HospitalInspections.org

Based on review of documentation and interview, it was determined that the governing body of the hospital was not effective in carrying out its responsibilities for the conduct of the hospital.

Findings were:

1. The governing body failed to ensure quality care was provided to its patients. The facility governing body also failed to ensure that policies and procedures were enforced in regards to food storage. Cross refer to A0049.

2. The governing body failed to ensure that contracted service providers delivered patient care in a safe and effective manner. Cross refer to A0084.

In an interview with the CCO/CQO on 8/10/16, the above findings were acknowledged.

Based on review of documentation and interview, it was determined that the hospital failed to develop, implement, and maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program.

Findings were:

1. The governing body failed to ensure that contracted service providers delivered patient care in a safe and effective manner. Cross refer to A0084.
2. The governing body failed to ensure that every department of the hospital was involved in its Quality Improvement Committee meetings. Cross refer to A0308.
3. The facility the Medical Director did not assume oversight of the facility's dialysis program.. Cross refer to A0347.
4. The facility that nursing staff did not always weigh dialysis patients pre and post treatment per reasonable standard of care. Cross refer to A0386.

In an interview with the CCO/CQO on 8/10/16, it was admitted that the hospital's current Quality Assurance Program was not effective as a hospital wide program.

Based on review of documentation and interview, it was determined that the hospital failed to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings were:

1. The facility failed to ensure the dietary services followed their policies on food storage and sanitation practices. Also, the facility physical plant and equipment was not maintained in such a manner as to ensure an acceptable level of safety to patients and staff. Cross refer to A0724.
2. The facility Infection Control Officer did not have documents available related to on going training/education to oversee the infection control program. Cross refer to A0748.

3. The facility failed to provide a sanitary environment in all areas of the hospital. The facility also failed to ensure the infection control officer or officers developed a system for controlling infections of patients and personnel, as evidence by failing to address invasive procedures performed outside the operating room, including sterilization of instruments. Cross refer to A0749.

In an interview with the CCO/CQO on 8/10/16, it was confirmed the hospital infection control practices were not adequate to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Based on review of documentation and interview, it was determined that the governing body failed to ensure quality care was provided to its patients.

Findings were:

In the published article entitled "Body Water-Body Weight" by John De Palma MD, FACP and Joanne Pittard MS, RN dated 2001 and found at stated in part "Proper control of body weight - body water, like dialysis dose, is one of the important issues and risk factors that contribute to the morbidity and mortality of ESRD patients. Without knowledge of body weight - body water, the health-care giver cannot render adequate dialysis care. In a hemodialysis facility, the classic four vital signs of: temperature, pulse, respirations, and blood pressure should be supplemented with the patient's actual weight both pre and post dialysis."

The following dialysis patients' medical records were reviewed:

Review of the medical record of Patient # 1 Roster B, revealed no pre or post dialysis weights. Further, the patient who was admitted for "fluid overload" had been weighed only once since admission (on 7/31/16-date of admission.)

Review of the medical record of Patient # B2, revealed no pre or post dialysis weights. Among admission diagnoses was CHF (Congestive Heart Failure) and ESRD (End Stage Renal Disease.) Patient # B2 was weighed upon admission (7/14/16) but not weighed again until 8/1/16 and 8/7/16.

Review of the medical record of Patient # B3, was admitted for chest pain and wound care on 8/5/16. His admission weight was recorded. No pre or post weights were recorded for dialysis on 8/8/16.

Review of the medical record of Patient # B4, was admitted for wound care and ESRD on 7/29/16. He was weighed on 7/31/16. No pre or post dialysis weights were recorded.

Review of the medical record of Patient # B5, was admitted on 7/18/16 with the diagnoses of pneumonitis, congestive heart failure and ESRD. The patient was weighed on 8/7/16 and then again on 8/8/16 when patient had dialysis. No post dialysis weight was recorded on 8/8/16. Prior dialysis treatments had no pre and post treatment weights documented.

The contracted dialysis service policy entitled "Verbal and Written Orders" stated in part:
· Orders for patient treatment and medications, including the administration of medications, shall be carried out only when given by a qualified physician, surgeon, dentist, podiatrist or other person duly licensed or authorized to prescribe by the state of Texas and who has been approved as a member of the medical staff of this facility.
· All orders of medication and treatment shall be written into the medical record of the patient and signed by the ordering licensed independent practitioner ...
· All orders for treatment shall include the type of treatment, specific requirements of the treatment (such as wet to dry dressings, etc.) and the frequency of treatment.

Procedure: Verbal/telephone Orders:
· Verbal/telephone orders shall be used infrequently ...
· The order will be written on the physician order sheet by the person receiving the order and noting the date and time received, the name of the LIP issuing the order and the receiver's name and title.
· Record the verbal/telephone order immediately in the patient's medical record or, for pharmacists, on a prescription form as appropriate ...
· Indicate either telephone or verbal order in the written record.
· Sign the written record and indicate level of licensure.
· The prescribing physician must date, time and authenticate the verbal order within the time designated by state law, or if no state law exists, the verbal order must be authenticated within 48 hours."

Facility policy entitled "Outpatient Procedures" stated in part: "Please make sure the following is completed on all outpatient procedures:
1. The consent is completed in its entirety and signed by the MD. Make sure all the procedures are "spelled" out with no abbreviations.
2. The face sheet must be on the chart with the correct information verified with the patient.
3. Address the Advance Directive and Medicare Beneficiary
4. What is the code status?
5. Make sure the arm bands are on the patient.
6. You must perform a pre-assessment on the patient. Height, weight, vital signs. Medical/surgical history must be obtained.
7. Make sure that you document the education provided to the patient on the patient education sheet
8. You must have a plan of care for the procedure. IE relief of pain, will remain hemodynamically stable
9. DO NOT start the procedure until you have a History and Physical on the chart or the physician writes an H&P or dictates the H&P. If you have one from the nursing home, it must be updated within the last 30 days.
10. Make sure you have the most current labs and x-ray results on the chart if applicable."

Patient # B6, presented to the hospital for "outpatient dialysis" on 6/25/16. Per the CCO/CQO the Medical Director called and gave verbal orders to dialyze the patient. The patient was dialyzed without consent, written/signed orders, History & Physical or recent lab work. There is no documentation to demonstrate that the patient was assessed by the physician prior to treatment. The patient experienced chest pain during treatment and a "Code" was called. Treatment stopped and was then resumed when nursing assessment indicated patient was stable. Labs were drawn after the code. The survey team requested this patient's medical record. The only information provided to the survey team was the Code sheet, the dialysis treatment sheet, the results of the CBC and ECG that were drawn/performed after the code.

The Director of Dialysis was interviewed on 8/10/16. He claimed he had no knowledge of outpatient dialysis being conducted at the hospital. The RN (Staff member #B3) that performed the dialysis on 6/25/16 denied that the MD had called with verbal orders to dialyze the patient. He stated "I just walked in the room and was told to dialyze the patient."

The CEO was also interviewed on 8/10/16. He said that the patient had been hospitalized in December (6 months prior) so that the physician was familiar with him. He said that Patient # 6 was an "international" patient whose embassy paid for the services and that the Medical Director had him come in as an outpatient for various treatments including dialysis and CT scan.

In an interview with the CCO/CQO the above findings were confirmed. It was acknowledged that not weighing patients pre and post dialysis treatment was an unsafe practice. It was also acknowledged that policies and procedures were not followed concerning outpatient dialysis.



30250

The facility governing body also failed to ensure that policies and procedures were enforced in regards to food storage.

Findings included:

Facility policy titled "Food Storage and Prevention of Contamination" states in part "All food will be protected from contamination and stored at temperatures that will prevent spoilage. All refrigerators will be maintained at 36-40 degrees F and all thermometers will be visible for easy observation of temperatures. All food stored in refrigerators will be kept covered, labeled, and dated at all times. Frozen items will be maintained at a 10 to 0 degrees F and all thermometers will be visible for easy observation of temperatures. Stock will be rotated to assure that older items are used first."

Facility policy titled "General Cleanliness and Sanitation" states in part "Sanitary conditions will be maintained in the storage, preparation, and distribution of food. Cleaning assignments are initialed and dated by the employee who completes the job. Storage Temperature: Refrigerator and freezer temperatures will be taken daily and recorded. Equipment Maintenance: All equipment will be properly maintained to ensure food safety. Related forms: Sink Temperature Log; Dish Machine Temperature Log; Refrigerator Freezer Temperature Log."

Facility policy titled "Receiving Food and Supplies" states in part "Do not allow cold food to rise above 41 degrees F or frozen foods to rise above 0 degrees F. All food items are to be dated. All stock must be rotated with each new order received."

Facility policy titled "Infection Control" states in part "Maintain proper storage of perishable foods at 40-45 degrees or below. Provide continuing preventative maintenance of equipment to meet safety and infection control standards."

Failure to ensure that the proper refrigeration temperature was maintained for food storage increased the risk for contamination creating a potential for food borne illness.


During a tour of the dietary department on 8/8/16 and 8/9/16 the following was noted:

* Refrigerator/Freezer Temperature Log for Refrigerator P1 for August 2016 with temperature ranges 34F-40F reveals refrigerator temperature documented for 8/4 at 7:00 pm is documented as DEF. Refrigerator temperature on 8/5 at 6:30 am is documented as DEF. Refrigerator temperature is documented on 8/7 at 6:30 am and 7:00 pm as DEF. Refrigerator temperature on 8/8 is documented as DEF. Refrigerator temperature is documented on 8/9 as DEF.

* Refrigerator/Freezer Temperature Log for Freezer P1 with temperature range Below 0 reveals AM temperature readings for 8/1, 8/2, 8/3, 8/4, and 8/5 are documented as DEF. Temperature reading for 8/6 6:30 am and 7:30 pm are documented as DEF. Temperature documentation for 8/7 at 6:30 am is documented as 6.0.

* Refrigerator/Freezer Temperature Log for Refrigerator P2 for August 2016 with temperature ranges 34F-40F reveals refrigerator temperature was not documented for PM shift on 8/1, 8/2, and 8/3. Refrigerator temperature for 8/3 and 8/5 at 5:30 am was documented as 30F degrees. The refrigerator temperature for 8/8 was unreadable.

* Refrigerator/Freezer Temperature Log for Refrigerator P2 for August 2016 with temperature ranges 34F-40F was documented at 33F on 8/3 5:30 am, 8/5 5:30 am, 8/6 5:30 am, and 8/8 5:30 am.

* Review of log titled "Dish Machine Temperature Log" for August 2016 on 8/9/16 at 11:30 am revealed there was no documentation of the dish machine temperature for the breakfast shift of 8/5, 8/6, 8/8, or 8/9.

* Review of log titled "3 Compartment Sink Log" on 8/9/16 at 11:30 am revealed no documentation of testing of the wash and sanitizing water in the sink for the dinner shift on 8/7 and 8/8.

* 11 plastic glasses and 4 dessert cups were stacked wet on a shelf in the kitchen.

* Round, square, and rectangular plastic and metal containers were stacked and stored wet on a shelf in the kitchen.

* Flour was stored in a container that was labeled "pineapple" with no date as to when it was placed in the container.

* A container holding dried cranberries was not labeled as to contents or date it was placed in the container.

* A toaster oven in the kitchen area had peeling and cracked material at the point the toasted items would enter the oven allowing for the possibility of the peeling paint to fall on the food items.

* 5 large containers of assorted seasonings did not have the lid properly closed and secured as to protect the contents from moisture and contamination.

* Large jugs of red wine vinegar, worcestershire sauce, teriyaki sauce, and smoke sauce were not dated as to when they were opened.

* Bags of sweet potato fries, french fries, and onion rings were not sealed completely after being opened to protect the contents from damage from freezer burn.

* Bags of shredded cheese, sliced cheese, and tortillas were not sealed as to protect contents from contamination and spoilage.

* The freezer had a bag of garlic bread that was no sealed or labeled as to contents or the date received and opened. It also contained a tray of bacon and a tray of turkey sausage that was not covered to prevent contamination.

* The freezers also contained multiple bags of frozen vegetables that had no date as to when received.

* Several areas of the floor in the food preparation area had tape adhering to the floor thus not allowing proper cleaning and sanitizing of the floor.

* On 8/8/16 at 2:10 p.m. there was a half gallon drinking container with water that had orange slices and cucumber slices in it on the food preparation table that was not labeled as to contents, preparation time, or name of patient. The dietary manager initially stated the container belonged to a patient and had not been labeled with the patient name at that time. Upon further questioning it was discovered it belonged to a dietary staff member, staff #C2.

* On 8/9/16 at 11:15 am there was a personal cell phone and a set of keys laying on the food preparation tables.


In an interview with the CEO, dietary manager, and CCO/CQO at the time of the findings all acknowledged the deficiencies as stated above.

Based on review of documentation and interview, it was determined that the governing body failed to ensure that contracted service providers delivered patient care in a safe and effective manner.

Findings were:

In an article entitled "Body Water-Body Weight" by John De Palma MD, FACP and Joanne Pittard MS, RN dated 2001 and found at stated in part "Proper control of body weight - body water, like dialysis dose, is one of the important issues and risk factors that contribute to the morbidity and mortality of ESRD patients. Without knowledge of body weight - body water, the health-care giver cannot render adequate dialysis care. In a hemodialysis facility, the classic four vital signs of: temperature, pulse, respirations, and blood pressure should be supplemented with the patient's actual weight both pre and post dialysis."

The following dialysis patients' medical records were reviewed:

Review of the medical record of Patient #B1, revealed no pre or post dialysis weights. Further, the patient, admitted for "fluid overload" had been weighed only once since admission (on 7/31/16-date of admission.)

Review of the medical record of Patient #B2, revealed no pre or post dialysis weights. Among admission diagnoses was CHF (Congestive Heart Failure) and ESRD (End Stage Renal Disease.) Patient # B2 was weighed upon admission (7/14/16) and then on 8/1/16 and 8/7/16.

Review of the medical record of Patient # B3, was admitted for chest pain and wound care on 8/5/16. His admission weight was recorded. No pre or post weights were recorded for dialysis on 8/8/16.

Review of the medical record of Patient #B4, was admitted for wound care and ESRD on 7/29/16. He was weighed on 7/31/16. No pre or post dialysis weights were recorded.

Review of the medical record of Patient # B5, was admitted on 7/18/16 with the diagnoses of pneumonitis, congestive heart failure and ESRD. The patient was weighed on 8/7/16 and then again on 8/8/16 when patient had dialysis. No post dialysis weight was recorded on 8/8/16. No prior dialysis treatments had pre and post weights documented.

Contracted dialysis service policy entitled "Verbal and Written Orders" stated in part:
· Orders for patient treatment and medications, including the administration of medications, shall be carried out only when given by a qualified physician, surgeon, dentist, podiatrist or other person duly licensed or authorized to prescribe by the state of Texas and who has been approved as a member of the medical staff of this facility.
· All orders of medication and treatment shall be written into the medical record of the patient and signed by the ordering licensed independent practitioner ...
· All orders for treatment shall include the type of treatment, specific requirements of the treatment (such as wet to dry dressings, etc.) and the frequency of treatment.

Procedure: Verbal/telephone Orders:
· Verbal/telephone orders shall be used infrequently ...
· The order will be written on the physician order sheet by the person receiving the order and noting the date and time received, the name of the LIP issuing the order and the receiver's name and title.
· Record the verbal/telephone order immediately in the patient's medical record or, for pharmacists, on a prescription form as appropriate ...
· Indicate either telephone or verbal order in the written record.
· Sign the written record and indicate level of licensure.
· The prescribing physician must date, time and authenticate the verbal order within the time designated by state law, or if no state law exists, the verbal order must be authenticated within 48 hours."

Facility policy entitled "Outpatient Procedures" stated in part: "Please make sure the following is completed on all outpatient procedures:
1. The consent is completed in its entirety and signed by the MD. Make sure all the procedures are "spelled" out with no abbreviations.
2. The face sheet must be on the chart with the correct information verified with the patient.
3. Address the Advance Directive and Medicare Beneficiary
4. What is the code status?
5. Make sure the arm bands are on the patient.
6. You must perform a pre-assessment on the patient. Height, weight, vital signs. Medical/surgical history must be obtained.
7. Make sure that you document the education provided to the patient on the patient education sheet
8. You must have a plan of care for the procedure. IE relief of pain, will remain hemodynamically stable
9. DO NOT start the procedure until you have a History and Physical on the chart or the physician writes an H&P or dictates the H&P. If you have one from the nursing home, it must be updated within the last 30 days.
10. Make sure you have the most current labs and x-ray results on the chart if applicable."

Patient # B6, presented to the hospital for "outpatient dialysis" on 6/25/16. Per the CCO/CQO the Medical Director called and gave verbal orders to dialyze the patient. The patient was dialyzed without consent, written/signed orders, History & Physical, or recent labwork. There is no documentation to demonstrate that the patient was assessed by the physician prior to treatment. The patient experienced chest pain during treatment and a "Code" was called. Treatment stopped and was then resumed when nursing assessment indicated patient was stable. Labs were drawn after the code. The survey team requested this patient's medical record. The only information provided to the survey team was the Code sheet, the dialysis treatment sheet, the results of the CBC and ECG that were drawn/performed after the code.

The Director of Dialysis was interviewed on 8/10/16. He claimed he had no knowledge of outpatient dialysis being conducted at the hospital. The RN (Staff member #B3) that performed the dialysis on 6/25/16 denied that the MD had called with verbal orders to dialyze the patient. He stated "I just walked in the room and was told to dialyze the patient."

The CEO was also interviewed on 8/10/16. He said that the patient had been hospitalized in December (6 months prior) so that the physician was familiar with him. He said that Patient # 6 was an "international" patient whose embassy paid for the services and that the Medical Director had him come in as an outpatient for various treatments including dialysis and CT scan.

In an interview with the CCO/CQO the above findings were confirmed. It was acknowledged that not weighing patients pre and post dialysis treatment was an unsafe practice. It was also acknowledged that policies and procedures were not followed concerning outpatient dialysis.

Based on policy review, signage, and staff interview the facility failed to follow their own policies regarding emergency room services.

Findings were:

During a tour of the facility, there were 4 signs outside the building that indicated the facility had an "Emergency Entrance". 2 signs on the second floor of the facility had arrows directing potential emergency patients to the "emergency room".

Facility policy titled "Level Four Emergency Room" states in part "The nursing supervisor will be notified STAT to triage the patient presenting at the hospital for emergency care. The RN after triaging will notify the emergency room physician of the patient's arrival upon completion of assessment. The emergency room physician will evaluate the patient within 30 minutes."

In an interview with the CCO/CQO she stated they do not provide emergency services at the hospital. She stated they have a treatment room and do not have an emergency room physician. She further stated they are not a Level Four emergency center and do not provide the services as per their policy.

Based on a review of documentation and interview, that facility failed to inform each patient whom to contact to file a grievance.

Findings included:

The regulations require that the hospital must inform the patient and/or the patient's representative of the internal grievance process, including whom to contact to file a grievance (complaint). As part of its notification of patient rights, the hospital must provide the patient or the patient's representative a phone number and address for lodging a grievance with the State agency. The hospital must inform the patient that he/she may lodge a grievance with the State agency (the State agency that has licensure survey responsibility for the hospital) directly, regardless of whether he/she has first used the hospital's grievance process.


The facility based policy entitled "Patient Rights"stated in part,

"3. Grievances...
The hospital Patient Representative functions as the primary contact to receive complaints from patients regarding Hospital services. You or the individual designated by the Hospital will be made aware of the state Department of health to which you may address grievances."


This policy which is provided to patient upon admission does not provide the patient or the patient's representative with a phone number and address for lodging a grievance with the State agency. This policy also does not make clear to the patient that he/she may lodge a grievance with the State agency (the State agency that has licensure survey responsibility for the hospital) directly, regardless of whether he/she has first used the hospital's grievance process.


The facility had the Texas Department of State Health Services contact information posted near the elevator and in the hall of the facility. All patients may not have the opportunity to view this posting. This information should be included in the policy which is provided to patient's upon admission.

The above findings were confirmed in an interview with staff member A8 on 08/10/16.

Based on observation, interview, and tour of the hospital, it was determined that the facility failed to protect the patients' right to personal privacy, by displaying patients name and room number in areas visible to non-hospital employees.

Findings were:

Facility document entitled "Patient Rights", stated in part, "Privacy: You will be assured confidential treatment of your personal and medical records and may approve or refuse their release to an individual outside the Hospital, except in the case of a transfer to another healthcare institution as required by law or a third party payment contact. You will have the right to obtain access to your personal and medical records in accordance with the Hospital's procedure and applicable law."

During a tour of the Medical Surgical Unit on the afternoon of 08/09/2016, revealed that the patients last name, first initial and room number were displayed in the nurses station on a white dry eraser board that were visible to visitors and nonhospital employees.

In addition, the patients' medical records were placed on a rack on the nurse's station counter top. The medical records were labeled on the spine of the binder. The labels were marked with the patients' last name, first initial, room number, and the physician's name. The medical records label were also visible to visitors and nonhospital persons.

The above findings were acknowledged by staff member D5 on the afternoon of 08/09/2016

Based on observation, interview, and tour of the hospital, it was determined that the facility failed to ensure the protection of the patients' right to care in a safe setting.

Findings were:

During a tour of the Medical Surgical Unit on the 3rd floor on the afternoon of 08/09/2016, it was noted that the door to the electrical room located on the in the hallway across from patient rooms was not locked. The Electrical room contained a large electrical box with multiple wires connected to the electrical box. Leaving the door unlocked could post a great danger to others and should be accessed only by authorized hospital staff.

The above findings were confirmed by the Chief Clinical Officer. She stated, "It should be locked, the maintenance person was working on the electrical box earlier today."

Based on review of documentation and interview, it was determined that the governing body failed to ensure that every department of the hospital was involved in its Quality Improvement Committee meetings.

Findings were:

Facility policy entitled "Performance Improvement and Patient Safety Plan" stated in part, "The purpose of this plan is to describe the framework on which improvement activities are designed as well as the role of leadership to establish a planned, systematic, organization-wide approach to process design/redesign and performance measure, analysis and improvement."

According to Medical Staff Bylaws effective as of March 31, 2015, "The MEC shall be a standing committee of the Medical Staff and shall consist of at least three physicians and include the officers of the Medical Staff, Chief Medical Officer, CEO, Nurse Executive or designee, and other assigned hospital senior managers as ex-officio members without a vote. The President of the Medical Staff shall be the Chairman of the committee ...(The MEC shall) receive and act upon reports and recommendations from Medical Staff committees and staff officers concerning quality management activities and the discharge of their delegated administrative privileges."

Review of Quality Assurance Performance Improvement meeting minutes for the months of January through June of 2016, revealed no involvement from the Dialysis Department. According to the CCO/CQO during an interview on 8/10/16, the Infection Control/Wound Care/Pharmacy and Therapeutics Committee collected data from the dialysis department during the first 6 months of 2016. This data would be handed to the Quality Committee for review and further action.

Infection Control/Wound Care/Pharmacy and Therapeutics Committee meeting minutes dated May 17, 2016 under "Actions Taken" stated "Need to include monitoring of Hepatitis B documentation on each dialysis flow sheet, pre and post treatment weights, and care of the dialysis catheter."


Infection Control/Wound Care/Pharmacy and Therapeutics Committee meeting minutes dated July 25, 2016, stated in part under "Recommendation" stated "discuss pre and post weight documentation with director. Education should be provided as needed. Perform monthly random audits to ensure pre and post weights are documented."

Quality Meeting Minutes dated 7/29/16 stated in part under "Action Taken" said "Dialysis Catheter dressing is to be changed after each dialysis treatment. Pre and post weights are to be obtained."

Problems in the dialysis department were identified in May of 2016. As of August 2016 no corrective action had been initiated or tracked in the Quality Assessment Performance Improvement department. This was confirmed by the CCO/CQO on 8/10/16.

Based on review of documentation and interview, it was determined that the Medical Director failed to provide effective oversight of the facility's dialysis program.

Findings were:

A-Team Dialysis Job Description stated in part under "Essential Job Functions" stated "Perform patient assessment: Vital signs and all parameters of critically ill patients, review dialysis orders, determine general physical and mental conditions of patient through observations, or review with physician and bedside nurse, assist in determining compliance to dietary or medication regimen, document observation appropriately ....Perform analysis of patient data: assess and monitor status of vascular accesses, review lab work, patient assessments, and report any relevant changes or abnormalities to physician."

A-Team Dialysis Skills Checklist determined that the staff were proficient in the following areas:
"Admission Protocol" stated in part that staff could perform the following skills:
· Pre-weight (accurate/recorded correctly)
· Dry weight established
· Fluid Status (RN notified is > 4 kg gain between dialysis treatments."

The following dialysis patients' medical records were reviewed:

Review of the medical record of Patient # B1, revealed no pre or post dialysis weights. Further, the patient was admitted for " fluid overload " had been weighed only once since admission (on 7/31/16-date of admission.)

Review of the medical record of Patient #B2, revealed no pre or post dialysis weights. Among admission diagnoses was CHF (Congestive Heart Failure) and ESRD (End Stage Renal Disease.) Patient #B2 was weighed upon admission (7/14/16) but not weighed again until 8/1/16 and 8/7/16.

Review of the medical record of Patient #B3, was admitted for chest pain and wound care on 8/5/16. His admission weight was recorded. No pre or post dialysis weights were recorded on 8/8/16.

Review of the medical record of Patient # B4, was admitted for wound care and ESRD on 7/29/16. He was weighed on 7/31/16. No pre or post dialysis weights were recorded.

Review of the medical record of Patient # B5, was admitted on 7/18/16 with the diagnoses of pneumonitis, congestive heart failure and ESRD. The patient was weighed on 8/7/16 and then again on 8/8/16 when patient had dialysis. No post dialysis weight was recorded on 8/8/16. Prior dialysis treatments had no pre and post treatment weights documented.

In an interview with the CCO/CQO on 8/9/16, it was acknowledged that dialysis patients were not weighed before and after treatment per reasonable standard of care. A nurse could not possibly report fluid gains >4kg without assessing weights and establishing a dry weight. It was confirmed that the dialysis department had little oversight from the medical staff.

Based on review of documentation and interview, it was determined that nursing staff failed to consistently weigh dialysis patients pre and post treatment per accepted standard of care.

Findings were:

A published article entitled "Body Water-Body Weight" by John De Palma MD, FACP and Joanne Pittard MS, RN dated 2001 and found at < http://www.hemodialysis-inc.com/articles/bodywater.pdf> stated in part "Proper control of body weight - body water, like dialysis dose, is one of the important issues and risk factors that contribute to the morbidity and mortality of ESRD patients. Without knowledge of body weight - body water, the health-care giver cannot render adequate dialysis care. In a hemodialysis facility, the classic four vital signs of: temperature, pulse, respirations, and blood pressure should be supplemented with the patient's actual weight both pre and post dialysis."

Infection Control/Wound Care/Pharmacy and Therapeutics Committee meeting minutes dated May 17, 2016 said under "Actions Taken" stated "Need to include monitoring of Hepatitis B documentation on each dialysis flow sheet, pre and post treatment weights, and care of the dialysis catheter."

Infection Control/Wound Care/Pharmacy and Therapeutics Committee meeting minutes dated July 25th, 2016 stated in part under "Recommendation" stated "discuss pre and post weight documentation with director. Education should be provided as needed. Perform monthly random audits to ensure pre and post weights are documented."

Quality Meeting Minutes dated 7/29/16 stated in part under "Action Taken" stated "Dialysis Catheter dressing is to be changed after each dialysis treatment. Pre and post weights are to be obtained."

Review of the medical record of Patient #B1, revealed no pre or post dialysis weights. Further, the patient was admitted for "fluid overload" had been weighed only once since admission (on 7/31/16-date of admission.)

Review of the medical record of Patient #B2, revealed no pre or post dialysis weights. Among admission diagnoses was CHF (Congestive Heart Failure) and ESRD (End Stage Renal Disease.) Patient #B2 was weighed upon admission (7/14/16) but not weighed again until 8/1/16 and 8/7/16.

Review of the medical record of Patient #B3, was admitted for chest pain and wound care on 8/5/16. His admission weight was recorded. No pre or post treatement weights were recorded for the dialysis done on 8/8/16.

Review of the medical record of Patient #B4, was admitted for wound care and ESRD on 7/29/16. He was weighed on 7/31/16. No pre or post dialysis weights were recorded.

Review of the medical record of Patient #B5, was admitted on 7/18/16 with the diagnoses of pneumonitis, congestive heart failure and ESRD. The patient was weighed on 8/7/16 and then again on 8/8/16 when patient had dialysis. No post dialysis weight was recorded on 8/8/16. Prior dialysis treatments had no pre and post weights documented.

In an interview with the Director of Dialysis (Staff Member #B4) on 8/8/16, it was acknowledged that pre and post weights were not taken pre and post dialysis treatment. He said fluid removal was determined by "blood pressure."

Based on review of facility documentation, and staff interview, the facility failed to document all of the required information on their consent forms for Intravenous Contrast Study Forms.

Findings include:

Facility policy titled, Contrast Injection, policy number 032, procedure 6 (B) states in part, "Prior to receiving I.V. contrast media, a signed consent form must be completed and placed in patient chart.

1 out of 7 (#E1) patient charts reviewed had a Intravenous Contrast Study Consent that did not have the procedure to be performed filled in and did not have the patient signature, time or date on the form.

In an in person interview on 8-10-2016 with staff #E20 in the facility conference room it was confirmed that one of the Intravenous Contrast Study Consent Forms did not have a patient signature, date, time or the procedure to be performed listed on the consent form.

Based on observation, document review, policy review, and staff interview, the facility failed to ensure the dietary services followed their policies on food storage and sanitation practices. The facility physical plant and equipment was not maintained in such a manner as to ensure an acceptable level of safety to patients and staff.

Findings were:

During a tour of the dietary department on 8/8/16 and 8/9/16 the following was noted:

* Refrigerator/Freezer Temperature Log for Refrigerator P1 for August 2016 with temperature ranges 34F-40F reveals refrigerator temperature documented for 8/4 at 7:00 pm is documented as DEF. Refrigerator temperature on 8/5 at 6:30 am is documented as DEF. Refrigerator temperature is documented on 8/7 at 6:30 am and 7:00 pm as DEF. Refrigerator temperature on 8/8 is documented as DEF. Refrigerator temperature is documented on 8/9 as DEF.

* Refrigerator/Freezer Temperature Log for Freezer P1 with temperature range Below 0 reveals AM temperature readings for 8/1, 8/2, 8/3, 8/4, and 8/5 are documented as DEF. Temperature reading for 8/6 6:30 am and 7:30 pm are documented as DEF. Temperature documentation for 8/7 at 6:30 am is documented as 6.0.

* Refrigerator/Freezer Temperature Log for Refrigerator P2 for August 2016 with temperature ranges 34F-40F reveals refrigerator temperature was not documented for PM shift on 8/1, 8/2, and 8/3. Refrigerator temperature for 8/3 and 8/5 at 5:30 am was documented as 30F degrees. The refrigerator temperature for 8/8 was unreadable.

* Refrigerator/Freezer Temperature Log for Refrigerator P2 for August 2016 with temperature ranges 34F-40F was documented at 33F on 8/3 5:30 am, 8/5 5:30 am, 8/6 5:30 am, and 8/8 5:30 am.

* Review of log titled "Dish Machine Temperature Log" for August 2016 on 8/9/16 at 11:30 am revealed there was no documentation of the dish machine temperature for the breakfast shift of 8/5, 8/6, 8/8, or 8/9.

* Review of log titled "3 Compartment Sink Log" on 8/9/16 at 11:30 am revealed no documentation of testing of the wash and sanitizing water in the sink for the dinner shift on 8/7 and 8/8.

* 11 plastic glasses and 4 dessert cups were stacked wet on a shelf in the kitchen.

* Round, square, and rectangular plastic and metal containers were stacked and stored wet on a shelf in the kitchen.

* Flour was stored in a container that was labeled "pineapple" with no date as to when it was placed in the container.

* A container holding dried cranberries was not labeled as to contents or date it was placed in the container.

* A toaster oven in the kitchen area had peeling and cracked material at the point the toasted items would enter the oven allowing for the possibility of the peeling paint to fall on the food items.

* 5 large containers of assorted seasonings did not have the lid properly closed and secured as to protect the contents from moisture and contamination.

* Large jugs of red wine vinegar, worcestershire sauce, teriyaki sauce, and smoke sauce were not dated as to when they were opened.

* Bags of sweet potato fries, french fries, and onion rings were not sealed completely after being opened to protect the contents from damage from freezer burn.

* Bags of shredded cheese, sliced cheese, and tortillas were not sealed as to protect contents from contamination and spoilage.

* The freezer had a bag of garlic bread that was no sealed or labeled as to contents or the date received and opened. It also contained a tray of bacon and a tray of turkey sausage that was not covered to prevent contamination.

* The freezers also contained multiple bags of frozen vegetables that had no date as to when received.

* Several areas of the floor in the food preparation area had tape adhering to the floor thus not allowing proper cleaning and sanitizing of the floor.

* On 8/8/16 at 2:10 p.m. there was a half gallon drinking container with water that had orange slices and cucumber slices in it on the food preparation table that was not labeled as to contents, preparation time, or name of patient. The dietary manager initially stated the container belonged to a patient and had not been labeled with the patient name at that time. Upon further questioning it was discovered it belonged to a dietary staff member, staff #C2.

* On 8/9/16 at 11:15 am there was a personal cell phone and a set of keys laying on the food preparation tables.


Facility policy titled "Food Storage and Prevention of Contamination" states in part "All food will be protected from contamination and stored at temperatures that will prevent spoilage. All refrigerators will be maintained at 36-40 degrees F and all thermometers will be visible for easy observation of temperatures. All food stored in refrigerators will be kept covered, labeled, and dated at all times. Frozen items will be maintained at a 10 to 0 degrees F and all thermometers will be visible for easy observation of temperatures. Stock will be rotated to assure that older items are used first."

Facility policy titled "General Cleanliness and Sanitation" states in part "Sanitary conditions will be maintained in the storage, preparation, and distribution of food. Cleaning assignments are initialed and dated by the employee who completes the job. Storage Temperature: Refrigerator and freezer temperatures will be taken daily and recorded. Equipment Maintenance: All equipment will be properly maintained to ensure food safety. Related forms: Sink Temperature Log; Dish Machine Temperature Log; Refrigerator Freezer Temperature Log."

Facility policy titled "Receiving Food and Supplies" states in part "Do not allow cold food to rise above 41 degrees F or frozen foods to rise above 0 degrees F. All food items are to be dated. All stock must be rotated with each new order received."

Facility policy titled "Infection Control" states in part "Maintain proper storage of perishable foods at 40-45 degrees or below. Provide continuing preventative maintenance of equipment to meet safety and infection control standards."

Failing to ensure that the proper refrigeratation temperature was maintained for food storage increased the risk for contamination creating a potential for food borne illness.

During a tour of the facility on the morning of 8/8/16 the following areas were noted to not be properly maintained for safety and quality:

* In the bathroom of the Rehab Gym area the emergency pull cord was wrapped up and tied approximately 3 foot off the floor. A patient who had fallen on the floor and needed assistance could not access the cord. There were also gaps in the floor tile around a floor drain. These gaps did not allow for effective cleaning of the floor area.

* A piece of equipment used in the Rehab Gym, called a "standing frame" had rips in several places of the vinyl that touched patients and did not allow for proper cleaning of the material between patients.

* The soiled utility room in the ICU had floor buffing equipment and floor maintenance supplies stored in the same area as dirty linen and trash.

* A storage room in the ICU area has 4 large pipes that penetrate the ceiling. The pipes are not sealed off and can allow insects and vermin to enter the room.

* The soiled utitlity room on the third floor that was a med-surg unit housed the biohazard boxes and the soiled linen and trash. There were 2 electrical outlets that had no covers; one of the outlets had wires exposed.

* There were several used vinyl gloves on top of bags of dirty linen in the linen storage carts. The carts were labeled "linen only".

* The main janitor closet on the second floor has pipes penetrating the ceiling that were not sealed. This practice can lead to insects and vermin entering the facility.

* A golf cart was parked inside the doors labeled "ambulance entry". The cart was sitting in front of fire alarm pull station and extended into the doorway by approximately 8 inches.


In an interview with the CEO, dietary manager, and CCO/CQO at the time of the findings all acknowledged the deficiencies as stated above. The CEO stated when the annual fire inspection was performed the cart was not located in the doorway or obstructing the fire alarm pull station.

Based on personnel file review and interview, it was determined that the Infection Control Officer did not have documents available related to on going training/education to oversee the infection control program.

Findings were:


"Infection Control Nurse Position Summary," stated in part, "Consults with physicians, managers, and staff for the management of infectious and/or immune-suppressed patients. Implements and effective hospital -wide infection control program in keeping with Center for Disease Control (CDC), JCAHO, and other regulatory agencies. Directs all functions of the Employee Health Program.

· Participates in ongoing infection control educational programs for employees, including TB, HIV/Hep/Universal precautions. May educate patients as necessary

· Completes annual health, safety and educational requirements. Maintains professional growth and development."


Review of the facility's infection control officer (ICO) personnel file, revealed that there was no documentation of training, education, or certifications completed within the past year to oversee the infection control program.

In an interview with the ICO, she reported that she did have documentation of training and education. She said that she request the information from her previous employer. ICO presented the following certifications to the surveyor at a later that afternoon. Certifications presented related to infection control were from years 2012 and 2014 as listed.

Certificates indicated that the training was done by Betty Helber RN, MS Director of Inpatient Education Select Medical Hospital
Infection Prevention Programs August 27 2014
Isolation Precautions/Disease/MDRO's August 28, 2014
Outbreaks August 28, 2014
OSHA Blood borne Pathogen Exposure Control August 28, 2012

In an interview with the ICO, she confirmed the above findings on the afternoon of 08/10/2016. She reported that she did not have documents of her other infection control training at this time.

Based on observation, interview, and tour it was determined that the facility failed to provide a sanitary environment in all areas of the hospital.

Findings were:

"OSHA/Blood borne Pathogen Regulations Policy #138-030-060 " stated in part "The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner."

Facility document entitled, "Infection Control: Disinfection Guidelines," stated in part, "Purpose: To reduce the risk of infection to our patients, employees, and visitors through thorough cleaning and/or disinfection/sterilization of environmental surfaces and patient care items and equipment. Policy: To provide safe and effective disinfection guidelines at Atrium Medical Center the Spaulding Classification categories for disinfection of patient care equipment will be used: Critical, Semi critical, and noncritical.
A. Cleaning: the removal of all visible dust, soil, and any other foreign material."

During a tour of the facility on the afternoon of 08/08/2016 revealed the following infection control concerns:

Intensive Care Unit (ICU) 2nd Floor

Vacant patient Room #4 bottom cabinet drawer was dirty and dusty. The presence of dirt and dust indicated improper cleaning and a risk for infection.

Tan color chair had a tear on the vinyl cover, making it impossible to clean properly.

Ceiling tile had a water stained, indicating a possible leak and a risk for infection.

Room #7, mattress had two spot stains which indicated improper cleaning.

A sterile Urethral Catheter Tray in the supply room had been opened and was available for patient use. This indicated that the catheter tray contents were no longer sterile and a high risk for infection if used.

Yellow top laboratory tubes in the nurses' station cabinet expired 07/2016 were available for patient use.

Several nurses stations chairs had tears on the arms of the chairs, making them impossible to clean properly.


Hyperbaric room had a water stain ceiling tile.


Wound Care Room:

Floor tile was broken and a tile piece was missing, making it impossible to clean properly.

Dark drop stain were noted on floor, indicated a spillage of an unknown liquid substance.

Laminate on the door was peeling off in some areas, making it impossible to clean/disinfect properly.


CT Scan Room

A large foam wedge pillow with no covering was stored on a top shelf of linen cart. The uncovered pillow collects dirt and dust and is a risk for infection when used during patient procedures.

Ceiling tile was noted with a water stain.

An Ultra Sound Machine was being stored in the patient bathroom in the CT scan area.

Medical equipment must be stored in an area that is clean, well-ventilated and dust-free in order to keep them free of microbial contamination.

A white positioning cloth strap on the CT scanning bed had a stained that appeared to be blood. The presence of stains indicated improper cleaning and are risk for infection.


In an interview with the Infection Control Officer on the afternoon of 08/08/16, the above findings were confirmed.


During a tour of the 3rd floor Medical-Surgical Unit on the afternoon of 08/09/2016 revealed the following infection control concerns:

Public Room noted with a water stain ceiling tile.

Biohazard waste room, had a white drainage pipe coming out from the floor that did not have a drain cover.

There were two flexible steel hose on the floor that were used for cleaning Dialysis equipment. Tools uses to clean medical equipment should be stored off the floor.

Patient Room # 336 hand washing sink was dirty and tape was noted on the counter top. The presence of dirt indicated improper cleaning.

Hand sanitizer container in the hallway by room #340 was not working.

In an interview with the Chief Clinical Officer on the afternoon of 08/09/16 the above findings were confirmed.


During a tour of the procedure area on 08/08/16, it was noted that dust was present on high horizontal surfaces such as the light fixtures and the x-ray light box. The presence of dust indicated ineffective cleaning and a risk of cross contamination during patient procedures.

According to The Society of Gastroenterology Nurses and Associates (SGNA) article, Standards of Infection Control in Reprocessing Flexible Gastrointestinal Endoscopes, 2015, found at states in part,

" 9. STORAGE
Endoscopes must be stored in an area that is clean, well-ventilated and dust-free in order to keep the endoscopes dry and free of microbial contamination. An endoscope that is not dry must be reprocessed before use. Endoscopes should also hang freely so that they are not damaged by physical impact ...

Key considerations in storage include:

a. Use storage cabinets that are made of a material that can be disinfected.

b. In conventional storage, hang endoscopes in a vertical position (with caps, valves, and other detachable components removed) to prevent moisture accumulation and subsequent microbial growth. Make sure that they hang freely so they are not damaged by contact with one another. "


In the closet where procedure scopes were stored, it was noted that the ends of 2 scopes were laying on top of an absorbent towel in the bottom of the closet. Staff member A1 was asked how often the towel was changed in the bottom of the storage closet. The staff member replied this was changed out weekly. The scopes should be have been stored vertically and free hanging, to prevent damage and prevent moisture accumulation. The scopes in contact with a towel that is changed weekly also presents a risk of bacterial growth due to moisture accumulation.

The above findings were confirmed on 08/08/16 with staff member A8.




30250


The facility failed to ensure that the sterilizer was maintained according to manufacturer' recommendations and control tests were performed. The facility also failed to ensure that staff responsible for the sterilization of instruments and cleaning of scopes used for invasive procedures were appropriately trained with documented education, competencies, and continuing education.

The manufacturer product profile for 3 M Attest 1262-S Biological Indicators for Steam stated in part,
"Instructions for Use ...
Positive Control Tests: Positive control (unprocessed indicators) should be tested to ensure that storage or handling has not been inadvertently affected the viability of the indicators organisms or the ability of the recovery media to promote bacterial growth. Positive controls also verify that incubation conditions are appropriate.
Test at least one positive control from the same biological indicators for each sterilizer load monitored."

Review of the sterilization logs for 2015 and 2016 revealed that biological control test results were not documented. In an interview on 08/09/16, sterilization staff member A1 stated that control tests were performed. This staff member was unable to provide documentation of these tests results. The staff member also verified that biological controls were not being used for sterilizer load.

By not performing biological indicator control tests, the facility was unable to ensure incubation conditions were appropriate for the proper sterilization of instruments.

The manufacturer operation manual for a M11/M11 D Self-Contained Steam Sterilizer by MidMark stated in part,
"Operator Maintenance...
Monthly
1. Clean chamber and Plumbing
(a) With a cooled chamber, drain reservoir and fill with clean, distilled water. Add one ounce of Speed Clean Sterilization Cleaner (E) directly into bottom of the chamber...
(d) Drain reservoir and refill with clean, distilled water."


In an interview on 08/09/16, staff, member #1 stated routine maintenance performed on the sterilizer included changing the water weekly and cleaning the chamber and tray daily. Staff member # 1 confirmed that currently the facility was not cleaning the chamber and plumbing monthly per manufacturer recommendations.


In an interview on 08/08/16, the COO confirmed that staff member A1 is in charge of sterilization at the facility. The COO also stated that staff member A2 also performed sterilization on a back up basis.


Review of the personnel file for staff members A1 and A2 revealed no documented continuing education, orientation, and/or on the job training on use of the M11 sterilizer or Medevator scope washer.


Staff member A1 stated a previous employee had trained them on the use of this sterilization equipment. Staff member A8 stated an ex-employee had taken the documentation of training and competency for staff members A1 and A2.
Based on a review of documentation and interview, the facility also failed to ensure the infection control officer or officers developed a system for controlling infections of patients and personnel, as evidence by failing to address invasive procedures performed outside the operating room, including sterilization of instruments.

Based on record review and interview, the facility failed to provide rehab services under the orders of a physician for one of seven patient's records did not contain a physician's order for their rehab therapy.

Findings included:

Facility "staff physical therapist" job description stated in part, "Responsible for the evaluation, planning, directing and administering of physical therapy modalities of treatment as prescribed by a licensed physician."

Review of patient #F4's medical record revealed a patient screening form dated 7/20/16 at 2:14 pm that recommended PT/OT [physical therapy/occupational therapy] that was signed by a therapist. A physical therapist narrative note on 7/29/16 at 4:30 pm revealed patient #F4 received PT at that time.

During an interview on the afternoon of 8/11/16 when asked for the order for PT, staff #A8 stated, "Here is the order" and pointed to the screening by the therapist. When asked for the order of a qualified and licensed practitioner, staff #A8 verified there was none in patient #F4's chart.

Based on observation and interview, the hospital failed to post conspicuously in places likely to be noticed by prospective patients, a sign specifying the rights of individuals with respect to examination and treatment for emergency medical conditions and women in labor and post information indicating whether or not the hospital participates in the Medicaid program under a State plan approved under Title XIX.

Findings included:

Observation on the mornings of 08/08/16, 08/09/16, and 08/10/16 revealed one sign on the street that stated, "Emergency entrance," two signs on the facility parking lot that stated, "Emergency entrance," and two signs on the second floor of the facility that stated, "Emergency room" with arrows on each sign. There were no signs throughout the facility specifying the rights of individuals with respect to examination and treatment for emergency medical conditions and women in labor.

The above was confirmed on the morning of 08/09/16 in an interview with staff #A8.