HospitalInspections.org

Based on observation, facility record review and interviews with staff,the hospital did not have an effective governing body. The governing body failed to ensure that facility policies and procedures were used by staff; that staff were properly trained, that the Quality Assurance/Performance Improvement Program provided quality indicators to monitor patient safety; and provide oversight to all departments and services in the facility.

The findings include:


1. The governing body failed to ensure the safety of patients who were receiving dialysis by not providing proper training for staff who performed dialysis treatments, allowing the use of outdated water testing strips, not performing bacterial sampling correctly, and not using and/or having manufacturers' instructions available for use by staff. Interview with the risk manager and the dialysis manager on 5/11/11 at 10:30 AM confirmed the facility did not have an emergency supply of water for the dialysis patients. They stated they would have to helicopter the patients out of the facility for dialysis treatments in the case of an emergency.
See A144, A397 and A703 for more specific information.


2. Based on observations, clinical record review, and staff interviews; the governing body failed to ensure that the infection control officer had a system in place to recognize and identify the potential for the spread of infection. The system failed to effectively test for bacterial contamination on dialysis machines and the water treatment system, failed to identify concerns with the consumption of potentially hazardous foods, failed to identify ineffective kitchen equipment, and failed to identify concerns relative to patients who tested positive for Hepatitis C.
See A144, A724, and A749 for specific information.


3. An interview with the Quality Assurance/Performance Improvement (QA/PI) manager on 5/10/2011 at 2:30 pm revealed the program did not develop standards for the dialysis area in minimum requirements of procedures, training overview to ensure staff were competent in the minimum requirements of quality control and the failed to monitor the dialysis program to ensure the safety of patients. Continuing interview at that time revealed no quality standards and oversight in the food service department. This department is critical to patient safety and may have a profound effect on patient safety.
See A 267 and A285 for more specific information.


4. The governing body failed to ensure that there was a system in place in the pharmacy for removal/disposal of outdated medications and biologicals.
See A505 for more information.

Based on observation, staff interview, and record review the facility failed to meet the Condition of Participation (CoP) to protect and promote each patient's rights for patient safety when they did not maintain dialysis equipment in a safe manner, did not effectively test the water treatment system for bacterial growth, and failed to provide staff with ongoing continuous dialysis education to ensure they could provide safe medical care to their patients. In addition, the facility failed to protect the patients from potential food borne illness and cross contamination when they failed to maintain the temperature of cold holding food at or below 41 degrees F, failed to date, label, and discard potentially hazardous foods, and failed to maintain the kitchen equipment safely and effectively.

The lack of safety precautions, adequate water testing, and ongoing training created an immediate jeopardy situation for all three of the patients who received dialysis treatments at this facility.

The findings include:

1. Based on observation, record review, and staff interviews; the facility failed to ensure patient safety for three of three dialysis patients, #1, #2, and #3. The patients received their routine dialysis treatments in a setting where the facility failed to appropriately monitor for bacterial growth, endotoxins and residual chlorine. In addition, the facility failed to develop policies and procedures for disinfection of the dialysis machines, did not have a schematic diagram describing the direction of the water flow, did not provide ongoing dialysis training and education to ensure the dialysis staff were knowledgeable and competent, and failed to utilize the most current guidelines provided by the Association for the Advancement of Medical Instrumentation (AAMI).

The lack of safety precautions, adequate water testing, and ongoing training created an immediate jeopardy situation for all three of the patients who received dialysis treatments at this facility.

For additional information relative to patient safety, refer to A 0144.


2. Based on observations, staff interviews and record review, the facility failed to meet the Condition of Participation (CoP) for infection control when they did not maintain the dialysis equipment in a safe manner, and when they did not effectively test the water treatment system for bacterial growth. In addition, the facility failed to protect the patients from potential food borne illness and cross contamination infection failed to maintain potentially hazardous cold food at or below 41 degrees F, failed to date/label and discard potentially hazardous foods, and failed to maintain their cold holding units in safe working condition. For additional information relative to deficient practice identified at infection control, refer to A749 and A724.


3. Based on interview with the administrator on 5/10/11, and review of the personnel files for nurses who provide hemodialysis to patients, the facility failed to ensure that 7 of 7 sampled nursing staff (#1, #2, #3, #4, #5, #6, #7) had ongoing specialized continuing education and training necessary to ensure competency in providing hemodialysis to patients. For additional information relative to the lack of staff training and competency, refer to A397.

Based on observations, facility record review and an interview with the Quality Assurance/Performance Improvement (QAPI) Manager, the facility failed to ensure that all hospital departments and services had developed indicators to ensure that policy and procedures were completed as required, failed to review the departments and services provided to assure compliance and provide for patient rights and safety especially for the services of dialysis, pharmacy, and the food service department.

The findings include:


1. Observations of the staff in the dialysis unit during the survey revealed that staff were not following appropriate policies and procedures, did not have quality indicators developed to ensure that quality controls of dialysis equipment were completed appropriately, and did not have indicators in place to ensure that appropriate standards of care were being used. Staff interviews in related deficiencies noted that staff were not reviewing usage documentation for obtaining quality testing for safe water quality in the dialysis unit. An interview with the QAPI manager on May 12, 2011 at 2:30 confirmed that quality indicators had not been developed for the dialysis unit and that the quality program did not complete a full review of the department.
See A144 and A749 for more information.


2. Observations of the food service department revealed spoiled food in the walk-in refrigerator, and food held at unsafe temperatures for consumption by patients and staff. Further review by staff, found the refrigerator was not working properly. A review of QAPI records revealed no quality indicators or quality review of the procedures used by staff to ensure the quality of food services and the safety measures that must be in place to protect the patients and staff. The facility failed to ensure their cleaning products, chemicals, and food seasonings were stored and maintained at an acceptable level of safety. In addition, they failed to ensure the dish machine had a water pressure of 15-25 pounds per square inch (PSI) to ensure the dishes were cleaned and sanitized effectively. An interview with the QAPI manager revealed that quality indicators had not been developed for food service and that quality monitoring was not being accomplished.
See A724 for more information.


3. Interview with the Director of Pharmacy on 5/10/11 at 9:30AM revealed that there was no log or record kept or responsibility assigned for regularly inspecting the drugs and biologicals stocked in the main pharmacy. When asked whose responsibility it was to inspect for outdated drugs, she stated that their system was to have the pharmacy technicians label the drug bins with a red dot and the expiration date when they observed any drugs that are within 3 months of expiration. She also acknowledged that drugs used infrequently would be missed using this system and did not know how frequently outdated drugs were found.
See A505 for further information.

Based on observations, staff interviews and record review, the facility failed to meet the Condition of Participation (CoP) for infection control by not maintaining the dialysis equipment in a safe manner when they did not effectively test the water treatment system for bacterial growth. Also, the facility failed to ensure the dialysis staff was trained and provided with ongoing continuing dialysis education to ensure competency in infection control. In addition, the facility failed to protect the patients from potential food borne illness and cross contamination infection when they maintained potentially hazardous foods in the danger zone, between 41-135 degrees F, failed to label, date, and discard potentially hazardous outdated foods, and failed to maintain their cold holding units in safe working condition.

The findings include:

1. Based on observation, record review, and staff interviews the facility failed to ensure patient safety for three of three dialysis patients, #1, #2, and #3. They failed to identify concerns relative to patients who tested positive for Hepatitis C. The patients received their routine dialysis treatments in a setting where the facility failed to appropriately monitor for bacterial growth, endotoxins and residual chlorine. They failed to effectively test for bacterial contamination on dialysis machines and the water treatment system. In addition, the facility failed to develop policies and procedures for disinfection of the dialysis machines, they did not have a schematic diagram describing the direction of the water flow, did not provide ongoing dialysis training and education to ensure the dialysis staff were knowledgeable and competent, and failed to utilize the most current guidelines provided by the Association for the Advancement of Medical Instrumentation (AAMI).

The lack of safety precautions, adequate water testing, and ongoing training created an immediate jeopardy situation for all three of the patients who had received dialysis treatments at this facility. For additional information relative to infection control and patient safety refer to A144.


2. Based on observation, clinical record review, and interviews with staff the facility failed to recognize and identify the potential for the spread of infection related to identifying concerns with the consumption of potentially hazardous foods, and failed to identify ineffective kitchen equipment. For additional information relative to infection control, refer to A749.

3. Based on interview with the administrator, and review of the personnel files for nurses who provide hemodialysis to patients, the facility failed to ensure that 7 of 7 sampled nursing staff (#1, #2, #3, #4, #5, #6, #7) had ongoing specialized continuing education and training necessary to ensure competency in providing hemodialysis to patients. For additional information relative to the lack of training and competency, refer to A397.

Based on observation, record review, and staff interviews; the facility failed to ensure patient safety for three of three dialysis patients, #1, #2, and #3. The patients received their routine dialysis treatments in a setting where the facility failed to appropriately monitor for bacterial growth, endotoxins and residual chlorine. In addition, the facility failed to develop policies and procedures for disinfection of the dialysis machines, did not have a schematic diagram describing the direction of the water flow, did not provide ongoing dialysis training and education to ensure the dialysis staff were knowledgeable and competent, and failed to utilize the most current guidelines provided by the Association for the Advancement of Medical Instrumentation (AAMI).

The lack of safety precautions, adequate water testing, and ongoing training created an immediate jeopardy situation for all three of the patients who received dialysis treatments at this facility.

The findings include:

1. Observation of the supplies on the dialysis treatment cart on 5/9/11 at 11:50 AM, in the Intensive Care Unit (ICU), revealed the strips that staff used to test for water safety were outdated. The Residual Chlorine testing strips were dated 6/19/10, the Bicarb PH II strips were dated 10/4/10, and the water hardness strips were dated 1/26/11.

Interview with Employee #4, the dialysis nurse, on 5/9/11 at 11:55 AM revealed the dates written on the water-testing strip containers reflected the date staff opened the product. She confirmed staff were to discard the strips three months after the containers were opened. When interviewed about why the strips were still in use, given they were outdated, Employee #4 was unsure. She removed the outdated water-testing strips from the treatment supply cart immediately.

Observation of the facility on 5/9/11 at 12:02 PM, revealed Employee #4 prepared the dialysis machine, tested the water, transported the machine to the room, and was prepared to continue with Patient #1's dialysis treatment.

Interview with Employee #4 and the risk manager on 5/9/11 at 12:02 PM revealed the facility had five dialysis machines and each of the machines was tested monthly for possible contamination. Employee #4 revealed the dialysis machines were disinfected monthly with bleach and then a water sample was collected and sent to the laboratory for endotoxin testing.

Interview with the risk manager on 5/9/11 at 12:30 PM confirmed the machines were disinfected before a water sample was drawn. She stated that if staff retrieved a water sample before they disinfected the machines, all of them would be positive for bacterial contamination. Per the Association for the Advancement of Medical Instrumentation (AAMI), adopted by reference for Water and Dialysate quality, water samples shall always be collected before disinfection of the water treatment system and dialysis machines to accurately assess for bacterial growth.


2. Interview with Employees #7 and #1 at 10 AM on 5/10/11 revealed their systematic description of the use of the Hi Sense Chlorine test system was contrary to the manufacturer's recommendations for safe use.

Review of the manufacturer's recommendations for the use of HiSense Chlorine testing revealed only one drop of the reagent was to be mixed with the post carbon water sample. Additionally, reading of the test strip was to be performed after the water sample had drained and after the test strip was removed from the holder. Once the water drained from the test strip, the final chlorine result was to be interpreted within 10 minutes.

Observation of Employee #7 at 9:45 AM on 5/10/11 revealed she had completed the testing process incorrectly. She did not remove the test strip from the holder and did not set a timer to ensure the result had been interpreted within 10 minutes.

Interview with Employee #7 at 9:45 AM on 5/10/11 confirmed she did not know how much of the HiSense reagent to add to the water sample. Consequently she added at least two drops.

Observation of Employee #7 at 9:50 AM on 5/10/11 revealed she had completed another water test for residual chlorine. She filled a small vial full of post carbon water, opened a small foil package of reagent, and mixed the two by shaking the bottle vigorously.

Interview with Employee #7 at 9:50 AM on 5/10/11 revealed she was unsure how much water was placed in the small vial or how much time should have passed before interpreting the results. She stated she did not have the manufacturer's recommendations for this chlorine test and the package insert could not be located.

Interview with Employee #1 at 10:00 AM on 5/10/11 revealed he did not know that the test strip needed to be removed from the holder and timed to ensure the result would be accurate.

Staff had failed to perform the chlorine testing per the manufacturer's directions, consequently, the chlorine testing documentation logs for 2011, could not be validated.

3. Review of the policies and procedures on 5/10/11 and 5/11/11, revealed the facility did not have current, up-to-date instructions for water and dialysis quality and safety to include: chlorine and chloramine testing, endotoxin testing, culture testing, instrument disinfection, testing of source water for maximum level of chemical contamination, monitoring of the filters, softeners, and carbon absorption tanks. The manufacturers' instructions were not immediately available in the dialysis testing room and the staff had to go to central supply to retrieve the directions for use, i.e. package inserts.

Review of the AAMI guidelines used by the facility revealed they were using outdated material. Their guidelines were dated 2003 and the most current guidelines were revised in 2008.

Interview with the director of nursing (DON) and the risk manager on 5/11/11 at 8:30 AM confirmed the facility did not possess the current guidelines and they immediately printed the most current guidelines from the Internet.

4. Observation of the mobile dialysis machine and water system on 5/10/11 at 10:00 AM revealed there was no schematic diagram (AAMI RD 52:2004 Requirement) available that identified all the components of the water system. In addition, the components of the water system were not labeled or identified, as to the name, function, and actions that were to be taken in the event that one or more of the components were malfunctioning and in need of corrective action.

5. Observation of Employee #7 on 5/10/11 at 9:45 AM, revealed she had begun to test the water sample that was collected post carbon tank to ensure the water was safe for Patient #1's dialysis treatment. Employee #7 collected the water sample before ensuring that the reverse osmosis (RO) tank had been operational for a minimum of 15 minutes. To ensure accurate testing, the "dwell time" that is required is a minimum of 15 minutes. Staff did not demonstrate competency relative to their ability to test for water quality to ensure their patients would be dialyzed safely.

Based on interview with the administrator, and review of the personnel files for nurses who provide hemodialysis to patients, the facility failed to ensure that 7 of 7 sampled nursing staff (#1, #2, #3, #4, #5, #6, #7) had the ongoing specialized continuing education and training necessary to ensure competency in providing hemodialysis to patients.

The findings include:

1. Review of the personnel and staff education files for 7 of 7 sampled nurses who provide hemodialysis services to patients at the facility, including the nurse who was identified as the manager of the dialysis program, revealed no evidence of continued education credits, courses, or specialized training in the complex specialty area of hemodialysis.

2. Review of the annual evaluations for staff nurses #1, #2, #3, #4, #5 and #7 revealed that they had attended an in-service titled Water Treatment since their last evaluation. However, there was no copy of attendance in the nurses' personnel files. On 5/11/11 at 3:00 pm, when the administrator was asked for a copy of the curriculum for the water training and the curriculum on which the form titled Hemodialysis Competency Validation was based, he stated he did not think that there was one.

3. Review on 5/11/11 of the personnel and staff education file for sampled staff nurse
#6, who was identified as the manager for dialysis and who had initialed the new hire and annual Competency Validation checklist forms for nursing staff, revealed no documentation of specialized qualifications or previous hemodialysis experience. There was no evidence of courses taken or continuing education in the area of dialysis.

4. Review on 5/11/11 of the policy Hospital Wide Education Plan, dated 11/2010 revealed that the policy stated under subparagraph A: "Provide competency-based orientation and on-going educational programs consistent with individual needs and the role expectations with emphasis on patient safety and patient population served". The policy also stated in subparagraph C: " Provide ongoing education and training to maintain and improve staff competency in accordance with standards set forth by Federal, State, and Accreditation organizations". There was no evidence found in the personnel files of nursing staff who provide hemodialysis that the hospital's policy for education was followed.


5. Interview with Employees #7 and #1 at 10:00AM on 5/10/11 revealed their systematic description of the use of the Hi Sense Chlorine test system was contrary to the manufacturer's recommendations for safe use.

Review of the manufacturer's recommendations for the use of HiSense Chlorine testing revealed only one drop of the reagent was to be mixed with the post carbon water sample. Additionally, reading of the test strip was to be performed after the water sample had drained and after the test strip was removed from the holder. Once the water drained from the test strip, the final chlorine result was to be interpreted within 10 minutes.

Observation of Employee #7 at 9:45 AM on 5/10/11 revealed she completed the testing process incorrectly. She did not remove the test strip from holder and did not set a timer to ensure the result had been interpreted within 10 minutes.

Interview with Employee #7 at 9:45 AM on 5/10/11 confirmed she did not know how much of the HiSense reagent to add to the water sample, consequently she added at least two drops.

Observation of Employee #7 at 9:50 AM on 5/10/11 revealed she had completed another water test for residual chlorine. She filled a small vial full of post carbon water, opened a small foil package of reagent, and mixed the two by shaking the bottle vigorously.

Interview with Employee #7 at 9:50 AM on 5/10/11 revealed she was unsure how much water was placed in the small vial or how much time should have passed before interpreting the results. She stated she did not have the manufacturer's recommendations for this chlorine test and the package insert could not be located.

Interview with Employee #1 at 10:00 AM on 5/10/11 revealed he did not know that the test strip needed to be removed from the holder and timed to ensure the result would be accurate.

Staff failed to perform the chlorine testing per the manufacturer's directions; consequently, the chlorine testing documentation logs for 2011 could not be validated. Staff did not demonstrate competency relative to their ability to test for water quality to ensure their patients would be dialyzed safely.






21354

28301

Based on clinical record review, interview with a physician (MD) who was responsible for ordering dialysis (hemodialysis) treatments, interview with the dialysis nurse, and a review of the facility's policies and procedures regarding the usage of verbal orders, the facility failed to ensure that when verbal orders are used, they are to be used infrequently and in emergency only situations.

The findings include:

1. On 5/10/11, the clinical record review for Patient #1 revealed that the patient received dialysis treatment. On 5/10/11 at 11:00am, an interview with the nurse who gave the dialysis treatment to Patient #1 revealed that the nurse followed a verbal order from the physician (MD) to provide sodium modeling so that the sodium level would be adjusted during the treatment. Further review of the clinical record revealed that there was no written order signed by the physician confirming the verbal order to the nurse for the sodium modeling.

2. On 5/10/11 at 12noon, the physician (MD) who was responsible for ordering dialysis treatments for Patient #1 was interviewed. The MD stated that prior to the dialysis treatment for all her patients, she discussed the targeted patient outcomes with the dialysis nurse for each patient. The targeted outcomes included, but were not limited to, a specific, numerical value of the sodium, and the amount of fluid weight loss to be achieved through the dialysis process. The MD further stated that these were face-to-face discussions with the dialysis nurses because she was physically present at the facility during the dialysis procedure. The MD confirmed that she did not write an order for sodium modeling for Patient #1. She further stated that in the future, she would need to write the orders for the nurse to follow during dialysis which would include sodium modeling, sodium levels, weight loss and other target outcomes for each patient based on their individual needs.

3. On 5/11/11, a review of the facility's written policy "Orders - Verbal and Telephone" revealed "Verbal orders will be limited to emergency situations." An interview with the Chief Clinical Officer on 5/11/11 at 9:00am confirmed that verbal orders were to be limited to emergency situations per the facility's policy.

Based on observation and interview with the Director of the Pharmacy the facility failed to have an effective inventory inspection system in the main pharmacy to ensure outdated drugs stored in the main pharmacy were not available for patient use as evidenced by the presence of outdated drugs and solutions.

The findings include:

1. Observation of the main pharmacy on 5/10/11 starting at 9:30AM revealed the following drugs in the pharmacy IV (intravenous room) to be outdated:
4 - 100 ml bags - IV (intravenous) - Zosyn 4.6 Gm - non-activated - expiration date: 4/26/11.
3 - 50 ml bags - IV -5% Dextrose - expiration date: 8/2010.
4 - 100 ml bags - IV - 0.9% Sodium Chloride with Piperacillin 2 Gm - non-activated - expiration date: 4/2010.
2 - 100 ml bags - IV - 0.9% Sodium Chloride with Piperacillin 250 mg - non-activated - expiration date: 5/02/11.
In a bright yellow metal cabinet - Marked Highly Flammable:
1 - 500 ml bottle - Liquefied Phenol - retest date: 9/2009
1 - 50 ml opened bottle - Liquefied Phenol - expiration date: 12/20/10.

Interview with the Director of Pharmacy on 5/10/11 at 9:30 am revealed that there was no log or record kept or responsibility assigned for regularly inspecting the drugs and biologicals stocked in the main pharmacy. When asked whose responsibility it was to inspect for outdated drugs, she stated that their system was to have the pharmacy technicians label the drug bins with a red dot and the expiration date when they observed any drugs that were within 3 months of expiration. She also acknowledged that drugs that are used infrequently would be missed using this system and she did not know how frequently outdated drugs were found.

Based on observation of the dry storage unit, the emergency food supply, review of the emergency food policy and procedure, and interview with the dietary manager; the facility failed to ensure they had an adequate supply of dry milk on hand in the case of an emergency. Supplies to keep in the facility in case of emergency/disaster situations include; pharmaceuticals, food, water and other supplies and equipment that may be needed during emergency/disaster situations;


The findings include:

1. Observation of the dry storage area and the emergency food supply on 5/9/11 at 10:55 AM revealed the facility did not have any non-fat powdered milk on the shelves in dry storage.

Review of the "Disaster Feeding/Menu Plan" policy and procedure dated 2010 revealed the facility was to keep enough non-fat powdered milk on hand to feed all the patients, staff and potential visitors for at least 3 meals. The facility is licensed for 80 patients.

Interview with the dietary manager on 5/9/11 at 10:55 AM revealed he did not have any non-fat powdered milk on the premises due to the lack of adequate storage space. He stated he was aware that the facility's policy was to have enough powdered milk for 3 days; however, he did not have enough space to store that much milk.

Based on observation, review of the policies and procedures, and interview with staff, the facility failed to provide facilities for emergency water supply and to develop an emergency water plan to ensure their dialysis patients would have sufficient water in the case of an emergency to continue their dialysis treatments safely.

The findings include:

1. Observation of the Intensive Care Unit (ICU) on 5/9/11 at 12:00 noon, revealed the facility used city water to provide dialysis treatments for their patients. Each of the dialysis machines was equipped with dedicated water and filtering tanks.

Interview with the risk manager and the dialysis manager on 5/11/11 at 10:30 AM confirmed the facility did not have an emergency supply of water for the dialysis patients. They stated they would have to helicopter the patients out of the facility for dialysis treatments in the case of an emergency.

Review of the emergency policy and procedures dated 2010 confirmed the facility had failed to developed a plan for emergency water to ensure a sufficient amount of water would be available to the dialysis patients so they could continue with their physician ordered dialysis treatments.






20921

20921

Based on observation and interview with the dietary manager, the facility failed to ensure their cleaning products, chemicals, and food seasonings were stored and maintained at an acceptable level of safety. In addition, they failed to ensure the dish machine had a water pressure of 15-25 pounds per square inch (PSI) to ensure the dishes were cleaned and sanitized effectively.

The findings include:

1. Observations of the kitchen on 5/9/11 at 10:30 AM revealed chemicals and cleaning products that were stored next to clean pots and pans, and very close to the food production area. The cleaning products that were stored within inches of the clean food service equipment included six spray bottles of sanitizing solution, two one-gallon containers of blue sanitizing solution, one un-clean red sanitizing bucket, three large soiled scrub brushes, a dirty mop and bucket, and a bag of garbage.

Observation of the kitchen and the clean pots and pan area revealed the mop handle was leaning on the dishes, the sanitizing spray bottles were pointed in the direction of the clean pots and pans and all of the products and chemicals were stored within inches of the clean storage rack.

Interview with the dietary manager at 10:45 AM on 5/9/11 confirmed that chemicals and food service equipment should not be stored together; however, he had limited storage space in the kitchen. In addition, he stated the gallon jugs of sanitizing solution were no longer in use and he was unsure why they were stored in the kitchen area.

2. Observation of the kitchen on 5/9/11 at 10:45 AM revealed a tall metal rack that was located next to the gas grill. The tall metal rack contained many plastic containers of food seasoning and spices. Some of the containers were misshaped and appeared to be melted. One container in particular had melted and was bent almost in half. Staff continued to use the seasonings even though the containers were melted and deformed.

Interview with the dietary manager at 10:47 AM on 5/9/11 confirmed the spices and seasonings were located too close to the gas grill and often times the plastic containers melted. The dietary staff did not maintain these spices and seasonings at an acceptable level of safety and quality.

3. Observation during operation of the dish machine on 5/10/11 at 12:15 PM, for seven separate trials, revealed the PSI gauge did not read above 5. To ensure the dishes would be cleaned and sanitized effectively, the water pressure was required to be between 15 and 25 PSI.

Interview with the dietary manager and the administrator on 5/10/11 at 12:30 PM confirmed the PSI gauge had not registered above 5 during the observation trials and they would contact the manufacturer immediately.

Based on observations, clinical record review, and interviews with staff; the facility failed to ensure that the infection control officer had a system in place to recognize and identify the potential for the spread of infection. The system failed to effectively test for bacterial contamination on dialysis machines and the water treatment system, failed to identify concerns with the consumption of potentially hazardous foods, failed to identify ineffective kitchen equipment, and failed to identify concerns relative to patients who tested positive for Hepatitis C.

The findings include:

1. Observation of the facility, on 5/9/11 at 12:02 PM, revealed Employee #4 had prepared the dialysis machine, tested the water, transported the machine to the patient's room, and was prepared to continue with Patient #1's dialysis treatment.

Interview with Employee #4 and the risk manager on 5/9/11 at 12:02 PM revealed the facility had five dialysis machines and each of the machines was tested monthly for possible contamination. Employee #4 revealed that the dialysis machines were disinfected monthly with bleach and then a water sample was collected and sent to the laboratory for endotoxin testing.

Interview with the risk manager on 5/9/11 at 12:30 PM confirmed the machines were disinfected before a water sample was collected. She stated that if staff collected a water sample before disinfection, all of the machines would test positive for bacterial growth. Per the Association for the Advancement of Medical Instrumentation (AAMI), adopted by reference for water and dialysate quality, "water samples shall always be collected before disinfection of the water treatment system and dialysis machines."

Staff failed to ensure the water and dialysis machines had been tested appropriately and were safe to use for dialysis treatments.

2. Observations in the cafeteria on 5/9/11 at 10:15 AM revealed many single servings of potentially hazardous foods had been placed on the counter and were ready for consumption. The individual servings were stacked on top of each other and only the bottom servings were exposed to ice. To ensure food safety, potentially hazardous cold holding food should remain at or below 41 degrees F. The chef calibrated his thermometer to 32 degrees F and recorded the following temperatures:

a. Chicken salad was holding at 47.8 degrees F.
b. One serving of tuna salad, the one that was placed on top of the others, was holding at 48.8 degrees F. The bottom serving of tuna salad, the one placed on ice, was holding at 48.1 degrees F.
c. Egg salad was holding at 48.6 degrees F.
d. Fresh fruit cup that was stacked three high was holding at 57.7 degrees F.
e. Cream filled chocolate eclair was holding at 52.5 degrees F.
d. Coconut cream pie was holding at 49.3 degrees F.

Interview with the chef at 10:20 AM on 5/9/11 confirmed he had just removed the food from the walk-in refrigerator and he did not understand why they were holding at unsafe temperatures. To ensure food safety, potentially hazardous cold holding food should remain at or below 41 degrees F.

Review of the policy and procedure for safe food production dated 2010 confirmed it was the policy of the facility to ensure the refrigerated units and cold holding foods remained between 38-41 degrees F to ensure food safety.

Observation of the walk-in refrigerator on 5/9/11 at 10:30 AM revealed the internal temperature gauge read 45 degrees F. Observation of the food inside the refrigerator revealed two boxes of fresh lettuce that appeared wet, wilted, and discolored. One full case of fresh heads of cabbage was discolored and many contained a white/gray fuzzy, circular substance on the outer surface. In addition, two containers of left-over foods, lasagna and green beans, did not contain the time they were placed into the refrigerator.

Interview with the chef on 5/9/11 at 10:30 AM confirmed the left-over foods were placed in the walk-in refrigerator on 5/8/11 and he did not monitor the cooling process to ensure the food had reached a safe temperature of 41 degrees F within 6 hours. The chef removed the lettuce and cabbage from the walk-in immediately and stated he would have the maintenance department adjust the temperature of the refrigerator.

Interview with the administrator on 5/11/11 at 8:00 AM confirmed the door on the walk-in refrigerator did not shut tightly; consequently, the cold air was able to escape which explained the unsafe internal temperature of the unit.

Observation of the reach-in refrigerated unit on 5/9/11 at 10:35 AM revealed the facility failed to date, label, and discard potentially hazardous foods. The ready-to-eat, open packages of roast beef, ham, and turkey did not contain a date or a label. In addition, one of the unopened, sealed packages of sliced ham was placed on top of ready-to-eat uncovered ham slices, which may have created a cross contamination concern. Also observed were two containers of left-over potentially hazardous foods that were not discarded timely. The roast beef was dated 5/1/11 and the turkey was dated 4/26/11. Interview with the chef at that time confirmed the policy of the facility was to discard left-over food within three days. The left-over roast beef and turkey were discarded immediately.

Observation of the nourishment room in the Intensive Care Unit (ICU) on 5/11/11 at 9:00 AM revealed one open container of apple juice that did not contain a date or a label.

Observation of the nourishment room on the medical/surgical unit on 5/11/11 at 9:05 AM, revealed a defrosted 4-ounce, honey thickened, vanilla milk shake that did not contain a date or a label. Review of the manufacturer's recommendations on the milk shake container, revealed it was to be discarded after 14 days of defrost. Interview with the nurse manager at that time, confirmed the milk shake did not contain a date or a label and it was discarded immediately.

3. Review of the clinical record for Patient #1 on 5/10/11 revealed she was diagnosed with cirrhosis of the liver secondary to Hepatitis C. This viral infection of the liver is blood borne and can potentially contaminate equipment and other surfaces. In addition, if not handled appropriately, the virus can spread from person to person.

Interview with Employee #7 at 3:00 PM on 5/10/11, revealed she had initiated and completed the dialysis treatment for Patient #1, but was unaware the patient tested positive for Hepatitis C.

Interview with the infection control officer at 8:30 AM on 5/11/11 revealed she was also unaware that Patient #1 tested positive for the Hepatitis C virus. She stated for patient and staff safety, universal precautions are required and she should have known that Patient #1 tested positive for the virus.

Based on facility record review and an interview with the Quality Assurance/Performance Improvement (QA/PI) Manager, the facility failed to develop quality indicators in the dietary, pharmacy and dialysis departments, to ensure the performance level of these areas met the minimum standards of patient care.

The findings include:

A review of QAPI tracking indicators revealed that in the dialysis unit the only indicator used was a review of infections in the department. There were no indicators developed to ensure that minimum department standards were reviewed. This led to the following issues that placed the patients at risk:

1. Observation of the supplies on the dialysis treatment cart on 5/9/11 at 11:50 AM, in the Intensive Care Unit (ICU), revealed the strips that staff used to test for water safety were outdated. The Residual Chlorine testing strips were dated 6/19/10, the Bicarb PH II strips were dated 10/4/10, and the water hardness strips were dated 1/26/11.

Interview with Employee #4, the dialysis nurse, on 5/9/11 at 11:55 AM revealed the dates written on the water-testing strip containers reflected the date staff had opened the product. She confirmed staff were to discard the strips three months after the containers were opened. When interviewed about why the strips were still in use, given they were outdated, Employee #4 was unsure. She removed the outdated water-testing strips from the treatment supply cart immediately.

Observation of the facility on 5/9/11 at 12:02 PM, revealed Employee #4 prepared the dialysis machine, tested the water, transported the machine to the room, and was prepared to continue with Patient #1's dialysis treatment.

Interview with Employee #4 and the risk manager on 5/9/11 at 12:02 PM revealed the facility had five dialysis machines and each of the machines was tested monthly for possible contamination. Employee #4 revealed the dialysis machines were disinfected monthly with bleach and then a water sample was collected and sent to the laboratory for endotoxin testing.

Interview with the risk manager on 5/9/11 at 12:30 PM confirmed the machines were disinfected before a water sample was drawn. She stated that if staff retrieved a water sample before they disinfected the machines, all of them would be positive for bacterial contamination. Per the Association for the Advancement of Medical Instrumentation (AAMI), adopted by reference for Water and Dialysate quality, water samples shall always be collected before disinfection of the water treatment system and dialysis machines to accurately assess for bacterial growth.


2. Interview with Employees #7 and #1 at 10 AM on 5/10/11 revealed their systematic description of the use of the Hi Sense Chlorine test system was contrary to the manufacturer's recommendations for safe use.

Review of the manufacturer's recommendations for the use of HiSense Chlorine testing revealed only one drop of the reagent was to be mixed with the post carbon water sample. Additionally, reading of the test strip was to be performed after the water sample had drained and after the test strip was removed from the holder. Once the water drained from the test strip, the final chlorine result was to be interpreted within 10 minutes.

Observation of Employee #7 at 9:45 AM on 5/10/11 revealed she had completed the testing process incorrectly. She did not remove the test strip from the holder and did not set a timer to ensure the result had been interpreted within 10 minutes.

Interview with Employee #7 at 9:45 AM on 5/10/11 confirmed she did not know how much of the HiSense reagent to add to the water sample, consequently she added at least two drops.

Observation of Employee #7 at 9:50 AM on 5/10/11 revealed she completed another water test for residual chlorine. She filled a small vial full of post carbon water, opened a small foil package of reagent, and mixed the two by shaking the bottle vigorously.

Interview with Employee #7 at 9:50 AM on 5/10/11 revealed she was unsure how much water was placed in the small vial or how much time should have passed before interpreting the results. She stated she did not have the manufacturer's recommendations for this chlorine test and the package insert could not be located.

Interview with Employee #1 at 10:00 AM on 5/10/11 revealed he did not know that the test strip needed to be removed from the holder and timed to ensure the result would be accurate.

Staff failed to perform the chlorine testing per the manufacturer's directions, consequently the chlorine testing documentation logs for 2011 could not be validated.

3. Review of the policies and procedures on 5/10/11 and 5/11/11 revealed the facility did not have current, up-to-date instructions for water and dialysis quality and safety to include chlorine and chloramine testing, endotoxin testing, culture testing, instrument disinfection, testing of source water for maximum level of chemical contamination, monitoring of the filters, softeners, and carbon absorption tanks. The manufacturer's instructions were not immediately available in the dialysis testing room and the staff had to go to central supply to retrieve the directions for use, i.e. package inserts.

Review of the AAMI guidelines used by the facility revealed they were using outdated material. Their guidelines were dated 2003 and the most current guidelines were revised in 2008.

Interview with the director of nursing (DON) and the risk manager on 5/11/11 at 8:30 AM confirmed the facility did not possess the current guidelines and they immediately had printed the most current guidelines from the Internet.

4. Observation of the mobile dialysis machine and water system on 5/10/11 at 10:00 AM revealed there was no schematic diagram (AAMI RD 52:2004 Requirement) available that identified all the components of the water system. In addition, the components of the water system were not labeled or identified, as to the name, function, and actions that were to be taken in the event that one or more of the components were malfunctioning and in need of corrective action.

5. Observation of Employee #7 on 5/10/11 at 9:45 AM, revealed she had begun to test the water sample that was collected post carbon tank to ensure the water was safe for Patient #1's dialysis treatment. Employee #7 collected the water sampled before ensuring that the reverse osmosis (RO) tank had been operational for a minimum of 15 minutes. To ensure accurate testing, the "dwell time" that is required is a minimum of 15 minutes. Staff did not demonstrate competency relative to their ability to test for water quality to ensure their patients would be dialyzed safely.

6. Observation of the facility on 5/9/11 at 12:02 PM, revealed Employee #4 prepared the dialysis machine, tested the water, transported the machine to the patient room, and was prepared to continue with Patient #1's dialysis treatment.

Interview with Employee #4 and the risk manager on 5/9/11 at 12:02 PM revealed the facility had five dialysis machines and each of the machines was tested monthly for possible contamination. Employee #4 revealed that the dialysis machines were disinfected monthly with bleach and then a water sample was collected and sent to the laboratory for endotoxin testing.

Interview with the risk manager, on 5/9/11 at 12:30 PM confirmed the machines were disinfected before a water sample was collected. She stated that if staff collected a water sample before disinfection, all of the machines would test positive for bacterial growth. Per the Association for the Advancement of Medical Instrumentation (AAMI), adopted by reference for water and dialysate quality, "water samples shall always be collected before disinfection of the water treatment system and dialysis machines."
Staff failed to ensure the water and dialysis machines had been tested appropriately and were safe to use for dialysis treatments.

7. Observation of the Intensive Care Unit (ICU) on 5/9/11 at 12:00 noon, revealed the facility used city water to provide dialysis treatments for their patients. Each of the dialysis machines was equipped with dedicated water and filtering tanks.

Interview with the risk manager and the dialysis manager on 5/11/11 at 10:30 AM confirmed the facility did not have an emergency supply of water for the dialysis patients. They stated they would have to helicopter the patients out of the facility for dialysis treatments in the case of an emergency.

Review of the emergency policy and procedures dated 2010 confirmed the facility failed to developed a plan for emergency water to ensure a sufficient amount of water would be available to the dialysis patients so they could continue with their physician ordered dialysis treatments.

An interview with the QAPI manager on May 10, 2011 at 2:30 pm revealed that the program did not develop standards for the dialysis area in minimum requirements of procedures, training overview to ensure staff were competent in the minimum requirements of quality control and the failure to monitor the dialysis program to ensure the safety of patients.


8. The pharmacy department failed to have an effective inventory inspection system in the main pharmacy to ensure outdated drugs and biologicals stored in the main pharmacy were not available for patient use. The pharmacy failed to implement measures of tracking that would measure and assess the accurateness of their current system.

Observation of the main pharmacy on 5/10/11 starting at 9:30 am revealed the following drugs in the pharmacy IV (intravenous room) to be outdated:
4 - 100 ml bags - IV (intravenous) - Zosyn 4.6 Gm - non-activated - expiration date: 4/26/11.
3 - 50 ml bags - IV -5% Dextrose - expiration date: 8/2010.
4 - 100 ml bags - IV - 0.9% Sodium Chloride with Piperacillin 2 Gm - non-activated - expiration date: 4/2010.
2 - 100 ml bags - IV - 0.9% Sodium Chloride with Piperacillin 250 mg - non-activated - expiration date: 5/02/11.

In a bright yellow metal cabinet - marked Highly Flammable:
1 - 500 ml bottle - Liquefied Phenol - retest date: 9/2009
1 - 50 ml opened bottle - Liquefied Phenol - expiration date 12/20/10.

Interview with the Director of Pharmacy on 5/10/11 at 9:30AM revealed that there was no log or record kept or responsibility assigned for regularly inspecting the drugs and biologicals stocked in the main pharmacy. When asked whose responsibility it was to inspect for outdated drugs, she stated the process was to have the pharmacy technicians, as they were dispensing drugs, label the drug bins with a red dot and the expiration date when they observe any drugs that are within 3 months of expiration. She also acknowledged that drugs that are used infrequently would be missed using this system and did not know how frequently outdated drugs were found by others in their pharmacy stock.

9. Observations in the cafeteria on 5/9/11 at 10:15 AM revealed many single servings of potentially hazardous foods had been placed on the counter and were ready for consumption. The individual servings were stacked on top of each other and only the bottom servings were exposed to ice. To ensure food safety, potentially hazardous cold holding food should remain at or below 41 degrees F. The chef calibrated his thermometer to 32 degrees F and recorded the following temperatures:

a. Chicken salad was holding at 47.8 degrees F.
b. One serving of tuna salad, the one that was placed on top of the others, was holding at 48.8 degrees F. The bottom serving of tuna salad, the one placed on ice, was holding at 48.1 degrees F.
c. Egg salad was holding at 48.6 degrees F.
d. Fresh fruit cup that was stacked three high was holding at 57.7 degrees F.
e. Cream filled chocolate eclair was holding at 52.5 degrees F.
d. Coconut cream pie was holding at 49.3 degrees F.

Interview with the chef at 10:20 AM on 5/9/11 confirmed he had just removed the food from the walk-in refrigerator and he did not understand why they were holding at unsafe temperatures. To ensure food safety, potentially hazardous cold holding food should remain at or below 41 degrees F.

Review of the policy and procedure for safe food production dated 2010 confirmed it was the policy of the facility to ensure the refrigerated units and cold holding foods remained between 38-41 degrees F to ensure food safety.

Observation of the walk-in refrigerator on 5/9/11 at 10:30 AM revealed the internal temperature gauge read 45 degrees F. Observation of the food inside the refrigerator revealed two boxes of fresh lettuce that appeared wet, wilted, and discolored. One full case of fresh heads of cabbage was discolored and many contained a white/gray fuzzy, circular substance on the outer surface. In addition, two containers of left-over foods, lasagna and green beans, did not contain the time they were placed into the refrigerator.

Interview with the chef on 5/9/11 at 10:30 AM confirmed the left-over foods were placed in the walk-in refrigerator on 5/8/11 and he did not monitor the cooling process to ensure the food had reached a safe temperature of 41 degrees F within 6 hours. The chef removed the lettuce and cabbage from the walk-in immediately and he stated to ensure food safety, he would have the maintenance department adjust the temperature of the refrigerator.

Interview with the administrator on 5/11/11 at 8:00 AM confirmed the door on the walk-in refrigerator did not shut tightly; consequently, the cold air was able to escape which explained the unsafe internal temperature of the unit.

Observation of the reach-in refrigerated unit on 5/9/11 at 10:35 AM revealed the facility failed to date, label, and discard potentially hazardous foods. The ready-to-eat, open packages of roast beef, ham, and turkey, did not contain a date or a label. In addition, one of the unopened, sealed packages of sliced ham was placed on top of ready-to-eat uncovered ham slices, which may have created a cross contamination concern. Also observed were two containers of left-over potentially hazardous foods that were not discarded timely. The roast beef was dated 5/1/11 and the turkey was dated 4/26/11. Interview with the chef, at that time, confirmed the policy of the facility was to discard left-over food within three days. The left-over roast beef and turkey were discarded immediately.

Observation of the nourishment room in the Intensive Care Unit (ICU), on 5/11/11 at 9:00 AM revealed one open container of apple juice that did not contain a date or a label.

Observation of the nourishment room on the medical/surgical unit, on 5/11/11 at 9:05 AM, revealed a defrosted 4-ounce, honey thickened, vanilla milk shake that did not contain a date or a label. Review of the manufacturer's recommendations on the milk shake container, revealed it was to be discarded after 14 days of defrost. Interview with the nurse manager, at that time, confirmed the milk shake did not contain a date or a label and it was discarded immediately.













.



















































20921




21354

Based on facility record review and an interview with the medical director of dialysis, the food service manager and the QAPI manager the facility failed to ensure the safety of patients in the hospital by not including performance improvement activities that focused on areas that affected health outcomes, patient safety, and quality of care.


The findings include:

In the dialysis unit:
1. On 5/10/11, the clinical record review for Patient #1 revealed that the patient received dialysis treatment. On 5/10/11 at 11am, an interview with the nurse who gave the dialysis treatment to Patient #1 revealed that the nurse had followed a verbal order of the physician (MD) to provide sodium modeling so that the sodium level would be adjusted during the treatment. Further review of the clinical record revealed that there was no written order by the physician for the sodium modeling.

2. On 5/10/11 at 12 noon, the physician (MD) who was responsible for ordering dialysis treatments for Patient #1 was interviewed. The MD stated that prior to the dialysis treatment for all her patients, she discussed the targeted patient outcomes with the dialysis nurse for each patient. The targeted outcomes included, but were not limited to, a specific numerical value of the sodium, and the amount of fluid weight loss to be achieved through the dialysis process. The MD further stated that these were face-to-face discussions with the dialysis nurses because she was physically present at the facility during the dialysis procedure. The MD confirmed that she did not write an order for sodium modeling for Patient #1. She further stated that in the future, she would need to write the orders for the nurse to follow during dialysis which would include sodium modeling, sodium levels, weight loss and other target outcomes for each patient based on their individual needs.