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Based on record review and interview the facility failed to follow the Governing Body Bylaws for membership of the board members. The facility failed to conduct Board Committee Meetings with a quorum and review the Hospital Committee Reports concerning issues of the on-going operations of the facility, including utilization review and quality of patient care on three out of five meetings.

Review of the Governing Body Bylaws revealed no documentation that the Bylaws had been approved, updated, or customized specifically for this facility.

Reviewed record titled Governing Body Bylaws revealed: Article VI Governing Body Procedure " 1. Appointment and Term of Office The Governing Body shall be composed of not less than five individuals appointed by resolution of the Board of Directors of Promise Healthcare, Inc. The Governing Body shall include the Hospital Administrator and a
representative from the Medical Staff. In the event that a management company manages the Hospital, a management company representative shall be appointed to attend all Governing Body meetings but shall not be entitled to vote. The Medical Staff shall be entitled to representation and voice at each meeting of the Governing Body. The term of each Board Member shall be two years and shall begin on January 1. Notwithstanding any provision contained herein to the contrary, the Board of Promise Healthcare, Inc., may remove any Governing Body member by resolution and may alter the dates on which terms of office
begin."

Review of record titled Promise Healthcare Leadership Policy and Procedure Number L11, Subject: Governing Board Bylaws and Guidelines revealed "When Promise Healthcare owns or leases these facilities; the Board consists of at least the following members: Vice President of Region, the Promise Healthcare facility CEO, the president of Medical Staff, the Promise Healthcare Vice President of Risk and Compliance." The Governing Body Bylaws revealed Promise Healthcare Leadership Policy and Procedure had not been approved by the Governing Body. Membership of the Governing Body is not composed of at least five individuals.

Review of record titled Governing Body Bylaws revealed: Article VI Governing Body Procedure 3. Quorum "The presence at any meeting of a majority of the members of the
Governing Body then in office shall constitute a quorum for the transaction of business, and except as otherwise required by law or these bylaws, the act of a majority present at the meeting at which a quorum is present shall constitute the act of the Governing Body. The act shall be instituted unless it conflicts with business matters relating to the financial operation or management of the Hospital. In the absence of a quorum, a majority of the Governing Body present at the time and place of any meeting may adjourn such meeting until such time as a quorum is present. Notice of any adjourned meeting need not be given."

Review of record titled Governing Body Bylaws revealed: Article XI Quality of Professional Services 1. Governing Body Responsibility. "After considering the recommendations of the Medical Staff and other professional staffs, the Governing Body shall conduct a review and evaluation of activities on a continuing basis to assess, preserve, and improve the over-all
quality and efficiency of patient care in the Hospital. The Governing Body shall within the reasonable capabilities of the Hospital provide whatever administrative assistance is reasonably necessary to support and facilitate the implementation and the on-going operation of these review and evaluation activities, including utilization review and review of the quality of patient care."

Attendance records of the Board Meetings on July 14, 2010, October 13, 2010, and November 10, 2010 revealed only the President of Medical Staff, the Chief Executive Officer, and the Chief Clinical Officer (who is not a member of the Board) were present. The Board meetings did not make quorum per the Governing Board Bylaws.

Review of records titled Governing Board Committee Meeting Minutes dated April 29, 2010, July 14, 2010, August 11, 2010, October 13, 2010, and November 10, 2010 revealed the following. Three of five Governing Board Committee Meetings did not have a quorum or address Hospital Committee Reports (Performance Improvement, Employee Health, Human Resource Issues, and Quality Issues, Risk Management, Environment Control, Mortality/Morbidity Report, Blood Utilization, Medical Records, Policy Review, and Pharmacy and Therapeutics).

The July 14, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer). The Governing Board committee reviewed credential files and reappointed 23 physicians and 10 consulting physicians to the facility staff membership without a Governing Board committee quorum. There was no documentation of Hospital Committee Reports.

The October 13, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer). The Governing Board committee reviewed credential files and reappointed 8 physicians to the facility staff membership without a Governing Board committee quorum. There was no documentation of Hospital Committee Reports.

The November 10, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer). The Governing Board committee reviewed credential files and reappointed 4 physicians and 1 consulting physician to the facility staff membership without a Governing Board committee quorum. There was no documentation of Hospital Committee Reports.

An interview was held with the Chief Executive Officer (CEO) on February 9, 2011 at 2:00 PM in the conference room. The CEO confirmed the Governing Board Committee did not meet quorum on three of five meetings.

Based on document review and interview the facility failed to ensure a Quality Assessment and Performance Improvement (QAPI) program that included Dialysis Services services furnished under contract or arrangement. The facilities incomplete process placed all patients dialyzed in this facility at risk. Citing 12 of 12 months of QAPI meeting minutes reviewed.

Findings:
Review of the QAPI meeting minutes for year 2010 on 2/8/2011 at 2:00 pm revealed no documentation of quality indicators relating to Dialysis care. No evidence of any tracking or trending of health associated infections, water quality(chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system), dialysis equipment preventative maintenance, adverse events. Including infection control(staff and patient screening, sepsis episodes, and patient infections), staffing to include(training, certification of water policies, and non-adherence to policies and procedures by facility staff). Also no documentation of a clinical record review to include dialysis treatment errors and medication errors.



Refer to Tag number: 0144 and Tag 0724

Based on record review and interview the Governing Body failed to conduct Governing Board Committee Meetings with a quorum to reappoint physicians to the medical staff of the facility on three of five meetings.

Attendance records of the Governing Board Committee Meetings on July 14, 2010, October 13, 2010, and November 10, 2010 revealed only the President of Medical Staff, the Chief Executive Officer, and the Chief Clinical Officer (who is not a member of the Board) were present. The Board meetings did not make quorum per the Governing Board Bylaws.

Reviewed record titled Governing Body Bylaws revealed: Article VI Governing Body Procedure 1. Appointment and Term of Office "The Governing Body shall be composed of not less than five individuals appointed by resolution of the Board of Directors of Promise Healthcare, Inc. The Governing Body shall include the Hospital Administrator and a representative from the Medical Staff. In the event that a management company manages the Hospital, a management company representative shall be appointed to attend all Governing Body meetings but shall not be entitled to vote. The Medical Staff shall be entitled to representation and voice at each meeting of the Governing Body. The term of each Board Member shall be two years and shall begin on January 1. Notwithstanding any provision contained herein to the contrary, the Board of Promise Healthcare, Inc., may remove any Governing Body member by resolution and may alter the dates on which terms of office
begin."

The July 14, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer). The Governing Board committee reviewed credential files and reappointed 23 physicians and 10 consulting physicians to the facility staff membership. Physicians # 27-59 were reappointed to the medical staff without a Governing Board committee quorum.

The October 13, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer). The Governing Board committee reviewed credential files and reappointed 8 physicians to the facility staff membership. Physicians # 60-67 were reappointed to the medical staff without a Governing Board committee quorum.

The November 10, 2010 Board meeting had only two members present (President of Medical staff and the Chief Executive Officer).The Governing Board committee reviewed credential files and reappointed 4 physicians and 1 consulting physician to the facility staff membership. Physicians # 22-26 were reappointed to the medical staff without a Governing Board committee quorum.

Interview was held with the Chief Executive Officer (CEO) on February 9, 2011 at 2:00 PM in the conference room. CEO confirmed the Governing Board Committee did not meet quorum on three of five meetings.

Based on record review and interview, the Governing Body failed to evaluate the quality of the dialysis contracted service.

Review of records titled Governing Board Committee Minutes dated April 29, 2010, July 14, 2010, August 11, 2010, October 13, 2010, and November 10, 2010 revealed the dialysis contracted service had not been evaluated in the year 2010 by the Governing Body.

Review of records titled Medical Executive Committee Meetings dated April 14, 2010, June 22, 2010, July 13,2010, August 4, 2010, October 6, 2010, and November 3, 2010 revealed the dialysis contracted service had not been evaluated in the year 2010 by the Medical Executive Committee.

Interview with Chief Clinical Officer on 2/8/2011 at 5:00 PM in the conference room, confirmed the Governing Body and Medical Executive Committee had not evaluated the quality of the dialysis contracted service.


Refer to Tag 0263

Based on record review and interviews the facility failed to develop and adopt a policy that encompasses all the elements of the Patient Rights.

Review of the Policy and Procedure, " Patient Rights and Responsibilities " revealed no reflection of the Patient Rights.

An interview with the Administrator in the Administration Conference Room on 02/08/2011 at 3:00PM confirmed the Policy and Procedure, " Patient Rights and Responsibilities " lacked the Patients Rights.

Based upon observation, record review, and interview, the facility failed to ensure 23 of 23 patients received information about their right to be informed how to lodge a complaint or grievance. The facility also failed to ensure that the written policy included the information for lodging a complaint or grievance.

Observation tour on 2/7/11 at 3:00 pm accompanied by the CEO revealed patient rights postings in 2 elevators and on the wall outside of the elevator on the 2nd floor. The posted patient rights did not contain the right to receive information how to lodge a complaint or grievance. The posted patient rights were in English but there was no posting of the rights in a second language.

Review of the patient's rights given to patient's on admission in a patient handbook revealed the right to lodge a complaint or grievance was not listed in the patient rights section of the handbook. The handbook did have a section titled "Patient/Family Problems solving Process" which told the patient to contact the Quality Manager, Chief Clinical Officer, or Chief Executive Officer with their concerns. There also was a section titled "Grievance Process" that instructed the patient to complete a Grievance Form if their concerns were not addressed to their satisfaction. The patient handbook did not contain the telephone number for the Department of State Health Services as another option for reporting a complaint or grievance.

An interview was conducted with the CEO on 2/8/11at 4:00 pm. The CEO confirmed there were no other postings except the 3 identified. The CEO reviewed the patient handbook and confirmed the information being given to patients was not sufficient.

Based on record review and interview the facility failed to have policies and procedures or manufactures instructions for 1 out of 1 Portable RO system (Wet 600) and failed to follow the manufactures instructions on 1 out of 1 Portable RO system (Semper Pure 750). The facility also failed to have accurate maintenance logs to indicate if the water system was being used at this facility, as evidenced by numerous cultures and endotoxin reports indicating the water system was tested at different hospitals. In addition the facility failed to conduct on 2 out of 2 portable RO systems, microbiological tests including cultures and endotoxin of the product water. In addition they failed to repeat the test if the cultures are above 50 CFU/ml and endotoxins above 1 EU/ml and analyze and trend the results as required by the State of Texas regulation 133.41 (t)(2)(B)(xix) (IV). Also the facility failed to test the RO systems water for chlorine/chloramines every hour as required by facility policy in 3 out of 3 months reviewed.
In addition the facility failed to screened for hepatitis B surface antigen (HBsAg) prior to admission, at the time of admission or have a known HBsAb status prior to admission on 3 out of 3 patient records reviewed (HD 1, HD2, and HD3), as required by the State of Texas regulations. The facility also failed to administer hepatitis vaccine if indicated and provide dialysis patients with literature outlying the risk and benefits of the vaccine. The facility also failed to remove opened medication and RO purified water that was not dated and initialed properly.
These findings have the potential to cause harm to all patients receiving care in the hospitals dialysis unit by increasing the risk of exposure to contaminated water, expired medication, and failure to protect
the patient against the spread of infection.

Finding:

Review of policies and procedures at the facility on 02/08/2011, revealed there were no policies and procedures for the safe operation and cleaning of either portable RO system.

Interview with staff # 5 and the Director of Nurses on 02/08/2011 confirmed there were no policies in the dialysis manual to instruct the staff on the correct operation of the Wet 600 and the Semper Pure 750.

On 02/10/2011, after the dialysis surveyors had left the facility, Physician # 44 owner of the contract service, approached the surveyor at another dialysis unit informing the surveyor that staff # 5 was going to send the surveyor all the requested documents for the operation and cleaning of the RO system. Surveyor contacted Staff # 5 by telephone on 02/10/2011 at approximately 10:00 a.m., Staff # 5 later sent a fax of the manufactures instructions for the Semper Pure 750. Staff # 5 was contacted again by telephone at approximately 11:00 a.m., after receiving the fax. Staff #5 indicated to the surveyor that he had not been cleaning the equipment, except for measuring the flow rate with a graduated cylinder, changing the carbon tanks and random other repairs and the system was cleaned by Nelson Environmental as out line on the repair log on 03/26/09. He then stated that he had not been documenting the monthly testing or the results.

Surveyor asked Staff # 5, during this call ask for the policies or manufactures instructions for the Wet 600. Staff # 5 stated the system was too old and the requested information is no longer available. In addition he did not have any documentation of the cleaning for this system other that on the equipment repair log that indicated the system was cleaned by Nelson Environmental service on 07/25/209, 10/06/209 and 04/22/2010.

Review of the Semper Pure 750 manufactures instructions revealed the unit was to have the above flow rate testing as well as the following procedures. The manufactures direction states under the section titled " WARNING " " 4.2 #3. "Once every 3 days, operate the RO with both the purified water and drain hoses running to sink for 30 minutes to keep membranes clean. Operate the Sempur Purse 750 RO, in the flush mode (use the membrane flush valve) for approximately five to ten minutes. Do not allow the water hose to come in contact with the bottom of the sink"
Staff #5 stated that this procedure had not been conducted and there was no documentation documenting the cleaning.
The manufactures instruction further states under the section titled " IMPORTANT " " 2. clean fan monthly. 3. Change pre-filter monthly or with excessive pressure drop 4. Daily lift the flush valve handle for 10 minutes to flush the unit membrane.
In addition the instructions under 5.3 " CLEANING " states, " periodic cleaning of the Semper Pure 750 is vital and should be performed regularly at a minimum it is recommended that the cleaning be done monthly. 1.0 State remove the purified water hose from the kidney machine and route to cleaning container. Collect 2 gallons 7.6 of Semper pure RO (purified water) in a five gallon container and record the PH. 2.0 Turn off the Semper Prue RO using green power button: turn off the feed water supply by turning off the wall facet. " )

Interview with staff # 5 on 02/10/2011 by telephone at approximately 11:30 a.m. confirmed the recommended cleaning and testing did not exist.

Review of culture and endotoxin reports for the Semper Pure portable RO system revealed the facility failed to collect the culture and endotoxin for the month of October 2010. On 08/23/2010 the endotoxin level was reported as 1.76 EU/ml and there was no evidence the facility repeated the test as required.

Review of the culture reports for the Wet 600 RO portable RO system revealed the facility failed to conduct a required water culture for the month of November 2010 and repeat the endotoxin results of 107 EU/ml, as required. The endotoxin results on the Wet 600 indicated it was collected from another hospital (Hospital # 1). This report was provided to the surveyor on 02/08/2011 and was told it was a test result for Promise Hospital. This RO system was observed at this facility on 02/08/2011 and the maintenance records provided did not provide details of when the machines were taken out of service and placed back in service at this hospital. Review of other culture and endotoxin reports for this RO system were reviewed for the months of June 2010, August 2010, September 2010, October 2010, December 2010 and January 2011 and the tests indicates it was from the WET 600 at Promise Hospital.

Review of the endotoxin report for the Wet 600 on 02/08/2011, for 06/29/2010 revealed the results were 1.09 EU/ml. On 07/27/2010 the results were 1.30 EU/ml. On 08/25/2010 the results were reported as 1.12 EU/ml. On 01/13/2011, the results were reported as 1.92 EU/ml. There is no evidence the facility re-tested the RO as required.

Interview with the Director of Nurses on 02/08/2011 at 4:30 p.m., confirmed the testing was not conducted as required. Interview with staff # 2 per telephone on 02/10/2011, confirmed the RO system may have been moved to other hospitals when one of their systems is out of order. In addition he confirmed there is no inventory tracking completed to tell when equipment was in use at all the different facilities.

Review of the water cultures from June 2010 until January 2011 revealed there was no evidence the cultures were trended and analyzed over time and no evidence the Medical Director #44 had reviewed the cultures as required.

Interview with the Director of Nurses on 02/08/2011 at 4:30 p. m., confirmed there was no evidence the facility had trended through it Quality Improvement processes the RO water cultures for the 2 portable RO systems and no evidence the Medical Director was involved in the process.

Review of the policy (#17:00) for Chlorine and Chloramine testing of water on 02/08/2011, In the policy statement stated "RO water will be tested to ensure absence of chlorine every hour"

Review of the Chlorine and Chloramine logs at the facility on 02/8/2011 revealed the facility collected the test during the hours of operation every four hours verses the every hour testing as required by the facility policy.

Interview with the Director of Nurses on 02/08/2011 at 4:00 p.m., confirmed the facility policy required the every hour testing of the RO water and that there was no evidence on the facilities logs that the every hour testing occurred.

On review of the medical record on 02/08/2011, at the facility, patient HD 1 record revealed the patient was admitted and began dialysis at the facility between the dates of 09/14/2010-10/12/2010 and there was no evidence the facility drew the HBsAg test during the stay or obtained the results form the previous hospital or patients chronic dialysis unit.

On review of the medical record on 02/08/2011, at the facility, patient HD 2 record revealed the patient started dialysis at the unit from December 10, 2010 thru January 28, 2011 and the HBsAg test was not collected until January 5, 2011.

On review of the medical record on 02/08/2011 at the facility, patient HD 3 record revealed the patient started dialysis at the unit from September 10, 2010 thru September 09/30/2010 and the HBsAg test was not collected during this stay or obtained from the transferring hospital.

Review of HD 1 medical record on 02/08/2011, revealed on 01/05/2011 the facility received Laboratory results indicating the patients Hepatitis Antibody level was non-reactive. There was no evidence documented in the medical record that indicated the physician or patient was notified of the antibody status and was provided the immunization it indicated.

Review of patient HD 2 medical record on 02/08/2011, revealed there was no evidence documented that this Hepatitis antibody negative patient received the required literature describing the risks and benefits of the hepatitis B vaccination prior to discharge. This patient 's antibody status was known on 01/05/2011 and the patient was not discharged until 02/03/2011.

Interview of the Director of Nurses on 02/08/2011 at 4:30 p.m. confirmed there was no evidence the facility drew the required laboratory test determine the HBsAg and antibody status and provided the patient with the required immunization if indicated. In addition the Director of Nurse confirmed that there was no evidence that indicated the patients received the literature covering the risk and benefits to the patient.

Observation on the dialysis treatment unit on 02/07/2011 revealed a vial of heparin dated 02/04 which did not indicate if the (04) was the month or year of opening, as well as the initial of the person opening the vial. This vial of heparin was found on the Semper Pure 750 RO system. There was a container of RO water on the tri station for use in the conductivity testing not dated or initialed. This solution is only good for a 24 hour time period.

Interview with staff # 5 confirmed the items were not dated correctly or initialed when opened.

Based upon record review and interview, the facility failed to ensure patient medical records were dated timed and authenticated on 23 of 23 records reviewed.

Review of policy # HIM-07 titled "Documentation Standards" revealed the following: "Each entry must be authenticated by the full date, time and the full signature and title of the person makeing the entry.

Review of policy #HIM-31 titled "Physician's Orders" revealed the following: "All physician's orders must be dated and signed by the physician responsible for the order." This policy failed to include timing orders.

Review of 23 medical record revealed all records contained entries that were not dated, timed and authenticated ranging physician's orders, verbal orders, nurse's notes, physician progress notes, etc.

An interview was conducted with the Chief Executive Officer on 2/10/2011 at 10:00 am. The CEO reported that she was aware that times were not being documented on medical record entries that was being addressed ongoing.

Based on record review and interview the facility failed to ensure that 2 of 2 Hemodialysis Portable Reverse Osmosis (RO) Machine logs included each components operating parameters and the action taken when a component was not within the facility's set parameters. Also facility failed to ensure that Medical Director of Dialysis Unit reviewed the result of the water quality testing and directed corrective action when indicated. This practice created the potential to harm all patients that were dialyzed in this facility. Citing 6 of 6 months of RO logs and culture reports reviewed.

Findings:
Manufacturer Instructions for SEMPER PURE 750: Operation and maintenance manual #500-15-360. Dated 1/10/2005 revealed in section 5.0 #3. Change prefilter monthly or with excessive pressure drop. 4. Daily lift flush valve handle up for 10 minutes to flush the unit membranes. Note: Utilize the Sempur Pure Daily Log Sheet to assist in maintaining your Sempur RO machine.

1. Review of RO logs for year 2010 for Semper Pure 750 and WET 600 on 2/8/2011 at 2:00 pm revealed no documentation of parameters for each component of the water treatment system on RO log sheets.
2. RO logs for Semper Pure 750 revealed no documentation of daily lift flush valve handle for 10 minutes. No documentation of parameters for prefilter pressure found, so technician could identify a excessive drop in pressure.
3. Review of Dialysis Policy and Procedure book revealed no documentation of policies related to RO component parameters or any actions to be taken when a component is not within the facility's set parameters.

Review of RO logs for Sempur 750 and WET 600 on 2/8/2011 at 2:00 pm revealed no documentation of the RO start up time for months June 2010 thru December 2010. There was also no documentation of Medical Director review of logs and/or signature and date of review.
Review of microbiological culture reports on 2/8/2011 at 11:00 am for machines 925L and J163 revealed for the months 7/2010 thru 1/2011 there was no documentation that Medical Director reviewed results and/or advised corrective action if one was required for abnormal result.

Interview with Director of Nurses on 2/8/2011 at 2:00 pm confirmed no documentation of parameters and/or daily lift flush valve handle for 10 minutes were on the log sheet. There was no documentation of policies and procedures for components parameters and follow-up actions when measurements are out of range. Also, no documentation found that Medical Director reviewed microbiological culture report and/or RO water logs..

Based on interviews and record review the facility failed to follow their Policy and Procedure for identify, track and reports communicable diseases.

Review of Policy and Procedure (P&P), Infection Control, "1. Hospital employees shall report any infectious disease or process to their supervisor/department head. 2. The employee ' s supervisor/department head shall notify the Employee Health Nurse. H/She will complete and forward an Infection Surveillance/ IC Admission Form to the Infection Control Professional/Coordinator for evaluation. (NOTE: Documentation on the form is to indicate that it is an EMPLOYEE report.) 3. The Employee Health Nurse and/or the Medical Director in consultation with the Infection Control Professional/Coordinator shall determine if any restriction of job duties is required by utilizing the following information. H. Employee illness or injury is reported to the Human Resources Department. "

Review of the Employee Illness/Injury List maintained by Human Resources Department revealed no employee illness had been documented.

Review of the Infection Control Reports revealed that employee illness had been reported.

Interview with the Infection Control Nurse # 5 at 9:30 AM on 2/10/2011 in the Administration Conference Room confirmed that employee infections had not been tracked or monitored.