19/13, visits were made to three off campus clinics that operated under the hospital license. A Nurse Practitioner and a Physician Assistant were observed working at two of the clinics.

Appendix III - Rules and Regulations for Allied Health Practitioners is appended to the MS Bylaws. This document was reviewed on 3/19/13 and it reads, in part, (beginning at page 97), section III - C: "All allied health professionals may generate progress notes. They may not generate orders themselves, and may not transcribe orders except on verbal order of the physician with the exceptions of Physician Assistants & Nurse Practitioners.. Physician Assistants & Nurse Practitioners may generate orders, subject to protocols approved by the Medical Executive Committee." ... V. - A: "Allied health professionals shall be subject to a continuing audit by the attending supervision. A probationary review after 90 days will be formalized by and through the Credentials Committee. Protocols and operating procedures will be reviewed annually."

On 3/19/13 at 3:40 p.m., Administrative (Admin) Nurse A stated that the hospital did not have an IDPC (interdisciplinary practices committee) and to her knowledge, the only review of the patients' health records by members of the medical staff took place during meetings of the Medical Executive Committee (MEC) acting as the Utility Review Committee, or at closed sessions of the MEC. She stated she was unaware of any meetings between AHP staff and physicians to review health records and there were no records that such reviews had been taking place.

During an interview on 3/21/13 at 8:50 am, Admin Nurse F provided an agreement between a supervising physician and a physician assistant. He confirmed this was the only protocol the clinic had and he did not know if it had been approved by the MEC.

During an interview on 3/21/13 at 9:50 am, Admin Nurse A confirmed that no protocols regarding physician assistants had been approved by the MEC.

A document titled, "Standardized Procedures for the Nurse Practitioner", dated 8/2009, was reviewed. It read, "Annual review, between the nurse practitioner and an associate physician or nurse practitioner, of 20 randomly selected charts written by the nurse practitioner. A written record of the review will be kept."

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by:

1. Failure to ensure the emergency (crash) carts were checked daily to ensure readiness for a patient emergency. (Refer to C 271)

2. Failure to have nursing and radiology policies reviewed by medical professionals. (Refer to 272)

3. Failure to ensure that one of one patients, who had a Fentanyl (pain medicine) patch, was prescribed in accordance with product labeling and with pharmacist oversight, as per hospital policy. (Refer to C 276, items 1-5)

4. Failure to ensure that the contents of the emergency drug supply located in the CT (computerized tomography - imaging) Scanner Unit was approved by the hospital, contained the drugs listed on the outside, had accurate expired dates posted on the outside, and that restocking and resealing procedures were followed. Failure to ensure the Medical Surgical crash cart (emergency supplies and medications) matched the contents list and had accurate expiration dates posted on the outside. (Refer to C 276, item 6)

5. Failure to secure medications from unauthorized personnel. (Refer to C 276, Item 7)

6. Failure to ensure that infection control policies were followed. (Refer to C 278, Items 1-3)

7. Failure to store clean linen so that it was protected from cross-contamination. (Refer to c 278, Item 4)

8. Failure to ensure safe food handling practices. (Refer to C 279, Item 1)

9. Failure to ensure the nutritional needs of the patients were met. (Refer to C 279, Items 2-6)

10. Failure to have qualified supervision of the radiology services to ensure competency of staff performing imaging procedures. (Refer to C 283)

11. Failure to maintain a complete list of all services provided by contracts, arrangements or agreements, and have the scope and nature of the contracted services listed. (Refer to C 291)

12. Failure to review all nursing staff at least annually for competency. (Refer to C 295)

13. Failure to accurately administer medications for two of three patients (Patients 6 and 7). (Refer to C 297, items 1-2)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.

Based on interview and record review, the hospital failed to ensure that the medical surgical (MS) crash cart (drugs and supplies in the case of a patient emergency) was checked for readiness daily, as outlined in the hospital policy. This failure had the potential for an ineffective response in the case of a patient emergency.

Findings:

On 3/18/13 at 10:05 am, the medical surgical unit crash cart log was reviewed. The log indicated that daily checks had not been done on 3/2, 3, and 3/17/13.

The hospital policy titled, "Check Crash Carts," revised 2/14/13, read, "The crash cart on the nursing floor will be checked daily by the RN on the floor.

In a concurrent interview, Administrative Nurse A acknowledged that the crash cart should be checked daily and the policy was not followed.

Based on interview and record review, the hospital failed to ensure that nursing, laboratory, radiology, and emergency department policies were developed and reviewed by a group of professional personnel. This failure had the potential for unsafe care to occur to patients.

Findings:

On 3/21/13, the facility policy titled, "Management of Policy and Procedure," last reviewed 2/13, indicated the policies will be reviewed at least every three years. The policy further indicated that physician would review policies for clinical content.

On 3/21/13, the policy books for nursing, laboratory, and radiology were reviewed:

1. Nursing

Individual policies had review and revision dates on the policies. The book did not have a cover sheet that demonstrated the medical staff, the nursing officer, or the governing body had approved the nursing policies.

On 3/21/13 at 10:40 am, Administrative (Admin) Nurse A described the flow of nursing policies which went to the medical staff and the the Pharmacy and Therapeutics Committee of the Medical Staff for review. After their suggestions had been incorporated the policies went to the Quality Committee then to the Medical Executive Committee (MEC) and the the Board for approval. Admin Nurse A stated that the hospital was reformatting and updating policies and while some individual policies had been approved, not all the nursing policies had been developed and reviewed by the medical staff , the Quality Committee, or the Board since 2009.

2. Laboratory

On 3/21/13, the On Touch Service (blood sugar monitoring) policy book was dated 9/29/08 and had no evidence that it was developed, reviewed, approved, or signed by the medical staff or the board.

The Microbiology policies had a cover sheet indicating review was done 3/22/12 but did not contain evidence of when these policies were originally developed, reviewed, or revised. These policies contained signature lines for laboratory medical director that were not signed.

The General Laboratory Procedures Manual (Volume 1) contained policies which had been signed by the laboratory medical director on 3/3/12 but did not have evidence of when these policies were originally developed, reviewed, or revised. A cover sheet indicated MEC and Board review but there was not date of this review or which policies were reviewed.

The General Laboratory Procedures Manual (Volume 2) contained policies which had been signed by the laboratory medical director on 3/22/12 but failed to have a cover sheet that demonstrated the MEC or Board had approved the policies.

3. Radiology

On 3/21/13, the (Radiology) Imaging Service policies had no evidence of MEC or Board review.

There was no evidence that there were policies for CT scan (computerized tomography) although until 3/1/13, the hospital had a CT unit in the Radiology department. Since 3/1/13, a mobile unit was present on site until the installation of a new permanent CT scan unit in one month.

On 3/21/13 at 8:20 am, Admin Staff F stated he was the manager for Radiology and the Laboratory. Admin Staff F acknowledged the above findings that were not consistent with the hospital policy on policy management for review by the MEC.


22705

4. Emergency Department (ED)

On 3/19/13, a review of the "EMTALA (Emergency Medical Treatment and Labor Act) Patient Transfer Policy," last reviewed on 2/2013, was conducted. The policy did not contain necessary elements required under Federal law, including patient consent, a physician's certification documenting the reason for transfer, risks and benefits of the transfer, name of accepting hospital and physician, copies of record sent with patients, and transportation arrangements. This information was contained in a transfer form routinely used in the ED but had not been incorporated into the facility's transfer policy.

During an interview on 3/19/13 at 12:10 pm, Admin Nurse A confirmed that the transfer form was used. She stated that the information contained in the transfer form had not been incorporated into the facility's EMTALA transfer policy.

Based on observation, interview, and clinical record and document review:

1. The hospital failed to ensure physicians only used a hospital approved pre-printed FENTANYL PATCH ORDER FORM developed by the hospital one year prior to the survey, to be the sole way for prescribers to order fentanyl patches for hospital patients and the hospital failed to ensure hospital nursing staff were aware of the form (see finding 1).

2. The hospital failed to ensure that a process was in place for staff to verify that the patient met conditions of opioid (having the qualities of opium) tolerance as documented on the FENTANYL PATCH ORDER FORM (which matched the Food and Drug Administration (FDA) approved product labeling for the fentanyl patch) prior to the placement of a fentanyl patch on Patient 6 and potentially for any patient with an order for a fentanyl patch (see finding 1).

3. The hospital failed to ensure that the FENTANYL PATCH ORDER FORM documented that after the first dosage increase, subsequent dosage increases should only occur after 6 days and then only based on supplemental usage of immediate release opioids as documented in the FDA approved fentanyl patch product labeling (see finding 1).

4. The hospital failed to provide nursing staff with any reference information that would be readily available to them that provided the dosing guidelines documented in the fentanyl patch product labeling used to establish opioid tolerance for a given dose of a fentanyl patch and for dosage increases in the fentanyl patch so they could verify patients met conditions of opioid tolerance (see finding 1).

5. The hospital failed to ensure staff knew of and followed the hospital procedure to provide first dose review by the contract pharmacy of the fentanyl patch order for one of one patients (Patient 6) who had a fentanyl patch placed in the 30 day period, prior to the survey (see finding 2).

As a result, Patient 6, and potentially any patient in the hospital for whom a physician ordered a fentanyl patch was at risk of having a fentanyl patch placed on them when they did not meet the product labeling requirements of opioid tolerance potentially placing them at risk of serious respiratory depression (decrease in the rate and depth of breathing) up to an including death.

6. The hospital failed to ensure that the CT Scanner Emergency Medication Supply (CT E-Kit) contents had been approved by the hospital Pharmacy and Therapeutics Committee as required by State regulation, which the hospital policy entitled MEDICATION DISTRIBUTION stipulated the hospital would follow, that the contents of the CT E-Kit matched the protocol developed by the hospital to treat serious allergic (anaphylactic) reactions to contrast media used in the mobile CT Scanner Unit, to stock the kit with the medications listed on the content list, to ensure that posted expiration dates were accurate and contained no expired medications, and failed to ensure a replacement kit sealed by the pharmacist was available for exchange as stipulated by the hospital policy entitled MED BOXES, MED CABINETS, CRASH CARTS. The CT E-Kit did not contain epinephrine 1:1000, IV cimetidine, ranitidine, or famotidine, methylprednisolone, dopamine, or glucagon all of which appeared in a hospital approved protocol developed to guide the treatment of anaphylactic reactions. It contained Epinephrine 1; 10,000 and atropine 0.1mg/ml, neither of which appeared on the content list. It contained a vial of diphenhydramine that had expired 4/2012 almost one year prior to the survey. As a result, not all medications, especially Epinephrine 1:1000, identified by the hospital as the most important medication used to manage anaphylactic reactions, were available for staff use to manage this emergency and one of the medications, diphenhydramine was expired so that its efficacy in managing the emergency would be questionable. These issues could have resulted in a less than optimal outcome if the kit had been needed to treat a patient's anaphylactic reaction. The contract pharmacist did not seal the supply, as required by hospital policy and State regulation.

The hospital failed to ensure that all items documented to be in the crash cart (contains medications and equipment used to manage medical emergencies) located on the Medical Surgical Nursing Unit were in fact in the cart as it was short one out of six packets of surgical lubricant and failed to ensure that the posted expiration dates on the crash cart accurately reflected the date of the first drug to expire within the supply, that posted expiration dates accurately reflected the expiration of the medication with the cart, and that the pharmacist sealed the crash cart after ensuring that all medications were in the cart and that posted expiration dates were accurate. The documented first date of a medication to expire within the cart that was posted outside the cart was 4/1/2013 (the medication was listed to be magnesium sulfate in 100 ml of 5% dextrose: used to treat certain irregular heartbeats) while the cart contained a pre-filled syringe (PFS) of normal saline (NS: 0.9% sodium chloride solution used to flush IV-intravenous- lines) that expired at the end of 3/2013. The external content list that documented the expiration dates for the PFSs of NS documented that the first of those would expire 6/2013 while the cart contained one of six syringes labeled to expire 3/2013.

It is the pharmacist's role, by State regulation, to ensure that such emergency supplies are accurately assembled, that all medications are accounted present, and that all posted expirations dates are accurate before the pharmacist seals the supply (see finding 3).

7. The hospital failed to ensure staff followed the hospital policy requiring that either the pharmacist or a physician identified home medications brought into the hospital by a patient to ensure they actually were the medications as labeled on the home prescription vials before they were administered to the patient in the hospital. Patient 7 received three home medications that had not been positively identified by the hospital pharmacist or a physician before Patient 7 received these medications (see finding 4).

8. The hospital failed to ensure medications met requirements for potency, were stored under temperatures stipulated by the manufacturers, and were protected from light if the medication was light sensitive as required by two hospital policies. Medications documented to be stored at or below 77 degrees F were stored in the Central Supply Room at 80 degrees F over a two day period with the potential that these medications did not meet potency standards, vials of mannitol did not meet labeled concentrations as the mannitol had precipitated out of solution rendering the remaining solution less concentrated than documented on the label, and ondansetron was not protected from light over a two day period with the potential that the ondansetron did not meet potency standards (see finding 5).

9. The hospital failed to ensure that a list of light sensitive medications was attached to Policy and Procedure PH044 entitled LIGHT SENSITIVE MEDICATIONS as indicated in the policy. As a result, staff would not have a ready reference to refer to in order to determine if a medication needed special storage to protect it from light (see finding 6).

10. The hospital failed to ensure that medications in two out of three inspected cabinets that contained medications in the Central Supply room were secured against access by non-authorized personal as stipulated by hospital policy (see finding 7).

11. The hospital failed to ensure that all medications in its off campus clinics did not contain expired medications.

Findings:

1. The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the FDA to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that "Respiratory depression and death may occur with the use of the (fentanyl patch), even when (it) has been used as recommended and not misused or abused." It documents that use of this patch "is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including ... use in non-opioid tolerant patients ...." Under "Indications and Usage" the product labeling documents opioid-tolerant patients as those who have taken at least 60 mg (milligrams) of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opioid medications used to treat pain) or an equianalgesic dose of another opioid medication daily for a week or longer. It documents in the "Titration and Maintenance of Therapy" section that after an initial fentanyl patch of a given dose has been placed, subsequent dosage increases in the patch should be based on the daily dose of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12 micrograms/hr increase in the fentanyl patch dose and that subsequent dosage increases should only occur after evaluation of the patient who has worn the increased dose through two 3 day cycles. It documents in the "Warnings" section of the product labeling that the fentanyl patch "...Monitor patients with significant chronic obstructive pulmonary disease (COPD: a disease which results in decreased exchange of oxygen for carbon dioxide in the lungs) ...as in these patients, even usual therapeutic doses of (the fentanyl patch) may decrease respiratory drive to the point of apnea" (cessation of breathing).

On 3/21/13, a review of a pre-printed order form entitled FENTANYL PATCH ORDER FORM indicated it stipulated: "This form must be used to order a Fentanyl patch for any patient admitted to (the hospital)." The form provided check boxes that a prescriber could use to document that a patient was opioid tolerant, as documented in the FDA approved product labeling for this medication. The form documented: "If patch strength is increased, the patient has tolerated the previous strength for a minimum of 3 days." There was no provision on the form, after the first dosage increase, to leave the patch on for six days before further attempts were made to increase the dose based on supplemental use of immediate release narcotics, as documented in the product labeling.

On 3/21/13, a review of Patient 6's clinical record indicated he was admitted to the hospital on 2/28/13 at 10:11 pm Admission diagnosis included chronic obstructive pulmonary disease (COPD: which the product labeling listed as a risk factor for respiratory depression if a fentanyl patch had been placed on Patient 6). A review of the "Admission Medication History and Orders" (AMHO: a list of home medications generated by hospital staff which the admitting physician could approve for continued use in the hospital or discontinue upon admission to the hospital) indicated Patient 6 did not use a fentanyl patch at home. Patient 6 did have a home order for oxycodone 30 mg orally every four to six hours, as needed, and the admitting physician continued this order on the AMHO by indicating that the medication was to be continued and signing the order on 3/1/13 at 8:15 am

In addition, on 2/28/13 at 9:41 pm the following medications were ordered for Patient 6:

Morphine sustained release (SR) tablets 30 mg every 8 hours.
Hydrocodone 5 mg/acetaminophen 325 mg every 4 hours as needed for moderate pain.
Hydrocodone 10 mg/acetaminophen 325 mg every 4 hours as needed for severe pain.
Morphine and hydrocodone are opioid pain relieving medications and acetaminophen is the active ingredient in Tylenol.

One and a quarter hours later at 11 pm, a physician increased the morphine SR order to 45 mg orally every 8 hours.

On 3/1/13 at 10:35 am, a physician discontinued the oral morphine SR tablets.

On 3/3/13 at 7:30 pm, a physician ordered a 50 mcg/hr fentanyl patch for Patient 6 to be changed every 72 hours (3 days). The order was written on a standard PHYSICIAN'S ORDER SHEET rather than the FENTANYL PATCH ORDER FORM.

A review of Patient 6's medication administration records (MARs: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated staff placed a 50 mcg/hr fentanyl patch on Patient 6 on 3/4/13 at 2:46 pm The MARs indicated the following doses (oral morphine equivalents in parentheses) of opioid narcotics were administered to Patient 6 in the four 24 hour periods after admission to the hospital, and prior to placement of the fentanyl patch on Patient 6:

2:45 pm 2/28/13 to 2:44 pm 3/1/13: 90 mg morphine and 10 mg hydrocodone (100 mg oral morphine equivalent)

2:45 pm 3/1/13 to 2:44 pm 3/2/13: 120 mg oxycodone and 10 mg hydrocodone (250 mg oral morphine equivalent)

2:45 pm 3/2/13 to 2:44 pm 3/3/13: 120 mg oxycodone and 10 mg hydrocodone (250 mg oral morphine equivalent)

2:45 pm 3/3/13 to 2:44 pm 3/4/13: 60 mg oxycodone (120 mg oral morphine equivalent)

The product labeling for the fentanyl patch documents that a patient should receive a 60 to 134 mg of oral morphine daily for seven days in order to be considered opioid tolerant enough to place a 25 mcg/hr patch, 135 to 224 mg of oral morphine daily for seven days in order to place a 50 mcg/hr patch, and 225-314 mg of oral morphine daily for seven days in order to place a 75 mcg/hr patch. Therefore, Patient 6 had not received the required amount of oral morphine equivalents for seven days, that the product labeling documents would be required to consider Patient 6 opioid tolerant enough to receive a 50 mcg/hr fentanyl patch.

A review of the clinical record indicated there was no documentation as to the quantity of opioid pain relieving medication (oxycodone) that Patient 6 took for the three days prior to admission.

During an interview of Administrative (Admin) Nurse R on 3/21/13 at 9:31 am, she verified the above observations. She stated she knew Patient 6 well and Patient 6 was up walking and talking during the last admission. She stated she was not aware of any special forms for ordering fentanyl patches in the hospital. When the surveyor showed Admin Nurse R a copy of the FENTANYL PATCH ORDER FORM she stated she had not seen it before. She stated she was not aware of any special processes regarding the prescribing of a fentanyl patch. She stated that if a physician ordered a fentanyl patch on the standard PHYSICIAN'S ORDERS form she would check the home medication list to see if one had already been placed on the patient. She said then she would go down and tell the patient they had an order for a fentanyl patch, ask the patient if they were currently using the fentanyl patch, and ask them if they were wearing one. She said she would then place the patch, as ordered by the physician, after doing a "skin check" to see if the patient was wearing a patch (so the old patch could be removed before the new patch was placed). Admin Nurse R was not able to find any reference in the medication room or in the emergency room area that provided dose equivalence information staff would need to double check the opioid tolerance requirements, before placing the patch or to double check the immediate release use of opioids that would support a dosage increase and the amount of dosage increase such use would justify. No evidence was provided that Patient 6 underwent an assessment of opioid tolerance, prior to placement of the fentanyl patch.

On 3/21/13 at 2:02 pm, during an interview of Admin Nurse A, she stated the hospital had developed the FENTANYL PATCH ORDER FORM on 3/15/12 which was a year ago. She stated from that time forward, physicians had been expected to use that form to prescribe fentanyl patches for hospital patients.

2. On 3/20/13, a review of Policy and Procedure AD038 entitled MEDICATION MANAGEMENT: ADMINISTRATION (Effective 7/29/2010, Reviewed 2/2013, Revised 8/2011) indicated under Procedure 2: "Medications may only be administered based on an order from a Provider and a first dose review by the pharmacist via fax to (the contract pharmacy of record). It also provided for review of an order by two "Licensed Care Givers" if a medication was needed immediately but 2(b) stipulated: "Nurse/Licensed Care Giver reviewed medications will have a Pharmacist review as soon as possible."

On 3/21/13, a review of Patient 6's clinical record indicated he was admitted to the hospital on 2/28/13 at 10:11 pm Admission diagnosis included COPD which the product labeling listed as a risk factor respiratory depression if a fentanyl patch had been placed on Patient 6. A review of the AMHO indicated Patient 6 did not use a fentanyl patch at home. Patient 6 did have a home order for oxycodone 30 mg orally every four to six hours as needed and the admitting physician continued this order on the AMHO by indicating that the medication was to be continued and signing the order on 3/1/13 at 8:15 am

On 3/3/13 at 7:30 pm, a physician ordered a 50 mcg/hr fentanyl patch for Patient 6 to be changed every 72 hours (3 days). The product labeling documents that fentanyl levels increase gradually and level off between 12 to 24 hours with peak levels occurring between 20 and 72 hours after initial application so this medication would not be considered needed for "immediate use."

A review of Patient 6's MARs indicated staff placed a 50 mcg/hr fentanyl patch on Patient 6 on 3/4/13 at 2:46 pm

During an interview of Admin Nurse R on 3/21/13 at 9:31 am, she verified the above observations. She stated she knew Patient 6 well and Patient 6 was up walking and talking during the last admission. No evidence was provided that Patient 6 underwent an assessment of opioid tolerance, prior to placement of the patch on Patient 6. During a second interview of Admin Nurse R on 3/21/13 at 11:12 am, she stated nursing staff faxed the admission orders for a given patient to the contracted pharmacy service for review by a pharmacist, but nursing staff did not fax subsequent orders. She stated she would not have expected staff to fax the fentanyl patch order to the contract pharmacy service.

On 3/20/13 at 1:43 pm, during an interview of Admin Nurse A, she said medication orders are faxed to (the contract pharmacy) for a first dose review. She stated all new orders are faxed. She stated she did not know what (the contract pharmacy) did on their end.

3. On 3/19/13 a review of Policy and Procedure PH015 entitled MEDICATION DISTRIBUTION (Effective 10/2001, Revised 2/2006, Reviewed 2/2013) indicated it stipulated that the hospital provided pharmaceutical services would comply with all State and Federal Laws.

On 3/21/13, a review of Policy and Procedure PH018 entitled MED BOXES, MED CABINETS, CRASH CARTS (Effective 12/2005, Reviewed 2/2013, Revised 7/2011) indicated that: "Medications for emergency use shall be kept in a small box that has been sealed by the Consultant Pharmacist. This box shall be stored in the C.T. Immediately after use of any medication, this box shall be taken to the Pharmacy Coordinator for replacement with a fully stocked box that has been sealed after double checking content with an RN. These boxes are held in cupboard "NN" this is locked and accessible to authorized licensed staff only. The Consultant Pharmacist shall check these boxes on a monthly basis and replace any expired medications. The earliest expiration date shall be listed on the outside of the box."

California Code of Regulations, Title 22 Section 70263(f)(1) stipulates: "Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed. Section 70236(f)(2) stipulates: "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within." It is expected that the contents list should match the contents of the supply. The hospital need only post the date of the first medication to expire on the outside of an emergency medication supply but if it chooses to post more than one expiration date it is expected that the posted expiration dates accurately reflect the expiration dates of the representative medications contained in the supply. It is also expected that the emergency supply will be hospital approved and the contents of the emergency supply will supply all the medications listed in any protocol developed or used by the hospital to manage the emergency the emergency supply was created to treat.

a. On 3/19/13 at 2:08 pm, an inspection of the CT Scanner Mobile Unit indicated that staff had placed a plastic red tackle box sealed with yellow seals in the cabinet where medications were stored. Staff T and Admin Nurse A identified this box as an emergency medication supply used to treat serious (anaphylactic) allergic reactions that patients receiving contrast medication (used to help image vital body structures during radiologic procedures) could experience secondary to administration of contrast media when they were in the CT Scanner Mobile Unit (referred to in this report as the CT E-Kit).

A content list on the outside of the box documented it contained:

Four pre-filled syringes of normal saline (NS: 0.9% sodium chloride solution used to dissolve medication or to flush intravenous - IV - lines). The listed expiration date was 2/2014.

Two 10 ml vials of NS for use as a diluent. The listed expiration date was 5/2014.

Two Diphenhydramine 50 mg vials (used to treat allergic reactions). The listed expiration date was 12/2013, but one vial had expired 4/2012 (almost a year prior to survey).

Two Epinephrine 1:1000 vials (comes as a 1 ml vial and is used to treat serious allergic reactions). The listed expiration date was 3/2013.

One SoluCortef 100 mg (used to treat allergic reactions). The listed expiration date was 7/2017.

One 500 ml IV bag of NS (can be used to mix with other medications for an IV infusion or to provide fluid). The listed expiration date was 9/2013

Two atropine 0.4 mg/ml (used to dry airway secretions). The listed expiration date was 9/30/09 (3.5 years prior to the survey).

During an interview of Admin Nurse A at that time, she stated that if a listed expiration date just included the month and the year the hospital would consider the medication good to the end of that month.

Inspection of the contents of the red tackle box indicated the following:

It contained 20 ml vials of NS (not 10 ml vials) and the expiration date on both of the vial labels was 5/1/14 (30 days earlier than the posted expiration date).

It contained one 10 ml pre-filled syringe (PFS) of Epinephrine 1:10,000 (one tenth the concentration of the Epinephrine listed on the content list) rather than a 1:1000 ampule of Epinephrine. This dosage form is given IV and is used to re-establish spontaneous circulation in patients with heart and lung emergencies. It cannot be given subcutaneously to treat an anaphylactic reaction. The PFS had an expiration date of 3/1/13 (30 days earlier than the posted date).

It contained one 10 ml PFS of atropine 0.1 mg/ml (not the 0.4 mg/ml concentration as listed on the content list). This dosage form is given IV to patients with slowly beating hearts and is usually contained in crash carts which contain medications used to manage heart and lung emergencies.

Therefore, out of seven medications and expiration dates listed on the exterior content list, three posted expiration dates were inaccurate, two listed medications (epinephrine 1:1000 and atropine 0.4 mg/ml) were not in the cart, and one medication, diphenhydramine, had expired almost a year prior to the survey. These findings were verified by interview of Admin Nurse A at that time.

On 3/19/13 at 2:45 pm, during an interview of the Pharmacy Coordinator, she stated that she did not fill the red tackle box. She stated she provided the medication to Radiology Staff.

On 3/20/13, a review of Policy and Procedure 2041 entitled PROTOCOL FOR REACTION TO CONTRAST MEDIA (No effective date, Revised 2/2013, Approved by Eastern Plumas Hospital Board of Directors 4/2013) which was provided by Admin Nurse A indicated it provided for the management of allergic reactions to contrast media. It documented the following:

The use of epinephrine 1:1000 (as opposed to the epinephrine 1:10,000 that was found in the kit) to treat such reactions. It documented that the epinephrine was to be given by subcutaneous injection (into the tissue just under the skin) at a volume of 0.3 ml. It documented that: "The first and most important therapy in anaphylaxis (a very severe allergic reaction that can result in death if not treated properly) is epinephrine."

That cimetidine, ranitidine, or famotidine (available as IV medications and used to block histamine, a mediator of allergic reactions, at specific receptors) could be used with or instead of epinephrine. None of these medications were found in the supply.

That albuterol (used to dilate constricted airways that may be seen in a severe allergic reaction) could be administered as a nebulized mist. Albuterol is available in unit of use vials for nebulization but none was found in the emergency medication supply.

That 125 mg of methylprednisolone (related to but not identical to hydrocortisone, brand name SoluCortef) could be given to a patient with an allergic reaction to contrast media. SoluCortef, not methylprednisolone was found in the supply. The doses of these two medications used to treat an allergic reaction are not identical.

That dopamine could be infused to treat patients with an adverse reaction to contrast media (used to support a patient's blood pressure if it gets too low) but none was found in the red tackle box.

It provided for the use of glucogan (used to raise blood sugar levels that have fallen too low but also used, off-label (not in the FDA package insert), to treat beta-blocker toxicity. No glucagon was found in the red tackle box.

On 3/20/13 at 1:43 pm, during an interview of Nurse Administrator A, she stated she had obtained the P&P 2041 from Manager U. She stated she had asked Manager U if they had a policy regarding the CT E-Kit and he had told her there was none. She stated she had not been able to verify if the Pharmacy and Therapeutics Committee had approved the contents of the kit. She verified that the medications in the policy documented above had not been included in the CT E-Kit.

On 3/21/13 at 2:02 pm during an interview of Nurse Administrator A she review Policy and Procedure PH018 and stated that this policy needed to be followed and that medications should not have been provided to Radiology Department staff members to restock the CT E-Kit.

b. On 3/20/13 at 3:44 pm an inspection of the Crash Cart located on the Medical Surgical Nursing Unit indicated the following:

The cart contained a sealed tray that contained advanced cardiac life support (ACLS) medications.

The earliest posted expiration date on the outside of the crash cart was 4/1/13 (for two IV bags of magnesium sulfate 1 gram (gm) in 100 ml 5% dextrose in water), but the cart contained six PFSs of NS one of which expired 3/2013.

The external content list that listed these six PFSs of NS documented that the earliest expiration date for these syringes was 6/2013.

The external content list documented that the cart contained six surgical lubricant packages but inspection indicated it only contained five such packages.

On 3/20/13 at 1:43 pm, during an interview of Nurse Administrator A, she stated the consultant pharmacist sealed the ACLS medication tray and that Central Supply staff replenished everything else on the cart. She stated that when staff had finished stocking the cart, a nurse would check the cart and then seal the cart. She stated the hospital had a program flex that addressed the crash cart. A review of the program flex, dated 12/4/97, referred to a letter which Nurse Administrator A did not supply to the surveyor. Review of this program flex indicated nothing there explicitly exempted the hospital from the requirement for a pharmacist to seal emergency drug supplies (after checking to see that all medications were present and that all posted expiration dates accurately reflected the manufacturers' expiration dates found on the labels of the medication containers in the emergency supply).

4. On 3/19/13 at 10:47 am, Staff Nurse S passed one 30 mg capsule of phenteramine (decreases appetite and is used to help lose weight), one 2 mg tablet of estradiol 2 mg (used as hormone replacement) and one 50 mg tablet of chlorthalidone (used to decrease high blood pressure) to Patient 7. While Staff Nurse S set these medications up in the hospital medication room prior to administration to Patient 7, she obtained the medications from pharmacy labeled prescription bottles for Patient 7 labeled to contain the three above medications. During an interview of Staff Nurse S at that time she stated these pharmacy labeled medications were Patient 7's home medications. Staff Nurse S used printouts of capsule/tablet imprint codes (provided by the Pharmacy Coordinator) to identify two of the medications and looked up the imprint code for the third tablet on-line to determine that the medications in the home prescription bottles actually were the medications labeled to be in the prescription bottles.

On 3/19/13, a review of Policy and Procedure PH015 entitled MEDICATION DISTRIBUTION (Effective 10/2001, Revised 2/2006, Reviewed 2/2013) indicated it stipulated the hospital would comply with State law and that personal medications brought into the hospital would be identified by a pharmacist or a physician prior to administration to a patient in the hospital. It documented "The medication cannot be used until confirmation is complete and documentation is in the medical record." Title 22 Section 70263(m) stipulates: "medication brought by or with the patient to the hospital shall not be administered to the patient unless ...the medication containers are clearly and properly labeled (and) the contents of the containers have been examined and positively identified, after arrival at the hospital, by the patient's physician or the hospital pharmacist."

On 3/20/13 at 1:43 pm, during an interview of Admin Nurse A, she verified that the hospital policy stipulated that a physician or a pharmacist must verify the imprint code on a tablet or capsule brought in from the patient's home before it was administered to a patient.

On 3/20/13, a review of the policy and procedure (no number) entitled MEDICATIONS: PATIENT'S PERSONAL (Effective 5/1996, Reviewed 2/2013, no revision date) indicated that the contents of a patient's personal medications needed to be identified by a physician or a local pharmacist before they were administered to a patient and that to do this they needed to check the "ID # on tablet or capsule ..."

5. On 3/19/13, a review of Policy and Procedure #PH010 entitled DRUG PROCUREMENT INVENTORY CONTROL indicated it documented: "All medications must meet USP, NF, or FDA requirements for potency and labeling. All medications shall be stored under appropriate conditions of temperature." The FDA is the Food and Drug Administration which is the federal agency charged with approving medications and regulating the safe manufacture, distribution, storage, and proper use of medications in the United States. It enforces standards published by the United States Pharmacopeial Convention in the United States Pharmacopeia/National Formulary (USP/NF).

On 3/21/13, a review of Policy and Procedure PH044 entitled LIGHT SENSITIVE MEDICATIONS (Effective 8/10/2000, Reviewed 2/2013, and Revised 2/2006) indicated it stipulated that light sensitive medications were to be stored protected from light and that such medications were to be stored in an amber bag if removed from their containers.

On 3/18/13 an inspection of the hospital Central Supply Room indicated the following:

a. At 3:20 pm, an inspection of Cabinet 4 in the Central Supply Room indicated staff stored twenty-six 5 ml PFS of lidocaine 100 mg/5 ml (used to

Based on observation, interview, and document review, the facility failed to develop an effective system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel as evidenced by failure to ensure:

1. That the hospital's infection control plan was followed;

2. That the hospital's policy regarding flu vaccines for staff was followed;

3. That the hospital had an appropriate policy for cleaning instruments used in its off campus clinics;

4. The cart that contained clean linen was kept stored, uncovered, in the shower.

The failure to implement an effective infection control system could result in serious infections for patients and staff.

Findings:

1. A review of the hospital's Infection Control Plan, last reviewed 11/26/12, read, "Focused surveillance includes, but is not limited to hand hygiene compliance and monitoring."

This portion of the Infection Control Plan was reviewed with the infection control nurse, Administrative (Admin) Nurse B. During an interview on 3/21/13 at 12:20 pm, Admin Nurse B confirmed that she has not started any focused surveillance monitoring yet.

2. A review of the hospital's policy titled, "Influenza Vaccination for Health Care Personnel," last revised on 10/8/12, read, "Any Health Care Provider who declines the flu vaccine or does not provide proof of vaccination status shall wear a facility approved mask and gloves during direct patient care activities and while in patient common areas for the duration of flu season (October 1 through March 31)."

During the initial tour of the Emergency Department (ED) on 3/18/13 at 10:50 am, RN M was observed without a mask. There was one patient in the ED at that time.

During an interview on 3/20/13 at 1:45 pm, Admin Staff D stated that Registered Nurse (RN) M had signed a declination for the flu vaccine.

During an interview on 3/21/13 at 10 :30 am, Admin Nurse B stated that staff who decline the flu vaccine and are in patient care areas must wear a mask during flu season. She stated that the nurse managers should enforce this.

During an interview on 3/21/13 at 8:05 am, Admin Nurse A confirmed that RN M had not worn a mask on 3/18/13 during the initial tour of the ED.

3. On 3/19/13, visits were made to three off campus clinics. Staff interviews disclosed that instruments were used at all clinics.

A policy for instrument cleaning at the clinics was requested from Admin Nurse F. During an interview on 3/21/13 at 8:50 am, Admin Nurse F confirmed that there was no such policy.



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4. On 3/18 through 3/21/13, the medical surgical unit linen cart was observed. The linen cart was kept in the shower room. The linen cart was observed, several times each day, with the cover clipped back to the cart frame, thus allowing aerosolized microorganisms from the patients showering to contaminate the linen, potentially creating a cross contamination hazard.

On 3/18/13 at 10:30 am, Patient 19 confirmed that she had showers in the shower room.

On 3/21/13, the facility policy titled, "Storage, Collection and Transport," revision date 2/13, read, "Clean linens will be transported to patient areas by use of covered carts...The clean linen will be stored in a clean, dry area.

On 3/21/13 at 12:07 pm, Administrative Nurse A acknowledged that the linen policy did not instruct staff to keep linen covered, but it should, to prevent cross contamination.

Based on observations, staff interview, medical record review, and dietary document review, the hospital failed to ensure safe food handling practices and ensure the nutritional needs of patients were met as evidenced by: 1) retention of expired foods; 2) hospital menu was not being followed; 3) nutrient analysis not meeting the nutritional needs of patients'; 4) lack of timely assessment for Patient 17; 5) nutrition screening policy not followed for Patient 17; 6) hospital policies and procedures not consistent with each other and policy not consistent with criteria in electronic medical record. Failure to ensure comprehensive dietetic services systems may put patients at risk for foodborne illness. Lack of accurate and effective clinical nutrition care may result in a complete lack of or delay in medical nutrition therapy. Lack of timely and effective nutrition interventions may result in poor dietary intake, weight loss, and malnutrition, further compromising patients' medical status.

Findings:

Food Service

1. On 3/18/13 at 2:20 p.m., an observation of the reach-in refrigerator in the nutrition center on the acute unit was conducted with the interim Dietary Manager (DM). Two small sandwiches with fruit were observed with a label that indicated an expiration date of Sunday (3/17/13). A concurrent interview was conducted with the interim DM. The interim DM stated the dietary aide would have pulled the expired products this morning.

On 3/18/13 at 1:53 p.m., an interview was conducted with Dietary Staff 4 regarding her job duties. Dietary Staff 4 stated she stocks the nutrition center, rotates food items, pulls out expired foods, cleans, and checks temperatures in the refrigerator.

Review of the job duties for the dietary aide indicated they should check and restock all items in acute nutrition center and document temperatures in the area. This did not specify to discard any expired products.

2. On 3/19/13 at 11:35 p.m., an observation of the lunch tray line was conducted. Review of the lunch meal indicated the following items were to be served: turkey, gravy, candied yams, green beans, custard, and a roll with margarine. It was observed during tray line that the following items were served: pork, yams, green beans, and custard. There was turkey as an alternate if a patient did not like pork. There were no rolls on the tray line or on the trays when served to the patients.

On 3/19/13 at 12:00 p.m., an interview was conducted with the Dietary Cook 3. Dietary Cook 3 stated they used pork as the primary entree and turkey was the alternate. The Dietary Cook 3 stated she did not look on the menu, therefore, she did not know if the patients were supposed to get a roll. After reviewing the menu, Dietary Cook 3 stated, "I guess they were supposed to get a roll."

On 3/19/13 at 2:00 p.m., an interview was conducted with the interim DM. The interim DM stated they used the substitution list and used pork because they did not have enough turkey for the menu. The interim DM stated she was aware that the cook forgot to provide rolls for the patients.

3. Review of the nutrient analysis of the menu was conducted. The nutrient analysis was just a summary of the four week cycle. Further review of the analysis indicated for Week 3 of the menu (the week of 3/18/13) the menu did not meet 100% of the following nutrients: Dietary fiber, Potassium, Vitamin D, Vitamin D, Niacin, and Choline. There was no breakdown by food item and meal for each day of the menu cycle.

An emailed correspondence with the consultant Registered Dietitian (RD 2) received on 3/23/13 at 1:35 p.m., indicated by RD 2 that she will be "purchasing service for the next cycle to better meet the requirements of CMS."

Nutrition Care

1. Review of the medical record was initiated for Patient 17. Patient 17 was admitted to the hospital on 8/27/12 with diagnoses that included Malignant Neoplasm of middle lobe, bronchus or lung (malignant lung cancer) and pulmonary embolism [blockage of the main artery of the lung or one of its branches by a substance that has traveled from elsewhere in the body through the bloodstream (embolism)].

Review of the Nursing Inpatient Admission, dated 8/27/12, indicated on the nutrition screen that Patient 17's usual weight was 205 pounds and the patient had lost over 20 pounds in over 30 days. It indicated that the patient was at Moderate Nutrition risk (Priority II) because of the unintentional weight loss of 20 pounds in over 30 days. Review of the Day 3/6/9/12 Nutrition Screening, dated 8/30/12, indicated Patient 17's weight was 161 pounds and there was weight loss and the patient was eating less than 50% of meals. It indicated Patient 17's nutrition priority was Priority 1 - high risk and the RD was notified.

Review of the Nutrition Assessment, dated 8/31/12, indicated the patient was 6'1" and 161 pounds and with a Body Mass Index (measurement of body fat based on height and weight) of 21(normal is 18.5 to 24.9) at a moderate nutrition risk, had poor appetite and was eating less than 50% of meals, and was at risk for decline related to Cancer with metastasis (cancer that has spread from its original location to a non-adjacent organ or body part) as evidenced by history of poor appetite with weight loss.

There were no further reassessments in the chart from either the RD or nursing. The patient was discharged from the hospital on 9/8/12 (8 days after the RD assessment and 9 days after the last nutrition screen by nursing.

On 3/20/13 at 10:00 a.m., a telephone interview with the consultant RD (RD 1), covering the hospital while the regular consultant RD was on vacation, was conducted. RD 1 stated nursing does the reassessment for the patients every 3 days. RD 1 stated if they do not get another reassessment or re-screen about the patient then they would assume the patient was discharged. RD 1 stated nursing does the re-screens/reassessments for the patients because the RD is not at the hospital very often.

On 3/20/13 at 11:20 a.m., an interview was conducted with Licensed Nurse (LN) G. LN G stated all the criteria for the three priorities were in the electronic medical record. LN G acknowledged this was not stated anywhere in the policy. LN G stated she thought maybe since the patient went on comfort measures they stopped reassessing or screening the patient. LN G acknowledged this is not stated in the hospital policy and procedure.

Review of the hospital policy and procedure titled, "Nutrition Screening and Assessment Acute Care," dated 10/01, indicated on admission all patients admitted to the Medical/Surgical Unit will have a nutrition screening evaluation completed within 24 hours of admission. The Registered Nurse overseeing the patient's admission will ensure: the nutritional screening evaluation is completed and priority determined for all new admissions. Priority I High Risk, the RD is notified for consultation; Priority II Moderate Risk: all patients identified as Priority II Moderate Risk. Every three days patients will be reevaluated for priority change. It indicated the RD will respond within 24 hours of a Priority I and 48 hours for a Priority II notifications. This policy does not identify any criteria for the priority levels. There are three priority levels in the electronic medical record but only Priority I and II are addressed in the policy. The policy indicated every three days patients would be re-evaluated. This did not occur with Patient 17.

Review of the hospital's policy and procedure titled, "Patient Assessment/Reassessment and Care Planning," dated 7/10, indicated for nutrition services the initial assessment is within 24 hours of referral, seven days a week; and reassessment for all other assessments is the RD follows up every 7 days or sooner per RD judgement based on patient acuity. The policy is not consistent with the above policy regarding Nutrition Screening and Assessment. The RD did not follow up on Patient 17 every 7 days or sooner, per RD judgement. The policy is not clear about what priority level would be reassessed by the RD and what time frame this would occur. The standard of practice is that each priority would state the criteria and when the RD would assess and reassess the patients.

Based on interview and record review, the hospital failed to ensure that patient care policies were reviewed annually by the Medical Executive Committee(MEC) . This failure could result in unsafe patient care.

Findings:

On 3/21/13, the facility policy titled, "Management of Policy and Procedure," last reviewed 2/13, indicated the policies will be reviewed at least every three years (not annually as required by regulation for patient care policies.)

On 3/21/13 at 10:40 am, Administrative (Admin) Nurse A was asked about how often patient care policies were reviewed, and she replied, "Annually." She further stated that the hospital was reformatting and updating policies and while some individual policies had been approved, not all the nursing policies had been developed and reviewed by the medical staff (MEC), the Quality Committee, or the Board since 2009. Admin Nurse A acknowledged that radiology and laboratory policies were also not current with annual review.

Based on interview and document review, the facility failed to have a qualified Radiology Manager supervise the functions of the department and supervise radiology technicians according to its policy. This had the potential to result in substandard patient care in this department and posed a safety risk to both staff and patients.

Findings:

A review of Radiology Tech 1 and 2's personnel files disclosed that there were no competency checklists. During an interview on 3/20/13 at 2 pm, Admin Staff D stated that the manager of each department was responsible for their employees' competency checks.

During an interview on 3/20/13 at 3:40 pm, Admin Staff F stated that he was trained as a clinical lab scientist and not trained in Radiology. He confirmed he was unable to perform competency checks for the radiology technicians. He stated that their radiologist would perform the evaluations and competency checks that involved actual technique for radiology, CT (computerized tomography - imaging), and mammography but had no documentation that this had been done.

A facility policy titled, "Supervisor Responsibilities," last reviewed 2/2013, read, "the Radiologist/supervisor shall be responsible for ascertaining compliance with the stated of California Radiation Control Regulations and with the Rules of Good Practice for Mammography. The Imaging Services Supervisor, by law, has responsibility for and control of the quality, radiation safety and technical aspects of all x-ray examinations and procedures."

Based on interview and document review, the hospital had not maintained a complete list of all services furnished under arrangements or agreements, and the available partial list did not contain descriptions of the nature and scope for all of the services listed.

Findings:

On 3/18/13, the hospital was asked to provide the list of all services furnished under arrangements or agreements. On 3/19/13, the list was again requested and at 10:15 am the DQ introduced the Administrative Assistant and Clerk of the Board, Administrative (Admin) Staff G, who explained she kept information about service contracts in her computer on a spreadsheet. A paper printout titled, "Contracted Services," was provided. On 3/20/13, review of the printed "Contracted Services" list showed that it did not contain all of the contracted services utilized by the hospital, and did not contain a full listing of the nature and scope for each contract listed.

1. The hospital has over the past several months been utilizing the services of a Health Information (HIM) Staff B, who's name is on the "Contracted Services" list, however, the description of services provided is "HIM-OSHPD Reporting" without further description of the full nature or scope of services.

2. The "Contracted Services" list has the names of many health care providers, that have only a single word under the description column, typical of this are Medical Staff Members (MSM) 1, 2, and 3, each of which have only the word "Physician" as a description of their services provided. Their specialty, where (out-patient clinic, in-patient acute care, etc.) they provide services and the scope of the services is not provided.

During an interview on 3/21/13 at 10:40 am, Admin Nurse A acknowledged that the list of contracted services was incomplete, did not contain all of the contracted services, and did not contain the full nature and scope for all of the services listed. Admin Nurse A acknowledged that contracted services were not assessed as part of the Quality and Performance Improvement program (Q/PI) to assure all services provided by agreement were delivered in a safe and effective manner.



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3. On 3/18/12 at 11:35 a.m., an interview was conducted with the interim Dietary Manager (DM). The interim DM stated the regular Registered Dietitian (RD 2) was on vacation and there was another RD (RD 1) who was covering the hospital at this time.

Review of the hospital's contracted services indicated RD 1 was not on the list of services.

On 3/20/13 at 11:50 a.m., an interview was conducted with Admin Nurse A. Admin Nurse A stated they had found RD I's contract and acknowledged it was not indicated on the list of all of the services and this would need to be updated.

Based on interview and record review, the facility failed to ensure that the needs of the patients were assessed and interventions done to meet the needs for seven of 31 sampled patients. (Patients 1, 2, 3, 10, 11, 22 and 23).

1. Patients 1, 2 and 3 had incomplete nursing assessments, prior to surgery.

2. Patient 1 was discharged on a pain medication for which she had a listed allergy.

3. Patient 11 was given discharge instructions that did not address all of her health problems.

4. Patients 22 and 23 did not have timely nursing reassessments during their emergency room visits.

5. Patient 10's record contained a verbal order that did not comply with the hospital's policy for writing verbal orders.

These failures had the potential for patients needs to go unattended and suffer adverse health consequences.

Findings:

1. The facility policy titled, "Patient Assessment and Reassessment and Care Planning," last reviewed 2/13, indicated, "Patients shall have an initial assessment by an RN ... for surgery patients..upon arrival in the holding area..on the Pre-op Flowsheet. The integration of assessment findings forms the basis for developing the patient's plan of care. The integration of assessment findings allows for members of the healthcare team to identify and prioritize patient problems."

a. Patient 1's record was reviewed on 3/18/13. Patient 1 was admitted for surgery on 1/16/13. Patient 1's record contained a form, titled, "Pre-Operative Nursing Admission Notes" which had areas for nursing assessment by systems to be completed. The sections for respiratory and cardiovascular assessments were blank.

b. Patient 2's record was reviewed on 3/18/13. Patient 2 was admitted for surgery on 2/12/13. Patient 2's "Pre-Operative Nursing Admission Notes" section for cardiovascular assessment was blank.

c. Patient 3's record was reviewed on 3/18/13. Patient 3 was admitted for surgery on 11/7/12. Patient 3's "Pre-Operative Nursing Admission Notes" section for dentures and nutrition.

On 3/20/13 at 9:50 am, Administrative (Admin) Nurse A reviewed Patient 1, 2, and 3's records and acknowledged that all sections of the nursing assessment form were to be assessed and documented to ensure the patients' safety during surgery.

2. Patient 1's record contained a clinic note documented by physician assistant (PA) 1, dated 1/14/13, which listed the patient problem as "Preoperative history and physical (H&P)." This H&P read under the section on allergies, "Vicodin (pain medication, active ingredients hydrocodone bitartrate and acetaminophen) as well has given her an itch and a rash."

Patient 1's record contained a clinic note, dated 1/4/13, that indicated that Patient 1 required surgery. This note did not include a complete history or physical and did not have a notation regarding Patient 1's allergies.

Patient 1's record contained a form, dated 1/9/13, titled, "Pre-procedural Data Collection," completed by Licensed Nurse (LN) I which was blank in the area where allergies should have been documented.

Patient 1's Pre-operative Nursing Admission Notes, dated 1/16/13, included a notation that Patient 1 was allergic to Vicodin.

Patient 1's pre-anesthesia evaluation form, dated 1/16/13, included a notation that Patient 1 was allergic to Vicodin.

Patient 1's record contained post operative orders, dated 1/16/13 at 1510 (3:10 pm), for Norco (pain medicine with same active ingredients as Vicodin but in different proportions) and noted by LN J at 3:30 pm. Patient 1's discharge instructions also listed Norco for pain.

On 3/20/13 at 9:50 am, Admin Nurse A reviewed Patient 1's record and acknowledged that Patient 1 was ordered a drug for which she was allergic and nursing staff should have contacted the physician regarding this discrepancy.

3. On 3/21/13, Patient 11's record was reviewed. Patient 11 presented at the Emergency Department with injuries after a fall. Patient 11's record contained a physician's emergency room report, dated 3/19/13, that indicated that Patient 11's diagnoses included as number 1, mild intoxication from accidentally taking her medications in greater than prescribed amounts.

Patients 11's written discharge instructions were related to the possible effects of a head injury. Patient 11's written discharge instructions did not address medication management.

On 3/21/13 at 12:05 pm, Admin Nurse A reviewed Patient 11's record and acknowledged that Patient 11's written discharge instructions did not address her number one diagnosis, and the need for taking medications in the prescribed doses.


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4 a. A record review of Patient 23's record and interview was conducted on 3/19/13 at 3:30 pm with the Emergency Department (ED) Manager (LN G). Patient 23 arrived to the ED on 2/6/13 at 11:50 am with a complaint of left ear pain and jaw pain. She was assessed including vital signs (blood pressure, pulse, respiratory rate, temperature) and assigned a Triage Acuity level of 2 (Levels range from Level 1 where patients require immediate resuscitation, Level 2 High Risk, Urgent, Level 3 Urgent to Levels 4 and 5 where the patient could be seen in the clinic). She was transferred to another facility for a higher level of care at 3 pm. No repeat vital signs were seen in the record.

LN G confirmed that repeat vital signs should have been done prior to transfer, but were not repeated.

4 b. A record review of Patient 22's record and interview was conducted on 3/19/13 at 3:30 pm with LN G. Patient 22 arrived to the ED on 3/2/13 at 12:47 am with a complaint of right sided chest pain. He was assessed including vital signs and assigned a Triage Acuity level of 3. He was transferred to another facility for a higher level of care at 5:15 pm. No repeat vital signs were seen in the record.

LN G confirmed that repeat vital signs should have been done prior to transfer, but were not repeated.

A facility policy titled, "Patient Assessment/Reassessment and Care Planning," last reviewed in 2/2013, under the Emergency Services heading, read, "Admission assess on all patients after placement in treatment area within 30 minutes." For Level 2 patients, it read, "every 15 minutes unless directed otherwise by a physician," and for Level 3 patients, "every two hours, after medication or treatment and a minimum of one hour prior to discharge."

5. A record review of Patient 10's record and interview was conducted on 3/19/13 at 3:05 pm with LN G. The initial orders for Patient 10 were hand written on 11/2/12 at 2:43 am without the nurse's signature or either verbal or telephone order beside it.

LN G confirmed that this order had been written by the nurse without her signature or any indication of whether it was a verbal or written order. She also stated it was not possible to determine from the record if the physician saw Patient 10 before the nurse wrote the medication order at 2:43 am.

A hospital policy titled, "Documentation Standards," last reviewed in 2/2013, read, "medical record entries must be signed with the first initial, last name and category (e.g. RN. . .) on all entries."

A hospital policy titled, "Verbal Telephone Orders," last reviewed in 2/2013, read, "all verbal/telephone orders should be transcribed in the medical record . . . all telephone or verbal orders will be transcribed as read back."

Based on interview and record review, the facility failed to review all nursing staff at least annually for competency, as required by its policy. This had the potential to result in poorly trained staff and poor patient outcomes.

Findings:

A review of RN N's personnel file disclosed no competency checks since 10/2011.

During an interview on 3/21/13 at 9:45 am, Admin Nurse A confirmed the above and stated that this nurse should have had a competency evaluation done, in 10/2012.

A facility policy titled, "Competency Standards", last revised 2/14/13, read, "All patient care staff will be tested for competency on hiring, during orientation and throughout the year. A copy of the performance evaluation sheet will be placed in the employee's record."

Based on observation, interview, and record review, the hospital failed to ensure the accurate administration of medications and that medications were ordered, according to accepted standards of practice evidenced by:

1. Failure to accurately administer medications to one of three sampled patients during a medication administration observation. (Patient 8)

2. Failure to ensure that post operative pain medications were ordered in a fashion that allowed nurse to function within their scope of practice for one of 31 sampled patients. (Patient 1)

These failures could result in an ineffective dosing or an overdose of medication, and subsequent harm to patients.

Findings:

1. On 3/19/13, a review of Patient 8's electronic medical record indicated that on 3/18/13 at 6:47 pm, a physician ordered Wellbutrin 300 mg to be administered to Patient 8 daily in the morning.

On 3/19/13 at 8:57 am, during a medication pass observation, Staff Nurse S administered medication to Patient 8 but Wellbutrin 300 mg was not one of those medications.

On 3/19/13 at 11:42 am, during a review of Patient 8's medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) and Patient 8's electronic medical record, and a concomitant interview of Administrative (Admin) Nurse R, the surveyor did not see Wellbutrin on Patient 8's MAR and this was confirmed by Admin Nurse R at that time. Admin Nurse R verified Patient 8 had an order for Wellbutrin 300 mg every morning. She stated that the order had been missed by hospital staff when they entered the medication orders into Patient 8's computerized medication record.

During the medication pass, one medication error was made out of a total of 21 opportunities for error for an error rate of 4.5%.



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2. On 3/18/13, Patient 1's record was reviewed. Patient 1 was admitted for surgery on 1/16/13. Patient 1's record contained Post Anesthesia Order PACU (recovery from surgery), dated 1/16/13 at 14:30 (2:30 pm), which ordered under Analgesia both Morphine and Dilaudid for pain. The orders did not contain any differentiating information as to which drug should be given first or if both could be given together.

On 3/20/13 at 9:50 am, Admin Nurse A reviewed Patient 1's record and acknowledged that the order was not clear for the nurse to know what the physician's intent was regarding the administration of pain medications. Admin Nurse A further acknowledged that the nurses would be working outside the scope of their practice to decide which physician's orders that they would choose to follow.

Based on interview and review of medical records and hospital documents, the hospital failed to ensure nursing care plans were developed and kept current for three of 31 sampled patients.

1. Patient 17 did not have a care plan for nutrition when nutrition risk was identified.
2. Patient 7 did not have a care plan that addressed pneumonia and nausea.
3. Patient 14 did not have a care plan that addressed nutrition, generalized weakness, depression, end of life care, or urinary retention.

These failures had the potential for patients needs to go unaddressed and adverse health consequences to occur.

Findings:

1. On 3/20/13, review of the medical record was initiated for Patient 17. Patient 17 was admitted to the hospital on 8/27/12 with diagnoses that included malignant neoplasm of middle lobe, bronchus or lung (lung cancer); and pulmonary embolism [blockage of the main artery of the lung or one of its branches by a substance that has traveled from elsewhere in the body through the bloodstream (embolism)].

Review of the form, Nursing Inpatient Admission, dated 8/27/12, indicated on the nutrition screen that Patient 17's usual weight was 205 pounds and the patient had lost over 20 pounds in over 30 days. The form indicated that Patient 17 was at Moderate Nutrition risk (Priority II) because of the unintentional weight loss of 20 pounds in over 30 days. Review of the Day 3/6/9/12 Nutrition Screening dated 8/30/12, indicated Patient 17's weight was 161 pounds and there was weight loss and patient was eating less than 50% of meals. It indicated Patient 17's nutrition priority was Priority 1 - high risk and the Registered Dietician (RD) was notified.

Review of the Nutrition Assessment, dated 8/31/12, indicated Patient 17 was 6'1" and 161 pounds and with a Body Mass Index (measurement of body fat based on height and weight) of 21 (normal is 18.5 to 24.9) at a moderate nutrition risk, had poor appetite and eating less than 50% of meals and at risk for decline related to cancer with metastasis (cancer that has spread from its original location to a non-adjacent organ or body part) as evidenced by history of poor appetite with weight loss.

Review of the nursing care plans for Patient 17, indicated there was only care plans for activity intolerance and risk for falls.

On 3/20/13 at 11:25 am, an interview was conducted with Licensed Nurse (LN) H. LN H stated when the nurse determines a patient is a nutrition risk with priority 1 (high) or priority 2 (moderate) then the nurse should have generated a nutrition care plan for that patient.

Review of the hospital's policy and procedure titled, "Patient Assessment/Reassessment and Care Planning," dated 7/10, indicated data gathered from the various clinical disciplines are integrated into a common patient medical record to effectively identify patient needs and to promote coordinated care and service. The integration of assessment findings forms the basis for developing the patient's plan of care. The plan of care is developed in conjunction with the patient/family wherever possible and will formally or informally, outline the following: the need(s) to be addressed; the care goal(s) relative to the need identified; and interventions planned by the healthcare team to address the need(s) and meet the care goal(s).



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2. On 3/20/13, Patient 7's record was reviewed. Patient 7 was admitted on 3/18/13 with diagnoses that included aspiration pneumonia (inhaling food or fluids into the lungs), a fall with rib pain, and right sided abdominal pain. patient 7's nursing assessment dated 3/18/13 indicated that Patient 7 was having ongoing problems with nausea. Patient 7's record contained a care plan, dated 3/18/13, that addressed acute pain. No care plan was present for nursing issues related to her diagnoses of aspiration pneumonia, nutrition, or her symptoms of nausea.

On 3/21/13 at 12 pm, Administrative (Admin) Nurse A reviewed Patient 7's record and acknowledged that Patient 7's care plan did not address all of her nursing problems.

3. On 3/20/13, Patient 14's record was reviewed. Patient 14 was admitted on 1/16/13 with diagnoses that included heart and respiratory failure, diabetes, atrial fibrillation (irregular heartbeat), and coronary artery (circulation for the heart) disease. Patient 14's record revealed that she had lost weight, become depressed regarding her declining health status, and asked her physicians to discontinue all her medications so she could die. Patient 14 had problems with urinary retention and had a catheter placed to drain her urine. Patient 14's care plan did not address nursing problems associated with nutrition, generalized weakness, depression, end of life care, or urinary retention.

On 3/21/13 at 11:50 am, Admin Nurse A reviewed Patient 14's record and acknowledged that Patient 14's care plan did not address all of her nursing problems.

Based on document and medical record review and staff interview, the facility failed to ensure that the clinical records system was maintained in accordance with written policies and procedures because the Health Information Management Department's (HIMD) policies and procedures were not reflective of current practices. In addition, the facility failed to ensure that there were safeguards in place for the use of electronic signatures by the medical staff. These failures could result in falsified orders and miscommunication regarding patient care.

Findings:

1. The HIMD policy and procedure (P & P) manual was reviewed on 3/18/13. The most recent approval page contained signatures from January-March 2006. Individual policies within the manual showed revision dates from November 2006. On 3/19/13 at 8:40 AM, Administrative Nurse A was asked for the facility's policy stating how frequently departmental policies were to be reviewed and she stated that there was no written policy, however they try to review them annually. She acknowledged that the HIMD P&Ps were overdue for review/revision because there had been three different managers in the past three years.

The policy, "Acceptable Abbreviations" HIM #302, was last revised on 11/13/06; however the policy states: "On a yearly basis it will be the responsibility of the HIM Manager to ask all departments ... to submit any suggested changes or additions to the list....."

Some of the other outdated/inconsistent policies were ones regarding the charges for providing copies of medical records to patients (HIM#313 and 370); the location where older medical records were stored (HIM #324); the release of protected health information authorization form was not the one currently used,, and the fee charged for copies was not accurate (HIM #328). The policy "Retention of Health Information" HIM #332 did not definitely state which retention period was to be followed (listed were both the legal requirement and one recommended by a hospital association).

2. On 3/20/13, Records 26, 27, 28, 29 and 31 were reviewed. These records contained dictated and transcribed reports that had been electronically signed by the physician/allied health practitioner. During interview with HIM Staff B on 3/20/13, she confirmed that the facility did not have a system in place to ensure that the computer codes would not be used by unauthorized persons and no medical staff/allied health practitioner had signed a statement of confidentiality and security, similar to one that was signed by facility employees upon hire.

Based on document and medical record review and staff interview, the facility failed to ensure that records were complete, with dates and times, approved, and corrected, according to hospital policy in six of 31 records reviewed. (Patients 1, 2, 3, 26, 27, and 28). This failure had the potential for miscommunication regarding patient care.

Findings:

1. The Medical Staff Bylaws, Rules and Regulations (revised 1/1/12) were reviewed on 3/18/13. Appendix 1, Section 10 states that the practitioner signature on verbal and telephone orders must be dated and timed within 24 hours. Section 34 states: "All progress notes and orders are to be timed and dated for all patients."

The following medical records were reviewed on 3/20/13 and the findings were confirmed either with HIM Staff C concurrently or with Administrative (Admin) Nurse A beginning at 4:45 pm:

a. Records 26 and 28 each contained two verbal orders (given on 12/29/12 and 1/16/13) which had not been signed at all. Records 26 and 29 each contained two verbal orders (given on 12/28/12, 12/29/12, and 1/21/13) that had not been dated and timed when signed by the physician.

b. Record 27, an outpatient who had a same-day procedure, contained a physician progress note on 1/15/13 that had not been timed when written. The pre-operative orders did not have one of the boxes checked to indicate the type of anesthesia that was to be administered; and this order was not timed.

c. Record 26 did not indicate the disposition of the patient in the space provided on the emergency department record (the patient was admitted to the hospital).

d. Records 26 and 27 contained abbreviations that were not on the list of those approved for use in the medical record.

e. The Discharge Instructions (Nurse) in Record 28 did not have one of the boxes checked (Yes or No) to answer, "Was patient ready for discharge in regard to his/her severity of illness". This outpatient had a same-day procedure.



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2. On 3/18/13, Patient 1 and 2's records contained pre-operative orders which did not contain a time that the physician signed the orders.

Patient 3's record contained an update to the surgical history and physical that did not contain the time of the update.

On 3/20/13 at 9:50 am, Admin Nurse A acknowledged the above documents should have been timed with their authentication.

3. On 3/18/13, Patient 2's record was reviewed. Patient 2 was admitted on 2/12/13 for surgery. Patient 2's record contained Pre-Operative Orders, dated 1/28/13, which had been noted by the nurse on 2/12/13 at 7:15 am. This form contained an additional verbal order for Ancef (antibiotic) on 2/12/13 at 9:30 am.

On 3/20/13 at 9 am, Admin Nurse A reviewed Patient 2's record and stated that the verbal order should not have been added to an existing set of orders written by the physician. This did not allow for the proper authentication of the verbal order by the physician and made it appear as if his signature for the 1/28/13 orders also covered the 2/12/13 verbal order, which it was not intended to do.

4. Patient 2's record contained Outpatient Post-Op Orders, dated 2/12/13 at 9:40 am, which included an order to resume Coumadin on ____________ (an illegible entry) 2/13/13.

The hospital policy titled, "Legibility of Medical Record Documentation," last reviewed 2/13, read, "All entries into the medical record shall be legible... illegible orders will not be carried out until clarified with the provider."

On 3/20/13 at 9 am, Admin Nurse A reviewed patient 2's record and confirmed that the order was not legible and there was no evidence that the order was clarified with the provider.

Based on review of hospital documents, personnel files, and staff interviews, the hospital failed to ensure there was confidentiality and security agreement with one employee that was contracted to provide services to the hospital.

Findings:

Review of the personnel file for the consultant Registered Dietitian's (RD 1) indicated there was a contract, but no confidentiality and security agreement was with it.

On 3/20/13 at 4:25 pm, an interview was conducted with Administrative (Admin) Staff K. Admin Staff K stated she just spoke with Admin Staff L who confirmed they did not have any business associate agreement with RD 1, therefore, there was no confidentiality agreement.

Based on record review and interview, for two of 31 reviewed records (Patients 1 and 4) the hospital failed to ensure that each patient undergoing a non-emergent surgical procedure had a complete history and physical conducted, in accordance with the hospital rules and acceptable standards of practice, and that the written document of the history and physical was placed in the medical record, prior to surgery. This failure to have a timely and proper medical history and physical examination conducted and recorded within 30 days prior to surgery, permitted the possibility that a patient could suffer harm as a result of an unrecognized preexisting medical condition that may increase the risk of surgery or anesthesia during surgery

Findings:

On the 3/19/13, review of the "Medical Staff (MS) Bylaws, Rules and Regulations (Revised 12/8/12)" it was noted that Rule 8 and 9 (page 86) are consistent with the state regulations and states that: "8. All patients shall have a history and physical written within 24 hours of admission. A n interval admission history and physical examination may be substituted on patients readmitted within thirty (30) days of last admission (with complete history and physical). This shall be written or dictated within twenty-four (24) hours of admission and will include the chief complaint, history or present illness, and pertinent changes to history and physical examination...9. An interval history and physical examination must be performed and documented on patient's chart within 24 hours of (before) surgery. Except in dire emergency circumstances, this documentation shall be present on the patient's chart before any surgical operation is undertaken."

California Code of Regulations (sections 70233 and 70717) require that in hospitals licensed by the state a patient scheduled for a surgical procedure must have an admission H&P that has been done prior to the surgery, and in the event that the H&P has been done earlier, that an update to the H&P must also be performed and recorded no more than 24 hours prior to the surgery. Federal regulations allow the admission H&P to be done no more than 30 days prior to admission. Both the written admission H&P and the update to the H&P must be authenticated and placed in the medical record prior to the surgery.

During the survey, the medical records of 31 patients were reviewed and two records were noted to be missing an admission H&P that met the requirements of Medical Staff Rules 8 and 9, and the State regulations for licensed hospitals.

* Patient 1 was admitted to the hospital on 1/16/13 for an outpatient surgical procedure. The record did not contain of a properly authenticated admission history and physical examination (H&P) as required by Rules 8 & 9. (Also refers to C-322)

* Patient 4 was admitted to the hospital on 2/11/13 for an outpatient diagnostic procedure and biopsy to be done under moderate sedation. The record contained an H&P conducted and dictated on 1/11/13 (31 days prior to the procedure) that had not previously been authenticated (signed). The patient had not been admitted during the 30 days prior to surgery and the record did not contain an "interval admission history and physical examination" as referenced in Rules 8 & 9. The record did not contain a documentation of the patient being examined by a physician or other qualified practitioner during the 24 hours prior to the procedure.

On 3/19/13 at 10:15 am, these records were reviewed with the Director of Quality (DQ) and she verified the absence of the required H&Ps, as noted above.

Based on record review and interview, for five of 31 reviewed records (Patients 1, 2, 3, 4 and 5), the hospital failed to ensure that:
1) Each patient undergoing a surgical procedure was examined by a qualified practitioner immediately before surgery, to evaluate the risk of the procedure to be performed; and
2) Each patient undergoing anesthesia for a procedure, was examined by a qualified anesthetist, immediately before the procedure, to evaluate the risk of anesthesia.This failure permitted the possibility that a patient could suffer harm as a result of unrecognized surgical or anesthesia risk.

Findings:

The medical records of 31 patients were reviewed during the survey and the following four records demonstrated the following deficiencies:

a. Patient 1 was admitted to the hospital on 1/16/13 for an outpatient surgical procedure. The record contained documentation of a history and physical examination (H&P) performed by an allied health practitioner (AHP) on 1/14/13, however, the H&P was not authenticated (signed) by the AHP, and was not authenticated by a dated signature of a physician. The record did not contain documentation of an examination by the surgeon or other qualified practitioner within 24 hours, prior to the surgery. The record did contain a page titled, "preanesthesia evaluation," however, this page did not document an examination of the patient and the record did not contain any other documentation of a physical examination of and evaluation for anesthetic risk by the anesthetist, prior to the anesthesia.

b. Patient 2 was admitted to the hospital on 2/12/13 for an outpatient surgical procedure. The record did contain a "preanesthesia evaluation" form which did not document an examination of the patient and was not dated, timed or signed. The record did not contain any other documentation of a physical examination by the anesthetist, prior to the anesthesia.

c. Patient 3 was admitted to the hospital on 11/7/12 for an outpatient surgical procedure. The record did contain a "preanesthesia evaluation" form which did not document an examination of the patient however this page did not document an examination of the patient and the record did not contain any other documentation of a physical examination by the anesthetist, prior to the anesthesia.

d. Patient 4 was admitted to the hospital on 2/11/13 for an outpatient diagnostic procedure and biopsy to be done under moderate sedation. The record did not contain either a qualified admission H&P or a physical examination by a qualified practitioner in the 24 hours prior to surgery, to evaluate the risk of the procedure to be performed. (Refer to C 320)

e. Patient 5 was admitted to the hospital on 3/13/13 for an outpatient surgical procedure. The record did contain a "preanesthesia evaluation" form which did not document an examination of the patient and the record did not contain any other documentation of a physical examination by the anesthetist, prior to the anesthesia.

On 3/19/13 at 10:15 a.m., the above patient records were reviewed with the Director of Quality (DQ) and she verified the absence of the required H&Ps, as noted above.

Based on staff interview and document review, the hospital failed to ensure that requirements were met for the condition of participation: Periodic Evaluation and Quality Assurance Review as evidenced by:

1. Failure to evaluate services provided by outside contractors. (Refer to C 337, items 1, 4, and 5)

2. Failure to have quality assurance programs to evaluate the effectiveness and safety of the radiology services for patients and staff. (Refer to C 337, item 2)

3. Failure to have a quality assurance program to evaluate the effectiveness of food service and nutritional care. (Refer to C 337, Item 3)

4. Failure to maintain evidence of the evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital.

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on interview and record review, the hospital failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished, and of treatment outcomes for all patient care services and other services affecting patient health and safety.

1. Failure to evaluate services provided by outside contractors providing patient care;

2. Failure to have quality assurance programs to evaluate the effectiveness and safety of the radiology services for patients and staff.

3. Failure to have a quality assurance program to evaluate the effectiveness of food service and nutritional care.

4. Failure to evaluate outside contractors providing health information services of transcription and coding.

The failure to evaluate patient care services may result in the lack of identification of problems that may harm patients or negatively impact their health status.

Findings:

1. On 3/21/13 at 10:40 am, Director of Quality (DQ) was asked about how contracts that involve patient care or impact patient care were evaluated. DQ stated the hospital did have a form that was recently developed to monitor the quality of services provided through contracts but that it had not been implemented. DQ provided a hospital policy regarding Contracts, last reviewed 2/13, however it did not include any policy statements regarding how contracts were evaluated for quality of services. DQ acknowledged that the hospital did not evaluate the quality of services as part of the quality program.

2. On 3/19/13 at 11:40 pm, Radiology Manager F was interviewed regarding the quality program for the services provided in Radiology. Radiology Manager F stated mammography indicators were reported regularly to the Quality Committee but none of the other imaging services had data that was reported to the Quality Committee. When asked if data regarding the radiation exposure to patients and staff was evaluated as part of the quality program, he stated it had not been.

On 3/21/13 at 10:40 am, DQ acknowledged the radiology quality program did not include indicators for all imaging services provided.



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3. On 3/19/13 at 8:45 a.m., the performance improvement program for food services was discussed and reviewed with the interim Dietary Manager (DM). The interim DM stated for quality assurance they do patient satisfaction surveys which is mostly for the patients in the skilled nursing facility attached to the hospital and she submits temperatures and cool down documentation to the infection control committee.

Review of the consultant Registered Dietitian's (RD 2) monthly reports, indicated there was a nutrition screening and assessment performance improvement evaluation done monthly. The record audit included evaluation of elements such as screen done within 24 hours, CP Priority 1 and 2 within 24 hours, Priority 1 and 2 faxed to RD, 100%, RD assessment completed in 24 hours for Priority 1 and 48 hours for Priority 2, Length of stay greater than three days, re-screen every three days and RD recommendations followed. While there were several data elements being collected, there was no formal evaluation of the data. Additionally, there were no set parameters for acceptable data nor was there a plan to address problem areas. It was noted that while the RD was collecting the process data, there was no evaluation of the effectiveness of nutrition care.

On 3/20/13 at 11:50 a.m. an interview was conducted with the Admin Nurse A regarding the Quality Assurance program for food and nutrition services. Admin Nurse A stated at this time she would summarize the data from the RD and present to the board or governing body on an annual basis and this has not been done for this last year. Admin Nurse A stated she plans to start doing this on a quarterly basis now. Admin Nurse A acknowledged that she had no written documentation of any corrective actions that were done with the outliers when screens, faxes or assessments were not done or done timely.



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4. The facility has an agreement with an outside service to transcribe all reports that are dictated by physicians and allied health professionals (such as history and physicals, operative reports, emergency room reports, discharge summaries). The agreement states that the service will conduct quarterly quality monitoring activities, and outcomes will be provided to the hospital. During an interview with HIM Staff A & B on 3/19/13 beginning at 11:00 AM, they stated that they had not seen these reports. Upon further investigation, on 3/20/13 at 11:30 AM, HIM Staff B stated that they had been unable to determine that these quality reports had ever been shared with the facility.

5. The HIM department has three staff who assign final diagnostic and procedure codes for all the patients seen in the hospital. Two of these staff had only been employed within the past one and six months ago. During an interview with HIM Staff A & B on 3/19/13 beginning at 11:00 AM, they stated that there was no process to monitor and evaluate the quality of their work. These codes are used as the basis for financial reimbursement

Based on interview and document review, the hospital failed to maintain evidence that it had utilized an agreement with a hospital, QIO (Quality Improvement Organization), or other equivalent/qualified outside entity to evaluate the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital, and failed to maintain documentation that any such evaluation had been conducted within the hospital.

Findings:

On 3/19/13 and 3/20/13, review of the provided list of services by contract or agreement (see Q-291 for details) did not list a hospital, QIO, or other entity that was listed as providing an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital. The list did contain one QIO, however, the "Contracted Services" list did not describe the services provided other than to read, "Medicare Quality Assurance." The hospital provided no documentation to show that this QIO had, in the past 15 months (since 1/1/12), been utilized to conduct an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by practitioners at the hospital.

On 3/18/13 through 3/20/13, review of the Medical Executive Committee (MEC) minutes and review of the minutes of the Board of Directors, from January 2012 to date, showed no references to an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by physicians or other practitioners at the hospital.

The Administrative Policy #AD066 titled, "Quality and Performance Improvement" (Q/PI), last reviewed 2/2013, does not specify a plan to evaluate or detail any means of evaluating the diagnoses and treatments furnished by practitioners at the hospital. In a telephone interview at 4 pm, the DQ acknowledged that the hospital's Q/PI program did not include an evaluation of diagnoses or treatments provided by the physicians or allied health practitioners (AHP) in the hospital.

In a meeting with the Administrative (Admin) Staff A at 10:40 am on 3/21/13, she stated that the MEC did do some review of clinical cases when they met in closed session for "peer review", however, those discussions were not recorded in any minutes. In the past several years, a couple of cases were sent to physicians outside of the hospital for an external review. In 6/2012, the MEC had concluded an internal review of one practitioner that resulted in that individual resigning from the medical staff, and the MEC made a report to the National Practitioners Data Bank. However, for the average medical staff members and other practitioners at the hospital, they had no professional proficiency data on individual practitioners or aggregate data for the practitioners as a whole, and there was no documentation that they had conducted a systematic review of the quality and appropriateness of the diagnoses and treatments furnished by the practitioners providing care in the hospital.

On 3/19/13 and 3/20/13, during review of 9 credential files (Medical Staff Members 4, 5, 6, 7, 8, and 9; Licensed Clinical Social Worker (LCSW); and Physician Assistant (PA) 1), it was noted that none of the files contained any proctor reports, any data concerning a review or evaluation of the number of patient encounters or procedures done in the hospital or at other facilities where they provided health care services.

During an interview at 2 pm on 3/20/13, the Medical Staff Coordinator (MSC), verified that the practitioners' credential files do not contain any information about the number of health care procedures or patient encounters, for any period of time, for any of the medical staff members or AHP members at this hospital or at other facilities. The MSC further acknowledged that she had never seen an indication that the medical staff had no apparent means of recording or tracking any performance data. She had never seen any reports of professional proficiency data on staff members to document that such information had been considered, prior to their appointment or reappointment or granting of privileges.

At 2 pm on 3/21/13, in an interview with the Chief Executive Officer (CEO) and a member of the Board of Directors (BOD 1), it was acknowledged that the hospital had no documentation of any evaluation of quality, safety or practitioners' performance. Any considerations by the BOD or the MEC, related these quality indicators had been conducted in closed session, and there were no minutes or other documentation of the matters discussed or the action taken. The BOD, CEO, and MEC had not maintained evidence to show that a system-wide evaluation of the quality and appropriateness of the diagnoses and treatments furnished at the hospital had been conducted; nor had they maintained evidence that the overall quality and safety in the hospital had been evaluated. They had no information to show these evaluations had been done within the hospital or by an outside entity, such as a quality improvement organization (QIO) or hospital.