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Tag No.: A0043
Based on a review of facility documentation, a tour of the facility and staff interviews, the hospital failed to have an effective governing body which was legally responsible for the conduct of the hospital.
Findings were:
A review of facility documentation revealed the governing body had not:
· Appointed physicians or granted physician privileges per regulatory requirements. One physician credentialing files included an appointment letter signed by the facility's CEO. Only one physician file, the facility Medical Director, contained an appropriate credentialing letter and listing of granted privileges.
· Ensured contracted physician services were provided in a safe manner as physicians contracted by the hospital Emergency Department were credentialed by the facility's CEOs and had not been granted privileges of any sort by the hospital.
· Updated outworn and inconsistent facility policies as many of the existing policies, regarding for example infection control or patient rights, had been written in the late 1990s. In addition, each department appeared to have their own version of a number of critical policies, for example infection control and patient rights, rather than hospital-wide policies.
· Ensured an effective and ongoing Quality Assurance and Performance Improvement Program. Though data was being extensively collected by Staff #11, there was no documented evidence of that data being used to improve patient outcomes. In addition, there was no documented evidence of performance improvement projects being conducted by the hospital. The QAPI program also included no significant involvement of the hospital infection control program, as no such program existed.
· Ensured a safe and sanitary patient environment which was monitored by an infection control program as no infection control committee existed. With the exception of occasional cultures being done on the premises, no other organized infection control activities were occurring, including monitoring of handwashing or infection control staff training.
The By-Laws of the Board of Managers of Lamb County Hospital included the following:
"Article VI
Powers and Responsibilities
Responsibility for medical-administrative policies and operation of the Center will be vested in the Board of Managers. The responsibilities and obligations of the Board of Managers shall be:
Section 6.1 - Responsibility for all medical, professional, and ethical activities of the Center, including the granting of staff privileges and the establishment of organizations and committees necessary for the proper and ethical conduct and the monitoring of all clinical activities...
Section 6.11 - The Board will ensure an effective Performance Improvement Program is implemented hospital-wide. Performance Improvement results will be reported to the Board through the Chief Executive Officer..."
These findings were confirmed in an interview with the facility CEO on the afternoon of 4/1/15 in the facility conference room.
Cross refer CFR 482.12(a)(2)
Cross refer CFR 482.12(e)(1)
Cross refer CFR 482.13(a)(1)
Cross refer CFR 482.21
Cross refer CFR 482.22
Cross refer CFR 482.42
Tag No.: A0046
Based on a review of facility documentation and staff interviews, the facility's governing body failed to reappoint members of the medical staff based on recommendations of the existing members of the medical staff. Only one physician, the facility medical director, was appropriately credentialed and privileged.
Findings were:
A review of the credentialing file of Staff #31, a physician, revealed a reappointment letter which stated in entirety, "After review of the credentialing package, [Staff #31] has been approved for privileges at Lamb Healthcare Center with no changes in previously requested privileges." The letter was dated 1/27/15 and included a checkmark by "Approved From 01-2015 To 01-2017." The letter was signed only by Staff #1, the Chief Executive Officer. There was no documented evidence in the governing board meeting minutes from October, 2014 through March 2015 that the board had reappointed this physician. There was no documented evidence in the minutes that the medical staff had made any recommendation to the governing board regarding this matter.
The only privilege list in the credentialing file of Staff #31 was a standardized "Privilege List for Family Practice Departments in Hospitals" which included a list of privileges with a column to the left of the list headed by an "R." The form defined this as "privilege requested: indicates you believe you can properly diagnose and treat this problem ..." A column to the right of the privileges list was headed by a "G" which the form defined as "privilege granted." This column included entries of "8/04" or "8/04 assist" by the marked requested privileges. The file included no documented evidence that the privileges had been reviewed by the facility Medical Executive Committee since August 2004.
The credentialing file of Staff #30, D.O., included a re-appointment letter which stated, in entirety, "After review of the credentialing package, [Staff #30] has been approved for privileges at Lamb Health Center with no changes in requested privileges." The letter was dated 4/16/13 and was "Approved From 4/16/13 To 4/16/15." The file included no listing of privileges.
In an interview with Staff #21, Administrative Assistant of the CEO, on the afternoon of 4/1/15 in the facility conference room, she stated she was the individual who had "pretty much been handed" the job of credentialing. When asked about the privileges of Staff #30, she stated, "We've tried over and over to get his list of privileges from him. We've just not been able to. He just hasn't brought it in."
She also stated the Emergency Room physicians were supplied by Concord Medical Group. A review of 3 of the credentialing files for these physicians revealed no list of privileges in 3 of 3 files reviewed [Staff #32-34]. The credentialing letters in these files included the same wording for each physician, and stated, in entirety, "After review of the credentialing package, [physician name] has been approved for Emergency Room privileges as requested." Each form was signed by either the current or former CEO of Lamb Healthcare Center. There was no documented evidence available that the facility governing board had appointed these individuals or granted them privileges.
Staff #21 agreed that the files included no list of privileges and stated she'd not be aware of the need to obtain those privileges. She also stated, "We just weren't aware we had to go through that whole procedure with the Governing Board and the committee for all the doctors." She agreed that currently the only physician appropriately credentialed and with a current list of privileges was the facility Medical Director.
A review of the Lamb Healthcare Center Bylaws of the Medical and Dental Staff revealed the following:
"Membership on the Medical Staff of LHC is a privilege which shall be extended only to professionally competent practitioners who continuously meet the qualifications, standards, and requirements set forth in these Bylaws ...All applicants for appointment or re-appointment shall be qualified mentally, physically and by training and work experience to practice their profession and procedures with sound judgment ...
Section 3.3 - Conditions and Duration of Appointment:
A. Initial appointments and re-appointments to the Medical Staff shall be made by the Governing Body. The Governing Body shall act on all appointments, re-appointments, or revocation of appointments only after there has been a recommendation from the Medical Staff as provided by these Bylaws ...
C. Appointment to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Governing Body, in accordance with these Bylaws ...
F. Reappointment and/or the renewal or revision of clinical privileges is based on a reappraisal of the individual at the time of reappointment and/or the renewal or revision of clinical privileges ...
Article VI: Clinical Privileges ...
A. Every practitioner practicing at this Hospital by virtue of Medical Staff membership shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him/her by the Governing Body ...
C. Periodic predetermination [sic] of clinical privileges and the increase or curtailment of same shall be based upon the direct observation of care provided, review of the records of patients treated in this or other hospitals, and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care ... "
In an interview with Staff #1, the Chief Executive Officer, on the afternoon of 4/1/15 in the facility conference room, he confirmed all the above findings. He stated, "I've only been here since the beginning of January. None of this is a surprise."
Tag No.: A0084
Based on a review of facility documentation and staff interviews, the facility's governing body failed to credential and grant privileges to contract physicians supplying services to the facility's emergency department.
Findings were:
In an interview with Staff #21, Administrative Assistant of the CEO, on the afternoon of 4/1/15 in the facility conference room, she stated she was the individual who had "pretty much been handed" the job of credentialing. She also stated the Emergency Room physicians were supplied by Concord Medical Group. A review of 3 of the credentialing files for these physicians revealed no list of privileges in 3 of 3 files reviewed [Staff #32-34]. The credentialing letters in these files contained the same wording for each physician, and stated, in entirety, "After review of the credentialing package, [physician name] has been approved for Emergency Room privileges as requested." Each form was signed by either the current or former CEO of Lamb Healthcare Center. There was no documented evidence available in the files that indicated the governing board had received recommendations on the appointment of these physicians from the medical executive committee, or that they had been approved for privileges by the governing board.
Staff #21 agreed that the files included no list of privileges and stated she'd not be aware of the need to obtain those privileges. She also stated, "We just weren't aware we had to go through that whole procedure with the Governing Board and the committee for all the doctors." She agreed that currently the only physician appropriately credentialed and with a current list of privileges was the facility Medical Director.
In an interview with Staff #1, the Chief Executive Officer, on the afternoon of 4/1/15 in the facility conference room, he confirmed all the above findings.
Tag No.: A0117
Based on a review of facility documentation and staff interview, the facility failed to provide documented evidence of having current information available for patients regarding patient rights, and of having informed each patient, or patient's representative, of these rights.
Findings were:
A review of patient clinical records revealed that 20 of 20 charts included no documented evidence of patients having received information about their rights. While the facility did have a pamphlet entitled Rights and Responsibilities of Patients, the pamphlet did not contain complete patient rights information. For example, no information was included on the following rights:
o the facility grievance process and who to contact regarding a complaint related to patient care
o the right to formulate advance directives.
o visitation rights, including any clinical restriction or limitation on such rights
A document in small type entitled Your Rights as a Hospital Patient, was posted at two entrances of the hospital. This document did contain the following statement, "You have the right to have an advance directive, such as a living will or health care proxy..."
A document was posted regarding contact information for complaints related to privacy rights, but no contact information was available on complaints or grievances related to patient care.
In addition, the various departments of the hospital each appeared to have their own policy related to patient rights, each of which differed from one another. For example, each of the following patient rights policies included a different list of rights and different wording of those rights:
· Administration Policy #PR18, entitled Patient Rights, last reviewed June 1999
· Obstetric Policy #4001, entitled Patient's Rights and Responsibilities, last reviewed January 2010
· Radiology Policy, entitled Patient's Rights, last reviewed 12/10/14 (originally written January 1994 with no changes).
· Administration Policy entitled Patient Rights, last revived December 1994
None of these policies contained a complete or accurate listing of patient rights as required by current regulations.
The most up-to-date and comprehensive listing of patient rights was located in the Dietary Department Policy & Procedure Handbook. While being the most comprehensive, the policy, revised January 2014, still did not contain complete information on patient rights.
In an interview with the facility CEO on the afternoon of 4/1/15 in the facility conference room, he confirmed that the patient rights policies varied from department to department and were out of date. In addition, the incomplete listing in the patient pamphlet and the lack of patient acknowledgement of receipt of the pamphlet made it impossible to ascertain whether patients had been accurately informed of their patient rights as delineated by current regulatory standards.
Tag No.: A0118
Based on a review of facility documentation and staff interview, the facility failed to establish a process for prompt resolution of patient grievances and to inform each patient whom to contact to file a grievance.
Findings were:
A review of patient charts revealed that 20 of 20 charts contained no documented evidence that the patients were informed of the facility patient rights, including how to make a complaint and whom to contact to file a grievance. There appeared to be no posting in the facility related to this matter, with the exception of whom to contact regarding a violation of privacy.
Review of facility policy #PR 11, entitled Complaints and last revised February 1997, revealed it contained a small section addressing personnel complaints. Another section addressed patient complaints, and read as follows, in its entirety:
"Patient/Family/Visitor Complaints:
These are resolved on the unit when possible.
1. Staff will inform the immediate supervisor/department head of complaint.
2. Supervisor/department head will discuss complaint with patient. Problem resolved at this level if possible.
3. If unresolved, the Hospital Administrator is notified by the department head.
4. Complaints of a serious nature are immediately addressed to the Director of Nursing, and CEO.
Documentation of complaints will be maintained in Administration."
In an interview with the new facility CEO on the afternoon of 4/1/15 in the facility conference room, he agreed the hospital's complaint and grievance policy "was probably from 1997" and did not contain the required, accurate information.
Tag No.: A0121
Based on a review of facility documentation and staff interview, the facility failed to establish a clearaly explained procedure for the submission of a patient's written or verbal grievance to the hospital which met current requirements.
Findings were:
A review of facility policy #PR 11, entitled Complaints and last revised February 1997, contained a small section addressing personnel complaints. Another section addressed patient complaints, and read as follows, in its entirety:
"Patient/Family/Visitor Complaints:
These are resolved on the unit when possible.
1. Staff will inform the immediate supervisor/department head of complaint.
2. Supervisor/department head will discuss complaint with patient. Problem resolved at this level if possible.
3. If unresolved, the Hospital Administrator is notified by the department head.
4. Complaints of a serious nature are immediately addressed to the Director of Nursing, and CEO.
Documentation of complaints will be maintained in Administration."
In an interview with the new facility CEO on the afternoon of 4/1/15 in the facility conference room, he agreed the hospital's complaint and grievance policy "was probably from 1997" and did not contain the required, accurate information.
Tag No.: A0143
Based on a review of facility documentation, a facility tour and staff interview, the facility failed to ensure each patient's right to personal privacy as a video monitor for four rooms in patient use was situated such that anyone walking into that area of the hospital could view the monitor. The area was open to all visitors and staff.
Findings were:
During a tour of the facility on the morning of 4/2/15, it was noted a monitor of four patient rooms, #6, 7, 26 and 27, was placed in a round nursing station which had no back walls. The nursing station could be approached from four different hallways. One of the hallways was one of two primary entrances through which members of the public and staff could enter the facility. The monitor screen was divided into four shots, one of each room, and was clearly visible by anyone near the nursing station.
A posted document in small print entitled Your Rights as a Hospital Patient included the following, in part: "You have the right to privacy. The hospital, you doctor, and others caring for you will protect your privacy as much as possible ... "
In an interview with the Director of Nursing during the tour on the morning of 4/2/15, she acknowledged that she'd wondered herself if the video monitor was a patient privacy issue, and agreed it clearly revealed each room monitored to anyone in the vicinity of the nursing station.
Tag No.: A0263
Based on a review of facility documentation and staff interviews, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide quality assessment and performance improvement (QAPI) program.
Findings were:
A review of the facility Performance Improvement and Quality Improvement Committee meeting minutes for 2014 and 2015 revealed the following:
o the QAPI program did not involve all hospital departments and services, most notably infection control and the emergency department services.
o though much data was collected related to indicators, there was no documented evidence that the data was not implemented to improve patient health outcomes or reduce medical errors.
o The minutes included no documented evidence of current or past performance improvement projects available for surveyor review.
The above findings were confirmed in an interview with Staff #11, Quality Assurance Staff, and the DON on the afternoon of 4/1/15 in the facility conference room. They were also confirmed in an interview with the CEO the morning of 4/2/15 in the facility conference room. He agreed the facility was collecting a vast amount of data, but was not implementing resulting interventions which used that data to improve patient care or outcomes.
Cross refer CFR 482.21(a), (b)(1), (b)(2)(i), (b)(3)
Cross refer CFR 482.21(d)
Cross refer CFR 482.21(e)(1), (e)(2), (e)(5)
Tag No.: A0273
Based on a review of facility documentation and staff interviews, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide quality assessment and performance improvement (QAPI) program. Though much data was collected related to indicators, there was no documented evidence that the data was analyzed and implemented to improve patient health outcomes or reduce medical errors.
Findings were:
In an interview with the DON and Staff #11, Quality Assurance Staff, on the afternoon of 4/1/15 in the facility conference room, they identified the Quality Improvement Committee as the facility QAPI committee. Staff #11 stated the committee was now called the Performance Improvement committee.
A review of the minutes of the Quality Improvement and Performance Improvement committee meetings for all of 2014 through February, 2015 revealed data being collected on a number of quality indicators. However, the minutes revealed simply a listing of the numbers for each indicator reviewed. There was some discussion of contract renewals, a task of the Governing Body, as well as reports from each department in a staff meeting format. There was no documentation of how the gathered facility data was analyzed or implemented to improve patient care or outcomes, or of current or past hospital-wide performance improvement projects.
Involvement of other departments appeared sporadic. Surgery services reported at the 3/13/14 meeting, respiratory services reported at the 6/14/14 meeting and 2/10/15 meeting. Though certain departments occasionally noted infection control issues in their report to QAPI, the infection control program did not exist and hence, was not involved in the QAPI program. The Emergency/Trauma Department appeared to have little to no involvement as well. Many of the departmental reports included a report of an issue or problem that had been noticed by the department, and an advisory statement on how to handle the issue, or an assignment of a specific staff member to follow up on the issue. The committee meeting appeared to be essentially a staff meeting.
As an example, the minutes of the 2/10/15 Quality Improvement Committee included a long listing of data and statistics, including:
"Medication Errors
10 Medication Error for the Month of January
1 Wrong Dose Given
3 Wrong Time
6 Missed Doses
1 Adverse Drug Reaction (ER)
0 Recalls will follow up with CS (Central Stores) Department Manager ...
Reporting Departments...
Dietary
Texas Dietetics Association approved diets are now available for Nursing Staff & Physicians. A cheat sheet will be placed a nurses station for reference.
Plate Warmer In-service ...
Labor & Delivery
Hepatitis B Vaccines are administered according to insurance coverage. OB nurses are to complete proper form, and administer vaccine from proper stock. For questions see OB Supervisor ...
Nursing
10 medication errors for January, Medication Verify was 94%.
Nursing staff is to call Environmental Services anytime the shower in rooms 102/104 have been used (show is to be cleaned after every use). Nursing staff need to use patient's shower when patient is ambulatory ..."
There was no information regarding the use of the data collected related to medication errors. There was little documented discussion of indicators which had been used by departments to monitor an issue. No indicator values were available which reflected the result of interventions implemented.
The above findings were confirmed in an interview with Staff #11 and the DON on the afternoon of 4/1/15 in the facility conference room. They were also confirmed in an interview with the CEO the morning of 4/2/15 in the facility conference room. He agreed the facility was collecting a vast amount of data, but was not analyzing or implementing interventions which used that data to improve patient care or outcomes.
Tag No.: A0297
Based on a review of facility documentation and staff interviews, the hospital failed to conduct performance improvement projects
Findings were:
A review of the facility Performance Improvement and Quality Improvement Committee meeting minutes for 2014 and 2015 revealed no documented discussion of formal, hospital-wide performance improvement projects.
In an interview with the DON and Staff #11, Quality Assessment Staff on the afternoon of 4/1/15 in the facility conference room, they stated they were gathering data and about to approach the board regarding approval of performance improvement projects. They agreed that documented projects had not been performed in the past few years at the hospital, but stated that individual departments had informally worked to improve performance.
These findings were confirmed with the CEO and other administrative staff on the morning of 4/2/15 in the facility conference room.
Tag No.: A0309
Based on a review of facility documentation and staff interviews, the hospital's governing body, medical staff and administrative officials did not ensure that the hospital had an ongoing program for quality improvement and patient safety, that formal, hospital-wide quality assessment and performance improvement efforts were implemented and evaluated, and that the determination of the number of distinct improvement projects was conducted annually.
Findings were:
Minutes of the Lamb County Board of Managers were reviewed for 2014 and 2015. The meetings were held on the following dates:
· 2/18/14
· 6/17/14
· 8/19/14
· 2/17/15
The minutes of the 6/17/14 meeting included the following entry related to quality assessment and performance improvement at Lamb County Hospital:
"PERFORMANCE IMPROVEMENT REPORT:
[Staff name] presented the Performance Improvement Report ...There were 35 admissions and 32 discharges in May. Average length of stay was 4.41. Highest Census was 10 and the lowest was 3. Emergency Services saw 253 patients. There were 12 newborn deliveries ..."
The minutes of the 8/19/14 meeting included the following entry related to quality assessment and performance improvement:
"[The DON] presented the Performance Improvement Report. There were 26 admissions and 32 discharges in July. Average length of stay was 6.6. Highest Census was 10 and the lowest was 2. Emergency Services saw 248 patients. There were 6 newborn deliveries. There were no patient incidents and 2 employee incidents for the month of July. Med Verify was 95.91%. There were 4 medication errors in July those being 1 wrong dose and 3 missed doses ..."
The minutes of the 2/17/15 meeting included the following entry related to quality assessment and performance improvement:
"QAPI stands for Quality Assurance Performance Improvement. This term basically means that Departments will identify a project and work toward a goal of completing it in the next 3 months. Department Heads will report where they are with the project and where they are going with it. The Quality Improvement Report was presented to the board members. There were 47 admissions and 43 discharges in January. Average length of stay was 5.21. Highest Census was 13 and the lowest was 4. Emergency Services saw 280 patients. There were 8 newborn deliveries. There were 0 patient incidents and 1 employee incident for the month of January. Med Verify was 94.0%. There were 10 medication errors in January ..."
In an interview with the CEO on the afternoon of 4/1/15 in the facility conference room he stated he had been at the facility since January 2015. He stated he understood the concept of QAPI and said he believed there was much education about QAPI yet ahead for staff and the board. He also confirmed that the hospital was currently collecting much data, but not utilizing that data as required by regulatory standards.
Tag No.: A0338
Based on a review of facility documentation, a tour of the facility and staff interviews, the hospital failed to have an organized medical staff that operated under bylaws approved by the governing body, and which was responsible for the quality of medical care provided to patients by the hospital as staff and contract physicians were not credentialed or granted privileges according to the medical staff bylaws.
Findings were:
A review of facility documentation revealed the hospital had not:
· Appointed physicians or granted physician privileges per regulatory requirements. One physician credentialing files included an appointment letter signed by the facility's CEO. Only one physician file, the facility Medical Director, contained an appropriate credentialing letter and listing of granted privileges.
· Ensured contracted physician services were provided in a safe manner as physicians contracted by the hospital Emergency Department were credentialed by the facility's CEOs and had not been granted privileges of any sort by the hospital.
· Ensured an effective and ongoing Quality Assurance and Performance Improvement Program. Though data was being extensively collected by Staff #11, there was no documented evidence of that data being used to improve patient outcomes. In addition, there was no documented evidence of performance improvement projects being conducted by the hospital. The QAPI program also included no significant involvement of the hospital infection control program, as no such program existed.
· Ensured a safe and sanitary patient environment which was monitored by an infection control program as no infection control committee existed. With the exception of occasional cultures being done on the premises, no other organized infection control activities were occurring, including monitoring of handwashing or infection control staff training.
These findings were confirmed in an interview with the facility CEO on the afternoon of 4/1/15 in the facility conference room.
Cross refer CFR 482.22(a)(1)
Cross refer CFR 482.22(a)(2)
Cross refer CFR 482.21(e)(1), (e)(2), (e)(5)
Cross refer CFR 482.42(b)
Tag No.: A0340
Based on a review of facility documentation and staff interview, the facility failed to periodically conduct reappraisals of its members as the only physician properly credentialed and privileged was the facility Medical Director.
Findings were:
A review of the credentialing file of Staff #31, a physician, revealed a reappointment letter which stated in entirety, "After review of the credentialing package, [Staff #31] has been approved for privileges at Lamb Healthcare Center with no changes in previously requested privileges." The letter was dated 1/27/15 and included a checkmark by "Approved From 01-2015 To 01-2017." The letter was signed only by Staff #1, the Chief Executive Officer. There was no documented evidence in the governing board meeting minutes from October, 2014 through March 2015 that the board had reappointed this physician.
The only privilege list in the credentialing file of Staff #31 was a standardized "Privilege List for Family Practice Departments in Hospitals" which included a list of privileges with a column to the left of the list headed by an "R." The form defined this as "privilege requested: indicates you believe you can properly diagnose and treat this problem ..." A column to the right of the privileges list was headed by a "G" which the form defined as "privilege granted." This column included entries of "8/04" or "8/04 assist" by most of the requested privileges. The file included no documented evidence that the privileges had been reviewed by the facility Medical Executive Committee since August 2004.
The credentialing file of Staff #30, D.O., included a re-appointment letter which stated, in entirety, "After review of the credentialing package, [Staff #30] has been approved for privileges at Lamb Health Center with no changes in requested privileges." The letter was dated 4/16/13 and was "Approved From 4/16/13 To 4/16/15." The file included no listing of privileges.
In an interview with Staff #21, Administrative Assistant of the CEO, on the afternoon of 4/1/15 in the facility conference room, she stated she was the individual who had "pretty much been handed" the job of credentialing. When asked about the privileges of Staff #30, she stated, "We've tried over and over to get his list of privileges from him. We've just not been able to. He's just not brough it in."
She also stated, "We just weren't aware we had to go through that whole procedure with the Governing Board and the committee for all the doctors." She agreed that currently the only physician appropriately credentialed and with a current list of privileges was the facility Medical Director.
A review of the Lamb Healthcare Center Bylaws of the Medical and Dental Staff revealed the following:
"Membership on the Medical Staff of LHC is a privilege which shall be extended only to professionally competent practitioners who continuously meet the qualifications, standards, and requirements set forth in these Bylaws ...All applicants for appointment or re-appointment shall be qualified mentally, physically and by training and work experience to practice their profession and procedures with sound judgment ...
Section 3.3 - Conditions and Duration of Appointment:
A. Initial appointments and re-appointments to the Medical Staff shall be made by the Governing Body. The Governing Body shall act on all appointments, re-appointments, or revocation of appointments only after there has been a recommendation from the Medical Staff as provided by these Bylaws ...
C. Appointment to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Governing Body, in accordance with these Bylaws ...
F. Reappointment and/or the renewal or revision of clinical privileges is based on a reappraisal of the individual at the time of reappointment and/or the renewal or revision of clinical privileges ...
Article VI: Clinical Privileges ...
A. Every practitioner practicing at this Hospital by virtue of Medical Staff membership shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him/her by the Governing Body ...
C. Periodic predetermination [sic] of clinical privileges and the increase or curtailment of same shall be based upon the direct observation of care provided, review of the records of patients treated in this or other hospitals, and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care ... "
In an interview with Staff #1, the Chief Executive Officer, on the afternoon of 4/1/15 in the facility conference room, he confirmed all the above findings. He stated, "I've only been here since the beginning of January. None of this is a surprise."
Tag No.: A0341
Based on a review of facility documentation and staff interviews, the facility's governing body failed to appoint members of the medical staff after considering the recommendations of the existing members of the medical staff as only one physician, the facility medical director, was appropriately credentialed and privileged.
Findings were:
A review of the credentialing file of Staff #31, a physician, revealed a reappointment letter which stated in entirety, "After review of the credentialing package, [Staff #31] has been approved for privileges at Lamb Healthcare Center with no changes in previously requested privileges." The letter was dated 1/27/15 and included a checkmark by "Approved From 01-2015 To 01-2017." The letter was signed only by Staff #1, the Chief Executive Officer. There was no documented evidence in the governing board meeting minutes from October, 2014 through March 2015 that the board had reappointed this physician. There was no documented evidence in the minutes that the medical staff had made any recommendation to the governing board regarding this matter.
The only privilege list in the credentialing file of Staff #31 was a standardized "Privilege List for Family Practice Departments in Hospitals" which included a list of privileges with a column to the left of the list headed by an "R." The form defined this as "privilege requested: indicates you believe you can properly diagnose and treat this problem ..." A column to the right of the privileges list was headed by a "G" which the form defined as "privilege granted." This column included entries of "8/04" or "8/04 assist" by most of the requested privileges. The file included no documented evidence that the privileges had been reviewed by the facility Medical Executive Committee since August 2004.
The credentialing file of Staff #30, D.O., included a re-appointment letter which stated, in entirety, "After review of the credentialing package, [Staff #30] has been approved for privileges at Lamb Health Center with no changes in requested privileges." The letter was dated 4/16/13 and was "Approved From 4/16/13 To 4/16/15." The file included no listing of privileges. There was no documented evidence that the Medical Executive Committee had recommended to the governing board which privileges the physician should be granted.
In an interview with Staff #21, Administrative Assistant of the CEO, on the afternoon of 4/1/15 in the facility conference room, she stated she was the individual who had "pretty much been handed" the job of credentialing. When asked about the privileges of Staff #30, she stated, "We've tried over and over to get his list of privileges from him. We've just not been able to. He's just not brought it in."
She also stated the Emergency Room physicians were supplied by Concord Medical Group. A review of 3 of the credentialing files for these physicians revealed no list of privileges in 3 of 3 files reviewed [Staff #32-34]. The credentialing letters in these files was the same for each physician, and stated, in entirety, "After review of the credentialing package, [physician name] has been approved for Emergency Room privileges as requested." Each form was signed by either the current or former CEO of Lamb Healthcare Center. There was no documented evidence available in the files that indicated the governing board had received recommendations on the appointment of these physicians from the medical executive committee, or that they had been approved for privileges by the governing board.
Staff #21 agreed that the files included no list of privileges and stated she'd not be aware of the need to obtain those privileges. She also stated, "We just weren't aware we had to go through that whole procedure with the Governing Board and the committee for all the doctors." She agreed that currently the only physician appropriately credentialed and with a current list of privileges was the facility Medical Director.
A review of the Lamb Healthcare Center Bylaws of the Medical and Dental Staff revealed the following:
"Membership on the Medical Staff of LHC is a privilege which shall be extended only to professionally competent practitioners who continuously meet the qualifications, standards, and requirements set forth in these Bylaws ...All applicants for appointment or re-appointment shall be qualified mentally, physically and by training and work experience to practice their profession and procedures with sound judgment ...
Section 3.3 - Conditions and Duration of Appointment:
A. Initial appointments and re-appointments to the Medical Staff shall be made by the Governing Body. The Governing Body shall act on all appointments, re-appointments, or revocation of appointments only after there has been a recommendation from the Medical Staff as provided by these Bylaws ...
C. Appointment to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Governing Body, in accordance with these Bylaws ...
F. Reappointment and/or the renewal or revision of clinical privileges is based on a reappraisal of the individual at the time of reappointment and/or the renewal or revision of clinical privileges ...
Article VI: Clinical Privileges ...
A. Every practitioner practicing at this Hospital by virtue of Medical Staff membership shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him/her by the Governing Body ...
C. Periodic predetermination [sic] of clinical privileges and the increase or curtailment of same shall be based upon the direct observation of care provided, review of the records of patients treated in this or other hospitals, and review of the records of the Medical Staff which document the evaluation of the member's participation in the delivery of medical care ... "
In an interview with Staff #1, the Chief Executive Officer, on the afternoon of 4/1/15 in the facility conference room, he confirmed all the above findings. He stated, "I've only been here since the beginning of January. None of this is a surprise."
Tag No.: A0747
Based on a review of facility policies, staff interviews, and a tour of the facility, the facility failed to ensure a functional and sanitary environment for patients as there were multiple risks for cross contamination and patient infection. In addition, the facility failed to have an active infection control program for the prevention, control, and investigation of infections and communicable diseases as there was no real infection control committee. There were also issues found related to the storage of medications in the labor & delivery suite and the sterilization of instruments in the OR.
Findings were:
During a tour of the facility the morning of 4/2/15 with the Director of Nursing and Maintenance Director, the following was observed:
In the kitchen, a number of wet cooking pans were stacked together. When asked to identify the status of the pans, the dietary director stated they were dried pans available to be used when needed.
In the physical therapy area, patient supplies were stored below stained and ill-fitting acoustic ceiling tiles. Ill-fitting tiles provide an opening for dust, debris, or insect penetration, as well as affect smoke detector functioning. Stained tiles can harbor mold or mildew. When asked the source of the stains, the facilities plant manager stated there had been a water leak at one point. Next to the patient whirlpool, there was an approximately 6" x 6" hole in the drywall out of which a pipe emerged to connect the whirlpool. The DON identified the whirlpool as no longer being used by patients, but added a smaller pool next to the whirlpool was still in use. Again, the hole allowed for dust, debris and insect penetration into the area.
The Radiology Department had a number of stained and ill-fitting acoustic ceiling tiles, including a water-stained area approximately 10" by 10" directly above the x-ray bed. There was a layer of dust and dirt on the floors throughout the department and on high horizontal surfaces, indicating a lack of cleaning and disinfection. In Room #2, the vinyl baseboard was missing from an approximate 3' area, and subfloor and dirt were visible there. Thick, globular dust was visible between the wall and equipment. Radiology Room #1 was identified by the Director of Radiology as being available for "back-up when the machine in Room #2 is down." Room #1 also had areas of stained and ill-fitting ceiling tiles, as well as a layer of dust and dirt on the floors. In Room #1, there was an area of thick, overt dirt near one wall. Both radiology patient rooms #1 and #2 had tables on which uncovered towels and other patient linens were stored. These tables each had areas of broken laminate which left exposed, porous wood surfaces, making the tables impossible to clean adequately. The CT scan room had a thick layer of dust on high horizontal surfaces and dirt on the floor. One of the cabinets housed several stained, wadded paper towels. When asked to identify these, the Director of Radiology stated, "Those are from our equipment guys. They use these cabinets." The patient restroom had peeling, sticky wall paper which made it difficult to clean the room.
On the Nursing Unit, a housekeeping closet had a large puddle of standing water on the floor which was approximately 2' x 2'. When asked what the source of the water was, the DON stated she didn't know and speculated that maybe it had been spilled. The crash cart side railings were covered in a layer of thick dust. In the Patient Nutrition Room, several items were found under the sink, including an old plastic cup lying on its side, a large bucket sitting under the pipe and a dead roach carcass. The Maintenance Director stated the bucket had probably been placed there at some time when there was concern about a leak. Stains in the form of circular rings and general dirt and debris were also under the sink. In the patient linen closet, four carcasses of what appeared to be dead insects were visible in the light fixture.
In Labor & Delivery, a freezer contained 15 boxes of the medication Cervidil. A log sheet next to the freezer showed daily temperature readings which monitored freezer functioning. The heading stated the acceptable range of the freezer was from 0 to 10 degrees. Several entries were 11 degrees. When the DON and Director of Labor & Delivery were asked about the entries, they stated the Pharmacy Department was responsible for the freezer log. When the pharmacy tech was questioned about the consequence of the freezer temperature being out of range several times, she stated, "I didn't do anything. Maybe I should have."
In the OR, there was dust, lint, dirt and debris under the sink and drip stains on cabinet exteriors of the scope reprocessing room.
In an interview during a tour of the OR area on the morning of 4/2/15, Staff #13, the OR Director, and Staff #18, the sterile processing technician, were asked for the manual to the sterilizer. Neither individual could locate the manual. When asked if daily and weekly maintenance, as well as other recommended maintenance, was carried out according to manufacturer's recommendations, the OR Director said, "All we ever do is wipe it off every now and then." She indicated they were unsure of other required maintenance.
The Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, states in part, "Chemical indicators are affixed on the outside of each pack to show that the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration. Chemical indicators usually are either heat-or chemical-sensitive inks that change color when one or more sterilization parameters (e.g., steam-time, temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are present. Chemical indicators have been grouped into five classes based on their ability to monitor one or multiple sterilization parameters ...If the internal and/or external indicator suggests inadequate processing, the item should not be used ... An air-removal test (Bowie-Dick Test) must be performed daily in an empty dynamic-air-removal sterilizer (e.g., prevacuum steam sterilizer) to ensure air removal ..."
A Bowie-Dick Test tests the sterilizer's mechanical air removal system to remove air from the chamber and is not a process indicator.
In an interview with Staff #18, the OR sterile processing technician, on a tour of the OR suite on the morning of 4/2/15 she stated she ran a Bowie-Dick Test each day and a biological indicator each week, and "those are the only tests I know about."
In an interview with Staff #7, the Infection Control Nurse, on the afternoon of 4/1/15 in the facility conference room, she was asked about her background in infection control. She answered, "I just have my bachelor's degree. I attended a TSICP (Texas Society of Infection Control & Prevention) conference one year. That was probably about four years ago. I don't really have any other infection control training." Documented evidence of attendance at the TSICP conference was not available in her personnel record for surveyor review. When asked what kind of infection control training she was conducting with staff, she stated, "I do general infection control topics with new staff during orientation. Otherwise, that's it." She stated she had been handling infection control for the hospital since approximately 2010. When it was mentioned there appeared to be no minutes of meetings of an infection control meeting, Staff #7 confirmed there was no real infection control committee. She stated, "I just write a report to the board each month with the results of some culture tests and with results of inspecting a couple of patient rooms for maintenance issues. There's no committee."
As an example, the January 2015 Governing Body Monthly Infection Control Report read as follows, in its entirety:
"Inpatient Culture Results:
Findings: Four inpatient cultures were collected. There were no hospital acquired infections. Actions: Will continue to monitor on monthly basis for hospital-acquired infections.
Environment/Equipment Culture Results:
Findings: Two cultures were performed this month. Both cultures were negative.
Actions: Will continue to monitor and collect cultures on a monthly basis.
Room Inspection results:
Findings: Room 105 and 128 were inspected. There were no problems found with 105. Room 128 was found to have wallpaper lifting up by AC unit and small tear in blue overnight chair. Actions: Spoke to maintenance supervisor [name] and turned in maintenance request. Will continue to inspect rooms monthly and report findings as necessary."
The facility Environmental Services policy entitled Procedure for Cleaning Radiology Department, last reviewed March 1994, stated in part, "The X-Ray area is included into the sub-critical section because patients are brought into this area for diagnostic examination. Environmental Services should not be held responsible for the maintenance or cleaning of X-Ray equipment or tables ...Environmental Services, however, should assume responsibility for cleaning all other surfaces and furniture in the area ...
Daily Procedure:
X-Ray Examination Rooms: ...
2. Dust mop floors with clean, treated dust mop. Be sure to get behind machines and into corners.
3. Dust ledges, tops, sides, plexiglass viewing windows, chairs, counter tops, etc. in the areas. De sure to wipe dry after damp dusting with germicidal detergent solution.
4. Damp mop floors using germicidal detergent solution ... "
The facility Environmental Services policy entitled Floor Care Procedures, last reviewed March 1994, stated in part, "Daily Maintenance: Dust mop, wet mop, and spot clean daily ... "
Facility Pharmacy policy of Subject: Infection Control - Pharmacy, last reviewed 1996, stated in part:
"IV. MEDICATIONS
A. General
1. All medications shall be stored under proper conditions with regard to light, moisture, and temperature..."
All of the above findings were confirmed with the Director of Nursing and other staff noted above during a tour of the facility on the morning of 4/2/15, and the risks of possible contamination were acknowledged.
The findings were again confirmed in an interview with the facility CEO and other administrative staff on the morning of 4/2/15 in the facility conference room.
Cross refer CFR 482.42(b)
Tag No.: A0756
Based on a review of facility documentation, a hospital tour and staff interviews, the hospital leadership failed to ensure that infection control issues were addressed in the hospital-wide quality assessment and performance improvement (QAPI) program.
Findings were:
In an interview with the DON and Staff #11, Quality Assurance Manager, on the afternoon of 4/1/15 in the facility conference room, they identified the Quality Improvement Committee as the facility QAPI committee. Staff #11 stated the committee was now called the Performance Improvement committee.
A review of the minutes of the Quality Improvement and Performance Improvement committee meetings for 2014 through present revealed occasional input from Environmental Services somewhat related to infection control issues, but no additional information from infection control was documented.
The only entries related to infection control were as follows, in their entirety:
4/15/14 "Infection Control: Deferred. Will follow-up with department manager for May QI meeting. "
7/14 "Infection Control: Report not avail. "
10/16/14 Infection Control: 6 cultures were done for the quarter 3 came back positive. Environmental services was notifies [sic] and will continue to monitor. Flu shots are avail. LHC (Lamb Healthcare Center) encourages all staff member [sic] to get vaccinated. "
1/13/15 "Infection Control: Report not avail. "
In the interview above, when Staff #11 was asked about whether there was additional input from infection control, she stated, "No, there's just usually no information. "
The above findings were confirmed in an interview with the CEO and DON on the afternoon of 4/2/14 in the facility conference room.
Tag No.: A0952
Based on a review of facility documentation and staff interview, the facility failed to ensure that a medical history and physical examination was completed and documented no more than 30 days before or 24 hours after admission for 2 of 4 surgical patients.
Findings were:
A review of 4 surgical patient clinical records revealed that 2 records, those of Patients #18 and #19, included no evidence of a history and physical having been performed within the previous 30 days or prior to the patient procedure.
The clinical record of Patient #18 included a history and physical completed on 10/17/14. His procedure was performed on 12/5/14.
The clinical record of Patient #19 included a history and physical completed on 7/31/14. His procedure was performed on 10/31/14.
In an interview with the Medical Records Manager on the morning of 4/2/15 in her office, she agreed the history and physicals had not been performed within the required time frame and speculated a lack of awareness of the 30 day time frame as the cause.
The above findings were confirmed in an interview with the CEO and other administrative staff on the morning of 4/2/15 in the facility conference room.