HospitalInspections.org

Based on observation, interview and record review the Governing Body failed to:

1) Provide contracted dialysis services in a safe manner for patient ID# 3.

2) Ensure contracted services for dialysis and sleep studies were included in their quality assurance program.

Cross Refer to:
-Condition of Participation: Nursing Services A0385
-Condition of Participation: Quality Assessment A0263

Findings include:

Record review of "Governing Board By-laws and Rules and Regulations" dated 9/6/2006 stated:
-"Functions and Responsibilities of the Board: The duties of the Governing Board include:
L) Review contracted services to ensure that all services provided are in compliance with all regulatory and accrediting agencies and the services provided are performed safely and effectively..
M) Oversee and recommend resources and support systems for effective performance improvement, risk management......"

The Chief Operating Officer (COO ID# 52) acknowledged 8/17/11 at 9:30 a.m. that Dialysis is a contracted service. The COO further stated that the hospital only leases space to a company to perform sleep studies on patients.

Record review of a contract with a diagnostic sleep consultant organization dated 10/1/09 stated "University General Hospitals Responsibilities:
-Hospital shall allow contract staff to market the proposed sleep center as the hospitals authorized sleep facility.
-Hospital shall provide billing and collections for all sleep services conducted
-Hospital agrees to pay $625 per study conducted.

Record review of a sleep study log revealed 55 sleep studies were performed in 2010. The sleep log also showed that the hospital performed 15 sleep studies in 2011.

The Chief Executive Officer (CEO ID# 53) acknowledged 8/18/11 at 3 p.m. that the hospital has contracted with a company to perform sleep studies. The CEO stated the hospital bills the patients for the sleep studies and pays the contracted company to provide staff and equipment.

Interview 8/17/11 at 3 p.m. with the quality assurance Director (ID# 51) revealed the contracted dialysis and sleep study services are not integrated in the hospital quality assurance program.

Record review of a policy titled "Performance Improvement Plan" dated 1/2011 stated "Policy: The scope of the Performance Improvement Plan encompasses's all services provided at University General Hospital including inpatient, outpatient and clinical contract services. The hospital-wide program will monitor the performance of medical staff and hospital department indicators..."

Based on observation, interview and record review the hospital failed to:

1) maintain an effective quality assessment and performance improvement program regarding the hemodialysis services provided under contract with one of one hemodialysis contract company.

2) ensure contracted services for dialysis and sleep studies were included in their quality assurance program.

3. ensure that contracted services for dialysis were provided in a safe manner and that patients' hepatitis status was known prior to initiation of dialysis and when status not known that machines were disinfected properly.

4. ensure that Hemodialysis staff performed tests on dialysis machines and dialysate appropriately.

FINDINGS INCLUDE:
Record review of a sleep study log revealed 55 sleep studies were performed in 2010. The sleep log also showed that the hospital performed 15 sleep studies in 2011.

The Chief Executive Officer (CEO ID# 53) acknowledged 8/18/11 at 3 p.m. that the hospital has contracted with a company to perform sleep studies. The CEO stated the hospital bills the patients for the sleep studies and pays the contracted company to provide staff and equipment.

Interview 8/17/11 at 3 p.m. with the quality assurance Director (ID# 51) revealed the contracted dialysis and sleep study services are not integrated in the hospital quality assurance program.

Record review of a policy titled "Performance Improvement Plan" dated 1/2011 stated "Policy: The scope of the Performance Improvement Plan encompasses's all services provided at University General Hospital including inpatient, outpatient and clinical contract services. The hospital-wide program will monitor the performance of medical staff and hospital department indicators..."

Interview with Quality Assurance (QA) Director on 8/17/2011 at 1:20 p.m., the quality assurance activities were not conducted on the provision of hemodialysis treatments provided to patients by an outside contract company. QA director stated the contract company sent in monthly cultures to Infection Control Department and these are then brought to QA meetings. This was the only QA activity conducted on the contract hemodialysis services.

When patients' hepatitis B status was unknown, hemodialysis staff did not disinfect dialysis machines when completing hemodialysis on one patient and taking machine directly to another patient to provide hemodialysis with the same machine.

Hemodialysis policy from the Contract Technical Policies Manual entitled: "DIALYSIS DELIVERY SYSTEM LOG POLICY"---"Revision August 2011". Policy stated: "Independent verification of dialysate conductivity and the pH is performed prior to each dialysis treatment".

Chlorine testing policy and procedure effective September 2002 stated:
"Chlorine and chloramines must be removed from the water that is used to make dialysate. The presence of chlorine or chloramines in the blood stream inhibit the efficient use of oxygen in the blood stream and could eventually lead to hemolysis. This test must be performed prior to initiating patient treatments".

"Chlorine Test kit includes: one DPD free chlorine and one DPD total Chlorine reagent sample, two test tubes, a color comparator"

Testing for total chlorine/chloramine of water includes the following procedure:

"Rinse a separate test tube with test sample, fill with 5 ml in the tube with the sample. Rinse off cap. Add one DPD total chlorine reagent powder. This first test measures the chloramine level. Cap the test tube and shake to dissolve the powder and wait for three minutes. Remove the top of test tube. Place the test tube in the comparator and match the color of the sample. The maximum allowable total chorine level per standards is 0.1 mg/L (PPM)".

Hemodialysis staff verbalized conducting a test (chloramine) that did not meet written policy and procedure. Chlorine testing had not been done according to above written policy based on interview with the hemodialysis staff #18 at 11:00 a.m. on 8/17/2011 and interview with Staff #19 on 8/17/2011 at 2:00 p.m.

On 8/17/2011, at 11:00 a.m., Staff #18 demonstrated Chlorine testing by obtaining a 10 ml of RO water and placed it in a clear medicine cup and added powder from Chlorine Total-DPD packet. She stated "You wait 5 seconds and hold the cup up to the light and it should be clear to light pink. If dark, you test the second tank". Surveyor asked if she had a color comparable chart for the chlorine test, and #18 replied, "No, you just hold medicine cup up to the light".

On 8/17/2011 at 14:00 while in patient #4's room #325, the Hemodialysis Contract R.N. #19 was interviewed and asked how she did her chlorine testing. She stated: "I take sample and add the powder to a 20 cc water sample in a medicine cup. As soon as the powder hits the water you can read it. It's supposed to be clear, less than 0.1". Staff stated she had no comparable color chart to use in conducting this test.

Independent verification of the dialysate conductivity and pH had not been done prior to the initiation of patient #3's dialysis at 08:00 on 08/17/2011.

Rationale for Independent verification of the dialysate conductivity and pH from Resource: Myron L Company (supplier of independent testing solution and equipment):

"Problems in dialysate dispensing can and do occur due to human error. different types of dialysis machines require different proportioning ratios. Lines can be crossed or an incorrect solution type selected, making it possible to administer a wrong dialysate. If the conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance can be altered. It is also possible for concentrate dispensed by the dialysis system to be proportioned to the correct conductivity and yet have the incorrect pH, which can result in acidosis or alkalosis and ultimately death to the patient".


Rationale: Conductivity of the dialysate is checked to assure the dialysate's conductivity is in proper range to prevent hemolysis or crenation of the patient's blood. (Per written hemodialysis policy).

The dialysis machine's conductivity reading is checked against an independent meter. There is a requirement that the meter be calibrated with a standardizing conductivity solution prior to checking the dialysate's conductivity with the meter.

Contract Licensed Vocational Nurse (LVN) #18 at the patient's bedside at this time and stated she had done the conductivity but had not documented it yet. She said she had not tested the pH as she stated this was not necessary because, "It is part of the bicarbonate range that is tested with the meter".

Staff #18 stated: "I used conductivity solution and testing equipment earlier but I don't know where the standardizing solution has gone to". Later towards the end of the treatment the contract LVN #18 had documented both a conductivity reading and a pH.

Conductivity standardizing solution was not in evidence in the patient's room and was not in evidence in the locked storage room used by the Dialysis contract company to store equipment and supplies. pH testing supplies and equipment were not evident in either place. There were no other dialysis contract personnel on the premises at this time.

The next dialysis contract person to log in on that date was Dialysis Contract R.N. #19 at 12:15 p.m. This R.N. stated when interviewed on 8/17/2011 at 1400 while dialyzing Patient #4 in room 325 that she brings her own conductivity testing equipment, standardizing solutions and her own pH testing supplies with her when she comes to the hospital.

Safety of patients regarding Hepatitis B:
Hemodialysis policy entitled "Infection Control" issued September 2002 and updated February 2011 stated: "All patients will be tested for HBsAg per policy and procedure. Patients transferring will have a documented negative HBsAg result (less than 30 days old) prior to acceptance into the unit or will be treated as positive until the result is obtained. Patients with unknown status will be treated on a machine that can be isolated until their status is obtained, but will not be placed on a machine that is used by a known HBsAg positive patient"........ "A separate hemodialysis machine will be used ONLY for HBsAg positive patients".

Another policy in a three ring binder in ICU used by dialysis staff stated: "ATTENTION NURSES: These labs are required for all dialysis patients on initiation and every 30 days. You, as a nurse, can write this as an order to include:
* Hepatitis B Surface Antigen (HBsAg)
* Hepatitis B Surface Antibody (HBsAb or Ant-Hbs)
* Hepatitis B Core Antibody (HBcAB or Anti-Hbc)"

6 of 6 patients whose charts were reviewed and who were receiving hemodialysis did not have evidence of Hepatitis B surface antigen (HBsAg) screening.

The presence of HBsAg is indicative of ongoing HBV infection and potential infectiousness. A hemodialysis staff member with no antibodies to Hepatitis B and assigned to care for a HBsAg positive patient is at risk for contracting Hepatitis B. If strict isolation guidelines are not followed in the provision of hemodialysis, hepatitis B could spread to the general patient and staff population of the hospital.

Without knowing patients' Hepatitis B status, a potential HBsAg-positive patient would be treated without proper isolation precautions. The dialysis machine's fluid pathway and outside of the machine would not be disinfected properly after each treatment prior to storing the dialysis machine or using on the next patient the same day.

Citing Patients #3, #4, #13, #52, #55, and #56:

Patient #3: Admitted 8/5/2010 and has been receiving hemodialysis treatments. ICU Charge Staff #10 on 8/18/2011 at 2:00 p.m. called the lab to find out if any hepatitis testing had been done and reported that there had been none. She also confirmed there was no evidence of hepatitis status in his clinical record.

Patient #4: Admitted 7/27/2011 and receiving hemodialysis since admission date and no evidence of hepatitis status. Interview with Staff #10 who also called lab services on 8/18/2011 at 2:30 p.m. and confirmed patient had not had hepatitis testing done until physician order of 8/17/2011 at 13:32 when the dialysis nurse wrote an order for "labs (hepatitis testing) with next hemodialysis".

Patient #13: CNO #50 confirmed by calling lab on 8/18/2011 at 3 p.m., that patient had not had any hepatitis testing done as per hemodialysis protocol. Patient was admitted 8/9/2011 and received hemodialysis on 8/17/2011 and again 8/18/2011 without having evidence of his hepatitis status documented in his clinical record.

Patient #52: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 7/30/2011 and receiving hemodialysis since admission, had not had hepatitis testing and no evidence of hepatitis status documented in his clinical record.

Patient #55: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 7/14/2011 and receiving hemodialysis treatments had not had hepatitis testing and no evidence of hepatitis status documented in her clinical record as of interview date and time.

Patient #56: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 8/16/2011 and receiving first hemodialysis treatment on 8/16/2011 had not had hepatitis testing ordered and no evidence of hepatitis status documented in his clinical record as of interview date and time.

The contract hemodialysis company had conflicting policies regarding disinfection of hemodialysis machines.

Policy entitled "Infection Control" and issued September 2002 and updated February 2011 stated: "Single patient machines are disinfected weekly with Sodium Hypochlorite. The machines are heat disinfected daily".

Another policy stated: Machines are to be cleaned with vinegar and bleach at the end of the day and tested for post bleach residual via: Bicarb Jug and Machine Drain Line".

Hemodialysis machines were not disinfected properly between the use of patients whose hepatitis status was unknown.

External and internal disinfection process takes a minimum of 40 to 55 minutes.

This time frame includes: a 10 to 15 minutes pre-rinse, 10 to 15 minutes chemical disinfection, a mandatory 10 to 15 minute post-rinse. The machine then needs to be brought up to conductivity and safety checks performed which adds another 10 minutes.

Citing the following times machines were not disinfected between patients:

Machine #01 used to provide hemodialysis treatment on patient #4 from 0800 to 11:00 on 8/10/2011. Following the end of the treatment at 11:00, Machine #01 was brought from the third to the fourth floor and used on Patient #3 from 11: 30 to 15:30.

Machine #21 was used to provide hemodialysis treatment on patient #4 from 12:00 to 15:00 on 8/12/2011. Following the end of the treatment at 15:00, Machine #21 was brought from the third floor to the fourth floor and used on Patient #4 from 15:15 to 19:15.

Cross Refer to:
-Condition of Participation: Nursing Services A0385
-Condition of Participation: Quality Assessment A0263

Based on observations, review of documents and interviews, hemodialysis provided by a licensed vocational nurse to one of one patient (ID# 3) was not supervised by a registered nurse knowledgeable in the provision of hemodialysis and with the ability to recognized that hemodialysis was not being provided in a safe manner.

A Licensed Vocational Nurse providing hemodialysis under contract gave two units of blood to a patient within thirty minutes.

Cross refer to 0395

An immediate and serious threat of harm to patient ID# 3 resulted in an Immediate Jeopardy (IJ) related to Nursing Services.

Findings include:

Contract Hemodialysis company's job description for Staff Registered Nurse stated the RN Staff Nurse "supervises LVN staff nurses and technical personnel".

Hemodialysis provided by a contract licensed vocational nurse # 18 to one of one patient (# 3 ) was not being supervised by a registered nurse. On 8/17/2011 at 11:00 am, a licensed vocational nurse was providing hemodialysis to Patient #3 without performing independent verification of the dialysate conductivity and pH prior to the initiation of patient #3's dialysis. The physician orders for hemodialysis were not followed.

Hospital staff #50 stated at 11:00 on 8/17/2011 that no registered nurse under hemodialysis contract was in the hospital to supervise the LVN providing hemodialysis.

A log Sign-in Sheet revealed the contract hemodialysis registered nurse signed in upon arrival on 8/17/2011 at 12:15.

The hospital staff registered nurse #10 assigned to patient #3 reported in an interview on 8/17/2011 at 4:20 p.m. that she did not know nurse providing hemodialysis was an LVN. She also stated she would not know about conductivity and/or PH testing and could not tell if the LVN was following physician hemodialysis orders. Nurse #10 stated she was unaware she was responsible for the over-sight of the dialysis LVN.

Hospital's Contract with one of one hemodialysis company stated: "Global shall retain responsibility for the day-to-day supervision and control of Global Staff and the administration of services shall be determined at the discretion of Global".

At the time dialysis was being provided by the licensed vocational nurse there were no Global registered nurse on the premises to supervise the LVN and the dialysis she was providing.
Cross refer to A0395

Physician Orders for hemodialysis on 8/17/2011 were not being followed as evidenced by the following:

Patient's (#3)treatment started at 08:00 and observations were made at 11:00 a.m. with the Director of nurses present, following observations were made and compared to physician orders:

Physician ordered Blood flow at 350 and blood pump speed was noted to be 450 at 11:00.

Physician ordered 140 sodium and the LVN hemodialysis staff still had machine set at 155 sodium at 11:00.

Physician ordered 3.5 potassium and 2.5 calcium bath. Jug container with this bath was not labeled as to the adding of the extra potassium when inspected at 11:00. The jug had no label at all.

Hemodialysis nursing service under contract was not integrated into the hospital wide QAPI program. Only monthly machine cultures sent by the contract company were discussed in QAPI.

The director of nursing failed to ensure that non-employee licensed nurses had adequate supervision by hospital staff with some knowledge of hemodialysis and hemodialysis machines in order to determine if contract staff providing the service were proving it in a safe manner and that physician hemodialysis orders were being followed . RN Charge ICU Staff #10's knowledge of hemodialysis was not at a level to understand if proper testing of hemodialysis machine and solutions had been done prior to initiation of dialysis and whether physician orders were being followed.
Cross refer to A-0398.

The supervising registered nurse failed to assure that hepatitis B surface antibody and antigen testing had been done on patients prior the administration of the first hemodialysis treatment as required by hemodialysis policy:

Rationale for having these test results: The dialysis delivery system is not routinely disinfected after each patient's treatment.

According to Policy for cleaning and disinfection, weekly interval disinfections required unless it is known the patient is HBsAg positive. The same dialysis delivery system is not to be used for both HBsAg positive and HBV susceptible patients unless the internal fluid pathway of the delivery system has been disinfected and the external surfaces cleaned with a 1:100 bleach solution.

Independent verification of dialysate conductivity and pH was not performed as required by policy prior to the initiation of a dialysis treatment for one of one patient whose treatment was being observed on August 17, 2011 at 11:00 a.m. Cross Refer to 0398

Based on observations, review of documents and interviews, hemodialysis provided by a licensed vocational nurse to one of one patient (ID# 3) was not supervised and evaluated by a registered nurse knowledgeable in the provision of hemodialysis and with the ability to recognized that hemodialysis was not being provided in a safe manner or that physician's hemodialysis orders were not being followed. Citing patient #3.

The registered nurse failed to assure patients being provided hemodialysis had evidence of their hepatitis B status prior to the initiation of their first treatment. Citing six of six hemodialysis patient records reviewed. Citing patients #3, #4, #13, #52, #55, #56.

Hemodialysis was not supervised on 8/10/11 and 8/12/11 on Patients #3 and #4 to assure hemodialysis machines were disinfected properly between use on these two patients whose hepatitis status was unknown.

Based on observation, interview and review of records the hospital failed to follow policy for blood administration guidelines. Blood was administered by a Licensed Vocational Nurse. Each unit of blood was administered within 15 minutes. Citing one of one clinical record reviewed. Patient #52.

Findings include:

Hemodialysis provided by a contract licensed vocational nurse # 18 to one of one patient (# 3 ) was not being supervised by a registered nurse. On 8/17/2011 at 11:00 am a licensed vocational nurse was providing hemodialysis to Patient #3 without performing independent verification of the dialysate conductivity and pH prior to the initiation of patient #3's dialysis.

Contract Licensed Vocational Nurse (LVN) #18 at the patient's bedside at this time and stated she had done the conductivity but had not documented it yet. She said she had not tested the pH as she stated this was not necessary. She stated she had used conductivity solution and testing equipment earlier but did not know where the standardizing solution had gone to. Later towards the end of the treatment the contract LVN #18 had documented both a conductivity reading and a pH.

Conductivity standardizing solution was not in evidence in the patient's room and was not in evidence in the locked storage room used by the Dialysis contract company to store equipment and supplies. pH testing supplies and equipment was not evident in either place. There were no other dialysis contract personnel on the premises at this time. The next dialysis contract person to log in on that date was Dialysis Contract R.N. #19 who logged in at 12:15 p.m.

This R.N. stated when interviewed on 8/17/2011 at 1400 that she brings her own conductivity testing equipment, standardizing solutions and her own pH testing supplies with her when she comes to the hospital.

Rationale for Independent verification of the dialysate conductivity and pH from Resource: Myron L Company (supplier of independent testing solution and equipment):
"Problems in dialysate dispensing can and do occur due to human error. different types of dialysis machines require different proportioning ratios. Lines can be crossed or an incorrect solution type selected, making it possible to administer a wrong dialysate. If
the conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance can be altered. It is also possible for concentrate dispensed by the dialysis system to be proportioned to the correct conductivity and yet have the incorrect pH, which can result in acidosis or alkalosis and ultimately death to the patient".


The physician hemodialysis orders for 8/17/2011 were not followed.
Review of these orders and observations made at the bedside while the LVN provided hemodialysis to Patient #3 revealed the following:

Patient's treatment started at 08:00 on 8/17/2011 and observations were made at 11:00 a.m. with the Director of nurses present, the following Physician orders were compared to observations made:

Physician ordered Blood flow at 350 and blood pump speed was noted to be 450 at 11:00.

Physician ordered 140 sodium and the LVN hemodialysis staff still had machine set at 155 sodium at 11:00.

Physician ordered 3.5 potassium and 2.5 calcium bath. Acid Container with this bath was not labeled as to the adding of potassium to equal 3.5 when inspected at 11:00.


The hospital staff registered nurse #10 assigned to patient #3 and also in charge in ICU reported in an interview on 8/17/2011 at 4:20 p.m. that she did not know nurse providing hemodialysis was an LVN. She also stated she would not know about conductivity and/or PH testing and did not know that LVN was not following physician hemodialysis orders. Nurse #10 stated she was unaware she was responsible for the over-sight of the dialysis LVN. She stated she did not know that patients' hepatitis B status needed to be obtained prior to the initiation of hemodialysis.

Safety of patients regarding Hepatitis B:
Hemodialysis policy entitled "Infection Control" issued September 2002 and updated February 2011 stated: "All patients will be tested for HBsAg per policy and procedure. Patients transferring will have a documented negative HBsAg result (less than 30 days old) prior to acceptance into the unit or will be treated as positive until the result is obtained. Patients with unknown status will be treated on a machine that can be isolated until their status is obtained, but will not be placed on a machine that is used by a known HBsAg positive patient"........ "A separate hemodialysis machine will be used ONLY for HBsAg positive patients".

Another policy in a three ring binder in ICU used by dialysis staff stated: "ATTENTION NURSES: These labs are required for all dialysis patients on initiation and every 30 days. You, as a nurse, can write this as an order to include:
* Hepatitis B Surface Antigen (HBsAg)
* Hepatitis B Surface Antibody (HbsAb or Ant-Hbs)
* Hepatitis B Core Antibody (HBcAB or Anti-Hbc)"

Six of six patients whose charts were reviewed and who were receiving hemodialysis did not have evidence of Hepatitis B surface antigen (HBsAg) screening.

Rationale: The presence of HBsAg is indicative of ongoing HBV infection and potential infectiousness. A hemodialysis staff member with no antibodies to Hepatitis B and assigned to care for a HBsAg positive patient is at risk for contracting Hepatitis B. If strict isolation guidelines are not followed in the provision of hemodialysis, hepatitis B could spread to the general patient and staff population .

Thus a potential HBsAg-positive patient would be treated without proper isolation precautions. The dialysis machine's fluid pathway and outside of the machine would not be disinfected properly after each treatment prior to storing the dialysis machine for the next patient's use.

Citing Patients #3, #4, #13, #52, #55, and #56:

Patient #3: Admitted 8/5/2010 and has been receiving hemodialysis treatments. ICU Charge Staff #10 on 8/18/2011 at 2:00 p.m. called the lab to find out if any hepatitis testing had been done and reported that there had been none. She also confirmed there was no evidence of hepatitis status in his clinical record.

Patient #4: Admitted 7/27/2011 and receiving hemodialysis since admission date and no evidence of hepatitis status. Interview with Staff #10 who also called lab services on 8/18/2011 at 2:30 p.m. and confirmed patient had not had hepatitis testing done until physician order of 8/17/2011 at 13:32 when the dialysis nurse wrote an order for "labs (hepatitis testing) with next hemodialysis".

Patient #13: Chief Nursing Officer (CNO) #50 confirmed by calling lab on 8/18/2011 at 3 p.m., that patient had not had any hepatitis testing done as per hemodialysis protocol. Patient was admitted 8/9/2011 and received hemodialysis on 8/17/2011 and again 8/18/2011 without having evidence of his hepatitis status documented in his clinical record.

Patient #52: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 7/30/2011 and receiving hemodialysis since admission, had not had hepatitis testing and no evidence of hepatitis status documented in his clinical record.

Patient #55: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 7/14/2011 and receiving hemodialysis treatments had not had hepatitis testing and no evidence of hepatitis status documented in her clinical record as of interview date and time.

Patient #56: CNO confirmed during interview and by calling lab on 8/18/2011 at 3:00 p.m. that patient, admitted on 8/16/2011 and receiving first hemodialysis treatment on 8/16/2011 had not had hepatitis testing ordered and no evidence of hepatitis status documented in his clinical record as of interview date and time.

The hospital staff registered nurse #10 assigned to patient #3 and also in charge in ICU reported in an interview on 8/17/2011 at 4:20 p.m. that she did not know that patients' hepatitis B status needed to be obtained prior to the initiation of hemodialysis

Hemodialysis machines were not disinfected properly between the use of patients whose hepatitis status was unknown.

External and internal disinfection process takes a minimum of 40 to 55 minutes.

This time frame includes: a 10 to 15 minutes pre-rinse, 10 to 15 minutes chemical disinfection, a mandatory 10 to 15 minute post-rinse. The machine then needs to be brought up to conductivity and safety checks performed which adds another 10 minutes.

Citing the following times machines were not disinfected between patients:

Machine #01 used to provide hemodialysis treatment on patient #4 from 0800 to 11:00 on 8/10/2011. Following the end of the treatment at 11:00, Machine #01 was brought from the third to the fourth floor and used on Patient #3 from 11: 30 to 15:30.

Machine #21 was used to provide hemodialysis treatment on patient #4 from 12:00 to 15:00 on 8/12/2011. Following the end of the treatment at 15:00, Machine #21 was brought from the third floor to the fourth floor and used on Patient #4 from 15:15 to 19:15.

REGARDING BLOOD ADMINISTRATION:
Based on observation, interview and review of records the hospital failed to follow policy for blood administration guidelines. Blood was administered by a Licensed Vocational Nurse. Each unit of blood was administered within 15 minutes.

Findings include:

Hospital Policy " Blood Administration Guidelines " , Policy # NSG.040 which was approved 08/21/2006 and last reviewed 02/08/2010. Policy states:

" Blood transfusions are administered by personnel who have received specialized training in accordance with State Law and approved medical staff policies and procedures. "

# 5 of policy states " The registered nurse or physician who administers the blood must check the blood with licensed nurse in the following way at the bedside. "


#21 of policy: "Regulate the flow and monitor constantly for the first ten minutes. Unless ordered otherwise, transfuse no more than 100 ml/hour for the first 15 minutes. If there is no evidence of reaction, the rate may be increased per physician ' s order".


Review of Blood Bank Transfusion Records dated August 2, 2011 for Patient # 52 documented transfusions was check by hospital RN employee # 10 and dialysis LVN # 18. Records review further documents that patient # 52 received two units of LRBC (Leukocytes removed Red Blood Cells) all within 30 minutes. Transfusion record indicate that 1st unit of blood was given on 8/2/11 starting at 1015 and end time 8/2/11 at 10:30. Second unit of blood was started on 8/2/11 at 10:30 and ended 8/2/11 at 10:45.
Interview with ICU RN on August 18 at 2:00 p.m., revealed that she did not now that dialysis nurse was an LVN. ICU RN verified that that dialysis nurse was the second check licensed nurse for the blood administration record. ICU RN also stated that the LVN administered both units of blood to the patient during dialysis.

On 8/18/2011 at 2:00 p.m., the DON #50, verified that contract dialysis LVN # 18 had administered and monitored both units of blood during the dialysis treatment. DON also acknowledged that this LVN had not received specialized training in blood transfusions and administered accordance staff policies and procedures.

Based on observations, review of documents and interviews, hemodialysis provided by a licensed vocational nurse to one of one patient (ID# 3) was not supervised by a registered nurse knowledgeable in the provision of hemodialysis and with the knowledge to recognized that hemodialysis was not being provided in a safe manner and that doctor's orders were not being followed.

Findings include:

Contract Hemodialysis company's job description for Staff Registered Nurse stated the RN Hemodialysis Staff Nurse "supervises LVN staff nurses and technical personnel".

Hemodialysis provided by a contract licensed vocational nurse # 18 to one of one patient (# 3 ) was not being supervised by a registered nurse. On 8/17/2011 at 11:00 am, a licensed vocational nurse was providing hemodialysis to Patient #3 without performing independent verification of the dialysate conductivity and pH prior to the initiation of patient #3's dialysis. The physician orders for hemodialysis were not followed.

Hospital staff #50 stated at 11:00 on 8/17/2011 that no registered nurse under hemodialysis contract was in the hospital to supervise the LVN providing hemodialysis.

A log Sign-in Sheet revealed the contract hemodialysis registered nurse signed in upon arrival on 8/17/2011 at 12:15.

The hospital staff registered nurse #10 assigned to patient #3 reported in an interview on 8/17/2011 at 4:20 p.m. that she did not know nurse providing hemodialysis was an LVN. She also stated she would not know about conductivity and/or PH testing and did not know that LVN was not following physician hemodialysis orders. Nurse #10 stated she was unaware she was responsible for the over-sight of the dialysis LVN.

Hospital's Contract with one of one hemodialysis company stated: "Global shall retain responsibility for the day-to-day supervision and control of Global Staff and the administration of services shall be determined at the discretion of Global".

At the time dialysis was being provided by the licensed vocational nurse there were no Global registered nurse on the premises to supervise the LVN and the dialysis she was providing.

Physician dialysis orders for patient #3 on 8/17/2011 were not being followed:

Observation and review of these orders and comparison of findings in patient #3's room at 8/17/2011 at 11:00 a.m. revealed the following:
Patient's treatment started at 08:00 and observations were made at 11:00 a.m. with the Director of nurses present, the following observations were made and compared to physician orders:

Physician ordered Blood flow at 350 and blood pump speed was noted to be 450 at 11:00.

Physician ordered 140 sodium and the LVN hemodialysis staff still had machine set at 155 sodium at 11:00.

Physician ordered 3.5 potassium and 2.5 calcium bath. Container with this bath was not labeled as to the adding of potassium to equal 3.5 when inspected at 11:00. There was no label at all on the acid/dialysate container.

Based on observation, interview and record review the hospital failed to ensure the Malignant Hyperthermia crash cart in the operating room suite did not have expired medications.

Findings include:

Observation 8/18/11 at 3 p.m. in the operating room suite revealed the following expired medications in the malignant hyperthermia crash cart:
-36 vials Dantrium 20mg vials expired January 2011
-2 bristojets Dextrose 50ml expired January 2011
-6 bristojets Sodium Bicarb expired January 2011
-2 syringes of Lidocaine 5ml expired May 2011

The Operating Room Director (ID# 64) stated she thought Pharmacy personnel were checking the malignant hyperthermia crash cart for expired medications.

Record review of a policy titled "Medication Storage" dated January 2011 stated "The Pharmacy and patient care areas will be inspected monthly. All expired medications will be removed from active patient stock and placed in separate containers in pharmacy while awaiting destruction."

Based on observation, interview and record review the hospital failed to ensure the operating room suite area was maintained in such a manner that the safety and well-being of patients are assured.
-Stained fabric chairs in 4 of 6 operating rooms (operating room #'s 2, 3, 4, and 5)
-Supply carts blocking return air / smoke exhaust vents
-Supply carts blocking hallways / fire exit

Findings include:

Observation 8/18/11 at 3 p.m. in the operating room suite area revealed the following:

-Rolling chairs with heavily stained fabric in operating room #'s 2, 3, 4, and 5

-Supply carts blocking return air / smoke exhaust vents in cath lab #2, operating room #'s 4 and 5

-Supply carts blocking hallways / fire exists outside operating room #3 and #4

The operating room Director (ID# 64) acknowledged the operating room suite area does not have enough storage space for the supply carts. The operating room Director also confirmed the fabric chairs should not be in the operating rooms if they cannot be wiped down.

Record review of a policy titled "Safety Management Plan: Environment of Care" dated 7/2011 stated "Safety inspection (environmental rounds) will be conducted on a regular basis with all patient care areas inspected at least every six months..."

Record review of Environment of Care rounds in the surgery area 3/17/11 and 7/15/11 revealed no concerns regarding blocked fire exits, blocked return air vents, or stained fabric chairs in the operating rooms.