HospitalInspections.org

Based on review of policies/procedures, information provided to patients for their patient rights, and staff interviews, the hospital failed to ensure all patients received the required patient rights to include the patient has the right to the confidentiality of his or her clinical records, freedom from corporal punishment, and personal privacy. Failure to present all of the required rights to patients could result in the patients being unaware of all their rights. This lack of awareness compromised the patient's ability to exercise their rights. The hospital administrative staff reported a census of 229 inpatients at the start of the survey.

Findings include:

1. Review of hospital policy titled "Patient Rights and Responsibilities," dated 2/2018, revealed in part, "...Patient has the right ... To ... confidential treatment of all aspects of their medical care, including all medical records...." "...Patient has the right ... To personal privacy...." The policy failed to address the patient had the right to freedom from corporal punishment.

2. Review of brochure titled "Patient Rights and Responsibilities," dated 8/13, provided to patients, failed to include the patient has the right to confidentiality of his or her clinical records, freedom from corporal punishment (physical punishment for wrongdoing), and personal privacy.

3. During an interview on 11/7/18 at 8:25 AM, the Privacy Officer and the Director of Risk Management/Patient Safety acknowledged the brochure titled "Patient Rights and Responsibilities," dated 8/13, provided to patients, failed to include the patient has the right to confidentiality of his or her clinical records, freedom from corporal punishment, and personal privacy..

Based on review of policy, medical records and staff interview the facility failed to ensure medical record documentation reflected all patients were given the opportunity to make an informed decision concerning whether to submit to or refuse a particular medical procedure such as hemodialysis.

Failure to provide documentation that reflected all patients were given the opportunity to make an informed decision concerning whether to submit or refuse to a particular medical procedure such as hemodialysis could lead a patient receiving a procedure that they may not have consented to if they were informed of any ramifications from receiving the procedure resulting in an infringement to the patient's right to informed consent.

The facility reported an inpatient acute hemodialysis census of 6 patients at the time of the survey. Findings for review of 3 of 4 (Patient #1, #2, and #4) hemodialysis patient medical records that lacked documentation that demonstrated informed consent was obtained prior to a dialysis procedure include:

1. Review of the facility policy titled, "Standard Operating Procedures INFORMED CONSENT", with a revised Date, 6/2016, included in part, "PURPOSE To establish a procedure for obtaining and documenting a patient's informed consent to a specific medical or surgical procedure. POLICY St. Luke's recognizes the patient's right, except in extenuating circumstances, to exercise control over his or her body by making an informed decision concerning whether to submit to or refuse a particular medical/surgical procedure.

2. Review of the facility consent document titled, "Consent to Dialysis and Acute Renal Services", date 10/2016, included in part, "1. The purpose of the form is to acknowledge that I...consent to and authorize the performance of the acute renal services and related procedures that my provider recommends. 2. I have been made aware that I suffer from either kidney failure, a condition in which my kidneys do not function in which a component or part of my blood (such as extra fluids, electrolytes or excessive medications) needs to be removed and or replaced. 3. The procedure necessary to treat my condition has been explained to me by Dr....and I understand the nature of the procedure as follows:... Hemodialysis (artificial kidney treatment) is a procedure that involves the passage of the patient's blood from his/her circulatory system via the dialysis machine, and then it is circulated through an artificial kidney that removes certain impurities and excess fluids from the blood...4. I have been made aware of the nature, purpose, effects, risks, benefits and alternatives to this procedure. I am aware of the likelihood of achieving my goals of care and any potential problems that might occur during recuperation have been explained. Risks and complications associated with this procedure (s) include but are not limited to: a. The possibility of contamination of blood or peritoneal cavity with various bacteria or germs that can result in an infection. b. the possibility of excessive bleeding as a result of clotting problems of the blood, or externally due to disconnection of the bloodline... I hereby acknowledge that I have read and understand the foregoing, that I have asked whatever questions I have regarding the proposed treatments(s) and that if I have any further questions during the course of treatment(s) I will ask them. I hereby consent to the administration of acute renal services as prescribed by Dr...and administered by the staff at UnityPoint Health -St. Luke's Hospital. I further consent to any care of treatment considered necessary due to complications that ay develop..." Closer review of the document showed an area for the patient to sign, date and included a time of day that indicated the document was signed.

3. Review of medical records and dialysis consent information for Patients #1, #2, and #4 showed the following:

a. Patient #1 was admitted to the hospital on 10/25/18 and received a hemodialysis treatment that began on 10/26/18 at 2:40 PM. Closer review of Patient #1's medical record revealed that consent to dialysis and acute renal services for Patient #1 was not obtained until 10/26/18 at 6:26 PM.

b. Patient #4 was admitted to the hospital on 10/25/18 and received a hemodialysis treatment that began on 10/26/18 at 8:23 AM. Closer review of Patient #4's medical record revealed that consent to dialysis and acute renal services for Patient #4 was not obtained until 10/26/18. Further review of Patient #4's consent to dialysis and acute renal services form lacked documentation that reflected the time of day the consent was obtained.

c. Medical record review for Patient #2 on 10/30/18 at 11:10 AM showed Patient #2 was admitted to the hospital on 10/29/18 and received a hemodialysis treatment that began on 10/30/18 at 9:45 AM. Closer review of the medical record lacked documentation that showed consent to dialysis and acute renal services was obtained prior to the start of the dialysis treatment.

4. During an interview on 10/31/18 at 8:50 AM the Director of Nursing Operations acknowledged the findings and reported that consent forms on all dialysis patients are to be completed prior to the initiation of the first dialysis treatment after being admitted to the hospital.

Based on observation, document reviews and staff interviews, the hospital's administrative staff failed to identify and remove or replace all non-breakaway hardware from all areas in the inpatient adult and child/adolescent psychiatric units including patient rooms for 18 of 25 adult psychiatric patients (Patients #5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22) and 13 of 15 child/adolescent psychiatric patients (Patients #23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35) identified on suicide precautions. Failure to establish and maintain a safe environment including non-breakaway hardware for psychiatric patients could potentially provide a point of attachment for a device used for patient strangulation or hanging and result in patient deaths or other life-threatening conditions.

Findings include:

1. Observations on 10/29/18 from 1:00 PM to 3:00 PM with Adult Psychiatric Nurse Manager and Director of Behavioral Health Services revealed 17 of 17 patient rooms had bathroom doors that opened into the patient room with exposed piano hinges that extended approximately 1 inch from the door (Patient rooms #265, 270, 271, 273, 276, 278, 279, 280, 282, 283, 284, 285, 293, 294, 295, 297, and 298). A piano hinge is a hinge that has a thin pin joint and extends along the full length of the bathroom door.

Observations on 10/30/18 from 7:55 AM to 9:00 PM with Child/Adolescent Psychiatric Nurse Manager revealed 14 of 14 patient rooms had bathroom doors that opened into the patient room with exposed piano hinges that extended approximately 1 inch from the door (Patient rooms #375, 377, 378, 379, 380, 393, 395, 396, 367, 368, 369, 370, 371, and 373). A piano hinge is a hinge that has a thin pin joint and extends along the full length of the bathroom door.

The bathroom door hinge may be utilized as ligature points and sufficient areas for attachment of a hanging device that a patient could use to hang themselves and resulted in an unsafe physical environment.

2. Review of policy titled "Patient Rights and Responsibilities", dated effective 2/2018, revealed in part, ". . .Patients have the right. . . To receive effective care, treatment and services in a safe and secure environment. . . ."

Review of hospital document titled "Patient Rights and Responsibilities", dated 8/13, provided to patients at the time of admission, contained information available to patients regarding their rights, revealed in part, ". . . To receive effective care, treatment and services in a safe and secure environment. . . ."

3. Review of adult psychiatric patient medical records on 10/29/18 at 2:30 PM with Staff A, Registered Nurse (RN), Adult Psychiatric RN, revealed Patients #5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22 were admitted with suicide ideations and placed on suicide precautions.

Review of child/adolescent psychiatric patient medical records on 10/30/18 at 9:00 AM with Child/Adolescent Nurse Manager revealed Patients #23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 were admitted with suicide ideations and placed on suicide precautions.

4. During an interview on 10/29/18 at 2:00 PM, the Adult Psychiatric Nurse Manager confirmed the piano hinges on the bathroom doors inside the patient rooms listed may be utilized as ligature points and sufficient areas for attachment of a hanging device that a patient could use to hang themselves and a risk for self harm to patients.

During an interview on 10/30/18 at 8:15, the Child/Adolescent Psychiatric Nurse Manager confirmed the piano hinges on the bathroom doors inside the patient rooms listed may be utilized as ligature points and sufficient areas for attachment of a hanging device that a patient could use to hang themselves and a risk for self harm to patients.

Based on review of facility policy, observation and interview the facility failed to ensure that all dialysis staff labeled and/or disposed of multidose medications after use at the patient's bedside.

Failure to ensure that all dialysis staff labeled and/or disposed of multidose medications could potentially lead to staff utilizing a drug which may be beyond the after opened use date or may lead to staff inadvertently moving an opened multidose vial for use on another patient which could lead to the potential of cross contamination of bacterial pathogens and patient harm.

The hospital reported an inpatient hemodialysis patient census of 6 patients at the time of the survey. Findings for observation of 1 of 2 (Patient #3) hemodialysis treatments include:

1) Review of the facility policy titled, "Standard Operating Procedures Medication Management", with a revised date 7/2018, included in part, "PURPOSE To develop, implement and maintain a Medication Management Program to ensure medication use within the organization is conducted in a safe and optimal manner...9. Multidose vials expire 28 days after opening. Vials will have this expiration date (28 days after opening) added to the label when opening. The multidose vial will be discarded 28 days after opening. Multidose vials will not be utilized in direct patient care areas of the hospital in accordance with CDC (Centers for Disease Control and Prevention) recommendations..."

2) Observation on in the inpatient dialysis treatment area 10/30/18 at 10:39 AM showed Patient #3 on dialysis at station #2. Closer observation showed an opened vial 1/4 full of clear fluid labeled in part, "Heparin Sodium Injection 10,000 USP units/10 ml [milliliters])" on a bedside table adjacent to Patient #3. Closer observation of the vial revealed the vial lacked information that indicated when the vial was opened or the discard date of the vial. Continued observation showed at 11:15 AM the vial remained on the bedside table of Patient #3.

3) During an interview on 10/30/18 at 11:20 AM the Dialysis Supervisor acknowledged the finding and reported that medication vials should be labeled with the date opened.

4) During an interview on 10/31/18 at 11:45 AM the Director of Nursing Operations reported that medications from multidose vials should be prepared away from the patient treatment area.

Based on document review and staff interviews the facility failed to complete and properly execute informed consent forms for 7 of 7 obstetrical records and procedures reviewed (Patient #36, Patient #37, Patient #38, Patient #39, Patient # 40, Patient # 41 and Patient # 42).

Failure to to perform a complete and properly executed informed consent form placed the patient at risk for not fully understanding the procedure performed, the risks and benefits of the procedure, and the assurance that the staff answered the patient's questions and concerns prior to authorizing the staff to perform the procedure. The hospital's administrative staff identified approximately 200 patients per month gave birth at the hospital.


Findings include:

1. Review of the policy "Informed Consent," revised 6/2016, revealed the policy lacked a requirement of the hospital staff to include the name of the responsible practitioner who is performing the procedure.

2. Review of Patient #36's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #36.

3. Review of Patient #37's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #37.

4. Review of Patient #38's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #38.

5. Review of Patient #39's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #39.

6. Review of Patient #40's medical record revealed it lacked a signed informed consent for labor epidural analgesia for vaginal delivery.

7. Review of Patient #41's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #41.

8. Review of Patient #42's medical record revealed the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH lacked the name of the responsible practitioner who was performing the epidural for Patient #42.

9. During an interview on 11-8-2018 at 1:10 PM the Risk Manager acknowledged the records lacked the identification of the provider responsible for performing the procedure in the CONSENT FOR LABOR EPIDURAL ANALGESIA/ANESTHESIA FOR CESAREAN BIRTH.

I. Based on review of manufacturers labeling information, observation, and staff interview, the facility failed to ensure all staff maintained the facility's pHoenix meter's (a pHoenix meter is a handheld device used to ensure the accuracy of the dialysis machine conductivity and its ability to correctly mix the solutions used for dialysis treatments) calibration station by providing documentation or labeling that ensures the RO (reverse osmosis) water used at the station is replaced daily.

Failure to ensure staff followed labeling instructions regarding care and processes involved with maintaining the facility's pHoenix meter calibration station could lead to the introduction of bacterial contaminants into the pHoenix meter by utilizing RO water that potentially has bacterial growth present and could inhibit the meter's accuracy and potentially place the patients in harms way from improperly constituted dialysate (dialysate is the fluid mixed for use in dialysis).

The facility reported an inpatient hemodialysis patient census of 6 patients at the time of the survey. Findings for observation of the facility's sole pHoenix meter calibration station include:

1. Observation during an inpatient dialysis unit tour on 10/29/18 at 11:45 AM showed an opaque bottle 3/4 full with colorless fluid connected to the dialysis unit's sole pHoenix meter calibration station and labeled, "RO (Reverse Osmosis) water". Closer observation of the bottle included in part the following label information, "Empty this bottle daily and refill with fresh RO water". Further observation of the bottle lacked documentation that demonstrated when the bottle was filled with fluid including information that reflected the fluid was fresh for the current treatment day.

2. During an interview on 10/29/18 at 2:00 PM the Manager of Intensive Care and the Advanced Practice Nurse for Acute Adult Services acknowledged the findings and reported that going forward the dialysis staff will document the date and time the RO bottle was filled to ensure documentation reflected fresh water was present in the bottle each day.

II. Based on review of manufacturer's labeling information, observation and staff interview the facility failed to ensure that all dialysis staff labeled bicarbonate containers used for hemodialysis with the date and time the containers were opened.

Failure to ensure bicarbonate containers are labeled with an opened date and time could lead to staff failing to recognize a bicarbonate jug that has been previously opened for an extended period of time potentially allowing for the growth of pathogenic organisms in the bicarbonate placing the hemodialysis patients at risk from exposure to harmful bacteria.

The hospital reported an inpatient hemodialysis census of 6 patients at the time of the survey. Findings for observation of 2 of 2 patients (Patient #2 and Patient #3) on dialysis include:

1) Review of the manufacturer's labeling information on the bicarbonate jugs utilized by the dialysis program included in part, "Centrisol Liquid Bicarbonate Concentrate...Bacterial growth may occur in concentrated bicarbonate solutions...concentrate must be used within 24 hours..."

2) Observation of the inpatient dialysis treatment area on 10/30/18 at 10:38 AM showed Patient #2 on dialysis at dialysis station #3. Closer observation of the station showed an opened opaque jug 1/4 full of colorless fluid labeled in part, "Centrisol Liquid Bicarbonate". Additional observation of the jug lacked information that indicated the date and time the jug was originally opened. Continued observation of the treatment area showed Patient #4 on dialysis at station #2. Observation of dialysis station #2 showed an opened opaque jug 1/2 full of colorless fluid labeled in part, "Centrisol Liquid Bicarbonate" adjacent to Patient #4's dialysis machine. Closer observation of the jug lacked documentation or information that indicated the date and time the jug was originally opened.

3) During an interview on 10/31/18 at 10:45 AM the Dialysis Supervisor acknowledged the findings and reported that the dialysis bicarbonate jugs are to be labeled with the date and time opened and discarded at the end of the treatment day.

Based on observation, document review, and staff interviews, the acute care hospital's administrative staff failed to:


1. Ensure all surgical services staff completely covered their hair during surgical procedures. Please refer to A-0749.

2. Ensure the endoscopy staff changed the sterile water for irrigation flush bottles after each patient. Please refer to
A-0749.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital staff performed an average of 822 surgical procedures per month and approximately 5,000 endoscopic procedures per year.

I. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure 10 out of 25 observed surgeons and anesthesia providers wore head coverings which fully covered all of their hair. Failure to wear head coverings that fully cover all hair could potentially result in bacteria, fungi, or viruses on the surgical staff members' hair entering the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The hospital's administrative staff identified the surgical services staff performed an average of 822 surgical procedures per month.

Findings include:

1. During an interview on 10/31/18 at approximately 4:00 PM, the Director of Surgical Services revealed the hospital followed the AORN (Association of peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines and American College of Surgeons (a professional organization for surgeons) statement for surgical attire.

2. Review of the AORN Guideline for Surgical Attire, copyright 2018, revealed in part, "A clean surgical head covering or hood that confines all hair and completely covers the ears, scalp skin, sideburns and nape of the neck should be worn." "Hair and skin can harbor bacteria that can be dispersed into the environment. The collective body of evidence supports covering the hair and ears while in the [operating rooms.]"

3. Review of the American College of Surgeons Statement on Operating Room Attire, posted online 8/4/16, revealed in part, "During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential would contamination."

4. Review of the hospital's Operative Suite Attire Policy, reviewed 8/2018, revealed the policy lacked a requirement for the surgical staff in the operating rooms to fully cover their hair and ears during invasive procedures.

5. Observations on 10/31/18 at approximately 9:45 AM, during a tour of the operating rooms, revealed the following:

a. Patient #43 was undergoing a surgical procedure in operating room #3. Observations from outside the operating room revealed Surgeon F and Anesthesiologist G (a physician with specialized training in administering medication to render a patient unconscious for surgery) wore a skull cap. The skull cap consisted of a cap covering Surgeon F's forehead and central part of Surgeon F's hair. The skull cap did not cover the lower approximately one inch of Surgeon F's hair on the side of Surgeon F's head and the back of Surgeon F's hair. The skull cap consisted of a cap covering Anesthesiologist G's forehead and central part of Anesthesiologist G's hair. The skull cap did not cover the lower approximately one inch of Anesthesiologist G's hair on the side of Anesthesiologist G's head and the back of Anesthesiologist G's hair.

b. Patient #44 was undergoing a surgical procedure in operating room #4. Observations from outside the operating room revealed Surgeon H wore a skull cap. The skull cap consisted of a cap covering Surgeon H's forehead and central part of Surgeon H's hair. The skull cap did not cover the lower approximately one inch of Surgeon H's hair on the side of Surgeon H's head and the back of Surgeon H's hair.

c. Patient #45 was undergoing a surgical procedure in operating room #9. Observations from outside the operating room revealed Surgeon I, Surgeon J, and Anesthesiologist K wore skull caps. The skull cap consisted of a cap covering Surgeon I's forehead and central part of Surgeon I's hair. The skull cap did not cover the lower approximately one inch of Surgeon I's hair on the side of Surgeon I's head and the back of Surgeon I's hair. The skull cap consisted of a cap covering Surgeon J's forehead and central part of Surgeon J's hair. The skull cap did not cover the lower approximately one inch of Surgeon J's hair on the side of Surgeon J's head and the back of Surgeon J's hair. The skull cap consisted of a cap covering Anesthesiologist K's forehead and central part of Anesthesiologist K's hair. The skull cap did not cover the lower approximately one inch of Anesthesiologist K's hair on the side of Anesthesiologist K's head and the back of Anesthesiologist K's hair.

d. Patient #46 was undergoing a surgical procedure in operating room #10. Observations from outside the operating room revealed Anesthesiologist L was wearing a skull cap. The skull cap consisted of a cap covering Anesthesiologist L's forehead and central part of Anesthesiologist L's hair. The skull cap did not cover the lower approximately one inch of Anesthesiologist L's hair on the side of Anesthesiologist L's head and the back of Anesthesiologist L's hair.

6. Observations on 10/31/18 at approximately 11:00 AM, during a tour of the operating rooms, revealed Patient #47 was undergoing surgery in operating room 5, the only active surgical procedure at the time of the tour. Observations from outside the operating room revealed Surgeon M wore a skull cap. The skull cap consisted of a cap covering Surgeon M's forehead and central part of Surgeon M's hair. The skull cap did not cover the lower approximately one inch of Surgeon M's hair on the side of Surgeon M's head and the back of Surgeon M's hair.

7. Observations on 11/5/18 at approximately 2:00 PM, during a tour of the operating rooms, revealed Patient #48 was undergoing surgery in operating room 6. Observations from outside the operating room revealed Surgeon N wore a skull cap. The skull cap consisted of a cap covering Surgeon N's forehead and central part of Surgeon N's hair. The skull cap did not cover the lower approximately one inch of Surgeon N's hair on the side of Surgeon N's head and the back of Surgeon N's hair.

8. Observations on 11/1/18 at approximately 9:00 AM revealed Patient #49 underwent a surgical procedure in the cardiac catheterization lab (a surgical procedure where a physician inserts a long, flexible wire into the patient's heart and injects dye to visualize the blood vessels in the patient's heart). Cardiologist P (a physician with specialized training in disorders of the heart) wore a skull cap. The skull cap consisted of a cap covering Cardiologist P's forehead and central part of Cardiologist P's hair. The skull cap did not cover the lower approximately one inch of Cardiologist P's hair on the side of Cardiologist P's head and the back of Cardiologist P's hair.

9. During an interview on 10/31/18 at approximately 4:00 PM, the Director of Surgical Services acknowledged the surgeons and anesthesiologists wore skull caps that did not completely cover their hair and ears.

II. Based on observation, document review, and interviews, the acute care hospital's administrative staff failed to ensure the endoscopy staff changed the sterile water flush bottles in 4 of 4 endoscopy rooms after each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in bacteria growing in the sterile water and potentially causing an infection in the next patient. The Endoscopy Manager identified that the endoscopy staff performed an average of 5,000 endoscopy procedures per year.

Findings include:

1. Observations during a tour of the endoscopy center on 11/1/18 at approximately 4:00 PM revealed 4 endoscopy (a surgical procedure where a physician inserters a flexible camera into a patient's body) procedure rooms. Observations in endoscopy procedure room A revealed 1 of 1 bottle Hospira 500 mL bottle of sterile water for irrigation connected to the endoscopy equipment. Review of the manufacturer's instructions on the bottle indicated the hospital staff must discard any unused portions of the sterile water for irrigation after use on a single patient. The sterile water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water once the hospital staff opened the bottles of sterile water for irrigation.

2. During an interview at the time of the tour, the Endoscopy Manager stated the endoscopy staff in each endoscopy procedure room opened a bottle of sterile water for irrigation each morning and connected it to the equipment. The equipment contained an one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The endoscopy staff changed the flush tubing between the patient and the one-way valve after each endoscopy procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscopy procedures. The endoscopy staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscopy procedures for the day or if the bottle ran empty.

3. During an interview on 11/2/18 at approximately 07:30 AM, the Endoscopy Manager stated she reviewed the manufacturer's directions for the Hospira 500 mL bottles of sterile water for irrigation and the professional literature on endoscopy staff using the bottles of sterile water for irrigation. The Endoscopy Manager acknowledged the manufacturer and professional literature did not support using the bottles of sterile water for irrigation for more than one patient.