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Based on observation, interview and record review,the facility's failed to ensure contracted staff providing care and services to facility's patients were tested for the Hepatitis B virus in 3 of 6 contracted staff personnel/ health files reviewed. Contracted Dialysis Assistant (A), Contracted Licensed Vocational Nurse (W) and Contracted Dietary Aide (N).

Cross reference A 83


The Facility's Governing Body failed to:

1. ensure contracted hemodialysis staff providing hemodialysis treatment to the facility's patients, followed manufacture's recommendation when checking product water used for hemodialysis treatment of patients for total chlorine/ chloramine in 1 of 2 staff observed. Contracted Dialysis Assistant (A)


2. ensure contracted hemodialysis staff checked conductivity and PH of dialysate solution prior to initiation of hemodialysis treatment on patients in 1 of 1 contracted staff observed initiating hemodialysis treatment on patients. Contracted Registered Nurse (B).


3. ensure contracted hemodialysis staff followed manufacture's recommendation to conduct electrolyte analysis on dialysate solutions mixed by hemodialysis machines in use in the facility, in 3 of 3 hemodialysis machines in use in the facility. Hemodialysis machine #s PH 31329, PH 31330 and PH 31346


The Facility's Quality Assessment Performance Improvement Committee failed to analyze data, identify deficient practice and trends, conduct root cause analysis and develop and implement a plan to address issues is services provided by contracted hemodialysis service.

Cross Reference A 84

Based on observation, interview, and record review, the facility failed to ensure contracted staff providing care and services to facility's patients were tested for the Hepatitis B virus in 3 of 6 contracted staff personnel/health files reviewed. Contracted Dialysis Assistant (A), Contracted Licensed Vocational Nurse (W), and Contracted Dietary Aide (N).


Findings:



Review of the Contracted Dietary Company's Policy on Exposure Control Plan #33 revised 10/2014 direct staff as follows: "The hepatitis B vaccination series is available at no cost after initial team member training and within 10 days initial assignment to all team members identified in the exposure determination section of this plan"



Contracted Dialysis Assistant (A)
Review on 08/23/2017 of Contracted Dialysis Assistant (A's) personnel/health file revealed no documentation that the staff was tested for the Hepatitis B Antigen or antibody.


Interview on 08/23/2017 at 12:15 p.m. with the Contracted Staff Director for the hemodialysis company, revealed Contracted Dialysis Assistant (A) was not tested for Hepatitis B. antigen or antibody.


Contracted Licensed Vocational Nurse (W)
Review on 08/23/2017 of Contracted Licensed Vocational Nurse (W's) Personnel/health file, revealed no documentation that Licensed Vocational Nurse (W) was tested for the Hepatitis B Antigen or antibody.


Interview on 08/23/2017 at 12:15 p.m. with the Contracted Staff Director for the dialysis company, revealed Contracted Licensed Vocational Nurse (W) did not have any test for Hepatitis B virus on file.


Dietary Aide N
Review on 08/23/2017 of Contracted Dietary Aide (N's) Personnel/health file revealed no documentation that the staff was tested for the Hepatitis B Antigen or antibody.


Interview on 08/23/2017 at 1:00 p.m with Contracted Dietary Regional Director revealed Dietary Aide (N) said she was tested before starting employment at the facility but he did not have the result.

Based on observation, interview, and record review, the Facility's Governing Body failed to ensure that contracted hemodialysis, staff providing hemodialysis treatment to the facility's patients followed the manufacture's recommendation when checking product water used for hemodialysis treatment of patients for total chlorine/ chloramine in 1 of 2 staff observed. Contracted dialysis Assistant (A).


The Facility's Governing Body failed to ensure contracted hemodialysis staff checked conductivity and PH of dialysate solution prior to initiation of hemodialysis treatment on patients in 1 of 1 contracted staff observed initiating hemodialysis treatment on patients. Contracted Registered Nurse (B).


The Facility's Governing Body failed to ensure contracted hemodialysis staff followed manufacture's recommendation to conduct electrolyte analysis on dialysate solutions mixed by hemodialysis machines in use in the facility, in 3 of 3 hemodialysis machines in use in the facility. Hemodialysis machine #s PH 31329, PH 31330, and PH 31346


The Facility's Quality Assessment Performance Improvement Committee failed to analyze data, identify deficient practice and trends, conduct root cause analysis, and develop and implement a plan to address issues is services provided by contracted hemodialysis service.


Findings


Contracted Dialysis Assistant (A)

On 08/21/2017 at 10:25 a.m. Contracted Dialysis Assistant (A) was observed in the facility at room 233. The Dialysis Assistant was checking the water used for hemodialysis of patients for Total Chlorine / Chloramine. Contracted Dialysis Assistant (A) was setting up a Gambro Phoenix 36 hemodialysis machine and a GE portable reverse osmosis machine in preparation for hemodialysis of the patient.


Observation revealed Contracted Dialysis Assistant (A) removed a Serim Guardian Hisense Ultra 0.1 Test strip from the container and held it in his hand, collected 20 mls of water in a cup and proceeded to test for total chlorine. During testing for total chlorine the Dialysis Assistant did not use a clock/ timer to determine the required 30 seconds to swish the test strip before reading the result.


The Surveyor informed him that he did not use a clock with a second hand or a timer to determine the thirty seconds time required for swishing of the test strip.
The Surveyor then directed him to the instructions on the label of the container.


Review of the manufactures instruction on Serim Guardian Hisense Ultra 0.1 Test for Total Chlorine directs user as follows: "Fill the enclosed sample cup with water to be tested. Discard the contents and refill with 20 ml of water. Start the timer and immerse the indicator pad into the water sample. Vigorously swish test strips back and forth for a full thirty seconds. "


Contracted Dialysis Assistant (A) stated "I did one 1000 when checking the time."


Contracted Registered Nurse (B)

On 08/21/2017 at 11:05 a.m., Contracted Registered Nurse (B) was observed initiating hemodialysis treatment on Patient #2 in room # 233. Observation revealed prior to initiation of hemodialysis treatment, Contracted Registered Nurse (B) did not check the PH and conductivity of the dialysate concentrate prior to initiation of hemodialysis treatment on the Patient. The Patient was using a Phoenix 36 hemodialysis machine.


Interview on 08/21/2017 at 11:10 a.m., with Contracted Registered Nurse (B), the Surveyor informed Contracted Registered Nurse (B) that she did not check the PH and conductivity of the dialysate solution prior to initiating hemodialysis treatment on Patient #2.


Contracted Registered Nurse (B) said to Dialysis Technician (A) who was present during the interview "Do we have a Phoenix meter?" The Dialysis Technician responded "We have a Myron-el. I check it in the morning when I set it up."


Contracted Registered Nurse (B) said she was not aware that the facility had an equipment to check for PH and conductivity and that she did not perform the test prior to initiating the hemodialysis treatment on the Patient. The hemodialysis machine was previously utilized on Patient #1.


Review on 08/21/2017 of the manufacturer's recommendation Phoenix Operators manual page 5.A5 directs users as follows: "Performing Dialysate sample: Samples for conductivity testing may be obtained at the following times: Prior to initiation of treatment, after the appearance of the operator message" Dialysate preparation complete "' and before starting to prime the dialysate side of the dialyzer, during dialysis."


Dialysate Analysis


Observation on 08/22/2017 at 8:40 a.m., revealed three hemodialysis machines were observed in use in the facility, hemodialysis machine #s PH 31329, PH 31330, and PH 31346.


Review on 08/22/ 2017 of the facility's Water Treatment Log revealed no evidence of electrolyte analysis of the dialysate solution for the following hemodialysis machines in use in the facility: hemodialysis machine #s PH 31329, PH 31330, and PH 31346.


Interview on 08/22/2017 at 12:47 p.m., with the contracted company dialysis Chief Biomedical Technician revealed electrolyte were not done on the machines since they were put in service. He said he could not recall when the hemodialysis machines were put in service.


Review of Phoenix Installation checklist revealed documentation which indicated the the following hemodialysis machines were installed/ put in service on:
Hemodialysis machine # PH 31329 installed 12/09/2015

Hemodialysis machine # PH 31330 installed 12/09/2015

Hemodialysis machine # PH 31346 installed 01/07/20116



Review of the Manufacturer's recommendation Phoenix Operators manual Section 5 A, special procedures directed uses as follows; "Warning it is the responsibility of the user to determine the correspondence between the dialysate conductivity , displayed by the machine and the dialysate solute content, verified by clinical laboratory results , for each dialysate concentrate used for dialysis treatment. This can be done by taking dialysate sample at different conductivity values (e.g.. 13,14, 15 mS/cm and sending them to a laboratory for analysis."


Quality Assessment Performance Improvement

Review of the Facility's Quality Assessment Performance Improvement data dated April, May and June 2017 revealed documentation which indicated the contracted hemodialysis company which provide hemodialysis service to patients receiving hemodialysis in the facility audits for hemodialysis service were 100 % for all areas audited.

Handwashing techniques 100%

Water and Dialysate Cultures final results are within AAMI Regulation 100%

Maintenance and Repair of equipment completed and documented 100%


Review of the data revealed no documentation identifying staff lack of testing for the Hepatitis B virus in 3 of 6 contracted staff personnel/ health files reviewed. Contracted Dialysis Assistant (A), Contracted Licensed Vocational Nurse (W) and Contracted Dietary Aide (N).


There was no documentation in the Quality Assessment Performance Improvement meeting minutes identifying the lack of contracted hemodialysis staff implementing manufacture's recommendation to conduct electrolyte analysis on dialysate solutions mixed by hemodialysis machines in use in the facility, in 3 of 3 hemodialysis machines in use in the facility. Hemodialysis machine #s PH 31329, PH 31330 and PH 31346.


Further review of contracted dialysis hemodialysis machine cultures and endotoxin results for water and dialysate solution, revealed documentation which indicated that Hemodialysis Machine # PH 30493 was in use in the facility. However observation and interview revealed Hemodialysis machine # PH 30493 was not in use in the facility but hemodialysis PH 31346 was being utilized in the facility for hemodialysis treatment.


Interview on 08/22/2017 at 12:40 p.m with Contracted Hemodialysis Biomedical Chief Technician revealed hemodialysis machine # PH 30493 was located at another facility which the company have a contract with. He said he did not know when the hemodialysis machine was moved from the facility because " We move machine around."


Review of the Facility's Quality Assessment Performance Improvement data revealed no evidence that the committee identified that the hemodialysis machine documented as being utilized in the facility was at another facility and that hemodialysis machine #PH 31346 which was in use in the facility did not have a current laboratory values for cultures and endotoxin.

Based on interview and record review, the facility failed to ensure that two physicians participated on the utilization review committee.


Findings include:


Interview with case manager (ID #AM) on 8/22/2017 at 0845 AM, revealed that she is member of the utilization review committee and records meeting minutes at each quarterly meeting. The committee consists of herself, one (1) physician, the chief executive officer (CEO), the chief nursing officer (CANO), the health information management (HIM) director and the director of case management.


Record review of facility policy titled Utilization Review Committee dated April 2017 revealed the following information:

Procedure:
3. Membership includes at least two (2) physicians, case management leader. representatives from Administration and hospital clinical departments.

Based on observation, interview, and record review, the facility's direct care staff failed to wear personal protective equipment when caring for patients on isolation and failed to wash/sanitize hands after direct contact with contaminated items in 6 of 15 direct care staff observed, and failed to ensure expired supplies were not available in the facility for use. Registered Nurse (D), Contracted Registered Nurse (B), Staff, W, V, X and GG.


Findings:


Facility's Policy

Review of the Facility's current Policy and Procedure on Standard, Transmission Based, and Neutropenic Precautions and Discontinuation of Precautions, Policy # ICP 04,03 , revised 4/2017 directed staff as follows:


"Contact Precautions applies to patients with any of the following conditions and/or disease: MRSA, VRE, ESBL, other multi-drug resistant organism (MRDO,) draining wounds and in diapered or incontinent patients-Shigella, campylobacter, rotavirus, Hepatitis A, E-Coli 0157. Presence of generalized rash or exanthema, until a diagnosis is confirmed .


Infectious patients with draining wounds and/or uncovered skin lesions cannot leave the room.


Perform hand hygiene before touching patient and prior to wearing and after removal of gloves.


PPE use:

Wear gloves and gown when in patient room regardless of anticipated contact with patient or patient's surroundings. Perform hand hygiene after removal of PPE; note:use soap and water when hands are visible soiled ( e.g. blood, body fluids ), or after caring for patients with known or suspected infectious diarrhea( e.g., Clostridium difficile , norovirus)."



On 08/21/2017 at 9:20 a.m. Registered Nurse (D) was observed in Room 230. The Registered Nurse was administering medication to Patient #1. Observation revealed Registered Nurse (D) was wearing a partial blue plastic apron tied below her breast. The nurse's arms and upper chest were exposed. Registered Nurse (D) was not wearing a full gown or mask.


Interview with Respiratory Therapist Director (C) on 08/22/2017 at 9: 25 a.m. revealed, the Patient was on isolation for multi drug resistant organism.


In an interview on 08/21/2017 at 9:30 a.m, with Registered Nurse (D) the Surveyor asked registered nurse (D) why she was not wearing a full personal protective equipment. Registered Nurse (D) stated, "I get hot and sweat, that's the reason I was not wearing full PPE."


Interview on 08/23/2017 at 12:20 p.m. with the Facility's infection Control Nurse revealed the Patient came from another hospital and was placed on isolation for multi drug resistant organism and will remain on it until an order was received.


On 08/21/2017 at 10:45 a.m. Contracted Registered Nurse (B) was observed in room 233. Registered Nurse (B) was providing central venous catheter care to Patient #2 prior to initiation of hemodialysis treatment.


Observation revealed during initiation of hemodialysis treatment Contracted Registered Nurse (B) donned a mask, then applied a pair of gloves, then she applied a mask to patient #2's face. She touched the Patient's ear while applying the mask to his face. She then accessed the Patient's central venous catheter with the contaminated gloves used to mask herself and the Patient and pulled back blood in syringes.


During an interview on 08/22/2017 at 11:00 The Surveyor notified Contracted Registered Nurse (B) , that the nurse applied mask to herself and the Patient and then accessed the Patient's central venous catheter, Registered Nurse (B) said "That is true."


Review of Patient # 2's clinical record revealed a laboratory result dated 08/10/2017 for " Multi drug resistant gram negative rods. May require contact isolation."


Review of the Patient's clinical record revealed a History and Physical dated 7/16/2017 with the following diagnoses "Epidural abcess S/P incision and drainage with meningitis"


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Observation on 8/21/2017 at 9:23 a.m. in the intensive care unit, room 238, revealed Physician (ID #GG) was observed completing a physical assessment on Patient #10 who was on strict contact precautions for multi-resistant Klebsiella Pneumonia. The physician had no protective clothing on except gloves.


Interview on 8/21/2017 at 9:25 a.m. with the RN (ID#G), she stated, "Yes, the physician should have had a gown on."


Review of Strict Contact Precautions sign on the door, instructed those entering the room to wear gloves, gown, mask, shoe covering, hair bouffant protector, and use single use disposal equipment, or clean and disinfect all equipment before removing the environment.

Review of Patient #10's clinical record revealed a laboratory result dated 8/21/2017 which showed the Patient was positive for Carbapenem resistant enterbacteriaceae.
Urinalysis done 8/23/2017 showed Kiebsiella.


Expired Supplies.

Observation of the bronchoscopy cart in Procedure room on 8/21/2017 at 10:25 a.m. revealed:

Nineteen (19) expired MetriSponges dated 5/2017

Two (2) expired Picco Solo Catheters dated 1/28/2017 and 2/28/2017

Interview on 8/21/2017 at 10:25 a.m. with RN (ID#G), stated, "Yes, those supplies are expired".


Record review of the hospital current policy titled Expiration Dates-Guidelines for Disposable Trays and Supplies dated January 2016, revealed the following information:

1. Supplies are checked monthly for expiration dates.

2. Expired disposable trays will be disassembled and all medication/needles- disposed of in an appropriate manner.


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Observation on 8/21/2017 on the Medical/Surgical Unit at 9:30 am, revealed the following information:

Staff (#W), Registered Nurse (RN) was observed in room 305 providing care to Patient # 19 who was on contact isolation for MRSA(Methicillin Resistant Staphylococcus Areus) of wound and was also receiving hemodialysis treatment.


Staff (# W) was observed touching the patient's hemodialysis machine, patient's used food tray and the patient's bed linen. Staff(# W) was wearing only one hand of gloves.


The Surveyor asked Staff (#W) why she was providing care with only one hand of glove. The staff stated she was only using "one of her hands".


Review of Patient #19's clinical record revealed a laboratory result dated 08/18/2017, which indicated the Patient was positive for MRSA of wound to the patient's arm.


Staff (#V) Licensed Vocational Nurse (LVN) entered Patient # 19's room at 9:38 am carrying two bags of intravenous (IV) fluids, IV medication and the patient's paper Medication Administration Records (MAR).


Staff #( V) (LVN) placed the paper folder on the hemodialysis machine/ Reverse Osmosis cart used to provide hemodialysis dialysis to the patient.


After providing care and touching the patient's equipment, the nurse charted on the paper record without removing the soiled gloves and washing her hands.


Staff V left the isolation room with the paper record, she placed them on the nurses' station then took them into the medication room.


During an interview on 8/21/2017 at 9:55 AM with Staff (#V), she stated she had to take the paper MAR into the patient's room to verify the orders and patient's identity.


Observation on 8/21/2017 at 10:35 am revealed, Staff (# X) RN was observed in room 113 where Patient #17 was on contact isolation for MRSA of infected wound. The staff placed the paper MAR on the patient's tray table where he had used utensils from his breakfast and other objects he was seen touching.


During the process of providing care for the Patient, including accessing his IV site, and administering intravenous medication, Staff (#X), went into her uniform pocket with her contaminated gloved hands to retrieve alcohol prep swabs.


After the staff completed her activities in the contact isolation room, she folded the MAR and place them in her pocket. Staff (#X) took the MAR to the medication room.


During an interview on 8/21/2017 at 10:45 PM with Staff (# X), she stated she had to take the records to the Patient's room to verify name and order. She stated she went into her pocket to remove alcohol swabs but should have changed her gloves.


Review of Patient #17's clinical record revealed a laboratory result dated 08/17/2017, which indicated the Patient was positive for MRSA of wound to the patient's leg.


During an interview on 8/22/2017 in the conference room at 1:15 PM with Staff (#C) RN, Infection Control Officer, she stated staff are supposed to wear gown and both hands gloved when going into a Contact Isolation room to provide care.


Staff (# C) stated the facility had identified that taking the paper record into the patient's room was an infection control issue, however they have not yet identified a strategy to fix the problem.

Based on record review and interview, the facility failed to have systems in place to ensure when there is a patient's death at the facility, the Organ Procurement Organization (OPO) is notified, and when the notification is made, it is done within the defined "timely manner" required by their agreement with the OPO.


The facility failed to comply with their responsibility to develop a policy that defines "Timely manner and Immanent Death'' as required by their Agreement with the OPO. This failed practice had the potential for the inability for life gift to procure organs at the facility for possible donation.


Citing four (4) of five (5) death records that was reviewed. Patient #s 24, 21, 22, and 23.


Findings:


Patient # 24

Review of Nurses" notes for Patient # 24 revealed the patient was pronounced dead on 7/25/2017 at 08:19. There was documentation the patient's body was released to the funeral home on 7/25/2017 at 10:50 a.m. There was no documentation on the patient's medical record that LifeGift was notified.


Patient # 21

Review of Death Record/Release of body documentation for Patient # 21 revealed, the patient was pronounced dead on 6/20/2017 at 6:47 PM. There was documentation that LifeGift was informed but there was no time or date on the record of the notification.

Review of nurses' notes dated 6/20/2017 revealed no information that LifeGift was notified.


Patient # 22

Review of Death Record/Release of body documentation for Patient # 22 revealed the patient was pronounced dead on 7/14/2017 at 12:20 PM.

There was documentation that LifeGift was informed, however there was no time or date on the notification record.

Review of nurses' notes dated 7/14/2017 revealed no documentation that LifeGift was notified.


Patient # 23

Review of nurses' notes dated 7/19/2017 revealed no information that LifeGift was notified.

Review of Death Record/Release of body documentation for Patient # 22 revealed the patient was pronounced dead on 7/19/2017 at 10:33 am.

There was documentation that LifeGift was informed however there was no time or date on the record.

Review of nurses notes dated 7/19/2017 revealed no information that LifeGift was notified.


Review of the Facility's Donor Institution Agreement dated May, 2017 revealed the following information:

"Whereas, Lifegift is an organ procurement organization ("OPO") established to perform and coordinate the recovery, preservation and transportation of organ and tissues;

For the purpose of this Agreement, the following terms shall have the meanings ascribed to them in this Article 1.

1.7 Imminent Death: A patient with severe, acute brain injury, disease or illness that may or may not be traumatic in origin; and:

(1) Who requires mechanical ventilation; and,

(2) Meets one or more of the following criteria:

(a) Has clinical findings consistent with Glasgow Coma Score (GCS) that is less than or equal to mutually-agreed-upon threshold (such as 4 or 5); or

(b) For whom physicians are evaluating a diagnosis of brain death; or

(c) For whom physicians has ordered withdrawal of life-sustaining therapies, consistent with the family's decision.


1.10 Timely Notification/Referral: Timely notification/referral means notification to LifeGift of an imminent death within 1(one) hour of the patient's meeting clinical trigger criteria for imminent death.

Notification shall be made prior to the withdrawal of any life sustaining therapies. With respect to cardiac death, timely notification means notification to LifeGift within one hour of the cardiac death".


Article III of the agreement titled Responsibilities of Hospital gave the following information:

Hospital shall establish a procedure for notifying LifeGift whenever a patient reaches the criteria for imminent Death or Cardiac Death. Hospital shall timely notify LifrGift of all Hospital deaths as required by A and Standards.

Hospital shall call the LifeGift referral line. Hospital agrees to designate health care professionals responsible for making timely referrals to LifeGift 24 hours a day if there is any Hospital deaths, patients experiencing imminent Death , or cardiac death in the Hospital".

Review of the facility's Tissue and Organ Donation Policy # CL-7.3 dated May, 2016 presented by the facility at the time of the survey revealed the policy did not define "Timely Notification nor Imminent Death."

During an interview on 8/23/2017 at 11:35 am with the Chief Nursing Officer she stated she did review the death records and there was no times documented so she is not able to tell if the notification to LifeGift was "timely". She stated staff will be educated."

Based on record review and interview, the facility failed to educate staff on organ procurement and donation policy. Citing 2 of 3 staff #s FF, H and GG.


Findings:


During an interview on 8/22/2017 at 2:00 PM on the Intensive Care Unit (ICU) with Staff # (FF) Registered Nurse regarding timely response to LifeGift when there was a patient's death at the facility, he stated he thinks it should be should be "about two (2) hours after a patient's death but he was not sure.


According to Staff (FF) he never received education regarding organ donation protocols.


Licensed Vocational Nurse (H)

During an interview on 8/22/2017 at 2:10 PM with Staff (H) Licensed Vocational Nurse, she stated she thinks LifeGift should be informed about an hour after a patient's death but she is not sure if that time frame is correct.


Registered Nurse (GG)

During an interview on 8/22/2017 at 2:15 am in the ICU with Staff (#GG) Registered Nurse, she stated she was not sure what the time requirement was to notify LifeGift when there was a patient's death at the facility.

During an interview on 8/22/2017 at 3:10 PM with the Facility's Director of Quality, she stated the facility realized they were deficient in organ procurement protocols, however, no corrective measures were implemented as yet. She stated LifeGift requirements were not incorporated in the Facility's QAPI process.

During an interview on 8/23/2017 at 9:10 am with the Facility's Chief Nursing Officer ( CNO ) , she stated it was identified in May 2017, that the staff lacked knowledge in the process to inform LifeGift when a patient died in the facility. She stated plans were developed to educate the staff however the plans were not implemented.