The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PALESTINE REGIONAL MEDICAL CENTER 2900 S LOOP 256 PALESTINE, TX 75801 April 3, 2017
VIOLATION: PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION Tag No: A0133
Based on observation, interview and document review the facility failed to establish a process that provided and insured patients were given an oportunity to provide informed consent upon admission to the facility for 1 (labor and Delivery) of 5 (Nursing, Outpatient Surgery, Medical Surgical, and Emergency) departments reviewed.

This deficient practice had the likelihood to effect all patients of the hospital.

Findings included:


On the morning of 4/4/2017 an interview with the Director of the Health Information's Management Department confirmed the Labor and Delivery department of women's services had been identified as not consistently providing an oportunity for informed consent to women admitted to the unit. Over the month of March 2017, 17 patients who were treated in the L&D unit failed to receive informed consent upon admission.

On the morning of 4/4/2017, in the conference room an interview with staff #2, the Emergency Department (ED) Director confirmed all patient's (Pt/pt) who came through the ED for direct admission to the Labor and Delivery (L&D) unit were given oportunity to provide informed consent for admission and treatment signed in the ED, prior to transfer to the L&D unit.


On the morning of 4/4/2017 an interview with L&D staff Registered Nurse (RN) #6 indicated, "They (the nurses) did not do the admission paper work and admission consent. They called an admission clerk who would come to the unit and complete the consent and admission process with the patient".


On the morning of 4/4/2017 in the office of the Admission Coordinator, an interview with the Director, staff #3 confirmed "no admission staff went to the Labor and Delivery unit to complete patient admission information or provide oportunity for informed consent". She further explained that all pt's, who were preadmitted by a physician's order, would be completely registered by the admission department prior to their arrival to the L&D unit. All information obtained during that process was scanned into the electronic medical record system. However, any patient who might walk into the hospital (after hours or by-pass the ED) could walk directly to the L&D unit. They could be admitted with a telephone order from their physician, without being preadmitted or the admissions department being aware of it.


On the morning of 4/4/2017, in the L&D unit, interview with staff RN #5 revealed the process for admission and consent for a newly admitted patient to the Labor and Delivery unit. Staff #5 accessed the computer data base and printed a consent to admit and treat with patient #12's name printed on the form. The form was not signed by the patient. Staff #5 then explained she printed the form to show they had access to the form.

Staff #5 confirmed the L&D unit used a paper medical record. When asked to review patient #12's medical record there was no consent to admit or treat found in the paper medical record. Staff #5 was asked, "Wouldn't completion of the consent to admit and treat be the responsibility of the admitting nurse"? Staff #5 replied "Well, I suppose". She then recalled that pt #12 had been pre-registered and they would have already obtained the consent. However, staff #5 could not verify that an informed consent had been obtained for pt #12.

On 4/4/2017 in the late morning an interview with the Admission Coordinator, staff #3, indicated the nurses had received admission packets from their unit supervisor. Staff #3 indicated the L&D unit supervisor had inserviced her staff on the use of the admission packets. The L&D unit supervisor, staff #4 was working nights to fill in for a vacancy and was not present for interview.

On 4/4/2017 in the afternoon, an interview with staff #9, the Quality Manager, confirmed she had not received any education from the L&D unit supervisor on the use of admission packets for her staff or department. She could not confirm education had in fact occurred.


On 4/5/2017 in the conference room the policies for the facility revealed there was no policy found that included "Informed Consent" upon admission as a part of the required chart content.


On the afternoon of 4/4/2017 in the conference room a review of the Medical Record Quality data indicated on2/21/2017 and again on 3/28/2017 "Informed consent obtained: Consent for procedure-not informed consent" the facility was aware through it's Quality program that for 60 days the L&D Department was not consistently obtaining informed consent upon admission.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review, observation, and interview, the facility Quality Committe failed to ensure that the staff were disinfecting the RO (Reverse Osmosis) prior to use and at least monthly as recommended by the manufacturer's guidelines. Citing 2 of 2 portable RO systems ( and ) . Also, the portable RO was used on 1 (#16) of 1 (#16) patient for a dialysis treatment.
These deficient practices had the likelihood to cause harm to all patient receiving dialysis treatments at the facility.

Findings:

A review of the Ameri-Water system instructions stated "As a general guideline, Ameri-Water recommends that the system should be disinfected prior to initial use and at least monthly." A review of the facility's biomedical records revealed the ROs with serial numbers and was brought into the hospital and biomedical clearance was conducted. There was no documented evidence the two ROs were cultured or disinfected when they entered the hospital prior to patient use.

A review of the RO logs for portable ROs and revealed the following:

A review of the water log for RO revealed the RO was started on 03/01/2017 by a staff member listed as "LF." The top of the form had Hospital "HUB" marked out and "PRMC" written in the blank designated as the hospital name. The disinfection record for RO 2 was documented as conducted on 03/07/2017 at 1600 p.m. (4:00 p.m.). There was an additional RO for log dated "February 2017" with "WNJ" written in the blank designated for the hospital name. On 2/08/2017 through 02/28/2017 the RO entry on the log indicated "RO was in storage and "ran according to schedule" with the initial of "LF". There was no documentation to indicate what was performed as part of the "run according to schedule" and again the documentation was initial by "LF". There was no documented evidence what part of the standard start up procedure was performed on RO .

A review of the medical record titled "Acute Hemodialysis Flow sheet" for patient #16 for 03/04/2017 at 0837 a.m. revealed the patient water was provided by RO . RO was used to treat patient #16 prior to the hospital staff disinfecting and culturing the equipment.

A review of the log for RO revealed the machine was started up on 03/01/2017 by a staff listed as "LF". The top of the form had Hospital "TMC" marked out and "PRMC" written in the blank designated for the hospital name. The disinfection record for this RO was documented as conducted on 03/07/2017 at 1300 p.m. (1:00 p.m.)
Review of the hospital Dialysis Quality Meeting on April 13, 2017 at 9:00 a.m. revealed that on "March 3, 2017 two different Reverse Osmosis (RO) was brought to the facility. Biomed was notified and performed safety checks. Both machines were cleaned". There was no evidence in the Quality Meeting Minutes that the two RO's numbered and , were cultured and disinfected. In addition, there was no evidence the Quality Committee ensured the ROs were culture and disinfected after arriving at the hospital and prior to use on the patient.

An interview with Staff #10 (Director for the Dialysis Unit) and Staff #7 on April 5, 2017 at 10:00 a.m., both stated that they did not know who staff member "LF" was and there was no one working in the dialysis unit or the biomedical department with those initials. Also, Staff #10 stated "I do not know" who hospital 'TMC, WNJ, or HUB' was. Staff #10 agreed that the logs were part of patient medical records. Staff #10 confirmed that the RO documents that were provided during the dialysis treatments for patients at the facility should not contain another hospitals name or staff initials. Also, Staff #7 and #10 agreed there was no evidence documented that RO was cultured and disinfected after the equipment was delivered to the hospital and prior to use on patient #16. In addition, Staff #10 confirmed that the Quality Committee failed to ensure the processes for equipment being used in the hospital were appropriately maintained and checked prior to use on patients.
A review of the water log for RO revealed the RO was started on 03/01/2017 by a staff member listed as "LF." The top of the form had Hospital "HUB" marked out and "PRMC" written in the blank designated as the hospital name. The disinfection record for RO 2 was documented as conducted on 03/07/2017 at 1600 p.m. (4:00 p.m.). There was an additional RO for log dated "February 2017" with "WNJ" written in the blank designated for the hospital name. On 2/08/2017 through 02/28/201 the RO entry on the log indicates the "RO was in storage and "ran according to schedule: with the initial of "LF" There was no documentation to indicate what was performed as part of the "run according to schedule" again the documentation was initial by "LF". There was no documented evidence what part of the standard start up procedure what performed on the RO .

A review of the medical record titled "Acute Hemodialysis Flow sheet for patient #16 for 03/04/2017 at 0837 a.m. revealed the patient water was provided by RO . The RO was used to treat patient #16 prior to the hospital staff disinfecting and culturing the equipment.

A review of the log for RO revealed the machine was started up on 03/01/2017 by a staff listed as "LF". The top of the form had Hospital "TMC" marked out and "PRMC" written in the blank designated for the hospital name. The disinfection record for this RO was documented as conducted on 03/07/2017 at 1300 p.m. (1:00 p.m.)
Review of the hospital Dialysis Quality Meeting on April 13, 2017 at 9:00 a.m., revealed that on "March 3, 2017 two different Reverse Osmosis (RO) was brought to the facility. Biomed was notified and performed safety checks. Both machines were cleaned". There was no evidence in in the Quality Meeting Minutes that the two RO's number and were cultured and disinfected. In addition, there was no evidence the Quality Committee ensured the RO's were culture and disinfected after arriving at the hospital and prior to use on the patient.

An interview with Staff #10 (Director for the Dialysis Unit) and Staff #7 on April 5, 2017 at 10:00 a.m., both stated that they did not know who staff member "LF" staff was and there was no one working in the dialysis unit or the biomedical department with those initials. Also, Staff #10 stated. "I do not know who hospital 'TMC, WNJ, or HUB' was." Staff #10 agreed that the logs were part of patient medical records. Staff #10 confirmed that the RO documents that were provided during the dialysis treatments for patients at the facility, should not contain another hospitals name or staff initials. Also, Staff #7 and #10 agreed there was no evidence documented that RO was cultured and disinfected after the equipment was delivered to the hospital and prior to use on patient #16. In addition, Staff #10 confirmed that the Quality Committee failed to ensure the processes for equipment being used in the hospital is appropriately maintained and checked prior to use on patients.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on document review and interview the facility failed to take action on data collected for 60 days (February and March 2017) which indicated the Labor and Delivery unit failed to provide opportunity for informed consent upon admission, for patients who failed to pre-admit or did not admit through the Emergency Department.

This deficient practice had the likelihood to effect all obstetrical patients of the hospital.

Findings included:

On the morning of 4/4/2017 an interview with the Director of the Health Information's Management Department confirmed the Labor and Delivery (L&D) department of women's services had been identified as not consistently providing opportunity for informed consent to women admitted to the unit. Over the month of March 2017, 17 patients who were treated in the L&D unit failed to receive opportunity to provide informed consent upon admission.

On the afternoon of 4/4/2017 in the conference room a review of the Medical Record Quality data indicated on 2/21/2017 and again on 3/28/2017 seen at the following heading, "Informed consent obtained: Consent for procedure-not informed consent". The facility was aware through it's Quality program that for 60 days the L&D Department was not consistently providing opportunity for informed consent from patients upon admission.

On 4/4/2017 in the afternoon, an interview with staff #9, the Quality Manager, confirmed she had not received any staff education from the L&D unit supervisor or any other documentation of corrective action taken within the Labor and delivery unit to insure women who came into the unit for delivery of their child would be provided opportunity to provide informed consent prior to delivery of their baby.

On the afternoon of 4/5/2017 a review of data collected and documented in the Quality program review, confirmed, that the Director of Quality was aware provision of opportunity to provide informed consent upon admission in the L&D unit was not being consistently obtained. A review of documentation to correct the lack of informed consent upon admission was found to be a verbal coaching submitted on the L&D Department manager for February and March. No other corrective action was identified or referenced in the Quality meeting minutes. There was no evidence of investigation or problem solving into why the consents were not being obtained.

On 4/5/2017 in the conference room the policies for the facility revealed there was no policy found that included "Informed Consent" upon admission as a part of the required chart content.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on document review the governing body, medical staff and administrative officials failed to ensure an effective Quality Program. The administrative officials:

A. did not provide quality oversite and monitoring of blood product being administered to patients.
B. allowed an unapproved policy (Medication Administration Guidelines) to be implemented facility wide.

A. A follow up survey for a previous survey conducted on 01/31/2017 revealed the emergency room director will monitor 100% of blood transfusions in that department and the medical-surgical director will monitor 100% of the blood transfusion in that department.
A review of the document titled Quality and Patient Safety Council dated March 23, 2017 revealed no evidence of the monitoring of blood transfusions or discussion of the plan to monitor blood transfusions.

B. Review of the facility policy titled "Medication Administration Guidelines" revealed a revision date of 03/2017.

A review of the document titled Medical Executive Committee Minutes and dated March 22. 2017 revealed no evidence the policy titled Medication Administration Guidelines was approved.
An interview on 4/5/2017 with staff #9, 10, and staff #11confimed the policy titled "Medication Administration Guidelines" with the revision date of 3/2017 had been implemented through out the facility.

An interview on 4/5/2017 with staff #9 revealed the policy had not been to Medical Staff for approval. Staff #9 confirmed the policy required Medical Staff approval before it could be implemented.