HospitalInspections.org

Based on interview and record review, the Governing Body did not ensure:
1. The Medical Staff requirements were met (See A-044).
2. The Medical Staff Bylaws were enforced (See A-048).
3. Contracted services were evaluated for quality and safety (See A-084).
The cumulative effect of these systemic deficiencies increased the risk of substandard health care for all facility patients.

Based on interview and document review, the facility did not ensure that the Medical Staff operated under the facility Medical Staff Bylaws when they did not ensure physician credential files included:

1. Documented evidence of current competency for privileges granted at time of reappointment (See A-340, A-353).
2. Documented Department Chairman summary letter of physician proctoring performance for one of three physician files reviewed (See A-340).
3. Primary source verification (evidence of attendance from the school or hospital training program) of physician residence training (post Medical school) (See A-341).
4. Documentation of competence or experience (activity list) for privileges granted at time of initial appointment to the Medical Staff for two of three physician files reviewed (See A-341).
5. Documented evidence of completion of Continuing Medical Education (CME) requirements (See A-353).
6. Documented evidence of a current California Medical license (See A-353).

The cumulative effect of these systemic deficiencies increased the risk of a poor health outcome for all facility patients.

Based on interview and document review, the Governing Body did not ensure the Medical Staff Condition of Participation was met when the facility did not ensure that the Medical Staff credential files (education and training information) included:
1. Documented evidence of current competency (ability) for privileges granted at time of reappointment to the Medical Staff for two of three (Medical Doctor [MD] 1, MD 2) physician files.
2. A Department Chairman summary letter of physician proctoring performance for one of three physician files (MD 1).
3. Primary source verification (evidence of attendance from the school or hospital training program) of physician residency training (post Medical school) for two of three physician files (MD 2 , MD 3).
4. Documentation of competence or experience (activity list) for privileges granted at time of initial appointment to the Medical Staff for two of three physician files (MD 1, MD 3).
5. Documented evidence of completion of required Continuing Medical Education (CME) for one of three physician files (MD 1).
6. Documented evidence of a current California Medical License for one of three physician files (MD 3).
These failures resulted in increased risk of substandard health care for all facility patients.

Findings:

1a. A review of the credential file for MD 1, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documented evidence of current competency. The CEO was asked, "Is there any evidence that MD 1 has performed a patient intubation (placement of a breathing tube) in the last year? That is a privilege he was granted at reappointment." The CEO stated, "It (credential file) doesn't show any intubations." The CEO was asked, "Is there any information regarding MD 1's competence in intubation? MD 1's technical skill?" The CEO answered,"No."

1b. A review of the credential file for MD 2, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 2 and was unable to find documentation of current competence or experience for the privileges granted at time of reappointment.

The facility Medical Staff Bylaws, revised March, 2014, indicated "...Article I. Name and Purposes ...1.3-2. The Medical Staff's responsibilities are ...b.3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ...5.3-2. Bases for Privileges Determination. Requests for privileges shall be evaluated on the basis ...performance of a sufficient number of procedures each year to develop and maintain the applicant's skills and knowledge ..."

2. During a review of the credential file for MD 1, the document titled "(Facility name) proctoring form (physician observation and evaluation of competence of another physician performing patient care): Non-procedure review," dated September 11, 2014, indicated, "Discharge Diagnosis: Chest Pain. Under "Evaluation of Patient Care" indicated a list of parameters to be scored. Next to each parameter, there were four possible physician performance scores. The performance score options included: "Acceptable," "Un-acceptable," "Room for Improvement," and "N/A (Non-Applicable)." The proctoring form for MD 1 indicated the parameter "Diagnostic Judgment" was scored "Room for Improvement." The parameter "Clinical Management" was scored "Room for Improvement." The parameter "Documentation supports action taken" was scored "Room for Improvement." The parameter "Use of Consultants" was scored "Room for Improvement." The parameter "Appropriate Discharge Plan and Follow-up Instructions" was scored "Room for Improvement." The proctoring form was signed by MD 2. The second proctoring form, dated September 11, 2014, indicated "Discharge Diagnosis: Chest wall pain." The form for MD 1 indicated the parameter "Diagnostic Judgment" was scored "Room for Improvement." The parameter "Clinical Management" was scored "Room for Improvement." The parameter "Use of Medications" was scored "Room for Improvement." The parameter "Documentation supports actions taken" was scored "Room for Improvement." The parameter "Use of Consultants" was scored "Room for Improvement." The parameter "Appropriate Discharge Plan and Follow-up Instructions" was scored "Room for Improvement." The proctoring form was signed by MD 2.

During a telephone interview with MD 2 on July 20, 2016, at 5:30 p.m., MD 2 confirmed the absence of a summary report of the proctoring of MD 1.

The facility Medical Staff Bylaws, revised March 2014, indicated, "Article VII. Performance Evaluation and Monitoring ...d. Completion of Proctoring. The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with: 1. A report signed by the Chair of the Department to which the member is assigned describing the types and number of cases observed and the evaluation of the member's performance, a statement that the member appears to meet all of the qualifications for unsupervised practice in the hospital ..."

3a. A review of the credential file for MD 2 (Chief of Staff), indicated no documented evidence of independent primary source verification (evidence of attendance from the school or hospital training program) of MD 2's residency training (post Medical school). During a review of the document titled "AMA Physician Profile," dated July 20, 2016, at 11:13 a.m., indicated the following regarding MD 2's training: a. University of California (San Francisco) School of Medicine-General Surgery. Training from July 1989 to June 1990. "Not yet Verified."

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 2 and was unable to find documentation of primary source verification of MD 2's residency training. The MSC also confirmed the two training entries on the "AMA Physician Profile," indicated that they were "Not yet Verified." The MSC stated, "I was surprised they didn't have on-line verification of residency. The MSC stated, "I thought I had verified it."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 2's credential file and was unable to find primary source verification of MD 2's residency training.

3b. A review of the physician credential file for MD 3, indicated no documented evidence of independent primary source verification of MD 3's residency training.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find evidence of primary source verification of MD 3's residency training.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "...Article I. Name and Purposes ...1.3-2. The Medical Staff's responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ...2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

4a. A review of the credential file for MD 1, indicated no documented evidence of competence or experience for the privileges granted to MD 1 at the time of initial appointment to the Medical Staff.

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of competence for privileges granted to MD 1 at the time of initial appointment. The MSC stated, "MD 2 (Chief of Staff) does phone interviews with peer references, hospital affiliations, the CV (resume) and the file."

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 1's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 1. The CEO replied, "No" when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 1 was granted at initial appointment.

4b. A review of the credential file for MD 3, indicated no documented evidence of competence or experience for the specific privileges granted to MD 3 at the time of initial appointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 3. The CEO replied, "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 3 was granted at initial appointment to the Medical Staff.

The facility Medical Staff Bylaws, revised March, 2014, indicated ...2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ... "

5. A review of the credential file for MD 1, indicated there was no documented evidence of completion of required Continuing Medical Education (CME).

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of completion of his CME requirements. The MSC stated, "CME is still in process. It should be in the file."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documentation of CME and stated, "It does not appear to be here "

The facility Medical Staff Bylaws, revised March, 2014, indicated "...1.3-2. The Medical Staff's responsibilities are ...b 4. A continuing education program based at least in part on needs demonstrated through the medical care evaluation program ...2. 3. Basic Responsibilities of staff membership ...each Medical Staff member ...shall continuously meet all of the following responsibilities ...k. Complete continuing medical education that meets all licensing requirements and is appropriate to the practitioner ' s specialty ..."

6. A review of MD 3's credential file indicated no documented evidence of a current California Medical license. A review of the document titled "Department of Consumer Affairs Breeze," dated September 22, 2015, at 1:31 a.m., indicated that MD 3's medical license expired May 31, 2016.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 3 and was unable to find documentation of a current California Medical license.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "2.2 Qualifications for membership ...Medical staff membership (except honorary Medical Staff) shall be limited to practitioners who are current licensed or qualified to practice Medicine, Podiatry, Clinical Psychology or Dentistry in California ..."

Based on interview and document review, the Governing Body did not ensure the Medical Staff complied with the facility Medical Staff Bylaws when the facility did not ensure:

1. Primary source verification (evidence of attendance from the school or hospital training program) of physician residence training (post Medical school) for two of three physician files (Medical Doctor [MD] 2, MD 3).
2. Documentation of competence or experience (activity list) for privileges granted at time of initial appointment to the Medical Staff for two of three physician files (MD 1, MD3).
3. Documented evidence of current competency (ability) for privileges granted at time of reappointment to the Medical Staff for two of three physician files (MD 1, MD 2).
4. MD 3 had documentation of a current California Medical license in the credential file.
5. MD 1 had completed Continuing Medical Education (CME) requirements.

This practice increased the risk of substandard health care for all facility patients.

Findings:

1a. During a review of the credential file for MD 2 (Chief of Staff) indicated no documented evidence of independent primary source verification (evidence of attendance from the school or hospital training program) of MD 2's residency training (post Medical school). A review of the document titled "AMA (American Medical Association) Physician Profile," dated July 20, 2016, at 11:13 a.m., indicated the following regarding MD 2's training: a. University of California (San Francisco) School of Medicine-General Surgery. Training from July 1989 to June 1990. "Not yet Verified."

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 2 and was unable to find documentation of primary source verification of MD 2's residence training. The MSC also confirmed the two training entries on the "AMA Physician Profile," indicated that they were "Not yet Verified." The MSC stated, "I thought I had verified it."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 2 and was unable to find documentation of primary source verification of MD 2's residency training.

1b. A review of the physician credential file for MD 3, indicated no documented evidence of independent primary source verification of MD 3's residency training.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 3 and was unable to find documentation of primary source verification of MD 2's residency training.

The facility Medical Staff Bylaws, revised March, 2014, indicated "...Article I. Name and Purposes ...1. 3-2. The Medical Staff ' s responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ... 2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

2a. A review of the credential file for MD 1, indicated no documented evidence of competence or experience for privileges granted to MD 1 at the time of initial appointment to the Medical Staff.

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of competence or experience for privileges granted to MD 1 at the time of initial appointment. The MSC stated, "MD 2 (Chief of Staff) does phone interviews with peer references, hospital affiliations, the CV (resume) and the file."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 1. The CEO replied, "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 1 was granted at initial appointment.

2b. A review of the credential file for MD 3, indicated no documented evidence of competence or experience for specific privileges (past activity list) granted to MD 3 at the time of initial appointment to the Medical Staff.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 3 and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 3. The CEO replied, "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 3 was granted at initial appointment.

The facility Medical Staff Bylaws, revised March, 2014, indicated "... 2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

3a. A review of the credential file for MD 1, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documented evidence of current competency. The CEO was asked, "Is there any evidence that MD 1 has performed a patient intubation (placement of a breathing tube) in the last year? That is a privilege he was granted at reappointment." The CEO stated, "It (credential file) doesn't show any intubations." The CEO was asked, "Is there any information regarding MD 1's competence in intubation? MD 1's technical skill? " The CEO stated, "No."

3b. A review of the credential file for MD 2, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 2 and was unable to find documentation of current competence or experience for the privileges granted at time of reappointment.

The facility Medical Staff Bylaws, revised March, 2014, indicated "...Article I. Name and Purposes ...1. 3-2. The Medical Staff's responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ...5. 3-2. Bases for Privileges Determination. Requests for privileges shall be evaluated on the basis ...performance of a sufficient number of procedures each year to develop and maintain the applicant's skills and knowledge ..."

4. A review of MD 3's credential file indicated no documented evidence of a current California Medical license. A review of the document titled, "Department of Consumer Affairs Breeze," dated September 22, 2015, indicated that MD 3's Medical license expired May 31, 2016.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 3 and was unable to find documentation of a current California Medical license.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "2.2 Qualifications for membership ...Medical staff membership (except honorary Medical Staff) shall be limited to practitioners who are current licensed or qualified to practice Medicine, Podiatry, Clinical Psychology or Dentistry in California ..."

5. A review of the credential file for MD 1, indicated there was no documented evidence of completion of required Continuing Medical Education (CME).

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of completion of his CME requirements. The MSC stated, "CME is still in process. It should be in the file."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documentation of CME and stated, "It does not appear to be here."

The facility Medical Staff Bylaws, revised March, 2014, indicated "...1.3-2. The Medical Staff's responsibilities are ... b4. A continuing education program based at least in part on needs demonstrated through the medical care evaluation program ... 2. 3. Basic Responsibilities of staff membership ... each Medical Staff member ... shall continuously meet all of the following responsibilities ... k. Complete continuing medical education that meets all licensing requirements and is appropriate to the practitioner's specialty ..."

Based on interview and document review, the Governing Body did not ensure facility contracted services were evaluated for quality of service and patient safety. This failure increased the risk of a poor health and safety outcome for all facility patients.

Findings:

A review of the facility Governing Body Meeting Minutes for July 29, 2015 through June 27, 2016, indicated no documented evidence of Governing Body evaluation of the quality and safety of contracted services.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 11:30 a.m., the CEO stated, "We don't evaluate contracted services, not for two years. If we have an issue, I discuss it with them." The CEO further stated, "If the manager finds a problem ...the manager will discuss it with the vendor (supplier)." The CEO answered, "No," when asked if the Governing Body hears about those problems. The CEO stated she doesn't hear about the problems either. If the manager can't resolve the issue, then they come to her."

The facility Bylaws of (name of facility), (a California Local Health Care District), dated April 28, 2010, indicated, " ...Article II. Organization, Powers and Purposes ...2. 2. 21. To contract with Physicians and Surgeons, Podiatrists, health care provider groups and nonprofit corporations for the rendering of professional health services on such basis as does not result in any profit or gain to the District from the services so rendered and as allows the Board to ensure that fees and charges, if any, are reasonable, fair and consistent with the basic commitment of the District to provide adequate health care to all residents within it's boundaries."

Based on interview and document review, the hospital failed to implement effective error-prevention strategies, other than staff counseling and education, to reduce and prevent recurrence of medication errors. As a result, the ongoing program did not show an improvement in the reduction or prevention of medication errors.

Findings:

During an interview on 7/20/16 at 2:15 p.m., the Chief Executive Officer (CEO) stated the hospital's Medication Error Reduction Plan (MERP) Committee, comprised of various disciplines including the CEO, was the body responsible for the medication error reduction and prevention in the hospital. She said the pharmacist-in-charge (Pharmacist 1), who was not available for interview, was responsible for collecting and presenting the medication errors at the monthly MERP Committee meetings. The Committee would review, analyze, and recommend corrective actions aimed at eliminating and preventing further medication errors.

On 7/20/16, the MERP Committee meeting minutes from January 2015 to June 2016 were reviewed. The minutes reflected the number of errors varied from month to month. However, certain type of errors, such as "medication not wasted," "med not started within allowed time," "meds taken out without orders" were recurring month after month.
The monthly meeting minutes reflected the corrective action for preventing and reducing the medication errors was staff education or counseling. For each of the errors reported, the corresponding action was: "It will be verified that the nurse understands the six rights of medication administration." For example, in June 2015, there were 15 reported medication errors; six of 15 were related to dose omission; four were categorized as wrong medication; and two were related to "meds not started within allowed time." The documented actions for the 15 errors were that the Director of Patient Services "has discussed the mentioned errors with appropriate nurses," and "it will be verified that the nurses understand the six rights of medication administration." No other error-prevention strategies, or system changes, were documented in the minutes.

On 7/20/16 at 3 p.m., the CEO acknowledged the MERP Committee's corrective action for medication errors reflected in the meeting minutes was mostly staff education/counseling despite the recurrence of the same type of errors month after month. This meant that staff counseling/education was ineffective in preventing the recurrence of medication errors. She said Pharmacist 1 may have other error-prevention strategies reported in the 2015 MERP. At 3:55 p.m., the CEO said she could not locate any MERP other than one from 2014. The CEO was asked to have Pharmacist 1 forward to the surveyor any medication error-prevention strategies from 2015 and 2016. As of 7/27/16, no additional information was received.

In the August 2013 article entitled "Leveraging Error Reduction Strategies" from the American Pharmacists Association, indicated staff "education and information are important when combined with other strategies that strengthen the medication-use system. Because they rely on memory, education and information do not significantly reduce errors on their own."

Based on interview and document review, the Governing Body did not ensure the contracted services were evaluated for quality and safety of services provided to the facility patients. This practice increased the risk of a poor health and safety outcome for all facility patients.

Findings:

A review of the facility Governing Body Meeting Minutes for July 29, 2015 through June 27, 2016, indicated no documented evidence of Governing Body evaluation of the quality and safety of contracted services.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 9:25 a.m., the CEO stated, "We don't have any evaluations (for contracted services) in the past one to two years."

During a Quality Assurance and Performance Improvement group interview on July 20, 2016, at 11:30 a.m., the CEO stated, "We don't evaluate contracted services, not for two years. If we have an issue, I discuss it with them." The CEO further stated, "If the manager finds a problem, the manager will discuss it with the vendor (supplier). The CEO answered "No," when asked if the Governing Body hears about those problems. The CEO stated she doesn't hear about the problems either. If the manager can't resolve the issue, then they come to her.

The facility Bylaws of (name of facility), (a California Local Health Care District), dated April 28, 2010, indicated, "...Article II. Organization, Powers and Purposes ...2.2.21. To contract with Physicians and Surgeons, Podiatrists, health care provider groups and nonprofit corporations for the rendering of professional health services on such basis as does not result in any profit or gain to the District from the services so rendered and as allows the Board to ensure that fees and charges, if any, are reasonable, fair and consistent with the basic commitment of the District to provide adequate health care to all residents within it's boundaries."

Based on interview and credential file review, the facility did not ensure Medical Staff credential files contained documented evidence of:

1. Current competence or experience (recent activity list), at time of reappointment, for two of three physician files reviewed (Medical Doctor [MD] and MD 2/Chief of Staff ).

2. A Department Chairman summary letter of physician proctoring performance for one of three physician files reviewed (MD 1).

This practice increased the risk of substandard health care for all facility patients.

Findings:

1a. A review of the credential file for MD 1, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documented evidence of current competency. The CEO was asked, "Is there any evidence that MD 1 has performed a patient intubation (placement of a breathing tube) in the last year? That is a privilege he was granted at reappointment." The CEO stated, "It (credential file) doesn't show any intubations." The CEO was asked, "Is there any information regarding MD 1's competence in intubation? MD 1's technical skill?" The CEO stated, "No."

1b. A review of the credential file for MD 2, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 2 and was unable to find documentation of current competence or experience for the privileges granted at time of reappointment.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "...Article I. Name and Purposes ...1.3-2. The Medical Staff's responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ... 5 .3-2. Bases for Privileges Determination. Requests for privileges shall be evaluated on the basis ...performance of a sufficient number of procedures each year to develop and maintain the applicant's skills and knowledge .."

2. A review of the credential file for MD 1, the document titled, "(Facility name) proctoring form (physician observation and evaluation of competence of another physician performing patient care): Non-procedure review," dated September 11, 2014, indicated, "Discharge Diagnosis: Chest Pain." Under "Evaluation of Patient Care" indicated a list of parameters to be scored. Next to each parameter, there were four possible physician performance scores. The performance score options included: "Acceptable," "Un-acceptable," "Room for Improvement," and "N/A (Non-Applicable)". The proctoring form for MD 1 indicated the parameter "Diagnostic Judgment" was scored "Room for Improvement." The parameter "Clinical Management" was score "Room for Improvement." The parameter "Documentation supports action take" was scored "Room for Improvement." The parameter "Use of Consultants" was scored "Room for Improvement." The parameter "Appropriate Discharge Plan and Follow-up Instructions" was scored "Room for Improvement." The proctoring form was signed by MD 2. The second proctoring form, dated September 11, 2014, indicated, "Discharge Diagnosis: Chest wall pain." The form for MD 1 indicated the parameter "Diagnostic Judgment" was scored "Room for Improvement." The parameter "Clinical Management" was scored "Room for Improvement." The parameter "Use of Medications" was scored "Room for Improvement." The parameter "Documentation supports actions taken "was scored "Room for Improvement." The parameter "Use of Consultants" was scored "Room for Improvement." The parameter "Appropriate Discharge Plan and Follow-up Instructions" was scored "Room for Improvement." The proctoring form was signed by MD 2.

During a telephone interview with MD 2 on July 20, 2016, at 5:30 p.m., MD 2 confirmed the absence of a summary report letter of the proctoring of MD 1.

The facility Medical Staff Bylaws, revised March 2014, indicated. "Article VII. Performance Evaluation and Monitoring ...d. Completion of Proctoring. The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with: 1. A report signed by the Chair of the Department to which the member is assigned describing the types and number of cases observed and the evaluation of the member's performance, a statement that the member appears to meet all of the qualifications for unsupervised practice in the hospital ..."

Based on interview and credential file review, the facility did not ensure the Medical Staff credential files contained:

1. Primary source verification (evidence of attendance from the school or hospital training program) of physician residency training (post Medical school) for two of three physician files ( Medical Doctor [MD] 2, MD 3)

2. Documentation of competence or experience (activity list) for privileges granted at time of initial appointment to the Medical Staff for two of three physician files (MD 1 and MD 2).

This practice increased the risk of substandard health care for all facility patients.

Findings:

1a. A review of the credential file for MD 2 (Chief of Staff), indicated no documented evidence of independent primary source verification (evidence of attendance from the school or hospital training program) of MD 2's residency training (post Medical school). During a review of the document titled. "AMA Physician Profile," dated July 20, 2016, at 11:13 a.m., indicated the following regarding MD 2's training: a. University of California (San Francisco) School of Medicine-General Surgery. Training from July 1989 to June 1990. "Not yet Verified."

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 2 and was unable to find documentation of primary source verification of MD 2's residency training. The MSC also confirmed the two training entries on the "AMA Physician Profile," indicated that they were "Not yet Verified." The MSC stated, "I was surprised they didn't have on-line verification of residency. The MSC stated, "I thought I had verified it."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 2's credential file and was unable to find primary source verification of MD 2's residency training.

1b. A review of the physician credential file for MD 3, indicated no documented evidence of independent primary source verification of MD 3's residency training.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find evidence of primary source verification of MD 3's residency training.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "...Article I. Name and Purposes ... 1. 3-2. The Medical Staff's responsibilities are ... b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ... 2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

2a. A review of the credential file for MD 1, indicated no documented evidence of competence or experience for the privileges granted to MD 1 at the time of initial appointment to the Medical Staff.

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of competence for privileges granted to MD 1 at the time of initial appointment. The MSC stated, "MD 2 (Chief of Staff) does phone interviews with peer references, hospital affiliations, the CV (resume) and the file."

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 1's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 1. The CEO replied "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 1 was granted at initial appointment.

2b. A review of the credential file for MD 3, indicated no documented evidence of competence or experience for the specific privileges granted to MD 3 at the time of initial appointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 3. The CEO replied "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 3 was granted at initial appointment to the Medical Staff.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "... 2. 2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

Based on interview and credential file review, the facility did not ensure that the Medical Staff Bylaws were enforced when there was no documented evidence in the physician credential files that:

1. Documented evidence of completion of required Continuing Medical Education (CME) for one of three physician files (Medical Doctor [MD] 1).
2. Documented evidence of a current California Medical License for one of three physician files (MD 3).
3. Primary source verification (evidence of attendance from the school or hospital training program) of physician residency training (post Medical school) for two of three physician files (MD 2, MD 3).
4. Documentation of competence or experience (activity list) for privileges granted at time of initial appointment to the Medical Staff for two of three physician files (MD 1, MD 2).
5. Current competence or experience (recent activity list), at the time of reappointment, for two of three physician files reviewed (MD 1, MD 2).
This practice increased the risk of substandard health care for all facility patients.

Findings:

1. A review of the credential file for MD 1, indicated there was no documented evidence of completion of required Continuing Medical Education (CME).

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of completion of his CME requirements. The MSC stated, "CME is still in process. It should be in the file."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 1 and was unable to find documentation of CME and stated, "It does not appear to be here."

The facility Medical Staff Bylaws, revised March, 2014, indicated, "...1.3-2. The Medical Staff ' s responsibilities are ...b 4. A continuing education program based at least in part on needs demonstrated through the medical care evaluation program ... 2. 3. Basic Responsibilities of staff membership ...each Medical Staff member ...shall continuously meet all of the following responsibilities ...k. Complete continuing medical education that meets all licensing requirements and is appropriate to the practitioner ' s specialty ..."

2. A review of MD 3's credential file indicated no documented evidence of a current California Medical license. A review of the document titled, "Department of Consumer Affairs Breeze," dated September 22, 2015, at 1:31 a.m., indicated that MD 3's Medical license expired May 31, 2016.

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 3 and was unable to find documentation of a current California Medical license.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "2.2 Qualifications for membership ...Medical staff membership (except honorary Medical Staff) shall be limited to practitioners who are current licensed or qualified to practice Medicine, Podiatry, Clinical Psychology or Dentistry in California ..."

3a. A review of the credential file for MD 2 (Chief of Staff), indicated no documented evidence of independent primary source verification (evidence of attendance from the school or hospital training program) of MD 2's residency training (post Medical school). During a review of the document titled, "AMA Physician Profile," dated July 20, 2016, at 11:13 a.m., indicated the following regarding MD 2's training: a. University of California (San Francisco) School of Medicine-General Surgery. Training from July 1989 to June 1990. "Not yet Verified."

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 2 and was unable to find documentation of primary source verification of MD 2's residency training. The MSC also confirmed the two training entries on the "AMA Physician Profile," indicated that they were "Not yet Verified." The MSC stated, "I was surprised they didn't have on-line verification of residency. The MSC stated,"I thought I had verified it."

During an interview with the Chief Executive Officer (CEO) on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 2's credential file and was unable to find primary source verification of MD 2's residency training.

3b. A review of the physician credential file for MD 3, indicated no documented evidence of independent primary source verification of MD 3's residency training.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find evidence of primary source verification of MD 3's residency training.

The facility Medical Staff Bylaws, revised March, 2014, indicated, "...Article I. Name and Purposes ... 1. 3-2. The Medical Staff's responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ...2.2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ..."

4a. A review of the credential file for MD 1, indicated no documented evidence of competence or experience for the privileges granted to MD 1 at the time of initial appointment to the Medical Staff.

During a telephone interview with the Medical Staff Coordinator (MSC) on July 19, 2016, at 10:20 a.m., she electronically reviewed the credential file for MD 1 and was unable to find documentation of competence for privileges granted to MD 1 at the time of initial appointment. The MSC stated, "MD 2 (Chief of Staff) does phone interviews with peer references, hospital affiliations, the CV (resume) and the file."

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 1's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 1. The CEO replied, "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 1 was granted at initial appointment.

4b. A review of the credential file for MD 3, indicated no documented evidence of competence or experience for the specific privileges granted to MD 3 at the time of initial appointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., the CEO reviewed MD 3's credential file and was unable to find documented evidence of competence or experience in the specific privileges (past activity list) granted to MD 3. The CEO replied, "No," when asked if the file contained documentation of intubation skills (placing a breathing tube), a privilege that MD 3 was granted at initial appointment to the Medical Staff.

The facility Medical Staff Bylaws, revised March, 2014, indicated,"...2.2-2. Additional Qualifications for membership. In addition to meeting the basic standards, the Practitioner must: a. Document his or her: 1. Adequate experience, education and training in the requested clinical privileges. 2. Current professional competence (ability) ... "

5a. A review of the credential file for MD 1, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the Chief Executive Officer (CDO) on July 20, 2016, at 8:20 AM, she reviewed the credential file for MD 1 and was unable to find documented evidence of current competency. The CEO was asked, "Is there any evidence that MD 1 has performed a patient intubation (placement of a breathing tube) in the last year? That is a privilege he was granted at reappointment." The CEO stated, "It (credential file) doesn't show any intubations." The CEO was asked, "Is there any information regarding MD 1's competence in intubation? MD 1's technical skill?" The CEO answered, "No."

5b. During a review of the credential file for MD 2, indicated there was no documented evidence of current competence or experience for the privileges granted at time of reappointment to the Medical Staff.

During an interview with the CEO on July 20, 2016, at 8:20 a.m., she reviewed the credential file for MD 2 and was unable to find documentation of current competence or experience for the privileges granted at time of reappointment.

The facility Medical Staff Bylaws, revised March, 2014, indicated "...Article I. Name and Purposes ...1.3-2. The Medical Staff's responsibilities are ...b. 3. A Credentials program, including mechanisms of appointment, reappointment and the matching of clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or member ...5 .3-2. Bases for Privileges Determination. Requests for privileges shall be evaluated on the basis ...performance of a sufficient number of procedures each year to develop and maintain the applicant's skills and knowledge ..."

Based on observation, interview, and record review, the facility failed to ensure medications were prepared and administered in accordance with approved policies and procedures and accepted standards of practice when:

1. Staff did not follow approved policies and procedures for pain score and pain assessment for two of four sampled patients (Patients 34 and 35) who were administered intravenous (IV - to be administered into a patient's vein) narcotics. This failure had the potential for patients to experience inadequate pain relief from administered medications.

2. The facility failed to implement accepted standards of practice for the preparation of intravenous medications. Two of two Registered Nurses (RNs) stated they compound "Banana Bags (for patients experiencing alcohol intoxication; an IV solution containing multivitamins, folic acid, and thiamine [vitamin B1]. )" in the ER. This failure had the potential to increase the risk of infection to patients administered IV medications not prepared in accordance with accepted standards of practice for sterile compounding.

Findings:

1a. Clinical Record Review for Patient 34 was initiated on 7/20/16. Patient 34 visited the Emergency Room (ER) on 7/14/16. The reason for the ER visit was listed as epigastric (the area of the body between the ribs and upper abdomen) pain. Review of the prescriber's orders indicated a medication order for IV morphine sulfate (Morphine sulfate is a narcotic pain medication used to treat moderate to severe pain.) 4 milligram (mg) at 5:32 a.m. on 7/14/16. The clinical record indicated the IV morphine sulfate was administered to Patient 34 at 5:39 a.m. on 7/14/16. No pain score or pain assessment documentation following the pain medication adminstration on 7/14/16 at 5:39 a.m. was located in Patient 34's clinical record.

During a concurrent interview on 7/2016 at 8:56 a.m., the Health Information Management Manager (HIM Manager) acknowledged she was unable to locate a pain assessment or a pain score in Patient 34's clinical record following the pain medication administered at 5:39 a.m. on 7/14/16.

On 7/20/16 at 9:39 a.m., during an interview, Registered Nurse (RN) 3 stated she could not locate a pain assessment or a pain score in the Patient 34's clinical record after the IV morphine was administered at 5:39 a.m. on 7/14/16. She stated that nursing conducts pain assessment within 1 hour of pain administration or sooner. She stated pain assessments should be documented in the patient's clinical record.

The facility policy and procedure titled, "Pain Assessment - Emergency Department" dated 7/14, indicated "The patient will undergo reassessment of pain at least once per shift and after every pain control mechanism employed by patient care providers. Pain control mechanisms include, but are not limited to: ...Use of pain medications as ordered by MD (physician) ...Any patient care provider, from any department, that has implemented a pain control mechanism will reassess the patient within one-half (1/2) hour to determine amount of pain control or relief achieved."

The facility policy and procedure titled, "Medication Administration Standards" dated 1/13, indicated "All nursing practice will include vital signs, including... Pain Scale... immediately before administering intravenous narcotics and 15 minutes following the administration of intravenous narcotics."

1b. Clinical Record Review for Patient 35 was initiated on 7/20/16. Patient 35 visited the ER on 7/11/16. The reason for the ER visit was listed as right flank (upper abdomen or back area of the body) pain. Review of the prescriber's orders indicated a medication order for IV morphine sulfate 4 milligram (mg) at 3:16 p.m. on 7/11/16. The clinical record indicated the IV morphine sulfate was administered to Patient 35 at 3:33 p.m. on 7/11/16. Patient 35's clincial record indicated the next pain score was documented at 5:25 p.m. on 7/11/16 which was approximately two hours after the IV morphine was administered.

During a concurrent interview on 7/20/16 at 9:06 a.m., the Health Information Management Manager (HIM Manager) acknowleged the pain score was documented approximately two hours after the IV morphine was administered at 3:33 p.m. on 7/11/16. She stated the next pain assessment for Patient 35 was conducted on 7/11/16 at 5:25 p.m. with a pain score of 8/10.

On 7/20/16 at 9:55 a.m., during an interview, RN 3 stated the IV morphine sulfate was administered to Patient 35 at 3:33 p.m. on 7/11/16. She acknowledged the next pain score was documented on 7/11/16 at 5:25 p.m. which was approximately two hours after the IV morphine was administered to Patient 35.

The facility policy and procedure titled, "Pain Assessment - Emergency Department" dated 7/14, indicated "The patient will undergo reassessment of pain at least once per shift and after every pain control mechanism employed by patient care providers. Pain control mechanisms include, but are not limited to: ...Use of pain medications as ordered by MD (physician) ...Any patient care provider, from any department, that has implemented a pain control mechanism will reassess the patient within one-half (1/2) hour to determine amount of pain control or relief achieved."

The facility policy and procedure titled, "Medication Administration Standards" dated 1/13, indicated "All nursing practice will include vital signs, including ... Pain Scale... immediately before administering intravenous narcotics and 15 minutes following the administration of intravenous narcotics."

2. On 7/18/16 at 10:55 a.m., during an observation, a Compounding Aseptic Isolator (CAI) was located in the Pharmacy Department. A CAI is a work area designed for sterile (germ-free) compounding (mixing) of medications that will be administered to be the patient intravenously. During a concurrent interview, Pharmacist 2 stated the IV work area was not currently being used. She stated they used to use the IV work area in the past but not anymore.

On 7/18/16 at 2:55 p.m., during an observation in the Emergency Room (ER), the refrigerator in the ER Medication Room was inspected accompanied by the Registered Nurse (RN) 2 and Pharmacy Technician The refrigerator was opened to show the contents inside. The ER refrigerator contained an opened 10 milliliters (mLs) vial of the folic acid injection labeled with a drug strength of 5 milligrams (mg) per milliliter (mL). During a concurrent interview, RN 2 acknowledged the presence of the vial of folic acid injection in the ER Medication Room refrigerator during inspection. RN 2 stated the folic acid was used to make "Banana Bags". She stated injectable multivitamins, injectable thiamine, and injectable folic acid are all added to IV fluids to make a "Banana Bag".

On 7/18/16 at 8:44 a.m., during an interview, RN 3 stated "Banana Bags" do not come from the Pharmacy Department, so the nursing staff would prepare them and administer them for alcoholic patients. She stated that thiamine 100 mg, folic acid 1 mg, and multivitamin 10 mLs were added to 1000 mLs of IV fluids. RN 3 stated she was told there was no sterile compounding done in the Pharmacy Department.

A review of the California State Board of Pharmacy online website, accessed 7/15/16, did not show that the facility had an approved license for "Sterile Compounding".

On 7/19/16 at 4:33 p.m., during an interview, Pharmacist 1 acknowledged there was no sterile compounding of IV medications currently done in the facility's Pharmacy Department.

On 7/20/16 at 9:57 a.m., during an interview, RN 3 stated nursing staff would prepare approximately five to six "Banana Bags" per week.

A review of the United States Pharmacopeia (USP) Chapter <797>, titled "Pharmaceutical Compounding - Sterile Preparations" revised 2012, indicated on page 7, "IMMEDIATE-USE CSPs - The immediate use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include ...emergency room treatment ...where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy. Preparations that are medium-risk level and high-risk level shall not be prepared as immediate-use CSPs. Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: 1) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers' original containers and not more than two entries into one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device... Compounding in worse than ISO Class 5 (see Table 1) conditions increase the likelihood of microbial contamination, and administration durations of microbially contaminated CSPs exceeding a few hours increase the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients."

USP <797> is an accepted standard of practice for sterile compounding which apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared.

A review of the American Society of Health Systems Pharmacists (ASHP) Guidelines titled, "Minimum Standards for Pharmacies in Hospitals" dated 2013, indicated on page 7, "Sterile Preparations ...All sterile medications shall be prepared and labeled in a suitable environment by appropriately trained personnel in accordance with established quality-assurance and expiration dating procedures (14,19). The use of sterile medications compounded outside the pharmacy should be avoided to the extent possible; when they are used, there shall be procedures for aseptic preparation, quality assurance, expiration dating, and ongoing competency evaluations for compounding personnel (14, 19, and 37). Sterile compounding outside the pharmacy or satellite pharmacies (e.g., on nursing units) should be minimized and occur only in emergency situations (14, 19)."

The facility policy and procedures titled, "Admixing by Registered Nurse", dated 8/14, indicated, "Purpose & Scope: To be compliant with regulatory standards and establish guidelines for Registered Nurses admixing medications in patient care areas" and "Policy: All compounded sterile products and IV admixtures are to be prepared by Pharmacy, except after hours, emergency situations, or when not feasible due to stability of the drug. In these exception scenarios, RN is responsible for admixing intravenous medications."

Based on observation, interview, and document review, the hospital failed to store a high-risk/high alert (HR/HA) medication in accordance with the hospital policy and procedure when pancuronium (a neuromuscular blocking agent, to paralyze skeletal muscles during surgery) vials were identified without warning labels to alert the staff that the medication was a paralyzing, high-risk medication so extra precaution could be taken to avoid mix-up error (i.e. wrong selection).

HR/HA medications are those that bear a heightened risk of causing significant patient harm when they are used in error, according to the Institute of Safe Medication Practices (ISMP), a nationally recognized institution focusing on safe medication practices.

Also, the hospital failed to ensure lorazepam (a controlled substance medication - to relieve anxiety and to treat seizure disorder) injection vials, in two of two medication refrigerators, were stored in a manner to prevent theft and diversion.

Findings:

1. During a visit to the Emergency Room (ER) with Registered Nurse 2 (RN 2) and Pharmacy Technician (Pharm Tech) on 7/18/16 at 3:08 p.m., six vials of pancuronium were identified in a zip-lock bag inside the medication refrigerator. There was no warning label on each vial or outside the bag to identify the medication as a HR/HA medication and that they were a paralyzing agent. Posted in the ER's medication room was a list of the hospital's HR/HA medications, which included neuromuscular blocking agents. RN 2 stated the nursing staff would double check and take extra precaution when handling HR/HA medications. Pharm Tech verified that the pancuronium vials should have warning labels on them.

The hospital's "High Risk/High Alert Medications" policy and procedure, dated 7/2016, indicated, "All vials of neuromuscular agents will be labeled with a warning auxiliary label indicating that it is a paralyzing agent which may cause respiratory [breathing] arrest" and "HIGH ALERT stickers will be affixed to the container holding the medication and/or individual medication that are categorized high risk/high alert."

The 6/16/2016 ISMP Medication Safety Alert indicated there had been well over 100 reported cases of errors involving neuromuscular blocking agents. As safe practice recommendations, the Institute recommended to institute limiting access, segregating storage, and affixing visible warning labels on storage bins and final medication containers (e.g., vials, syringes, IV bags) that clearly communicate respiratory paralysis will occur and that the patient must be intubated (placement of flexible plastic tube into the windpipe to maintain an open airway) and ventilated when used.

2. On 7/18/16 at 3:15 p.m. in the company of RN 2 and Pharm Tech in ER's medication room, the medication refrigerator was inspected. It contained various medications and vaccines. It also included a clear lock box with a keyed lock, about the 5 inch high x 8 inch wide x 6 inch deep in size (small enough to fit in a regular-sized purse or bag). The lock box contained fifteen 1-milliliter (ml) vials of lorazepam 2 milligram (mg)/ ml (unit of concentration), and was not secured, mounted, or fastened to a permanent part of the refrigerator. RN 2 said the ER nursing staff members had access to the medication refrigerator, and they did not check the inventory (or the presence of) the lorazepam vials in the refrigerator daily during shift change. She said the staff only conducted inventory of controlled medications once a week on Wednesdays. RN 2 and Pharm Tech acknowledged the lorazepam-containing lock box could be removed from the refrigerator by any nursing staff member who had the intention of removing it, and this activity would not be detected until the weekly inventory was performed.

During a visit to the Medical/Surgical Unit on 7/19/16 at 8:50 a.m. with Pharm Tech, the medication refrigerator was identified containing the unsecured, clear lock box inside. It contained 18 lorazepam injection vials. Pharm Tech acknowledged it was not stored in a manner to prevent theft and diversion.

The hospital's "Receiving and Storage of Controlled Medications" policy and procedure, dated 7/2012, indicated the placement of controlled substance medications in the refrigerator lock box but did not address the effective manner for which to store them.

Title 21, Code of Federal Regulations Section 1301.71(a) requires that all Drug Enforcement Administration (DEA) registrants provide effective controls and procedures to guard against theft and diversion of controlled substances.

Based on observation, interview, and document review, the facility failed to ensure the Emergency Room (ER) Malignant Hyperthermia (MH - a rare but potentially fatal emergency situation triggered by certain medications) supply in one of one MH kits contained chilled intravenous (IV - to be administered through a patient's vein) saline fluids. Signs and symptoms of MH include increased heart rate, increased body temperature, increased body metabolism, and muscle rigidity. The cold IV saline is used as treatment to reduce a MH patient's body temperature. This failure had the potential to result in adverse health consequences due to lack of refrigerated IV saline solution needed to cool a patient with high body temperature.

Findings:

On 7/18/16 at 3:04 p.m., during an observation in the Emergency Room (ER) accompanied by Registered Nurse (RN) 2, the refrigerator in the ER medication room was opened to show the contents. The inside of the ER refrigerator did not contain any cooled saline solution for IV infusion.

During a concurrent interview, RN 2 acknowledged there was no chilled saline inside the ER refrigerator. She acknowledged the facility followed Malignant Hyperthermia Association of the United States (MHAUS - an organization that provides medical information on how to care for a patient experiencing MH) guidelines for Malignant Hyperthermia.

On 7/19/16 at 4:36 p.m., during an interview, Pharmacist 1 stated the facility followed MHAUS guidelines. He stated MHAUS guidelines were addressed in the hospital's policy and procedures.

The facility policy and procedure titled, "Malignant Hyperthermia" dated 8/14, indicated, "If malignant hyperthermia has occurred, followed Malignant Hyperthermia Association of the United States guidelines for aftercare ...Contents - Refrigerator (b) 100cc [cubic centimeters, a unit of measure] 0.9% NaCl [abbreviation for saline solution] IV."

Review of the MHAUS website section titled, "FAQs: Stocking an MH Cart - What Should Be On An MH Cart" accessed 7/25/16, indicated, "Drugs - 8. Refrigerated cold saline solution - A minimum of 3,000 ml (milliliters) for IV cooling."

Based on observation, interview and document review, the hospital failed to ensure effective food and nutrition service systems to prevent foodborne illness. Failure to ensure implementation of effective food handling procedures may result in unsafe food handling practices, putting all inpatients at risk for foodborne illness, further compromising their medical and nutritional status.

Findings:

On 7/18/16 during kitchen observations with Dietary Manager (DM):

1. The coffee dispenser "House Blend Coffee" concentrate container had a sticker dated 2/18/16. DM stated it was the received date. The container had a space on the label for users to mark the date it was inserted into the machine. The space was blank. The label instructions indicated, "Once pierced this product is good for 30 days refrigerated." The coffee dispenser also held a container labeled "Decaffeinated Coffee" with no dates.

During a concurrent interview, DM stated the bags should have been labeled when they were placed in the machine.

2. On a cart containing bread; one opened bag of bagels dated 6/25/16, one opened bag of white sliced bread dated 6/30/16, and one opened bag of wheat rolls dated 7/7/16. DM stated the bread was good for seven days from the marked dates and that all kitchen staff were responsible for checking dates and discarding outdated items.

3. In the walk-in refrigerator:
a. An opened bag of shredded carrots with a use by date of 7/6/16.
b. An opened bag of kale with a best by date 7/7/16. The bag contained several brown colored leaves.
c. A honeydew melon cut in half, with one half of the melon in a storage bag with no date.
d. A container of chopped garlic with an opened date 5/31/16.
e. A stainless steel pan marked "tri-tip" dated 7/4/16.

DM validated these observations and stated the items should have been labeled and used or discarded prior to their expiration dates.

Review of the hospital policy dated March 1, 2013 entitled "Food Storage" indicated, "12. h. All foods will be covered, labeled and dated. All foods will be checked to assure that foods will be consumed by their safe use by dates, or frozen (where applicable) or discarded."

On 7/18/16 at 3 p.m., during pantry observations with DM:

1. In the Emergency Room (ER) pantry, the coffee dispenser held a container labeled "Decaffeinated Coffee" with a best by date of 3/18/16. DM stated all the food in the pantry was checked daily by dietary staff except for the coffee dispenser.
2. In both the Medical-Surgical (Med-Surg) and ER pantry refrigerators, several cartons labeled "cranberry cocktail" with no date labels. DM stated the cartons were from a dated box in the main kitchen refrigerator, but agreed that once they were removed from that box, the dating information was lost.
3. In the Med-Surg pantry refrigerator, cartons labeled "apple juice" with 8/2/16 dates in the front part of the refrigerator and cartons dated 7/24/16 in the back part of the refrigerator. In addition, milk cartons dated July 28 in the front part of the refrigerator and cartons dated July 18 in the back part of the refrigerator. DM stated the items to be used first should have been located in the front section of the refrigerator.
4. In the Med-Surg pantry coffee dispenser a container labeled "House Blend" with an inserted date of 6/15/16. The container label indicated, "Product is good for 30 days once opened."

Review of the hospital policy dated March 1, 2013 entitled "Kitchenettes and Pantries" indicated, "2. Rotate stock and remove outdated items."

Based on interviews and record reviews, the hospital failed to monitor the inpatient intake of between meal nutritional supplements ordered by the physician (2 of 2 patients receiving nutritional supplements between meals, Patient 3 and Patient 18).

Monitoring nutritional interventions was critical for the Registered Dietitian (RD) to accurately assess its effectiveness on patients nutritional status. This failure had the potential to compromise the nutritional and health status of patients receiving nutritional supplements.

Findings:

1. On 7/19/16 during Patient 3's record review with RD, Patient 3's diagnoses included: pressure ulcers, poor appetite, and sepsis (a blood infection). Patient 3's Physician's Orders indicated, "8 oz. (ounces, a unit of measure) HN (High Nitrogen, a high protein and calorie liquid nutritional supplement) nectar thick TID (three times a day), between meals."

The initial (admit) Nursing Screen dated 7/4/16 indicated no nutritional concerns. However, a nutritional consult was requested. Review of the Nutritional Assessment dated 7/18/16, conducted by RD, indicated Patient 3's nutritional risk factor was "high".

Upon review of meal and liquid intake records and nursing progress notes, the amount of supplement consumed was not documented in the record.

During a subsequent interview at 3 p.m. with Registered Nurse 4 (RN 4), she stated nutritional supplement intake was recorded as part of the meal intake when provided with meals, she did not know it should be recorded separately. She wasn't sure how or where to record in-between meal supplement intake.

During a concurrent interview with Certified Nursing Assistant 2 (CNA 2), she stated the supplement was provided to Patient 3 starting on 7/18/16. She agreed the intake wasn't recorded.

2. On 7/19/16 during closed record review with RD, Patient 18 was admitted to the hospital on 1/5/16. Their diagnoses included stroke, low blood potassium, difficulty swallowing and diarrhea.

The admit nursing screening documentation indicated no nutritional concerns. However, a nutritional consult was requested regarding swallowing concerns. Review of the Nutritional Assessment dated 1/7/16, conducted by RD, indicated Patient 18's nutritional risk factor was "high".

Physician's orders dated 1/7/16 included, "Honey thick 8 oz. HN 6X/day (six times per day)."

Review of documented meal intakes indicated the between meal supplements were not recorded, nor was any documentation found in the nursing notes.

Review of the hospital policy dated July 1, 2011, entitled "Nourishments and Supplements" indicated, "Nursing staff reports intake problems to the nursing supervisor and documents percent intake of nourishment/supplement on the appropriate form." Upon request, a copy of the form indicated in this policy was not provided.

Based on observation, interview and document review the hospital failed to ensure the dietary service kitchen and cafeteria were maintained in good repair when:

1. There were insufficient airgaps to prevent sewage backflow into the drinking water supply,
2. Walls near the food preparation area were in disrepair, and
3. A plumbing repair project was not reported to the local enforcement agency as required.

These failures had the potential to cause cross-contamination and foodborne illness to inpatients, compromising their health and nutritional status.

Findings:

1. a. On 7/18/16 at 11:25 a.m., during kitchen observations with Dietary Manager, the plumbing drain pipe from the ice machine was inside the floor sink drain. DM validated the observation and stated it must have fallen down, and needed to be braced.

During a subsequent observation and interview at 2:25 p.m. with Maintenance Worker (MW), he stated he was not aware the drain pipe had dropped into the floor sink drain. He stated he relied on DM to report items needing repair to the maintenance department.

1. b. On 7/19/16 at 9:30 a.m., during cafeteria observations with DM, the floor sink had two pipes and one white tube below the rim. DM stated the pipes and tubing were from the water dispenser, beverage dispenser and refrigeration unit. She stated she was not aware they were like that, but would report it to the maintenance department for repair.

According to standards of practice within the foodservice industry, "An air gap between the water supply inlet [drain pipe] and the flood level rim of the plumbing fixture [floor sink drain], equipment or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch. During periods of extraordinary demand, drinking water systems may develop negative pressure in portions of the system. If a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system." (2013 Federal Food Code section 5-202.13)

2. On 7/18/16 at 2:25 p.m., during kitchen observations with MW and DM the wall by the food preparation area had large sections broken off and damaged causing paint to flake and sheet rock exposure. Both MW and DM stated they were unaware of the damage and didn't know when it occurred. MW stated it must have just happened, since he had installed some glove dispensers directly above the damaged area approximately one month ago, and hadn't noticed the damage.

According to the Federal Food Code 2013 Section 6-501.11, "Physical facilities shall be maintained in good repair." Section 6-101.11 indicated, "...materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be: (1) Smooth, durable, and easily cleanable for areas where food establishment operations are conducted."

3. On 7/18/16 at 11:25 a.m., during kitchen observations with Dietary Manager (DM), a large section of the floor in the food preparation area was torn up with bare cement exposed. DM stated the drain had clogged and an emergency repair was done, but the project wasn't finished.

During a subsequent interview at 2:35 p.m., Maintenance Manager (MM) stated the pipe broke and they contacted the Office of Statewide Health Planning and Development (OSHPD) who authorized an emergency repair. She was not aware of the requirement to contact the local health department enforcement agency as required by the California Health and Safety Code, Division 104, Part 7, Chapter 1, Section 113715. Section 113715 indicated, "Any construction, alteration, remodeling, or operation of a food facility shall be approved by the enforcement agency..."

Based on interview and document review, the facility did not ensure it had a policy and procedure to treat drug overdose patients who presented to the Emergency Department. This practice increased the risk of substandard treatment of Emergency Department patients.

Findings:

During a review of the Emergency Department policy and procedure manual, there was no documented evidence of policy and procedure for the treatment of patients with a drug overdose.

During an interview with RN 1, on July 18, 2016, at 11:45 a.m., she stated there was no Emergency Department protocol for treatment of patients with a drug overdose.

During a phone interview with MD 2 (Chief of staff), on July 20, 2016, at 4:30 p.m., MD 2 stated the facility had protocols for "CP (Chest pain), Stroke (a clot or bleed in the brain), Sepsis (overwhelming infection that is life-threatening) and no others."

The facility "Emergency Department Services Agreement," dated November 5, 2007, indicated"...Schedule A. Emergency Department Medical Director Job Description ....Duties and Responsibilities ... The director shall work closely with the nurse manager of the Emergency Department (or person of similar position) to ensure a high standard of patient care; to ensure that proper patient care protocols are developed and maintained; ...Work performed ...11. Assisting in development of policy and procedure manuals, follow-up instruction sheets, protocols and record retrieval systems ..."