The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

JEWISH HOSPITAL & ST MARY'S HEALTHCARE 200 ABRAHAM FLEXNER WAY LOUISVILLE, KY 40202 March 23, 2012
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observations, interviews, review of facility policy/procedures and review of Association for the Advancement of Medical Instrumentation (AAMI) standards, the facility failed to ensure patients received hemodialysis treatments in a safe manner. During observations of preparation for patient treatment in the Intensive Care Unit the Registered Nurse (RN) responsible for monitoring the chlorine/chloramine in the portable treated water system used reagent strips that were not sensitive to the maximum allowable level of 0.1 milligrams per liter (mg/L). The RN was unaware the reagent strips in use were not sufficiently sensitive to safely test the treated water. Other staff responsible for monitoring the portable water system and the dialysis manager were unaware the reagent strips would not measure to the low level required and were unaware of safe parameters for the treated water. The facility's policy/procedure did not address the appropriate reagent strips or method to use for testing the water. The policy/procedure did not address the maximum allowable limits for chlorine/chloramine in the treated water used for hemodialysis. The facility's failure to ensure safe water for hemodialysis placed the patients receiving hemodialysis treatment via the portable water system at risk for serious harm. Immediate Jeopardy was identified related to patient safety.

The findings include:

Observations in Intensive Care Unit 4 of hemodialysis preparation for Patient #35's hemodialysis treatment by RN #16 on 03/21/22, at 8:35 AM, revealed the facility utilized portable Reverse Osmosis (RO - a water purification process) machines to produce dialysis quality water for hemodialysis treatments. The RO machines contained carbon absorption containers to remove chlorine/chloramine from the water intended for dialysis treatments (exposure of the patient to small amounts of chlorine/chloramine would cause rupture of the red blood cells). Observations of RN #16 performing testing of the treated water for chlorine/chloramine revealed the RN used a Serim Residual Chlorine Reagent Strip to determine the level of chlorine/chloramine in the treated water. The RN dipped the water into a sample obtained from the RO machine. The strip had no color change and the RN read the strip as "negative".

Review of the manufacturer's directions for use of the Serim Residual Chlorine reagent test strips revealed the reagent strips were intended to provide an accurate means of measuring the concentration of chlorine bleach remaining in water being used to rinse out hemodialysis machine dialysate lines following disinfection of hemodialysis equipment. The reagent strips could detect levels of chlorine above 0.5 mg/L. The reagent strips were not intended for testing of the treated water for chlorine/chloramine.

Review of the facility policy/procedure Chlorine and Chloramine Checks, dated as revised 12/2011, revealed between patients on the portable RO (Reverse Osmosis-used to remove chemicals in the tap water except chlorine/chloramines) machines, the dialysis RN or technician of the Dialysis Unit would perform checks. The amount of chlorine/chloramine (sometimes called Total Chlorine) added to city water can vary day to day and even hour to hourly. Even a short exposure to chlorine/chloramine can cause hemolysis. A powder test was to be done on machines outside the unit due to accuracy variants because of temperature. Dip sticks could be used in the unit. Findings on the portable RO's would be documented on the Total Chlorine Shift Log. The facility's policy/procedure revealed no procedure that indicated what testing product was to be used or what the maximum allowable level of chlorine should be.

Review of the AAMI standards (American National Standard for Water Treatment Equipment for Hemodialysis Applications RD62:2001) for monitoring the treated water for chlorine/chloramines revealed for carbon absorption beds, the facility should monitor the product water (water treated by the RO machine) levels of free chlorine and/or total chlorine prior to beginning each patient shift. The expected result should be equal to or less than 0.1 milligrams per liter (mg/L) of total chlorine. Test strips with color comparison charts that indicate a low level reading of zero and a first "number" of 0.5 are not sufficiently sensitive to detect levels as low as 0.1 mg/L and must not be used for testing of product water for safe levels of chlorine/chloramine. An indication of "0" on the comparison charts does not suffice to demonstrate the strips are sensitive to "0".

An interview was conducted with RN #16 03/21/12, at 8:45 AM. RN #16 stated the Serim Residual Chlorine reagent strips were the only strips she had used for testing the treated water. According to the RN, she did not know the parameters for chlorine/chloramine in the treated water to ensure safety, but the reagent strip must be "0".

During an interview on 03/21/12, at 1:30 PM, with RN #18, it was revealed the RN had been performing hemodialysis treatments in the facility for approximately one (1) year. RN #18 stated she had only used the Serim Residual Chlorine reagent strips for testing the chlorine of the treated water in the portable RO machines. According to RN #18, the residual chlorine reagent strip was the only one she had used for the year she had been conducting hemodialysis treatments. RN #18 was unaware of the safe parameters for chlorine in the treated water. The RN stated if the reagent strip did not turn purple the water was safe to use.

An interview was conducted on 03/21/12, at 1:38 PM, with RN #19. According to RN #19 she had been using the residual chlorine strips to test the treated water for approximately one and one half (1 ) years. According to RN #19 if the strip did not change colors the water was safe for patient treatment. RN #19 was unaware of the safe parameters for treated water used for hemodialysis treatments.

Interview on 03/21/12, at 9:45 AM and 12:25 PM, with the Dialysis Manager revealed the manager was not aware the reagent strips in use for testing the treated water were not of sufficient sensitivity to ensure safe water for patient treatments. The Dialysis Manager stated staff had been trained to use the Serim Residual Chlorine reagent test strips to test the treated water from the portable RO machines. Additionally, staff had not been trained in the safe parameters (less than 0.1 mg/L) for treated water for hemodialysis treatments.

The immediacy of the jeopardy was abated on site during the survey. The Biomedical Technician tested the treated water with a hand held meter that was sufficiently sensitive to detect total chlorine below 0.1 mg/L prior to each hemodialysis treatment conducted with the portable RO machines. The Biomedical Technician provided in-service education to all staff on duty on 03/21/12 and 03/22/12 to include the evening shift nurse in the use of the hand held meter. Staff would not be allowed to perform hemodialysis treatments using the portable RO Machines until they had received education on the hand held meter and deemed competent in the use of the meter.

(Reference A0144)
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observations and interviews it was determined the facility failed to ensure patient privacy when confidential information was posted on electronic boards in the emergency room departments at St. Mary's and Elizabeth, Jewish Southwest, and Jewish South that could be observed by anyone who passed by.

The findings include:




1. Observations made during a tour of Sts. Mary and Elizabeth Hospital's emergency department (ED), on 03/20/12 at 10:05 AM, revealed an electronic board that contained the room number, patient's last name and first initial, the provider, the assigned nurse, x-ray, and lab. The electronic board was on the wall in the hallway in plain view of anyone that was in the area.
Interview with Staff #90, on 03/20/12 at 10:55 AM, confirmed the electronic board was in an area that could be viewed by the public. She stated they were aware the electronic board was a concern regarding patient privacy. They had discussed the patient privacy concern but had not made any changes at that time.





2. Observation made of the Nurses station, of the emergency room at Jewish Hospital Southwest, on 03/20/12 at 10:00 AM, revealed an electric board that contained the patients last name, first initial, the nurse providing care, the patient room number and the physician providing care for the patient. The electric board was on the wall of the nurses station in plain view of anyone that was in the area.





3. Observations made during a tour of Jewish South's emergency department (ED), on 03/20/12 at 10:05 AM, revealed an electronic board that contained the patient's last name and first initial, room number and the physician. The electronic board was visible to staff, patients, and visitors in that area.
Interview with Staff #116, on 03/20/12 at 10:55 AM, confirmed the electronic board was in an area that could be viewed by the public. She stated the electronic board has been in the same location since the hospital had opened.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observations, interviews, review of Association for Advancement of Medical Instrumentation (AAMI) standards and review of facility policy/procedure the facility failed to ensure the portable water treatment system was monitored in accordance with AAMI standards. During observations of a hemodialysis treatment in the Intensive Care Unit Registered Nurse (RN) #16 used reagent strips to test the treated water for chlorine/chloramine that were not sensitive to the maximum allowable level of 0.1 milligrams/L (mg/L). The RN was unaware the reagent strips in use were not sufficiently sensitive to safely test the treated water. Other staff responsible for monitoring the treated water for chlorine/chloramines was unaware the reagent strips would not measure to the low level required to ensure safety. The facility's policy/procedure did not address the appropriate reagent strips or method to use or the maximum allowable limits for chlorine/chloramine.

The findings include:

Review of the facility policy/procedure Chlorine and Chloramine Checks, dated as revised 12/2011, revealed between patients on the portable RO (Reverse Osmosis-used to remove chemicals in the tap water except chlorine/chloramines) machines, the dialysis RN or technician of the Dialysis Unit would perform checks. The amount of chlorine/chloramine (sometimes called Total Chlorine) added to city water can vary day to day and even hour to hourly. Even a short exposure to chlorine/chloramine can cause hemolysis. A powder test was to be done on machines outside the unit due to accuracy variants because of temperature. Dip sticks could be used in the unit. Findings on the portable RO's would be documented on the Total Chlorine Shift Log. The facility's policy/procedure revealed no procedure that indicated what testing product was to be used or what the maximum allowable level of chlorine should be.

Review of the manufacturer's recommendations for the RO machines utilized for patient treatments revealed a chlorine/chloramine test should be run on the equipment before each patient treatment. The manufacturer recommended the user refer to AAMI standards for acceptable levels of chlorine and chloramines.

Review of the AAMI standards (American National Standard for Water Treatment Equipment for Hemodialysis Applications RD62:2001) for monitoring the treated water for chlorine/chloramines revealed for carbon absorption beds, the facility should monitor the product water (water treated by the RO machine) levels of free chlorine and/or total chlorine prior to beginning each patient shift. The expected result should be equal to or less than 0.1 milligrams per liter (mg/L) of total chlorine. Test strips with color comparison charts that indicate a low level reading of zero and a first "number" of 0.5 are not sufficiently sensitive to detect levels as low as 0.1 mg/L and must not be used for testing of product water for safe levels of chlorine/chloramine. An indication of "0" on the comparison charts does not suffice to demonstrate the strips are sensitive to "0".

Observations on 03/21/12, at 8:35 AM, revealed Registered Nurse (RN) #16 preparing the hemodialysis machine and portable RO machine for Patient #35's hemodialysis treatment in the Intensive Care Unit #4. After connecting the RO to the water source (faucet in the sink) and to the machine the RN turned the machines on. The RN obtained a water sample from a port on the front of the RO machine that read "Chlorine Test Port". The RN placed a reagent strip into the water sample and compared the result with the color comparison chart on the container of Serim Residual Chlorine reagent strips. The reagent strip had no color change and the RN read the strip as "negative". Observation of the manufacturer's directions for use on the label of the reagent strips revealed the strips were intended for use in measuring the concentration of chlorine bleach remaining in water used to rinse out dialysate lines following disinfection of hemodialysis equipment. The reagent strips could detect chlorine levels above 0.5 mg/L. The reagent strips were not intended for testing of the treated water for chlorine/chloramines.

Interview with RN #16 03/21/12, at 8:45 AM, revealed the Serim Residual Chlorine reagent strips were the only strips she had used for testing the treated water. The RN stated she did not know the parameters for chlorine/chloramine in the treated water to ensure safety. According to RN #16, the reagent strip must be "0".

Interview on 03/21/12, at 1:30 PM, with RN #18 , revealed the RN had been performing hemodialysis treatments in the facility for approximately one (1) year. RN #18 stated she had only used the Serim Residual Chlorine reagent strips for testing the chlorine of the treated water in the portable RO machines. According to RN #18 , the residual chlorine reagent strip was the only one she had used for the year she had been conducting hemodialysis treatments. RN #18 was unaware of the safe parameters for chlorine in the treated water. The RN stated if the reagent strip did not turn purple the water was safe to use.

An interview was conducted on 03/21/12, at 1:38 PM, with RN #19. According to RN #19 she had been using the residual chlorine strips to test the treated water for approximately one and one half (1 ) years. According to RN #19, if the strip did not change colors the water was safe for patient treatment. RN #19 was unaware of the safe parameters for treated water used for hemodialysis treatments.

Interview on 03/21/12, at 9:45 AM and 12:25 PM, with the Dialysis Manager revealed the manager was not aware the reagent strips in use for testing the treated water were not of sufficient sensitivity to ensure safe water for patient treatments. The Dialysis Manager stated staff had been trained to use the Serim Residual Chlorine reagent test strips to test the treated water from the portable RO machines. Additionally, staff had not been trained in the safe parameters (less than 0.1 mg/L) for treated water for hemodialysis treatments.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on observation, interview, record review, and review of facility policy regarding "Assessment and Reassessment of Inpatients", it was determined the facility failed to assess and evaluate Patient #23 for the use of a Sara sit to stand lift on admission, nor during the 12 hour RN assessments.

The findings include:

Review of the facility policy regarding "Assessment and Reassessment of Inpatients" revised 12/2011, revealed that at the time of admission, the needs of each patient are assessed by an RN . The Admission Assessment is completed by the RN as soon as possible upon arrival on the nursing unit . The reassessment is based upon, but not limited to the following: systems status related to medical diagnosis, patient care needs of nursing diagnosis identified in the patient plan of care, response to treatment, or change in condition. Unit Specific time frames listed for Med/Surgical area included initial assessment within 2 hours, completion of nursing history/database with 8 hours, and shift assessment within 12 hours, with reassessment with condition change.

Patient #23 was admitted to the facility, on 02/07/12 at 4:05 PM, with Congestive Heart Failure, Atrial Fibrillation, and Pulmonary Hypertension End Stage. Review of the transfer information received from the referring nursing facility, on 03/21/12, revealed a change of status notification which determined the patient was no longer ambulatory and was now using a sit to stand lift for transfers. Interview with the patient's niece, on 03/22/12 at 9:00 AM, revealed this was the patient's means of transfer to the bathroom, and she had informed the Registered Nurse on admission.

Observation on the 3rd floor unit during the survey, on 03/20/12-03/23/12, revealed there were no patients requiring the Sara sit to stand lift.

Review of the initial Admission RN assessment completed, on 02/07/12 at 4:16 PM, revealed under the Genitourinary section comments: Bedside commode with lift.

Interview with the Unit Manager #104 , on 03/22/12 at 9:50 AM, revealed the documentation of bedside commode with lift would be the initial assessment for the use of the Sara lift.

However, interview with RN #112, on 03/23/12 at 2:30 PM, revealed he was unaware the patient needed a lift, and his admission assessment did not mean to transfer to the bedside commode with the Sara Lift, but with a manual transfer from the staff to the bedside commode. The RN stated he did not get this information in report from the facility, and did not see it in the admitting information.

Interview with the Unit Manager #104, on 03/22/12 at 9:50 AM, revealed there should be a lift assessment completed by the RN's on admission, and during each twelve hour assessment period, and if the condition changes.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, record review, and review of the facility policy "Assessment and Reassessment of Inpatients", it was determined the facility failed to develop and initial plan of care for the safe use of the Sara sit to stand lift for Patient #23.

The findings include:

Review of the facility policy and procedure "Assessment and Reassessment of Inpatient's ", revised 12/2011, revealed that data gathered and evaluated throughout the patient's stay is used to determine the need for further assessment and to develop modifications to the plan of care.

Patient #23 had admission diagnoses of Congestive Heart Failure, Atrial Fibrillation, and Pulmonary Hypertension End Stage. The patient was admitted on [DATE]. Review of the transfer information received from the referring nursing facility, on 03/21/12, revealed a change of status notification which determined the patient was no longer ambulatory, and now required a sit to stand lift for transfers. Interview with the patient's niece, on 03/22/12 at 9:00 AM, revealed this was the patient's only means of transfer to the bathroom, and stated she had informed the Registered Nurse on admission.

The initial RN assessment for Patient #23, on 02/07/12, revealed under the Genitourinary section comment the patient was to be transferred to bedside commode with lift.

However, interview with RN #112, on 03/23/12 at 2:30 PM, revealed he was unaware the patient needed a lift, and his admission assessment did not mean to transfer to the bedside commode with the Sara Lift, but with a manual transfer from the staff to the bedside commode. Further interview revealed he was not informed by the family until 6:15 PM; he stated he had already completed the care plan. RN #112 stated the next nurse should have care planned for the use of the lift.

However, review of the initial plan of care and ongoing care plan revealed no evidence the Sara sit to stand lift had been addressed by the facility during the patient's stay.

Observation on the 3rd floor unit during the survey, on 03/20/12-03/23/12, revealed there were no patients requiring the Sara sit to stand lift.

Interview with the Unit Manager #104, on 03/22/12 at 10:15 AM, revealed that after the RN assessment, the RN is responsible for development of the care plan. The Unit Manager stated she would not care plan the lifts because they should be re-evaluated every time you have contact or assess the patient and that would not be included in the care plan.

Interview with the Chief Nursing Officer, on 03/22/12 at 1:00 PM, revealed there was no policy for use of the Sara sit to stand lifts, and did not feel the use of the type of lift for transferring residents should be developed in the plan of care.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on observation, interview and record review, and review of the "Sara 3000 Operating and Product Care Instruction" , it was determined the facility failed to provide adequate training to staff for use of the Sara sit to stand lift, and failed to provide a policy or procedure to direct or guide staff on the use of the lift. Refer to A395 and A397

The findings include:

Review of the "Sara 3000 Operating and Product Care Instruction" , dated June 2003, revealed: "Caution: Only use this or other methods after a satisfactory professional assessment has been carried out on the individual patient." There was no specific facility policy provided for use of the Sara sit to stand lift.

Interview with Patient #23's family member, on 03/22/12 at 9:00 AM, revealed the patient was to be transferred using a sit to stand lift which the patient had been using in the previous nursing facility. The family member stated she informed the facility of this and was told there were no sit to stand lifts; however, later the nurse returned with a Sara sit to stand lift, and stored the lift in the patient's bathroom. The family member also stated that nursing assistant #113 came into the room later, and asked them to leave the room to transfer patient #23 to the bedside commode. The patient was not transferred to the bedside commode using the lift; however, was transferred by pivoting the patient.

Interview with Nursing Assistant #113, on 3/22/12 at 5:00 PM, revealed he had not been trained on use of the Sara lift, and was not comfortable using it. He stated there was an in-service conducted by the lift representative last year; however, could not attend because he was working in the monitor room on that day.

Interview with Nursing Assistant #110, on 3/22/12 at 2:30 PM, revealed they didn't usually use the Sara sit to stand lift there, and did not remember attending the training on the lift. NA #110 stated another nursing assistant helped her use the lift the second day of the patient's stay on 02/08/12, because she was unaware of how to use it.

Interview with the Chief Nursing Officer, on 03/22/12 at 1:00 PM, revealed there was no training sign in sheets or documented evidence of the training last year by the lift representative, or who attended.

Review of the new hire orientation check list, or training logs, on 03/22/12, also revealed no evidence the Sara sit to stand lift had been included in the new hire orientation, or yearly competency training.

Interview with the Systems Education Coordinator, on 03/22/12 at 12:15 PM, revealed she was responsible for training for the use of the Sara sit to stand lift; however, stated the lift had not been included into the overall training program, because she was not in the building at that time, and was not involved in the planning of the purchase of the Sara lift. She stated that would explain why there was no documentation of who attended.

Interview with the Chief Nursing Office, on 03/22/12 at 12:15 PM, revealed the use of the sit to stand lift would need to be put into the competency training and new hire training, and there should be some type of policy or procedure for use of the lift.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and review of the facility policy it was determined the facility failed to ensure expired medications and solutions were not available for patient use. At Jewish South campus: three (3) bags of expired solutions were found in the OR and two (2) expired vials of 50% Dextrose were found in the [DIAGNOSES REDACTED] Crash cart. At Jewish Main: two (2) vials of insulin with no opened date listed, and three (3) expired pre-filled insulin syringes, and at Jewish Frazier: one (1) Novolin R Insulin vial, ten (10) milliliters (ml), 100 units/ml, were found in the medication refrigerator on 7 South. The vial was opened without an opened date listed, and a label was on the vial that stated, "Do not use after March 10, 2012."

The findings include:

Review of the policy "Unusable, expired, or returned medications", revised 01/20/12, revealed unused, expired or returned medications are accounted for, controlled, and disposed of by Pharmacy. Pharmacy inspects all medication storage areas on a regular basis for unusable/outdated medications. Expired drugs and short-dated medications are removed and the inventory count adjusted.

1. Jewish South- Inspections of OR suite #1, on 03/21/12 at 11:00 AM, revealed one 250 ml bag of Normal Saline solution in the Anesthesia medication cart. Observation of OR suite #3 revealed one 500 ml bag of Normal Saline solution with expiration date of February 2012 and one liter (1000 ml) bag of Normal Saline solution with expiration date of December 2011. These solutions were observed to be in the Anesthesia medication cart.

Observation of the [DIAGNOSES REDACTED] Crash cart, located in the Sterile Core on 03/21/12 at 11:30 AM, revealed two vials of Dextrose 50% (50 ml) with expiration dates of 03/01/12. Review of the medication content log revealed the crash cart had been checked daily and the pharmacy last inspection was 02/13/12 with an expiration date of 04/30/12.


Interview with the Nurse Manager, Surgical Services, on 03/21/12 at 11:30 AM, revealed the pharmacy was supposed to check the medication and crash carts. She indicated she did not know why the solutions were in the Anesthesia medication carts because that was not the solution of choice during surgery. She said the pharmacy checked the carts frequently; however, when she spoke with the pharmacy tech for this hospital, the tech stated she had not checked all drawers of the medication cart, only restocked the Anesthesia medication tray. The director indicated the expired Dextrose vials were a pharmacy oversight. She revealed there was no pharmacy onsite and medications were delivered from another pharmacy within the Jewish system. The pharmacy was responsible for checking the crash carts for expired medications. No pharmacy representative was onsite at this campus and was not available to be interviewed.

2. Observation, on 03/21/12 at 11:50 AM, on Jewish Main Campus, of the 5 Tower Unit medication refrigerator revealed an opened vial of Novolin R insulin with no date indicating when the vial was opened or when it was to expire. Additional observation of the refrigerator revealed three (3) prefilled Levemir insulin syringes that were expired. The documentation on the first syringe stated "do not use after 03/17/12". The second syringe label stated it was prepared on 03/18/12, and expired after twenty-four (24) hours (03/19/12). The third syringe label indicated it was prepared on 03/19/12, and stated "do not use after 03/20/12".

Interview, on 03/21/12 at 12:10 PM, on the Jewish Main Campus, with the 5 Tower Unit Manager revealed it was facility policy that insulin vials were to be dated when opened and the vial would expire twenty-eight (28) days after being opened. She stated the syringes should not have been in the refrigerator as they had expired. She stated the medication refrigerator is checked daily for expired medications.

Observation, on 03/22/12 at 10:45 AM, on the Jewish Main Campus, of the 5 East Neuro Unit medication refrigerator revealed an opened vial of Humulin R insulin with no documented date of when the vial was opened or when it was to expire.

Interview, on 03/22/12 at 10:45 AM, with the 5 East Neuro Unit Manager revealed it was facility policy that insulin vials were to be dated with the opened date as it would expire within twenty-eight (28) days. She stated the opened vial of insulin should not have been in the medication refrigerator.


3. Observation of the medication refrigerator on 7 South at Jewish Frazier, on 03/20/12 at 11:10 AM, revealed an opened ten (10) ml vial of Novolin R Insulin. The vial did not have a date listed for opening, but did have a label that stated "Do not use after March 10, 2012." This was the only vial of Novolin R in the medication refrigerator for this patient. According to the Medication Administration Record (MAR), this patient received four (4) doses of Novolin R after 03/10/12: one (1) on 03/13/12 at 11:42 AM; two (2) on 03/14/12 at 5:31 PM and 8:45 PM; and one (1) on 03/15/12 at 10:09 PM.

Interview with the Director of Nursing, Jewish Frazier, on 03/21/12 at 11:53 AM, revealed the "Do not use" labels were put on insulin vials by Pharmacy when they were stocked in the Pyxis. Therefore, these labels may or may not correspond to the twenty-eight (28) day expiration date after the vial is opened. She stated this process could be confusing with the vial having two (2) different expiration dates on it. She further revealed the process of placing the label on insulin vials may not be appropriate for Jewish Frazier which has a longer average length of stay than acute care. She also stated vials were to be dated and initialed by the Registered Nurse (RN) when opened.
VIOLATION: DISPOSAL OF TRASH Tag No: A0713
Based on observation, interview and facility policy review, it was determined the facility failed to follow their policy for sharps disposal which endangered hospital personnel. In one (1) of twelve (12) Operating Rooms, in the Main Jewish campus, a sharps container was overflowing.

The findings include:

Review of the policy, Procedure for Sharps Disposal, revealed the sharps containers should be closed when 2/3 to 3/4 full and glass should be disposed of in Glass waste container.

Observation of Operating Room 3 in Jewish Main, on 3/20/12 at 3:15 PM, revealed a red sharps container in the corner of the room that was over filled. There were two staple guns hanging out of the container. Needles and glass bottles could be seen in the top of the sharp's container.

Interview with Staff #14 (Operating Room Manager), on 3/20/12 at 3:15 PM, revealed all sharps containers should be changed when the container is no more than 3/4 full. She stated the danger in having the containers full is that as staff try to secure the lid they may get stuck by a dirty needle or cut by broken glass. She stated the staplers should never have been put in the sharps container as there is another container for those to be placed in for reprocessing and recycling.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and review of facility policy it was determined the facility failed to consistently implement the infection control program to prevent the development and transmission of disease and infections. Jewish South- observation of multiple attempts to start an intravenous line revealed cross-contamination and failure to wash hands between glove changes. Jewish Main- failure to wash hands and change gloves during a PICC (peripheral inserted central catheter) dressing change and the failure to maintain a sterile field during a PICC line insertion.

The findings include:

Review of the facility's policy "Central Line Dressing Change" last reviewed date 03/20/2010 revealed the purpose is to maintain asepsis and reduce the possibility of introducing infection at the catheter insertion site. Continued review of the policy Section III. Revealed the Luer Lock adapters or injection ports will be disinfected prior to accessing each time.

Review of the exposure control plan for bloodborne pathogens policy, revised 09/20/11, revealed gloves are to be worn when performing venipucture or other vascular access procedures. Hands will be washed immediately or as soon as feasible after removal of gloves or other PPE. Under PPE requirements, handwashing and gloves are required with IV insertion.

1. Observation, on 03/21/12 at 2:10 PM, revealed Registered Nurse (RN) #21 performed a PICC Central Line flush for an antibiotic infusion for Patient #36. RN #21 performed hand hygiene and applied clean gloves. Further observation of RN #21 revealed the nurse placing an opened box of clean 4x4's into the trash. She then opened a bag of NS IV fluids placing the outer bag into the trash. Observation revealed the nurse's gloved hands touched the trash. RN #21 proceeded to disinfect the Luer Lock of the purple lumen and connected the IV antibiotic. The nurse did not change her gloves nor wash her hands after touching the trash.

Interview, on 03/21/12 at 2:20 PM with RN#21, revealed she was aware hand hygiene and glove change should be performed anytime clean gloves come in contact with a dirty surface. She further stated by not performing a glove change the patient could get an infection because the PICC is a direct access line. She further stated she was unaware she had touched the trash with her gloved hand.

2. Observation, on 03/21/12 at 2:30 PM, revealed RN #22 performed a PICC Line dressing change for Patient #37. RN #22 performed hand hygiene and then utilized a bedside table as her sterile field. Observation revealed a urinal with 300 ml of yellow urine sitting next to the sterile field.

Interview, on 03/21/12 at 2:45 PM with RN #22, revealed she has been trained on how to set up a sterile field. She further stated the importance of keeping the bedside table clean to reduce the chances of bacteria from contaminating the PICC site. RN #22 stated a urinal should not have been sitting next to the sterile field.

Interview, on 03/21/12 at 3:00 PM, with Unit Manager RN #23, revealed nurses are trained in infection control. She further stated performing infection control observations of nurses every week; however, she could not produce any documented evidence. She further stated hand hygiene and glove changes should be performed anytime clean gloves come in contact with a dirty surface to prevent cross contamination. She stated it is important when performing a PICC Line Dressing change to maintain a clean work surface to prevent the risk of infection.

Interview, on 03/22/12 at 3:10 PM, with the Infection Control Nurse revealed staff are trained on infection control in general orientation. She further stated she conducted weekly audits of random units to ensure infection control procedures were followed. The Infection Control Nurse further stated when clean gloves come into contact with something dirty, hand hygiene should be performed and gloves changed to prevent contamination. She continued to state PICC Central Line dressing changes should be performed on a sterile field to reduce the introduction of organisms.





3. Jewish South-observation of multiple attempts to insert an intravenous peripheral line in Pre-OP, on 03/20/12 at 1:30 PM for Patient # 62, revealed the Anesthesia physician came into the room to administer a block prior to surgery. A peripheral intravenous (IV) line was started in the patient's left arm. IV fluids were infusing per gravity flow. The patient was administered Versed (5 mg) and Fentyl (2 mg) per the IV line. However, before Anesthesia could administer the block, the IV infiltrated and had to be removed. The Anesthesia physician attempted three (3) times without success. Observation during the attempted insertion of the IV angio revealed the Anesthesiologist touched the side rail, bed linens, monitor, and the patient's body on several places without changing gloves or washing his hands.

In addition, his assistant, CCRN (Critical Care Registered Nurse) attempted to insert the IV twice. She also touched the side rail, monitor, IV pole, and patient's body (arms, legs,and right foot) with the same pair of gloves. She removed the gloves after two (2) attempts and immediately applied another pair of gloves without washing or sanitizing her hands. The Nurse Manager of Surgical Services and two (2) other registered nurses were present during the procedure. The nurses changed their gloves upon contamination and washed their hands between glove changes.

Interview with the Nurse Manager of Surgical Services, on 03/20/12 at 2:00 PM, revealed it was facility practice to change gloves whenever contaminated and you should wash hands between glove changes. The anesthesiologist and the CCRN were in surgery and unavailable for interview.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observations, interviews, review of the server reports for operating rooms, and review of the 2012 Edition of Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, it was determined the facility failed to monitor and maintain the humidity and temperature levels in the operating rooms to ensure patients received care in a safe environment. This was identified for Jewish Hospital Main Campus, St. Mary's and Elizabeth Campus, and Jewish East Campus. Observation of the operating rooms at the Jewish Hospital Main revealed no mechanism to monitor humidity levels. Upon investigation of their system for monitoring humidity, it was found the alarms had not been enabled to the buildings automated system (BAS), no one was monitoring the system, no system was in place to observe and document any readings for humidity levels or temperatures, and there was no policy in place to direct staff. Review of the server report printed on 03/20/12 revealed a total of eight (8) of eight (8) Heart and Lung operating rooms with humidity levels ranging from 62% to 72%, greater than the acceptable high limit of 60% (RH). Review of the facility's main operating rooms server report, printed on 03/20/12, revealed four (4) of eleven (11) randomly selected operating rooms (OR) from the main hospital revealed humidity levels ranged from 60.6 % to 68.9 %, greater than the acceptable high limit of 60 % RH. Review of a graphical representation provided by the facility, with the report print date of 03/21/12, revealed from 02/20/12 through 03/21/12 fifteen (15) of fifteen (15) OR's had humidity levels that dropped below 30% RH and 20% RH routinely for numerous days. In addition, the facility did not ensure the alarms to monitor the humidity levels were enabled and set at the appropriate settings.

At the St. Mary's and Elizabeth Campus, the humidity and temperature alarms were set outside the AORN recommended range. In addition, the facility failed to monitor humidity and temperature levels daily.

At the Jewish East Campus, the facility did not have a policy to monitor the relative humidity (RH) or the temperatures in the operating room suites (OR). The facility did not maintain a log to document the humidity or the air temperatures in the OR.

The facility's failure to ensure humidity levels were monitored and maintained at appropriate levels placed patients at risk for serious harm, injury or death. Immediate Jeopardy was identified under the Condition of Participation for Surgical Services. The facility was notified of the immediate jeopardy on 03/22/12. The jeopardy was removed prior to exit on 03/23/12; however, a Condition level deficiency remains.

Validation of the immediate jeopardy removal:
The facility checked each OR to verify what the humidity levels were. The Operations Manager revealed no further surgeries/procedures would be performed until the OR room had been determined to be safe by engineering.

Engineering immediately ordered expedited calibrated humidity temperature sensors to be mounted on the wall in OR in an area to receive optimum readings. An OR Humidity Level Log (with humidity ranges to be between 30-60%) was developed for the OR nursing staff and engineers to monitor humidity levels and room temperatures daily.

The engineering staff were trained to use the manual humidity test called "the sling" and were checking the newly placed humidity sensors in all OR's on 03/23/12 to ensure the accuracy of the new humidity sensors.

The facility developed a new policy for Environmental Control that included monitoring humidity and temperature levels recommended by AORN.

The facility provided immediate on-site training for OR nurses, physicians, and engineering department on the new policy, the OR checklist, and AORN guidelines on 03/23/12. Those staff not present for on-site training will be trained prior to working in the OR.

Observations of OR suites at Jewish Main Campus, St. Mary's & Elizabeth Campus, and Jewish East on 03/22/12 and 03/23/12 validated the humidity and temperature level sensors were in place and within acceptable ranges according to the AORN guidelines.

Interviews with nursing, physicians, and engineering at all facility sites revealed staff had been trained on the new policy, humidity guidelines, documentation and AORN guidelines.

Refer to A951
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observations, interviews, review of the server reports for operating rooms, and review of the 2012 Edition of Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, it was determined the facility failed to monitor and maintain the humidity and temperature levels in the operating rooms to ensure patients received care in a safe environment. This was identified for Jewish Hospital Main Campus, St. Mary's and Elizabeth Campus, and Jewish East Campus. Observation of the operating rooms at the Jewish Hospital Main revealed no mechanism to monitor humidity levels. Upon investigation of their system for monitoring humidity, it was found the alarms had not been enabled to the buildings automated system (BAS), no one was monitoring the system, no system was in place to observe and document any readings for humidity levels or temperatures, and there was no policy in place to direct staff. Review of the server report printed on 03/20/12 revealed a total of eight (8) of eight (8) Heart and Lung operating rooms with humidity levels ranging from 62% to 72%, greater than the acceptable high limit of 60% (RH). Review of the facility's main operating rooms server report, printed on 03/20/12, revealed four (4) of eleven (11) randomly selected operating rooms (OR) from the main hospital revealed humidity levels ranged from 60.6 % to 68.9 %, greater than the acceptable high limit of 60 % RH. Review of a graphical representation provided by the facility, with the report print date of 03/21/12, revealed from 02/20/12 through 03/21/12 fifteen (15) of fifteen (15) OR's had humidity levels that dropped below 30% RH and 20% RH routinely for numerous days. In addition, the facility did not ensure the alarms to monitor the humidity levels were enabled and set at the appropriate settings.

At the St. Mary's and Elizabeth Campus the humidity and temperature alarms were set outside the AORN recommended range. In addition, the facility failed to monitor humidity and temperature levels daily.

At the Jewish East Campus the facility did not have a policy to monitor the relative humidity (RH) or the temperatures in the operating room suites (OR). The facility did not maintain a log to document the humidity or the air temperatures in the OR.


The findings include:

Review of the 2010 edition of the Association of Operating Room Nurses (AORN) revealed established recommended practices to reflect the acceptable relative humidity (RH) ranges of 20-60% and temperature ranges of 68-73 degrees Farenheit (F). The 2010 edition of AORN revealed low humidity increases the risk of electrostatic charges, which pose a fire hazard in the oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk for microbial growth in ares where sterile supplies are stored or procedures are preformed. The facility had no policys for environmenal safety regarding monitoring humidity levels and temperatures. The facility stated they use the Association of Operating Room Nurses (AORN) guidelines and American Institute of Architecture (AIA).

1. Jewish Main Hospital: Observation on 03/20/12 during the tour of OR's at 3:15 PM of operating room #3 at the Main campus revealed a thermostat mounted on the wall controlled the temperature; however, no mechanism for monitoring the humidity levels was in place. Additional observations of the Main OR's #'s 2, #4, #15 and Heart and Lung OR's #'s 2, #3, #4, and #6 revealed no mechanisms were in place for monitoring the humidity levels.

Interview, on 03/20/12 at 1:20 PM, with the Operations Manager for the facility's main operating rooms and Heart and Lung operating rooms revealed the operating room staff did not monitor the humidity and temperature levels. She stated the facility had an automated system which alerted engineering when the humidity and/or temperature levels were out-of-safe ranges. She identified the safe humidity range was thirty (30) to sixty (60)%. She stated the engineer would alert her or the charge nurse of unsafe conditions if they were to occur. Additional interview, on 03/21/12 at 8:47 AM, revealed she stated an engineer had notified her last August 2011 of concerns with humidity levels in the middle of the night and they would need to shut the operating rooms down until the problem was corrected. She did not know how the engineer was alerted and thought the alarm system was working. She had not questioned the engineers regarding on-going humidity levels being within the acceptable ranges. She stated during a meeting one to two months prior to the call she had met with the safety, infection control, and environmental staff to discuss temperatures and humidity out-of-range levels to develop a policy; however, the draft policy was not approved or implemented. She stated there was no mechanism in the OR's for staff to monitor information regarding humidity; therefore, staff had no way of knowing if there were any problems with the humidity levels unless they were notified by engineering. She revealed it was a serious concern because high humidity could contribute to increased infection due to bacteria growth, moisture could absorb through the sterile barriers, and pathogens could enter. If the humidity was too low it could cause wicking of the instrumentation, and could cause fires. She stated she had not received any reports of alarms since August of 2011.

Interview, on 03/21/12 at 8:47 AM, with the Intrim Director Vice President of Facilities, revealed once the facility was made aware of the out-of-range humidity levels they tried to find a written polity to include documentation or follow-up actions. He stated the facility had no policy to address monitoring of the humidity and temperature levels. He stated in discussing with the mechanic he had found the system was monitored on a daily basis by the automated system and was not sure of the frequency. He stated if the humidity or temperatures were out of set range an alarm should sound and generate a message to the mechanic that was in the facility. The mechanic was to notify two (2) people, an OR staff and somebody in engineering (craft mechanic airconditioning or contractor), to get the humidity levels back in range. He stated for some unknown reason the alarm system had been "turned off". After additional investigation he stated he learned the system had never been enabled. He stated they did not know how long the alarm had been off, but approximated four (4) to five (5) months. He stated the system could reproduce a report but the BAS would over-write itself after thirty (30) days and did not retain the data. He stated there was no evidence of humidity and temperature levels documented. He stated he was not aware of the reports that had been generated for the surveyors and only knew of the graph reports. He stated nobody was monitoring or reviewing any reports and they had not been proactive.

Interview, on 03/21/12 at 10:00 AM, with the Nurse Manager for the Outpatient Care Clinic (OCC) and the Hand Care Center (HCC) revealed she was responsible for twelve (12) OR's; eight (8) in the OCC and four (4) in the HCC. She stated the engineers monitored the humidity levels and they would notify her or the charge nurse of any out-of-range levels. She stated the HCC and OCC OR's humidity levels had not been out of safe ranges since she had been the manager (2010). She stated she was not aware of any concerns with the humidity levels in the OR's.

Review of the server report printed on 03/20/12 revealed a total of eight (8) of eight (8) Heart and Lung operating rooms with humidity levels ranging from 62% to 72%, greater than the acceptable high limit of 60% (RH). Review of the facilities main operating rooms server report printed on 03/20/12 revealed four (4) of eleven (11) randomly selected operating rooms (OR) from the main hospital revealed humidity levels ranged from 60.6 % to 68.9 %, greater than the acceptable high limit of 60 % RH. Review of a graphical representation provided by the facility, with the report print date of 03/21/12, revealed from 02/20/12 through 03/21/12 fifteen (15) of fifteen (15) OR's had humidity levels that dropped below 30% RH and 20% RH routienly for numerous days.





2. Review of the facility policy "Environmental Control" (last approval date 01/2011) which applied to Sts. Mary and Elizabeth Hospital, revealed "Appropriate monitoring of environmental control indicators will be handled by engineering personnel. Temperature: Individual thermostats in each OR are maintained at 68-72 degrees, monitored daily and documented. Humidity: Maintained at 30-60% throughout the OR suites and monitored daily and documented."

Interview with Staff #105 on 03/21/12 at 2:00 PM, revealed they followed the recommendations of the Association of Peri Operative Registered Nurses (AORN), regarding the operating rooms temperatures and humidity levels. Staff #105 provided a copy of the AORN 2012 recommendation the facility was using.

Review of the AORN recommendations revealed, "The quality of the air entering the operating rooms should be carefully controlled. Relative humidity should be maintained between 30% and 60% within the operating rooms. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Temperature should be maintained between 68 degrees to 73 degrees F within the operating room suite and general work area in sterile processing."

A review of the monitoring log for Sts. Mary and Elizabeth Hospital, of the temperatures and humidity levels, for 01/01/12 through 03/21/12 at 7:00 AM revealed that in Room 6 on 01/17/12 at 2:00 AM and on 02/16/12 at 10:00 AM the humidity level was 60.14%. Review of the temperature logs revealed the temperatures, more often than not, were below the AORN recommended temperature of 68 degrees F.

Interview with Staff #106 on 03/21/12 at 2:00 PM and at 3:50 PM revealed engineering set the temperatures as instructed by management of surgery. He stated the thermostats were set to maintain the rooms at the following temperatures: Room 1 was set at 65 degrees Fahrenheit (F), Room 2 was 66 degrees F, Room 3 was 68 degrees F, Room 4 was 69 degrees F, Room 5 was 65 degrees F, Room 6 was 65 degrees F, and Room 7 was 72 degrees F. The alarm for the temperatures was set for 65 degrees F to 73 degrees F. If the temperatures went outside of the range of 65 degrees F to 73 degrees F for 10 minutes or longer, the alarms would go off. The humidity alarms were set to go off when the humidity was below 30% or greater than 70%. Additional interview with Staff #106, on 03/22/12 at 11:00 AM, revealed his supervisor had informed him on 03/22/12 that the alarm system for the humidity in the operating rooms should have been set on 30% to 60%. He was not aware how it happened that the settings were changed to 70% or for how long it had been that way. Staff #106 stated the system was set to monitor the temperatures and humidity levels every eight (8) hours and set the alarms off if they remained out of the parameters for ten (10) minutes. He stated if the humidity levels were high, they were limited as to what they could do about it, because the system did not have any dehumidification on it.

Additional interview with Staff #105 on 03/21/12 at 2:00 PM and 3:50 PM revealed she was not aware the humidity levels had been above 60% on two (2) days in the past three (3) months or that the humidity alarms were set to go off at 70% instead of 60%. She also was not aware of the operating rooms temperatures not being in the AORN recommended ranges. Staff #105 stated the complications of the room temperatures being too low, was that it could cause the patient's body temperature to get too low causing complications. She stated she was given a print out monthly of the monitoring of the humidity levels and temperatures, but she had failed to review them thoroughly.





3. Jewish Hospital Medical Center East did not have a policy to monitor the relative humidity (RH) or the air temperatures in the operating room suites (OR).

Jewish Medical Center East did not maintain a log to document the humidity or the air temperatures in the OR.

Jewish Medical Center East could produce "live" time documentation of the current humidity and temperature readings of the OR from the computer; however, the facility could not produce a readout of previous humidity and temperature readings of the OR. The current reading provided on 03/21/12 revealed one (1) of the nine (9) operating room suites, Room Three (3), had a humidity reading of 63%, three (3) percent higher than the acceptable high range of 60%.

Interview, on 03/21/12 at 11:10 AM, with the Quality Director of Risk and Safety, Staff #142, revealed there was not a policy related to or addressing humidity or temperatures in the OR. Continued interview revealed that one engineer covered the entire facility and the computer screen with the current humidity and temperature readings would be more unmonitored than monitored. In addition, it was noted there was no alarm in place if the temperatures or humidity were in unacceptable ranges.

Interview, on 03/21/12 at 11:40 AM, with Systems Mechanic (engineering) Staff #148, revealed there was not a policy for either the humidity or the air temperatures related to the environment of the OR. He stated the process to monitor the humidity and temperatures within the OR was to look at the computer. It was revealed the computer reading was looked at every day. It was also revealed there was no fail safe or alarm on the computer to alert staff should the temperatures or the humidity fall out of an acceptable range.

Interview, on 03/21/12 at 1:50 PM, with the Director of Surgical Services Staff #144, revealed the humidity and air temperatures in the OR were to be monitored daily. She revealed the humidity was to be within 30% to 60% and the temperatures were to remain within a specific range. She stated each OR had a thermostat to monitor the temperature and the humidity was monitored by "the system". In addition, she stated if not visually observed, the humidity and temperatures may fluctuate without notice.

Interview, on 03/21/12 at 2:45 PM, with Systems Mechanic (engineering) Staff #165, revealed a log was not maintained for either humidity or temperatures in the OR. He stated he did not know the acceptable standards of practice for monitoring the humidity and temperatures in the OR. However, engineering was responsible to monitor the computer for the humidity and temperatures in the OR. He revealed he physically looked at the computer monitoring the humidity and temperatures in the OR at least once a day. He stated he was aware that high humidity contributed to mold growth and too low a humidity level may create static and cause a fire.