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Based on interview, observation, and record review, the hospital failed to have a Governing Body which took full legal responsibility for determining, implementing and monitoring policies and procedures to ensure the provision of health care in a safe environment when:

1. The hospital failed to have a system in place to ensure the hospital's bylaws governing Medical Staff membership, or the granting of privileges was applied equally to all practitioners. (refer to A-050)

a. Five of eleven members of the Medical Staff (Medical Doctor [MD] 4, MD 7, Doctor of Osteopathy [DO] 8, MD 9, Physician Assistant [PA] 11) who had previously been granted privileges were reappointed without being reappraised for competence. (refer to A-050)

b. Three of eleven members of the Medical Staff (MD 1, MD 10, Nurse Practitioner [NP] 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence. (refer to A-050)

2. The hospital failed to have a system in place to ensure Medical Staff By-Laws, Rules and Regulations were followed, and to ensure the Medical Staff were regularly appraised. There was no means to ensure the Medical Staff were professionally qualified for the positions to which they were appointed and for the performance of privileges granted. (refer to A-340)

a. Five of eleven members of the Medical Staff (MD 4, MD 7, DO 8, MD 9, PA 11) who had previously been granted privileges were reappointed without being reappraised for competence. (refer to A-340)

b. Three of eleven members of the Medical Staff (MD 1, MD 10, NP 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence. (refer to A-340)

3. The hospital failed to ensure an effective, active, system wide infection surveillance control program was in place for the prevention, control, and investigation of infections and communicable diseases. (refer to A-747, A-701, A-748, and A-749)

4. The hospital failed to maintain their fire and life safety systems to ensure a safe environment in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition, NFPA 72 National Fire Alarm Code 1999 Edition, NFPA 13 Standard for the Installation of Sprinkler Systems 1999 Edition, and NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems 1998 Edition. (refer to A-700)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the hospital failed to have an effective Quality Assessment and Performance Improvement (QAPI) program when it failed to capture and recognize:

1. The Governing Body did not provide adequate resources or oversight to implement and maintain a Medical Staff credentialing program which assessed all Medical Staff members for competency. (refer to A-050 and A-340)

2. An effective, active, system wide infection surveillance control program was not in place for the prevention, control, and investigation of infections and communicable diseases. (refer to A-747, A-701, A-748, and A-749)

3. The hospital failed to maintain their fire and life safety systems to ensure a safe environment in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition, NFPA 72 National Fire Alarm Code 1999 Edition, NFPA 13 Standard for the Installation of Sprinkler Systems 1999 Edition, and NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems 1998 Edition. (refer to A-700)

4. The hospital failed to utilize Discharge Planning for 30 of 30 sampled patients. (refer to A-799)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and administrative document review, the hospital failed to have a Governing Body which took full legal responsibility for determining, implementing, and monitoring policies to ensure the provision of health care in a safe environment when:

1. No system was in place to ensure Medical Staff By-Laws, Rules and Regulations were followed and to ensure the Medical Staff were regularly appraised. There was no means to ensure the Medical Staff were professionally qualified for the positions to which they were appointed, and for the performance of privileges granted (refer to A-340)

a. Five of 11 members of the Medical Staff (Medical Doctor [MD] 4, MD 7, DO [Doctor of Osteopathy] 8, MD 9, PA [Physician Assistant] 11, who had previously been granted privileges, were reappointed without being reappraised for competence. (refer to A-340)

b. Three of 11 members of the Medical Staff (MD 1, MD 10, Nurse Practitioner (NP) 3 were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence. (refer to A-340)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, record review, and interview, the hospital failed to maintain their fire and life safety systems to ensure a safe environment in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition, NFPA 72 National Fire Alarm Code 1999 Edition, NFPA 13 Standard for the Installation of Sprinkler Systems 1999 Edition, and NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems 1998 Edition.

This was evidenced by the failure to:

1. Provide and maintain fire alarm system notification devices at all areas of the hospital. (See LSC K51)
2. Maintain a fully functional fire alarm system. (See LSC K51, K52, K54, and K62)
3. Maintain a fully functional automatic sprinkler system. (See LSC K51 and K62)
4. Correct deficiencies identified during tests and inspections of the fire alarm and automatic sprinkler systems. (See LSC K52, K54, and K62)

The cumulative effect of these systemic problems, identified during the Life Safety Code (LSC) Survey, resulted in the failure to demonstrate the ability to ensure the provision of quality health care in a safe environment. This affected all patients in the main campus building and could result in injury due to the delay in notifying occupants of a fire, a failure of the fire alarm and automatic sprinkler systems, a delay in evacuating areas, and the delay in fire containment during a fire. (Refer to the LSC Survey dated 1/7/16)

Findings:

During a tour of the hospital with the Director of Plant Operations, Safety Officer, Facility Coordinator, and Lead Maintenance, from 1/4/16 to 1/7/16, the fire alarm and automatic sprinkler systems were observed, test and inspection records were reviewed, and staff was interviewed.

Main Building:

1. On 1/4/16 at 11:43 AM, the fire alarm control panel indicated 2 trouble signals. Trouble signals indicated that the fire alarm system is not fully working as designed.

At 11:45 AM, the Director of Plant Operations said during an interview that he believed one trouble was due to a possible electrical short somewhere. He did not know what the second trouble signal was for. He indicated that the panel trouble signals started approximately 8 months ago (6/2015). He indicated the hospital started a fire watch on 12/16/15.

On 1/5/16 at 9:11 AM, PBX Staff 1 said during an interview that the two trouble signals on the fire alarm control panel were there for at least 6 months, maybe longer. (See LSC K52)

2. On 1/4/16 at 4:10 PM, the fire alarm system test and inspection record dated 6/26/15, indicated that 31 of 67 smoke detectors failed smoke sensitivity testing on 3/31/15. Four of the 31 failed smoke detectors were repaired on 6/26/15. The locations of the four repaired smoke detectors were not identified. There was no documentation that indicated the remaining 27 failed smoke detectors were repaired or replaced. (See LSC K54)

The following 31 smoke detectors were listed as failed: Rooms 102, 103, 104, 105, 106, 107, 109, 110, 111, 112, 113, 114, 115, 116, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, and in the Birthplace.

At 4:12 PM, the Director of Plant Operations said during an interview that he has been searching for the smoke detector replacement components and has been having trouble finding them. He said that the smoke detectors are old and hard to find.

3. On 1/4/16 at 4:10 PM, fire alarm system test and inspection records were reviewed. The fire alarm system test and inspection record, completed by a licensed vendor on 3/31/15, identified several deficiencies with the fire alarm system. There was no documentation that indicated actions were completed to correct the deficiencies. (See LSC K52) The following items were identified on the report as deficient:

a. Battery load test
b. Operational test
c. CPADR Addressable (list 2) one failed
d. Remote charger failed
e. SGPW Signal/Aux power failed
f. Waterflow in the kitchen
g. Tamper
h. Door holder
i. 4 smoke detectors failed

4. On 1/4/16 at 4:14 PM, the fire alarm system test and inspection record, completed on 6/26/15 by a licensed vendor, was reviewed. The record identified several deficiencies with the fire alarm system. There was no documentation that indicated actions were completed to correct the deficiencies. (See LSC K52) The following items were identified on the report as deficient:

a. CPADR Addressable
b. SGPWR Signal Aux power
c. Dialer
d. Tamper switch
e. Waterflow in the kitchen
f. (Basement) battery load test failed
g. 6 of 67 smoke detectors failed

On 1/4/16, at 4:16 PM, there was no documentation that indicated the authority having jurisdiction was notified of an unusual occurrence when the fire alarm system was not working as designed for greater than four hours.

5. On 1/5/16, at 12:15 PM, the waterflow alarm valve in the old Medical Records Room failed to activate the fire alarm system when tested. The water flowed for more than 2 minutes (127 seconds) without activating the fire alarm system. (See LSC K62)

At 1:45 PM, the fire alarm vendor indicated during an interview that sometimes the waterflow valves fail, then works, during a retest. He said that he was not sure why.

6. On 1/5/16 at 12:19 PM, the fire alarm system was activated. The fire alarm could not be heard in the old medical records section of the basement. There were no audible or visual fire alarm notifications devices installed in that section of the basement. (See LSC K51)

At 12:20 PM, the Safety Officer acknowledged that the fire alarm system could not be heard in that portion of the basement.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active, and a systematic surveillance program in place to prevent, control, and investigate infectious and communicable diseases. The Infection Control program did not meet the needs of forty in-patients admitted for care. The hospital's Infection Control program did not meet the needs of the approximately fifty patients scheduled for surgical procedures during the survey, from 1/4/16 to 1/7/16. The hospital failed to:

1. Have an active surveillance program in place to ensure infection control program policy and procedure were implemented. (refer to A-0748 No: 1, A-0749 No: 1-6)

2. Have an effective surveillance program to identify and correct environmental conditions to prevent the spreading of infective and communicable diseases. (refer to A-0748 No: 2, A-0749 No: 3, 4, 6)

3. Clean blood glucose monitoring devices and a dirty instrument cart in accordance with manufacturer's recommendations in the outpatient area and procedural rooms. (refer to A-0749 No: 1-6)

4. Provide and maintain patient care equipment in Outpatient Units, GI (Gastro-Intestinal) Procedure Room (i.e. blood glucose monitor; a device that measures the level of glucose in a patient's blood). Staff failed to maintain it in a condition that would permit the equipment to be disinfected. (refer to A-0748, A-0749)

5. Train staff to ensure the staff were competent in effectively sterilize and maintain hinged surgical instruments open. (refer to A-0749 No:1, 2, 4, 5)

6. Train staff to ensure the staff were competent to effectively disinfect and proper storage of the endoscopes (a long, flexible tube inserted into patient's digestive tracts). (refer to A-0748 No: 2, A 749 No: 6)

7. Integrate active hospital-wide infection prevention and control program into the hospital's Quality Assurance and Performance Improvement (QAPI) program. (refer to A-0748 No: 2, A-0749 No: 1-6)

8. Communicate the suspected "mold-like" material in the outpatient procedural rooms. (refer to A-0748 No: 1, A-0749 No: 6)

9. Adhere to the posted isolation protocols in the Intensive Care Unit. (refer to A-748 No: 4)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure an effective system-wide Infection Control program and failure to provide an environment free of transmission sources of infections and communicable disease.

Based on staff interview and administrative document review, the hospital failed to have a Governing Body which took full legal responsibility for determining, implementing, and monitoring policies to ensure the provision of health care in a safe environment when:

1. The hospital did not have a system in place to ensure Medical Staff By-Laws, Rules and Regulations were followed, and to ensure the Medical Staff were regularly appraised. There was no means to ensure the Medical Staff were professionally qualified for the positions to which they were appointed and for the performance of privileges granted,

a. Five of eleven members of the Medical Staff (Medical Doctor [MD] 4, MD 7, Doctor of Osteopathy [DO] 8, MD 9, Physician Assistant [PA] 11) who had previously been granted privileges were reappointed without being reappraised for competence,

b. Three of eleven members of the Medical Staff (MD 1, MD 10, Nurse Practitioner [NP] 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence.

These failures resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

During an interview with the District Operations Manager (DOM) 5 the Credential files of eight physicians (MD 1, MD 4, MD 5, MD 6, MD 7, DO 8, MD 9, MD 10), two allied health professionals (NP 3) and Physician Assistant (PA 11) and one dentist (DDS 2) were reviewed with the following findings:

a. Five of eleven members of the Medical Staff (MD 4, MD 7, DO 8, MD 9, PA 11) who had previously been granted privileges, were reappointed without being reappraised for competence.

b. Three of eleven members of the Medical Staff (MD 1, MD 10, NP 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence.

During an interview with DOM 5 on 1/4/16 at 4 PM, she stated overseeing and managing the credential files was one of her responsibilities within the hospital. She stated the credential files had been out of order for some time. She stated they knew there were numerous credentialing issues, including lack of proctoring, lack of reappraisals, and lack of evaluations for competence. She stated theses were chronic problems that had been brought to the attention of the Medical Staff leadership, and the representatives of the Governing Body. In spite of their efforts to make leadership aware of the credentialing and Medical Staff issues, the problems persisted. She stated the physicians were uncooperative in addressing Medical Staff credentialing issues. She simply did not have enough time or assistance from the Medical Staff leadership to correct all the problems with the credential files. She stated the Chairman (MD 2) had been made aware of the numerous problems and issues with the physician credential files, including lack of documentation of proctoring, lack of documentation of peer review, and lack of Advance Health Care Practitioner (AHP)evaluations for competence. DOM 5 stated the Governing Body was usually not actively involved in the credentialing process on a regular basis.

During an interview with MD 2 and DOM 5 on 11/9/15, at 2:30 PM, MD 2 acknowledged his position of leadership, and stated he knew he had the responsibility for ensuring these duties were performed. He stated he was aware of the fact that there were many problems, irregularities and issues with regard to the Medical Staff credential files, acknowledged the fact that DOM 5 had made efforts to inform both him and the Medical Staff leadership of those problems. He stated he had been made aware of the numerous problems and issues with the physician credential files including lack of documentation of proctoring, lack of documentation of peer review, and regular reappraisals and a lack of regular evaluations for allied health professionals. He stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. He stated the Governing Body was usually not actively involved in the credentialing process on a regular basis.

The hospital Healthcare District Bylaws, undated and unsigned, indicated "DUTIES Members of the Governing Board shall govern the District in accordance with the best interests of the public health and make and enforce all rules, regulations, and bylaws necessary for the administration, government, protection and maintenance of the District under their supervision and property belonging thereto. The members of the Governing Board shall perform the duties and responsibilities required by The Local Health Care District Law, other public agencies laws applicable to the District, and applicable state and federal laws and regulations.

The duties and the responsibilities of the Governing Body are: PRIMARY RESPONSIBILITY - The Governing Board's primary responsibility is to develop and follow the organization's mission, vision and values statement, which leads to the development of specific policies in the following key areas of: A. Quality, B. Compliance / Ethics, C. Finance, D. Growth, E. Governance, F. Community.

The Board accomplishes the above by adopting specific outcome targets to measure the organization's performance. To accomplish this, the Board must: Establish policy guidelines and criteria for implementation of the mission, vision and core values. Evaluate proposals brought to the Governing Board to ensure that they are consistent with the mission, vision and core values statement. Monitor programs and activities of the hospital and subsidiaries to ensure consistency. Periodically review, discuss, and if necessary amend the mission, vision and values statements to ensure its relevance. A. QUALITY - The Governing Board has the moral, legal, and regulatory responsibility for services provided at Tulare Regional Medical Center, including the quality of patient care services provided by all individuals who perform their duties in Tulare Regional Medical Center facilities or under Board sponsorship. To accomplish this quality oversight responsibility, the Board must: 1) Understand and accept responsibility for the actions of all physicians, allied health nurses, other caregivers and individuals who perform their duties in the organization's facilities. 2) Review and carefully discuss quality reports that provide comparative statistical data about services, and set measurable policy targets to ensure continual improvement in quality performance. 3) Review recommendations of the Medical Executive Committee regarding new physicians who wish to practice in the organization and be familiar with the fair hearing policies. 4) Reappoint individuals to the medical staff using comparative outcome data to evaluate how they have performed since their last appointment. 5) Consult with Medical Executive Committee and seek physician participation in the quality process to assist the Board in its patient quality-assessment responsibilities. 6) Fully understand the Governing Board's responsibilities and relationships with the Medical Executive Committee at large and maintain effective mechanisms for communicating with them. 7) Regularly receive and discuss malpractice data reflecting the organization's experience and the experience of individual physicians who have been appointed to the medical staff. 8) Adopt a Performance Improvement Plan and Risk Management Plan for the District and provide for resources and support systems to ensure that the plans can be carried out. 9) Regularly perform physician needs assessment, receive and discuss data about the medical staff to assure that future staffing will be adequate in terms of ages, numbers, specialties, and other demographic characteristics. 10) Ensure that management reviews and assesses the opinions of those who work in the organization to identify strengths, weaknesses, and opportunities for improvement. 11) Take corrective action when appropriate and necessary to improve quality."

The hospital's Medical Staff Rules, dated 6/2009, indicates on page Page 35, "Rule 8: Proctoring 8.1 General 8.1.1 Except as otherwise determined by the Medical Executive Committee, all Medical Staff members initially granted Privileges shall be proctored. All practitioners granted temporary privileges during the pendency of an application shall be proctored. Practitioners granted privileges to care for a specific patient shall not be proctored, but shall comply with any special supervision required by the service chief. 8.1.2 The MEC must develop privilege control forms that identify the different privileges a practitioner may request and the requisite training, experience or other qualifications required for exercising the privileges. These forms will be used for requesting and granting privileges and must be approved by the Board of Directors. The forms must be periodically reviewed and revised as necessary to reflect new procedures, treatment modalities and like advances or changes. When the forms are revised, all staff members holding privileges must, as appropriate to the circumstances, either relinquish the privileges affected by the changes or complete the new forms and be processed for added privileges. 8.2 Assignment of Proctor 8.2.1 The proctor must have unrestricted privileges to perform the procedures that he or she will proctor. If no Medical Staff members who have the necessary expertise are available to proctor, special arrangements may be made for proctoring by non-medical staff members either at TLHD or at sites other than TLHD and/or by staff members who have related privileges. Special arrangements must be approved by the Medical Executive Committee. All active, courtesy and provisional staff members who have completed proctoring must assist in proctoring as requested. 8.3 Function and Responsibility of the Proctor 8.3.1 The proctor shall be responsible for evaluating the proctored practitioner's performance from the time of the patient's admission until discharge and shall evaluate the indications for admission, discharge, diagnostic work-up and therapy management. 8.3.2 If surgery or an invasive procedure is performed, the proctor shall evaluate the indication for the procedure, the technique for the procedure, how it is performed, and the pre¿ operative, operative, and post-operative care of the patient. He or she shall utilize the patient's chart, discussions with the practitioner, and actual observation as the basis for the review. If medical care is provided, the proctor shall review the care of the patient, utilizing the patient's chart, discussions with the practitioner, and actual observation, as necessary, as the basis for the review. Invasive medical procedures will be proctored by observation unless the case is an emergency or as otherwise specified in the service rules. 8.3.3 For each case that is proctored, the proctor shall complete the proctoring form, and submit it to the service chief through the Medical Staff office. 8.3.4 Proctoring reports shall be completed fully and in a timely manner after the patient's discharge. 8.3.5 The proctor's primary responsibility is to evaluate the proctored practitioner's performance. However, if the proctor believes that intervention is warranted in order to avert harm to a patient, he or she may take any action he or she finds reasonably necessary to protect the patient. 8.3.6 If the proctor and the proctored practitioner disagree on the appropriate treatment of a patient, the dispute shall be referred to the service chief or Chief of Staff for resolution. 8.3.7 A proctor may or may not act as the assistant in a surgical procedure. Except when the proctor acts as a surgical assistant, no fee shall be charged by the proctor."

The hospital's Medical Staff Bylaws, dated 8/2009, states on page 16 "Content of Reappointment Form a) The reappointment form shall be approved by the Medical Executive Committee and the Governing Body, and once approved shall be considered part of these Bylaws/ Rules. The form shall seek information concerning the changes in the applicant's qualifications since his or her last review. Specifically, the form shall request an update of all of the information and certifications requested in the initial appointment application form, with the exception of that information which cannot change over time, such as information regarding the member's pre-medical and medical education, date of birth, and so forth. The form shall also require information as to whether the applicant requests any change in his or her staff status and/or in his or her clinical privileges, including any reduction, deletion, or additional privileges. Requests for additional privileges must be supported by the type and nature of evidence as specified on the privilege request forms. b) If the staff member's level of clinical activity at this Hospital is not sufficient to permit the staff and Governing Body to evaluate his or her competence to exercise the clinical privileges requested, the staff member shall have the burden of providing evidence of clinical performance at his or her principal institution in whatever form as the Medical Staff and/or Governing Body may require. c) Complete the information requested on the reappointment form and pay any reappointment application fee."

Based on staff interview and administrative document review, the Governing Body did not provide adequate resources or oversight to implement and maintain a Medical Staff credentialing program which assessed all Medical Staff members for competency. (refer to A-050 and A-340)

This failure resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

During an interview with Medical Doctor (MD) 2 on 1/5/16, at 10 AM, he stated he was the Chairman of the hospital, and he represented the Governing Body. MD 2 stated he was aware of the fact that there were many problems within the hospital. He stated the hospital's Quality Assessment and Performance Improvement (QAPI) program was inadequate because the hospital did not perform QAPI projects which focused on high volume, problem prone areas. He was aware of the fact that there were numerous irregularities and serious issues with regard to the Medical Staff credential files. MD 2 stated the hospital's QAPI program was limited. There were no QAPI projects performed which involved collecting credentialing data which was analyzed in ways that would lead to improvement in the hospital's performance of the credentialing responsibilities. The hospital's quality improvement activities did not have the support or assistance of the Governing Body. MD 2 stated the quality improvement activities lacked sufficient Governing Body support to be implemented in an ongoing basis in all areas of the hospital. He stated District Operations Manager (DOM) 5 had made an effort to inform him and make him aware of the numerous problems and issues with the physician credential files, and had made an effort to inform him, and make him aware of the fact the physician credential files were lacking documentation of peer review, proctoring and ongoing assessments of the Medical Staff's competence. He stated he knew these practices were violation of the Healthcare District Bylaws as well as the Medical Staff Bylaws. He stated he was not actively involved in the credentialing process on a regular basis. MD 2 stated that as the Chairman who also represented the Governing Body he knew he had the responsibility for ensuring these duties were performed.

The hospital's QAPI policy was reviewed, as well as documentation of annual QAPI projects performed within the hospital. The hospital failed to provide documentation that the Governing Body provided adequate resources or oversight to implement and maintain a Medical Staff credentialing program, which assessed all Medical Staff members for competency.

The hospital's Healthcare District Bylaws, undated and unsigned, were reviewed. The Bylaws indicated the members of the Governing Board were to govern the District in accordance with the best interests of the public health and make and enforce all rules, regulations, and bylaws necessary for the administration, government, protection and maintenance of the district under their supervision. The members of the Governing Board were to perform the duties and responsibilities required by The Local Health Care District Law, other public agencies laws applicable to the District, and applicable state and federal laws and regulations. The duties and the responsibilities of the Governing Body were: PRIMARY RESPONSIBILITY - The Governing Board's primary responsibility was to develop and follow the organization's mission, vision and values statement, which leads to the development of specific policies in the following key areas of: A. Quality, B. Compliance/Ethics, C. Finance, D. Growth, E. Governance, F. Community.

The policy indicated the Board was to accomplishes the above by adopting specific outcome targets to measure the organization's performance. To accomplish this, the Board would: Establish policy guidelines and criteria for implementation of the mission, vision and core values. Evaluate proposals brought to the Governing Board to ensure that they are consistent with the mission, vision and core values statement. Monitor programs and activities of the hospital and subsidiaries to ensure consistency. Periodically review, discuss, and if necessary amend the mission, vision and values statements to ensure its relevance. Under the heading titled QUALITY, it indicated the Governing Board had the moral, legal, and regulatory responsibility for services provided at Tulare Regional Medical Center, including the quality of patient care services provided by all individuals who perform their duties in Tulare Regional Medical Center facilities or under Board sponsorship. To accomplish this quality oversight responsibility, the Board must: 1) Understand and accept responsibility for the actions of all physicians, allied health nurses, other caregivers and individuals who perform their duties in the organization's facilities. 2)Review and carefully discuss quality reports that provide comparative statistical data about services, and set measurable policy targets to ensure continual improvement in quality performance. 3) Review recommendations of the Medical Executive Committee regarding new physicians who wish to practice in the organization and be familiar with the fair hearing policies. 4) Reappoint individuals to the medical staff using comparative outcome data to evaluate how they have performed since their last appointment. 5) Consult with Medical Executive Committee and seek physician participation in the quality process to assist the Board in its patient quality-assessment responsibilities. 6) Fully understand the Governing Board's responsibilities and relationships with the Medical Executive Committee at large and maintain effective mechanisms for communicating with them. 7) Regularly receive and discuss malpractice data reflecting the organization's experience and the experience of individual physicians who have been appointed to the medical staff. 8) Adopt a Performance Improvement Plan and Risk Management Plan for the District and provide for resources and support systems to ensure that the plans can be carried out. 9) Regularly perform physician needs assessment, receive and discuss data about the medical staff to assure that future staffing will be adequate in terms of ages, numbers, specialties, and other demographic characteristics. 10) Ensure that management reviews and assesses the opinions of those who work in the organization to identify strengths, weaknesses, and opportunities for improvement. 11) Take corrective action when appropriate and necessary to improve quality.

Based on staff interview and administrative document review, the hospital failed to have a Governing Body which took full legal responsibility for determining, implementing and monitoring policies to ensure the provision of health care in a safe environment when:

1. No system was in place to ensure Medical Staff By-Laws, Rules and Regulations were followed and to ensure the Medical Staff were regularly appraised. There was no means to ensure the Medical Staff were professionally qualified for the positions to which they were appointed and for the performance of privileges granted.

a. Five of eleven members of the Medical Staff (Medical Doctor [MD] 4, MD 7, DO [Doctor of Osteopathy] 8, MD 9, PA [Physician Assistant] 11) who had previously been granted privileges were reappointed without being reappraised for competence,

b. Three of eleven members of the Medical Staff (MD 1, MD 10, Nurse Practitioner [NP] 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence.

These failures resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

During an interview with District Office Manager (DOM) 5 on 1/4/16, at 4 PM, she stated overseeing and managing the credential files was one of her responsibilities within the hospital. She stated the credential files had been out of order for some time. she was aware there were numerous credentialing issues including lack of proctoring, lack of reappraisals and lack of evaluations for competence. DOM 5 stated theses were chronic problems that had been brought to the attention of the Medical Staff leadership and the representatives of the Governing Body. DOM 5 stated in spite of her efforts to make leadership aware of the credentialing and Medical Staff issues, the problems persisted. The physicians were uncooperative in addressing Medical Staff credentialing issues. She stated she simply did not have enough time or assistance from the Medical Staff leadership to correct all the problems with the credential files. The Chairman (Medical Doctor [MD] 2) had been made aware of the numerous problems and issues with the physician credential files including lack of documentation of proctoring, lack of documentation of peer review and lack of Advance Health Care Practitioners (AHP) evaluations for competence. DOM 5 stated the Governing Body was usually not actively involved in the credentialing process on a regular basis.

During an interview with MD 2 and DOM 5 on 11/9/15, at 2:30 PM, MD 2 acknowledged his position of leadership and stated he knew he had the responsibility for ensuring these duties were performed. He stated he was aware of the fact that there were many problems, irregularities and issues with regard to the Medical Staff credential files. He acknowledged the fact that DOM 5 had made an effort to inform both him and the Medical Staff leadership of those problems. He stated he had been made aware of the numerous problems and issues with the physician credential files including lack of documentation of proctoring, lack of documentation of peer review and regular reappraisals and a lack of regular evaluations for allied health professionals. He stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. MD 2 stated the Governing Body was usually not actively involved in the credentialing process on a regular basis.

During a review of eleven credential files, the following was noted: a. Five of eleven members of the Medical Staff (MD 4, MD 7, DO 8, MD 9, PA 11) who had previously been granted privileges were reappointed without being reappraised for competence; b.) three of eleven members of the Medical Staff (MD 1, MD 10, NP 3) were granted initial clinical privileges and allowed to practice without being proctored and assessed for competence.

The hospital's Bylaws, undated and unsigned, stated on page 6 "DUTIES Members of the Governing Board shall govern the District in accordance with the best interests of the public health and make and enforce all rules, regulations, and bylaws necessary for the administration, government, protection and maintenance of the District under their supervision and property belonging thereto. The members of the Governing Board shall perform the duties and responsibilities required by The Local Health Care District Law, other public agencies laws applicable to the District, and applicable state and federal laws and regulations. The duties and the responsibilities of the Governing Body are: PRIMARY RESPONSIBILITY - The Governing Board's primary responsibility is to develop and follow the organization's mission, vision and values statement, which leads to the development of specific policies in the following key areas of: A. Quality, B. Compliance / Ethics, C. Finance, D. Growth, E. Governance, F. Community. The Board accomplishes the above by adopting specific outcome targets to measure the organization's performance. To accomplish this, the Board must: Establish policy guidelines and criteria for implementation of the mission, vision and core values. Evaluate proposals brought to the Governing Board to ensure that they are consistent with the mission, vision and core values statement. Monitor programs and activities of the hospital and subsidiaries to ensure consistency. Periodically review, discuss, and if necessary amend the mission, vision and values statements to ensure its relevance. A. QUALITY - The Governing Board has the moral, legal, and regulatory responsibility for services provided at Tulare Regional Medical Center, including the quality of patient care services provided by all individuals who perform their duties in Tulare Regional Medical Center facilities or under Board sponsorship. To accomplish this quality oversight responsibility, the Board must: 1) Understand and accept responsibility for the actions of all physicians, allied health nurses, other caregivers and individuals who perform their duties in the organization's facilities. 2) Review and carefully discuss quality reports that provide comparative statistical data about services, and set measurable policy targets to ensure continual improvement in quality performance. 3) Review recommendations of the Medical Executive Committee regarding new physicians who wish to practice in the organization and be familiar with the fair hearing policies. 4) Reappoint individuals to the medical staff using comparative outcome data to evaluate how they have performed since their last appointment. 5) Consult with Medical Executive Committee and seek physician participation in the quality process to assist the Board in its patient quality-assessment responsibilities. 6) Fully understand the Governing Board's responsibilities and relationships with the Medical Executive Committee at large and maintain effective mechanisms for communicating with them. 7) Regularly receive and discuss malpractice data reflecting the organization's experience and the experience of individual physicians who have been appointed to the medical staff. 8) Adopt a Performance Improvement Plan and Risk Management Plan for the District and provide for resources and support systems to ensure that the plans can be carried out. 9) Regularly perform physician needs assessment, receive and discuss data about the medical staff to assure that future staffing will be adequate in terms of ages, numbers, specialties, and other demographic characteristics. 10) Ensure that management reviews and assesses the opinions of those who work in the organization to identify strengths, weaknesses, and opportunities for improvement. 11) Take corrective action when appropriate and necessary to improve quality."

The hospital's Medical Staff Rules, dated 6/2009, states on page Page 35 "Rule 8: Proctoring 8.1 General 8.1.1 Except as otherwise determined by the Medical Executive Committee, all Medical Staff members initially granted Privileges shall be proctored. All practitioners granted temporary privileges during the pendency of an application shall be proctored. Practitioners granted privileges to care for a specific patient shall not be proctored, but shall comply with any special supervision required by the service chief. 8.1.2 The MEC must develop privilege control forms that identify the different privileges a practitioner may request and the requisite training, experience or other qualifications required for exercising the privileges. These forms will be used for requesting and granting privileges and must be approved by the Board of Directors. The forms must be periodically reviewed and revised as necessary to reflect new procedures, treatment modalities and like advances or changes. When the forms are revised, all staff members holding privileges must, as appropriate to the circumstances, either relinquish the privileges affected by the changes or complete the new forms and be processed for added privileges. 8.2 Assignment of Proctor 8.2.1 The proctor must have unrestricted privileges to perform the procedures that he or she will proctor. If no Medical Staff members who have the necessary expertise are available to proctor, special arrangements may be made for proctoring by non-medical staff members either at TLHD or at sites other than TLHD and/or by staff members who have related privileges. Special arrangements must be approved by the Medical Executive Committee. All active, courtesy and provisional staff members who have completed proctoring must assist in proctoring as requested. 8.3 Function and Responsibility of the Proctor 8.3.1 The proctor shall be responsible for evaluating the proctored practitioner's performance from the time of the patient's admission until discharge and shall evaluate the indications for admission, discharge, diagnostic work-up and therapy management. 8.3.2 If surgery or an invasive procedure is performed, the proctor shall evaluate the indication for the procedure, the technique for the procedure, how it is performed, and the pre¿ operative, operative, and post-operative care of the patient. He or she shall utilize the patient's chart, discussions with the practitioner, and actual observation as the basis for the review. If medical care is provided, the proctor shall review the care of the patient, utilizing the patient's chart, discussions with the practitioner, and actual observation, as necessary, as the basis for the review. Invasive medical procedures will be proctored by observation unless the case is an emergency or as otherwise specified in the service rules. 8.3.3 For each case that is proctored, the proctor shall complete the proctoring form, and submit it to the service chief through the Medical Staff office. 8.3.4 Proctoring reports shall be completed fully and in a timely manner after the patient's discharge. 8.3.5 The proctor's primary responsibility is to evaluate the proctored practitioner's performance. However, if the proctor believes that intervention is warranted in order to avert harm to a patient, he or she may take any action he or she finds reasonably necessary to protect the patient. 8.3.6 If the proctor and the proctored practitioner disagree on the appropriate treatment of a patient, the dispute shall be referred to the service chief or Chief of Staff for resolution. 8.3.7 A proctor may or may not act as the assistant in a surgical procedure. Except when the proctor acts as a surgical assistant, no fee shall be charged by the proctor."

The hospital's Medical Staff Bylaws, dated 8/2009, stated on page 16, "Content of Reappointment Form a) The reappointment form shall be approved by the Medical Executive Committee and the Governing Body, and once approved shall be considered part of these Bylaws/ Rules. The form shall seek information concerning the changes in the applicant's qualifications since his or her last review. Specifically, the form shall request an update of all of the information and certifications requested in the initial appointment application form, with the exception of that information which cannot change over time, such as information regarding the member's pre-medical and medical education, date of birth, and so forth. The form shall also require information as to whether the applicant requests any change in his or her staff status and/or in his or her clinical privileges, including any reduction, deletion, or additional privileges. Requests for additional privileges must be supported by the type and nature of evidence as specified on the privilege request forms. b) If the staff member's level of clinical activity at this Hospital is not sufficient to permit the staff and Governing Body to evaluate his or her competence to exercise the clinical privileges requested, the staff member shall have the burden of providing evidence of clinical performance at his or her principal institution in whatever form as the Medical Staff and/or Governing Body may require. c) Complete the information requested on the reappointment form and pay any reappointment application fee."

Based on record review and interview, the hospital failed to ensure up to date and accurate nursing care plans were implemented for five of thirty sampled patients (4, 10, 15, 18, and 21) in areas involving:

1. skin break down,

2. discharge planning,

3. ventilator use.

This had the potential to result in lack of nursing care.

Findings:

1. During an concurrent review of Patient 10's clinical record and interview with Registered Nurse (RN) 12, on 1/7/16, at 11:25 AM, she indicated Patient 10 had a suspected deep tissue injury (SDTI, an intact area of discolored skin that is damaged due to pressure or shearing forces, and rapidly worsen, and become an open area).

The document titled "Observation Detail Report", dated 1/5/15, at 4 AM, indicated she had a "Very large deep tissue injury to back coccyx [tailbone] and bottom." RN 12 indicated this entry was the first notation of the injury in Patient 10's clinical record. RN 12 indicated there was no care plan entry on that date for the newly noted SDTI, no measurement of the area, no description of color, no assessment entries at all, other than what was noted above.

Over 48 hours later, the document titled "Care Driver Detail", dated 1/7/15, at 11:18 AM, read "purple or maroon localized area of discolored intact skin or blood filled blister due to damage from pressure or shear." The entry was made by RN 12 seven minutes earlier. The entry does not include where this area is, but RN 12 indicated it was the same area as the SDTI on Patient 10's coccyx.

RN 12 indicated the care plan for Patient 10 had not been updated to include the SDTI until that day, 1/7/16, two days after the SDTI had been discovered.

During an interview with the Clinical Analyst (CA) on 1/7/16, at 3:50 PM, he also indicated the care plan for Patient 10 had not been updated to include the SDTI until that day, two days after the SDTI had been discovered.



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2 a. During an interview with RN 14, on 1/5/16, at 10 AM, she reviewed Patient 18's clinical record. She stated Patient 18 had been discharged from the hospital in the morning. She was asked to provide a discharge care plan for Patient 18. No discharge care plan was provided. Patient 18 was admitted on 12/31/15.

2 b. During an interview with the Case Manager (CM), on 1/7/16, she reviewed Patient 15's clinical record. The CM was unable to find documented evidence that a discharge care plan had been initiated. Patient 15 was admitted on 1/1/16.

2 c. During an interview with RN 12, on 1/7/16, at 4:04 PM, she reviewed Patient 4's clinical record and was unable to find documentation that a discharge care plan had been completed. RN 2 stated she was unable to find a discharge care plan for Patient 4. Patient 4 was admitted on 1/2/16.

2 d. During an interview with the CA on 1/6/16, at 4:31 PM, he reviewed the clinical record for Patient 21 and was unable to find a discharge care plan for Patient 21. Patient 21 was admitted on 12/26/15.

During an interview with the Chief Nursing Officer (CNO), on 1/7/16, at 4:58 PM, she was informed that the above patients did not have a paper discharge care plan, or electronic discharge care plan in their clinical records. The CNO stated she was aware an electronic discharge care plan was not done, ... "I guess we could have done a paper one."



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3. During a review of the clinical record for Patient 21 on 12/26/15, at 9 AM, it was noted the patient was intubated (insertion of a tube down the throat to maintain an open airway) on 12/26/15, and extubated (removal of tube used to maintain an open airway) on 12/27/15. There was no care plan (a plan of care developed by nursing staff to direct individualized patient care) noted in Patient 21's record to address his intubation and extubation.

During an interview with RN 13 on 1/7/16, at 4:20 PM, she stated she did not admit Patient 21, and was "not aware she had been admitted on a ventilator" (a machine that assists with breathing). RN 13 stated "There is not a care plan for ventilators."

Based on interview and record review, the hospital failed to:

1. Consistently identify the title and/or licensure of those making entries in the clinical record for two of thirty sampled patients (8 and 10). This resulted in incomplete clinical records for Patients 8 and 10.

2. Failed to ensure medication orders were complete for one of 30 sampled patients (30). This had the potential to result in Patient 30 receiving the wrong medication.

Findings:

1. During a review of the clinical record for Patient 8, the document titled "Clinicians User Record", dated 1/4/16 to 1/7/16, indicated only a partial listing of title/licensure of those making entries.

During a review of the clinical record for Patient 10, the document titled "Clinicians User Legend", dated 1/4/16 to 1/7/16, indicated only partial listings for the title/licensure of those making entries.

During an interview with the Clinical Analyst (CA) on 1/7/16, at 2:55 PM, he indicated the clinical record should include the title and/or licensure of those persons making entries.



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2. During a review of the clinical record for Patient 30, the "Physician Orders" were noted. The physician's order dated 1/5/16, at 8:40 AM, indicated "Regular 5 units now then check blood sugar in 1/2 hr [hour] IV [intravenous, in the vein] NS [normal saline - a typical IV fluid] @ [at] 150 ml/hr [milliliters per hour] T.O. [Telephone order]. The order did not include the name of the drug to be given.

Further review of the clinical record did not reveal a clarification of the order. The Medication Administration Record (MAR) listed the drug as Insulin (a medication used to help control blood sugar level).

During an interview with the CA, on 1/7/16, at 9:52 AM, he stated "This is an incomplete telephone order, it does not indicate the medication. I believe it should be Insulin, but it should state."

The hospital policy and procedure titled "Medical Staff Orders, Written, Verbal and Telephone", dated 9/27/12, indicated "4. Drug orders shall include the name of the patient, name of the drug, the strength, the dosage, the route and frequency of administration."

Based on interview and record review, the hospital failed to ensure prescribers signed their verbal orders in a timely manner for two (21 and 26) of thirty sampled patients. This has the potential to cause transmission of infectious disease, and/or medication errors for Patients 21 and 26.

Findings:

1. During a review of the clinical record for Patient 21, on 1/6/16, at 9 AM, the physician orders (PO) written on 12/26/15 at 2:25 PM were noted. The PO for "Standard MRSA [Methicillin-resistant Staphylococcus aureus - a serious, invasive bacterial infection] Screening Order" was not signed. A second review of the clinical record on 1/7/16, at 4:20 PM, indicated the order was still unsigned.

The hospital document titled "Standard MRSA Screening Order" dated 10/10/12, indicated "In compliance with state Bill 1058 (Nile's Law) every patient fitting the criteria for MRSA screening will have a nasal culture performed to verify the presence of MRSA colonization [the presence of the bacteria, but no signs of illness or infection] within 24 hours of admission."

During an interview with the Clinical Analyst (CA), on 1/7/16, at 9:52 AM, he indicated the "Standard MRSA Screening Order" had not been signed, and stated "the forms were to be flagged [by the Registered Nurse (RN)] and signed by the physician within 24 hours according to facility policy."

2. During a review of the clinical record for Patient 26, on 1/6/16, at 10:20 AM, her medication orders were noted. Patient 26 had been ordered the drug Levophed (a medication used to control blood pressure) on 12/27/15, at 11:30 PM by Medical Doctor (MD) 18. The order had not been signed by MD 18.

During an interview with the CA, on 1/7/16, at 9:52 AM, he verified the order was not signed, and stated the order should have been stamped and flagged [by the RN] for MD 18 to sign.

The hospital policy and procedure titled "Medical Staff Orders: Written, Verbal and Telephone", dated 9/27/12, indicated "Telephone orders must be timed, dated and signed by the ordering physician or his/her covering physician or attending within 48 hours. Verbal orders must be timed, dated and signed by the prescriber as soon as possible after the situation/procedure is completed."

Based on observation, interview and record review, the facility failed to ensure the kitchen was maintained in a clean and sanitary condition. This had the potential to place patients, staff and visitors at risk for infection, foodborne illnesses and attraction of vermin to the kitchen and the facility.

During a concurrent observation and interview with the Dietary Manager (DM) and the Lead Chef, on 1/4/16, at 1:45 PM, the following items were identified during a tour of the hospital kitchen:

1. One plastic bowl, two plastic lids were on the floor under the cooking area.
2. Stored inside a refrigerator, were two large metal trays holding multiple small cakes, without protective covering.
3. Food residue observed on the floor of one refrigerator.
4. Multiple food stains on the east and south walls inside dry food storage room one.
5. Several items of food observed on the floor (sweet potato fries and lettuce leaf piece)
6. One open bag of cereal observed inside the small pantry.
7. Two open boxes of gloves with multiple food stains on packaging.
8. Dust observed on a metal rack used to store bread.
9. A metal baking pan with brown and orange debris inside it was observed lying on the floor under a refrigerator.
10. Food debris observed on the floor under cook and prep areas.
11. Four cans of energy drinks lying on the side and one case of mineral water were observed stored on the floor inside storage room one.
12. One glass tumbler observed lying on the floor under tray prep area.
13. Dust debris observed on a white electrical cord and the north wall of the kitchen.
14. Observed sidelying on the floor inside storage room two; three 24 ounces bottles of soda, plastic packing wrapping, one 16 ounce can of soda, one bottle of water.
15. Two packages of crackers observed were on the floor inside storage room one.
16. Multiple soft drink stains observed on the east and west walls of storage room two (soft drink storage).
17. A opened case of mineral water was observed stored on the floor under the storage shelving inside storage room one.

The above findings were verified by the DM and the Lead Chef .

The facility policy and procedure titled "Safety and Equipment Maintenance" dated 1/15, indicated, "Floors, keep floor clean and dry! Clean up refuse, food and water spills immediately."

The facility policy and procedure titled "Sanitation and Infection Control" dated 1/15, indicated, "Subject: Cleaning of Food and Nonfood Contact Surfaces, Policies: FOOD CONTACT SURFACES...The food-contact surfaces of all cooking equipment shall be kept free of encrusted grease deposits and there accumulated soil.."

Based on observation, interview, and document review, the hospital failed to implement an effective Infection Control program, as evidenced by failure to:

1. Have an effective and qualified Infection Control Preventionist (ICP) to oversee the hospital's Infection Control program (under the direction of the Infection Control Committee, the ICP is responsible to develop and coordinate the Infection Prevention and Control Program throughout the hospital.

2. Integrate an active system-wide Infection Prevention and Control Program into the hospital's Quality Assurance and Performance Improvement (QAPI) program.

These failures had the potential to affect the health and safety of patients undergoing surgical procedures, or any procedures, which required the use of sterile instruments.

3. Ensure proper isolation techniques were implemented by multiple direct care personnel for one of 30 sampled patients (5). This had the potential to spread infection to other patients in the Intensive Care Unit (ICU) including staff, visitors, and students.

Findings:

1. During an interview with the ICP, on 1/4/16, at 1:30 PM, she stated the hospital's Infection Control policies and practices were based on nationally recognized standards, from the Centers for Disease Control and Prevention (CDC), the Association for Professionals in Infection Control and Epidemiologist (APIC), and the Association of PeriOperative Registered Nurses (AORN).

During an interview with the ICP, on 1/6/16 at 11:45 AM, she stated she was not familiar with the required qualifications an ICP should have. She stated, "I've peeked at them." The ICP stated she was unsure how the hospital determined she was qualified for her position as an ICP, which she had been functioning in as of 3/2015.

During a concurrent interview and record review of the ICP's personnel file on 1/6/16, at 12:05 PM, the ICP's file did not contain any documented evidence to demonstrate she had ongoing infection control training. The document titled "Job Description", signed by the ICP, indicated the ICP had, "working knowledge of principles of epidemiologist and infection control..." The ICP was asked to explain her knowledge base regarding principles of epistemology and infection control measures. The ICP was unable to provide examples of her experience in epidemiology and infection control. The ICP also stated her nursing background was primarily in obstetrics (practice in the field of women's reproductive health, including in childbirth services). The ICP stated, "Honestly, it's been a 'learn as you go' but I have support if needed."

2. On 1/6/16 at 9:45 AM, the survey team conducted an interview with the hospital's QAPI Committee members, the Chairman of the QAPI Committee (CEO), the Assistant Chief Nursing officer (ACNO), and the Chairman of the Governing Board (Medical Doctor [MD] 7). After sharing the survey's findings with the Committee members, the survey team asked if they were aware of some of the issues identified, and if so, what was the reason(s) for the Committee not to provide recommendations to correct the issues. The Chairman of the QAPI Committee stated, "We have Medical Staff that won't do what they are supposed to do."

During an interview with the ICP, on 1/6/16, at 12:50 PM, she was asked about QAPI Committee's involvement with the hospital's Infection Control program, and to provide documented evidence to show they were actively involved. The ICP was unable to describe the Committee's involvement nor could show the documented evidence.

3. During an observation in the ICU on 1/7/16, at 9:55 AM, Patient 5 was noted in a private room. There was a handwashing sink located inside the room. There were two signs by the entrance to her room, the first one read in part:

a. "STOP! DROPLET PRECAUTIONS - Wear Mask - Wear regular mask if within three feet of patient."

And, the second sign read:

b. "STOP! SPECIAL CONTACT PRECAUTIONS - Remove gloves before leaving patient room. Wash Hands - Remove gloves & wash hands with SOAP & WATER before leaving patient room. Avoid recontamination of hands."

At this time, Respiratory Therapist (RT) 17 was noted entering Patient 5's room with two RT students (not hospital staff) from a local school. After delivering hands-on bedside care involving suctioning excessive secretions (with a long flexible tube) from Patient 5's airway, the three RT personnel left the room. They did not wash their hands in Patient 5's room, instead, all three went out to the nursing station and washed their hands at a sink there, approximately 50 feet away.

During an interview with RT 17, on 1/7/16, at 10:05 AM, he stated the two RT students were following him while he provided patient care that day, and he was their "preceptor". RT 17 was asked why, after he suctioned Patient 5, did not he (and his students) wash their hands with soap and water before leaving Patient 5's room, as the posted sign dictates. RT 17 stated "I was concerned the sink in the room was contaminated." RT 17 also indicated that since he was wearing gloves in the room, and since he removed them in the room, his hands were "clean" and "not visibly contaminated" with any pathogen.

At the same time, Registered Nurse (RN) 16 was noted entering Patient 5's room on 1/7/16, at 9:55 AM. RN 16 did not put on a mask. RN 16 was noted to approach the head of Patient 5's bed on two occasions, the first one was about 10 seconds, the second for about 20 seconds. On both occasions, RN 16 was standing closely to Patient 5's head, the front of her scrubs touching the siderail of the bed, while the three RT personnel were suctioning Patient 5's airway on the opposite side of the bed. Upon leaving Patient 5's room, RN 16 did not wash her hands. RN 16 was noted walking to the nursing station and spoke to a physician. RN 16 was not observed washing her hands with soap and water after leaving Patient 5's room. About five minutes later, she re-entered Patient 5's room, this time she put on a gown, gloves, and a mask.

During an interview with RN 16, on 1/7/16, at 11:30 AM, she was asked why she did not wear a mask while in Patient 5's room, since the posted sign dictates a mask for anyone "within three feet of patient." RN 16 stated "I wasn't aware she was on droplet precautions. That's my bad."

During an interview with the Chief Nursing Officer on 1/7/16, at 10:30 AM, she stated RN 16 and the three RT personnel's actions in Patient 5's room were incorrect, and they all "should have been following the protocols" posted on the signs.

Based on observation, record review, and interview, the hospital failed to maintain a system for controlling sources of infections in accordance with its policies and procedures, nationally recognized infection control practices and guidelines and applicable regulations when the hospital:

1. Failed to ensure sterile and clean supplies were not stored in the decontamination room (a non-sterile room used to clean dirty instruments).

2. Failed to monitor the temperature of the decontamination room.

3. Failed to ensure staff observed contact time (the time the disinfectant needs to remain wet on equipment being cleaned, in order for the disinfectant to inactivate or kill germs) required in accordance with the manufacturer's guidelines when using Sani-Cloth wipes (pre-moistened disposable cloths containing a solution to sanitize surfaces) to clean a dirty instrument cart and a glucometer after patient use.

4. Failed to ensure staff disposed of items contaminated with blood or infectious materials in accordance with standards of practice.

5. Failed to ensure hinged instruments were not sterilized in closed position; the integrity of the identification tape taped on surgical instruments; and instruments were stacked on top of each other during sterilization process.

6. Failed to maintain a sanitary condition of the Endoscopy Suite (a dedicated area where medical procedures are performed, using endoscopes. Endoscope is a long, flexible tube with camera at one end, which are used to visualize structures within the body, such as the digestive tract and genitourinary system) and Bronchoscopy Room (a room where a procedures are used to look inside the lungs' airways) when stained sink and a scope cleaning equipment were found to have stain build up in the endoscope processing area and dusty floor as well as mold-like material were seen on the window seals of both areas.

The failures had the potential to increase the risk of spreading infections to all patients who received surgical, digestive, or bronchoscopic procedures at the hospital.

Findings:

1 a. An observation of the decontamination room and a concurrent interview with the ICP and Instrument Technician (IT), were conducted on 1/4/16, at 3:30 PM. On entering the decontamination room, a sterile supply of various types and sizes of Foley catheters (sterile tube inserted into the bladder to drain urine) were seen stacked on top of each other, on a wire storage rack. Also found were multiple bottles of distilled water. The IT was asked if these were the supplies currently used for patients. The IT stated yes.

1 b. During the same observation, it was noted a yellow air hose, one end was connected to a tank located in the decontamination room, the other end went through an open window to the sterile processing room. The IT stated the yellow hose was used to "air hose dry scopes". The ICP stated, "They need to be moved, they shouldn't be there," referring to the tank and the yellow hose. The ICP also stated, the hospital follows the nationally recognized standards of CDC (Centers for Disease Control and Prevention), APIC (Association for Professionals in Infection Control and Epidemiology), and AORN (Association of PeriOperative Registered Nurses).

According to CDC guidelines, sterile supplies should be stored in a manner which prevents contamination, there should be a clear separation of sterile items and dirty items, and there must be separate clean/dirty rooms or the designated utility room must flow from clean to dirty.

2. During an interview with the IT on 1/4/16, at 3:30 PM, in regards to the monitoring of temperature in the decontamination room; the IT stated he did not have a method for determining the temperature in the decontamination room. He also stated he did not know why he needed to monitor the temperature of the decontamination room.

AORN's guidelines for Safe Environment of Care, effective 5/2015, recommended the appropriate temperatures for the decontamination room ranges from 72 degrees Fahrenheit (º F) to 78º F. When the room temperatures is above 75º F, it decreases bacterial survival rates in general.

3. An observation was conducted on 1/4/16, at 3:40 PM, of the IT cleaning a dirty instrument cart, located in the decontamination room. The IT indicated the cart had been used to transport dirty instruments from the operating room (OR) to the decontamination room. The IT used a Sani-Cloth wipe (cloth wipes used to clean and disinfects in one step), which had a "2-minute contact time." The IT did not verify the contact time and the cart was visibly dried in less than two minutes.

During an observation of the Ambulatory Surgical Unit (ASU) and a concurrent interview with a Registered Nurse (RN), on 1/6/15, at 2:30 PM, the ASU RN was asked how she cleaned the patient glucometers (reusable patient equipment used to obtain a patient's blood sugar level). The ASU RN was unable to provide the manufactures recommendations for cleaning and disinfecting the glucometer. The ASU RN stated that she wipes the glucometer with the Sani-Cloths and said, "It must be dried within 2 minutes."

According to the CDC, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 and Prevention Guidelines for Disinfection and Sterilization in Healthcare Settings, the overall contact time is the time it takes the product to disinfect all the microorganisms."

According to the Sani-Cloth manufacturer's instructions, listed on the container, the surface wiped should remain wet for two minutes, in order for the product to properly kill microorganisms. The IT wiped the interior of the cart and then proceeded to wipe the exterior of the cart, without ensuring the manufacturer instructions were followed.

During an interview with the IT, on 1/4/16, at 3:42 PM, the IT was asked if he understood what the two-minute contact time signified. Both the IT and RN 16 stated the surface area should be dried within 2 minutes.

During an interview with the ICP, on 1/6/16, at 4 PM, regarding their policy for cleaning the instrument carts, she indicated they did not have a policy specifically for cleaning the carts and they would follow the "low level disinfection" policy.

During a document review of the hospital policy titled, "Cleaning and Performing Low Level Disinfection, effective 10/29/15, "the document indicated the following:

"...The efficacy of disinfection is affected by a number of factors, including the type and level of microbial contamination, the activity of the disinfectant and the disinfectant contact time..."

4. During an observation of the decontamination room on 1/4/16, at 3:45 PM, a partially uncovered, unlabeled cart lined with a black trash bag was placed in front of a dirty instrument cart.

During an interview with the IT, immediately following the observation, he stated the cart was used by him to discard bloody items needed to be discarded from the dirty instrument cart. The IT and the ICP stated the bloody items should be placed in a red or biohazard bag and easily identifiable.

During a review of a hospital document titled, "Infectious Waste Handling, dated 10/1/15", it read, "Use only red waste can liners labeled 'INFECTIOUS WASTE' or 'BIOHAZARDOUS WASTE' for infectious waste..."

5. During an observation of the Central Sterile Room, on 1/5/16, at 2:20 PM, accompanied by the Director of Central Sterile Processing (DCSP), the ICP and the IT. The following were identified:

a. Three of four peel packages contained sterilized instruments with closed hinges.

b. Multiple trays containing surgical instruments had identification tape on them. These tapes were noted to be chipped or partially lifted. These trays were filled with instruments stacked on top of each other.

During an immediate interview, the DCSP informed the IT, "You don't stack them on top of each other." The IT was asked about the training he was provided, and policies regarding the sterilization process. The IT stated he was not certain if there was a policy that instructed him how to process sterile instruments. He stated he was taught by a former employee, and he also "learns as he goes."

During the same interview, at 3 PM, with the DCSP, the DCSP was asked to provide the monitoring log for the integrity of the surgical identification tape. He stated the hospital was"moving away" from using tape on instruments, and he was aware of not to use the identification tape anymore. He explained the tape was "sticky and gummy" and "It's an infection control issue."

The AORN "Standards and Recommended Practices, 2013 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment" was reviewed. Under Recommendation XII, it read:

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

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

XII.b. Broad-surfaced instruments and those with concave surfaces (e.g., malleable retractors, hip skids) should be placed on edge. Instruments placed on edge facilitate drying because in this position, steam condensate will drain off the instrument rather than pool on it.

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

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

6. During an observation of the Endoscopy Room on 1/6/15, at 3:05 PM, the sink where the endoscopes were cleaned had a visible brown build up around the entire surface of the sink like a brown ring. There were also some brown particles seen at the bottom of the sink. A tabletop endoscope medivator (a machine used to clean and disinfect endoscopes) had copious amounts of thick, sticky, yellow residue around the top rim of the machine. The foam which sealed the lid of the machine when closed and the hinges of the medivator also contained the same residue.

The room also had black powdery substance around the window bases. The ICP indicated it looked like "mold."

During an interview with an Endoscopy Technician (ET), immediately following the observations, she stated she used the ring around the sink to determine the water level required for cleaning the scopes. She also stated the yellow residue on the medivator "is stained" and it is cleaned periodically. No logs were provided to verify cleaning of the medivator.

During an interview with the ICP, on 1/6/16, at 3:15 PM, she stated the brown ring around the sink and the particles on the bottom needed to be cleaned. She stated the last time (no date provided and no logs maintained to verify) she conducted rounds, she did not notice these findings.

On 1/6/15, at 3:30 PM, during the same observation, adjacent to the Endoscopy Room, was the Bronchoscopy Room, visible dust was noted around the bases of the windows and the floors. In addition, there was mold-like material noted on the window seals.

On 1/6/16, at 5:20 PM, the DCSP, Chief Nurse Officer, and the Assistant Chief Nurse Officer were informed of the above findings.

Based on interview and record review, the hospital failed to ensure a discharge planning evaluation was completed for three of 30 sampled patients (18, 16, and 20). This had the potential to result in the lack of continuity of care to meet patients needs.

Findings:

1. During a concurrent interview and record review with Registered Nurse 14, on 1/5/16, at 9:59 AM, she reviewed the clinical record for Patient 18 and could not find a completed discharge planning evaluation. Patient 18 was discharged from the hospital on 1/5/16 at 9:45 AM. RN 14 stated she had not completed a discharge planning evaluation.

During an interview with the Case Management (CM), on 1/7/16, at 11 AM, she said upon admission nurses complete a preparation for discharge assessment in the electronic medical record.

2. During a concurrent interview and record review for Patient 16 with the CM,on 1/17/16 at 11:05 AM, she was asked to find the discharge planning evaluation record for Patient 16. No discharge planning evaluation was found or provided. The CM said, "The discharge planning on Patient 16 was not completed by nursing."

3. During a concurrent review of the clinical record for Patient 20, on 1/7/16 at 11:05 AM, with the CM, the discharge planning evaluation was not found.

The hospital policy and procedure titled "Discharge Planning" dated 8/26/10, indicated that "Effective discharge planning is essential to the continuum of care of each Patient. Such planning is vital to maintaining a course of treatment specific to each patient from admission until discharge. If the patient discharge plan is clearly and specifically put into place, than the likelihood for readmission may be prevented."