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Based on observation, interview and record review, the facility's staff and contracted dialysis staff failed to ensure solutions used to calibrate patient's equipment was not expired and were calibrated based on manufacturer's recommendation.

Failed to ensure conductivity and PH of the dialysate solution is verified after changing the dialysate concentrate by adding powered concentrate to the concentrate prepared by the hemodialysis machine in 1 of 2 nurses observed. Licensed Vocational Nurse (F)

The facility failed to ensure a patient's head was elevated while receiving tube feeding, to prevent the risk of aspiration in 1 of 1 patient observed receiving gastrostomy tube feeding. Patient #5.


Findings:


Review on 01/29/2020 at 3:30 p.m. of the acute dialysis current policy and procedure; Dialysis Treatment, Policy 910, titled; "Independent Verification of Dialysate Conductivity". Revised: September 2019. Purpose: To ensure that the delivery system provides dialysate with proper conductivity to deliver safe hemodialysis treatments. Policy: 1. Unless more frequent testing is required by state, local or network regulations, verification of dialysate conductivity and pH using an independent test method will be done daily prior to the initiation of treatment and: Each time pre-mixed manufactured dialysate is modified in the facility by the use of additives (per the approved Core Dialysis procedure for Acid Concentrate Additives). Whenever the delivery system has been turned off and restarted. After bleach clean has been done. 2. Acceptable equipment or test methods for measuring dialysate conductivity and pH will be used according to manufacturer's guidelines and approved Core Dialysis policies and procedures. 3. Documentation of independent verification of dialysate conductivity and pH will be done on the Equipment Log for each delivery system used each time the test are done."

Review on 1/29/2029 at 3:45 p.m. of the Manufacturer's Instructions for Myron - L D-1 Meter directed users as follows: "The Conductivity Standard Solutions and pH Buffers below are used for factory calibration. Regular use of these solutions is recommended to ensure specified instrument accuracy. Frequency of conductivity recalibration depends upon use, but once every month should be sufficient for an instrument used daily."

Observation

Review of records presented by Contract Dialysis Employee ID # (J 11) on 1/29/2020 at 9:45 a.m. of the Myron Meter Daily Calibration Log for Hospital #2 dated January 2020 revealed a log for Myron Meter ID # 516751.

Myron Meter used by dialysis staff on 1/29/2020 was Meter ID # 510170.
Dialysis Employee ID # (J 11) was unable to find Myron Meter ID # 516751 and no verification log was presented for Meter ID # 510170.

During an interview on 1/29/2020 at 9:45 a.m. with Dialysis Employee ID ( J 11), he was asked for the Myron Meter Daily Calibration Log for Myron Meter ID # 510170. Employee ID (J 11) stated "the dialysis nurse Employee ID (# A) said she had calibrated the meter prior to used but had not documented the calibration." When ask for the calibration log for Meter ID #510170 Employee ID ( J 11) stated that it could not be found.

Record Review of hemodialysis treatment record on 1/30/2019 at 2:00 p.m. revealed:

Hemodialysis record dated 1/29/2020 for Patient ID # 2 B revealed the following documentation: Machine number AX 119, RO # 507. Meter Conductivity reading 14. Machine Conductivity R 13.8. Machine pH reading 7.5.

Review of hemodialysis record dated 1/29/2020 for Patient ID # 4 B revealed the following documentation; Machine number AX 120, RO # 506. Meter Conductivity reading 14. Machine Conductivity reading 13.8. Machine pH reading 7.1.

Interview with Contracted Dialysis Nurse Employee ID (# A) on 1/29/2020 at 9:15 a.m., she was asked how she verified the machine conductivity and Employee ID #( A) replied, she had used the Myron L meter but had given it to dialysis Nurse Employee ID # (D) to use.

Interview on 1/29/2020 at 9:50 a.m. with Dialysis Nurse Employee ID #(D) when asked if she had calibrated the conductivity meter, she replied "no, the meter was shared, and the other Dialysis Nurse Employee ID # (A) had said she calibrated the meter."


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Expired supplies.
Observation on 01/28/2020 at 8:20 a.m. of the facility's water treatment room at Hospital 1 revealed a bottle of conductivity solution 14.0 millisiemens used for calibration and verification of conductivity of dialysate solution with the expiration date of October 2019.

Interview on 01/29/2020 at 6:35 a.m. with Licensed Vocational Nurse (G 7) revealed he was waiting on the Contracted Dialysis Manager to bring solution for calibration of the Maron L, so that the conductivity of the dialysate solution could be verified with the independent meter. He said the expired bottle of conductivity solution was used prior to calibrate the meter and no other solution was available.

Review of the record revealed the Myron L machine was calibrated on the following days using the expired solutions. January 1, 3, 4, 6, 7, 8, 9, 10, 13, 15, 17, 20, 22, 24, 27.

Conductivity and PH

Observation on 01/29/2020 at 7:45 a.m. revealed Licensed Vocational Nurse (F) was observed at the bedside of Patient #5 in room 505. The Licensed Vocational Nurse was checking the conductivity and PH of the dialysate solution prior to initiating hemodialysis treatment on Patient #5. After checking the conductivity and PH the Nurse put the machine in prime mode while doing central venous catheter care on the patient.

Subsequent observation revealed that at 9:02 a.m. Licensed Vocational Nurse (F) increased the potassium concentrate from 2 Potassium to 3 potassium by adding 1 mg of potassium from a packet and then initiated hemodialysis treatment on the patient.

The Surveyor notified Licensed Vocational Nurse (F) that she had done the conductivity and PH of a 2 potassium, 2.5 calcium dialysate concentrate but she had added 1 mg of potassium which has the potential of changing the PH and conductivity of the dialysate solution.

She stated " OK."

Gastrostomy Tube.

Patient #5
On 01/29/2020 at 7:45 a.m. Patient #5 was observed in the Facility's intensive care unit. The Patient had a tracheostomy to ventilator with oxygen at 40 %. The Patient was receiving tube feeding of Nepro at 50 mls/ hour via pump.

On 01/29/2020 at 8:14 a.m. Radiology Technician (H) was observed in the Patient's room doing a radiology procedure of KUB. Observation at that time revealed the Technician had the patient's head flat and had rolled the Patient off his back to place the films.
Observation revealed the Patients tube feeding of Nepro was still in progress at 50 mls/ hour. The Surveyor immediately informed the Registered Nurse ( R) who was assigned to the Patient that the Patient's head was placed flat while receiving the tube feeding.

Registered Nurse (R) informed the Technician that the feeding needed to be stopped. She informed the Registered Nurse that she could not touch the feeding pump because her hands were soiled.
Registered Nurse (R) then applied her gown, entered the patient's room and turned the patient's tube feeding off.

Interview with Radiology Technician (H) after she exited the patient's room revealed she was not aware that the Patient was receiving tube feeding at that it had to be stopped before lowering the Patient's head.

Based on observation, interview and review of the manufacturer's recommendation for use revealed, the facility failed to ensure pre- filters were replaced monthly and monitor the water temperature in 1 of 2 water treatment system monitored;

The facility's contracted dialysis service failed to ensure staff notified the biomedical department and take action for the water treatment reading outside the set parameter on the facility's water treatment log log sheet.

Findings:

Review of the facility's current policy and procedure for contracted hemodialysis staff, directed staff as follows: " Acceptable equipment or test methods for measuring dialysate conductivity and PH will be used according to manufacturer's guidelines and approved -- Dialysis policies and procedures."

Observation on 01/29/2020 at 6:10 a.m. of the facility's water treatment room at hospital #1, revealed a water treatment system with a Marcor Reverse Osmosis System in place. Observation of the system revealed an ultra- filter attached to the Reverse Osmosis System. The date on the system indicated that the filter was last replaced on 11/15/2019.

Interview at that time with the Facility's Chief Biomedical Technician revealed another staff member had replaced the filter and scheduled it to be replaced if the delta pressure was greater than 15. He said the pre-filter is to be replaced monthly.

Review on 01/29/2020 of the Manufacturer's recommendation for use of 23-Series RO system Page 57, directs users as follows: "Replace pre- filter monthly or when pressure drop doubles from the new conditions."
Measure and record the feed water temperature on the operation log. A hand-held thermometer may be used. The water temperature has a significant effect on the flow rate of the RO membrane. "

Review of the Facility's Water Treatment Log for the following dates the system was in operation, revealed no documentation that feed water temperature was monitored as per- manufacturers recommendation: January 1, 3, 4, 6, 8, 10,13, 15, 17, 20, 22, 24, 27, and 29.

Interview on 01/29/2020 at 2:40 p.m. with Licensed Vocational Nurse (G) revealed he does not monitor the feed water temperature when he does the daily startup of the RO.


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Review of the Dialysis Ameri Water Treatment Log reads as follows: "RO verification Test: RO filter Delta pressure (<15) ......Note: If any verification/limits/tests are outside the preset parameters, the Chief Technician must be notified immediately."

Observation of the facility's water treatment room ( hospital #2) on 01/30/2020 at 9:30 a.m. along with Chief Bio-medical Technician revealed the RO water purification system was observed with a pre-pressure reading of 40 psi and post pressure reading of 20 psi. Delta pressure reading of 20 psi.

Interview with Employee ID # D 4 at that time confirmed this reading was higher than the set limits that were acceptable for use.

Interview with facility Chief Bio-medical Technician, Employee ID # D 4 on 01/30/2020 at 9:30 a.m. revealed he stated he was unaware that the reading was outside the parameter limits on the water log sheet. Employee ID # D 4 stated he was not notified of this.

Review on 01/30/2020 at 9:30 a.m. of January 2020's Ameri Water Treatment Log along with Employee ID # D 4 who verified the parameter set limits documented on the log for January 2020, revealed the documented readings were outside the set limits and should have been reported to him. Signature on bottom of water log sheet for January 2020 was listed as Licensed Nurse Employee ID# A.

The readings were as follows:
1/01/2020 - 48 psi
1/03/2020 - 50 psi
1/06/2020 - 40 psi
1/08/2020 - 50 psi
1/10/2020 - 30 psi
1/13/2020 - 30 psi
1/15/2020 - 40 psi
1/17/2020 - 30 psi
1/20/2020 - 30 psi
1/22/2020 - 30 psi
1/24/2020 - 40 psi
1/27/2020 - 40 psi
1/29/2020 - 40 psi. Set readings <15 psi

Based on observation, interview and record review, facility's direct care staff failed to change gloves and wash/ sanitize hands after providing care and services to patients 3 of 21 patients observed. Patient #s 1, 3, 8.

Facility staff and contracted dialysis staff failed to ensure the infection control policies were implemented to maintain a sanitary environment in the facility. The facility staff failed to ensure that the facility's hemodialysis equipment were properly cleaned and maintained.

Findings

Interview on 01/28/2020 at 7:45 a.m. with Registered Nurse ( C) revealed Patient #1 was on contact Isolation for VRE.

On 01/28/2020 at 8:00 a.m. Respiratory therapist (A1) was observed at the bedside of Patient #1 located in Intensive Care Unit 10. The Respiratory Therapist was suctioning the Patient who had a tracheostomy in place to oxygen at 40%.
Observation revealed the Respiratory Therapist donned a pair of gloves and applied her gown and then suctioned the Patient's tracheostomy.

After suctioning the Patient, the Respiratory Therapist removed her contaminated gloves, then secured a clean pair of gloves stored outside the room on the door with her contaminated hands. She did not wash/ sanitize her contaminated hands after removing her contaminated gloves. She then applied a clean pair of gloves and proceeded to document on the clipboard.
The Surveyor immediately notified her of the break in infection control. She stated "oh."

Review of the Patient's clinical record revealed laboratory results dated 1/12/2020 of pleural fluid which was positive for candida tropicalis.
Laboratory results dated 11/16/2019 rectal swab, positive for Resistant enterococci.

Patient #3
On 01/28/2020 at 9:25 a.m. Physician Assistant (B2) was observed entering the room of Patient #3. The sign on the door indicated the patient was on contact isolation and required gloves, gown and handwashing.
Observation revealed the Physician Assistant wearing his lab coat which he wears on the unit, he walked into the room, he then examined the Patient's legs and listened to the Patient's chest with his stethoscope. The Physician Assistant was not wearing gown or gloves. After doing the examination on the Patient, the Physician Assistant placed the stethoscope around his neck and placed his hands in his coat pocket and left the room. He did not wash or sanitize his contaminated hands.

He then picked up a pair of clean gloves from the adjacent room # 503, applied a gown and entered the room of patient #4. He examined the Patient, removed his contaminated gloves and gown and left the room without washing or sanitizing his contaminated hands. He then proceeded over to the charting area on the unit and proceeded to chart.

The Surveyor immediately notified him of break in infection control of not wearing gown, gloves or washing / sanitizing his hands when moving from one patient to another. The Physician assistance said he did not see the sign on the door that Patient # 3 was on contact isolation.

PATIENT #8
On 01/29/2020 at 11:30 a.m. revealed Physician (I 10) was observed entering the room of Patient #8. The sign on the door indicated the patient was on contact isolation and required gloves, gown and handwashing.

Observation revealed the Physician wearing his lab coat which he wears on the unit entered the Patient's room. He did not wash/ sanitize his hands and applied a gown and gloves. He then manipulated the telemetry screen in the room, printed a strip and examined the Patient with his stethoscope.
A nurse then entered the room and spoke with Physician (I 10). The Physician then used his contaminated hands to retrieve a pair of gloves from the clean box of gloves outside the patient's door.

Review on 01/30/2020 of a laboratory report dated 1/28/2020 revealed a urinalysis which showed occasional bacteria. Vancomycin Resistant Enterococci of rectal swab dated 1/30/2020 was pending.

Review of the Facility's current Policy and Procedure on Personal Protective Equipment Policy # ICP.03.01 directed staff as follows: "Gowns gloves, masks protective eyewear will be worn as appropriate to the type of isolation. Personal Protective (Equipment (PPE) will be supplied for all hospital employees, patients and visitors. Gloves are to be worn at all times when performing care. Perform Hand Hygiene before and after care,"


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Policy Reviewed:

Review on 1/29/2020 at 2:00 p.m. of the facility's current policy and procedure titled "Storage of Medical Equipment, Devices and Supplies", ICP.03.01, Infection Control and Prevention Manual, Effective Date 2/14, Review Date 1/19. Purpose: To prevent the spread of infection/infectious disease on medical equipment, devices and supplies.

Policy: "All Medical Equipment and Supplies will be stored in a sanitary environment, which is dry, and temperature controlled. Central Supply will be the intake of all new and re-ordered supplies. All Equipment and Supplies will be stored in designated area. A. Clean - All medical equipment and supplies will be inspected to ensure the proper packaging without evidence of tampering or tearing. B. Contaminated: Large pieces of equipment are to be thoroughly wiped down with a hospital approved disinfectant and any visible contamination (e.g. blood, secretions) will be cleaned prior to taking the equipment out of the room. 7. Contaminated reusable (non-disposable) critical medical devices or patient care equipment are sterilized or disinfected after use to reduce the risk of transmission of microorganisms to other patients. The type of reprocessing is determined by the article and its intended use, the manufacture's recommendations, hospital policy and any applicable guidelines and regulations. 8. Reusable, non-critical equipment (i.e. equipment that touches intact skin) which becomes contaminated with blood, body fluids, secretions or excretions is cleaned and disinfected using hospital-approved disinfectant/cleaning solutions and manufacturer's directions."

Review on 1/29/2020 at 2:00 p.m. of the facility's current policy and procedure titled "Management of Equipment, Devices and Supplies", ICP.03.01, "Infection Control and Prevention Manual, Effective Date 2007, Review Date 1/20. Purpose: To prevent the spread of microorganisms when using equipment, devices and supplies in the healthcare setting. Policy: Work surfaces that become contaminated with blood or other body fluids can cause exposure to a blood born disease through cross-contamination. Cross-contamination is the spread of germs from one surface to another by contact. Disinfect surfaces that may have been in contact with blood or other body fluids .....All equipment must be cleaned at the point of care ....Shared Equipment: All shared equipment must be cleaned, with hospital approved cleaning agent, In between patient use to reduce the chance or cross contamination. Central Supply: All delivered supplies should be processed, logged and tagged in central supply prior to being place in general use."

Review on 1/29/2020 at 4:15 p.m. of the acute dialysis current Policy 732 titled "Disinfection of Non-Delivery System Equipment", Originated: March 1, 2015, Revised: September 2019. "Purpose: To prevent transmission of infectious agents through contact with equipment surfaces, dialyzers, tourniquets, clamps and any reusable supplies. Policy: 1. Standard precautions and use of PPE (personal protective equipment) are used when disinfecting and cleaning reusable supplies and equipment surfaces. 2. If an equipment surface is contaminated with blood, it will be disinfected with a cloth soaked in 1:100 concentrate bleach/water solution or bleach wipes. 4. All equipment surfaces including chairs will be disinfected after each treatment. Blood spills will be cleaned immediately. 7. All surfaces or reusable equipment that is frequently touched will be cleaned and disinfected daily. 9. Dialysis staff performs cleaning/disinfection between patients."

Review on 01/29/2020 at 3:30 p.m. of the acute dialysis current policy and procedure; Dialysis Treatment, Policy 910, titled; "Independent Verification of Dialysate Conductivity". Revised: September 2019. Purpose: To ensure that the delivery system provides dialysate with proper conductivity to deliver safe hemodialysis treatments. Policy: 1. Unless more frequent testing is required by state, local or network regulations, verification of dialysate conductivity and pH using an independent test method will be done daily prior to the initiation of treatment and: Each time pre-mixed manufactured dialysate is modified in the facility by the use of additives (per the approved Core Dialysis procedure for Acid Concentrate Additives). Whenever the delivery system has been turned off and restarted. After bleach clean has been done. 2. Acceptable equipment or test methods for measuring dialysate conductivity and pH will be used according to manufacturer's guidelines and approved Core Dialysis policies and procedures. 3. Documentation of independent verification of dialysate conductivity and pH will be done on the Equipment Log for each delivery system used each time the test are done."

Review on 1/29/2020 at 4:00 p.m. of Manufacture's recommendations Alcavis: www.dialmedsupply.com/alcavis50/index.html. Indications for Use: "All catheter caps and connections, medication poet and peritoneal dialysis set disinfection. Effective high-level disinfectant, fast acting, active against bacteria, fungi, spores, mycobacteria and viruses. Compatible: Can be used with all catheters and connectors currently on the market. Stable for 180 days once opened."

Review on 1/29/2020 at 3:30 p.m. of Manufactures recommendations from BD Vacutainer Evacuated Blood Collection System. " BD vacutainer tubes are evacuated tubes with color coded stoppers. Most tubes contain additives in varying concentrations depending on the amount of vacuum and the required additive to blood ratio for the tubes ......Do not use tubes after their expiration date. Tubes expire on the last day of the month and year indicated."

Observation

Observation of the facility's patient care area and supply/storage area along with Employee ID # (E) Director of Quality Management and Employee ID # ( F) Chief Nursing officer on 1/28/2020 at 10:00 a.m. the following was observed:

Expired Items

3rd floor medical/surgical unit clean supply room - 94 test tubes, BD Vacutainer PST Gel & Lithium Heparin 3.5 ml test tubes, Lot # 8345617, Expiration date 12/21/2020.
Renal Suite - 2nd floor - 1 Bottle Hisense Ultra 0.1 Test for total Chlorine 100 strips, Lot # 090127A, Expiration Date 12/31/2019.

Renal Suite - 2nd floor - 1 Bottle, Serim Guardian, Water Hardness 50 strips. Test for total hardness, Lot # 066057, Expiration date 11/30/2019.

Renal Suite - 2nd floor - 2 bottles, 32-ounce, Conductivity Standard Solution,14.0 Millisiemens (Millimhos), Batch # 091981 JM, Expires 10-2019.

Renal Suite - 2nd floor - 1 bottle, 17 - fluid ounces, Alcavis 50, High Level disinfectant, for dialysis sets and connectors. Lot # 0341201810, Expiration date 04-03-2021. Bottle was found to be open with no open date on container.
Approximately1/4 of solution was remaining in bottle.

Interview on 1/29/2019 at 11:00 a.m. with Dialysis Employee # (J 11) stated the supplies expiration dates should have been checked monthly by the charge nurse and any expired items should have been thrown away. Employee # J 11 also confirmed the container of Alcavis should have been labeled when opened and should be thrown away.

Interview with on 1/28/2020 at 9:15 a.m. with Employee ID # ( E) , Director of Quality Management when asked about the expired test tubes stated that the supplies are checked by hospital staff monthly and should have been disposed of.

Equipment Observation

1st floor dialysis supply room - Reverse Osmosis Machine (RO) and Cart # 506 found with multiple areas of visible rust and paint chips on the RO cart and wheel casters and frame and an accumulation of rust, dust and debris on the bottom shelf holding the carbon tanks along.

Observation of the dialysis supply room and renal suite on January 29, 2019 at 9:15 a.m , along with Employee ID # ( E ) Director of Quality Management and Employee ID (# F) Chief Nursing officer, the following was observed:

Dialysis Supply room - Gambro Phoenix X 36 Dialysis Machine, Machine ID # AX 119 PH 31344 was observed to be covered by a large clear plastic bag. The cover was removed, and the machine was found to have brownish red droplets splatter on the front panel along with brownish red smears on blood pump button.

Dialysis Supply room - Gambro Phoenix X 36 Dialysis Machine, Machine ID # AX 120 PH 31342 was observed to be covered by a large clear plastic bag. The cover was removed, and the machine was observed to have brownish red droplet splatter on the bottom front side panel.

Renal Suite - Gambro Phoenix X 36 Dialysis Machine, Machine ID # AX 118 PH 31345 was observed to be covered by a large clear plastic bag. The cover was removed, and the machine was observed to have brownish red droplet splatter on the bottom front side panel.

Interview with on 1/29/2020 at 11:30 a.m. with Employee ID # (F), Chief Executive Officer, when asked about the condition of the RO #506 cart with the rust, paint chips and dust, she stated that the machine is not acceptable for use in the hospital and would have the dialysis company replace it.
Employee ID # (F) stated that all the equipment should be checked in and inspected. When Employee ID #( F) was asked about the dialysis equipment. The Chief Nursing Officer confirmed if the machines were covered they were cleaned.

Employee ID # F observed the brownish/red splatter and smears found on the dialysis equipment stated that was unacceptable and the machines had not been disinfected after use.

Interview on 1/29/2019 at 11:40 a.m. with Dialysis Employee # (J 11) stated "the dialysis machines should have been cleaned by the dialysis technician Employee # B."
Employee # (J 11) stated, "it is obvious he did not disinfect the machines, the machines are to be wiped down after each use with the bleach wipes."

Based on observation, interview and record review of contracted direct care staff personnel record revealed no documentation that facility's staff who are susceptible for the Hepatitis B virus was offered the vaccination in 2 of 8 staff records reviewed, Licensed Vocational Nurse (G 7 and Dialysis technician E 5)

Findings

G 7
On 01/29/2020 at 8:55 a.m Contracted Licensed Vocational Nurse ( G 7) was observed in the facility providing hemodialysis treatment to patients in the intensive care unit.

Review of Contracted Licensed Vocational Nurse G 7' s' personnel and training record revealed a laboratory result dated 10/4/17 which indicated the staff was ( non reactive) susceptible to the Hepatitis B virus.
Review of the record revealed no documentation that Licensed Vocational Nurse (G 7 ) was offered the Hepatitis (B) vaccination.

Contracted Hemodialysis Technician (E 5)
On 01/29/2020 at 11:30 a.m Contracted Dialysis Technician (E 5) was observed in the facility terminally cleaning contaminated hemodialysis machine.

Review of Contracted Dialysis Technician (E5's) personnel record revealed a laboratory result dated 2/6/19 which indicated the staff was (non reactive) susceptible to the Hepatitis B virus.
Review of the record revealed no documentation that contracted dialysis technician (E 5 ) was offered the Hepatitis (B) vaccination.

Review on 01/29/2020 of the contracted hemodialysis company's policy and procedure # 715, documented the following :" All staff will be required to have the Hepatitis B vaccine."
Review of Her training record revealed no documentation that she received training on infection control.

On 01/31/2020 at 11:00 a.m the Surveyor requested documentation that the contracted staff was offered the Hepatitis B vaccination. The Director of Quality at Hospital (1) said none was provided by the contracted dialysis facility. She said the contacted staff was provided fit testing by the facility for N 95 mask but no training on infection control.