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Based on review of Board of Director meeting minutes, the hospital Quality Performance and Improvement (QAPI) Plan, QAPI policies and procedures, the QAPI Director Job Description, and staff interview, the QAPI Director failed to review the grievance process with the governing body annually for the calendar year 2013.

Failure to review the grievance process with the governing body resulted in the governing body's lack of knowledge of concerns identified in grievances and could potentially cause lack of governing body follow through regarding identified, formal and informal grievances received from patients regarding quality of care or services provided.

The QAPI Director identified there were 35 patient grievances received for the calendar year 2013. None of these grievances were reviewed with the governing body.

The Chief Nursing Officer (CNO) identified a census of 78 patients at the time of the survey.

Findings include:

1. Review of Board of Directors Minutes dated 8/26/12 revealed the QAPI Committee presented key performance measures, activities and grievance reports to the Board of Directors for analysis and review. The QAPI Director did not provide additional quarterly meeting minutes that contained key performance measures, activities and grievance reports reviewed with the governing body.

Review of Board of Directors Minutes for the year 2013 lacked documentation of review by the QAPI Committee of performance measures, activities and grievance reports to the Board of Directors for analysis and review.

2. Review of the job description titled, "Director of Quality Management" dated 1/98, revealed the following in part, "...cooperates and collaborates with hospital administration, management... Performance Responsibilities - Department/Job Specific...organization of the Department of Quality Management...Development of effective reporting mechanisms to and from...the Board of Trustees...."

3. Review of policy titled, "Receiving and Responding to Complaints and/or Grievances regarding Services Provided", approval date by the Board Of Directors, 7/12, revealed the following in part, "... Patient care is a collaborative and coordinated effort. The administrative leaders and medical staff of the organization incorporate quality and safety planning into the strategic planning process...Policy: The Board of Directors...delegates the responsibility for the effective operation of the grievance process to the Performance Improvement Committee. ..."

4. Review of "QAPI Plan", approval date by the Board of Directors, 3/28/13, revealed the following in part, "...the administrative leaders and medical staff of the organization incorporate quality and safety planning into the strategic planning process...The Performance Improvement Committee (PI) reviews recommendations for PI activities...Communicates to the Board of Directors...through the following mechanisms and individuals...Reports to the Board of Directors...QAPI committee reviews activities and communicates to the Board of Directors...reports trending to the Performance Improvement Committee and through PI [Performance Improvement] to the Board of Directors on a quarterly basis."

5. During an interview on 1/8/14 at 8:30 AM, the QAPI Director acknowledged she failed to provide grievance reports and/or activities to the hospital board for analysis and review in 2013. Additionally, she acknowledged she failed to follow the QAPI plan. The QAPI Director reported communicating the results of patient grievances reports and/or grievances to the Board of Directors in 2012 but not in 2013.

I. Based on review of facility policy and record review, observation, and staff interview, the acute care hospital failed to measure, record, and maintain hot water temperatures for patient care areas throughout the hospital in accordance with the hospital policy. The hospital identified a census of 78 patients at the time of the survey.

Failure to adequately measure, record, and maintain hot water temperatures in patient care areas could potentially result in burns and cause harm to the patient.

Findings include:

1. Observations on 1/6/14 at 3:00 PM, with Nursing Department Director, the hot water temperature in room 5717 measured 112.1 degrees Fahrenheit, and the hot water temperature in room 5720 measured 114.8 degrees Fahrenheit.

2. Observations on 1/7/14 during the initial tour of the nursing areas revealed the following water temperatures:

a. At 8:30 AM, with the Nursing Manager, the hot water temperature for Room #3 in the ICU (Intensive Care Unit) measured 128.1 degrees Fahrenheit and the hot water temperature for Room # 6 measured 130.1 degrees Fahrenheit.

b. At 10:00 AM, with Director of Obstetrics and Nursery, the hot water temperature for Room 302 measured 123.1 degrees Fahrenheit and the infant bathing sink in the nursery measured 121.5 degrees Fahrenheit. The Director explained that staff measured the temperature of the water before each infant is bathed. A thermometer was available at the sink for these measurements.

3. Review of the policy titled "Facilities Management, Hot Water Regulation", dated 5/13, stated in part "...Purpose: Monitor and control the hot water system to ensure both the adequacy and hot water at a temperature which is safe for patient use. Policy: Hot water may not exceed 110 degrees Fahrenheit at any outlet ..."

4. Review of the Rounds Sheets from 6/24/13 to the time of the survey revealed a daily measurement of #1 Domestic hot water temperature was required. All readings recorded consistent temperatures above 110 degrees Fahrenheit and some days lacked a recording.

5. During an interview on 1/9/14 at 8:25 AM, Staff B, Maintenance Worker, revealed water temperature measurements were taken in the boiler room off of the hot water gauge found on the hot water tank, and the hot water temperature is set at 120-125 degrees Fahrenheit. Staff B acknowledged the readings recorded by the surveyor, and stated he did turn down the temperature on the hot water tank yesterday (1/8/14).

6. On 1/9/14 the surveyor requested current hot water temperatures from patient care areas. At 9:30 AM, Staff B went to patient care rooms and measured hot water temperatures. Staff B reported all temperatures measured below 120 degrees Fahrenheit, and exceeded 110 degrees Fahrenheit.

7. During an interview on 1/9/14 at 1:30 PM, the Director of Facilities, Staff C and B, Maintenance Workers all acknowledged that the hospital failed to follow the established policy for maintaining and recording hot water temperatures.







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II. Based on review of CSA (Contracted Services A) policies and procedures for the provision of hemodialysis, observation, and staff interview, the CSA staff failed to ensure the nurse was present in the room at all times while a patient was being dialyzed in accordance with the CSA's policy and procedure and that the patient was in view of staff during the dialysis treatment to ensure patient safety.

Failure to ensure the nurse was present in the room and that the patient was in view of staff at all times during a patient dialysis treatment could potentially provide an opportunity for dialysis needle dislodgement or a dialysis blood line disconnection to go undetected or staff's failure to identify a change in the patient's condition and provide the needed care and services for the patient, which could result in adverse patient outcomes. Dislodgement of a needle or disconnection of a blood line during the patient dialysis treatment could result in the loss of a great amount of the patient's blood which could result in adverse patient outcomes and even patient death in minutes from the loss of blood.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4. Findings for observation of 1 of 3 patients (Patient D8) observed during the dialysis treatment and for 1 of 2 staff observed providing care during the patient dialysis treatment (RN [Registered Nurse] DH), include:

1. CSA had a policy and procedure titled "HEMODIALYSIS GUIDELINES FOR IN-PATIENT ACUTE OR CHRONIC DIALYSIS," with a revised date of 01/2007, which stated in part, "... Purpose To delineate patient care and treatment responsibilities during hemodialysis for the hospitalized patient... PROCEDURE... One nurse will be present in the room at all times while the patient is being dialyzed..."

2. Observation on 1/6/14 at 1:35 PM in the Intensive Care Unit with the CSA Dialysis Director showed RN DH out of Patient D8's room and standing at the nurses station, while Patient D8 was on hemodialysis. Observation showed the privacy curtain for Patient D8's hospital room covered the room's entry way and the wall of the room that faced the nurses station, and Patient D8 could not be viewed from outside of the room. Further observation showed no staff in the room at the time of the observation.

3. During an interview on 1/8/14 at 2:00 PM, the CSA Dialysis Director verified the observed findings on 1/6/14. During the interview, the CSA Dialysis Director reported in response to the observation, the CSA Dialysis Director talked with RN DH on 1/6/14 about not leaving the patient unattended during the dialysis treatment and that staff needed to keep the patient within eye sight at all times during the dialysis treatment.

III. Based on observation and staff interview, the CSA staff failed to ensure staff placed the 2 containers holding a 1% (percent) bleach solution for cleaning and disinfection of the dialysis equipment and items, in an area that provided a safe setting for patients during the dialysis treatment, for patients receiving the dialysis treatment in the dialysis unit.

Placing the containers holding the 1% bleach solution in an area near a bed where patients received the dialysis treatment could potentially result in the patient, receiving the dialysis treatment in the bed, having the bleach solution splashed or spilled on them which could result in patient harm.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4. Findings for interview and/or observation of care for 2 of 2 staff (RN [Registered Nurse] DH and RN DI) and for 1 of 2 patients observed receiving a dialysis treatment in the dialysis unit on 1/7/14 (Patient D9) include:

1. Observation on 1/6/14 at 5:20 PM and on 1/7/14 at 7:30 AM showed the dialysis unit had a hand washing sink located between 2 dialysis stations. Interview and observation on 1/6/14 at 5:20 PM with RN DH showed the CSA staff prepared a 1% bleach solution, in 2 containers, for cleaning and disinfection of the dialysis equipment and items, with the containers holding the bleach solution located on one side of the counter of the hand washing sink. During the interview, RN DH reported the CSA staff prepared the 1% bleach solution for each container by mixing 2 liters of water with 20 milliliters of bleach. Observation on 1/7/13 during Patient D9's dialysis treatment showed one side of the counter for the hand washing sink had the 2 containers holding the bleach solution, with the containers approximately one and a half feet away from the bed where Patient D9 received the dialysis treatment. Observation showed Patient D9 received the dialysis treatment at the dialysis station with dialysis machine F4.

2. During an interview on 1/7/14 at 4:00 PM, the CSA Dialysis Director acknowledged the findings and verified the location of the containers holding the bleach solution did not ensure a safe setting for the patient receiving the dialysis treatment, for the patient receiving the dialysis treatment in the bed in close proximity to the containers holding the bleach solution.

Based on review of medical records and staff interview, the CSA (Contracted Services A) staff failed to ensure the hospital medical records included a physician order for the acute care patient hemodialysis treatment and physician orders specific for the current hemodialysis treatment (the hemodialysis treatment prescription) provided in the hospital.

Failure to ensure the hospital medical records included a physician order for the patient hemodialysis treatment and physician orders specific for the current hemodialysis treatment could potentially result in the lack of continuity of care, staffs' failure to provide the hemodialysis treatment as ordered, and/or the failure of staff to have the necessary information to monitor the patient's condition which could result in failure of staff to provide the necessary care and services to the patient and potentially result in adverse patient outcomes.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4. Findings for 2 of 2 patient medical records reviewed (Patient D8 and Patient D9) include:

1. Review of the medical records for Patient D8 and D9 showed the hospital medical records lacked a physician order for the hemodialysis treatment provided in the hospital and the hospital medical record did not include a hemodialysis order for the areas such as the duration of the dialysis treatment, the dialyzer, the blood flow rate, the dialysate flow rate, the dialysate, ultrafiltration, dry weight, orders for the patient blood pressure, and medications for the dialysis treatment. Review of the medical records showed Patient D8 had received 2 dialysis treatments in the hospital, 1/6/14 and 1/8/14, and Patient D9 had received 4 dialysis treatments in the hospital, 1/1/14-1/7/14.

2. During an interview on 1/9/14 at 10:30 AM, the CSA Dialysis Director verified the hospital medical records did not contain physician orders for the hemodialysis treatment and orders specific for the dialysis treatment. During the interview, the CSA Dialysis Director reported the physician wrote the orders for the hemodialysis treatment in the chronic hemodialysis outpatient medical record and that the nurses had the chronic hemodialysis outpatient medical record, including the physician orders, with them when providing the hemodialysis treatment for the patient in the hospital. During the interview, the CSA Dialysis Director verified the hospital medial record should include a physician order for the hemodialysis treatment and physician orders specific for the hemodialysis treatment.

Based on policy review, medication error document review and staff interview, the hospital staff failed to notify the physician when medication errors occurred for 7 of 19 Patients, (Patients #1, #2, #3, #4, #5, #6, and #7). The Chief Nursing Officer (CNO) identified a census of 78 patients at the time of the survey.

Failure to report medication errors to the physician could potentially cause harm to patients that received the incorrect medication, dose, route, or did not receive the medication at all.

Findings include:

1. Review of the facility policy titled "Medication Error Reporting System", revised 12/1/07, revealed in part, "... All errors involving medication administered to patients (including errors of omission) will be reported through the electronic event reporting system (Peminic Reporter). The person who discovers the error will complete the report with as much detail as possible. All medication administration errors must also be reported immediately to the patient's physician. Documentation of notification and physician's response will be made in the electronic variance recorder and in the medical record. ..."

2. Review of patient Medication Event reports revealed:

a. The Medication Event report for Patient #1 dated 12/23/13 at 7:00 AM revealed the patient received the wrong dose of IV (intravenous) Acetaminophen (pain medication). The documentation lacked evidence of physician notification.

b. The Medication Event report for Patient #2 dated 11/24/13 at 2:23 AM revealed the patient did not receive Vancomycin (antibiotic) IV at the scheduled time ordered. The documentation lacked evidence of physician notification.

c. The Medication Event report for Patient #3 dated 11/19/13 at 6:18 AM revealed the patient did not receive Hydromorphone (pain medication) IV at the scheduled time ordered. The documentation lacked evidence of physician notification.

d. The Medication Event report for Patient #4 dated 10/26/13 at 4:30 PM revealed the patient did not receive Vancomycin IV as ordered by the physician. The documentation lacked evidence of physician notification.

e. The Medication Event report for Patient #5 dated 10/19/13 at 11:00 PM revealed the patient received Zofran (anti nausea medication) instead of Reglan (anti nausea medication) as ordered by the physician. The documentation lacked evidence of physician notification.

f. The Medication Event report for Patient #6 dated 10/3/13 at 9:00 AM revealed the patient was discharged home with the incorrect dosage of Primidone (anticonvulsant medication). The documentation lacked evidence of physician notification.

g. The Medication Event report for Patient #7 dated 8/29/13 at 11:00 PM revealed the patient did not receive Lasix (diuretic) IV as ordered by the physician. The documentation lacked evidence of physician notification.

3. During an interview on 1/9/14 at 2:55 PM, Staff A, Director of Performance Improvement, acknowledged the seven medication error reports identified failed to document staff notifying the physician when medication errors occurred in accordance with the facility policy.

Based on review of policy and procedure, preventative maintenance documentation, observation, and staff interview, the facility failed to record annual preventative maintenance checks for 3 of 11 patient care beds located in ancillary nursing departments (Dialysis, Respiratory Therapy, and Wound Care) included within the hospital. The hospital identified a census of 78 patients at the time of the survey.

Failure to monitor and record yearly preventive maintenance procedures on patient care beds could potentially result in malfunction of those beds in emergency situations and could potentially cause patient harm.

Findings include:

1. Observation on 1/7/14 at 8:00 AM, with the Director of Dialysis, revealed an electric patient bed in the dialysis unit with no preventive maintenance label.

Observation on 1/8/14 at 2:30 PM, with the Director of Respiratory Therapy, revealed an electric patient bed located in the Respiratory Department. The bed was identified Spare 08237 and the label for preventive maintenance expired 2/12.

Observation on 1/9/14 at 9:30 AM, with the Manger of Wound Care, revealed an electric bariatric bed (a bed specifically designed for overweight patients. The bed often has a reinforced frame and can be fitted with a pressure relieving mattress.) in the wound care unit. Observation showed the bed lacked a preventive maintenance label.

2. Review of the policy titled "Electrical Devices", dated 7/12, stated in part "...Purpose: to provide for the safe and effective use of electrical devices. Procedure: Three-pronged electrical devices used inside patient care rooms or in any area of the hospital that provides direct patient care, e.g. Radiology treatment rooms, Emergency Department treatment areas, OR suites, and Physical Therapy gym areas will be checked for electrical safety by the Maintenance Department annually...."

3. Review of the Electric Bed Test Form for Dialysis 2013 revealed testing was not completed.

Review of the Electric Bed Test Form for Wound Care 2013 revealed testing was not completed.

Review of the Electric Bed Test Form for Respiratory Therapy 2013 revealed testing was not completed.

4. During an interview on 1/9/14 at 2:45 PM, Staff D and E, Maintenance Workers acknowledged the preventive/electrical checks for 2013 were not completed for the Dialysis, Wound Care, and Respiratory Therapy departments.

Based on review of policies, facility documents, and staff interview, the facility failed to ensure the provision of a written agreement for emergency potable/nonpotable water and fuel, to meet the needs of the patients and staff caring for the patients, in the event of a disruption in their normal service. The administrative staff identified a census of 78 patients and approximately 882 employees at the time of the survey.

Failure to ensure emergency water and fuel are available to meet the facility's critical functions during an emergency/crisis situation inhibits the facility's ability to ensure patient safety and quality of care while responding to and recovering from a situation that resulted in the disruption.

Findings include:

1. During an interview, on 1/8/14 at 3:15 PM, the Director of Facilities, the Chief Operating Officer and the Maintenance Manager, reported the hospital had some type of written agreement for emergency fuel and water supplies, but were not sure which department kept the agreements. The Director of Facilities, the Chief Operating Officer and the Maintenance Manager reported no knowledge if any calculations had been considered to evaluate the supplies on hand compared to the potential needs, in the event of a disruption in the fuel and/or water supply.

During a follow-up interview on 1/9/14 at 10:00 AM, the Director of Facilities acknowledged administrative staff were unable to locate any written agreements for emergency fuel and water and were currently working to put something into place.

During an interview on 1/9/14 at 10:50 AM, the Director of Foodservice reported the department kept a consistent supply of bottled water on hand, but acknowledged there had been no calculation to determine how long the supply would last in the event of a disruption in their normal water service.

2. Review of a policy titled "Fuel, Potable Water, Security Sustainability Plan", reviewed in 8/13, revealed in part ". . . 1. The Maintenance/Security Department will maintain an inventory of available fuel and potable water that may be needed to meet the needs of patients."

3. Review of the facility's Emergency Preparedness Manual revealed no documented evidence of estimated fuel/water needs in the event of the disruption of service.

I. Based on review of CSA (Contracted Services A) policies and procedures for the provision of hemodialysis services, manufacturer's information, observation, and staff interview, CSA's staff failed to ensure staff compared the color of the total chlorine test strip to the color blocks as specified in the written policy and procedure and the manufacturer's information to obtain the total chlorine test result of the RO (reverse osmosis) water used for the patient dialysis treatment and failed to ensure a written policy and procedure addressed the procedure regarding returning the patient blood for an elevated total chlorine test result.

Failure of staff to compare the test strip with the color blocks for the total chlorine test result could potentially result in staff failing to identify an elevated total chlorine level in the water used for the patient dialysis treatment. Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to have a written policy and procedure that addressed the procedure regarding returning the patient blood for an elevated total chlorine test result could potentially result in failure of staff to take the action needed to keep the patient safe. Elevated total chlorine in the water used for patient dialysis treatments could cause patient harm, patient illness, hemolysis (the rupture of red blood cells), or patient death.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs for 4 hemodialysis machines. Findings for interview with 2 of 2 staff providing patient care [RN (Registered Nurse) DH and RN DI] and for 2 of 2 observations of the total chlorine test performed with RN DI include:

1. CSA had a policy and procedure titled "Chlorine Testing of Portable R.O. Units," with a revised date of 3/19/08, which stated in part, "... Purpose: Chlorine testing is performed to monitor for adequate removal of total chlorine and chloramine from the water used for the dialysis treatment. Tests for total chlorine, which include both free and combined forms of chlorine may be used as a single analysis to safeguard patients. When total chlorine tests are used, the maximum allowable concentration is 0.1 mg/L [milligram/Liter]. Maximum allowable level for chloramine is also 0.1 mg/L... Policy: Prior to starting any dialysis treatments and after the portable R.O. (or stationary R.O. at Finley) has been running for at least 15 minutes, the water is assessed for presence of chlorine. If not in acceptable range, that unit is not used until corrective measures have been taken and carbon tank performance is acceptable... Procedure:... 1. Collect water sample from the worker tank on portable R.O. discard. 2 Fill sample cup with 20 mL [milliliter] or more of test water. Sample cup should be at least two inches in diameter. 3. Immerse reagent area of test strip in test water and move strip back and forth moderately for 30 seconds. 4. Remove strip from test water. Compare the strip color with the color blocks... 5. Result of < (less than) 0.1 mg/L is acceptable. Acceptable color block is white. (0ppm [parts per million])..." For a total chlorine test result of 0.1 mg/L, the policy and procedure addressed repeating the test from the worker carbon tank to verify the test result, if the repeat test was 0.1 mg/L to check the total chlorine using water from the sample port following the polisher carbon tanks, and if the test result was < 0.1 mg/L continue to check hourly, notify the Medical Director, document on water logs, and notify BioMed Technician of the need to change the carbon tanks. The policy and procedure included to discontinue dialysis immediately if the sample collected following the polisher carbon tank was 0.1 mg/L and to not resume dialysis until the carbon tanks were changed and test results were within acceptable range.

CSA had policies and procures for the ROs that included the test for total chlorine. The policy and procedure titled "PORTABLE R.O. WITH FRESENIUS DIALYSIS MACHINE (Zyzatech F-800 series)," with a revised date of 10/2007 and the policy and procedure titled "Free Standing R.O. with Fresenius Dialysis Machine (Zyzatech Series 700)," with a revised date of 10/07, included in part, "... PURPOSE: R.O. water purification is used with Fresenius hemodialysis machine in hospital setting to provide efficient and safe hemodialysis and to abide per AAMI [Association for the Advancement of Medical Instrumentation] standards... CHLORINE TEST-Water Check 2 Low Level Chlorine/Chloramine Test Strips will be used... To perform CHLORINE TEST: a. Collect water sample from the worker carbon tank or portable RO. b. Fill sample cup with 20 mL or more of test water. Sample cup should be at least two inches in diameter. c. Immerse reagent area of test strip in test water and move strip back and forth moderately for 30 seconds. d. Remove strip from test water. Compare the strip color with the color blocks... e. Result of < 0.1 mg/L is acceptable. Acceptable color block is white. (0ppm) f. Repeat procedure above using water from polisher tank if result is greater than 0.1 ppm. Check total chlorine hourly from polisher tank sample port. If polisher tank has any breakthrough (> [greater than] 0.1 ppm), dialysis must be stopped immediately, and machine taken out of use until serviced. g. Notify Dialysis Bio-Med supervisor of need to change tanks. Document same on log sheet..."

2. Observation and interview on 1/6/14 at 1:40 PM with RN DH and on 1/7/14 at 7:30 AM with RN DI showed staff used WaterCheck 2 test strips to test the water for total chlorine, for the water used for the patient dialysis treatment. Observation of the bottle of test strips showed the test strips had color blocks that specified values for the total chlorine test results.

3. The manufacturer's information for the WaterCheck 2 test strips, titled "WaterCheck 2," included in part, "... 1. Collect 20 mL or more of test water in a 100 mL beaker or a container of at least two inches in diameter. 2. Dip a test strip in the test water, and move the strip back-and-forth moderately... for 30 seconds... 3. Compare the strip color with the color blocks...."

4. Observation of the total chlorine test on 1/7/14 at 7:30 AM and at 11:15 AM with RN DI showed RN DI did not compare the total chlorine test strip color with the color blocks on the bottle of test strips. The observations showed when obtaining the test strip results, after immersing the test strip in the water sample, RN DI observed the color of the test strip, however RN DI did not compare the color of the total chlorine test strip to the color blocks as specified in the written policy and procedure and the manufacturer's information.

5. Interview with CSA staff showed inconsistencies in the actions staff would take regarding a total chlorine test result of 0.1 ppm (mg/L) for the water obtained from the worker carbon tank sample port. During an interview on 1/6/14 at 1:40 PM, RN DH reported for a total chlorine test result of 0.1 ppm or greater for the water from the worker carbon tank, RN DH would repeat the total chlorine test and if the value remained at 0.1 ppm or greater, RN DH would discontinue the patient dialysis treatments and not return the patient blood. During an interview on 1/7/14 at 8:05 AM, RN DI reported for a total chlorine test result of 0.1 ppm or greater for the water from the worker carbon tank or if the test strip had discoloration, RN DI would stop the patient dialysis treatments, return the patient blood and call the BioMed Technician.

Review of CSA's total chlorine policy and procedure as referenced above showed the policy and procedure did not address the facility's system regarding returning the patient's blood in regards to the total chlorine test result.

6. During an interview on 1/8/14 at 2:00 PM, the CSA Dialysis Director acknowledged the findings regarding staff not comparing the test strip with the color blocks to obtain the total chlorine test strip results and acknowledged the differences in the staffs' stated practice regarding returning the patient's blood for a total chlorine test result of 0.1 ppm or greater. The CSA Dialysis Director verified staff should compare the test strip with the color blocks to obtain the total chlorine test strip results. During the interview, the CSA Dialysis Director verified the written policies and procedures should address the procedure regarding returning the patient blood for an elevated total chlorine test result.

II. Based on review of CSA policies and procedures for the provision of hemodialysis, observation, and staff interview, CSA staff failed to ensure all CSA staff would stop dialysis when the RO alarmed for the TDS (total dissolved solids) during the patient dialysis treatment, for a TDS at or above the CSA's established TDS alarm set point in accordance with CSA staffs' stated procedure and failed to ensure the written policies and procedures addressed CSA staffs' stated procedure that staff should stop dialysis when the RO alarmed for the TDS during the patient dialysis treatment, for a TDS above of the CSA's established acceptable parameter.

The RO purifies the water used for the patient dialysis treatments and produces the quality water needed for dialysis. TDS measurements are used to assess the performance of the RO and is a means of monitoring the quality of the RO product water for the patient dialysis treatments. The set point for the RO activates an alarm when the quality of the product water (RO water) diminishes alerting the staff of poor quality product water. The use of poor quality water for the patient dialysis treatments could potentially result in patient illness and adverse patient outcomes. Written policies and procedures provide for guidance among staff and serves as a resource for staff in the performance of procedures. Failure to have written policies and procedures that addressed CSA staffs' stated procedure that staff should stop dialysis when the RO alarmed for the TDS during the patient dialysis treatment, for a TDS above the CSA's established acceptable parameter, could potentially result in a delay in staff stopping the flow of poor quality water from reaching the dialysis patients, which could potentially cause patient illness and adverse patient outcomes.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs for the patient dialysis treatments and 4 hemodialysis machines. Findings for 1 of 2 staff (RN [Registered Nurse] DI) observed providing patient care and interviewed regarding the TDS include:

1. CSA had a policy and procedure titled "PORTABLE R.O. WITH FRESENIUS MACHINE (Zyzatech F-800 series)," with a revised date of 10/2007, which stated in part, "... PURPOSE: R.O. water purification is used with Fresenius hemodialysis machine in hospital setting to provide efficient and safe hemodialysis and to abide per AAMI standards.... TDS alarm- (total dissolved solids) indicator of the R.O. membrane performance. A gradual increase may indicate the R.O. membrane needs to be cleaned or changed. A sudden increase may indicate a tear in the R.O. membrane. ** Notify Biomed if upward trend, or greater than 20 mg/L. TSD [sic] alarm Set-at mg/L. RO will be taken out of service for investigation of TDS alarm greater than 25 mg/L..."

CSA had a policy and procedure titled "Free Standing R.O. with Fresenius Dialysis Machine (Zyzatech Series 700)," with a revised date of 10/07, which stated in part, "... PURPOSE: R.O. water purification is used with Fresenius hemodialysis machine in hospital setting to provide efficient and safe hemodialysis and to abide per AAMI standards... The TDS monitor should stabilize within 2 minutes of startup. The TDS during this may be higher than the alarm set point... A gradual increase may indicate the R.O. membrane needs to be cleaned. A sudden increase may indicate a tear in the membrane. ** Notify Biomed if upward trend, or greater than 20 mg/l...."

2. Interview and observation in the dialysis unit on 1/7/14 at 8:05 AM with RN DI showed the RO in the treatment room connected to 2 dialysis machines for the patient dialysis treatments. Interview and observation with RN DI showed the RO had a TDS set point of 25 and that the RO had both an audible and visual alarm for a TDS reading at or above the set point. During the interview, RN DI reported if the RO alarmed for TDS when patients were receiving a dialysis treatment, RN DI would call the CSA Operations Manager to see what to do and that dialysis could continue.

3. During an interview on 1/7/14 at 2:15 PM with the CSA Dialysis Director and CSA Operations Manager, the CSA Operations Manager reported the ROs did not have an automatic divert to drain or an automatic shut off when the RO alarmed for TDS. The CSA Operations Manager reported if a hemodialysis staff called and reported TDS at or above the alarm set point, that the RO was alarming for TDS during the patient dialysis treatment, the CSA Operations Manager would tell the staff to stop dialysis and not use that RO.

4. During an interview on 1/8/13 at 2:00 PM with CSA's Dialysis Director, Nurse Manager, Educator, and Operations Manager, the CSA staff acknowledged the findings regarding the TDS and reported staff should take immediate action and stop dialysis when the RO alarmed for the TDS during the patient dialysis treatment. During the interview, the CSA Dialysis Director verified the CSA written policies and procedures should address CSA staffs' stated procedure regarding stopping dialysis when the RO alarmed for the TDS during the patient dialysis treatment, for a TDS outside of the CSA's established acceptable parameter.

III. Based on review of the CSA policies and procedures for the provision of hemodialysis, manufacturer's information, observation, and staff interview, the CSA staff failed to ensure evaluation of CSA's procedure for testing the conductivity of the dialysate from the dialysis machine, using the Myron L Dialysate Meter, with the manufacturer's information for the Myron L Dialysate Meter to ensure the CSA written policy and procedure was in accordance with the manufacturer's information.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to ensure that CSA's policy and procedure was in accordance with the manufacturer's information for the conductivity testing procedure could potentially result in an inaccurate reading for the conductivity test. Failure to ensure an accurate reading of the dialysate conductivity with the conductivity meter could potentially allow use of the dialysis machine with a conductivity reading outside of the acceptable safe range for the patient's dialysis treatment which could potentially result in patient illness and adverse patient outcomes, such as hemolysis (the rupture of red blood cells).

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs and 4 hemodialysis machines for the patient dialysis treatments. Findings for interview with 2 of 2 staff providing patient care [RN (Registered Nurse) DH and RN DI] and for 2 of 2 observations of staff performing the conductivity test with the Myron L Dialysate Meter (on 1/7/14 with RN DI) include:

1. The manufacturer's information for the Myron L Dialysate Meter included in part, "... USING YOUR METER... 1. Fill the cell cup to just above the top electrode with a sample of the dialysate you want to test... 2. Drop the plunger into the cell cup. Lift it about half way out of the cell and drop it back in three or four times. Discard the sample. NOTE: This procedure must be conscientiously performed for samples at working (body) temperature to avoid artificially low readings. 3. Repeat steps 1 and 2 at least three times. 4. Take another sample, drop in the plunger and press the black button. When the pointer stops, IMMEDIATELY read and release the button. 5. Repeat step 4 twice and record the last reading..."

2. CSA had a policy and procedure titled "Dialysate Confirmation Testing," with a revised date of 06/2008, which stated in part, "... Purpose: To provide guidelines for confirmation testing of the dialysate solution from the dialysis machines... Policy: The conductivity... will be checked before each dialysis treatment to ensure proper machine dialysate composition. Acceptable conductivity is a reading within the range of 0.5 below or above the TCD (Theoretical Conductivity)... A machine with conductivity... outside of range should not be used... Myron L Dialysate Meter... Using the Meter: 1. Allow conductivity and temperature of the Fresenius to stabilize... and then obtain sample from the blue Hanson or "To Dialyzer" hose. Rinse cell three times with sample. Alternate Method: If collecting dialysate sample into sample cup, rinse sample cup 3 times prior to collecting adequate dialysate sample for conductivity reading. Proceed to rinse cell three times with sample. 2. Fill the cell cup to just above the top electrode with sample of the dialysate you want to test. 3. Drop the plunger into the cell cup and push button. When the needle stops oscillating, immediately read and release. 4. Repeat step 3 twice and record the last reading. 5. Document results on daily dialysis flow sheet..."

3. Observation and interview with RN DI on 1/7/14 at 7:35 AM with dialysis machines F3 and F4 and interview with RN DH on 1/6/14 at approximately 2:35 PM for testing the dialysate from the dialysis machine with the Myron L Dialysate Meter showed that staff described or performed the procedure which included rinsing a sample cup with the dialysate from the Hanson 2 times, collecting a third dialysate sample from the Hanson in the sample cup, and using that sample to fill the cell cup of the Myron L Dialysate Meter. Observation and/or interview showed the staff then continued the procedure as specified in CSA's written policy and procedure.

4. Review of the Myron L Dialysate Meter manufacturer's information and the CSA's policy and procedure as indicated above showed differences in CSA's policy and procedure and the manufacturer's information regarding the procedure for testing the dialysate conductivity using the Myron L Dialysate Meter.

5. During an interview on 1/7/14 at 4:00 PM and on 1/8/13 at 12:15 PM, the CSA Dialysis Director acknowledged differences between the Myron L Dialysate Meter manufacturer's information and the CSA's policy and procedure for testing the dialysate using the Myron L Dialysate Meter. During the Interview, the CSA Dialysis Director verified CSA should evaluate the manufacturer's information in relation to the CSA's policy and procedure to ensure the policy and procedure was in accordance with the manufacturer's information.

IV. Based on review of CSA policies and procedures for the provision of hemodialysis, manufacturer's information, logs, and staff interview, the CSA staff failed to ensure the RO logs, used by staff to document the checks and monitoring of the RO for the patient dialysis treatment, included or specified an acceptable (normal) range/parameter and/or had an acceptable range/parameter specified in accordance with the CSA staffs' reported acceptable range or parameter for the areas of Product Pressure, Percent Rejection, and TDS.

Dialysis equipment, including the RO, requires monitoring by staff to ensure the equipment is functioning within acceptable (normal) ranges or parameters. An acceptable range/parameter provides a reference for staff to verify the area checked or monitored by staff is within an acceptable range/parameter. Failure to provide a parameter or range for an area monitored or checked by staff or a range/parameter that was in accordance with the CSA staffs' reported acceptable range/parameter could potentially result in the staffs' failure to identify a concern or that maintenance was needed for the RO water treatment system. A functioning water treatment system is needed for patients to receive dialysis treatments. Failure of a water treatment system could potentially result in patients' exposure to unsafe water which could result in adverse patient outcomes.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs to provide the patient dialysis treatments. Findings for 2 of 2 ROs reviewed (Portable Zyzatech 800 RO for dialysis machine Z-8 and Stationary Zyzatech 704 RO for dialysis machine F3) include:

1. CSA had policies and procedures addressing the ROs.

The policy and procedure titled "PORTABLE R.O. WITH FRESENIUS DIALYSIS MACHINE (Zyzatech F-800 series)," with a revised date of 10/2007, stated in part, "... PURPOSE: R.O. water purification is used with the Fresenius hemodialysis machine in hospital setting to provide efficient and safe hemodialysis and to abide per AAMI standards... POLICY: R.O. Water checks, including... % [percent] rejection, TDS (Total Dissolved Solids)... will be done before each dialysis treatment. Document results on the Equipment Operation and Water Quality Log sheet... R.O. Equipment Logs:... Product Pressure (varies 0- >60 P.S.I. [pounds per square inch]... Percent Rejection Indicator- Lights must be in the green region before continuing... Percent rejection should display in the green region between 85% - 95%... TDS alarm- (total dissolved solids) indicator of the R.O. membrane performance. A gradual increase may indicate the R.O. membrane needs to be cleaned or changed. A sudden increase may indicate a tear in the R.O. membrane. ** Notify Biomed if upward trend, or greater than 20 mg/L. TSD [sic] alarm Set-at 25 mg/L. RO will be taken out of service for investigation of TDS alarm greater than 25 mg/L..."

The policy and procedure titled "Free Standing R.O. with Fresenius Dialysis Machine (Zyzatech Series 700)," with a revised date of 10/07, stated in part, "... PURPOSE R.O. water purification is used with Fresenius hemodialysis machine in hospital setting to provide efficient and safe hemodialysis and to abide per AAMI standards... POLICY: R.O. Water checks, including... % rejection, TDS (Total Dissolved Solids)... will be done before each dialysis treatment. Document results on the Equipment Operation and Water Quality Log sheet... R.O. Equipment Logs:... Product pressure ranges from 0 to > 60 p.s.i... The "Percent Rejection" monitor... It is acceptable to use minimum percent rejection of 85%... The TDS monitor should stabilize within 2 minutes of startup... A gradual increase may indicate the R.O. membrane needs to be cleaned. A sudden increase may indicate a tear in the membrane. ** Notify Biomed if upward trend, or greater than 20 mg/l..."

2. The manufacturer's information for the ZyzaTech Water Systems, Inc. - 700 Series RO System included the following "... The Product Water Total Dissolved Solids (TDS) digital display indicates product water purity.... The Less Than .5 mg/L Check System lamp indicates when the TDS is .5 mg/L or less. This indicates a need to evaluate the RO system performance. RO units do not normally have this low of a product TDS. Verify this reading with an independent meter and take corrective action if indicated. RO membranes under optimum conditions (good feed water) may achieve this level of performance..."

The manufacturer's information for the Zyzatech F-800 series, titled ZyzaTech Water Systems, Inc. F-801 Internal Reverse Osmosis System, included the following "... Total Dissolved Solids: Should display normal for the region... The TDS monitor displays the actual product water quality that is delivered to the dialysis machine... NOTE: An alarm light is located to the right of the mute button that will illuminate if the product water total dissolved solids displays less than 0.5 mg/L. This is a rare phenomenon that can occur if the source or feed water is already highly purified; otherwise, the system needs to be checked..."

3. Review of 2 of 2 logs used by CSA staff to document the monitoring, checks, and readings of the RO for the patient dialysis treatments, titled "STATIONARY ZYZATECH 704 R.O. EQUIPMENT OPERATION and WATER QUALITY LOG SHEET" and "PORTABLE ZYZATECH 800 R.O. EQUIPMENT OPERATION AND WATER QUALITY LOG SHEET," showed the logs included columns with areas specified for staff to monitor and check and included areas for the acceptable ranges/parameters as a reference for the CSA staff for the areas monitored and checked by staff. Review of the logs for the Stationary Zyzatech 704 RO, dated 6/19/13-1/7/14, and review of the logs for the Portable Zyzatech 800 RO, dated 5/8/13-1/7/14, showed the acceptable range/parameter specified for the Percent Rejection was "(=>85)," the acceptable range/parameter specified for the Product Pressure was "(varies)," and the acceptable range/parameter specified for the TDS was "(<25mg/l)."

Review of the logs showed the logs did not address the low value for TDS, of 0.5 mg/L, as indicated above in the manufacturer's information. The log for the Portable Zyzatech 800 RO had one day when CSA staff documented a TDS value of 0.3 mg/l.

4. During an interview on 1/8/14 at 2:00 PM, the CSA Dialysis Director and Operations Manager verified the acceptable range/parameter specified on the RO logs for the Percent Rejection and Product Pressure. During the interview, the CSA Operations Manager reported the acceptable range/parameter for the Percent Rejection specified on the log should be greater than 90. During an interview on 1/9/13 at 10:30 AM, the CSA Dialysis Director verified the log should include an acceptable range/parameter for the Product Pressure as a reference for CSA staff when staff performed the RO checks. During an interview on 1/9/14 at 3:30 PM, the CSA Dialysis Director and Operations Manager reported the RO logs should include monitoring for a TDS of less than 0.5 mg/L and CSA staff verified the documentation on one of the RO logs included that staff documented a TDS reading of less than 0.5 mg/L.

I. Based on review of CSA (Contracted Services A) policies and procedures for the provision of hemodialysis, observation, and staff interview, the CSA staff failed to ensure:

- staff performed hand hygiene and/or performed hand hygiene and donned clean gloves between dialysis stations and after touching potentially contaminated areas or items, prior to performing clean procedures or obtaining common unused patient care supplies or touching common areas or items.

- staff discarded or dedicated for use only on a single patient, the roll of tape taken to the patient dialysis station.

- staff had a hand washing sink dedicated only for hand washing purposes and failed to ensure CSA staff avoided placing, cleaning or draining used items in the "clean" hand washing sink and that used or contaminated items were handled in the designated "dirty" sink in accordance with the written and CSA staff's stated policy and procedure.

- staff cleaned and disinfected all surfaces of the dialysis machine and the dialysis machine and portable RO (reverse osmosis), for the portable RO taken to a patient hospital room for the patient dialysis treatment, the bedside table at a patient dialysis station in the dialysis unit, and that the cabinet for the hand washing sink had intact surfaces to facilitate effective cleaning and disinfection of the surface.

Failure to ensure that staff performed hand hygiene and/or performed hand hygiene and donned clean gloves between dialysis stations and after touching potentially contaminated areas or items, prior to performing clean procedures or obtaining common unused patient care supplies or touching common areas or items could potentially result in the transmission of infectious agents to objects such as medical equipment, environmental surfaces, common supplies, and to patients, staff, and/or visitors which could result in illness and/or adverse outcomes to those exposed to the infectious agents.

A roll of tape taken to a patient dialysis station could become contaminated with blood and other fluids and serve as a vehicle of transmission of infectious agents/cross-contamination if used on other patients which could result in patient illness and/or adverse patient outcomes. Failure to ensure staff cleaned and disinfected all surfaces of the dialysis machine and the dialysis machine and portable RO, for the portable RO taken to a patient hospital room for the patient dialysis treatment, and the bedside table at a patient dialysis station in the dialysis unit could potentially result in the transmission of blood borne pathogens and other infectious agents from one patient to another. Most hemodialysis patients have suppressed immune systems and exposure of bacterial contaminants and infectious agents could potentially cause patient illness and/or adverse patient outcomes.

Failure to ensure an intact surface for the cabinet of the hand washing sink failed to ensure effective cleaning and disinfection of the surface could occur which could potentially result in transmission of an infectious agent remaining on the surface, to objects such as medical equipment, supplies or environmental surfaces, patients, staff, and/or visitors and cause illness to those exposed to the infectious agents.

Failure to have a hand washing sink dedicated only for hand washing purposes and failure to ensure CSA staff avoided placing, cleaning or draining used items in the "clean" hand washing sink and that used or contaminated items were handled in the designated "dirty" sink could potentially result in cross-contamination of the hand washing sink from the used or contaminated items and result in patient illness and/or adverse patient outcomes.

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs for 4 hemodialysis machines. Observation of care and infection control practices occurred on 2 days of the survey (1/6/14 and 1/7/14) during the provision of patient care. Findings for 2 of 2 observations of initiation of the patient hemodialysis treatment (Patient D9 and Patient D10), 1 of 2 observations of discontinuation of a patient hemodialysis treatment (Patient D9), 2 of 2 observations of staff cleaning and disinfecting the hemodialysis machine, hemodialysis machine and portable RO, and/or hemodialysis patient station after the patient hemodialysis treatments (RN [Registered Nurse] DH and RN DI), for 1 of 1 dialysis unit, and for 2 of 3 patients observed during the dialysis treatment (Patient D9 and Patient D10) and for 3 of 3 staff observed (RN DH, RN DI, and RN DJ) failing to ensure: staff performed hand hygiene and/or performed hand hygiene and donned clean gloves between dialysis stations and after touching potentially contaminated areas or items, prior to performing clean procedures or obtaining common unused patient care supplies or touching common areas or items; staff discarded or dedicated for use only on a single patient, the roll of tape taken to the patient dialysis station; and/or that staff had a hand washing sink dedicated only for hand washing purposes and failed to ensure CSA staff avoided placing, cleaning or draining used items in the "clean" hand washing sink and that used or contaminated items were handled in the designated "dirty" sink, include:

1. CSA had a policy and procedure titled "INFECTION CONTROL," with a revised date of 12/27/13, which stated in part, "... PURPOSE: To provide the framework to assist staff and visitors in the surveillance, prevention of infections and control of infections... General Guidelines For Infection Control All staff members must follow the following procedures:... Examples of when disposable gloves must be worn: - Staff members should wear gloves while performing procedures that have the potential for exposure to blood, dialysate and other potentially infectious substances... Examples of when fresh pair of gloves must be put on... - When going from a "dirty" area or task to a "clean" area or task. The CDC [Centers for Disease Control and Prevention] defines a "dirty" area as an area where there is a potential for contamination with blood or body fluids and areas where contaminated or "used" supplies, equipment, blood supplies or biohazard containers are stored or handled. A "clean" area is an area designated only for clean and unused equipment and supplies... - After touching one patient or their machine and before arriving to care for another patient or touch another patient's machine. - In addition, a new pair of clean gloves must be used each time for access site care, vascular access cannulation,... or to perform invasive procedures. The intention is to ensure that clean gloves, which have not previously touched potentially contaminated surfaces, are in use whenever there is a risk for cross contamination to a patient's blood stream to occur... Gloves must be removed and hands washed between each patient or station. In all cases gloves must be put on FIRST, before dealing with patient or equipment... Thorough hand washing must be done after gloves are removed and between each patient contact, as well as after touching blood,... and contaminated items; before and after direct contact with patients; before performing any invasive procedure such as vascular access cannulation... after contact with inanimate objects, including medical equipment or environmental surfaces at the patient station... According to the CDC, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from outer surface of gloves during glove removal... Avoid placing, cleaning or draining used items in "clean" sinks. Used, or contaminated items will be handled in designated "dirty" sinks... Correct cleaning and disinfection of environmental surfaces, (including patient chair, dialysis equipment surfaces, adjacent tables and work surfaces) must be performed between patient uses to prevent transmission of dangerous pathogens... Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient's dialysis station, including those places on top of dialysis machines, should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected (tourniquets, hemostats) before being returned to a common clean area or used for other patients. Unused... supplies... taken to the patient's station should not be returned to a common clean area or used on other patients... Sinks in the clinical area must be designated as clean or dirty... Staff must be aware of the separation of clean and dirty areas to prevent cross-contamination... Surface Disinfection... The following surfaces should be disinfected at the completion of each patient's treatment. hemodialysis machines (all external surfaces)..."

2. Observation on 1/7/14 at 7:35 AM showed RN DI did not perform hand hygiene between dialysis stations when performing the conductivity and pH test of the dialysate from the dialysis machines. Observation showed RN DI collected a dialysate sample from dialysis machine F3 at a dialysis station, performed the conductivity and pH test of the dialysate, then collected a dialysate sample from dialysis machine F4 at another dialysis station, and performed the conductivity and pH test of the dialysate.

3. Observation on 1/7/14 at 7:45 AM showed RN DI, not wearing gloves, placed strips of tape to the front of dialysis machine F4 at a dialysis station, opened the packages containing the fistula needles at the bedside table at the dialysis station, and did not perform hand hygiene before going to the desk in the dialysis unit and answering the telephone. Continued observation showed RN DI did not perform hand hygiene after touching the phone and went to a cupboard containing common supplies, picked up gauze from the common supply cupboard, and placed part of the gauze on dialysis machine F3 at a dialysis station and the other portion of the gauze on dialysis machine F4 at another dialysis station.

4. Observation on 1/7/14 at 8:20 AM showed RN DI, wearing gloves, placed the bell of the stethoscope on the chest of Patient D9, pre-dialysis treatment at the dialysis station with dialysis machine F4. After use of the stethoscope, RN DI removed the gloves, performed hand hygiene, and after donning new gloves, RN DI wiped the bell of the stethoscope at the dialysis station with an alcohol prep pad. Continued observation showed RN DI removed one of the gloves, and did not perform hand hygiene prior to obtaining gauze from a common supply cupboard with the ungloved hand. Further observation showed RN DI donned a new glove, from a common glove box to the ungloved hand, wet the gauze at the hand washing sink and applied a skin cleanser to the part of the gauze, went to Patient D9's dialysis station, and cleansed the skin over the patient's vascular access with the gauze. Continued observation showed RN DI removed the gloves and did not perform hand hygiene prior to obtaining new gloves from a common glove box, donned the gloves, applied antiseptic to the skin over the patient's access, and inserted the needles into the patient's vascular access for the dialysis treatment.

5. Observation on 1/7/14 at 8:50 AM showed RN DI at the dialysis station with dialysis machine F3 preparing to initiate the dialysis treatment for Patient D10. Observation prior to the patient dialysis treatment showed RN DI with gloved hands, touched the dialysis machine, the dialysis blood lines (containing normal saline prior to the patient treatment), and the skin over the patient's vascular access. Continued observation showed RN DI removed one of the gloves, touched the telephone with the ungloved hand to answer the phone, and after talking on the phone, RN DI did not perform hand hygiene prior to donning a new glove. Continued observation showed RN DI wearing the same gloves applied antiseptic to the skin over the patient's vascular access, removed a scab from the patient's access, applied antiseptic to the site, and then removed the gloves and did not perform hand hygiene prior to obtaining a vascular access needle from the common supply cupboard.

6. Observation 1/7/14 at 12:20 PM showed RN DI at the dialysis station for Patient D9 preparing to discontinue the dialysis treatment. Observation showed after performing hand hygiene and donning gloves, RN DI touched the phone with a gloved hand and then wearing those same gloves (potentially contaminated from touching the phone), RN DI removed a needle from the patient's vascular access and placed gauze (touching the gauze with the gloves) over the needle puncture site. RN DI held the gauze, applying pressure, over the needle puncture site.

7. During an interview on 1/8/14 at 2:00 PM with the CSA Dialysis Director, Nurse Manager, Educator, and Operations Manager, the CSA staff acknowledged the above findings and verified staff should perform hand hygiene and/or perform hand hygiene and don clean gloves between dialysis stations and after touching potentially contaminated areas or items, prior to performing clean procedures or obtaining common unused patient care supplies or touching common areas or items.

8. Observation of the dialysis unit during the patient treatment day on 1/7/14 showed 2 patients received dialysis, Patient D9 beginning at approximately 8:35 AM and Patient D10 beginning at approximately 9:00 AM. Observation showed each patient at a dialysis station and each dialysis station contained a bedside table which held items such as the patient medical record, a box of gloves and a roll of tape. During an interview on 1/7/14 at 4:00 PM, the CSA Dialysis Director acknowledged the findings and reported after the patient dialysis treatment, CSA dialysis staff returned the rolls of tape to a common cupboard, that CSA staff did not designate the rolls of tape to a specific patient or discard the rolls of tape at the end of the patient dialysis treatment. During the interview, the CSA Dialysis Director verified that items taken into the dialysis station should be disposed of, dedicated for use for that specific patient, or cleaned and disinfected before taken to a common clean area or used on another patient. The CSA Dialysis Director verified staff should not return the rolls of tape, that had been at the dialysis station (potentially contaminating the roll of tape), to the common supply cupboard making the rolls of tape available for use with other patients and verified the bedside tables were at the dialysis station during the patient dialysis treatment.

9. Observation of the dialysis unit on 1/6/14 and 1/7/14 failed to show the CSA dialysis staff had a hand washing sink dedicated only for hand washing purposes and failed to show CSA staff avoided placing, cleaning or draining used items in the "clean" hand washing sink and that used or contaminated items were handled in the designated "dirty" sink in accordance with the written and the CSA staff's stated policy and procedure.

a. Observation of the dialysis unit on 1/6/14 at 5:20 PM with RN DH and on 1/7/14 with RN DI at 7:30 AM showed the dialysis unit had a sink between 2 dialysis stations. Observation on 1/6/14 at 5:20 PM showed RN DH discarded solution from the prime waste container, from a dialysis machine used for Patient D8's dialysis treatment, in the sink, and placed the bicarbonate and acid concentrate solution probes/pick up tubes, used for Patient D8's dialysis treatment, in a container of bleach solution on the sink's counter. Observation on 1/7/14 at 8:30 AM and at 8:55 AM showed RN DI used the sink to wet gauze and apply a cleansing agent to the gauze for cleaning the skin over Patient D9's and Patient D10's vascular access respectively, in preparation for initiation of the patient dialysis treatment. Observation on 1/7/14 during the dialysis treatments for Patient D9 and Patient D10 showed RN DI and RN DJ used the sink to wash their hands. Observation on 1/7/14 at 12:50 PM showed after Patient D9's dialysis treatment, RN DI removed the hemostats/clamps from Patient D9's dialysis station and placed the hemostats in a container of bleach on the counter of the sink. Further observation showed RN DI discarded solution from the prime waste container, used for Patient D9's dialysis treatment, in the sink and placed the bicarbonate and acid concentrate solution probes/pick up tubes, used for Patient D9's dialysis treatment, in a container of bleach on the counter of the sink.

b. During an interview on 1/7/14 at 4:00 PM, the CSA Dialysis Director acknowledged the observed findings and reported the sink between the dialysis stations was a "clean" sink designated for hand washing. The CSA Dialysis Director verified staff should not place or clean used or potentially contaminated items in the sink and that staff should not discard the solution from the prime waste containers in the sink.

10. Observation on 1/6/14 and 1/7/14 showed staff did not clean and disinfect all surfaces of the dialysis machine and the dialysis machine and portable RO (for the RO taken to a patient room for the dialysis treatment).

a. Observation on 1/6/14 at 5:20 PM showed RN DH disinfecting the dialysis machine and portable RO used to provide the dialysis treatment in the hospital room for Patient D8. Observation of the disinfection procedure showed RN DH did not disinfect the basket on the side of the dialysis machine, the monitor line for the blood pressure cuff, 2 of the 4 holders for the IV (intravenous) solution on the top of the IV pole, and the hoses and carbon tanks on the back side of the dialysis machine.

b. Observation on 1/7/14 showed RN DI disinfecting one of the dialysis stations and dialysis machine F4 after Patient D9's dialysis treatment provided in the dialysis unit. Observation of the disinfection procedure showed RN DI did not disinfect the Hanson connectors, the dialysate hoses/lines, 1 of the 4 holders for the IV solution on the top of the IV pole, and the basket on the side of the dialysis machine.

c. During an interview on 1/8/13 at 2:00 PM with the CSA's Dialysis Director, Nurse Manager, Educator and Operations Manager, the CSA staff acknowledged the above findings regarding cleaning and disinfection and verified staff should clean/disinfect all surfaces of the dialysis machine and RO including the areas specified above.

d. Observation on 1/6/14 at 12:50 PM with the CSA Dialysis Director showed 2 areas approximately 1 inch long of dark build up on the top surface of the bedside table at the dialysis station with dialysis machine F4. Interview with the CSA Dialysis Director at the time of the observation showed the dark build up appeared to be tape residue. The dark build up on the top surface of the bedside table did not ensure effective cleaning and disinfection of the bedside table occurred.

e. Observation on 1/6/14 at 12:50 PM with the CSA Dialysis Director of the hand washing sink located between the 2 dialysis stations in the dialysis unit showed the front of the sink's cabinet, below the sink, had a panel that had missing laminate on the edges of the panel and one side of the panel had loose laminate present. Interview with the CSA Dialysis Director on 1/6/14 at 4:00 PM verified that the missing and loose laminate did not ensure effective cleaning and disinfection of the surface could occur.

II. Based on review of CSA policies and procedures for the provision of hemodialysis, logs, culture and LAL (Limulus Amoebocyte Lysate)/endotoxin laboratory reports, observation, and staff interview, the CSA staff failed to ensure:

- staff had obtained a dialysate culture and LAL/endotoxin sample from the dialysis machines and that CSA staff had a monitoring system in place to ensure staff collected dialysate cultures and LAL/endotoxin samples from the dialysis machines.

- the written policies and procedures addressed obtaining and collecting the dialysate samples from the dialysis machines for the LAL/endotoxin levels in the dialysate.

- evaluation of the CSA's system regarding when staff collected of the water culture and LAL/endotoxin samples in relation to when disinfection of the RO and dialysis machines occurred, to ensure collection of the water culture and LAL/endotoxin samples occurred when the risk for contamination was the highest, before disinfection of the RO water system/dialysis machine, as close to the time of disinfection as possible.

- consistency in the written policies and procedures regarding the day specified for staff to collect the dialysis machine cultures.

- consistency between the written policy and procedure regarding the frequency for completing the rinse and heat disinfection for the dialysis machine when not in use (i.e., no hospital patient) and the CSA staffs' stated policy and procedure regarding the frequency for completing the rinse and heat disinfection for the dialysis machine when not in use (i.e., no hospital patient) and failed to ensure staff completed and documented the disinfection and rinsing procedures for the dialysis machines at the frequency specified in the CSA staffs' stated policy and procedure.

Failure to ensure staff obtained a dialysate culture and LAL/endotoxin sample from the dialysis machines and failure to ensure CSA staff had a monitoring system in place to ensure staff collected dialysate cultures and LAL/endotoxin samples from the dialysis machines could potentially result in the failure of staff to identify elevated bacteria and/or endotoxin levels in the dialysate.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to have a policy and procedure that addressed obtaining and collecting the dialysate samples from the dialysis machines for the LAL/endotoxin levels in the dialysate and failure to ensure consistency in the written policies and procedures regarding the day specified for staff to collect the dialysis machine cultures could potentially result in staff performing the procedure inaccurately or inconsistently, which could result in staffs' failure to identify elevated bacteria and/or endotoxin levels.

Failure to ensure evaluation of the CSA's system regarding when staff collected of the water culture and LAL/endotoxin samples in relation to when disinfection of the RO and dialysis machines occurred, failed to ensure collection of the water culture and LAL/endotoxin samples occurred when the risk for contamination was the highest, before disinfection of the RO water system/dialysis machine, as close to the time of disinfection as possible, which could potentially result in staffs' failure to identify elevated bacteria and/or endotoxin levels.

Failure to ensure consistency between the written policy and procedure regarding the frequency for completing the rinse and heat disinfection for the dialysis machine when not in use and the CSA staffs' stated policy and procedure regarding the frequency for completing the rinse and heat disinfection for the dialysis machine when not in use and failure to ensure staff completed and documented the disinfection and rinsing procedures for the dialysis machines at the frequency specified in the CSA staffs' stated policy and procedure could potentially result in staff performing or completing the procedure inaccurately or inconsistently, which could result in elevated bacteria and/or endotoxin levels in the dialysate used for the patient dialysis treatment.

Elevated bacteria and/or endotoxins in the water and/or dialysate used for the patient dialysis treatments can cause adverse patient outcomes, patient illness, and pyrogenic reactions (a pyrogenic reaction may include symptoms of chills, shaking, fever, low blood pressure, vomiting, and/or muscle pain).

At the time of the survey, the CSA staff reported a hemodialysis patient census of 4 and reported the facility had 3 ROs for the patient dialysis treatments and 4 hemodialysis machines. Findings for 2 of the 2 ROs reviewed and for 2 of the 2 dialysis machines reviewed (Portable Zyzatech 800 RO for dialysis machine Z-8 and Stationary Zyzatech 704 RO for dialysis machine F3), for 12 months of culture and LAL/endotoxin laboratory reports reviewed (1/2013-12/2013), and for 6 of 6 months of dialysis machine and RO disinfection and rinsing logs reviewed (7/2013-12/2013), include:

1. CSA had a policy and procedure titled "WATER QUALITY TESTING HOSPITAL DIALYSIS UNIT," with a revised date of 03/2012, which stated in part, "... PURPOSE: Water used on the blood and dialysate side of the artificial kidney shall be AAMI [Association for the Advancement of Medical Instrumentation] quality water... POLICY: Water, dialysate cultures and LAL (Limulus Amebocyte Lysate) are collected minimally once per month to ensure dialysis water is within the AAMI standards for bacteria levels... Minimum testing to be performed to ensure... microbial water quality is:... Monthly A. Bacterial colony counts will be collected from each hospital machine (dialysate or water sample) on the first Monday of the month. Dialysate sample preferable, but water sample is acceptable if machine is not in use.... C. LAL (Limulus Amoebocyte Lysate) test for endotoxin will be collected from each hospital R.O... 1. Portable RO's:... Open the Hanson door... Collect a midstream sample... 2. 704 RO: Prior to the weekly Minncare disinfect, the LAL sample is taken from the sample port found on the RO product line..."

CSA's policy and procedure titled "FRESENIUS MACHINE POLICIES," with a revised date of 05/09/12, stated in part, "... PURPOSE: To define the cleaning, disinfecting and culture policies of the Fresenius dialysis machine... CLEANING/DISINFECTING POLICIES:... Hospital Machines with Attached Portable R.O. 1. 500 CC [cubic centimeter] acetic acid rinse followed by heat disinfect cycle at end of each day's use or chemical disinfect if client is considered high risk... or if it is chemical rinse weekly disinfect day. 2. Minncare Cold Sterilant disinfect weekly as per policy/procedure completed by Biomed technician. 3. Chemical disinfect (bleach) either Friday or Saturday. 4. When machines are not in use (i.e., no hospital patients), each machine will complete a rinse then heat disinfect cycle, except on the days of the disinfect. 5. Monthly dialysate samples will be obtained on Monday or Tuesday prior to Minncare disinfect and use... a. Dialysate culture procedure:... 6. If machine is not in use the day cultures are obtained, monthly water culture sample will be obtained on Monday or Tuesday prior to Minncare disinfect procedure... a. Water Culture Procedure... "

CSA's policy and procedure titled "Portable R.O. with Fresenius Dialysis Machine-Disinfect (Zyzatech 800 Series)," with a revised date of 01/02/14, stated in part, "... PURPOSE: To define the disinfect policy for the Zyzatech 800 Series Reverse Osmosis unit (R.O.)... POLICY: The Zyzatech 800 series R.O. will be disinfected weekly with Minncare Cold Sterilant..." CSA's policy and procedure titled "Free Standing R.O. with Fresenius Dialysis Machine-Disinfect (Zyzatech 700 Series)," with a revised date of 01/02/14, stated in part, "... PURPOSE: To define the disinfect policy for the Zyzatech 704 Series Reverse Osmosis unit (R.O.)... POLICY: The Zyzatech 704 series R.O. will be disinfected weekly with Minncare Cold Sterilant..."

2. Review of the culture and LAL/endotoxin laboratory reports, for the months 1/2013 through 12/2013, showed that CSA staff had not collected a dialysate culture and LAL/endotoxin sample for 2 of the 2 dialysis machines reviewed, dialysis machine F3 and dialysis machine Z-8, for the last 12 months. During an interview on 1/7/14 at 2:15 PM and on 1/8/14 at 2:00 PM, the CSA Dialysis Director and Operations Manager verified the findings. During the 1/8/14 interview, the CSA Dialysis Director reported the CSA staff had collected water culture and LAL/endotoxin samples from the dialysis machines every month. During the interviews, the CSA Dialysis Director verified staff should collect dialysate cultures and LAL/endotoxin samples from the dialysate from the dialysis machines and verified the CSA staff should have a monitoring system in place to ensure staff collected dialysate cultures and LAL/endotoxin samples from the dialysis machines.

3. Review of CSA's policies and procedures addressing obtaining and collection of the samples from the dialysis machines, as specified above, showed the policies and procedures did not address obtaining and collecting dialysate samples from the dialysis machines for the LAL/endotoxin levels in the dialysate. During an interview on 1/9/14 at 3:30 PM, the CSA Dialysis Director acknowledged and findings and verified the CSA written policies and procedures should address collecting dialysate samples from the dialysis machines for the LAL/endotoxin levels in the dialysate.

4. Review of the monthly water culture and LAL/endotoxin laboratory reports for the last 6 months in relation to disinfection of the ROs and the dialysis machines, reviewed for the months of 7/2013 through 12/2013 for the stationary RO (the Zyzatech 704 RO) and dialysis machine F3 and the portable RO (the Zyzatech 800 RO) and dialysis machine Z-8, documented on logs titled "Tri-State Dialysis -Hospital Dialysis Machine DISINFECT/DIASAFE/CULTURE/CUMULATIVE ... MACHINE Z-8" and "Tri-State Dialysis -Hospital Dialysis Machine DISINFECT/DIASAFE/CULTURE/CUMULATIVE ... MACHINE F3," revealed the CSA staff did not show evaluation of the CSA's system to ensure collection the water culture and LAL/endotoxin samples occurred when the risk for contamination was the highest (at the "worst case scenario"), before disinfection of the water system/dialysis machine, as close to the time of disinfection as possible. Review of the water culture and LAL/endotoxin laboratory reports for the last 6 months in relation to disinfection of the ROs and the dialysis machines, revealed for 6 of the 6 months, the CSA staff did not collect the water culture and/or LAL/endotoxin samples at the "worst case scenario" before disinfection of the water system/dialysis machines as close to the time of disinfection as possible. During an in interview on 1/7/14 at 2:15 PM with the CSA Dialysis Director and the Operations Manager and on 1/8/14 at 2:00 PM with the CSA Dialysis Director, Nurse Manager, Educator, and Operations Manager, the CSA staff verified the findings. During the interview on 1/8/14, the CSA Dialysis Director acknowledged the CSA staff should evaluate the system to ensure collection of the water culture and LAL/endotoxin samples occurred at the worst case scenario, before disinfection of the ROs and dialysis machines, as close to the time of disinfection as possible.

5. Review of the CSA written policies and procedures for collecting the dialysis machine cultures showed the policies and procedures did not match regarding the day specified for staff to collect the cultures. The policy and procedure titled "WATER QUALITY TESTING HOSPITAL DIALYSIS UNIT," with a revised date of 03/2012, stated in part, "...Monthly... Bacterial colony counts will be collected from each hospital machine (dialysate or water sample) on the first Monday of the month. Dialysate sample preferable, but water sample is acceptable if machine is not in use..." The policy and procedure titled "FRESENIUS MACHINE POLICIES," with a revised date of 05/09/12, stated in part, "... Monthly dialysate samples will be obtained on Monday or Tuesday prior to Minncare disinfect and use..." During an interview on 1/8/14 at 2:00 PM, the CSA Dialysis Director verified the findings and the CSA Dialysis Director verified the policies and procedures should have consistency regarding when staff should collect the cultures.

6. Review of CSA's policies and procedures, logs, and staff interview showed the CSA staff failed to ensure consistency between the CSA's written policy and procedure regarding the frequency for completing the rinse and heat disinfect cycle for the patient dialysis machine when not in use (i.e., no hospital patient) and the CSA staffs' stated policy and procedure for the frequency for completing the rinse and heat disinfection for the patient dialysis machine when not in use (i.e., no hospital patient) and failed to ensure staff completed and documented the disinfection