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Based on document review and staff interview, the hospital administrative staff failed to ensure the nursing staff obtained an order for medical restraints every 24 hours in 1 of 2 open medical records in the Critical Care Unit (CCU) where the patient was in restraints (Patient #20), 3 of 3 open medical records in the Intensive Care Unit (ICU) where the patient was in restraints (Patients #21, 23, and 24), and 2 of 3 closed medical records where the patient was restrained at the time of death (Patients #40 and 41). The Director of Compliance stated the hospital has an average of 3 patients in medical restraints per day.

Failure to ensure physicians wrote restraint orders within the time limits has the potential to place the patient at risk from physical or psychological harm from prolonged restraint.

Findings include:

1. Review of the policy "Restraint/Seclusion", effective 10/11, revealed in part, "... All restraint orders for nonviolent or non self-destructive behaviors: ... Must be time specific with a maximum limitation for 24 hours..."

2. Review of open medical records revealed:

a. Patient #20 was admitted on 11/29/11 to the CCU. The nursing staff placed Patient #20 in restraints, because Patient #20 was sedated as a result of requiring mechanical ventilation. The nurse modified the patient's care plan to reflect the restraints on 1/29/11. On the same sheet of paper, the physician who wrote the order to place Patient #20 in restraints on 11/29/11 dated the order "12/1/11", and did not time the order. The nurse modified the patient's care plan to reflect the restraints on 11/30/11, and the physician wrote the order to continue restraining Patient #20 on the same sheet of paper as the modification the care plan, dated the order "12/1/11", and did not time the order. The order to continue restraining Patient #20 on 12/1/11 lacked the time the physician wrote the order. Additionally, on 12/3/11, the physician did not date the order to restrain Patient #20.

b. Patient #21 was admitted on 11/25/11 to the ICU. The nursing staff placed Patient #21 in restraints on 11/30/11 because Patient #21 was sedated as a result of requiring mechanical ventilation. The order on 12/1/11 to restrain Patient #21 was written on 12/1/11 at 8:00 AM. The order on 12/2/11 to restrain Patient #21 was written on 12/2/11 at 9:00 PM (35 hours after the prior order was written). The order on 12/3/11 to restrain Patient #21 was written on 12/3/11 at 7:30 AM. The order on 12/4/11 to restrain Patient #21 was written on 12/4/11 at 2:00 PM (30.5 hours after the prior order was written).

c. Patient #23 was admitted on 11/30/11 to the ICU. The nursing staff placed Patient #23 in restraints on 12/3/11 because Patient #23 was sedated as a result of requiring mechanical ventilation. The order to restrain Patient #23 on 12/3/11 was written on 12/3/11 at 2:00 PM. Review of the document "Restraint Flow Sheet" revealed the nursing staff documented they released Patient #23 from the restraints at 1:30 PM, because Patient #23 did not require further mechanical ventilation. The order to restrain Patient #23 on 12/4/11 was written on 12/4/11 at 4:30 PM (26.5 hours after the prior order was written, and 3 hours after nursing staff had removed Patient #23 from restraints).

3. Review of closed medical records revealed:

a. Patient #40 was admitted on 11/8/11 to the ICU. The nursing staff placed Patient #40 in restraints on 11/8/11 because Patient #40 was sedated as a result of requiring mechanical ventilation. The order on 11/15/11 to restrain Patient #40 lacked the time the physician wrote the order. The order on 11/16/11 to restrain Patient #40 lacked the time the physician wrote the order.

b. Patient #41 was admitted on 10/7/11 to the ICU. The nursing staff placed Patient #41 in restraints on 10/7/11 because Patient #41 was sedated as a result of requiring mechanical ventilation. The order on 10/7/11 to restrain Patient #41 lacked the time the physician wrote the order.

4. During an interview on 12/12/11 at 1:40 PM, the Director of Compliance acknowledged the restraint orders for Patients #20, 40, and 41 lacked documented evidence of the time the physician wrote the order. The Director of Compliance also acknowledged without the time the physician wrote the order documented in the medical record, staff could not determine if the order was written within the 24 hours as required by the hospital's policy.

Additionally, the Director of Compliance acknowledged the physician wrote the restraint orders for Patients #21, 23, and 24, beyond the 24 hour time limit for medical restraints as required by the hospital's policy.

The Director of Compliance stated they monitored the restraint records to ensure the physicians wrote a new order for the medical restraints each day, but did not monitor to ensure the physicians wrote the orders within 24 hours, as required by the hospital's policy.

Based on document review, observation, and staff interview, the Hospital administrative staff failed to protect and secure confidential patient information from unauthorized access in Outpatient Therapy, Cesarean Section's Post Anesthesia Care Unit (PACU), Surgical, Testing, Admission, Registration (STAR), Child Protection Center, West Entrance public hallway, and Medical Record departments.

The Outpatient therapy department manager reported a daily average census of 18.

Cesarean section PACU supervisor reported monthly average census of 30.

A public hallway leading from the hospital's West entrance used by patients to register and by families and visitors for information.

STAR (Surgical, Testing, Admission, and Registration) Compliance officer reported a monthly average of 800 patients.

The Women's and Children's Obstetric Supervisor reported approximately 2700 deliveries per year.

The Neo Intensive Care Unit (NICU) manager reported an average daily census of 13 patients.

The Manager of Breast and Bone Health Services an average of 50 - 70 patients per day at the St. Luke's campus and an average of 15 to 25 patients per day at the Marion campus.

The Lead Wound Clinic Nurse reported an average of 230 patient visits to the Wound Clinic per month.


Failure to secure medical records against unauthorized access could result in unauthorized disclosure of personal medical information and/or identity theft.

Findings include:

1. Review of "Security and Confidentiality of Patient information" effective date 11/2011 revealed in part, "Access to St. Luke's Hospital patient information shall be limited to those entitled to access on the basis of specific care...
Patient information on paper...shall be kept in secure areas and not left unattended in areas accessible to unauthorized individuals..."

2. Observations of various departments revealed the following:

a. During initial tour of the Inpatient/Outpatient Therapy area on 12/06/12 at 11:10 AM, observation of the unoccupied documentation office revealed 6 unlocked files with 5 unlocked drawers each file. Staff J, Supervisor of the Therapy unit, opened an unlocked file drawer and stated the file drawer contained approximately 100 the current outpatient medical records and numerous billing statements. Staff J confirmed the patient medical records and billing statements contained personal and medical information, including but not limited to, name, address, phone number, diagnosis and treatment. Staff J stated housekeeping staff cleaned the area unsupervised and would have access to the medical records in the drawers.

b. During initial tour of the Post Anesthesia Care Unit (PACU) for Cesarean (C-section) surgery on 12/6/11 at 2:45 PM, observation of the back room revealed 2 logs with information that contained the patient names, procedures, complications and other personal and medical information. Staff K, supervisor for Obstetrics, stated the Certified Registered Nurse Anesthesia (CRNA) updated the book with procedures, complications, etc. Staff K confirmed the 2 logs contained information from January 2009 thru December 2011. Staff K confirmed the logs contained 25-30 separate sheets of paper with patient personal and medical information. Staff K stated the CRNA destroyed the separate sheets of paper after the completion of the log. Staff K stated staff did not always stay in the PACU area when housekeeping cleaned the area. Staff K confirmed housekeeping would have access to the log and information they contained.

c. During initial tour of room 3 of Nuclear Medicine on 12/6/11 at 2:40 PM, revealed a shelf along the left wall with approximately 40 patient medical records. Staff T, Lead Nurse of Nuclear Medicine department, stated the patient medical records contained names, addresses, medical diagnosis and procedures. Staff T stated the housekeeping personnel cleaned the area after hours and would have access to the patient medical records.

d. Observation of the public hallway from the west entrance registration on 12/7/11 at 10:35 AM, accompanied by Staff L, Manager of Radiology and Staff M, Supervisor of Radiology revealed an unattended mail courier cart with an envelope marked " medical records", personal mail and other informational items for various hospital offices. At 10:40 AM, Staff O, mail courier, arrived at the mail cart and stated the courier staff left the mail cart in the hallway because they could not take into the Emergency Department (ED).

e. Observation of the public hallway from the East entrance on 12/7/11 at 1:50 PM, revealed an unattended courier mail cart. Staff DD, Courier Support service, acknowledged the staff left the courier mail cart unattended and stated, "This was how I was trained." Staff DD stated, "The girl you talked with earlier today told me this is a problem."

During an interview on 12/7/11 at 11:05 AM, Staff Q, Director of family services, stated a mail cart left unattended would not be the hospital practice. Staff Q stated the mail cart carried inter facility mail so there would be medical records and other items of mail delivered from one office to another. Staff Q acknowledged the information needed to be protected and not for public access.

During an interview on 12/7/11 at 2:50 PM, Staff R, Compliance Officer/Privacy officer, acknowledged staff should not leave an unattended mail cart in the hallway.

f. An observation on 12/07/11 at 3:30 PM, with Staff BB, Manager of Child Protection Center (CPC), and Staff CC, Supervisor of CPC, revealed patient medical record storage in the area behind the secretary. The administrative staff of the CPC verified cleaning of the area occurs at the close of business when no CPC staffs are present. The CPC contracts with a local cleaning service to perform necessary cleaning duties.

g. An observation on 12/12/11 at 1:10 PM, with Staff AA, Manager of Medical Records, revealed the basement of the Medical Records department disposed of patient medical records in a large green reusable bag. The green bags were closed with a drawstring type closure that lacked a locking mechanism. The unescorted housekeeping staff transported the green bags to secured storage bins. The housekeeping staff lack the " need to know " the confidential patient information contained in the individual medical records.

h. Observations during a tour of the Surgery Testing, Admission, and Registration (STAR) department on 12/7/11 at 1:00 PM revealed the following:
- An unlocked filing cabinet that contained approximately 250 medical records in the Record Room. Review of the unsecured medical records revealed the records contained the patient's name, date of birth, surgical procedure scheduled, and the patient's past medical history.- An unlocked drawer in the Record Room that contained the surgical logs from January 2011 to April 2011. The surgical logs contained approximately 240 patient's names, date of birth, date of surgery, and the procedure the patient underwent.- A box in the Record Room labeled "Recycle - Confidential" filled approximately 0.5 inch thick with papers. Review of the paper revealed the papers contained the patient's name, date of procedure, surgical procedure performed, and the patient's past medical history.
During an interview at the time of the tour, Registered Nurse (RN) FF stated the housekeeping staff cleaned the Record Room after STAR staff had left for the day. RN FF acknowledged the housekeeping staff had access to the unsecured medical records. RN FF also stated the housekeeping staff did not have a need to know the patients' medical information. RN FF acknowledged they would not know if the housekeeping staff had accessed the medical records, and potentially obtained the patients' medical information.


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i. Observation during the environmental tour of the Women's and Children's Center - Obstetrics (an off-site location) area on 12/6/11 at 10:15 AM, with Staff GG, Supervisor, revealed, in the Dirty Utility room by Triage, one of one unsecured Ferning Log book on the counter beside the sink. The Ferning Log book contained approximately 250 patient stickers with confidential patient information dated from 9/24/11 to 12/5/11.

During an interview on 12/6/11 at 10:15 AM, Staff GG, Women's and Children's Center - Obstetric Supervisor, stated the housekeeping staff cleaned and obtained soiled linen from the Dirty Utility room by Triage without obstetrics staff present.

j. Observation during the environmental tour of the NICU (an off-site location) area on 12/6/11 at 3:00 PM, with Staff HH, Manager NICU, revealed, in the Clean Utility Room, an unsecured PICC (Peripheral Intravenous Central Catheter) Line Information Book on the PICC Cart. The PICC Line Information Book contained approximately 23 patient stickers with confidential patient information dated from 9/16/09 to 8/21/11.

During an interview on 12/6/11 at 3:00 PM, Staff HH, Manager NICU, stated the housekeeping cleaned the NICU Clean Utility Room without NICU staff present.

k. Observation during the environmental tour of the Breast and Bone Health (an off-site location) area on 12/7/11 at 8:00 AM, with Staff II, Manager Breast and Bone Health, revealed the following:
- In the unlocked Technologist Work Room, unsecured patient medical records on the work counter and in an open cabinet underneath a counter with confidential patient information.

- In the unlocked Radiologist Reading Room, unsecured patient medical records on the counter with confidential patient information.

- In the unlocked back secretary office, unsecured confidential patient information in 4 books and a hanging file.

During an interview on 12/6/11 at 8:00 AM, Staff II stated an outside cleaning agency cleaned the Breast and Bone Health area, including the Technologist Work Room, Radiologist Reading Room and the back secretary office after the area is closed for the day and staff are no longer present. Staff II stated staff leave 2 days worth of confidential patient information on the work counter and in the open cabinet underneath the counter in the Technologist Work Room and Radiologist Reading Room after the area is closed for the day. Staff II stated, in the back secretary office, the hanging files contained 13 months of confidential patient information and each of the 4 books contained 1 month of confidential patient information from both the St. Luke's and Marion campuses. Staff II stated the confidential patient information would be accessible to unauthorized personnel that cleaned the Breast and Bone Health area after hours.

l. Observation during the environmental tour of the Wound and Healing Center (an off-site location) area on 12/8/11 at 9:45 AM, with Staff JJ, Lead Wound Clinic Nurse, revealed, in the unlocked medical record storage area, approximately 160 unsecured wound clinic patient medical records with confidential patient information.

During an interview on 12/8/11 at 9:45 AM, Staff JJ, Lead Wound Clinic Nurse, stated an outside cleaning agency cleaned the Wound and Healing Center, including the unlocked medical record storage area, after the area is closed for the day and staff are no longer present. Staff JJ stated the confidential patient information would be accessible to unauthorized personnel that cleaned the Wound Clinic area after hours.

Based on review of documents and medical records and staff interview anesthesiology physicians failed to sign, date and or time the preoperative and or postoperative anesthesia records for 2 of 2 open obstetrical patients, 4 of 5 closed obstetrical patients, 9 of 9 open surgical records.

Failure to sign, date, and or time the preoperative anesthesia report could potentially result in a failure to identify and address any known complications in a safe and timely manner.

Failure to sign, date, and or time the postoperative anesthesia report could potentially result in failure to address and complications that may have occurred during the surgical procedure in a safe and timely manner.

Findings include:

1. Review of the Rules and Regulations of the Medial Staff dated 2009 revealed in part, ... " Each progress note must be; a. Dated, timed and authenticated by the author of the document ... "
2. Review of medical records revealed:
a. Reviews of Patient # 9's open medical record revealed the patient admitted for repair of a femur fracture procedure. A review of Patient #9's anesthesia record revealed the anesthesiologist failed to document an assessment for the post anesthetic progress note.
b. Reviews of Patient #10's open medical record revealed admit for L5-Discectomy procedure. A review of Patient #10's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
c. Reviews of Patient #11's open medical record revealed admit for tonsils and adenoids procedure. A review of Patient #11's anesthesia record revealed the anesthesiologist failed to time the Bypass PACU and pre-anesthetic progress note. The Anesthesiologist failed to document an assessment for the post anesthetic progress note.
d. Reviews of Patient #12's open medical record revealed admit for Hystoscopy procedure. A review of Patient #12's anesthesia record revealed the anesthesiologist failed to time the post anesthetic progress note.
e. Reviews of Patient #13's open medical record revealed admit for laparoscopic hernia repair procedure. A review of Patient #13's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic progress note.
f. Reviews of Patient #14's open medical record revealed admit for second stage bowel resection procedure. A review of Patient #14's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
g. Reviews of Patient #15's open medical record revealed admit for Da Vinci Lap Hysterectomy procedure. A review of Patient #15's anesthesia record revealed the anesthesiologist failed to time the post anesthetic progress note.
h. Reviews of Patient #16's closed medical record revealed admit for spontaneous vaginal delivery of twins. A review of Patient #16's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
i. Reviews of Patient #17's closed medical record revealed admit for spontaneous vaginal delivery of twins. A review of Patient #17's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
j. Reviews of Patient #18's open medical record revealed admit for Left Groin Incision and Drainage procedure. A review of Patient #18's anesthesia record revealed the anesthesiologist failed to sign, date and/or time the post anesthetic progress note.
k. Reviews of Patient #26's closed medical record revealed admit for spontaneous vaginal delivery of a baby. A review of Patient #26's anesthesia record revealed the anesthesiologist failed to time the Bypass
l. Reviews of Patient #27's closed medical record revealed admit for spontaneous vaginal delivery of twins. A review of Patient #27's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
m. Reviews of Patient #28's open medical record revealed admit for Left Groin Incision and Cystoscopy w/insertion of stent procedure. A review of Patient #28's anesthesia record revealed the anesthesiologist failed to time the pre-anesthetic evaluation, the Bypass Post Anesthesia Care Unit (PACU), and the post-anesthetic progress note.
3. On 12/12/11 at 11:00 AM, the Director of Surgical Services reviewed the above surgical records and acknowledged the anesthesia provider failed to document the date and/or time of the pre or post anesthesia evaluation/assessment on the surgical records reviewed.

4. Review of the following Obstetrical Records reviewed on 12/6/11 showed the following:

n. Patient #29 admitted 12/4/11 for a cesarean section. The pre-anesthesia evaluation dated 12/4/11 and the post-anesthesia evaluation dated 12/4/11 lacked a time of completion of the evaluations.

o. Patient #30 admitted 12/4/11 for a cesarean section. The pre-anesthesia evaluation dated 12/5/11 and the post-anesthesia evaluation dated 12/5/11 lacked a time of completion of the evaluations.

5. On 12/12/11 at 11:00 AM, the Director of Surgical Services reviewed the above obstetrical records and acknowledged the anesthesia provider failed to document the date and/or time of the pre or post anesthesia evaluation/assessment on the obstetrical records reviewed.

Based on observation, document review and staff interview, the hospital administrative staff failed to ensure 30 of 65 operating room staff members potentially exposed to ionizing radiation wore dosimetry badges. The Director of Surgical Services stated the operating room staff performed approximately 350 surgical procedures that involved ionizing radiation per month.

Failure to provide staff with radiation-detecting devices could potentially allow a staff member to receive unrecognized large quantities of radiation, and result in health hazards such as cancer or death.

Findings include:

1. Observations during a tour of the operating rooms on 12/7/11 at 7:30 AM, revealed 1 C-Arm fluoroscope, and 2 cystoscopy procedure rooms.

2. Review of the policy "PERSONNEL EXTERNAL EXPOSURE MONITORING PROGRAM", reviewed 10/11, revealed in part, "All individuals who are occupationally exposed to ionizing photon radiation on a regular basis will be issued a [dosimetry badge]..."

3. During an interview on 12/12/11 at 11:00 AM, the Director of Surgical Services stated the Operating Room contained approximately 6 staff members during the use of ionizing radiation. Of the 6 staff members in the room, 2 staff members, the anesthesia provider and the circulating nurse did not stand behind a lead shielding device or leave the room, in addition to wearing a lead apron. The Director of Surgical Services stated the 30 staff members that did not wear dosimetry badges included anesthesia providers and circulating nurses.

4. During an interview on 12/7/11 at 10:00 AM, Lead Radiology Technician QQ stated the Operating Room staff had to wear dosimetry badges for the first 3 months they worked in the Operating Room. After the first 3 months, the Operating Room staff member could choose to not wear the dosimetry badge.

5. During an interview on 12/12/11 at 11:00 AM, the Director of Surgical Services stated after an Operating Room staff member wore a dosimetry badge for 3 months, they could choose to not wear a dosimetry badge. Additionally, if the staff member moved from an area where the staff member was unlikely to receive exposure to ionizing radiation to an area where the staff member was likely to receive exposure to ionizing radiation, the staff member did not need to repeat a 3 month trial monitoring with a dosimetry badges.

The Director of Surgical Services also stated since the Operating Room staff did not all wear dosimetry badges, the Operating Room staff had to rely on the dosimetry badges worn by the Radiology Technician to indicate if the Operating Room staff members received an excessive dose of radiation. Additionally, the Director of Surgical Services acknowledged if the Operating Room staff did not wear dosimetry badges, the hospital lacked a method to detect if the Operating Room staff had received an excessive dose of radiation.

6. During an interview on 12/12/11 at 2:00 PM, the Radiation Safety Officer stated the operating room staff had approached the radiation safety committee about wearing dosimetry badges approximately 3 years ago. The radiation safety committee requested the operating room staff who wanted to not have to wear a dosimetry badge wear one for an additional 3 months. When the dosimetry badges for the staff showed they had not received any occupational exposure to radiation, the radiation safety committee allowed the operating room staff to decline to wear the dosimetry badges. The Radiation Safety Officer stated the hospital lacked a policy that allowed operating room staff occupationally exposed to radiation to request to not wear a dosimetry badges.

Based on clinical record review, policy review, document review and staff interviews the hospital nursing staff failed to ensure the diet ordered by the physician was communicated correctly to the Dining Services Department and failed to ensure diet order clarifications were documented on the medical record. The administrative staff reported a census of 231 inpatients. The Manager of Patient and Dietitian Services reported approximately 900 patient meals are served daily.

Failure to provide a patient with the correct therapeutic diet could potentially result in complications for the patient including gastrointestinal intolerance, texture intolerance, and inadequate or excess nutrient intake which could lead to weight loss, fluid imbalance, electrolyte imbalance, choking, aspiration, nausea or vomiting

Findings for 8 of 13 open medical records reviewed (Patients #1 - #8) include:

1. Review of the medical record for Patient #1 revealed a diet order, written on 12/6/11 at 7:17 AM, of 2500 calories. An additional order at 12:45 PM, indicated the patient may be upgraded to a mechanical soft diet. Review of the Care Cast (facility electronic order system) diet order entries, revealed an entry for a mechanical soft diet on 12/6/11 at 5:17 PM and lacked an entry for the 2500 calorie diet. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of mechanical soft. During an interview on 12/8/11 at 9:00 AM, Staff D, Clinical Dietitian, reported the 2500 calorie diet ordered as a nutrition goal, not as a restriction, but acknowledged the information had not been communicated to the Dining Services Department. Staff D further reported an order for a texture change would generally be added to an existing therapeutic diet order and not replace it.

2. Review of the medical record for Patient #2 revealed an order, written on 12/2/11 at 8:30 AM, for a swallowing evaluation at bedside, and if the patient passed, provide a general diet as tolerated. Review of the Care Cast diet order entries revealed an entry for a pureed diet on 12/3/11 at 9:58 AM. Review of the diet order sheet printed from Care Cast, dated 12/6/11 at 10:16 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of Pureed. During an interview on 12/7/11 at 11:20 AM, Staff F, RN reported the patient was edentulous and consumed a pureed diet at home as his/her usual diet, per the patient's spouse. Staff F attempted to find documentation related to this in the medical record but was unable to locate any. Staff G, RN, confirmed she cared for the patient in ICU and performed the bedside swallowing evaluation. Staff G was also unable to locate any specific documentation that addressed the patient's need for a pureed diet and acknowledged the lack of a physician order to change the diet from general.

3. Review of the medical record for Patient #3 revealed the most recent diet order, on 12/5/11 at 1:00 PM, written as general, no added salt. Review of the Care Cast diet order entries revealed an entry for consistent carbohydrate, heart healthy diet on 12/5/11 at 2:50 PM. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of Consistent Carbohydrate, Heart Healthy. During an interview on 12/8/11 at 8:00 AM, Staff E, Nurse Manager 3West, confirmed the diet order entered into the Care Cast system failed to match the diet ordered by the physician. Staff E reported the procedure for noting any physician order included verification by a Registered Nurse that the order entered into Care Cast matched the order written in the medical record.

4. Review of the medical record for Patient #4 revealed the most current diet order, on 12/7/11 at 3:00 AM, written as diabetic 2000 calorie. Review of the Care Cast diet order entries revealed an entry for a pureed, consistent carbohydrate diet on 12/7/11 at 11:00 AM. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of pureed, consistent carbohydrate.

5. Review of the medical record for Patient #5, revealed the post-op cardiac surgical orders, written on 12/6/11 at 7:30 AM, included a diet order for a general, no added salt diet. An additional order at 12:30 PM, included an order for a diabetic diet. Review of the Care Cast diet order entries revealed an entry for a consistent carbohydrate, no added salt diet on 12/6/11 at 1:35 PM. Review of the diet order sheet, printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of consistent carbohydrate, no added salt. During an interview on 12/12/11 at 11:15 AM, Staff B, Manager of Patient and Dietitian Services, reported a new therapeutic diet order should supercede the previous one and if a combination of the two diets was the intent, the diet order needed to be clarified with the physician and rewritten.

6. Review of the medical record for Patient #6 revealed the admission orders on 12/8/11 at 4:20 AM included an order for a Heart Healthy diet. Review of the Care Cast diet order entries revealed an entry for a consistent carbohydrate, heart healthy diet on 12/8/11 at 4:26 AM. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of Heart Healthy, Consistent Carbohydrate. During an interview on 12/8/11 at 10:30 AM, Staff D confirmed a review of the admission information lacked any indication for the need of a carbohydrate controlled diet.

7. Review of the medical record for Patient #7 revealed CCU admission orders on 12/3/11 at 2:45 AM included a diet order for NPO (nothing by mouth), and included no subsequent diet orders. Review of the Care Cast diet order entries revealed an entry for a consistent carbohydrate, heart healthy diet on 12/3/11 at 12:52 PM. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the Dining Services Department for patient meal tray line, revealed a diet order of consistent carbohydrate, heart healthy.

8. Review of the medical record for Patient #8 revealed a current diet order, written on 12/3/11 at 1:18 PM, of a diabetic diet. Review of the Care Cast diet order entries revealed an entry for a consistent carbohydrate, heart healthy diet 12/5/11 at 11:15 AM, and listed Staff H, RN, as the user. Review of the diet order sheet printed from Care Cast, dated 12/8/11 at 6:15 AM and used by the dining service department for patient meal tray line, revealed a diet order for consistent carbohydrate, heart healthy. During an interview on 12/8/11 at 10:00 AM, Staff H, RN, recalled the clinical dietitian requested an addition of heart healthy to the diabetic diet order and acknowledged he/she must have forgotten to write the physician order.

During an interview on 12/12/11 at 10:00, Staff A, Director of Nursing Operations confirmed one of the components to noting a physician order included the RN ensuring the order entered into Care Cast matched the order on the medical record. Staff A acknowledged a problem with verbal orders entered into the Care Cast system but not written in the medical record. He/She also confirmed an order for a texture change would be added to an existing therapeutic diet order and a new therapeutic diet order would supercede the previous one, so if a combination of the two desired, the diet order needed clarified with the physician.

Review of a Dining Service policy titled "Interpretation of Nutrition Care Orders", last reviewed in 8/2010, revealed in part " . . . Nutrition care orders are written by the physician in the Physician's Order Section of the patient's medical record or checked off in facility approved order sets, transcribed by nursing in the Care Cast Order system . . . ".

Review of a document titled Element X, Governing Rules, last reviewed in 6/2009, revealed in part " 14. Physician orders a. Obtaining . . . Physicians are encouraged to write their own orders. A registered nurse/licensed practical nurse . . . may receive a verbal or telephone order from a physician. . . . In the event a verbal or telephone order is given, the person receiving the order will write down the complete order in the patient's medical record and repeat it back to the ordering physician to verify accuracy. . . . b. Transcribing Orders 1) Responsibility A unit secretary may transcribe orders from a patient's record. The Registered Nurse will verify all orders done by Unit Secretary prior to implementation. 2) Mechanism The Unit Secretary will transcribe orders and enter orders into Care Cast. The RN noting the order shall sign her/his first initial, last name, title and date and time of notation and assures all orders are free from unapproved abbreviations and are carried out as directed . . .".

During interview on 12/6/11 at 2:00 PM, the Manager reported the acute in-patient hemodialysis services followed the Conditions for Coverage for End-Stage Renal Disease Facilities which included the guideline of the Association for the Advancement of Medical Instrumentation (AAMI).

Based on review of policies and procedures, AAMI requirements, manufacturer's information, water treatment system logs, observation, and interview with staff and a representative of the water treatment system, the facility administrative staff failed to ensure the safe provision of water and dialysate as evidenced by failure to ensure:

1. The safe operation of the DI (Deionization/Deionizer) water treatment system component regarding monitoring of the DI, the DI alarms and safety/protection systems for the DI, actions for staff to take if the DI system alarmed and/or diverted to drain, and staff knowledge regarding patient clinical outcomes for patients receiving poor quality water from the DI tanks. (Refer to A724)

2. A system to record the resistivity monitor readings for the DI twice each patient treatment day. (Refer to A724)

3. Staff identified the resistivity monitor readings were above the resistivity of pure water and evaluated the reason for the greater than pure water resistivity readings. (Refer to A724)

4. Staff consistently documented findings for the areas checked, tested, and monitored for the portable ROs (reverse osmosis), as specified on the facility logs, and included the time that staff completed the checks, tests, and monitoring. (Refer to A724)

5. The log that staff documented the total chlorine test result for the portable ROs reflected that the test was a total chlorine test result. (Refer to A724)

6. The facility's system of not testing for total chlorine after the polisher carbon tank for the portable ROs, when staff had a total chlorine test result of 0.1 after the worker carbon tank, was in accordance with the total chlorine test strip manufacturer's information. (Refer to A724)

7. A written policy and procedure that reflected the time that staff should run the portable ROs prior to staff performing the total chlorine test. (Refer to A724)

8. The logs for the acute hemodialysis in-patient water treatment system on 3 West included the time that staff completed the checks, tests, and monitoring of the system. (Refer to A724)

9. The logs for the acute hemodialysis in-patient water treatment system on 3 West, that staff documented the total chlorine test result, reflected the test was a total chlorine test result. (Refer to A724)

10. The facility's system of not testing for total chlorine after the polisher carbon tank for the acute hemodialysis in-patient water treatment system on 3 West, when staff had a total chlorine test result of 0.1 after the worker carbon tank, was in accordance with the total chlorine test strip manufacturer's information. (Refer to A724)

11. The facility identified acceptable range for the pH of the dialysate matched the pH range specified in the AAMI requirements. (Refer to A724)

12. Consistency among staff with the procedure of testing the conductivity of the dialysate with a manual meter regarding comparison of the conductivity reading from the manual meter with the conductivity reading of the dialysis machine. (Refer to A724)

13. A system to verify the calibration of the Myron L Dialysate Meter, with a standard solution when staff used of the meter between the monthly calibration of the meter, to ensure accuracy of the meter, and did not ensure the facility's written policy and procedure for checking the conductivity of the dialysate was in accordance with the Myron L D-2 Dialysate Meter's manufacturer's information. (Refer to A724)

14. The facility's system of testing the dialysate for residual chlorine occurred with test strips appropriate to test for chlorine in dialysate. (Refer to A724)

15. Staff practice and the facility's written policy and procedure for the water hardness test was in accordance with the manufacturer's information for the water hardness test strips. (Refer to A724)

16. Staff performed the total chlorine test for the RO/DI water in accordance with the facility's written policy and procedure. (Refer to A724)

17. Prior to the survey, that staff had evaluated the manufacturer's information regarding quality control procedures for the total chlorine and water hardness test strips. (Refer to A724)

At the time of the survey, the facility staff reported a hemodialysis patient census of 4. The facility had an acute hemodialysis in-patient treatment area with a water treatment system, 2 portable ROs and 5 hemodialysis machines to provide patient dialysis treatments.

The cumulative effect of these systemic failures and deficient practices resulted in the facility staffs' inability to ensure the safe provision and monitoring of dialysis services to its patients.

During interview on 12/6/11 at 2:00 PM, the Manager reported the acute in-patient hemodialysis services followed the Conditions for Coverage for End-Stage Renal Disease Facilities which included the guideline of the Association for the Advancement of Medical Instrumentation (AAMI).

I. Based on review of policies and procedures, AAMI requirements, water treatment system logs, observation, and interview with staff and a representative of the water treatment system, the facility staff failed to ensure:

1. The safe operation of the DI (Deionization/Deionizer) water treatment system component regarding monitoring of the DI, the DI alarms and safety/protection systems for the DI, actions for staff to take if the DI system alarmed and/or diverted to drain, and staff knowledge regarding patient clinical outcomes for patients receiving poor quality water from the DI tanks.

2. A system to record the resistivity monitor readings for the DI twice each patient treatment day as specified in the AAMI requirements.

3. Staff identified the resistivity monitor readings were above the resistivity of pure water and evaluated the reason for the greater than pure water resistivity reading.

DI is an ion exchange process that removes both anions (negatively charged ions) and cations (positively charged ions) from the water. DIs have a finite capacity for contaminant removal. Exhausted or depleted DI tanks (less than 1.0 megohm-centimeter) present a serious risk to patients, and use of exhausted DI tanks have resulted in patient deaths. The DI system must be closely monitored by knowledgeable staff to ensure the water is safe for the patient dialysis treatments.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and the facility had an acute hemodialysis in-patient treatment area with a water treatment system. Findings for 1 of 1 water treatment system for the acute hemodialysis in-patient treatment area on 3 West include:

1. Interview and observation of the acute hemodialysis in-patient area on 12/5/11 beginning at 10:30 AM with the Manager showed the area, located on 3 West, had a water treatment system room and a patient treatment room with 4 hemodialysis patient treatment stations. During interview with the Manager at the time of the observation, the Manager reported RN (Registered Nurse) DB was the Lead Dialysis Nurse for the acute hemodialysis in-patient treatment area and the water treatment system for this area. Interview on 12/5/11 at 11:05 AM with the Manager and Biomed Technician DC showed that Biomed Technician DC had responsibilities and performed preventative maintenance for the water treatment system. Further observation and interview at 11:05 AM with the Manager and Biomed Technician DC revealed the water treatment system included a RO (reverse osmosis) and DIs. Interview with the Manager at the time of the observation showed the Lead Dialysis Nurse, RN DB, provided orientation and competency evaluations for the nurses that worked at the dialysis area on 3 West.

2. The Conditions for Coverage for End-Stage Renal Disease Facilities included the following AAMI requirements "... Deionization: continuous monitor resistivity/logged 2 X day... Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm [centimeter] or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25°C [Celsius]... Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer Resistivity monitor readings should be recorded on a log sheet twice each treatment day."
In addition, the Conditions for Coverage for End-Stage Renal Disease Facilities included the following AAMI requirements "... Deionization: alarms/divert to drain... Deionization: An audible and visual alarm shall be activated when the product water resistivity falls below this level and the product water stream shall be prevented from reaching any point of use, for example by being diverted to drain. The alarm must be audible in the patient care area. The resistivity monitor following the final deionizer bed shall be connected to an audible and visible alarm in the dialysis treatment area, and the DI system shall divert product water to drain or otherwise prevent product water from entering the distribution system should an alarm condition occur. Under no circumstances shall DI be used when the product water of the final bed has a resistivity below 1 megohm-cm."

The Conditions for Coverage for End-Stage Renal Disease Facilities included that pure water has a resistivity of 18.3 megohms.

3. Interview with staff, the water treatment system representative, observation, and review of policies and procedures failed to ensure the facility staff had systems in place to ensure the safe operation of the DI water treatment system component regarding monitoring of the DI, the DI alarms and safety/protection systems for the DI, actions for staff to take if the DI system alarmed and/or diverted to drain, and staff knowledge regarding patient clinical outcomes for patients receiving poor quality water from the DI tanks.

a. During interview on 12/5/11 at 11:05 AM, Biomed Technician DC reported the water quality for the DIs was measured with a resistivity monitor. Biomed Technician DC reported if the water quality for the DI fell out of range, the DI system would not automatically divert to drain, the system would alarm at the nurses station and the nurses would shut the DI off. After further questions by the surveyor regarding an automatic divert to drain system for the DI, Biomed Technician DC contacted the Water Treatment System Representative from Organization A, Water Treatment System Representative DN. Biomed Technician DC then reported Water Treatment System Representative DN clarified the DI system did divert to drain when the DI alarmed. Biomed Technician DC further reported the DI diverted to drain after the worker DI tanks at 5 megohms. Biomed Technician DC reported after the worker DIs and before the polisher DI, the system had a censor that would alarm at 5 megohms and automatically divert to drain.

b. During interview in the water treatment system room on 3 West on 12/6/11 at 12:30 PM with Biomed Technician DC and on 12/7/11 at 7:00 AM with the Lead Dialysis RN, Biomed Technician DC and the Lead Dialysis RN explained the alarms for the DIs were located after the worker DI tanks, before the polisher DI tank, and the system included 2 audible and visual alarms. Biomed Technician DC and the Lead Dialysis RN explained the DI alarm light, located after the worker DI tanks, turned from green to red at 1 megohm (if the resistivity reading decreased to 1 megohm), and that an audible and visual alarm sounded and lit up in the patient treatment area. Biomed Technician DC and the Lead Dialysis RN reported if the resistivity reading decreased to 5 megohm, the DI water diverted to drain and an audible and visual alarm sounded and lit up in the patient treatment area.

However, interview on 12/8/11 at 3:20 PM with Water Treatment System Representative DN and observation in the water treatment system room and the patient treatment area on 3 West showed differences in the staffs' explanation of the location and/or function of the alarms for the DI component of the water treatment system. Interview and observation with Water Treatment System Representative DN, the Lead Dialysis RN, and Biomed Technician DC showed the alarm light that turned from green to red was located after the worker DI tanks and the light changed from green to red at 1 megohm, if the resistivity reading decreased to 1 megohms. However, Water Treatment System Representative DN reported the alarm in the patient care area, when the light in the water treatment system room turned from green to red, was a visual alarm with a yellow alarm light that lit up in the patient treatment area. Further interview with Water Treatment System Representative DN revealed the system to divert the DI water to the drain was located after the polisher DI tank with an audible and visual alarm activated in the patient treatment area when the resistivity reading decreased to 5 megohms.

c. During an interview on 12/7/11 at 7:00 AM, the surveyor asked the Lead Dialysis RN if patient treatments could occur if the DI was alarming and diverting to drain. The Lead Dialysis RN responded that dialysis treatments could continue and the Lead Dialysis RN would notify Biomed. The surveyor then asked Biomed Technician DC what actions Biomed Technician DC would take if the DI was alarming and diverting to drain. Biomed Technician DC reported that Biomed Technician DC would most likely take the DI off/out of the loop (take the DI off/out of the water treatment system and stop the flow of water through the DI tanks). Biomed Technician DC then reported that Biomed Technician DC would take the DI off/out of the loop. The surveyor asked the Lead Dialysis RN and Biomed Technician DC what clinical outcomes for the patients would occur if the patients received poor quality water from the DI tanks during the dialysis treatment. The Lead Dialysis RN and Biomed Technician DC reported not knowing the patient outcomes regarding the patients receiving poor quality water from the DI tanks.

d. Review of the facility's written policies and procedure for hemodialysis, contained in the "DIALYSIS MANUAL," revealed the facility lacked written policies and procedures addressing actions for staff to take regarding the DI system alarms and the DI water diverting to drain.

e. During an interview on 12/8/11 at 11:00 AM and 3:20 PM and on 12/9/11 in the morning, the Manager acknowledged the findings. On 12/9/11, the Manager showed an action plan developed in response to the survey findings titled "St. Luke's Hospital Hemodialysis Action Plan December 8, 2011," that stated in part "... 1. Effective immediately, NO further hemodialysis (HD) runs will take place in 3 West Dialysis area... 3. [Water Treatment System Representative DN]... will conduct Water Treatment Room Education... 4. Complete review of Water Treatment Room Policies and Procedures... 5. Revision of Water Room Log Sheets... 6. Develop Policy and Procedure for Water Treatment Room including Deionization critical values, who to notify for critical values and the need to stop Hemodialysis immediately... 7. Develop specific orientation for all Water Treatment Room Policies and Procedures... 8. Develop competencies for Water Treatment Room..."

4. Interview on 12/7/11 at 7:00 AM with the Lead Dialysis RN showed the staff documented the checks and monitoring of the water treatment system on logs titled "St Luke's Dialysis Daily Checkout." Review of the "St Luke's Dialysis Daily Checkout" logs, from 10/7/11-12/7/11, and interview on 12/7/11 at 7:00 AM with the Lead Dialysis RN showed that staff documented the resistivity monitor reading for the DIs one time each patient treatment day, prior to the start of patient treatments. Further review of the logs revealed staff did not document a resistivity monitor reading twice each treatment day as specified in the AAMI requirements.

Interview on 12/12/11 at 2:50 PM with RN DJ verified that staff did not document a resistivity monitor reading twice each patient treatment day and RN DJ acknowledged that staff should document the resistivity monitor reading twice each treatment day.

5. Review of the "St Luke's Dialysis Daily Checkout" logs, for the dates of 10/7/11-12/7/11, showed the logs contained a row with the facility specified monitoring for staff to complete of "Polisher DI Channel A Resistivity" with an acceptable range of "> [greater than] 5 megohms." For 45 of 45 days documented on the logs, the "Polisher DI Channel A Resistivity" included documented resistivity readings ranging from 18.78 to 18.97 (pure water has a resistivity of 18.3 megohms).

During interview on 12/8/11 at 11:00 AM, the Manager acknowledged the resistivity monitor readings documented were above the value of pure water. Interview on 12/6/11 at 3:20 PM with Water Treatment System Representative DN showed the resistivity monitor meter needed to be recalibrated.

II. Based on review of policies and procedures, manufacturer's information, portable RO logs, observation, and staff interview, the facility staff failed to ensure:

1. Staff consistently documented findings for the areas checked, tested, and monitored for the portable ROs, as specified on the facility logs, and included the time that staff completed the checks, tests, and monitoring.

2. The log that staff documented the total chlorine test result reflected that the test was a total chlorine test result.

3. The facility's system of not testing for total chlorine after the polisher carbon tank, when staff had a total chlorine test result of 0.1 after the worker carbon tank, was in accordance with the total chlorine test strip manufacturer's information.

4. A written policy and procedure that reflected the time that staff should run the portable ROs prior to staff performing the total chlorine test.

Hemodialysis treatments cleanse the blood of accumulated waste products and fluid for people with renal (kidney) failure. Hemodialysis treatments require special machines and use treated water for those treatments, often referred to as dialysis quality water. To provide dialysis quality water, water flows through several water treatment components including a RO to remove unsafe contaminants. Dialysis equipment, including the water treatment components, require staff to monitor and ensure all components function within the acceptable parameters. Failure to provide documentation that shows the water treatment components were safe for patient use and/or failure to ensure dialysis quality water for the dialysis treatments could potentially result in patients' exposure to unsafe water, which could result in adverse patient outcomes, patient illness, and even death.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and reported that the facility had 2 portable ROs. Findings for 2 of 2 portable ROs (#1685 and #2545) include:

1. During interview on 12/6/11 at 2:00 PM, Biomed Technician DC reported the facility had 2 portable ROs for use for the patient dialysis treatments, portable RO #1685 and #2545. Interview on 12/6/11 at 9:45 AM with RN DF showed the staff documented the checks and monitoring of the portable ROs for the patient treatments on logs titled "RO Log."

The RO Logs contained columns that specified the checks, tests, and monitoring that staff should perform, with an acceptable range for each area, and an area for staff to document the findings for the areas checked, tested, and monitored. Interview on 12/6/11 at 9:45 AM with RN DF and on 12/5/11 at 1:25 PM with RN DE and review of the RO Logs showed that staff documented the following checks, tests, and monitoring of the portable ROs before each patient treatment: "Total Chloramine/Test strip expiration date," "Total Hardness/Test strip expiration date," "% [Percent] Rejection," "Conductivity," "H2O [Water] Temp [Temperature]," "Pressure (PSI) [pounds per square inch]," "White Filter P. [Pressure]...," "Delta Pressure (difference between "white" filter static pressures)," and "Black valve P." In addition, the RO Logs included a column for staff to document "... End of day water hardness test results..."

2. However, further review of the RO Logs, for the months of 4/1/11-12/9/11 for RO #2545 and for the months of 5/2/11-12/5/11 for RO #1685, revealed staff did not consistently document findings for the areas checked, tested, and monitored as specified on the logs nor include the time that staff completed the checks, tests, and monitoring.

a. Findings for 91 treatment days documented on the RO Logs for Portable RO #2545 included:

i.) 5 treatment days when staff did not document a "Total Chloramine/Test strip expiration date" as specified on the RO Log.

ii.) 25 treatment days when staff did not document an "End of day water hardness test results" as specified on the RO Log.

iii.) 2 treatment days when staff did not document a "Total Hardness/Test strip expiration date" as specified on the RO Log.

iv.) 91 treatment days when staff did not document a time of day that staff performed the checks, tests, and monitoring for the portable RO.

v.) 1 treatment day, 11/22/11, had an "RO Recheck 2nd run" documented in the last column on the log, with numbers documented below the entry "RO Recheck 2nd run." Staff documented the "RO Recheck 2nd run" and numbers in a column on the log with the heading "Comments (ie. End of day water hardness test results, corrective actions, cleaning, etc)." The documentation did not show which facility specified check, test, or monitoring for the RO that the numbers reflected on the log.

vi.) The RO Logs included the statement "If any test value is outside of acceptable range (as listed), DO NOT proceed with set-up and notify Biomedical Engineering" and a column with the heading "Comments (ie. End of day water hardness test results, corrective actions, cleaning, etc)." For 15 of the treatment days, staff documented values/numbers outside of the acceptable range as listed on the log. For 14 of the 15 treatment days, documentation did not reflect notification of Biomedical Engineering and/or documentation showed Biomedical Engineering/Biomed Technician notified without further documentation on the log of the results of the notification or corrective action.

b. Findings for 115 treatment days, 116 runs, documented on the RO Logs for Portable RO #1685 included:

i.) 2 times when documentation on the RO Logs did not include a "Total Chloramine/Test strip expiration date" or a legible value documented for the total chloramine in the column "Total Chloramine/Test strip expiration date" as specified on the RO Log.

ii.) 34 times when staff did not document an "End of day water hardness test results" as specified on the RO Log.

iii.) The logs lacked a documented time of day that staff performed the checks, tests, and monitoring for the portable RO.

iv.) The RO Logs included the statement "If any test value is outside of acceptable range (as listed), DO NOT proceed with set-up and notify Biomedical Engineering" and a column with the heading "Comments (ie. End of day water hardness test results, corrective actions, cleaning, etc)." For 3 of the treatment days, staff documented values/numbers outside of the acceptable range as listed on the log and documentation did not reflect notification of Biomedical Engineering.

c. Interview on 12/9/11 at 12:00 PM with RN DP showed when staff were not using the portable ROs, the portable ROs were in standby and staff verified that the ROs were in standby. The manufacturer's information for the portable ROs titled "Aquaboss ECO 70 Quick Reference" stated in part, "... Standby is recommended during off-dialysis periods to minimize bacteria growth..." The facility lacked documentation reflecting the ROs were in standby and/or the verification checks that occurred regarding standby for the ROs.

3. Review of the portable RO Logs, manufacturer's information of the test strips used by staff to test the RO water for chlorine/chloramine, observation, and staff interview revealed that staff documented a total chlorine value in a column on the RO Log that did not reflect the test was a total chlorine test. Findings for the months of 4/1/11-12/9/11 for portable RO #2545 and for the months of 5/2/11-12/5/11 for portable RO #1685, included:

a. Interview and observation on 12/5/11 at 1:25 PM with RN DE and interview on 12/6/11 at 9:45 AM with RN DF showed staff tested the RO water for chlorine/total chloramine before each patient treatment using Serim GUARDIAN HiSENSE ULTRA 0.1 test strips and documented the test result on the RO Log in the column with the heading "Total Chloramine/Test strip expiration date."

b. Review of the RO Logs and the manufacturer's information for the test strips used by staff to test the RO water for chlorine/chloramine revealed that staff documented a total chlorine value (the sum of free chlorine and chloramine) in a column on the "RO Log" with the heading "Total Chloramine/Test strip expiration date." However, the manufacturer's information for the test strips included the following, "Serim GUARDIAN HiSENSE ULTRA 0.1 Test for Total Chlorine (chloramines/free chlorine) in feed or rinse water... SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips ... provide a means for indicating low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate... According to Guidance Document ANSI/AAMI RD62:2006, a single test for total chlorine may be used with the maximum allowable concentration of 0.1 mg/L [milligram/liter] total chlorine..."

4. Review of the portable RO Logs, manufacturer's information of the test strips used by staff to test the RO water for chlorine/chloramine, observation, and staff interview revealed the facility's system of not testing for total chlorine after the polisher carbon tank, when staff had a value of 0.1 after the worker carbon tank, was not in accordance with the test strip manufacturer's information. Findings for the months of 4/1/11-12/9/11 for portable RO #2545 and for the months of 5/2/11-12/5/11 for portable RO #1685, included:

a. Interview and observation on 12/5/11 at 1:25 PM with RN DE and interview on 12/6/11 at 9:45 AM with RN DF showed staff tested the RO water for chlorine/total chloramine before each patient treatment using Serim GUARDIAN HiSENSE ULTRA 0.1 test strips. During interview on 12/9/11 at 12:00 PM with RN DP and on 12/5/11 at 1:25 PM with RN DE, RN DP and RN DE reported a total chloramine value of 0.1 after the worker carbon tank for the portable ROs was an acceptable value and that staff did not have to perform a total chloramine test after the polisher carbon tank. The RO Logs included an acceptable range of "0.1 or less" for the "Total Chloramine..." Review of the RO Logs for portable RO #1685, from 5/2/11-12/5/11, showed 6 times when staff documented a "Total Chloramine..." test result of 0.1. Review of the RO Logs for portable RO #2545, from 5/6/11-12/9/11, showed 4 times when staff documented a "Total Chloramine..." test result of 0.1.

b. The test strip manufacturer's information on a form titled "PRODUCT PROFILE Serim HiSENSE ULTRA 0.1 TEST STRIPS" stated in part, "... WHERE DO I USE THIS product? Feed Water: Collect a water sample at the point where the water leaves the first carbon tank (worker) and before entering the second (polisher). If the results show any chlorine leaving the first tank, a second sample should be taken immediately after the water leaves the second tank. If there is chlorine leaving the second tank, dialysis should be discontinued in the facility. If there is no breakthrough, the chorine level should continue to be monitored after the second tank on an hourly basis until the primary tank is replaced. This is because there is not redundant protection..."

5. During separate interviews on 12/9/11 at approximately 11:00 AM, RN DB, RN DP, and RN DE reported the portable ROs needed to run 10 to 15 minutes prior to staff performing the total chlorine test. Review of the facility's policies and procedures in the "DIALYSIS MANUAL" showed the facility lacked a written policy and procedure reflecting the time staff should run the portable ROs prior to staff performing the total chlorine test.

6. During interview on 12/9/11 at 12:00 PM, RN DP verified and concurred with the findings regarding the RO logs. RN DP reported that staff did perform the tests and checks for the portable ROs as specified on the logs, however RN DP verified staff did not always document the tests and monitoring that occurred. RN DP reported the logs should include a time and that documentation for the portable ROs should reflect when the ROs were in standby. Interview on 12/12/11 at 2:15 PM with the Lead Dialysis RN verified the facility lacked a written policy and procedure addressing the time the portable RO should run prior to staff performing the total chlorine test and showed the facility should have a policy and procedure reflecting the amount of time the RO should run.

III. Based on review of policies and procedures, manufacturer's information, water treatment system logs for the acute hemodialysis in-patient area located on 3 West, observation, and staff interview, the facility staff failed to ensure:

1. The logs for the water treatment system included the time that staff completed the checks, tests, and monitoring of the system.

2. The logs that staff documented the total chlorine test result reflected that the test was a total chlorine test result.

3. The facility's system of not testing for total chlorine after the polisher carbon tank, when staff had a total chlorine test result of 0.1 after the worker carbon tank, was in accordance with the total chlorine test strip manufacturer's information.

Hemodialysis treatments cleanse the blood of accumulated waste products and fluid for people with renal failure. Hemodialysis treatments require special machines and use treated water for those treatments, often referred to as dialysis quality water. To provide dialysis quality water, water flows through several water treatment components including the RO and DIs to purify the water and remove unsafe contaminants. Dialysis equipment, including the water treatment components, require staff to monitor and ensure all components function within the acceptable parameters. Failure to provide documentation that shows the water treatment components were safe for patient use and/or failure to ensure dialysis quality water for the dialysis treatments could potentially result in patients' exposure to unsafe water, which could result in adverse patient outcomes, patient illness, and even death.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and the facility had an acute hemodialysis in-patient treatment area with a water treatment system. Findings for 1 of 1 water treatment system for the acute hemodialysis in-patient treatment area on 3 West include:

1. Observation on 12/7/11 at 7:00 AM with the Lead Dialysis RN showed the facility had an acute hemodialysis in-patient area on 3 West with a water treatment system for the patient dialysis treatments. Interview on 12/7/11 at 7:00 AM with the Lead Dialysis RN showed the staff documented the checks and monitoring of the water treatment system on logs titled "St Luke's Dialysis Daily Checkout."

The "St Luke's Dialysis Daily Checkout" logs specified the checks, tests, and monitoring that staff should perform, with an acceptable range for each area, and an area for staff to document the findings for the areas checked, tested, and monitored. Interview on 12/7/11 at 7:00 AM and at 2:00 PM with the Lead Dialysis RN review of the "St Luke's Dialysis Daily Checkout" logs showed that staff documented checks, tests, and monitoring specified on the log each patient treatment day, prior to the start of patient treatments and that staff performed a chlorine/chloramine test every 4 hours.

2. However, further review of the "St Luke's Dialysis Daily Checkout" logs, for the months of 10/7/11-12/7/11, revealed staff did not document the time of day that staff performed the checks, tests, and monitoring of the water treatment system, each patient treatment day prior to patient treatments. In addition, review of the logs showed staff did not consistently document a time for the "2nd shift Chloramine..." test.

3. Review of the "St Luke's Dialysis Daily Checkout" logs, policies and procedures, manufacturer's information of the test strips used by staff to test the RO/DI water for chlorine/chloramine, observation, and staff interview revealed that staff documented a total chlorine value in a section on the RO/DI log that did not reflect the test was a total chlorine test. In addition, the facility had a policy and procedure addressing the chlorine and chloramine testing that referred to the Total Chloramine test and observation showed the staff performed a total chlorine test. Findings for the months of 10/7/11-12/7/11 included:

a. Interview and observation on 12/7/11 at 6:45 AM with the Lead Dialysis RN showed staff tested the RO/DI water for chlorine/total chloramine each patient treatment day using Serim GUARDIAN HiSENSE ULTRA 0.1 test strips and documented the test result on the "St Luke's Dialysis Daily Checkout" log in a section with the heading "... Chloramine..."

b. Review of the "St Luke's Dialysis Daily Checkout" log and the manufacturer's information for the test strips used by staff to test the RO/DI water for chlorine/chloramine revealed that staff documented a total chlorine value (the sum of free chlorine and chloramine) in a section on the log with the heading "... Chloramine..." The facility's policy and procedure titled "CHLORINE AND CHLORAMINE TESTING IN HD UNIT WATER ROOM," developed 10/18/11, referred to a total chloramine test. However, the manufacturer's information for the test strips included the following, "Serim GUARDIAN HiSENSE ULTRA 0.1 Test for Total Chlorine (chloramines/free chlorine) in feed or rinse water... SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips ... provide a means for indicating low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate... According to Guidance Document ANSI/AAMI RD62:2006, a single test for total chlorine may be used with the maximum allowable concentration of 0.1 mg/L [milligram/liter] total chlorine..."

4. Review of the "St Luke's Dialysis Daily Checkout" log, policies and procedures, manufacturer's information of the test strips used by staff to test the RO/DI water for chlorine/chloramine, observation, and staff interview revealed the facility's system of not testing for total chlorine after the polisher carbon tank, when staff had a value of 0.1 after the worker carbon tank, was not in accordance with the test strip manufacturer's information.

a. Interview and observation on 12/7/11 at 6:45 AM with the Lead Dialysis RN showed staff tested the RO/DI water for chlorine/total chloramine each patient treatment day prior to patient treatments and every 4 hours using Serim GUARDIAN HiSENSE ULTRA 0.1 test strips. Interview with the Lead Dialysis RN showed a total chloramine value of 0.1 after the worker carbon tank was an acceptable value and that staff did not have to perform a total chloramine test after the polisher carbon tank. The most recent "St Luke's Dialysis Daily Checkout" logs, dated 11/28/11-12/7/11 included an acceptable range after the worker carbon tank of less than or equal to 0.1 ppm (parts per million) for the "... Chloramine..." test result.

b. The facility had a policy and procedure titled "CHLORINE AND CHLORAMINE TESTING IN HD UNIT WATER ROOM," developed 10/18/11, which stated in part, "PURPOSE 1. To assure stability of the carbon tank water purification system. 2. To provide a safe dialysis treatment to meet American Association for Medical Instrumentation (AAMI) standards. POLICY Patient safety and water quality will be maintained per AAMI standards and include testing for total chloramine from the feeder water supply... PROCEDURE 1. Perform test for Total Chloramine prior to first patient treatment after R.O. has been running for 15 minutes and every 4 hours each day while patients are dialyzing. 2. After R.O. has been running for 15 minutes, obtain a... water sample from post worker valve... and test using the Total Chloramine Test Policy in HD Policy Manual. 3. Total Chloramine result must be 0.1ppm or less. If results are 0.1ppm or less, proceed with unit start-up or continuation of patient treatments. 4. If results are greater than 0.1ppm, obtain a... water sample from post polisher valve... hourly and call for service from Biomedical Engineering or service provider

During interview on 12/6/11 at 2:00 PM, the Manager reported the acute in-patient hemodialysis services followed the Conditions for Coverage for End-Stage Renal Disease Facilities which included the guideline of the Association for the Advancement of Medical Instrumentation (AAMI).

I. Based on review of policies and procedures, AAMI requirements, water culture and LAL (Limulus Amebocyte Lysate)/endotoxin results, and staff interview, the facility staff failed to ensure for the acute hemodialysis in-patient water distribution system on 3 West:

1. The written policies and procedures addressed the specific sites that staff should collect the monthly culture and endotoxin samples to ensure collection of the samples occurred from the first and last outlets of the water distribution loop as specified in the AAMI requirements.

2. The sites that staff collected the monthly water culture and LAL/endotoxin samples included the first and last outlets of the water distribution loop as specified in the AAMI requirements.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to have a written policy and procedure that addressed the sites for staff to obtain the water culture and endotoxin samples for the first and last outlets of the water distribution loop could potentially result in staff performing the procedure inconsistently. Failure to obtain water culture and endotoxin samples from the specified outlets every month could potentially result in the staffs' failure to identify elevated bacteria and/or endotoxin levels in the water distribution system. Elevated bacteria and/or endotoxin in the water used for the patient dialysis treatments could cause adverse patient outcomes, patient illness, and pyrogenic reactions (a pyrogenic reaction may include symptoms of chills, shaking, fever, low blood pressure, vomiting, and/or muscle pain).

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and 1 acute hemodialysis in-patient water treatment system for the acute hemodialysis in-patient room on 3 West. Findings for 1 of 1 acute hemodialysis in-patient water treatment system on 3 West include:

1. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements that water distribution piping systems should be monitored for bacteria and endotoxin levels with bacteria and endotoxin testing conducted at least monthly. The AAMI requirements included that monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop.

2. The facility had a written policy and procedure titled "INFECTION CONTROL AND SURVEILLANCE OF PATIENTS, PERSONNEL AND HEMODIALYSIS EQUIPMENT," reviewed/revised 10/11, which stated in part, "PURPOSE... To provide a safe dialysis treatment to meet American Association for Medical Instrumentation (AAMI) standards... 5. Maintenance responsible for water testing per AAMI guidelines (see maintenance records). 6. Biomed will be responsible for obtaining cultures for portable R.O.s, water room, HD [hemodialysis] stations on 3 West, and disinfection of water room..." The facility had another policy and procedure addressing cultures titled "OBTAINING CULTURES FROM FRESENIUS 2008K," reviewed 10/11, which stated in part, "PURPOSE To ensure patient safety and promote infection control to all patients receiving hemodialysis. POLICY Patient safety and infection control will be maintained with the use of surveillance cultures obtained from the dialysis machine and the R/O unit on a monthly basis. Each set of cultures, regardless as to machine, will consist of a "pre-disinfection" (worst case scenario) and a "post disinfection" sample... PROCEDURE... Aquaboss R/O machine/Water room for HD Unit 1. Cultures from the R/O machine will be obtained by Biomedical Engineering on a monthly basis..."

However, review of the policies and procedures revealed the facility lacked policies and procedures addressing the specific sites for the acute hemodialysis in-patient water distribution system on 3 West that staff should collect the monthly bacteria and endotoxin samples to ensure collection of the samples occurred from the first and last outlets of the water distribution loop as specified in the AAMI requirements.

3. During interview on 12/8/11 at 11:00 AM, the Manager reported the facility started using the acute hemodialysis in-patient area on 3 West for patient dialysis treatments in 10/2011. Review of the culture and endotoxin testing results for the acute hemodialysis in-patient water system, documented on laboratory reports for the months of 10/11 and 11/11, failed to show culture and endotoxin samples from the first and last outlets of the water distribution system.

4. Interview on 12/6/11 at 2:00 PM with Biomed Technician DC regarding the monthly culture and endotoxin sample sites for the acute hemodialysis in-patient water system verified the facility staff had not identified the sample sites for the first and last outlets of the water distribution system. Interview with Biomed Technician DC revealed the facility's system did not include obtaining culture and endotoxin samples from the first and last outlets of the water distribution loop for the water system located on 3 West.

II. Based on review of policies and procedures, AAMI requirements, and staff interview, the facility staff failed to ensure evaluation of the facility's practice of removing the connection device from the portable RO water hose when obtaining the portable RO water culture and endotoxin samples in regards to the AAMI requirements. In addition, the facility failed to ensure a written policy and procedure that addressed the procedure for collection of the water culture and endotoxin samples from the portable ROs.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to evaluate the procedure for obtaining the water culture and endotoxin samples from the portable ROs and failure to have a written policy and procedure that addressed the procedure for collection of the water culture and endotoxin samples from the portable ROs could potentially result in staff performing the procedure inconsistently and failure of the staff to identify an elevated culture and/or endotoxin level in the water. Elevated bacteria and/or endotoxin in the water used for the patient dialysis treatments could cause adverse patient outcomes, patient illness, and pyrogenic reactions (a pyrogenic reaction may include symptoms of chills, shaking, fever, low blood pressure, vomiting, and/or muscle pain).

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and reported that the facility had 2 portable ROs. Findings for 2 of 2 portable ROs (#1685 and #2545) include:

1. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements that water distribution piping systems should be monitored for bacteria and endotoxin levels with bacteria and endotoxin testing conducted at least monthly. The AAMI requirements included that monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop.

2. During interview on 12/6/11 at 2:00 PM, Biomed Technician DC reported that the portable ROs had a connection device (a tube or hose with a connection device on each end with one end connecting to the portable RO hose and the other end connecting to the hemodialysis machine)/an extension of the RO water outlet hose to allow connection of the dialysis machine to the portable RO water hose. Biomed Technician DC reported the device remained on the portable RO water hose during the dialysis treatments and disinfection of the portable ROs and that the connection device was removed when obtaining the monthly water culture and endotoxin samples from the portable RO hose.

3. Review of the facility's policies and procedures, in the manual titled "DIALYSIS MANUAL," showed the facility had a policy and procedure titled "INFECTION CONTROL AND SURVEILLANCE OF PATIENTS, PERSONNEL AND HEMODIALYSIS EQUIPMENT," reviewed/revised 10/11, which stated in part, "PURPOSE... To provide a safe dialysis treatment to meet American Association of Medical Instrumentation (AAMI) standards... 5. Maintenance responsible for water testing per AAMI guidelines (see maintenance records). 6. Biomed will be responsible for obtaining cultures for portable R.O.s, water room, HD stations on 3 West, and disinfection of water room..." The facility had another policy and procedure titled "OBTAINING CULTURES FROM FRESENIUS 2008K," reviewed 10/11, which stated in part, "PURPOSE To ensure patient safety and promote infection control to all patients receiving hemodialysis. POLICY Patient safety and infection control will be maintained with the use of surveillance cultures obtained from... the R/O unit on a monthly basis. Each set of cultures, regardless as to machine, will consist of a "pre-disinfection" (worst case scenario) and a "post-disinfection" sample... Aquaboss R/O machine/Water room for HD Unit 1. Cultures from the R/O machine will be obtained by Biomedical Engineering on a monthly basis..."

However, review of the policies and procedures revealed the facility lacked a policy and procedure that addressed the staff practice of removing the connection device from the portable RO machine's water outlet hose when collecting the water culture and endotoxin sample.

4. During interview on 12/6/11 at 2:00 PM, the Manager acknowledged the facility's practice and the AAMI requirements as specified above. Interview on 12/6/11 at 2:00 PM, with the Manager and Biomed Technician DC showed the facility lacked evaluation of the facility's practice of removing the connection device from the portable RO water hose when obtaining the portable RO water culture and endotoxin samples in regards to the AAMI requirements.

III. Based on review of policies and procedures, AAMI requirements, and staff interview, the facility staff failed to ensure evaluation of the AAMI requirement of not disinfecting the sample taps/ports for the culture and endotoxin sample collection with the staff practice of: disinfecting the water sample ports with alcohol prior to collecting the water culture and endotoxin samples; soaking a connection device, used to obtain the bacterial samples from the dialysis station water ports, in alcohol prior to collecting the water bacterial samples from the water ports; and soaking a line off the post loop sample port in alcohol prior to connecting the line back on the sample port and collecting the water bacterial sample from the port through the line.

Residual disinfectant remaining on the sample ports, connection device, or line off a sample port could potentially result in residual disinfectant contaminating the water sample and a lower microbial level for the sample which would not reflect the actual microbial level of the water sample. Failure of staff to identify elevated bacteria or endotoxin levels in the water could potentially result in failure of the staff to take needed action to achieve acceptable bacteria and endotoxin levels in the water. Elevated bacteria or endotoxin levels in the water used for the patient dialysis treatment could result in adverse patient outcomes and patient illness.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and 1 acute hemodialysis in-patient water treatment system for the acute hemodialysis in-patient room on 3 West. Findings for 1 of 1 acute hemodialysis in-patient water treatment system on 3 West include:

1. The Condition for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements that water samples should be collected directly from outlet taps situated in different parts of the water distribution system, that the sample taps should be opened and the water should be allowed to run for at least 60 seconds before a sample is collected, and that sample taps should not be disinfected.

2. During interview on 12/5/11 at 11:05 AM and on 12/9/11 at 1:00 PM, Biomed Technician DC reported wiping the samples ports with alcohol prior to collecting the culture and endotoxin water samples from the acute hemodialysis in-patient water system sample ports and the dialysis station sample ports. In addition, Biomed Technician DC reported soaking a line off the post loop water sample port in alcohol prior to putting the line back on the sample port and collecting the water bacterial sample through the line. Biomed Technician DC reported using a connector device to obtain the water bacterial samples from the dialysis station water ports. Biomed Technician DC reported the connection device soaked in alcohol prior to obtaining the water samples from the dialysis station water ports. During the interview, Biomed Technician reported running water from the sample sites a few minutes and approximately 3 minutes prior to collecting the water samples.

3. The facility's policies and procedures in the manual titled "DIALYSIS MANUAL" contained a policy and procedure titled "INFECTION CONTROL AND SURVEILLANCE OF PATIENTS, PERSONNEL AND HEMODIALYSIS EQUIPMENT" reviewed/revised 10/11, which stated in part, "PURPOSE... To provide a safe dialysis treatment to meet American Association of Medical Instrumentation (AAMI) standards... 5. Maintenance responsible for water testing per AMMI guidelines (see maintenance records). 6. Biomed will be responsible for obtaining cultures for portable R.O.s, water room, HD stations on 3 West, and disinfection of water room..." The facility had another policy and procedure titled "OBTAINING CULTURES FROM FRESENIUS 2008K," reviewed 10/11, which stated in part, "PURPOSE To ensure patient safety and promote infection control to all patients receiving hemodialysis. POLICY Patient safety and infection control will be maintained with the use of surveillance cultures obtained from... the R/O unit on a monthly basis. Each set of cultures, regardless as to machine, will consist of a "pre-disinfection" (worst case scenario) and a "post-disinfection" sample... Aquaboss R/O machine/Water room for HD Unit 1. Cultures from the R/O machine will be obtained by Biomedical Engineering on a monthly basis..."

Review of the facility's written policies and procedure revealed the facility lacked a written policy and procedure addressing the facility's system of wiping the sample ports with alcohol, soaking the line of the water system post loop sample site with alcohol, and soaking the connection device for the dialysis station water ports in alcohol prior to collecting the culture and/or endotoxin samples from the sample sites.

4. During interview on 12/6/11 at 2:00 PM, the Manager acknowledged the facility's practice and the AAMI requirements as specified above and showed the facility lacked evaluation of the AAMI requirements in regards to the facility's practice.

IV. Based on review of policies and procedures, dialysate culture and endotoxin laboratory reports, AAMI requirements, and staff interview, the facility staff failed to ensure staff collected dialysate samples for the culture and endotoxin testing from at least 2 dialysis machines every month, so that each machine was tested at least once per year; as specified in the AAMI requirements.

Failure to obtain dialysate culture and endotoxin samples from at least 2 dialysis machines every month could result in the facility staffs' failure to identify elevated bacteria and endotoxin levels in the dialysate. Elevated bacteria and/or endotoxins in the dialysate used for the patient dialysis treatments can cause adverse patient outcomes, patient illness, and pyrogenic reactions (a pyrogenic reaction may include symptoms of chills, shaking, fever, low blood pressure, vomiting, and/or muscle pain).

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and that the facility had 5 hemodialysis machines. Findings for 3 of 3 hemodialysis machine dialysate culture and endotoxin results reviewed (Hemodialysis machine A, C, and E) include:

1. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements to culture dialysate fluid monthly unless a greater frequency is dictated by historical data and that dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year.

2. Interview with staff showed the staff collected hemodialysis machine culture samples from the Hanson portion of the dialysate line. However, during interview on 12/6/11 at 9:45 AM with RN (Registered Nurse) DF and on 12/9/11 at 12:00 PM with RN DP, RN DF and RN DP reported the culture collected from the Hanson portion of the dialysate line at the end of the patient treatment was a water sample or mainly a water sample, not a dialysate sample. The facility's policy and procedure titled "OBTAINING CULTURES FROM FRESENIUS 2008K" dialysis machine, as specified below, referred to collecting a water sample from the Hanson connector for the pre-disinfection culture. However, the AAMI requirements specified to culture dialysate fluid from at least two dialysis machines monthly.

3. The facility had a policy and procedure manual titled "DIALYSIS MANUAL" which contained several policies and procedures addressing cultures from the dialysis machine. The policy and procedure titled "INFECTION CONTROL AND SURVEILLANCE OF PATIENTS, PERSONNEL AND HEMODIALYSIS EQUIPMENT," reviewed/revised 10/11, stated in part, "PURPOSE... To provide a safe dialysis treatment to meet American Association for Medical Instrumentation (AAMI) standards PROCEDURE... 4... Monthly cultures will be performed from the dialysate hose of the Fresenius 2008K machine. Culture pre and post disinfection per HD procedure #8..." The policy and procedure titled "OBTAINING CULTURES FROM FRESENIUS 2008K," reviewed 10/11, stated in part, "PURPOSE To ensure patient safety and promote infection control to all patients receiving hemodialysis POLICY Patient safety and infection control will be maintained with the use of surveillance cultures obtained from the dialysis machine... on a monthly basis. Each set of cultures, regardless as to machine, will consist of a "pre-disinfection" (worst case scenario) and a "post-disinfection" sample... PROCEDURE Fresenius 2008K HD machine "Pre-disinfection" 1. At the end of a randomly selected patient treatment, the HD RN will obtain a 20ml water sample from the blue Hanson connector, into a... specimen cup..." The policy and procedure addressed collection of a post-disinfection culture sample from the dialysis machine.

4. Review of the facility's "DIALYSIS MANUAL" showed the facility lacked policies/procedures that addressed collection of an endotoxin dialysate sample from the dialysis machine. Review of dialysis machine A and C culture and endotoxin laboratory report results for the months of 5/2011-11/2011 and review of dialysis machine E culture and endotoxin laboratory report results for the months of 9/2011-11/2011, revealed the facility lacked dialysate endotoxin laboratory reports for the dialysis machines.

5. During interview on 12/6/11 at 2:00 PM, the Lead Dialysis RN and the Manager acknowledged the findings and verified the AAMI requirements specified that dialysate culture and endotoxin samples should be collected from at least 2 dialysis machines monthly and from enough machines so that staff tested each machine at least once per year. The manager reported the facility staff should follow the AAMI requirements.

V. Based on review of the AAMI requirements, policies and procedures, disinfection documentation, endotoxin laboratory reports, and staff interview, the facility staff failed to have a system in place, including policies and procedures, to ensure staff collected the routine monthly water endotoxin samples at the "worst case scenario" before disinfection of the water treatment system for both the acute hemodialysis in-patient area on 3 West and for the portable ROs.

Written policies and procedures provide for guidance and consistency among staff and serves as a resource for staff in the performance of procedures. Failure to ensure the water endotoxin samples were collected at the "worst case scenario," just prior to disinfection of the water treatment system, did not offer the facility the opportunity to ensure the bacterial analysis results met the AAMI guidelines at the "worst case scenario" and could result in the failure of staff to identify elevated bacterial levels in the water. Failure to have a policy and procedure that addressed collection of the endotoxin samples before disinfection of the water treatment system, including the portable ROs, could result in inconsistencies among staff in the performance of procedures and/or failure of staff to identify elevated endotoxin levels in the water and failure of staff to take corrective measures to reduce the levels in the water. Failure to identify elevated endotoxin levels could result in adverse patient outcomes, patient illness, and pyrogenic reactions (a pyrogenic reaction may include symptoms of chills, shaking, fever, low blood pressure, vomiting, and/or muscle pain).

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and reported that the facility had 2 portable ROs and 1 acute hemodialysis in-patient water treatment system for the acute hemodialysis in-patient room on 3 West. Findings for 2 of 2 portable ROs (#1685 and #2545) and for 1 of 1 acute hemodialysis in-patient water treatment system on 3 West include:

1. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements regarding microbial monitoring which included that collection of samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines.

2. Review of the routine monthly endotoxin laboratory reports for portable ROs #1685 and #2545, reviewed for the months of 4/2011-11/2011, showed endotoxin testing results for each month. However, interview on 12/9/11 at 1:00 PM with Biomed Technician DC revealed that Biomed Technician DC collected the endotoxin sample after disinfection of the portable ROs.

3. During interview on 12/8/11 at 11:00 AM, the Manager reported the facility started using the acute hemodialysis in-patient area on 3 West for patient dialysis treatments in 10/2011. Review of the endotoxin laboratory reports for the water treatment system for the acute hemodialysis in-patient room and documentation of staff disinfection of the water treatment system and distribution loop for the months of 10/11 and 11/11 revealed staff did not collect the endotoxin samples at the worst case scenario, before disinfection of the water treatment system.

4. Review of the facility's policies and procedures contained in the "DIALYSIS MANUAL" revealed the facility lacked a written policy and procedure addressing collection of the endotoxin samples before disinfection of the water treatment system, including the portable ROs.

5. Interview on 12/9/11 at 1:00 PM with Biomed Technician DC verified the laboratory report findings regarding the endotoxin samples for the portable ROs and the acute hemodialysis in-patient water treatment system. Interview with Biomed Technician DC revealed the facility's system did not include collection of the routine monthly endotoxin samples at the worst case scenario, before disinfection of the water treatment system. The manager reported the facility staff should follow the AAMI requirements.

VI. Based on review of policies and procedures, AAMI requirements, observation, and staff interview, the facility staff failed to ensure:

1. A system to document completion of the facility required procedure to disinfect the bicarbonate wands (also known as pick-up tubes) weekly.

2. Staff rinsed the wands, used for the patient dialysis treatment, with RO water at the end of each treatment day or at the end of the patient dialysis treatment.

Documentation showing completion of a procedure provides a record of the procedure performed and assists staff in evaluating the disinfection procedure if needed.
Bicarbonate concentrate solution provides an excellent media (substance/environment) for bacteria to grow or increase by rapid production of new bacteria; bicarbonate concentrate supports bacterial growth. Bacterial growth could potentially occur with residual bicarbonate remaining on the wands and/or from staff not disinfecting the wands at the frequency specified in the facility's policy and procedure. Elevated bacteria or endotoxin levels in the bicarbonate used for the dialysis treatment potentially could cause patient illness. When the wands are placed in the bicarbonate or acid concentrate solution, residual chemicals/substances remaining on the wands from cleaning could potentially enter the solution and the dialysate used for the patient's dialysis treatment.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and staff reported the facility had 5 hemodialysis machines to provide patient dialysis treatments. Findings for 2 of 2 patient treatment days observed (12/5/11 and 12/6/11) include:

1. The facility had a written policy and procedure titled "DISINFECTION OF DIALYSATE WANDS," developed 9/27/11, which stated in part, "PURPOSE To establish protocol for disinfecting the Fresenius 2008K and 2008K2 dialysate wands. POLICY The bicarbonate wands which are used for solution delivery during the hemodialysis treatment will be disinfected, rinsed and checked for negative residual chlorine on a weekly basis by the dialysis nursing staff to prevent contamination of wands..." The policy and procedure for disinfection of the wands included using a bleach solution and checking for residual bleach/chlorine with the rinsing procedure.

During interview on 12/6/11 at 2:00 PM, the Lead Dialysis RN reported disinfection of the bicarbonate wands occurred weekly. However, further interview with the Lead Dialysis RN showed the facility staff lacked a system to document implementation and completion of the procedure.

2. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements that pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day.

The facility had a policy and procedure titled "CLEANING," revised 10/11, which stated in part, "... Rinse Bicarbonate and acid wands with water..."

Observation on 12/5/11 at 1:25 PM with RN DE during Patient D1's dialysis treatment and observation on 12/6/11 at 8:05 AM with RN DB during Patient D2's dialysis treatment showed the hemodialysis machine acid and bicarbonate wands in containers of acid and bicarbonate concentrate solution respectively for the patient dialysis treatments. The wands, also known as pick-up tubes, were straw like tubes that staff placed in the concentrate containers to take up the concentrate solution from the containers into the dialysis machine for the patient dialysis treatment.

Further observation with RN DE on 12/5/11 and with RN DB on 12/6/11 showed at the end of the patient dialysis treatment, staff removed the acid and bicarbonate wands from the containers of acid and bicarbonate concentrate solution and placed the ends of the wands in a container holding a vinegar solution for the procedure to clean the dialysis machines. (The vinegar solution went through the pick-up tubes into the dialysis machine as part of the cleaning procedure for the dialysis machine.) Continued observation with RN DE and RD DB showed at the end of the vinegar procedure, staff placed the wands in a vertical position on the dialysis machine. Observation showed staff allowed the wands to air dry, however staff did not rinse the wands with RO water.

During interview on 12/6/11 at 2:00 PM, the Lead Dialysis RN acknowledged that the staffs' practice did not include rinsing the wands with RO water after removing the wands from the vinegar solution. During interview, the Lead Dialysis RN reported that staff should rinse the wands with RO water after staff removed the wands from the vinegar solution.

VII. Based on review of policies and procedures, AAMI requirements, and staff interview, the facility staff failed to ensure evaluation of the culture methods and medium for the cultures used by the laboratory for the water and dialysate cultures.

Water and dialysate cultures reflect the water quality and level of bacterial contamination of the water and dialysate used for dialysis. It is important that staff evaluate the culture methods and medium for the cultures in relation to the AAMI requirements to ensure the appropriate methods and medium are used to identify elevated bacteria in the water and dialysate. Failure to use the appropriate culture method and medium for the culture could result in failure of the staff to identify elevated bacterial levels in the water and dialysate and failure of staff to take corrective measures to decrease the reduce the levels. Elevated bacteria in the water and/or dialysate used for the patient dialysis treatment can cause adverse patient outcomes and patient illness.

At the time of the survey, the facility staff reported a hemodialysis patient census of 4 and staff reported the facility had 2 portable ROs, a water treatment system and distribution loop for the acute hemodialysis in-patient area located on 3 West, and 5 hemodialysis machines to provide patient dialysis treatments. Findings for the water cultures from the water treatment systems and water distribution loop and for dialysate cultures from the dialysis machines include:

1. The Conditions for Coverage for End-Stage Renal Disease Facilities included the AAMI requirements regarding heterotrophic plate count culture methods and medium for the culture. The AAMI requirement included in part that use of a calibrated loop to apply the sample to the agar plate was not permitted. The Conditions for Coverage for End-Stage Renal Disease Facilities referred to the AAMI requirement that trypticase soy agar (TSA, a soybean casein digest agar) was the medium of choice for culturing water and dialysate; other acceptable media include standard methods agar and plate count agar (also known as TGYE) and included that blood and chocolate agars were not appropriate for this test.

2. Interview on 12/6/11 at 2:00 PM with Biomed Technician DC and the Lead Dialysis RN showed every month the dialysis staff sent water and dialysate samples for the water and dialysate cultures to the hospital laboratory. Review of the policies and procedures in the "DIALYSIS MANUAL" showed the manual did not contain policies and procedures addressing the culture methods or medium used by the laboratory. Interview on 12/12/11 at 3:45 PM with hospital laboratory personnel regarding the culture methodology used by the laboratory showed the laboratory personnel did not use a calibrated loop for the culture, however the laboratory did use blood agar as the culture medium for culturing the water and dialysate. Interview with the laboratory personnel did not ensure staff had evaluated the AAMI requirements in relation to the culture methods and culture medium used by the laboratory for the water and dialysate cultures.

VIII. Based on review of the CDC (Centers for Disease Control and Prevention) recommendations, policies and procedures, medical records, and staff interview, the facility staff failed to have a system in place to ensure that the staff consistently documented the Hepatitis B status for the hemodialysis patients on admission and/or prior to hemodialysis treatments. In addition, the facility staff failed to have written policies and procedures in place that addressed isolation guidelines and facility requirements for patients with Hepatitis B that dialyzed in the acute hemodialysis in-patient area on 3 West.

Hepatitis B is a blood-borne pathogen transmitted through the blood or body fluids and is highly transmissible because of the high concentration of the virus in the blood