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On the days of the Validation Survey based on observations, record reviews, interviews, and review of the hospital's policies and procedures, and training requirements, the hospital's governance failed to ensure the hemodialysis unit operated in a responsible manner to ensure the safety of those patients receiving hemodialysis.

The findings are:

Cross Reference to A 0063: The governing body failed to ensure that specific patient care requirements of the Hemodialysis Unit were met.

Cross Reference to A 0115:

Cross Reference to A 0392:

On the days of the hospital Validation Survey based on observations, interviews, record reviews, review of hospital policy and procedure, and facility log review, the governing body failed to ensure that specific patient care requirements of the Hemodialysis Unit were met.

The findings are:

Cross Reference to A 0392: The hospital's governance failed to ensure its nursing service provided nursing care to all patients as needed.

Cross Reference to A 0396: The hospital's governance failed to ensure a well-organized nursing service with a plan of administrative authority and delineation of responsibilities for patient care in the hemodialysis unit.

On 02/25/2019, observations and interviews in the hospital's high risk Hemodialysis unit revealed 3 of 3 on duty Registered Nurses(RNs) responsible for ensuring the safety of the hemodialysis patients through sample testing the water quality for Chlorine/Chloramines failed to show competency and knowledge of the Chlorine/Chloramine testing procedure and failed to set the dialysis machine for the correct dialysate bath when the order for the patient changed. Review of the ten registered nurses revealed none of the registered nurses had completed their annual competencies for dialysis. Further review of the job descriptions and personnel files revealed the leadership for the hemodialysis unit
had no experience or training in hemodialysis. There were no indicators for monitoring or tracking data from the hemodialysis unit by either Infection Control or the hospital's Quality Program. Review of the hemodialysis units water cultures revealed the Medical Director had not signed the reports for the last seven months of 2018.

Based on review of the hospital's contracted services contracts and interview, the hospital failed to enforce the contractors's responsibility for annual employee training for its dialysis unit.

The findings are:

Cross Reference to A 0063: The governing body failed to ensure that specific patient care requirements of the Hemodialysis Unit were met that included but was not limited to staff competency for performance of the water quality Chlorine/Chloramine testing.

Review of hospital employee training records for 9 of 9 Registered Nurses in the hospital's hemodialysis unit revealed there was no documentation of annual water quality training completed by staff working in the hemodialysis area. Review of the contract that the hospital established with Mechanical Solutions revealed Mechanical Solutions was to provide annual water quality testing training for the hospital's employees in the hemodialysis unit. Review of 9 of 9 Registered Nurses assigned to the hospital's hemodialysis unit revealed there was no annual training for water quality testing performed by the contractor for the last 12 months. In an interview on 02/28/19 at 11:24 AM, the Director of Critical Care confirmed the contract with Mechanical Solutions for water quality test training was not monitored by the governing body or through the hospital's quality program.

Based on observations, record reviews, interviews, review of the hemodialysis water culture logs, reviewof the hosital's infection control program, review of the hospital's quality program, review of the manufacturer's directions for use, and review of the hospital's policies and procedures, it was determined the hospital failed to ensure that patient's requiring the services of the hospital's hemidialysis unit received care in a safe setting.

The findings are:

Cross Reference to A 0144: The hospital failed to ensure 3 of 3 Registered Nurses(RN) observed and assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room.

Cross Reference to A 0392: The hospital failed to ensure 3 of 3 Registered Nurses(RN) assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room. (RN G1, RN G2, and RN G9) Based on observations, interviews, and a review of the hospital's policy, entitled, "Infection Prevention in Dialysis" along with safety information related to the use of the PERMACHEM DPD Total Chlorine Reagent, the hospital failed to ensure dialysis 3 of 3 Registered Nurses who worked in the hemodialysis unit donned appropriate Personal Protective Equipment(PPE) to shield themselves from potential hazards in the water treatment room during the performance of the Chlorine/Chloramine water quality testing and RN G6 in the dialysis unit when RN G6 initiated a patient's hemodialysis treatment

Based on observations, record reviews, interviews, and review of the hospital's policies and procedures, the hospital failed to ensure 3 of 3 Registered Nurses(RN) observed and assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room. (RN G1, RN G2, and RN G9)


The findings are:


Hospital policy: Chlorine/Chloramine Testing for Water Quality- Hemodialysis Unit
Hospital policy and procedure, titled, "4015051 "Chlorine/Chloramines Water Testing", reads, "....Procedure: A. Test procedure: 1. Turn on Chlorine test port and allow water to slowly run for 1 minute to flush the system. 2. Fill 10 mls(milliliters) tube with a sample. 3. Press the POWER key to turn meter on. Arrow should indicate Medium Range Channel (MR). 4. Remove meter cap. Place the plain water tube in the cell holder with diamond mark facing the key pad. Fit the cap over the cell compartment to cover the cell. 5. Press ZERO/SCROLL. The display will show "--" then "0.00". Remove the tube from the cell holder- (this is a control). 6. Fill tube label "F" for Free "T" for Total, with 10 mls sample of water. 7. Add the contents of the one DPD Free Chlorine Powder Pillow and one DPD Total Chlorine Powder Pillow to labeled tubes. 8. Cap and shake gently for 20 seconds. 9. For Free chlorine, wipe excess liquid and fingerprints from the tube. After one minute, put tube in the cell holder and cover with cap. Press READ/ENTER. The instrument will show "--" followed by the results in mgs/L Chlorine. 10. For Total Chlorine: wait 5 minutes after adding DPD Total Pillow. Wipe excess liquid and fingerprints off tube. Place tube in cell holder and cover with cap. Press READ/ENTER. The instrument will show "--" followed by the results in mgs/L Chlorine. B. Test the water from the first set of carbon tanks at the SP2 port. 1. NEGATIVE SP2 PORT TEST: If the water sample is negative, no further testing is required. Continue with routine testing every shift or every 4 hours, whichever comes first. 2. POSITIVE SP2 PORT TEST: If the water sample is positive (>0.1 ppm(part per minute) Chlorine/Chloramines), obtain a new sample from the second set of Carbon tanks at the SP3 port. - Make arrangement to have the first Carbon tank serviced by a qualified service representative. i. NEGATIVE SP3 PORT TEST: if the sample from the second set of Carbon tanks is negative - Dialysis treatments may proceed. - Initiate hourly monitoring of test water at the R/O(Reverse/Osmosis) port until the 1st carbon tank is serviced and demonstrates a negative 0.1 ppm Chlorine test. If any test of the R/O port water comes up POSITIVE, skip to step below. ii. POSITIVE SP3 PORT TEST: if the sample from the second set of Carbon tanks is positive - Repeat the test immediately using a new sample to confirm POSITIVE result. - Note: if the repeat is negative, repeat all testing starting at the SP2 Port (section C). - Notify the Dialysis Medical Director and Dialysis Department Director or designee. Shut down the R/O. - Make arrangements to have the carbon tanks serviced by a qualified service representative. - Using the portable dialysis machines (with acceptable daily QC, including negative 0.1 ppm chlorine test) for remaining treatment runs. - If there are more patients on the schedule than the back-up portable dialysis machine water supply will support, notify the Dialysis Medical Director immediately for further instructions and orders on how to proceed.

Observation and Interview: RN G1
On 2/25/19 at 11:13 a.m., observations were conducted in the hospital's water treatment room in the dialysis area on the first floor of the hospital. Observations of Registered Nurse(RN) G1 perform the water quality test for Chlorine/Chloramine revealed RN G1 stated , "We use the Hach meter to check our Chlorine test every three hours. I turn the RO(Reverse Osmosis) on in the morning for 15 minutes. At the end of the day, after we heat disinfect, we turn it off. To perform a Total Chlorine Test, there is a test "T" for total and "F" for free. For the Total test, I rinse the sample jar 20 times including the lid and then, I will obtain my 5 mls(milliliters) sample. I add my reagent pillow pad, "Permachem DPD Total Chlorine Reagent", and shake vigorously for 20 seconds". Observations revealed RN G1 shook the water sample so hard that it splattered on the surveyors left neck and shoulder. When the surveyor asked how the water sample was mixed, RN G2 stated, "Vigorously, and the next step will be to stick the bottle in the Hach meter, and it stays in there for 5 minutes." RN G2 placed the water sample inside the Hach meter and closed the cap and the timer was started for five minutes. Observations showed RN G1 pushed the green button to obtain a digital reading of "0.04". RN G1 was asked if the result of the water quality test is greater than (>) 0.1, what would you do? RN G1 stated, "If it's greater than 0.1, I would do hourly checks behind the secondary tank. I would clean the sample jar real well and retest a water sample. I would gather my 5 ml water sample again, and go through the same process. There is no need to put the patients in bypass". RN G1 was asked if the repeat water sample test resulted as "0.4 ppm", RN G1 stated, "I wouldn't do anything else. I would just monitor the patients". When RN G1 was again asked what would you do if the water sample tested resulted as 0.4 ppm, RN G1, again stated, "Nothing else would be done now. We would just monitor." The observations and interview was verified by RN G 10, Director of Critical Care and Dialysis, and G 11, Risk Regulatory.

Observation and Interview: RN G2
On 2/25/19 at 11:26 a.m., an interview was conducted with RN G2 who stated, "I have worked in this facility in dialysis for twenty-three years". RN G2 was asked to demonstrate the Chlorine/Chloramine water quality test. RN G2 stated, "I will rinse my specimen jar a few times, and obtain a ten (10) mls sample. I will fill it to the line that says ten. I will add the Total Chlorine packet to the vial. I shake the vial for 20 seconds looking at my timer. You should only agitate the vial. Do not shake it vigorously. I wipe off the top of the vial and sit it inside the Hach meter. We wait for five minutes, and then read the result. My result is 0.03". When RN G2 was asked what the normal parameters should be, and RN G2 stated, "I'm not sure. I guess I'll have to look it up." Observations showed RN G2 fumbled with papers, and looked around the water treatment room for information for the action level for out of range results for the water quality test for Chlorine/Chloramines. Observation showed RN G2 finally read the top of the Chlorine log, and stated, "Oh, it looks like 0.1 is what it should be less than. If the test is greater than 0.1, then we will do the hourly test." When asked what would occur next if the result was 0.2, RN G2 stated, "We will do hourly sampling from port 3 which is the primary Carbon tank, but RN G2 pointed and touched the primary Carbon tank associated with the SP2 port. When asked again which tank the Chlorine water sample test would be repeated from, RN G2 stated,"I'm honestly not sure which carbon tank it is or which port correlates to the tanks. I will call Mechanical Solutions if the results are out of range and check hourly. Nothing will be done as far as the patients go now". When asked if the Chlorine test result was 0.3 ppm, what would you do, RN G2 stated, "We will just shut down and go to DI. The patients will come off, and I will switch over to DI and notify the Director." The observation and interview was witnessed and verified by RN G10, RN, Director of Critical Care and Dialysis, and Staff G11, AVP, Risk Legal, Regulatory.

Observations and Interview: RN G9
On 2/25/19 at 11:38 a.m., an interview was conducted with RN G9 who stated, "I have worked here since November 2018, and I work prn(as needed). I usually work 1 time a week." Observation of RN G9 performing the Chlorine/Chloramine water sample test revealed stated, "I will rinse the glass jar 3 times and obtain a 10 mls water specimen. I will add the pillow to the vial and shake the reagent for 15 seconds. I place the specimen inside the Hach meter and close it for 5 minutes." Observation showed the timer was turned to 5 minutes, and RN G9 raised the meter lid and read the result as 0.11. At 11:45 a.m., RN G9 stated, "Well, I have a positive result which is anything greater than 0.1. I will have to repeat the test." Observations showed RN G9 checked the test at the primary port SP2 tank. RN G9 stated, "I will rinse 3 times, get my 10 mls specimen, add reagent to total vial, swish 15 seconds, place inside the meter and wait 5 minutes for my results." Then RN G9 stated the result is now 0.04". At 11:52 a.m., RN G9 was asked if the result was greater than 0.1 to verify and demonstrate the test. RN G9 stated, "I think now I'll check behind the secondary tank. Now, maybe we will put the patients in bypass and check secondary. I will notify Biomed, the FA(Facility Administrator), and my Director. I'm not real sure here, honestly. I'd have to ask another nurse here. If the results come back greater than 0.1, no treatments can be given. Switch over to DI, and ask the other nurses." The observation and interview was witnessed and verified by RN G10, RN, Director of Critical Care and Dialysis, and Staff member G11, AVP, Risk Legal, Regulatory.

Interview RN G10:
On 2/25/19 at 10:55 a.m., in an interview RN G10, RN G10 stated, "I am the Director of Critical Care, ICU(Intensive Care Unit), and the Dialysis unit. I do not have any dialysis experience, so I rely heavily on the ladies here. I have been in this position for 2 years after the last director left. On 2/25/19 at 12:02 p.m., in an interview with RN G10, RN G10 stated, "The last time they(staff) had training was when the technician came from an outside dialysis corporation. I believe it was in 2010. No one else has done the training. They(staff) train each other here. They(staff) haven't completed any hands on training or annual skills check offs".

Staff Competencies for Hemodialysis and Water Quality Testing
On 2/25/19 at 3:12 p.m., a review of dialysis employee files was conducted.

RN G4 had no documented training for performing the Chlorine/Chloramine water quality test and no documentation of dialysis competencies. RN G10 stated, "I should have access to this training, but I don't. She(RN G4) was never assigned the training. It should be here, but it's not."

On 2/25/19 at 3:17 p.m., review of RN G1's file revealed there was no documentation of hemodialysis training and/or competencies. There was no documentation of training for the Chlorine/Chloramine test. RN G12 (Hospital Clinical Educator), stated, "You are not going to find those in the employees transcripts. The last water training was completed in 2010. RN G1 never received the annual competency training for hemodialysis or water training."

Review of the file for RN G2 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.

Review of the file for RN G7 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.

Review of RN G6's file revealed RN G6 who is the dialysis unit's "Unit Coordinator", had documentation of training but it was dated 4/6/2012.

On 2/25/2019 at 3:30 PM, in an interview with RN G12 who is the Hospital Clinical Educator, stated, "The employees receive a week of hospital onboarding, and then they go to their perspective unit. A head preceptor works with them. They complete a self-assessment. Once it's completed, it is sent to the Director". RN G10 stated, "The Coordinator of dialysis must have visual oversite, and there's no documentation of that."

Hospital policy: Water Purification System
Review of the Water Purification Systems Contracted service, reads ".... Annual....3. Water treatment In-service

Based on record reviews for 2 of 3 patient charts reviewed for restraint requirements and interview, the hospital failed to ensure the monitoring for restraints was documented every 2 hours. (Patient A5 and A6)

The findings are:

Review of Patient A5 ' s chart revealed the patient was ordered restraints. Review of the documentation for monitoring the patient's restraints every two hours was completed as of 12:41 PM on 02/26/19 revealed the patient had been restrained since 12:55 AM. The last documented monitoring of the patient's restraints was at 07:00 AM. There was no documentation of monitoring the patient's restraints at 9:00 AM or 11:00 AM. In an interview on 02/26/19 at 12:41 PM, Registered Nurse (RN A1) confirmed the monitoring of the restraints for the patient should have been completed at 9:00 AM and 11:00 AM, and the monitoring was not documented.

Review of Patient A6 ' s chart revealed the patient was ordered restraints. Review of the documentation for monitoring the patient's restraints every two hours that was completed as of 12:41 PM on 02/26/19 revealed the patient had been restrained since 5:00 AM. The last documented monitoring of the patient's restraints was at 8:00 AM. There was documentation of monitoring the patient's restraints at 10:00 AM or 12:00 PM. In an interview on 02/26/19 at 12:41 PM, RN A1 confirmed the monitoring of the restraints for the patient should have been completed at 10:00 AM and 12:00 PM, and the monitoring was not documented.

Based on observations, review of hemodialysis culture logs, and review of the hospital's quality program, and interview, the hospital failed to ensure an ongoing program that shows measurable improvement in indicators, for hemodialysis, for which there is evidence that it will improve health outcomes.

The findings are:

Cross Reference to A 0273: The hospital failed to ensure its Quality Assurance Process Improvement(QAPI) program included the high risk problem prone hemodialysis unit in the hospital's quality program.

Cross Reference to A 0286: The hospital failed to show that its quality program had established performance activities and indicators to track and identify potential safety issues in the high risk problem prone hemodialysis unit for ensuring safety in the hemodialysis unit's water treatment quality, infection control monitoring for water cultures and monitoring to ensure out of range water cultures were addressed timely, and ensuring maintenance of staff education and competency to perform critical duties in the hemodialysis unit.

There was no measurable improvement indicators related to staff performance or proficiency for monitoring the water quality which result in health outcomes. On 10/28/19 at 10:45 AM, Director E 30 stated presently there is no ongoing Performance Improvement Actions for the Dialysis Unit related to Quality of the Water or staff proficiency.

Based on review of the hospital's Quality data and interview, the hospital failed to ensure its Quality Assurance Process Improvement(QAPI) program included the high risk problem prone hemodialysis unit in the hospital's quality program.

The findings are:

Review of hospital QAPI data revealed the hospital had no documentation that the contracted services and responsibilities
for annual training of its hemodialysis nursing staff for testing the hospital's quality water had not been monitored through the hospital's quality program. There was no documentation of monitoring of outside contracts as part of the hospital's QAPI program. In an interview on 02/28/19 at 11:24 AM, the Director of Critical Care confirmed there was no QAPI monitoring of hospital contracts.

Review of the hospital's QAPI Program data revealed there was no monitoring or oversight of quality indicators for the high risk problem prone hemodialysis program. There was no indicator data for patient care, water quality monitoring, or staff competencies and training for the hemodialysis unit.

Based on review of the hospital's Quality Assessment Performance Improvement (QAPI) Program data and interview, the hospital failed to show that its quality program had established performance activities and indicators to track and identify potential safety issues in the high risk problem prone hemodialysis unit for ensuring safety in the hemodialysis unit's water treatment quality, infection control monitoring for water cultures and monitoring to ensure out of range water cultures were addressed timely, and ensuring maintenance of staff education and competency to perform critical duties in the hemodialysis unit.

The findings are:

Cross Reference to A 0273: The hospital failed to ensure its Quality Assurance Process Improvement(QAPI) program included the high risk problem prone hemodialysis unit in the hospital's quality program.

Cross Reference to A 0144: The hospital failed to ensure 3 of 3 Registered Nurses(RN) observed and assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room. (RN G1, RN G2, and RN G9)

Cross Reference to A 0392: The hospital failed to ensure 3 of 3 Registered Nurses(RN) observed and assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room. (RN G1, RN G2, and RN G9) Based on observations, interviews, and a review of the hospital's policy, entitled, "Infection Prevention in Dialysis" along with safety information related to the use of the PERMACHEM DPD Total Chlorine Reagent, the hospital failed to ensure dialysis 3 of 3 Registered Nurses who worked in the hemodialysis unit donned appropriate Personal Protective Equipment(PPE) to shield themselves from potential hazards in the water treatment room during the performance of the Chlorine/Chloramine water quality testing and RN G6 in the dialysis unit when RN G6 initiated a patient's hemodialysis treatment.

On 2/28/2019 at 10:45 a.m., review of the hospital's QAPI program data revealed there was no documentation for monitoring or tracking data for the hospital's hemodialysis unit. The finding was verified by Director E 30 at 10:45 a.m. on 2/28/2019.

Based on observations, record reviews, interviews, and review of the hospital's policies and procedures, the hospital failed to ensure 3 of 3 Registered Nurses(RN) assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine testing in the water treatment room. (RN G1, RN G2, and RN G9) Based on observations, interviews, and a review of the hospital's policy, entitled, "Infection Prevention in Dialysis" along with safety information related to the use of the PERMACHEM DPD Total Chlorine Reagent, the hospital failed to ensure dialysis 3 of 3 Registered Nurses who worked in the hemodialysis unit donned appropriate Personal Protective Equipment(PPE) to shield themselves from potential hazards in the water treatment room during the performance of the Chlorine/Chloramine water quality testing and RN G6 in the dialysis unit when RN G6 initiated a patient's hemodialysis treatment. (RN G2, RN G5, and RN G6) The hospital failed to ensure its staff had the knowledge to complete independent checks of the pH and conductivity of the dialysis machine after changing the dialysate concentrate for 1 of 1 patient whose dialysate bath was changed. (Patient C3). The dialysate concentrate did not match the settings in the patient's dialysis machine. The hospital failed to ensure its staff perform wound care as ordered and failed to obtain a nutritional consult for 1 of 1 patient with a sacral pressure ulcer and a verified nutritional deficits. (Patient C 1) The hospital failed to ensure 1 of 1 RNs followed its policies and procedures for recapping needles. (RN E7) Nursing failed to ensure bowel activity was monitored for 1 of 1 patient who required a surgical procedure for a bowel blockage. ( Patient F 15)


The findings are:


Hospital policy: Chlorine/Chloramine Testing for Water Quality- Hemodialysis Unit
Hospital policy and procedure, titled, "4015051 "Chlorine/Chloramines Water Testing", reads, "....Procedure: A. Test procedure: 1. Turn on Chlorine test port and allow water to slowly run for 1 minute to flush the system. 2. Fill 10 mls(milliliters) tube with a sample. 3. Press the POWER key to turn meter on. Arrow should indicate Medium Range Channel (MR). 4. Remove meter cap. Place the plain water tube in the cell holder with diamond mark facing the key pad. Fit the cap over the cell compartment to cover the cell. 5. Press ZERO/SCROLL. The display will show "--" then "0.00". Remove the tube from the cell holder- (this is a control). 6. Fill tube label "F" for Free "T" for Total, with 10 mls sample of water. 7. Add the contents of the one DPD Free Chlorine Powder Pillow and one DPD Total Chlorine Powder Pillow to labeled tubes. 8. Cap and shake gently for 20 seconds. 9. For Free chlorine, wipe excess liquid and fingerprints from the tube. After one minute, put tube in the cell holder and cover with cap. Press READ/ENTER. The instrument will show "--" followed by the results in mgs/L Chlorine. 10. For Total Chlorine: wait 5 minutes after adding DPD Total Pillow. Wipe excess liquid and fingerprints off tube. Place tube in cell holder and cover with cap. Press READ/ENTER. The instrument will show "--" followed by the results in mgs/L Chlorine. B. Test the water from the first set of carbon tanks at the SP2 port. 1. NEGATIVE SP2 PORT TEST: If the water sample is negative, no further testing is required. Continue with routine testing every shift or every 4 hours, whichever comes first. 2. POSITIVE SP2 PORT TEST: If the water sample is positive (>0.1 ppm(part per minute) Chlorine/Chloramines), obtain a new sample from the second set of Carbon tanks at the SP3 port. - Make arrangement to have the first Carbon tank serviced by a qualified service representative. i. NEGATIVE SP3 PORT TEST: if the sample from the second set of Carbon tanks is negative - Dialysis treatments may proceed. - Initiate hourly monitoring of test water at the R/O(Reverse/Osmosis) port until the 1st carbon tank is serviced and demonstrates a negative 0.1 ppm Chlorine test. If any test of the R/O port water comes up POSITIVE, skip to step below. ii. POSITIVE SP3 PORT TEST: if the sample from the second set of Carbon tanks is positive - Repeat the test immediately using a new sample to confirm POSITIVE result. - Note: if the repeat is negative, repeat all testing starting at the SP2 Port (section C). - Notify the Dialysis Medical Director and Dialysis Department Director or designee. Shut down the R/O. - Make arrangements to have the carbon tanks serviced by a qualified service representative. - Using the portable dialysis machines (with acceptable daily QC, including negative 0.1 ppm chlorine test) for remaining treatment runs. - If there are more patients on the schedule than the back-up portable dialysis machine water supply will support, notify the Dialysis Medical Director immediately for further instructions and orders on how to proceed.

Observation and Interview: RN G1
On 2/25/19 at 11:13 a.m., observations were conducted in the hospital's water treatment room in the dialysis area on the first floor of the hospital. Observations of Registered Nurse(RN) G1 perform the water quality test for Chlorine/Chloramine revealed RN G1 stated , "We use the Hach meter to check our Chlorine test every three hours. I turn the RO(Reverse Osmosis) on in the morning for 15 minutes. At the end of the day, after we heat disinfect, we turn it off. To perform a Total Chlorine Test, there is a test "T" for total and "F" for free. For the Total test, I rinse the sample jar 20 times including the lid and then, I will obtain my 5 mls(milliliters) sample. I add my reagent pillow pad, "Permachem DPD Total Chlorine Reagent", and shake vigorously for 20 seconds". Observations revealed RN G1 shook the water sample so hard that it splattered on the surveyors left neck and shoulder. When the surveyor asked how the water sample was mixed, RN G2 stated, "Vigorously, and the next step will be to stick the bottle in the Hach meter, and it stays in there for 5 minutes." RN G2 placed the water sample inside the Hach meter and closed the cap and the timer was started for five minutes. Observations showed RN G1 pushed the green button to obtain a digital reading of "0.04". RN G1 was asked if the result of the water quality test is greater than (>) 0.1, what would you do? RN G1 stated, "If it's greater than 0.1, I would do hourly checks behind the secondary tank. I would clean the sample jar real well and retest a water sample. I would gather my 5 ml water sample again, and go through the same process. There is no need to put the patients in bypass". RN G1 was asked if the repeat water sample test resulted as "0.4 ppm", RN G1 stated, "I wouldn't do anything else. I would just monitor the patients". When RN G1 was again asked what would you do if the water sample tested resulted as 0.4 ppm, RN G1, again stated, "Nothing else would be done now. We would just monitor." The observations and interview was verified by RN G 10, Director of Critical Care and Dialysis, and G 11, Risk Regulatory.

Observation and Interview: RN G2
On 2/25/19 at 11:26 a.m., an interview was conducted with RN G2 who stated, "I have worked in this facility in dialysis for twenty-three years". RN G2 was asked to demonstrate the Chlorine/Chloramine water quality test. RN G2 stated, "I will rinse my specimen jar a few times, and obtain a ten (10) mls sample. I will fill it to the line that says ten. I will add the Total Chlorine packet to the vial. I shake the vial for 20 seconds looking at my timer. You should only agitate the vial. Do not shake it vigorously. I wipe off the top of the vial and sit it inside the Hach meter. We wait for five minutes, and then read the result. My result is 0.03". When RN G2 was asked what the normal parameters should be, and RN G2 stated, "I'm not sure. I guess I'll have to look it up." Observations showed RN G2 fumbled with papers, and looked around the water treatment room for information for the action level for out of range results for the water quality test for Chlorine/Chloramines. Observation showed RN G2 finally read the top of the Chlorine log, and stated, "Oh, it looks like 0.1 is what it should be less than. If the test is greater than 0.1, then we will do the hourly test." When asked what would occur next if the result was 0.2, RN G2 stated, "We will do hourly sampling from port 3 which is the primary Carbon tank, but RN G2 pointed and touched the primary Carbon tank associated with the SP2 port. When asked again which tank the Chlorine water sample test would be repeated from, RN G2 stated,"I'm honestly not sure which carbon tank it is or which port correlates to the tanks. I will call Mechanical Solutions if the results are out of range and check hourly. Nothing will be done as far as the patients go now". When asked if the Chlorine test result was 0.3 ppm, what would you do, RN G2 stated, "We will just shut down and go to DI. The patients will come off, and I will switch over to DI and notify the Director." The observation and interview was witnessed and verified by RN G10, RN, Director of Critical Care and Dialysis, and Staff G11, AVP, Risk Legal, Regulatory.

Observations and Interview: RN G9
On 2/25/19 at 11:38 a.m., an interview was conducted with RN G9 who stated, "I have worked here since November 2018, and I work prn(as needed). I usually work 1 time a week." Observation of RN G9 performing the Chlorine/Chloramine water sample test revealed stated, "I will rinse the glass jar 3 times and obtain a 10 mls water specimen. I will add the pillow to the vial and shake the reagent for 15 seconds. I place the specimen inside the Hach meter and close it for 5 minutes." Observation showed the timer was turned to 5 minutes, and RN G9 raised the meter lid and read the result as 0.11. At 11:45 a.m., RN G9 stated, "Well, I have a positive result which is anything greater than 0.1. I will have to repeat the test." Observations showed RN G9 checked the test at the primary port SP2 tank. RN G9 stated, "I will rinse 3 times, get my 10 mls specimen, add reagent to total vial, swish 15 seconds, place inside the meter and wait 5 minutes for my results." Then RN G9 stated the result is now 0.04". At 11:52 a.m., RN G9 was asked if the result was greater than 0.1 to verify and demonstrate the test. RN G9 stated, "I think now I'll check behind the secondary tank. Now, maybe we will put the patients in bypass and check secondary. I will notify Biomed, the FA(Facility Administrator, and my Director. I'm not real sure here, honestly. I'd have to ask another nurse here. If the results come back greater than 0.1, no treatments can be given. Switch over to DI, and ask the other nurses." The observation and interview was witnessed and verified by RN G10, RN, Director of Critical Care and Dialysis, and Staff member G11, AVP, Risk Legal, Regulatory.

Interview RN G10:
On 2/25/19 at 10:55 a.m., in an interview RN G10, RN G10 stated, "I am the Director of Critical Care, ICU(Intensive Care Unit), and the Dialysis unit. I do not have any dialysis experience, so I rely heavily on the ladies here. I have been in this position for 2 years after the last director left. On 2/25/19 at 12:02 p.m., in an interview with RN G10, RN G10 stated, "The last time they(staff) had training was when the technician came from an outside dialysis corporation. I believe it was in 2010. No one else has done the training. They(staff) train each other here. They(staff) haven't completed any hands on training or annual skills check offs".

Staff Competencies for Hemodialysis and Water Quality Testing
On 2/25/19 at 3:12 p.m., a review of dialysis employee files was conducted.

RN G4 had no documented training for performing the Chlorine/Chloramine water quality test and no documentation of dialysis competencies. RN G10 stated, "I should have access to this training, but I don't. She(RN G4) was never assigned the training. It should be here, but it's not."

On 2/25/19 at 3:17 p.m., review of RN G1's file revealed there was no documentation of hemodialysis training and/or competencies. There was no documentation of training for the Chlorine/Chloramine test. RN G12 (Hospital Clinical Educator), stated, "You are not going to find those in the employees transcripts. The last water training was completed in 2010. RN G1 never received the annual competency training for hemodialysis or water training."
Review of the file for RN G2 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.
Review of the file for RN G7 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.
Review of RN G6's file revealed RN G6 who is the dialysis unit's "Unit Coordinator", had documentation of training was dated 4/6/2012.

On 2/25/2019 at 3:30 PM, in an interview with RN G12 who is the Hospital Clinical Educator, stated, "The employees receive a week of hospital onboarding, and then they go to their perspective unit. A head preceptor works with them. They complete a self-assessment. Once it's completed, it is sent to the Director". RN G10 stated, "The Coordinator of dialysis must have visual oversite, and there's no documentation of that."

Hospital policy: Water Purification System
Review of the Water Purification Systems Contracted service, Mechanical Solutions, Inc" reads ".... Annual....3. Water treatment In-service....".


28883

Patient C3
The hospital admitted Patient C3 on 2/25/19 with diagnoses including, but not limited to, End Stage Renal Disease. Observations on 2/27/19 from 10:10 AM through 10:25 AM revealed Registered Nurse (RN) G6 initiated the patient's dialysis treatment. After reviewing the patient's physician orders, RN G6 changed the dialysate concentrate jug from a 2K(Potassium) 2.5 Calcium dialysate to a 1K dialysate concentrate. Then, RN G6 initiated the patient's hemodialysis treatment, without but checking the conductivity and pH of the new dialysate using an independent method. During an interview on 2/27/19 at 10:30 AM, RN G6 stated s/he had not been aware the pH and conductivity needed to be checked after the dialysate concentrate was changed. When asked to verify the dialysis machine was set to the ordered dialysate concentrate, RN G6 checked the dialysis machine and verified the machine was still set to the 2K 2.5 Ca dialysis concentrate instead of the 1K dialysis concentrate. RN G6 stated s/he wasn't sure if a 1K dialysate concentrate could be set on the dialysis machine. After scrolling down the list of possible concentrates, RN G6 set the dialysis machine to the 1K dialysate concentrate. Review of the "2008K Hemodialysis Machine Operator's Manual" revealed on page 14, "...Warning! The operator should always check conductivity and approximate pH of the dialysate with an independent device prior to initiating treatment and whenever concentrates are changed during operation...". Page 66, "...Acid/bicarbonate concentrate types are programmed into computer memory of the 2008K hemodialysis machine. If the current patient's prescribed dialysate differs from the previous patient's or if the machine is new or has been recalibrated, a new acid/bicarbonate concentrate type matching the dialysate prescribed by the current patient's physician must be entered...".

Patient C1
The hospital admitted Patient C1 on 2/13/19 at 3:03 PM with diagnoses including, but not limited to, Aortic Stenosis, Chronic Kidney Disease, Diabetes Mellitus Type II, and Sacral Wound. On 2/25/2019 at 3:30 PM, review of the patient's Admission History and Physical dated 2/14/19 at 5:00 AM revealed, "S/he has urinary incontinence. (Patient's spouse) reports a sacral wound...". Under "Plan:" was listed "Will ask for wound consult...". Review of the physician orders revealed there had been a delay in placing the wound consult orders in the computer. The physician orders were placed in the electronic system on 2/15/19 at 7:32 AM. The wound nurse documented an assessment of the patient's wound on 2/15/19 at 10:51 AM. The sacral wound measured 3.0 x 3.5 x 0.1 cm (centimeters) and was documented as a Stage III Pressure Injury. "Patient also has scattered full and partial thickness wounds to the fleshy part of buttocks most likely related to moisture and incontinence. Plan: Barrier Wipes/ZGuard Barrier Cream (every) shift and as needed...".

Review of Patient C1's chart revealed the patient did not receive a wound assessment or treatment orders timely related to a sacral wound observed on admission. There was no documentation that the ZGuard barrier cream was applied every shift and as needed. Weekly measurements of the sacral wound were not included in the 2/21/19 wound care documentation. Nursing documentation showed that 2 different creams/ointments were ordered to alternate every 6 hours but were not applied correctly. Nursing staff documented the cream/ointment as "not available", but there was no documentation by nursing of attempts to obtain the medication for the patient's wound. Review of Patient C1's chart revealed the patient with wound and nutritional deficits did not receive a nutrition consult.

Review of Patient Care Technician and nursing documentation revealed there was no documentation to indicate the ZGuard Barrier Cream was applied every shift and as needed. There were no physician orders for the barrier cream. When asked, Patient Safety Officer C4/Administrator 4 stated that the Patient Care Technicians apply the cream since the cream was kept at the patient's bedside. No documentation was received that the barrier cream was applied by the Patient Care Technicians or that the plan related to the application of barrier cream was communicated to the Patient Care Technicians. A wound specialist note dated 2/21/19 revealed no measurements of the sacral wound were documented. The note revealed the patient's sacral wound was a Stage 2 pressure injury. Review of the hospital's policy, provided by the hospital, entitled, "Assessment and Reassessment of Patients", revealed, "Skin Program:...Inpatient screening assessments are performed by WOC (Wound, Ostomy, and Continence) services when triggered by the nursing admission/shift assessment or requested by nursing on all documented pressure injury. Parameters included in WOC patient assessments include:...Bed surface...Nutritional status...Reassessment: ...2. WOC services reassessment occurs at least weekly and depends on wound type, wound characteristics, and wound therapy, but minimally includes wound measurements....and nutritional status...".

Review of the wound assessment note dated 2/21/19 revealed the sacrum/buttocks wound had not improved and the ZGuard barrier paste would be discontinued. The treatment was changed to Aloe Vesta Antifungal cream alternated with Venelex Ointment every 6 hours after wiping with comfort shield barrier cloths. Review of physician orders revealed a physician order was entered for the AloeVesta Antifungal cream and Venelex Ointment on 2/21/19 at 9:12 AM. Review of the patient's medication administration records revealed the medication was not administered as per wound nurse instructions, i.e. alternating every 6 hours. The medications were administered almost simultaneously. Documentation showed the medications were applied as:
2/21/2019: 8:59 PM and at 9:00 PM,
2/22/2019: 9:46 AM, 9:47 AM, 10:18 PM, and 10:19 PM,
2/24/2019: 12:26 PM, 12:27 PM, 11:05 PM, and 11:06 PM,
2/25/2019: 10:05 PM and 10:06 PM.
2/23/2019: 11:52 AM and 10:05 PM, but the Aloe Vesta was not applied because documentation showed the medication was not available. There was no documentation of notification to the pharmacy to obtain the AloeVesta. Documentation on 2/23/19 at 11:53 AM and 10:05 PM revealed the Venelex Ointment was not administered because the Venelex ointment was not available. There was no documentation of notification to the pharmacy to obtain the medication. The findings were verified with Administrator C4 at the time of the review.

Review of lab results for Patient C1 revealed the patient's Albumin and Total Protein levels were low. The patient's Albumin level ranged from 2.7 (Low) on 2/20/19 to 1.7 gm/dl (grams/deciliter) on 2/26/19. The normal range was listed on the lab slip as 3.4-4.8. The patient's Total Protein was 5.7 gm/dl (Low) on 2/20/19 and was 4.0 on 2/26/19. The normal range listed on the lab slip was 6.1-8.0. Review of the patient's dietary orders revealed the patient was initially placed on a high protein nutritional supplement twice daily by a nurse, but the order was discontinued on 2/21/19 when the patient had a diet change. During an interview on 2/27/19 at 2:51 PM, Registered Dietitian(RD) C5 and RD C6 reported that no nutritional consult was completed for the patient. RD C5 and RD C6 reported they receive a pre-printed list each day with the names of patients who triggered for a nutritional assessment. The list is triggered by the nursing documentation on the patient's admission nursing assessment. RD C5 and RD C6 reported the patient would trigger if s/he had a stage II or greater pressure ulcer documented by nursing on the patient's admission assessment. The patient might also trigger for a nutritional consult based on other parameters, or a team member could contact the physician to see if a nutritional consult could be ordered. Review of the patient's nursing admission/shift assessment dated 2/14/19 at 6:20 PM revealed no skin alteration was documented which conflicted with the physician's admission history and physical which documented a skin issue. Review of the admission/shift assessment dated 2/14/19 at 8:13 PM showed skin alteration and stated, "other redness buttock bilateral", wound base visible "Yes", Stage: Superficial; and cream applied. Review of a nursing shift assessment dated 2/15/19 at 9:45 AM revealed skin alteration exists, and carried over the documentation from the wound nurse assessment for 2/15/19 that documented a Stage III pressure injury. The above findings were verified with Administrator C4 at the time of the record review.


18581

On 2/27/2019 at 11:00 AM, review of Patient 13 F's chart revealed the patient was admitted on 2/15/2019 via the hospital's emergency department for abdominal pain and urinary track infection. Patient 13 F had a suprapubic catheter and a pressure ulcer that extended to the bone. Review of the admission physician orders included but was limited to sepsis alert, wound consult, Vancomycin and Levaquin antibiotics, and Morphine 2 milligrams intravenous every 2 ours. Review of the patient's plan of care showed a pain goal of zero. Documentation on 2/16/2019 at 9:39 AM revealed the patient complained of pain at level 8 and was medicated with Morphine 2 milligrams(MGS). On 2/16/2019 at 10:24 AM, the patient complained at pain level 6, but there were no interventions or pain medication documented. On 2/16/2019 at 12:41 PM, the patient complained of pain at level 7. On 2/16/2019 at 13;34 PM, the patient complained of pain at level 5, but there were no interventions documented or pain medication documented as administered. Review of the patient's chart revealed the patient complained of pain on 2/18/2019 at 16:04 PM with a pain level of 8 and Morphine 2 milligrams was administered. On 2/18/2019, documentation showed the patient complained again at 17:16 PM with a pain assessment of 6, but there was no intervention documented or pain medication administered. On 2/18/2019 at 20:04 PM, documentation showed the patient complained of pain with a level of 8 and Morphine 2 milligrams was administered. On 2/18/2019 at 21:06 PM, the complained of pain with a level of 6 but there was no documentation of any intervention or medication administered. On 2/19/2019 at 23:50 PM, documentation showed the patient complained of pain at level 7 and Morphine 2 milligrams was administered. On 2/20/2019 at 00:04 AM, the patient complained of pain again at level 5, but there was no intervention or pain medication documented as administered. There was no documentation that nursing contacted the physician regarding the patient's ordered pain medication was ineffective based on the documented pain levels at reassessment of the patient's pain. There was no documentation in the patient's plan of care that the ordered pain medication was not meeting the patient's pain goal of zero pain.

On 2/27/2019 at 2:00 PM, review of Patient 15F's chart revealed the patient was admitted on 2/11/2019 in respiratory failure. Physician admission orders included but were not limited to Chest X-ray, Computerized Axial Tomography scan, intravenous fluids, Oxygen, and urology consult. Review of the patient's history and physical on admission revealed "Abdomen: tenderness (LUQ) (Left Upper Quadrant), soft, no distention". Review of the physician progress note dated 2/17/2019 revealed "constipation with abdominal pain, laxatives and fiber supplements". Review of physician progress note dated 2/18/2019 revealed "constipation with abdominal pain, laxatives and fiber supplements". Review of the physician progress note dated 2/19/2019 showed " increasing abdominal pain overnight, will check abd(abdominal) X-ray and start pre (as needed) morphine". Progress note dated 2/19/2019 showed Abdomen firm, distention, absent bowel sounds conservative treatment". Review of progress note dated 2/20/2019 showed "nausea and vomiting, no bowel movement, NG (nasogastric) to decompress". On 2/22/2019, the patient was transported to the operating room for a "LAP Small Bowel Lysis Adhesions".
Review of the nursing documentation for the patient's bowel activity showed there was no activity documented from the 2/11/2019 and 2/12 2019. On 2/13/2019, 2 bowel movements are documented but there was no description of the bowel movements. There was no bowel activity documented for the patient for 2/14/2019, 2/15/2019, 2/16/2018 2/17/2019, and 2/18/2019. On 2/19/2019, two bowel movements were documented but no description was documented. Review of the patient's chart revealed no bowel activity documented for the patient from 2/20/2019 through 2/27/2019 although the patient had surgery. There was no documentation in the nurse notes of notifying the physician of the lack of bowel activity for the patient before or after the patient's procedure. Review of the patient's plan of care revealed there was no problem addressing the patient's problem with either constipation or bowel blockage. On 2/23/2019, Gastrointestinal Alteration was added to the patient's plan of care with a target date of 2/26/2019.


39208

On 2/25/2019 at 10:00 a.m. revealed white blood cells (2.7 Low: normal value 4.0 to 10.9 ) and red blood cells (2.19 Low: normal value 3.70 to 5.00). Patient E1 spiked a fever on 2/24/2019 and 2/25/2019. Blood cultures were drawn and antibiotics begun. Awaiting bone marrow results. On 2/25/2019 at 2:25 p.m., observations of RN E7 revealed RN E7 took the cap from a syringe needle, and withdrew Dilaudid from a vial into a syringe for waste. RN E7 wasted the Dilauded, then recapped the needle and walked approximately five feet to the crash cart to dispose of the syringe with the capped needle. When asked the policy for recapping needles, RN E7 stated, "We are not supposed to recap needles." The finding was verified by RN E7 at 2:36 p.m. on 2/25/2019. On 2/27/2019 at 10:30 a.m., review of the hospital's policy and procedure, titled, Occupational Exposure Plan, states, " ... Needles shall not be re-capped ...".

Based on record reviews, interviews, and review of the hospital's policies and procedures, nursing failed to ensure that revisions occurred to address all of the patient's problems encountered in the patient's plan of care for 3 of 60 inpatient records reviewed for care and services. (Patient F15, Patient C2, and Patient E1)


The findings are:


On 2/27/2019 at 2:00 PM, review of Patient 15F's chart revealed the patient was admitted on 2/11/2019 in respiratory failure. Physician admission orders included but were not limited to Chest X-ray, Computerized Axial Tomography scan, intravenous fluids, Oxygen, and urology consult. Review of the patient's history and physical on admission revealed "Abdomen: tenderness (LUQ) (Left Upper Quadrant), soft, no distention". Review of the physician progress note dated 2/17/2019 revealed "constipation with abdominal pain, laxatives and fiber supplements". Review of physician progress note dated 2/18/2019 revealed "constipation with abdominal pain, laxatives and fiber supplements". Review of the physician progress note dated 2/19/2019 showed " increasing abdominal pain overnight, will check abd(abdominal) X-ray and start pre (as needed) morphine". Progress note dated 2/19/2019 showed Abdomen firm, distention, absent bowel sounds conservative treatment". Review of progress note dated 2/20/2019 showed "nausea and vomiting, no bowel movement, NG (nasogastric) to decompress". On 2/22/2019, the patient was transported to the operating room for a "LAP Small Bowel Lysis Adhesions".
Review of the nursing documentation for the patient's bowel activity showed there was no activity documented from the 2/11/2019 and 2/12 2019. On 2/13/2019, 2 bowel movements are documented but there was no description of the bowel movements. There was no bowel activity documented for the patient for 2/14/2019, 2/15/2019, 2/16/2018 2/17/2019, and 2/18/2019. On 2/19/2019, two bowel movements were documented but no description was documented. Review of the patient's chart revealed no bowel activity documented for the patient from 2/20/2019 through 2/27/2019 although the patient had surgery. There was no documentation in the nurse notes of notifying the physician of the lack of bowel activity for the patient before or after the patient's procedure. Review of the patient's plan of care revealed there was no problem addressing the patient's problem with either constipation or bowel blockage. On 2/23/2019, Gastrointestinal Alteration was added to the patient's plan of care with a target date of 2/26/2019. On 2/27/2019 at 3:00 PM, the findings were verified by Registered Nurse F1.


28883

Patient C2
Review of Patient C2's chart on 2/25/2019 at 3:30 PM revealed Patient C2 was admitted to the hospital on 2/25/19 with diagnoses including, but not limited to, Shortness of Breath and Acute Hypoxic Respiratory Failure status post Fall. Observations on 2/25/19 at approximately 3:15 PM revealed Patient C2 in the bed with Oxygen (O2) infusing at 4 1/2 Liters per minute by nasal cannula. Observations on 2/27/19 at approximately 10:00 AM revealed Patient C2 up in a chair in the room with Oxygen infusing via a nasal cannula at 12 Liters per minute with an Oxygen saturation reading of 94%(percent). Observations showed an empty bag of Azithromycin was hanging from the IV (Intravenous) pump. Review of Patient C2's chart on 2/27/19 at approximately 11:15 AM with the Administrator (A4) revealed a "Hospitalist Progress Note" dated 2/26/19 at 1:46 PM that stated, "...Increasing O2 requirement overnight, now on 15 Liter high-flow nasal cannula this morning...Patient started on antibiotics yesterday evening for right lower lobe pneumonia...". Review of the patient's current plan of care dated February 27, 2019 at 9:44 AM revealed an entry for alteration in respirations with the problem expected to improve or resolve by 3/4/19. According to the entry, the patient's respiratory status was "Stabilizing/Maintaining". There were no comments added by the nurse. There was no indication from the patient's care plan that the patient's respiratory status had worsened, or of any interventions in place to address the patient's decline. During an interview on 2/27/19 at 11:25 AM, Administrator A4 verified the findings and stated the nurses are to review/update the patient's care plan every shift.


39208

On 2/25/2019 at 11:40 a.m., review of Patient E1 ' s chart revealed the patient was admitted on 2/18/2019 with a diagnosis of Acute Chronic Anemia, Possible Gastrointestinal Bleed. Review of the patient's medical record revealed the patient was admitted with a low platelet count (20,000 platelets per microliter of blood: normal value 135,000 to 350,000 platelets per microliter of blood). Review of the patient's laboratory results of platelet counts per hospital stay showed: 2/19/2019 (15,000 platelets per microliter of blood), 2/20/2019 (16,000 platelets per microliter of blood), 2/21/2019 (62,000 platelets per microliter of blood), 2/22/2019 (43,000 platelets per microliter of blood ), 2/23/2019 (<10,000 platelets per microliter of blood), 2/24/2019 (15,000 platelets per microliter of blood), 2/24/2019 (<10,000 platelets per microliter of blood), and 2/25/2019 (38,000 platelets per microliter of blood).

On 2/25/2019 at 10:00 a.m. revealed white blood cells (2.7 k/mm3-Low: normal value 4.0 to 10.9 k/mm3) and red blood cells (2.19 M/mm3- Low: normal value 3.70 to 5.00 M/mm3). Patient E1 spiked a fever on 2/24/2019 and 2/25/2019. Blood cultures were drawn and antibiotics begun. Progress note revealed "Awaiting bone marrow results from 2/21/2019". Review of the medical record for E1 revealed the plan of care was updated by RN E9 on 2/25/2019 at 11:26 a.m. The nursing problems on the patient's plan of care were listed as Cardiac Output Alteration, Gastrointestinal Alteration, Activity Alteration, and Health Maintenance Alteration. Each of the problems was documented as "Stabilizing /Maintaining" with a target date of 2/27/2019. The patient's plan of care documented as updated 2/25/2019 did not include all of the patient's problems such as potential for bleeding or potential for infection. The finding was verified by Administrator E 10 at 11:40 a.m. on 2/25/2019. On 2/28/2019 at 10:15 a.m., review of the hospital's policy and procedure, titled, "Assessment and Reassessment of Patients", stated, " ... The plan of care is reviewed and updated every day ..."

Based on observations, review of the hospital's water culture log and reports, review of the manufacturer's directions for use, and review of the hospital's policies and procedures, and interviews, the hospital failed to ensure a system in its infection control program for surveillance of the hemodialysis unit for identifying, reporting, investigating, and monitoring out of range water culture reports, and controlling potential infections for patients requiring hemodialysis services in the hospital.

The findings are:

Cross Reference to A 0749: The hospital failed to ensure the safety of its patients in the hemodialysis unit in that there was no oversight and/or monitoring of the hemodialysis unit through the hospital's infection control body, and the hospital failed to ensure its water culture results were reviewed and monitored and authenticated by the Medical Director of the hemodialysis unit, and staff in the hemodialysis unit failed to wear personal protective equipment as required in the hemodialysis setting. Failure to ensure oversight and monitoring of the high risk problem prone hemodialysis unit activities and requirements that have potential negative impact for hemodialysis patients. Based on observations, interviews, and a review of the hospital's policy, entitled, "Infection Prevention in Dialysis" along with safety information related to the use of the PERMACHEM DPD Total Chlorine Reagent, the hospital failed to ensure dialysis 3 of 3 Registered Nurses who worked in the hemodialysis unit donned appropriate Personal Protective Equipment(PPE) to shield themselves from potential hazards in the water treatment room during the performance of the Chlorine/Chloramine water quality testing, and RN G6 in the dialysis unit when RN G6 initiated a patient's hemodialysis treatment.

Cross Reference to A 0756: The hospital failed to ensure the hospital's leadership that included but was not limited to the Chief Executive Officer, Medical Staff, and Director of Nursing failed to ensure an active infection control program that provided the monitoring and oversight of the hospital's hemodialysis unit necessary to identify elements of potential harm in a high risk problem prone area.

Based on record reviews and interview, the hospital failed to ensure the safety of its patients in the hemodialysis unit in that there was no oversight and/or monitoring of the hemodialysis unit through the hospital's infection control body, and the hospital failed to ensure its water culture results were reviewed and monitored and authenticated by the Medical Director of the hemodialysis unit, and staff in the hemodialysis unit failed to wear personal protective equipment as required in the hemodialysis setting. Failure to ensure oversight and monitoring of the high risk problem prone hemodialysis unit activities and requirements that have potential negative impact for hemodialysis patients. Based on observations, interviews, and a review of the hospital's policy, entitled, "Infection Prevention in Dialysis" along with safety information related to the use of the PERMACHEM DPD Total Chlorine Reagent, the hospital failed to ensure dialysis 3 of 3 Registered Nurses who worked in the hemodialysis unit donned appropriate Personal Protective Equipment(PPE) to shield themselves from potential hazards in the water treatment room during the performance of the Chlorine/Chloramine water quality testing and RN G6 in the dialysis unit when RN G6 initiated a patient's hemodialysis treatment. (RN G2, RN G5, and RN G6)

The findings are:

Hemodialysis Microbiology Water and Dialysate:
Hospital policy, titled, "3152671 Collecting Water Sample for Microbiological Requirements", reads, "....Policy- All microbiological results will meet standards set by AAMI for dialysis water and machine as follows: Type of fluid: water to prepare- Acceptable Level- < 50 CFU/ml (colony forming units)/ (milliliters); Alert Level- 50-99 CFU/ml; Positive Level- >100 CFU/ml....The Infection Prevention Practitioner and Dialysis Medical Director review the microbiologic culture and endotoxin results monthly and document on the Dialysis Equipment Monitoring Schedule....Positive results and trends will be reported through the Infection Control Committee....Document all corrective actions and notifications on the Dialysis Machine Endotoxin/Culture Results on culture results sheet with date and initials....if the culture testing is an alert level (50-99 CFU/ml) or positive (>100 ml) dialysis staff shall repeat the positive test....immediately notify Mechanical Solutions, the Dialysis Director, and Dialysis Medical Director....".
Review of the Water Purification Systems Contracted service, Mechanical Solutions, Inc" reads ".... Annual....3. Water treatment In-service....".

Water Culture Results
On 2/25/19 at 2:00 p.m., review of the hospital's hemodialysis microbiology water and dialysate results revealed:

The colony count water sample for RO(Reverse Osmosis) 24510 obtained on 3/38/2018 resulted as "TNTC- Too Numerous To Count". There was no redraw result provided. The Medical Director did not sign off on the water culture result until 12/25/18 which was nine months later.

The colony count water sample for RO 21402 obtained on 4/24/2018 resulted as 318. Alert levels for Colony Count is => 50 cfu/ml (colony forming unit/milliliter). There was no redraw result provided. The Medical Director did not sign off on the water culture result until 12/25/18 which was 8 months later.

The colony count water sample for MRS 180049 on 6/26/2018 resulted as 56. Alert levels for Colony Count is => 50 cfu/ml. There was no redraw result provided. The Medical Director did not sign off on the result until 12/25/18 which was 6 months later.

The colony count water sample for MRS 180047 dated 7/25/2018 resulted as 144 and the colony count water sample for MRS 180049 dated 7/25/2018 resulted as 152. Alert levels for Colony Count is => 50 cfu/ml. There was no redraw result provided. The Medical Director did not sign off on the result until 12/25/18 which was 5 months later.

Staff Competencies for Hemodialysis and Water Quality Testing
On 2/25/19 at 3:12 p.m., a review of dialysis employee files was conducted.

RN G4 had no documented training for performing the Chlorine/Chloramine water quality test and no documentation of dialysis competencies. RN G10 stated, "I should have access to this training, but I don't. She(RN G4) was never assigned the training. It should be here, but it's not."

On 2/25/19 at 3:17 p.m., review of RN G1's file revealed there was no documentation of hemodialysis training and/or competencies. There was no documentation of training for the Chlorine/Chloramine test. RN G12 (Hospital Clinical Educator), stated, "You are not going to find those in the employees transcripts. The last water training was completed in 2010. RN G1 never received the annual competency training for hemodialysis or water training."

Review of the file for RN G2 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.

Review of the file for RN G7 revealed there was no documentation of training for the Chlorine/Chloramine testing in the water treatment room or for hemodialysis.

Review of RN G6's file revealed RN G6 who is the dialysis unit's "Unit Coordinator", had documentation of training was dated 4/6/2012.

Interviews with Clinical Educator and Hospital Infection Preventionist
On 2/25/2019 at 3:30 PM, in an interview with RN G12 who is the Hospital Clinical Educator, stated, "The employees receive a week of hospital onboarding, and then they go to their perspective unit. A head preceptor works with them. They complete a self-assessment. Once it's completed, it is sent to the Director". RN G10 stated, "The Coordinator of dialysis must have visual oversite, and there's no documentation of that."

On 2/25/19 at 3:30 p.m., RN G10, stated, "The Medical Director comes here every 6 weeks. He should be signing the cultures then. I'm not sure why they aren't being signed then."

On 2/25/19 at 1:40 p.m., RN G21, Hospital Infection Preventionist, stated, "I make rounds in the hemodialysis unit one time a month or as needed. Cultures are sent to me when they are resulted via email. I look at them each month. If something is out of service, they let me know. I do not have a direct connection with the Medical Director, but the unit does. The dialysis nurses receive the email at the same time as I do, and they are verifying the test results. We use AAMI standards for the reports on dialysis results. We talk about anything on monthly rounds." The report provided by RN G21 was the hospital environmental rounds check sheet. Review of the "Infection Prevention Annual Program Appraisal for 2018", reads, "....Dialysis: The dialysis unit continues to be a focus for Infection Prevention. During 2018, the unit began providing service 24 hours a day. All monthly water and dialysate cultures are reviewed by Infection Prevention with no issues identified. New reverse osmosis units were purchased and implemented in 2018....".




28883

Observations on 2/27/19 between 10:10 AM and 10:30 AM in the dialysis unit revealed Registered Nurse (RN) G6 initiating a dialysis treatment for Patient C3. Observations revealed RN G6 wiped the patient's left arm fistula with a disinfectant wipe and then accessed the patient's dialysis fistula with 2 needles. RN G6 wore a gown and goggles, but did not have a mask or face shield to protect his/her face, nose, and mouth from potential blood splatter during the hemodialysis initiation procedure. The finding was verified with RN G6 during an interview on 2/27/19 at 10:30 AM. Review of the hospital's policy, entitled, "Infection Prevention in Dialysis", reviewed 5/2018, revealed the procedure, titled, "Reducing risk of exposure for dialysis staff:", included, "Universal precautions will be followed at all times in the dialysis unit. Dialysis staff will wear face and eye protection if splashing or exposure to blood or body fluids is anticipated...".

Observations on 2/28/19 between 3:30 PM and 4:00 PM in the dialysis water treatment room revealed Registered Nurse(RN) G2, RN G5, and RN G6 demonstrated how to check the RO (Reverse Osmosis) quality water for Chlorine/Chloramine. All of the nurses used "PERMACHEM REAGENTS" DPD Total Chlorine Reagent for the test. Each RN opened the reagent packet and poured the powdered reagent into the water vial, shook the solution, waited the required time frame, and performed the water quality test. During the testing procedure, RN G2 wore a gown and goggles, but failed to wear gloves or facial protection. RN G5 wore a gown, but did not wear any eye/face protection or gloves. RN G6 wore a gown, goggles, and gloves, but wore no face protection. Review of safety information on the reagent package revealed the reagent can cause skin and eye irritation and that protective gloves, clothing, eye, and face protection are required. During an interview on 2/28/19 at 4:10 PM, RN G2, RN G5, and RN G6 verified the findings.

Based on observations, record reviews, interviews, and review of the hospital's infection control program, the hospital failed to ensure the hospital's leadership that included but was not limited to the Chief Executive Officer, Medical Staff, and Director of Nursing failed to ensure an active infection control program that provided the monitoring and oversight of the hospital's hemodialysis unit necessary to identify elements of potential harm in a high risk problem prone area.

The findings are:

Cross Reference to A 0392: The hospital failed to ensure its staff assigned to the hospital's hemodialysis unit received the supervision, knowledge, training to demonstrate the necessary competencies to perform the duties and tasks for testing the water quality in the hemodialysis unit for Chlorine and Chloramine, failed to don personal protective equipment(PPE) in the water treatment room,

Cross Reference to A 0749: The hospital failed to ensure the safety of its patients in the hemodialysis unit in that there was no oversight and/or monitoring of the hemodialysis unit through the hospital's infection control body, and the hospital failed to ensure its water culture results were reviewed and monitored and authenticated by the Medical Director of the hemodialysis unit, and staff in the hemodialysis unit failed to wear personal protective equipment as required in the hemodialysis setting. Failure to ensure oversight and monitoring of the high risk problem prone hemodialysis unit activities and requirements that have potential negative impact for hemodialysis patients.

On 2/25/2019 at 3:30 PM, in an interview with RN G12 who is the Hospital Clinical Educator, stated, "The employees receive a week of hospital onboarding, and then they go to their perspective unit. A head preceptor works with them. They complete a self-assessment. Once it's completed, it is sent to the Director". RN G10 stated, "The Coordinator of dialysis must have visual oversite, and there's no documentation of that."

On 2/25/19 at 3:30 p.m., RN G10, stated, "The Medical Director comes here every 6 weeks. He should be signing the cultures then. I'm not sure why they aren't being signed then."

On 2/25/19 at 1:40 p.m., RN G21, Hospital Infection Preventionist, stated, "I make rounds in the hemodialysis unit one time a month or as needed. Cultures are sent to me when they are resulted via email. I look at them each month. If something is out of service, they let me know. I do not have a direct connection with the Medical Director, but the unit does. The dialysis nurses receive the email at the same time as I do, and they are verifying the test results. We use AAMI standards for the reports on dialysis results. We talk about anything on monthly rounds." The report provided by RN G21 was the hospital environmental rounds check sheet. Review of the "Infection Prevention Annual Program Appraisal for 2018", reads, "....Dialysis: The dialysis unit continues to be a focus for Infection Prevention. During 2018, the unit began providing service 24 hours a day. All monthly water and dialysate cultures are reviewed by Infection Prevention with no issues identified. New reverse osmosis units were purchased and implemented in 2018....".

Based on review of the hospital's Emergency Preparedness Program and interview, the hospital failed to ensure that its Emergency Preparedness Program for the requirement for testing and training included the hospital's physicians.

The findings are:

Review of the hospital's Emergency Preparedness Program documentation revealed there was no documentation that physicians working in the hospital were educated for the requirement for testing and training in the hospital's Emergency Preparedness Program. In an interview on 02/28/19 at 12:54 PM, the Director of Quality confirmed there was no documentation that physicians who worked in the hospital had received education for the hospital's Emergency Preparedness Program for testing and training.