Trident Medical Center

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, 51 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.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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, 51 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.....

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, [DIAGNOSES REDACTED], 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 [DATE] 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 [DATE] 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 [DATE] 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.

On 2/27/2019 at 11:00 AM, review of Patient 13 F's chart revealed the patient was admitted on [DATE] 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 [DATE] 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 2/25/2019 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 ....

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 [DATE] 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.

Patient C2

Review of Patient C2's chart on 2/25/2019 at 3:30 PM revealed Patient C2 was admitted on [DATE] 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.

On 2/25/2019 at 11:40 a.m., review of Patient E1 ' s chart revealed the patient was admitted on [DATE] 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, 71 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) 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 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 9 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 7 dated 7/25/2018 resulted as 144 and the colony count water sample for MRS 9 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.....

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 observation and staff interview, the facility failed to ensure that they maintained their egress doors per the requirements of:

NFPA 101 Life Safety Code (LSC) 2012 edition, Chapters 4.6.1.1, 4.6.12.1, 4.6.12.4, 4.6.12.5, 7.1.10.1, 7.2.1.6.1.1, 19.2.2.2.4

This deficiency is an isolated event and has the potential to affect a very small number of residents, staff and visitors located throughout the facility.

Findings include:

Observation during facility tour (Trident Medical Center Main Campus) on 2/25/2019 at approximately 0930 hrs to 1215 hrs and 1345 hrs to 1615 hrs revealed one (1) delayed egress door located on 4th floor in the Close Observation Unit (C.O.U) leading to nurses station and elevator would not open within 15 seconds when a force of not more than 15 lbf (67 N) was applied.

The Facilities Director was present when the deficiency was identified (during walk-through). Exit interview with the Facilities Director and Vice President of Operations on 2/28/2019 at approximately 1300 hrs verified knowledge of one (1) delayed egress door located in the C.O.U not opening within 15 seconds per the door signage.

Based on observations, interview, and review of the Emergency Department's Policy and Procedures, the hospital failed to ensure appropriate signs specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously information indicating whether or not the hospital or rural primary care hospital participates in the Medicaid program under a State plan approved under Title XIX were placed and visible to individuals presenting to the emergency department for care and services.

The findings are:

On 9/6/17 from 2:45 p.m. to 3:10 p.m., during a tour in the hospital's Emergency Department in the triage area, observations revealed there were no Emergency Medical Treatment and Labor Act (EMTALA) postings for the public to read. The findings were verified with Director 2, 3, and 4 on 9/6/2017 from 2:45 p.m. to 3:10 p.m. at the time of the observations. Director 4 stated, It used to hang right here while pointing to a wall near the entrance door of triage area, but since construction has been under way the past two weeks, they must have forgotten to put it back up.

Review of the hospital's policy, titled, EMTALA - Signage, reads, ....All emergency departments and any other place likely to be noticed by all individuals entering the emergency department....must post conspicuously, appropriate signage notifying individuals of their right to an MSE and stabilization or treatment for an EMC and required services for women in labor as specified under EMTALA as well as information indicating whether or not the hospital participates in the Medicaid program.....

Review of the hospital's procedure, titled, EMTALA-Signage, reads, ....all hospitals must post signage that, at a minimum, meets the following requirements:....entering the emergency department....signage must be readable from anywhere in the area....wording on signage must be clear and in simple terms in a language(s) that is (are) understandable.....

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the hospital's emergency department central log and interview, the hospital failed to ensure the emergency department's central logs showed the disposition of 69 patients who presented to the hospital's emergency department from May 2016 through September 2017.

The findings are:

On September 6, 2017 at 9:00 a.m., review of the hospital's central log from May 15, 2016 through September 5, 2017, there were 69 entries without the patient's disposition recorded.

1. May 15, 2016 at 1428: The hospital's emergency department central log revealed Random Sample Patient #46 presented to the emergency department for Psychosis, but the patient's disposition was omitted on the hospital's central log.

2. June 5, 2016 at 0958.: The hospital's emergency department central log revealed Random Sample Patient #43 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

3. June 24, 2016 at 0332: The hospital's emergency department central log revealed Random Sample Patient #22 presented to the emergency department for [DIAGNOSES REDACTED], but the patient's disposition was omitted on the hospital's central log.

4. June 24, 2016 at 0423: The hospital's emergency department central log revealed Random Sample Patient #23 presented to the emergency department for labor, but the patient's disposition was omitted on the hospital's central log.

5. May 8, 2017 at 2334: The hospital's emergency department central log revealed Random Sample Patient #41 presented to the emergency department for seizures, but the patient's disposition was omitted on the hospital's central log.

6. May 8, 2017 at 2029: The hospital's emergency department central log revealed Random Sample Patient #42 presented to the emergency department for blood in urine, but the patient's disposition was omitted on the hospital's central log.

7. May 8, 2017 at 1623: The hospital's emergency department central log revealed Random Sample Patient #44 presented to the emergency department for abnormal lab values, but the patient's disposition was omitted on the hospital's central log.

8. May 8, 2017 at 1657: The hospital's emergency department central log revealed Random Sample Patient #45 presented to the emergency department for migraine, but the patient's disposition was omitted on the hospital's central log.

9. May 8, 2017 at 1025: The hospital's emergency department central log revealed Random Sample Patient #47 presented to the emergency department for Code Neuro, but the patient's disposition was omitted on the hospital's central log.

10. May 8, 2017 at 0831: The hospital's emergency department central log revealed Random Sample Patient #48 presented to the emergency department for chest pain, but the patient's disposition was omitted on the hospital's central log.

11. May 11, 2017 at 1408: The hospital's emergency department central log revealed Random Sample Patient #36 presented to the emergency department for shortness of breath, but the patient's disposition was omitted on the hospital's central log.

12. May 9, 2017 at 1031: The hospital's emergency department central log revealed Random Sample Patient #37 presented to the emergency department for weakness with shortness of breath, but the patient's disposition was omitted on the hospital's central log.

13. May 10, 2017 at 1653: The hospital's emergency department central log revealed Random Sample Patient #35 presented to the emergency department for overdose, but the patient's disposition was omitted on the hospital's central log.

14. May 11, 2017 at 1931: The hospital's emergency department central log revealed Random Sample Patient #32 presented to the emergency department for Hyperglycemia, but the patient's disposition was omitted on the hospital's central log.

15. May 11, 2017 at 1450: The hospital's emergency department central log revealed Random Sample Patient #33 presented to the emergency department for lethargic sleepy, but the patient's disposition was omitted on the hospital's central log.

16. May 11, 2017 at 0716: The hospital's emergency department central log revealed Random Sample Patient #34 presented to the emergency department for shortness of breath, but the patient's disposition was omitted on the hospital's central log.

17. May 13, 2017 at 1554: The hospital's emergency department central log revealed Random Sample Patient #30 presented to the emergency department for left hip fracture, but the patient's disposition was omitted on the hospital's central log.

18. May 14, 2017 at 1600: The hospital's emergency department central log revealed Random Sample Patient #17 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

19. May 15, 2017 at 2334: The hospital's emergency department central log revealed Random Sample Patient #14 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

20. May 15, 2017 at 1146: The hospital's emergency department central log revealed Random Sample Patient #16 presented to the emergency department for dizziness when standing, but the patient's disposition was omitted on the hospital's central log.

21. May 17, 2017 at 1413: The hospital's emergency department central log revealed Random Sample Patient #15 presented to the emergency department for chest pain, but the patient's disposition was omitted on the hospital's central log.

22. May 18, 2017 at 2204: The hospital's emergency department central log revealed Random Sample Patient #54 presented to the emergency department for syncope, but the patient's disposition was omitted on the hospital's central log.

23. May 19, 2017 at 1055: The hospital's emergency department central log revealed Random Sample Patient #55 presented to the emergency department for ATE AA Battery and 4 Razor Blades, but the patient's disposition was omitted on the hospital's central log.

24. May 21, 2017 at 2236: The hospital's emergency department central log revealed Random Sample Patient #56 presented to the emergency department for needs to get Foley removed, but the patient's disposition was omitted on the hospital's central log.

25. May 25, 2017 at 1023: The hospital's emergency department central log revealed Random Sample Patient #65 presented to the emergency department for chest pain, but the patient's disposition was omitted on the hospital's central log.

26. May 27, 2017 at 2239: The hospital's emergency department central log revealed Random Sample Patient #66 presented to the emergency department for eye pain, but the patient's disposition was omitted on the hospital's central log.

27. May 28, 2017 at 2115: The hospital's emergency department central log revealed Random Sample Patient #67 presented to the emergency department for surgical site bleeding, but the patient's disposition was omitted on the hospital's central log.

28. May 28, 2017 at 2137: The hospital's emergency department central log revealed Random Sample Patient #68 presented to the emergency department for dog bite in leg, but the patient's disposition was omitted on the hospital's central log.

29. May 30, 2017 at 1815: The hospital's emergency department central log revealed Random Sample Patient #69 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

30. June 4, 2017 at 1122: The hospital's emergency department central log revealed Random Sample Patient #13 presented to the emergency department for Altered Mental Status, but the patient's disposition was omitted on the hospital's central log.

31. June 4, 2017 at 2059: The hospital's emergency department central log revealed Random Sample Patient #12 presented to the emergency department for Klonopin withdrawal, but the patient's disposition was omitted on the hospital's central log.

32. June 11, 2017 at 1639: The hospital's emergency department central log revealed Random Sample Patient #11 presented to the emergency department for [DIAGNOSES REDACTED], but the patient's disposition was omitted on the hospital's central log.

33. June 14, 2017 at 1348: The hospital's emergency department central log revealed Random Sample Patient #10 presented to the emergency department for cold like symptoms, but the patient's disposition was omitted on the hospital's central log.

34. June 15, 2017 at 1357: The hospital's emergency department central log revealed Random Sample Patient #9 presented to the emergency department for tremors, but the patient's disposition was omitted on the hospital's central log.

35. June 16, 2017 at 2034: The hospital's emergency department central log revealed Random Sample Patient #8 presented to the emergency department for high blood sugar, but the patient's disposition was omitted on the hospital's central log.

36. June 17, 2017 at 1728: The hospital's emergency department central log revealed Random Sample Patient #6 presented to the emergency department for altered mental status, vomiting blood, but the patient's disposition was omitted on the hospital's central log.

37. June 17, 2017 at 1811: The hospital's emergency department central log revealed Random Sample Patient #7 presented to the emergency department for sore throat, but the patient's disposition was omitted on the hospital's central log.

38. June 20, 2017 at 1218: The hospital's emergency department central log revealed Random Sample Patient #4 presented to the emergency department for weakness, but the patient's disposition was omitted on the hospital's central log.

39. June 20, 2017 at 1309: The hospital's emergency department central log revealed Random Sample Patient #5 presented to the emergency department for unresponsive, but the patient's disposition was omitted on the hospital's central log.

40. June 26, 2017 at 2136: The hospital's emergency department central log revealed Random Sample Patient #2 presented to the emergency department for feels bad, but the patient's disposition was omitted on the hospital's central log.

41. June 26, 2017 at 1525: The hospital's emergency department central log revealed Random Sample Patient #3 presented to the emergency department for kidney stones, but the patient's disposition was omitted on the hospital's central log.

42. June 28, 2017 at 1325: The hospital's emergency department central log revealed Random Sample Patient #1 presented to the emergency department for left foot skin graft coming off, but the patient's disposition was omitted on the hospital's central log.

43. August 5, 2017 at 0847: The hospital's emergency department central log revealed Random Sample Patient #18 presented to the emergency department for leg pain, but the patient's disposition was omitted on the hospital's central log.

44. August 7, 2017 at 0726: The hospital's emergency department central log revealed Random Sample Patient #21 presented to the emergency department for shortness of breath, but the patient's disposition was omitted on the hospital's central log.

45. August 8, 2017 at 2043: The hospital's emergency department central log revealed Random Sample Patient #20 presented to the emergency department for full arrest, but the patient's disposition was omitted on the hospital's central log.

46. August 9, 2017 at 1103: The hospital's emergency department central log revealed Random Sample Patient #19 presented to the emergency department for second round of [DIAGNOSES REDACTED], but the patient's disposition was omitted on the hospital's central log.

47. August 10, 2017 at 2151: The hospital's emergency department central log revealed Random Sample Patient #49 presented to the emergency department for wheezing, but the patient's disposition was omitted on the hospital's central log.

48. August 10, 2017 at 1718: The hospital's emergency department central log revealed Random Sample Patient #50 presented to the emergency department for lower abdominal pain, but the patient's disposition was omitted on the hospital's central log.

49. August 12, 2017 at 1130: The hospital's emergency department central log revealed Random Sample Patient #24 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

50. August 12, 2017 at 1212: The hospital's emergency department central log revealed Random Sample Patient #25 presented to the emergency department for right wrist injury, but the patient's disposition was omitted on the hospital's central log.

51. August 12, 2017 at 1301: The hospital's emergency department central log revealed Random Sample Patient #26 presented to the emergency department for right leg pain, but the patient's disposition was omitted on the hospital's central log.

52. August 12, 2017 at 1609: The hospital's emergency department central log revealed Random Sample Patient #27 presented to the emergency department for right foot injury, but the patient's disposition was omitted on the hospital's central log.

53. August 12, 2017 at 2003: The hospital's emergency department central log revealed Random Sample Patient #51 presented to the emergency department for out patient no use ER Doctor, but the patient's disposition was omitted on the hospital's central log.

54. August 15, 2017 at 1320: The hospital's emergency department central log revealed Random Sample Patient #29 presented to the emergency department for Gastritis, but the patient's disposition was omitted on the hospital's central log.

55. August 22, 2017 at 1156: The hospital's emergency department central log revealed Random Sample Patient #28 presented to the emergency department for needs staples removed, but the patient's disposition was omitted on the hospital's central log.

56. August 24, 2017 at 1348: The hospital's emergency department central log revealed Random Sample Patient #31 presented to the emergency department for abscess tooth, but the patient's disposition was omitted on the hospital's central log.

57. August 25, 2017 at 1716: The hospital's emergency department central log revealed Random Sample Patient #52 presented to the emergency department for dizzy/hands and feet numbness, but the patient's disposition was omitted on the hospital's central log.

58. August 26, 2017 at 1727: The hospital's emergency department central log revealed Random Sample Patient #53 presented to the emergency department for psych eval, but the patient's disposition was omitted on the hospital's central log.

59. August 29, 2017 at 1611: The hospital's emergency department central log revealed Random Sample Patient #38 presented to the emergency department for headache nausea vomiting, but the patient's disposition was omitted on the hospital's central log.

60. August 29, 2017 at 1726: The hospital's emergency department central log revealed Random Sample Patient #39 presented to the emergency department for not able to void, but the patient's disposition was omitted on the hospital's central log.

61. August 31, 2017 at 1840: The hospital's emergency department central log revealed Random Sample Patient #40 presented to the emergency department for ED OB, but the patient's disposition was omitted on the hospital's central log.

62. September 1, 2017 at 0753: The hospital's emergency department central log revealed Random Sample Patient #57 presented to the emergency department for knee pain, but the patient's disposition was omitted on the hospital's central log.

63. September 1, 2017 at 2306: The hospital's emergency department central log revealed Random Sample Patient #58 presented to the emergency department for cardiac arrest, but the patient's disposition was omitted on the hospital's central log.

64. September 2, 2017 at 1402: The hospital's emergency department central log revealed Random Sample Patient #59 presented to the emergency department for neck and arm pain/numbness, but the patient's disposition was omitted on the hospital's central log.

65. September 4, 2017 at 0947: The hospital's emergency department central log revealed Random Sample Patient #60 presented to the emergency department for swelling to feet and legs, shortness of breath , but the patient's disposition was omitted on the hospital's central log.

66. September 4, 2017 at 1039: The hospital's emergency department central log revealed Random Sample Patient #61 presented to the emergency department for shortness of breath, but the patient's disposition was omitted on the hospital's central log.

67. September 4, 2017 at 1112: The hospital's emergency department central log revealed Random Sample Patient #62 presented to the emergency department for mental eval, but the patient's disposition was omitted on the hospital's central log.

68. September 5, 2017 at 1004: The hospital's emergency department central log revealed Random Sample Patient #63 presented to the emergency department for abdominal pain, but the patient's disposition was omitted on the hospital's central log.

69. September 5, 2017 at 1803: The hospital's emergency department central log revealed Random Sample Patient #64 presented to the emergency department for left foot injury, but the patient's disposition was omitted on the hospital's central log.

On September 7, 2017 at 12:30 p.m., the findings were verified with Administrative Assistant 1 and Director 2.

Review of the hospital's Policy/Procedure, titled, EMTALA- Central Log, reads, ....3. The Central Log, including all additional logs incorporated into the Central Log by reference, shall be maintained in the same manner and with the same central core of information. The logs must contain, at a minimum, the name of the individual: refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged , or expired.....

Review of Policy/Procedure, EMTALA- Central Log, reads ....3. The Central Log, including all additional logs incorporated into the Central Log by reference, shall be maintained in the same manner and with the same central core of information. The logs must contain, at a minimum, the name of the individual: refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged , or expired.....

On the days of the EMTALA investigation based on observations, interview, record reviews, review of other hospital data to include Emergency Medical Services transport notes, and review of hospital policies and procedures, the hospital failed to provide a medical screening examination to determine the existence of an emergency medical condition for one of twenty-two patient records reviewed. (Patient #22)

The findings are:

Cross Reference to A2405: The hospital failed to ensure that a patient who presented to the Emergency Department requesting to be seen was entered on the Emergency Department's central log. (Patient #22).

Cross Reference to A2406: The hospital failed to provide a medical screening examination to determine the existence of an emergency medical condition for one of one patient whose data was reviewed. (Patient #22).

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews, review of facility/patient records, Emergency Department Central Log and hospital policies and procedures, the hospital failed to ensure that the Emergency Department(ED)'s system for maintaining a central log included all individuals presenting to the Emergency Department for treatment for 1 of 1 patient data reviewed in the Emergency Department and the patient was not entered on the hospital's Central Log. (Patient #22)

The findings include:

On 02-27-12 at 1500, a review of Patient #22's data and information showed an Emergency Medical Services Encode Record dated 02-12-12 at 1935 that revealed a [AGE] year old male with chief complaint of seizures presented to Hospital #1's Emergency Department with an estimated time of arrival (ETA) of 3-5 minutes. The Emergency Medical Services Encode form was hand stamped by an Emergency Department staff member on 02-12-12 at 1942 upon arrival of ambulance to Hospital #1's ED. Review of the County Emergency Medical system (EMS) trip report dated 2/12/2012 revealed that the EMS unit arrived at the County Jail on 2/12/12 at 19:25 to find a [AGE] year old male with chief complaint of seizures. The reported stated that the patient was in the care of the fire department and detention center staff. The report showed that Fire department staff gave the following report to EMS staff upon arrival. Fire Department stated that Jail Staff members informed them that Patient did not receive his seizure medication do [sic] to being asleep. The EMS reported showed that upon their arrival, their assessment of the patient showed the patient was conscious, alert, and oriented to time, place, and person,was able to speak in full sentences without shortness of breath while breathing at a rate of 16 breaths per minute with clear lung sounds, had a radial pulse of of good quality at 78 beats a minute with brisk capillary refill, skin was warm, dry, and pink, displayed adequate motor and sensory function, no neurological deficits were observed, was placed on a cardiac monitor which displayed normal sinus rhythm, and an intravenous access with a number 22 gauge catheter was obtained in the left hand. The trip report reads, Patient was continuously monitored enroute without significant changes. Hospital #2

encoded without questions or doctors orders. Patient turned over to staff in room 13. The arrival time was listed as 19:51 on 2/12/12.

Review of the Hospital #1's Emergency Department Central Log dated 2/11/12 through 2/13/12 showed Patient #22 had never been entered into the hospital's Emergency Department Central Log on either of those dates.

On 03/01/12 at 1130, a telephone interview conducted with Paramedic #1, who verified that he/she was on duty on the evening shift on 2-12-12. Paramedic #1 reported the patient was picked up from the detention center for a reported seizure times one, known history of seizures, and the patient did not receive his medication that day. Paramedic #1 reported the patient requested to be transported to Hospital #1. Paramedic #1 reported that the event was encoded-radioed to the Hospital #1's emergency department with description, age, reported seizures, history, vital signs. No physician orders were received. Paramedic #1 reported that upon arrival to Hospital

#1's Emergency Department around 1900-2000, a nurse informed us that the patient had a restraining order. Paramedic #1 reported that she informed the nurse that he/she didn't know anything about a restraining order, and this hospital was the patient's choice. Paramedic #1 stated the nurse repeated the patient can't be here because of the restraining order. The EMS crew waited a minute but the patient was not assigned a room. So, I said to the emergency department staff that we would do whatever the staff directed us to do. The nurse told us to leave.

On 02-28-12 at 1515, a telephone interview was conducted with Registered Nurse (RN) #4 who verified that he/she was on duty in Hospital #1's Emergency Department from 1900 to 0700 shift on the evening of 02-12-12 to the morning of 2-13-12. RN #4 verified that he/she took an Encode report and placed the report on the time clock so it would be stamped when the patient arrived. RN #4 stated that when the patient arrived, and he/she realized who the patient was, he/she informed the EMS crew that the patient had a restraining order. RN #4 reported the EMS crew member stated, I forgot. RN #4 reported that he/she assumed the EMS crew knew about the restraining order also. RN #4 reported the ED staff talked among themselves, and then, the EMS attendant said that he/she would transport the patient to Hospital #2. RN #4 reported that he/she didn't know if the ED could do that, so he/she did a visual assessment of the patient which showed the patient was sitting on the stretcher calmly looking around and was cooperative. RN #4 reported that he/she had assumed that the restraining order and the no trespass order were the same type of order that meant the patient couldn't be in the hospital unless in acute distress like post ictal, coding, or active seizures. RN #4 reported that all of the staff in the ED had the same thought in that we heard the patient had a restraining order. RN #4 reported that he/she didn't realize EMTALA could occur if a patient had a restraint order.

Review of facility policy, effective 05-01-10, titled, EMTALA Definitions and General Requirements, reads, ....Central Log is a log that a hospital is required to maintain on each individual who comes to the emergency department seeking assistance that documents whether he or she refused treatment, was refused treatment or whether he or she was transferred, admitted and treated, stabilized and transferred or discharged . The purpose of the Central Log is to track the care provided to each individual where EMTALA is triggered.... The facility failed to ensure that their policy and procedure on Central Log was followed on 2/12/2012 when patient #22 presented to the ED requesting medical assistance.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

On the days of the EMTALA Investigation based on interview, clinical record review, review of other data and written materials, and review of facility policy and procedure, the Hospital failed to ensure that all patients that came to the Dedicated Emergency Department were given a Medical Screening Exam(MSE) to determine if an Emergency Medical Condition existed for 1 of 1 patient data reviewed in that Patient #22 did not receive a MSE. (Patient #22)

The findings include:

On 02-27-12 at 1500, a review of Patient #22's information showed an Emergency Medical Services Encode Record dated 02-12-12 at 1935 revealed a [AGE] year old male with chief complaint of seizures presented to Hospital #1's Emergency Department with an estimated time of arrival (ETA) of 3-5 minutes. The Emergency Medical Services Encode form was hand stamped by an Emergency Department staff member on 02-12-12 at 1942 upon arrival of ambulance to Hospital #1's ED. Review of the County Emergency Medical system (EMS) trip report dated 2/12/2012 revealed that the EMS unit arrived at the County Jail on 2/12/12 at 19:25 to find a [AGE] year old male with chief complaint of seizures. The reported stated that the patient was in the care of the fire department and detention center staff. The report showed that Fire department staff gave the following report to EMS staff upon arrival. Fire Department stated that Jail Staff members informed them that Patient did not receive his seizure medication do [sic] to being asleep. The EMS reported showed that upon their arrival, their assessment of the patient showed the patient was conscious, alert, and oriented to time, place, and person,was able to speak in full sentences without shortness of breath while breathing at a rate of 16 breaths per minute with clear lung sounds, had a radial pulse of of good quality at 78 beats a minute with brisk capillary refill, skin was warm, dry, and pink, displayed adequate motor and sensory function, no neurological deficits were observed, was placed on a cardiac monitor which displayed normal sinus rhythm, and an intravenous access with a number 22 gauge catheter was obtained in the left hand. The trip report reads, Patient was continuously monitored enroute without significant changes. Hospital #2

encoded without questions or doctors orders. Patient turned over to staff in room 13. The arrival time was listed as 19:51 on 2/12/12. Patient #22's medical record was reviewed. Review of Hospital #2's form, titled, Emergency Department Chart revealed that Patient #22 arrived at Hospital #2's Emergency Department on 2/12/12 at 1950 via County EMS transport. The patient was triaged as a 3 - Urgent. Review of the Triage Notes revealed, Per EMS, they attempted to take pt (patient) to .......medical center, were inside facility, and were told that pt had trespass notice there and you need to take him somewhere else. Physician orders included but were not limited to: Stat Dilantin and Phenobarbital levels, Basic Metabolic Panel, Complete Blood Count. Review of the patient's lab work revealed the Dilantin Level was 21.1 ug/ml (milliliters). Therapeutic range was reported as 10.0 to 20.0 ug/ml. Potentially toxic levels were reported as greater than 20.0 ug/ml. The critical value was reported to the physician. The Phenobarbital level was recorded as 2.3 ug/ml. Optimal Therapeutic range was recorded as Adults: 20 - 40 ug/ml. Review of drug orders showed the patient received Phenobarbital 260 milligrams intravenously. The patient was discharged from the emergency department on 2/12/12 at 2209 with discharge instructions to: hold Dilantin tomorrow, Dilantin level was 21, Phenobarbital level was 2.3 got 260 mg intravenous in ED, call doctor tomorrow for recommendations to manage meds (medications).

On 03/01/12 at 1130, a telephone interview conducted with Paramedic #1 verified that he/she was on duty on the evening shift on 2-12-12. Paramedic #1 reported the patient was picked up from the detention center for a reported seizure times one, known history of seizures, and the patient did not receive his medication that day. Paramedic #1 reported the patient requested to be transported to Hospital #1. Paramedic #1 reported that the event was encoded-radioed to the Hospital #1's emergency department with description, age, reported seizures, history, vital signs. No physician orders were received. Paramedic #1 reported that upon arrival to Hospital

#1's Emergency Department around 1900-2000, a nurse informed us that the patient had a restraining order. Paramedic #1 reported that he/she informed the nurse that he/she didn't know anything about a restraining order, and this hospital was the patient's choice. Paramedic #1 stated the nurse repeated the patient can't be here because of the restraining order. The EMS crew waited a minute but the patient was not assigned a room. So, I said to the emergency department staff that we would do whatever the staff directed us to do. The nurse told us to leave. Paramedic #1 reported the patient was getting upset, stated that he did not want to be there anymore, and consented to be transported to another nearby hospital (Hospital #2). Paramedic #1 stated the EMS crew encoded to the nearby hospital (Hospital #2), and that Hospital #2 accepted the patient. Paramedic #1 verified that she did inform Hospital #2 of the situation that occurred at Hospital #1, and the reason why the patient was diverted because the Sheriff was upset about the situation that occurred at the first hospital (Hospital #1), and he/she informed Hospital #2 of the occurrence. Paramedic #2 reported that staff at Hospital #2 became inquisitive about the situation that the Sheriff was discussing with Physician #3 so I told the nurse when the nurse came to the patient. When Paramedic #1 was queried as to why there was no mention of the EMS trip to Hospital #1 on the trip ticket, Paramedic #1 responded, I didn't consider it to be pertinent care.

On 02-28-12 at 1050, an interview with Patient Support Technician(PST)#1 verified that he/she was on duty in the Hospital #1's ED that evening. PST#1 reported that an Encode came in from the EMS crew reporting the EMS crew had a patient with seizures. PST#1 reported that when he/she returned from the bathroom, the EMS crew was in the emergency department hallway loading the patient for transport. PST#1 reported he/she asked the emergency department's Charge Nurse why the patient was leaving. PST #1 stated the Charge Nurse informed him/her that the patient had a No Trespass Order. PST #1 reported that he/she recalled that the patient was belligerent, especially after drinking, and had been violent as in threatening staff on previous visits to the emergency department. PST#1 verified that he/she had no understanding of what a No Trespass Order was, but was informed by the Charge Nurse that the patient had a No Trespass order that he/she had signed on a previous visit to the emergency department.

On 02-28-12 at 1200, an interview was conducted with the Nurse Manager of Hospital #1's ED revealed that he/she first learned of the alleged incident by way of the Trident EMS Coordinator who received an e-mail from the EMS dispatch. When EMS rerouted, the dispatcher questioned the no trespass order, and this initiated the internal investigation. The ED Nurse Manager reported that the No Trespass Order was an inter facility document and not a restraining order issued by a court order. The ED Nurse Manager reported that the No Trespass Order was suggested by the ED physicians who rotate through the Hospital's Health Systems EDs. The ED Nurse Manager reported that he/she talked with the night shift in Hospital #1's ED, and the staff were confused about the meaning of a No Trespass Order. The ED Nurse Manager reported that staff reported to him/her that they did not know if a No Trespass Order included everything, and that the patient shouldn't be on the hospital grounds. The Nurse Manager of the ED verified that the hospital had no policy and procedure, no legal form, and no system in place for education and communication to the ED staff when the a No Trespass order was in effect prior to the incident.

On 02-28-12 at 1515, a telephone interview was conducted with Registered Nurse (RN) #4 verified that he/she was on duty in Hospital #1's Emergency Department on 1900 to 0700 shift the evening of 02-12-12 to the morning of 2-13-12. RN #4 verified that he/she took an Encode report and placed the report on the time clock so it would be stamped when the patient arrived. RN #4 stated that when patient arrived and he/she realized who the patient was, he/she informed the EMS crew that the patient had a restraining order. RN #4 reported the EMS crew member stated, I forgot. RN #4 reported that he/she assumed the EMS crew knew about the restraining order also. RN #4 reported that ED staff talked among themselves, and then the EMS attendant said that he/she would transport the patient to Hospital #2. RN #4 reported that he/she didn't know if the ED could do that, so he/she did a visual assessment of the patient which showed the patient was sitting on the stretcher calmly looking around and was cooperative. RN #4 reported that he/she had assumed the restraining order and the no trespass order were the same type of order that meant the patient couldn't be in the hospital unless in acute distress like post ictal, coding, or active seizures. RN #4 reported that all of the staff in the ED had the same thought in that we heard the patient had a restraining order. RN #4 reported that he/she didn't realize EMTALA could occur if a patient had a restraint order.

On 02-29-12 at 1155, a telephone interview was conducted with the Deputy Director of the County EMS who revealed the EMS crew informed him/her of the incident the next morning. The Director reported the patient called 911 with complaint of seizure, went to residence, requested transport, not sure if request was from the patient, or if the EMS crew thought the patient should go to Hospital #1. EMS encoded the trip, got to hospital (Hospital #1), went through the ED doors, and then, the Charge Nurse came up and said no because there was a restraining order on the patient. The EMS Director reported the EMS crew asked the patient if he minded going to the next hospital (Hospital #2), and the patient became aggravated. The Director reported the EMS crew transported the patient to Hospital #2. The Director stated that the EMS crew informed him/her that the charge nurse or the hospital (Hospital #1) had a restraining order on the patient. The Deputy Director stated that he/she had never heard of such a thing so he/she e-mailed the EMS Liaison at Hospital #1. The Director stated that the EMS crew reported that the charge nurse at Hospital #1 was rude to the EMS crew. The Director reported the EMS crew didn't know anything about restraining orders, and EMS crews couldn't keep track of something like that anyway.

On 02-29-12 at 1215, a telephone interview was conducted with RN #8 who verified that he/she was on duty in Hospital #1's Emergency Department from 1900 PM to 0700 AM from 02-12-12 to 02-13-12. RN #8 reported that the patient was well known in Hospital #1's ED, and the patient had a No Trespass Order that meant the patient was not to be seen at the facility. RN #8 reported that the patient presented to Hospital #1's ED with EMS crew transport for suspected Seizure. RN #8 reported that as soon as the patient was rolled in by the EMS crew, someone in the ED, he/she can't remember who, identified the patient had a restraining order. RN #8 reported that the restraining order was communicated by hearsay. RN #8 reported that he/she was informed after the incident that the patient had a no trespass order and not a restraining order. RN #8 reported that when the EMS crew was informed that the patient had a restraining order, the attendant said he/she knew but had forgotten about the restraining order. RN #8 reported that at that point the EMS crew left with the patient. RN #8 verified the patient wasn't at Hospital #1 more than 3-5 minutes. RN #8 verified that he/she had never received any education or training on restraining orders or No Trespass Orders prior to the incident. RN #8 verified that there were no policies and procedures or any written information about Restraining/No Trespass Orders, and all of his/her information was just hearsay. RN #1 reported that he/she had heard the hospital was trying to do it so the patient would cease to abuse the hospital 's ED system. RN #8 reported that didn't know how the EMS crew had been made aware of the Restraining/ No Trespass Order. RN #8 verified that no physician saw the patient. The facility failed to ensure that on 2/12/2012 Patient #22 received a Medical Screening examination that was within the capability and capacity of the hospital's ED to determine if an emergency medical condition existed. RN #8 reported that he/she was confused about what a No Trespass or Restraining Order meant, and that he/she thought it was a legal police order, and he/she had to abide by it. RN #8 reported that he/she was not an attorney. RN #8 reported, If it was a restraining order, I thought the person shouldn't be on the property. I am not sure what a No Trespass order means. I thought I was doing the right thing by abiding by the hospital's decision to block this patient by further abuse of ED system. RN #8 verified the hospital had no system that included policies and procedures, staff education, and communication of such orders to ED Staff members in place prior to the incident.