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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 the hospital's bylaws governing medical staff membership or the granting of privileges was applied equally to all practitioners: (Refer to A 0050)

a. Four of five members of the medical staff (Medical Doctor [MD] 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence;

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one Allied Health Professional (AHP), Physician's Assistant (PA) 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

2. 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 0340)

a. Four of five members of the medical staff (MD 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence.

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one AHP, PA 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

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 the hospital's bylaws governing medical staff membership or the granting of privileges was applied equally to all practitioners. (see A 0050)

a. Four of five members of the medical staff (Medical Doctor [MD] 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence;

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one Allied Health Professional (AHP), Physician's Assistant (PA) 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

Findings:

The Medical Staff Bylaws state on page 38: "PROCTORING REQUIREMENTS FOR INITIAL APPOINTMENT Each Provisional Staff member shall undergo a period of observation by designated monitors as described in Section 4.2. The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within Staff categories. Observations of Provisional Staff members shall follow whatever frequency and format each department deems appropriate in order to adequately evaluate the Provisional Staff member, including but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records thereto shall be maintained. The results of the observation shall be communicated by the Department Chair to the Credentials Committee. MODIFICATION IN STAFF CATEGORY AND PRIVILEGES When recommended by the Medical Executive Committee, and approved by the Governing Board, change in Staff category or Department affiliation or the granting of additional privileges, in accordance with Section 5.6 of these Bylaws, shall be made subject to the completion of proctoring. TERM OF PROCTORING PERIOD Each Department may establish, in Rules and Regulations, a term of proctoring which establishes a longer period of time and/or a greater number of cases, not less than six (6) cases or a specific number of cases applicable to particular clinical privileges, whenever such requirements are appropriate in view of the clinical privileges which are involved. The period of proctoring may be extended in increments of not more than six (6) months each, for a total proctoring period of not more than twenty-four (24) months. If an initial appointee fails within that period to complete the minimum number of cases and/or to furnish the documentation required, his Medical Staff membership or particular clinical privileges, as applicable, shall automatically terminate, and the member shall be entitled to a hearing, upon request, pursuant to Article XII. If a Medical Staff member requesting modification fails to complete the minimum number of cases and/or to furnish the documentation required by the Department, the change in Medical Staff category or Department assignment, or the additional privileges as applicable, shall be terminated. The Medical Executive Committee Chairman shall give the initial appointee or Medical Staff member so affected written notice that his or her Medical Staff -membership and/or clinical privileges have been terminated because of failure to satisfactorily complete the proctoring requirements. The affected practitioner has no rights to request a hearing, since this is an administrative action, unless the practitioner's failure is due to medical disciplinary action that is reportable to the Medical Board of California. MODIFICATION OF PROVISIONAL STATUS After a minimum of six months to his/her initial appointment to the Provisional Staff and pursuant to Section 3.8-2, a Medical Staff member may request, in writing, that he be advanced to another Staff category, providing that he/she has successfully completed the proctoring, activity and meeting attendance requirements. At the written request of the staff member, evaluations of Provisional Staff members may be done six (6) months following initial appointments. Advancement may be considered at that time, providing the proctoring requirements have been successfully completed. Provisional Staff members must be advanced from said status within twenty-four (24) months of initial appointment date, or automatically be dropped from the Medical Staff. RECIPROCAL PROCTORING ARRANGEMENTS
Evidence of proctoring at other hospitals to supplement actual observation at this Hospital, may be accepted only if the following conditions are present: the proctor must be a current member of the Medical Staff; and
the proctor must be someone who would have been eligible to serve as a proctor in the second hospital; and the same hospital range and level of privileges must have been requested in both hospitals. Copies of the actual proctoring reports or summaries, are to be kept in confidential files at both hospitals, in compliance with HIPAA Regulations; the number of reciprocal proctoring reports is not to exceed fifty (50) percent of the required proctoring. ARTICLE VII. ALLIED HEALTH PROFESSIONALS 7.1 QUALIFICATIONS Allied Health Professionals (AHP's) holding licenses, certificates, or such other legal credentials, if any, as required by California law, which authorize the AHP's to provide certain professional services, are not eligible for Medical Staff membership. Allied Health Professionals (AHP's) will consist of physicians' assistants and nurse practitioners. Such AHP's are eligible to practice privileges in this Hospital only if they: (a) hold a license, certificate or other legal credential in a category of AHP's, which the Governing Board has identified as eligible to apply for practice privileges; (b) document their experience, background, training, demonstrate ability, judgment, physical and mental health status, with sufficient adequacy to demonstrate that any patient treated by them will receive care of the generally recognized professional level of quality and efficiency established by the Hospital, and that they are qualified to exercise practice privileges within the Hospital; and (c) are determined, on the basis of documented references, to adhere strictly to the lawful ethics of their respective professions; to work cooperatively with others in the Hospital setting; and to be willing to commit to and regularly assist the Hospital in fulfilling its obligations related to patient care, within the areas of their professional competence and credentials. Agree to comply with all Medical Staff and Department bylaws, rules and regulations, and protocols to the extent applicable to the AHP. Maintain professional liability insurance coverage, provided by their Supervising Physician, with a suitable insurer, with minimum limits, which have been determined as acceptable by the Medical Executive Committee and Governing Board, in the amount of (I million/3 million dollars), with no shared limits. EFFECTIVE DATE OF REAPPOINTMENT MODIFICATIONS OF APPOINTMENT AND/OR STAFF PRIVILEGES On the date of the respective Governing Board meetings, a written notification will be forwarded to the physician, acknowledging the Board's decision. DURATION OF APPOINTMENT INITIAL APPOINTMENTS All initial appointments shall be for a minimum of a period of six 6 months with possibly, the recommendation for an eighteen (18) month extension. REAPPOINTMENTS Reappointments to any category of membership and renewals of any designation shall be for a period not to exceed two (2) years. ARTICLE VI. CLINICAL PRIVILEGES EXERCISE OF PRIVILEGES A practitioner providing clinical services at this hospital by virtue of Medical Staff or Allied Health Professional Staff membership or otherwise, shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted by the Governing Board,except as provided in subparagraphs 6.4 and 6.5 of this Article VI. DELINEATION OF·PRIVILEGES IN GENERAL REQUESTS Each application for appointment and reappointment to the Medical Staff must contain a request for the specific staff privileges desired by the applicant. A request by the Medical Staff member for a modification of privileges must be supported by documentation of training and/or experience that supports the request. Such requests shall be processed in accordance with the procedure outlined in Section 5.4. BASIS FOR DETERMINATION OF PRIVILEGES Privileges shall be determined on the basis of the practitioner's education, training, experience, demonstrated ability and judgment, including observed professional performance, peer recommendations, and documented results of the patient care audit and any other quality review activities required by these Bylaws of the Hospital. Privilege determinations shall also be based upon all of the following factors, without limitation: (a) information concerning professional performance obtained from other sources, especially other institutions and healthcare settings wherein a practitioner exercises privileges; (b) an assessment of the ability of the hospital to provide adequate facilities and support services for the practitioner and his/her patients; current clinical and surgical competence (for the five years immediately preceding the date of application)."

Credential files for the medical staff were requested on 11/9/15 at 9 AM. The hospital's policies for credentialing and peer review, complete medical staff roster and the medical staff rules, regulations and bylaws were among those documents requested and reviewed on 11/9/15 at 10 AM as a part of the usual survey process.

After discussing credentialing of medical staff including policies and procedures, nine physician credential files (MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 14, and MD 15) and one AHP (PA 13) were reviewed on 11/9/15 at 10:30 AM with Credentialing Coordinators (CC) 1 and CC 2.

The credential files for were chosen as a part of the credential file review sample because they had all been appointed to the medical staff and granted clinical privileges. Examination of the credential files revealed a. Four of five members of the medical staff (MD 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence; b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and, c. One out of a total of one AHP, PA 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

CC 1 and CC 2 were interviewed on 11/9/15 at 2 PM. They stated overseeing and managing the credential files was one of their responsibilities within the facility. They stated the credential files had been out of order for some time. They stated they knew there were numerous credentialing issues including lack of proctoring, lack of reappraisals and lack of evaluations for competence. They stated theses were chronic problems that had been brought to the attention of the medical staff leadership and the representatives of the governing body. They stated in spite of their efforts to make leadership aware of the credentialing and medical staff issues, the problems persisted. They stated the physicians were uncooperative in addressing medical staff credentialing issues. They stated they simply did not have enough time or assistance from the medical staff leadership to correct all the problems with the credential files. They stated the Chief of the Medical Staff (CS) 1 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 AHP evaluations for competence. They stated the governing body was usually not actively involved in the credentialing process on a regular basis.

The Chief Executive Officer and the Administrator were interviewed together on 11/9/15 at 2:30 PM. They acknowledged their positions of leadership and they stated they knew they had the responsibility for ensuring these duties were performed. They stated they were aware of the fact that there were many problems, irregularities and issues with regard to the medical staff credential files. They acknowledged the fact that the CC 1 and CC 2 made efforts to inform them of those problems. They stated they 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. They stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. They stated the governing body was usually not actively involved in the credentialing process on a regular basis.

The CS 1 was interviewed on 11/10/15 at 9:15 AM. He acknowledged his position of leadership and he stated he knew he had the responsibility for ensuring these duties were performed. He stated he were 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 the CC 1 and CC 2 made efforts to inform him 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 he 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.

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

1. Have informed consents for procedures for two of 26 sampled patients (16 and 20), (Refer to A 0131); and,

2. Ensure a staff physician (Medical Doctor [MD] 6), followed the terms of his probation, specifically, only entering patient rooms with another health care provider, i.e., MD 6 was not to visit a patient alone. (Refer to A 0145).

This practice had the potential for patient abuse. (Refer to A 0145)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure their patients' rights were honored by not informing some of risks and benefits of procedures performed by nursing staff, and failing to ensure a safe environment free of the potential for abuse.

Based on observation, interview, and record review, the hospital failed to have informed consents for procedures in the clinical record for two of 26 sampled patients (16 and 20). This practice has the potential for patients to receive procedures without knowing the benefits versus risks, and/or to make an informed decision about that procedure.

Findings:

[Note: "Dialysis" is a process involving a large, portable machine, that is attached to a patient so that all of their blood's toxins and other fluids can be removed when their own kidneys can no longer do it. If these waste products are not removed, the result can be death. Its purpose is to keep the right levels of chemicals, fluids, and salts in one's bloodstream, control blood pressure, and remove waste products. Dialysis treatments typically take between 3 to 4 hours; during this time, all the patient's blood is removed and ran through a filter in the machine, then returned to the patient. Treatments usually occur three times a week.

Before the dialysis treatments can happen, a surgical procedure must occur, to make a connection site on the patient. The dialysis machine usually connects to this site via two needles.]

1. During an interview with Registered Nurse (RN) 1 on 11/9/15, at 9:20 AM, she indicated Patient 16 was in her care, and was a dialysis patient.

During an interview with Patient 16, on 11/9/15, at 9:25 AM, she indicated she had just finished her dialysis treatment a few minutes ago.

During a concurrent record review and interview with the Medical Record Specialist (MRS) on 11/10/15, at 9 AM, the clinical record for Patient 16 was noted to not have an informed consent for her dialysis treatment.

During an interview with RN 1 on 11/10/15, at 11 AM, she indicated Patient 16 was still her patient, and also reviewed her clinical record. RN 1 indicated Patient 16 did not have an informed consent for her dialysis treatments.

2. During an observation of Patient 20 on 11/9/15, at 9:30 AM, she was receiving a dialysis treatment in the hospital's Intensive Care Unit (ICU).

During a concurrent record review and interview with the MRS on 11/10/15, at 9 AM, the clinical record for Patient 20 was noted to not have an informed consent for her dialysis treatment.

During an interview with RN 5 on 11/10/15, at 10:30 AM, she also reviewed Patient 20's clinical record and indicated there was no informed consent for her dialysis treatments. RN 5 stated it is normal hospital protocol to obtain these consents prior to the treatments, but could not locate one for Patient 20.

Based on record review and interview, the hospital failed to ensure a staff physician (Medical Doctor [MD] 6), followed the terms of his probation, specifically, only entering a patient's room with another health care provider, i.e., MD 6 was not to visit a patient alone. This practice had the potential for patient abuse.

Findings:

During a review of a letter written to the Department, dated 10/15/15, and signed by the Chief Executive Officer (CEO), it read, in part:

"Provider's Plan of Correction
1. Ensure that [MD 6] uses a chaperone for each patient visit:
a. [MD 6] will be required to check in with Charge Nurse prior to rounding.
b. Physician's Assistant (PA)/Nurse Practitioner (NP) will accompany [MD 6] during rounds.
c. If PA or NP not available, Charge Nurse will round with [MD 6] or assign staff to accompany [MD 6].
d. Medical Staff Director will notify [MD 6] that he needs to take the PA/NP with him, or round with Charge Nurse or assigned staff.
e. This practice will be implemented immediately.
f. If [MD 6] fails to round with assigned chaperone, he will be suspended.
2. Nursing staff needs to document in the nursing record that [MD 6] was accompanied during rounds.
b. Documentation of Rounding will be done by the PA/NP/Charge Nurse, or assigned staff."

During an interview with Patient 21, on 11/9/15, at 11:05 AM, he indicated MD 6 had examined him privately, with no other staff present.

During an interview with Patient 23, on 11/9/15, at 11:25 AM, she indicated MD 6 had examined her privately, with no other staff present.

During an interview with Patient 24, on 11/9/15, at 11:30 AM, he indicated MD 6 had examined him privately, with no other staff present.

During an interview with Registered Nurse (RN) 3, on 11/9/15, at 11:40 AM, she indicated she was a Charge Nurse in the hospital. RN 3 indicated she was familiar with MD 6, and the terms of his probation. RN 3 stated in the absence of a PA/NP, nursing staff accompany MD 6 into patient rooms only "sometimes."

During an interview with the CEO on 11/9/15, at 11:45 AM, while discussing the terms of MD 6's probation, she stated "[Our compliance is] not as tight as it should be on the nursing side."

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 0340)

a. Four of five members of the medical staff (Medical Doctor [MD] 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence;

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one Allied Health Professional (AHP), Physician's Assistant (PA) 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

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 the hospital's bylaws governing medical staff membership or the granting of privileges was applied equally to all practitioners:

a. Four of five members of the medical staff (Medical Doctor [MD] 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence;

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one Allied Health Professional (AHP), Physician's Assistant (PA) 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

Findings:

The Medical Staff Bylaws state on Page 38: "PROCTORING REQUIREMENTS FOR INITIAL APPOINTMENT Each Provisional Staff member shall undergo a period of observation by designated monitors as described in Section 4.2. The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within Staff categories. Observations of Provisional Staff members shall follow whatever frequency and format each department deems appropriate in order to adequately evaluate the Provisional Staff member, including but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records thereto shall be maintained. The results of the observation shall be communicated by the Department Chair to the Credentials Committee. MODIFICATION IN STAFF CATEGORY AND PRIVILEGES When recommended by the Medical Executive Committee, and approved by the Governing Board, change in Staff category or Department affiliation or the granting of additional privileges, in accordance with Section 5.6 of these Bylaws, shall be made subject to the completion of proctoring. TERM OF PROCTORING PERIOD Each Department may establish, in Rules and Regulations, a term of proctoring which establishes a longer period of time and/or a greater number of cases, not less than six (6) cases or a specific number of cases applicable to particular clinical privileges, whenever such requirements are appropriate in view of the clinical privileges which are involved. The period of proctoring may be extended in increments of not more than six (6) months each, for a total proctoring period of not more than twenty-four (24) months. If an initial appointee fails within that period to complete the minimum number of cases and/or to furnish the documentation required, his Medical Staff membership or particular clinical privileges, as applicable, shall automatically terminate, and the member shall be entitled to a hearing, upon request, pursuant to Article XII. If a Medical Staff member requesting modification fails to complete the minimum number of cases and/or to furnish the documentation required by the Department, the change in Medical Staff category or Department assignment, or the additional privileges as applicable, shall be terminated. The Medical Executive Committee Chairman shall give the initial appointee or Medical Staff member so affected written notice that his or her Medical Staff -membership and/or clinical privileges have been terminated because of failure to satisfactorily complete the proctoring requirements. The affected practitioner has no rights to request a hearing, since this is an administrative action, unless the practitioner's failure is due to medical disciplinary action that is reportable to the Medical Board of California. MODIFICATION OF PROVISIONAL STATUS After a minimum of six months to his/her initial appointment to the Provisional Staff and pursuant to Section 3.8-2, a Medical Staff member may request, in writing, that he be advanced to another Staff category, providing that he/she·has successfully completed the proctoring, activity and meeting attendance requirements. At the written request of the staff member, evaluations of Provisional Staff members may be done six (6) months following initial appointments. Advancement may be considered at that time, providing the proctoring requirements have been successfully completed. Provisional Staff members must be advanced from said status within twenty-four (24) months of initial appointment date, or automatically be dropped from the Medical Staff. RECIPROCAL PROCTORING ARRANGEMENTS
Evidence of proctoring at other hospitals to supplement actual observation at this Hospital, may be accepted only if the following conditions are present: the proctor must be a current member of the Medical Staff; and
the proctor must be someone who would have been eligible to serve as a proctor in the second hospital; and the same hospital range and level of privileges must have been requested in both hospitals. Copies of the actual proctoring reports or summaries, are to be kept in confidential files at both hospitals, in compliance with HIPAA Regulations; the number of reciprocal proctoring reports is not to exceed fifty (50) percent of the required proctoring. ARTICLE VII. ALLIED HEALTH PROFESSIONALS 7.1 QUALIFICATIONS Allied Health Professionals (AHP's) holding licenses, certificates, or such other legal credentials, if any, as required by California law, which authorize the AHP's to provide certain professional services, are not eligible for Medical Staff membership. Allied Health Professionals (AHP's) will consist of physicians' assistants and nurse practitioners. Such AHP's are eligible to practice privileges in this Hospital only if they: (a) hold a license, certificate or other legal credential in a category of AHP's, which the Governing Board has identified as eligible to apply for practice privileges; (b) document their experience, background, training, demonstrate ability, judgment, physical and mental health status, with sufficient adequacy to demonstrate that any patient treated by them will receive care of the generally recognized professional level of quality and efficiency established by the Hospital, and that they are qualified to exercise practice privileges within the Hospital; and (c) are determined, on the basis of documented references, to adhere strictly to the lawful ethics of their respective professions; to work cooperatively with others in the Hospital setting; and to be willing to commit to and regularly assist the Hospital in fulfilling its obligations related to patient care, within the areas of their professional competence and credentials. Agree to comply with all Medical Staff and Department bylaws, rules and regulations, and protocols to the extent applicable to the AHP. Maintain professional liability insurance coverage, provided by their Supervising Physician, with a suitable insurer, with minimum limits, which have been determined as acceptable by the Medical Executive Committee and Governing Board, in the amount of (I million/3 million dollars), with no shared limits. EFFECTIVE DATE OF REAPPOINTMENT MODIFICATIONS OF APPOINTMENT AND/OR STAFF PRIVILEGES On the date of the respective Governing Board meetings, a written notification will be forwarded to the physician, acknowledging the Board's decision. DURATION OF APPOINTMENT INITIAL APPOINTMENTS All initial appointments shall be for a minimum of a period of six 6 months with possibly, the recommendation for an eighteen (18) month extension. REAPPOINTMENTS Reappointments to any category of membership and renewals of any designation shall be for a period not to exceed two (2) years. ARTICLE VI. CLINICAL PRIVILEGES EXERCISE OF PRIVILEGES A practitioner providing clinical services at this hospital by virtue of Medical Staff or Allied Health Professional Staff membership or otherwise, shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted by the Governing Board,except as provided in subparagraphs 6.4 and 6.5 of this Article VI. DELINEATION OF·PRIVILEGES IN GENERAL REQUESTS Each application for appointment and reappointment to the Medical Staff must contain a request for the specific staff privileges desired by the applicant. A request by the Medical Staff member for a modification of privileges must be supported by documentation of training and/or experience that supports the request. Such requests shall be processed in accordance with the procedure outlined in Section 5.4. BASIS FOR DETERMINATION OF PRIVILEGES Privileges shall be determined on the basis of the practitioner's education, training, experience, demonstrated ability and judgment, including observed professional performance, peer recommendations, and documented results of the patient care audit and any other quality review activities required by these Bylaws of the Hospital. Privilege determinations shall also be based upon all of the following factors, without limitation: (a) information concerning professional performance obtained from other sources, especially other institutions and healthcare settings wherein a practitioner exercises privileges; (b) an assessment of the ability of the hospital to provide adequate facilities and support services for the practitioner and his/her patients; current clinical and surgical competence (for the five years immediately preceding the date of application)."

Credential files for the medical staff were requested on 11/9/15 at 9 AM as a part of the usual survey process. The hospital's policies for credentialing and peer review, complete medical staff roster and the medical staff rules, regulations and bylaws were among those documents requested and reviewed on 11/9/15 at 10 AM as a part of the usual survey process.

After discussing credentialing of medical staff including policies and procedures, nine physician credential files (MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 14, and MD 15) and one AHP, PA 13 were reviewed on 11/9/15 at 10:30 AM with Credentialing Coordinators (CC) 1 and 2.

The credential files were chosen as a part of the credential file review sample because they had all been appointed to the medical staff and granted clinical privileges. Examination of the credential files revealed; a. Four of five members of the medical staff (MD 9, MD 10, MD 11, and MD 12) who had previously been granted privileges were reappointed without being reappraised for competence;

b. Two of four provisional members of the medical staff (MD 7 and MD 8) were granted clinical privileges and allowed to practice without being proctored; and,

c. One out of a total of one AHP, PA 13, was granted clinical privileges and allowed to practice without being evaluated for competence on a regular basis.

CC 1 and CC 2 were interviewed on 11/9/15 at 2 PM. They stated overseeing and managing the credential files was one of their responsibilities within the hospital. They stated the credential files had been out of order for some time. They stated they knew there were numerous credentialing issues including lack of proctoring, lack of reappraisals and lack of evaluations for competence. They stated theses were chronic problems that had been brought to the attention of the medical staff leadership and the representatives of the governing body. They stated in spite of their efforts to make leadership aware of the credentialing and medical staff issues the problems persisted. They stated the physicians were uncooperative in addressing medical staff credentialing issues. They stated they simply did not have enough time or assistance from the medical staff leadership to correct all the problems with the credential files. They stated the Chief of the Medical Staff (CS) 1 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 AHP evaluations for competence. They stated the governing body was usually not actively involved in the credentialing process on a regular basis.

The Chief Administrative Officer and the Administrator were interviewed together on 11/9/15 at 2:30 PM. They acknowledged their positions of leadership and they stated they knew they had the responsibility for ensuring these duties were performed. They stated they were aware of the fact that there were many problems, irregularities and issues with regard to the medical staff credential files. They acknowledged the fact that CC 1 and CC 2 made an effort to inform them of those problems. They stated they 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. They stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. They stated the governing body was usually not actively involved in the credentialing process on a regular basis.

The Chief of the Medical Staff was interviewed on 11/10/15 at 9:15 AM. He acknowledged his position of leadership and he stated he knew he had the responsibility for ensuring these duties were performed. He stated he were 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 CC 1 and CC 2 made an effort to inform him 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 AHP. He stated he 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.

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

1. Nursing care plans were put in place for three of 26 sampled patients (16, 18, and 20), (Refer to A 0396); and,

2. Documented and completed competencies for six contracted dialysis nurses, (Refer to A 0398); and,

3. Contracted nurses were oriented to the hospital, (Refer to A 0398).

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure nursing competency and that nursing care needs of patients were met.

Based on observation, interview, and record review, the hospital failed to ensure nursing care plans were put in place for four of 26 sampled patients (16, 18, 20, and 26). This resulted in the potential for unmet care needs.

Findings:

[Note: "Dialysis" is a process involving a large, portable machine, that is attached to a patient so that all of their blood's toxins and other fluids can be removed when their own kidneys can no longer do it. If these waste products are not removed, the result can be death. Its purpose is to keep the right levels of chemicals, fluids, and salts in one's bloodstream, control blood pressure, and remove waste products. Dialysis treatments typically take between 3 to 4 hours; during this time, all the patient's blood is removed and ran through a filter in the machine, then returned to the patient. Treatments usually occurs three times a week.

Before the dialysis treatments can happen, a surgical procedure must occur, to make a connection site on the patient. The dialysis machine usually connects to this site via two needles.]

1. During an interview with Registered Nurse (RN) 1 on 11/9/15, at 9:20 AM, she indicated Patient 16 was a dialysis patient.

During an interview with Patient 16, on 11/9/15, at 9:25 AM, she indicated she had just finished her dialysis treatment a few minutes ago.

During a concurrent interview and record review with the Medical Record Specialist (MRS), on 11/10/15, at 9 AM, she reviewed Patient 16's medical record and stated there was no nursing care plan for her dialysis treatment, e.g., response to the treatment, fluid volume monitoring, or monitoring of the dialysis access site.

During a concurrent interview and record review with RN 1 on 11/10/15, at 11 AM, she indicated Patient 16 was still a patient of the hospital and she was the nurse assigned to her. When asked if there was a care plan for Patient 16's dialysis treatment, RN 1 stated "Actually, I don't have any."

2. During a concurrent interview and record review with the MRS, on 11/10/15, at 9:40 AM, Patient 18's physician's orders were noted. Patient 18 had a physician's order for the drug "hydroxyzine" (an antihistamine - class, multipurpose drug, used for anxiety, nausea/vomiting, allergies, skin rashes, and itchiness), to be given via injection directly into a muscle (a "shot"), as needed, up to twice daily, for "anxiety, sedation, or puritis [itching]".

The record contained no nursing care plan for the drug at all, nothing addressing which of the symptoms Patient 18 was displaying, and what non-medicinal interventions the nursing staff were using, or had tried, if any.

The MRS acknowledged the finding.

3. During an observation of Patient 20 on 11/9/15, at 9:30 AM, she was receiving a dialysis treatment in the hospital's Intensive Care Unit (ICU), administered with a dialysis nurse, RN 2.

During a concurrent interview and record review with the MRS, on 11/10/15, at 10 AM, she reviewed Patient 20's medical record and stated there was no nursing care plan for her dialysis treatment, e.g., response to the treatment, fluid volume monitoring, or monitoring of the dialysis access site.

During a concurrent interview and record review with RN 4 on 11/10/15, at 10:58 AM, she indicated Patient 20 was still in the ICU, and she was the nurse assigned to her. When asked if she had a care plan for Patient 20's dialysis treatment, RN 4 stated "I haven't added a dialysis care plan."



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4. During a concurrent interview and review of Patient 26's clinical record with the MRS on 11/10/15, at 11 AM, she confirmed Patient 26 was a dialysis patient and could not find a care plan for his dialysis treatment.

During an interview on 11/10/15, at 9:40 AM, with RN 6, she stated,"[Patient 26] speaks Spanish only, but he follows directions ok."

During a concurrent interview and clinical record review on 11/10/15, at 1:40 PM, with RN 7, RN 8, and the Chief Nursing Officer (CNO), they confirmed there was no dialysis care plan nor one for communication in Patient 26's clinical record. RN 8 stated Patient 26 is unable to write and his sister needed to sign his paperwork. She confirmed there was not a care plan for written or oral communication needs. The CNO stated "We are going to do in-services on these issues. It is not our practice to care plan for Spanish speaking patients, since we have several staff who speak Spanish." The CNO indicated there was no policy and procedure for language interpretation. She confirmed there was no Spanish speaking staff currently assigned to Patient 26.

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

1. Have documented and completed competencies for six contracted dialysis nurses; and,

2. Ensure contracted nurses are oriented to hospital.

This has the potential to result in a lack of qualified nurses providing care to patients and to ensure an acceptable standard of practice is maintained for patient care and safety.

Findings:

1. During a record review of the binder titled "[Dialysis Company] 2015 Staff Credentials" (which contained documents regarding the Registered Nurses (RNs) employed by that company, their competencies (a written and dated evaluation conducted by a health care professional), on 11/9/15 at 2:30 PM, the following was noted:

RN 9 - No competency located, only a job description
RN 10 - Partial competency, not dated or signed by evaluator
RN 11 - No competency located, only a job description
RN 12 - No competency located, only a job description
RN 13 - Partial competency found, not dated or signed by evaluator
RN 14 - Partial competency found, not dated or signed by evaluator

During an interview with Vice President (VP) 1, on 11/10/15, at 2:45 PM, she reviewed the binder and could not locate the competencies. VP 1 stated this company was an outside entity the hospital contracts with. She stated a missing page containing the evaluator's signature and date of completion did exist, but these pages were not provided during the survey, nor did she explain why these pages were not included in the binder.

The [Dialysis Company's] policy and procedure, titled "Staff Qualifications and Competency - Dialysis Services", dated 1/10/13, read, in part:

"[Dialysis Company] ...shall demonstrate, assess, maintain and improve staff competence on an ongoing basis. The competency of all staff, whether they are an employee of this facility or an employee of a licensed independent practitioner shall be assessed using a single set of criteria, and at the same frequency as an individual employed by the facility. Staff shall have a documented competency assessment completed as a part of their orientation; after the 90-day period of probation, and once every three (3) years, or more frequently as defined by the facility policy or law and regulation. Assessment methods that are used shall correspond to the skill being assessed. Methods include, but may not be limited to: Direct observation by qualified supervisor or preceptor... Successful completion of a general and unit-specific skills checklist. The competency assessment program is continuous and ongoing, with reports of competency outcomes forwarded to the Governing Body on a regular basis."



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2. During an interview with the Assistant Chief Nursing Officer (ACNO), on 11/9/15, at 1:55 PM, she was asked if the hospital checked competencies for contracted employees. The ACNO stated "No, the company (Dialysis Company) does it (competencies)." The ACNO was asked about hospital orientation for contracted employees and there was no response.

During an interview with the Human Resources Director (HR), on 11/10/15, at 8:55 AM, contracted employee files were requested. The HR stated "We don't have files for contracted employees." The HR was asked about orientation for contract employees, and she stated "We don't have orientation for contract employees."

The [Dialysis Company] policy and procedure titled "Staff Qualifications and Competency" dated 1/10/13, indicated "General competency requirements established by facility policy, such as attending facility orientation..."

Based upon record review and interview, the hospital failed to ensure prescribers signed their verbal orders for medications within 48 hours for four of 26 sampled patients (16, 17, 20, and 24). This creates the potential for medication errors.

Findings:

1. During a concurrent interview with the Medical Record Specialist (MRS), and review of the clinical record for Patient 16, on 11/10/15, at 9 AM, her medication orders were noted. Patient 16 had been ordered the drug "morphine" (a narcotic pain killer) on 11/3/15, at 3:35 AM, by Medical Doctor (MD) 6. The order had not been signed by MD 6 as of the record review, making it over five days late for signature (it should have been signed by 11/5/15, by 3:35 AM).

2. During a concurrent interview with the MRS, and review of the clinical record for Patient 17, on 11/10/15, at 9 AM, her medication orders were noted. Patient 17 had been ordered the drug "acetaminophen" (an over the counter pain killer and fever reducer) on 11/6/15, at 12:18 AM, by MD 13. The order was signed by MD 13 on 11/8/15, at 10:22 PM, making it over 10 hours late for signature (it should have been signed by 11/8/15, by 12:18 AM).

3. During a concurrent interview with the MRS, and review of the clinical record for Patient 20, on 11/10/15, at 9 AM, her medication orders were noted. Patient 20 had been ordered the drug "clonidine" (to lower blood pressure) on 11/7/15, at 1:02 PM, by MD 13. The order had not been signed by MD 13 as of the record review, making it twenty hours late for signature (it should have been signed by 11/9/15, by 1:02 PM).

4. During a concurrent interview with the MRS, and review of the clinical record for Patient 24, on 11/10/15, at 9 AM, her medication orders were noted. Patient 20 had been ordered the drug "atorvastatin" (lowers cholesterol) on 11/1/15, at 7:53 PM, by MD 6. The order had not been signed by MD 6 as of the record review, making it over six days late for signature (it should have been signed by 11/3/15, by 7:53 PM). The MRS acknowledged the findings.

The hospital policy and procedure titled "Telephone, Verbal, and Written Order for Medication", dated 2/2015, read, in part: "Verbal and telephone orders are allowed, however in an effort to reduce medication errors, the use of these types of orders is discouraged. The prescribing practitioner must sign the written record of the verbal/telephone medication order within 48 hours of giving order."

Based on observation, interview, and record review, the hospital failed to have documentation to indicate an informed consent was obtained prior to procedures in the clinical record for three of 26 sampled patients (16, 20, and 26). This practice has the potential for patients receiving procedures without knowing the benefits versus risks, and/or to make an informed decision about that procedure.

Findings:

1. During an interview with Registered Nurse (RN) 1 on 11/9/15, at 9:20 AM, she indicated Patient 16 was in her care, and was a dialysis (procedure to remove waste products from the blood when kidneys fail) patient.

During an interview with Patient 16, on 11/9/15, at 9:25 AM, she indicated she had just finished her dialysis treatment a few minutes ago.

During a concurrent record review and interview with the Medical Record Specialist (MRS) on 11/10/15, at 9 AM, she reviewed the clinical record for Patient 16 and was unable to find any documentation the patient was informed of the benefits and risks of her dialysis treatment.

During an interview with RN 1 on 11/10/15, at 11 AM, she indicated Patient 16 was still her patient, and also reviewed her clinical record. RN 1 could not find any documented evidence the patient was informed of the benefits and risks of the dialysis.

2. During an observation of Patient 20 on 11/9/15, at 9:30 AM, she was receiving a dialysis treatment in the hospital's Intensive Care Unit (ICU).

During a concurrent record review and interview with the MRS on 11/10/15, at 9 AM, the clinical record for Patient 20 was noted to not have a documented informed consent for her dialysis treatment.

During an interview with RN 5 on 11/10/15, at 10:30 AM, she also reviewed Patient 20's clinical record and agreed about the findings. RN 5 indicated it is a normal hospital protocol to obtain these consents prior to the treatments.



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3. During a concurrent record review and interviews with RN 7, RN 8, and the Chief Nursing Officer (CNO), on 11/10/15, at 1:40 PM, Patient 26's clinical record was reviewed. There was no documentation to indicate Patient 26 was informed of the benefits and risks of the dialysis treatment.

RN 8 indicated in addition to being Spanish speaking only, Patient 26 was unable to read and write. The CNO stated there was no signature from Patient 26 regarding his dialysis treatment. The CNO stated, "We are going to do inservices on these issues." The CNO indicated there was no policy and procedure regarding Spanish speaking and/or illiterate patient informed consents.

Based on observation and interview, the hospital failed to ensure:

1. The door to a dialysis room was locked on two occasions, and,

2. A pediatric (child) emergency resuscitation cart (crash cart) was locked.

This resulted in an unsafe environment, with the potential for unauthorized persons to enter the dialysis room and/or pediatric emergency resuscitation cart, and to disturb, remove, and/or contaminate the equipment therein, thereby jeopardizing the safe administration and treatments to patients, including during emergency and life-threatening situations.

Findings:

[Note: "Dialysis" is a process involving a large, portable machine, that is attached to a patient so that all of their blood's toxins and other fluids can be removed when their own kidneys can no longer do it. If these waste products are not removed, the result can be death. Its purpose is to keep the right levels of chemicals, fluids, and salts in one's bloodstream, control blood pressure, and remove waste products. Dialysis treatments typically take between 3 to 4 hours; during this time, all the patient's blood is removed and ran through a filter in the machine, then returned to the patient. Treatments usually occur three times a week.]

During a concurrent interview and observation of the dialysis room with a dialysis Registered Nurse (RN) 2 on 11/9/15, at 10:10 AM, the door to the dialysis room was left unlocked. The dialysis room was located across from patient Room 128, at the end of a hallway that had several patients, some of which were noted to be ambulating in the hallway. Inside the dialysis room were four dialysis machines and assorted dialysis supplies. RN 2 indicated all the machines were in working order, and the door should be locked at all times, to prevent access from unauthorized individuals, including patients who were lost or confused.

During a concurrent interview and observation of the dialysis room with the Medical Records Specialist (MRS) on 11/10/15, at 11 AM, the door was again unlocked, and also visibly open an inch or two. The MRS acknowledged the finding.



32946

During an observation on 11/9/15, at 8:54 AM, in a patient care area of the hospital emergency department, a posted note on the wall read "PEDS CRASH CART." A nine drawer pediatric crash cart had two unsecured drawers (first and third) allowing staff and non staff access to pediatric patients emergency care supplies. Seven of the nine drawers were individually secured with a single yellow zip tie. The first unsecured drawer contained multiple patient care supplies including the following; a sterile trachea (the windpipe) kit, sterile pediatric foley catheter (a tube into the bladder used to drain urine), peripheral intravenous catheter (small tube placed into a vein in order to administer medication or fluids).

During a concurrent observation and interview with RN 16 on 11/9/15, at 8:55 AM, she verified that the two drawers on the pediatric crash cart were unsecure. She stated the cart was used to get supplies to start pediatric foley catheters but was unable to verify when the cart was last used.

During an interview with Assistant Chief Nursing Officer, on 11/9/15, at 2 PM, she was asked to provide the hospital policy and procedure regarding hospital practice for maintaining security of the pediatric crash cart. No policy and procedure were provided.

Based on observation, interview, and record review, the hospital failed to maintain the hospital ground in a clean and orderly manner which had potential to provide an unsafe environment for its patients, visitors and staff.

Findings:

During a concurrent observation and interview with the Assistant Chief Nursing Officer (ACNO), Medical Records Specialist (MRS) and the Lead Engineer (LE) on 11/9/15, at 8:40 AM, the following items were identified during a tour of the Norwalk facility.

1. One patient gurney placed in front of a door identified as "Nurses lounge."
2. Dialysis Machine in the hospital dialysis storage room with brownish red substance on the left lower corner of the machine.
3. Pediatric crash cart with the first and third drawers unsecured.
4. One large linen storage (that would not close) container stored outside with exposed linen eastside of the hospital.
5. Several cardboard boxes lying on the ground behind a large gray bin northside of the hospital.
6. One bread rack with spider webbing and tree leaves on the lower base, one wood pallet and six black milk storage containers stored at the westside of the hospital.
7. One gray two drawer file cabinet and a brown folding table stored against the northside of the hospital.
8. One white cloth screen divider ripped in several places, out side the recovery room.
9. Ten hospital beds with mattresses lined up against the eastside of the hospital.
10. Stored on the ground between storage containers: One toilet, five halogen light bulbs, two metal stands, six wood boards, seven metal pipes on the ground, three wood doors, three green dirty and used metal gas containers.
11. Three patient mattresses stored outside a northside entry of the hospital.
12. One blue cart blocking the exit door on the northside of the hospital.
13. Three metal framed carts stored on the eastside of the hospital.
14. Four trash dumpster's uncovered.
15. One large cardboard box containing trash.
16. One white bucket with a unknown black liquid substance inside.
17. One ladder in the extended position stored against the east wall.
18. One bed side table stored against the eastside of the hospital.
19. One white closet door stored against the east wall of the hospital.
20. One gurney with a white sheet stored outside on the east wall of the hospital.
21. Emergency room waiting area air conditioner wall units electrical cord was not connected to electrical outlet (cord dangling against the wall).
22. Dialysis (is a process for removing waste and excess water from the blood and is used primarily as an artificial replacement for lost kidney function) machine in Intensive Care Unit leaking clear liquid on to a towel on the floor.

During a concurrent observation and interview of the hospital environment with the ACNO and MRS, on 11/9/15, at 8:48 AM, the above listed findings were verified by the ACNO and the MRS. At 9:50 AM the LE joined the tour, he verified the northside and the eastside findings.

The hospital policy and procedure titled "Environmental Services Scope of Services", dated 7/22/09, indicated: "Scope of Services: It is the mission and goal of the Environmental Services Department to maintain a clean environment for all who come into contact with the hospital... Scope of Care: Environmental Services is dedicated to provide a safe and clean environment for all patients, visitors and staff consistent with the values, vision and mission of the hospital."

The hospital policy and procedure titled "Infection Control linen and Laundry Storage Regulations," dated 5/2000, indicated: "All shelves must be covered to prevent clean linen from contamination through the air-borne pathogens."

The hospital policy and procedure titled "Environmental Services Safety Rules," dated 7/22/09, indicated: "Do not leave soiled rags lying around. Dispose of them... Keep all exits and fire doors free from any obstructions... Be sure all trash cans are covered... Keep all supply and utility rooms in a clean and orderly condition."

Based on observation, interview, and record review, the Norwalk hospital location failed to maintain a sanitary environment when four of four dumpsters were not covered. This had the potential for insect vermin infestation.

Findings:

During a concurrent observation and interview with the Assistant Chief Nursing Officer (ACNO), on 11/9/15, at 9:55 AM, on the northside of the Norwalk hospital, it was noted all four blue dumpsters' (used to dispose of the entire hospitals trash) lids were flipped backwards exposing the waste inside. The ACNO verified the findings but could not offer any comment. She stated, "I'll call the maintenance."

During a concurrent interview and observation with the Lead Engineer on 11/9/15, at 10:11 AM, he explained why the blue trash dumpsters were not covered. He stated, "It's a constant struggle with the waste company, they come at eight o'clock in the morning. When asked if staff comes out to close them (blue trash dumpster's) he had no comment.

The hospital's policy and procedure titled "Environmental Services Scope of Services," dated 7/22/09, indicated: "Scope of Services: It is the mission and goal of the Environmental Services Department to maintain a clean environment for all who come into contact with the hospital... Scope of Care: Environmental Services is dedicated to provide a safe and clean environment for all patients, visitors and staff consistent with the values, vision and mission of the hospital."

The hospital's policy and procedure titled "Environmental Services Safety Rules" dated 7/22/09 indicated to "...Be sure all trash cans are covered..."

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

1. Ensure the isolation cart contained only required supplies.

2. Ensure the dialysis (is a process for removing waste and excess water from the blood and is used primarily as an artificial replacement for lost kidney function) machine was maintained in safe working order.

This had the potential to place patient, staff, and visitors at risk for infection and injury.


Findings:

1. During a concurrent observation and interview with Registered Nurse (RN) 19, on 11/9/15, at 11:39 AM, inside the Intensive Care Unit (ICU) at the Norwalk hospital, it was noted just outside of a patient treatment room was a yellow cart, RN 19 explained "It's an Isolation Cart." During further inspection of the cart, the following items were found in the cart:
a. First drawer- sterile boarder gauze, unsterile boarder gauze, EKG (electrocardiogram - is a test that checks for problems with the electrical activity of your heart) electrodes (patches used in routine EKG testing), open used 10 cubic centimeter (cc) syringe with unknown fluid inside, 6 rolls of clothe tape, three 10 cc saline flushes a spray can of air freshener, and one abdominal pad.

b. Second drawer- one used dirty glove, and two rolls of two-inch plastic tape.

RN 19 verified the findings and replied "Gown, mask, gloves, and signs" were the items in the isolation cart.

During an interview with the Assistant Chief Nursing Officer (ACNO), on 11/9/15, at 2:54 PM, she was made aware of the condition of the isolation cart. She was asked who was responsible for maintaining the isolation cart, the ACNO replied, "The nurse."

During an interview with the Infection Control Officer (IC), on 11/9/15, at 3:05 PM, he was asked what items should be stored in the isolation cart. The IC stated, "Personal Protective Equipment (PPE), gloves, mask, and other items for PPE." The IC was informed of the items found in the isolation cart, he stated, "It shouldn't be in there."

2. During an observation on 11/9/15, at 11:50 AM, inside the ICU patient room (104), it was noted a dialysis (is a process for removing waste and excess water from the blood and is used primarily as an artificial replacement for lost kidney function) machine was being used to provide treatment to a patient. There was noted a towel lying on the floor at the rear of the dialysis machine to absorb the clear liquid dripping from the tubing connected to the dialysis machine. The dialysis electric power cord and the extension cord connection were lying next to the wet towel.

During an interview with RN 18, on 11/9/15, at 11:56 AM, RN 18 verified the findings and stated, "Yes, that's why I have the towel there."

During an interview with the Lead Engineer (LE) on, 11/9/15, at 3:16 PM, the LE said he was not aware the dialysis machine was leaking, he had not been notified.

The hospital policy and procedure titled "Environmental Services Scope of Services" indicated "Scope of Services and goal of the Environmental Services Department to maintain a clean environment for all who come into contact with the hospital. To achieve the goal and accomplish this mission, we shall work in harmony with other departments, organize efficiently, purchase economically, maintain equipment and train staff following accepted guideline and policies for department operation in an acute care facility... The service to the hospital includes: ...All other departments and areas of the hospital."

Based on observation, interview and record review, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to:

1. Remove dirty towels from dialysis machines (a large machine, that is attached to a patient so that all of their blood's toxins and other fluids can be removed when their own kidneys can no longer do it). (Refer to A 0749)

2. Ensure nothing stored on top of dialysis machine. (Refer to A 0749)

3. Ensure staff would wear Personal Protective Equipment (PPE, includes masks, gowns, and gloves) during dialysis. (Refer to A 0749)

4. Use hospital approved disinfectants. (Refer to A 0749)

5. Clean dialysis machine properly. (Refer to A 0749)

6. Maintain its dialysis room in a sanitary condition. (Refer to A 0749)

7. Discard expired supplies. (Refer to A 0749)

8. Discard opened sterile supplies. (Refer to A 0749)

9. Separate storage for nonsterile and sterile supplies. (Refer to A 0749)

10. Ensure isolation cart contained required supplies. (Refer to A 0749)

11. Dispose of used cardboard. (Refer to A 0749)

12. Cover trash cans. (Refer to A 0713 and A 0749)

13. Dispose of broken equipment. (Refer to A 0724 and 0749)

14. Store linens in a closed and covered area. (Refer to A 0749)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment which had placed its patients, staff, and visitors at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and record review, the hospital's infection control officer failed to develop an effective infection control program which had the potential to mitigate the risks of spreading healthcare-associated infections to its patients as evidenced by:

1. Leaving dirty towels on dialysis machines (a large machine, that is attached to a patient so that all of their blood's toxins and other fluids can be removed when their own kidneys can no longer do it).

2. Storing items on top of dialysis machine.

3. Failure to ensure staff wear Personal Protective Equipment (PPE) during dialysis.

4. Failure to use hospital approved disinfectants.

5. Failure to clean the dialysis machine properly.

6. Failure to maintain a sanitary condition in the dialysis room.

7. Not disposing of expired supplies.

8. Failure to dispose of opened sterile supplies.

9. Storing non-sterile and sterile supplies together.

10. Failure to ensure isolation cart contained only required supplies.

11. Failure to ensure cardboard was disposed of properly.

12. Failure to cover trash cans.

13. Failure to dispose of broken equipment.

14. Failure to store linens in a closed and covered area.

Findings:

1. During a concurrent interview and observation of the dialysis room, at the Los Angeles hospital location, with Registered Nurse (RN) 2, on 11/9/15, at 10:10 AM, the door to the dialysis room was noted to be unlocked. The dialysis machines were noted to have large, white terrycloth towels on the lower portions of the machines. RN 2 indicated the towels should not be there, and stated, "They should be removed when in storage."

During an observation on 11/9/15, at 8:40 AM, in the Dialysis room at the Norwalk hospital, with RN 15, a dialysis machine was found to have the following items on it:

One white towel with brown spots left on the lower base of a dialysis machine,
One white towel with brown spots wrapped around the tubing of the dialysis machine; and,
One white towel with brown spots hanging from a plastic holder on back of dialysis machine.

RN 15 verified the findings and could not provide a policy and procedure how dialysis machines should be stored.



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2. During an observation and interview on 11/9/15, at 9:40 AM, with RN 2, in the Intensive Care Unit (ICU), at the Los Angeles hospital location, the dialysis machine next to Patient 20's bed was noted to have a 3-ring binder, an open package of medical gauze, medical tape and several rubber gloves on it.

During a concurrent observation and interview with RN 18, on 11/9/15, at 9:20 AM, in the ICU bed 4 at the Norwalk hospital, RN 18 was monitoring the dialysis machine, and the dialysis machine was noted to have the following items on top: 3-ring binder, clipboard, and a box of gloves. RN 18 was asked about the items on top of the machine, and she stated "It's my binder and paperwork." RN 18 removed the items and placed them on the counter.

During an observation on 11/9/15, at 11:26 AM, in ICU, bed 4 at the Norwalk hospital, it was noted again the dialysis machine had a box of gloves on top.

During an interview with the owner of the Dialysis Company, on 11/9/15, at 3:40 PM, he was asked about items kept on the dialysis machine, he stated "It shouldn't be." When asked for a policy and procedure the Owner stated "I don't have one."

3. During an observation on 11/9/15, at 9: 40 AM, in Patient 20's room at the Los Angeles hospital, it was noted a sign posted outside the patients's room read, "Isolation Contact Precautions," and it indicated a gown, gloves and a mask were required to enter the room. RN 2 was observed inside the room providing care without gloves and a face mask.



29618

During observation on 11/9/15, at 11:40 AM, in ICU, bed 4, RN 18 was taking Patient 1 off of the dialysis machine, and RN 18 wore a mask and a pair of gloves.

During an interview with RN 18 on 11/9/15, at 11:47 AM, she was asked about wearing PPE during dialysis. RN 18 stated the policy is to wear mask, gloves, and gown. RN 18 was asked should she wear a gown while terminating the patient's dialysis treatment, and she stated "Yes, I just didn't put it on."

During an interview with the Infection Control Officer (IC), on 11/9/15, at 3:05 PM, he was asked about PPE the dialysis nurse should wear. The IC stated "I'm new on the job...they received the information on wearing PPE, but I haven't done any training."

During an interview with the Owner, on 11/9/15, at 3:30 PM, he was asked what PPE should the nurses wear while terminating patients dialysis treatment. The Owner stated "Gloves, mask, and maybe a gown, but they should follow the policy."

The Dialysis Company policy and procedure titled "Standard Precautions" dated 1/10/13, indicated "Standard Precautions apply to all patients regardless of their diagnosis or suspected infection status. Standard Precautions apply to the following: Blood, All body fluids, secretions... Standard Precautions include Personal Protective Equipment (PPE- used to protect staff from contact with infectious agents, and to prevent staff from carrying these infections agents from patient to patient): Gloves, Gowns, Mouth, Nose, Eye Protection."

The Dialysis Company policy and procedure titled "Personal Protective Equipment (PPE)" dated 1/10/13, indicated: "Staff shall wear PPE during: The initiation and termination of dialysis treatment."

4. During an observation with RN 15, on 11/9/15, at 8:40 AM, in the Dialysis Room, it was noted there was a container labeled "Lemon Scent disinfecting wipes (up & up brand from Target), a powerful cleaner for kitchen cuts through grease." The active ingredients listed: Dioctyl dimethyl ammonium chloride and dimethyl benzyl ammonium chloride.

During an interview with RN 18, on 11/9/15, at 9:20 AM, she was asked what is used to clean the dialysis machine. RN 18 stated "I have a technician that I call and he comes to clean it... It's kept in the cabinet in the room, the disinfectant that's used for everytime."

During an interview with RN 18, on 11/9/15, at 9:30 AM, she was shown the Lemon Scent up & up brand, and asked if this was the disinfectant. RN 18 stated "Yes, I usually keep it on the machine."

During an interview with the Assistant Chief Nursing Officer (ACNO), on 11/9/15, at 11:25 AM, she was asked for an approved list of hospital cleaners. The ACNO called to Central Supply, and said she was told there are two: Micro-Kill One (bleach free disinfectant cleaner) and Micro-Kill bleach (a bleach solution equivalent to a 1:10 dilution).

During an interview with RN 18, on 11/9/15, at 11:30 AM, she was asked where the Lemon Scent wipes were from, and she stated "The company (Dialysis Company) provides it."

During an interview with Owner, on 11/9/15, at 3:30 PM, he was asked if the company approved the Lemon Scent wipes to clean the dialysis machine. The Owner stated: "They should not use Lemon Scent wipes. It shouldn't be used on the machine. The bleach wipes should be used... maybe use those on the table."

The Dialysis Company policy and procedure titled "Cleaning and Disinfection of Medical Devices and Equipment" dated 1/10/13, indicated "Dialysis Services staff shall clean and disinfect surfaces, medical devices and equipment per manufacturer's instructions and using a facility-approved disinfectant."

The Dialysis Machine Model #2008K Operator's Manual, Chapter 5- Disinfection and Maintenance indicated "Cleaning the Exterior Surface- It can be cleaned with a very dilute bleach or other suitable hospital disinfectant. Freshly prepared dilute bleach solution (1:100) is currently recommended by the Center for Disease Control... Do not use foaming cleanser or disinfectants containing...dimethyl benzyl ammonium chloride. These ingredients attack the poly carbonate plastics used in the machine."

5. During a concurrent observation and interview with RN 18 on 11/9/15, at 11:50 AM, she was wearing a mask and gloves cleaning the front of the dialysis machine with a disinfectant wipe. RN 18 moved a gallon bottle of vinegar from the bottom shelf of the machine and placed it on the floor, she wiped the bottom shelf, and immediately picked the gallon bottle of vinegar off the floor and placed it back onto the bottom shelf of the machine. RN 18 was asked the wet time (amount of time for disinfectant to kill germs), and she stated "two minutes."

The Dialysis Company policy and procedure titled "Personal Protective Equipment (PPE)" dated 1/10/13, indicated: "Staff shall wear PPE during: Cleaning and disinfecting of patient care supplies and equipment."

The Dialysis Company policy and procedure titled "Standard Precautions" dated 1/10/13, indicated "Standard Precautions include Personal Protective Equipment (PPE- used to protect staff...: Gloves, Gowns, Mouth, Nose, Eye Protection)."

The Dialysis Machine Model #2008K Operator's Manual, Chapter 5- Disinfection and Maintenance indicated "Cleaning the Exterior Surface- It can be cleaned with a very dilute bleach or other suitable hospital disinfectant... Rinse off cleaning solution with a water-dampended cloth, especially if a corrosive, cleaning agent such as bleach is used."

6. During an observation on 11/9/15, at 8:40 AM, in the Dialysis Room with RN 15, the following items were found:

A dialysis machine had brownish red substance on left lower corner of the machine,
One white towel with brown spots placed on the front lower base of a dialysis machine,
One white towel with brown spots wrapped around the tubing on a dialysis machine,
One white towel with brown spots in a plastic holder on back of dialysis machine,
One dirty white wash cloth on the floor,
One blue glove placed on the opening of Bicarbonate Concentrate 9.5 Liter bottle (with a piece of tape dated 11/7/15 2130),
One blue glove place over the opening Pure Bright Ultra Bleach 1 gallon bottle; and,
Blood bank storage cabinet marked biohazard with a bag of blood inside.

The findings were verified by RN 15.

There was no policy and procedure provided regarding the sanitary condition of the Dialysis Room.

7. During an observation on 11/9/15, at 8:55 AM, in the Emergency Department, inside a cabinet labeled "Laceration" the following items were found:

13 packages of 2-0 Prolene SH 30 inch suture (a strand or fiber used to sew parts of the living body) with an expiration date of "Jan 2015."

One Gen-Probe urine specimen kit (swab used to collect and transport specimens) with an expiration date "1-31-2015."

During an interview with the ACNO, on 11/9/15, at 9 AM, she validated the findings and stated, "They (expired items) shouldn't be in there."

The hospital policy and procedure titled "Outdated Sterile Supplies" dated 5/2003, indicated "Unless an item is within its expiration date it shall be considered no longer sterile and must be returned to Central Service for processing or disposal, as appropriate. Items distributed to patient care units or departments shall be checked monthly to monitor outdated supplies..."

The hospital policy and procedure titled "Outdated Supplies, Handling of" dated 5/2003, indicated "All supplies which have reached the expiration date should be removed from service and returned to Central Service for reprocessing or disposal."

8. During a concurrent observation and interview with the ACNO on 11/9/15, at 8:55 AM, in the Emergency Department, inside a cabinet labeled "Laceration" a disposable scalpel (out of package) was found stored with sterile scalpels. The ACNO stated, "That's wrong...shouldn't be together."

The Centers for Disease Control and Prevention (CDC, the nation's health protection agency, working 24/7 to protect America from health and safety threats, both foreign and domestic. CDC increases the health security of our nation), Infection Control, indicated: "Unwrapped items are susceptible to contamination. Avoid storing items loose in drawers or cabinets because unwrapped items cannot be kept sterile. Items stored in this manner are subject to contamination from dust, aerosols generated during treatment, and the hands of personnel who must handle them."

9. During a concurrent observation and interview with the ACNO, on 11/9/15, at 9:05 AM, in the Emergency Department, inside a lower drawer the following items were found stored together:

A blue plastic basket containing multiple loose cotton balls, one vacutainer (translucent plastic holder for needle), 12 - sterile hypodermic needles, 4 - sterile eclipse needles (single-hand activation), and 4 - blood collection tubes

Gauze pads (sterile and non sterile), red poly cath rectal tube (tube which is inserted into the rectum in order to relieve gas or feces), and a dirty pressure infuser labeled with a black mark in three areas "ICU".

The ACNO verified the findings and stated "They shouldn't be together."

The CDC, Infection Control, recommends that sterile supplies should be stored separately from clean supplies. If clean and sterile supplies must be stored within the same shelving unit, the sterile items should be stored on the upper shelves above the clean items.



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10. During a concurrent observation and interview with RN 19, on 11/9/15, at 11:39 AM, inside the ICU, outside a patient treatment room was a yellow cart, RN 19 was asked what the cart was, and he stated "It's an Isolation Cart." The following items were found in the cart:

1. In the first drawer- sterile border gauze, unsterile border gauze, EKG (electrocardiogram - a test that checks for problems with the electrical activity of your heart) electrodes (patches used in routine EKG testing), open used 10 cubic centimeter (cc) syringe with unknown fluid inside, 6 rolls of clothe tape, 3 -10 cc saline flushes syringes, spray can of air freshener, abdominal pad.

2. second drawer- used dirty glove and 2- rolls of 2 inch plastic tape.

RN 19 verified the findings. RN 19 was asked what should be inside the isolation cart, and he stated "Gown, mask, gloves, and signs."

During an interview with the ACNO, on 11/9/15, at 2:54 PM, she was made aware of the condition of the isolation cart. The ACNO was asked who was responsible for maintaining the isolation cart, and she said the nurse.

During an interview with the IC, on 11/9/15, at 3:05 PM, he was asked what items belong in the isolation cart. The IC stated "Personal Protective Equipment (PPE), gloves, mask, and other items for PPE." The IC was asked about the extra items found inside, and he stated "It shouldn't be in there."

During an interview with the ACNO, on 11/9/15, at 2:54 PM, inside the hospital conference room, she was made aware of the items found on the yellow isolation cart. The ACNO was asked who was responsible for maintaining the isolation cart she said the nurses. The hospital policy and procedure for the isolation cart was requested from the ACNO, none were provided.

11. During a concurrent observation and interview with the ACNO, on 11/9/15, at 9:52 AM, near a north wall on the north side of the hospital where the medical surgical unit was, there were two gray bins observed. The bin on right side had a printed sign secured read "CARDBOARD ONLY." Several cardboard boxes were seen on the ground behind the gray bin on the right. The ACNO verified the findings said, "Those shouldn't be there (referring to the cardboard boxes on ground)."


12. During a concurrent observation and interview with the ACNO and the Lead Engineer (LE), on 11/9/15, at 9:55 AM, at the north side of the hospital, it was noted there were four blue dumpsters left uncovered and exposed the waste inside. The ACNO verified the findings and stated "I'll call maintenance."

During a concurrent interview and observation with the LE on 11/9/15, at 10:11 AM, the LE was asked why the blue trash dumpsters were not covered with the lids; LE stated, "It's a constant struggle with the waste company, they come at eight o'clock in the morning. When asked if staff comes out to close them (blue trash dumpster's) he did not offer any comment.

The hospital policy and procedure titled "Environmental Services Scope of Services" dated 7/22/09 indicated: "Scope of Services: It is the mission and goal of the Environmental Services Department to maintain a clean environment for all who come into contact with the hospital... Scope of Care: Environmental Services is dedicated to provide a safe and clean environment for all patients, visitors and staff consistent with the values, vision and mission of the hospital."

The hospital policy and procedure titled "Environmental Services Safety Rules," dated 7/22/09, read in part, "...Be sure all trash cans are covered..."

13. During a concurrent observation and interview with the ACNO, Medical Records Specialist (MRS), and the LE, on 11/9/15, at 8:40 AM, the following broken and unusable patient items were identified during a tour of the hospital:

a. One white two column storage cart containing linen with roll up doors that could not be shut.

b. One gray two drawer file cabinet and a brown folding table stored on the ground in a outside entry way (north side of the hospital).

c. One white cloth screen divider ripped in several places.

d. Ten hospital beds with mattresses lined up in a row at the east wall of the hospital, one of the hospital beds had a sign posted to it that read, "BROKEN keeps falling down."

e. One toilet, five halogen light bulbs, two metal stands and three wood doors were stored on the ground in a space between two large storage containers.

f. Three patient mattresses stored outside in a north entry of the hospital.

g. Three metal cart frames stored on the east wall of the hospital.

h. One white closet door stored against the east wall of the hospital.

The above findings were verified by the ACNO and MRS.

During a concurrent observation and interview with the LE, on 11/9/15, at 9:52 AM, the LE was asked why the beds (10 beds and 10 mattresses) were stored there, he said, "All my broken beds, these are here for parts." The LE verified the unusable equipment needed to be disposed of.

The hospital policy and procedure titled "Environmental Services Scope of Services" dated 7/22/09, indicated: "Scope of Services: It is the mission and goal of the Environmental Services Department to maintain a clean environment for all who come into contact with the hospital... Scope of Care: Environmental Services is dedicated to provide a safe and clean environment for all patients, visitors and staff consistent with the values, vision and mission of the hospital."


14. During an observation on 11/9/15, at 9:36 AM, outside the kitchen, a white two column storage cart with four divided sections contained linen (towels). The roll up doors of each divided section could not completely closed exposing the clean linens to outside environment.

During an interview with the ACNO, on 11/9/15, at 9:37 AM, she stated these linens may be used by the kitchen staff.

During an interview with the Dietician, on 11/9/15, at 9:40 AM, the Dietician was asked what the linen was used for and she stated, "They use it in the kitchen to clean."

During an interview with the Dietary Aide, on 11/9/15, 9:44 AM, he was asked who used the linen stored in the white two column storage cart he stated, "We use it to clean the kitchen." The Dietician acted as interpreter.

The hospital policy and procedure titled "Infection Control linen and Laundry Storage Regulations" dated 5/2000, indicated that "Procedure: All shelves must be covered to prevent clean linen from contamination through the air-borne pathogens.