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1111 DUFF AVENUE

AMES, IA 50010

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on document review and staff interview, the hospital's administrative staff failed to ensure the facilities staff kept 1 of 1 contract for emergency diesel fuel current. The hospital's administrative staff identified an average of 100 inpatients per day.

Failure to keep the contract for emergency diesel fuel could potentially result in the contractor failing to provide diesel fuel to the hospital in the event of an emergency. Failure to provide diesel fuel could potentially result in the hospital lacking diesel fuel needed to run the generators for emergency power and burn to heat the hospital if the hospital lost power or heating.

Findings include:

1. Review of the contract for emergency fuel, dated 9/9/10, revealed in part, "The term of this Agreement [sic] shall begin on September 9, 2010 and shall expire on September 8, 2013."

2. During an interview on 8/7/17 at 3:00 PM, the Facilities Director stated the contact for emergency diesel fuel had slipped through the cracks and had expired. The Facilities Director stated he was working on getting a new contract for emergency diesel fuel.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on review of CSA (Contracted Services A) policies, procedures, manufacturer's information, CSA logs, observation, and staff interview, the hospital administrative staff did not ensure CSA staff performed the pH test in accordance with CSA's policy and procedure and manufacturer's recommendations, knew the acceptable range for the dialysis machine pH test results, and notified CSA's biomedical staff when the product pressure values fell outside the acceptable range for the portable reverse osmosis (RO) machine.

The dialysis machine dialysate pH has to be within an acceptable range before it is safe to use with dialysis patients. Staff should be aware of the acceptable range and perform the test in accordance with a policy/procedure and manufacturer's recommendations to ensure the machine is safe to use. Failure for staff to know what the acceptable pH range is and failure to perform the test in accordance with the policy/procedure and manufacturer's recommendations could potentially cause the staff to use a dialysis machine with a pH that did not fall into the acceptable range and/or obtain an inaccurate pH test result thereby using a dialysis machine that the staff would think had an acceptable pH test result which actually did not which could potentially cause harm to the dialysis patient.

The RO purifies the water used for the dialysis treatments. Dialysis staff is responsible for monitoring the RO and documenting this on a water treatment log. Each component that is monitored has an acceptable range written on the log. When dialysis staff document anything outside of the acceptable range, the log should contain documentation of biomedical notification and the response of the biomed personnel notified. Failure to document notification of unacceptable values could potentially cause staff to use equipment that does not function within the acceptable ranges which could potentially cause adverse consequences for the dialysis patients.

The hospital reported 5 patients were admitted to the hospital that required acute hemodialysis services at the time of the survey. Findings for observation of CSA staff performing the pH test prior to use of the dialysis machine (8/3/17) and 42 of 60 RO Product Pressure (PSI) readings from 5/1/17 through 7/31/17 that fell outside of the acceptable range without any documentation of biomedical personnel notification include:

1. Review of CSA's procedure titled "TESTING pH OF DIALYSATE USING RPC E-Z CHEK K100-0117 6.8-8.5 TEST STRIPS" Procedure: 7-11-04A, with a revision date of April 2017, included in part, "...Obtain a disposable collection cup and collect a sample of dialysate to be tested. Dip the strip into the solution to be tested and move the strip back and forth in the solution for one (1) second. Dip the strip and shake off excess dialysate. After 10 seconds, compare the strip to the scale on the vial. ...pH test results should be between 6.9-7.6. ...If results are outside the limit of 6.9-7.6, repeat test on another dialysate sample. If repeat test is outside limit of 6.9-7.6, the dialysate delivery system is unsafe to use for patient treatments. Dialysis delivery system is unsafe to use for patient treatments. Dialysis delivery system is to be labeled "Do Not Use" and Biomed teammate should be notified. Dialysis delivery system needs to be removed from patient treatment area. ... ."

2. Review of the manufacturer's information titled "RPC E-Z Chek 6.8-8.5 pH Dialysate & Concentrate Test Strips" dated 2011 included in part, "...pH strips are an accurate, easy, ...means for validating the pH of dialysate and concentrate solutions. ...On the color scale, a red line square surrounds the 6.8 and 7.8 pH values to indicate "no go"values outside the AAAMI [Association for the Advancement of Medical Instrumentation] recommended range for dialysate. ... ."

Review of the manufacturer's information titled "Mar Cor Purification Millennium Reverse Osmosis Unit Operation and Maintenance Manual" included in part, "...Product Pressure Gauge reads the product pressure from 0 to 100 PSI [Pounds per square inch]. Product pressure will read zero when the product line is not connected to a dialysis unit and the product hose is connected to the product fitting and the valve is open. ...Product Flow Too Low Low water temperatures, fouled membrane elements, or inadequate pump pressure can cause low product flow. A partial blockage of feed stream (dirty pre-filter) can also result in low product water flow by causing the pump to draw a strong vacuum. Similarly, an obstruction (defective check valve) in the product flow path may cause reduced flow. ..."

3. Observation on 8/3/17 at at approximately 9:50 AM showed CSA RN (Registered Nurse) A at dialysis station #2. CSA RN A obtained dialysate fluid from the dialysis machine using a syringe. CSA RN A then used the syringe to wet the pH strip and immediately compared the pH strip to the color blocks on the pH strip.

During an interview on 8/3/17 following the above observation, CSA RN A reported the acceptable pH range for the dialysate used during the dialysis treatment was 6.8 to 7.8.

Review of the RPC pH strip container showed the dialysate should be collected in a container, the pH strip should dipped in the dialysate, moved back and forth for 1 second and then wait for 10 seconds prior to comparing the test strip to the color blocks.

4. During an interview on 8/4/17 at 10:56, the CSA Group Hospital Services Administrator reported the acceptable pH for dialysate range was 6.9 to 7.6, not 6.8 to 7.8 that CSA RN A had reported. The CSA Group Hospital Services Administrator acknowledged CSA RN A had not performed the pH test in accordance with the CSA procedure and manufacturer's recommendations.

5. Review of the portable RO log titled "... (Name of CSA) Water Treatment Safety Record " from 5/1/17 through 7/31/17 showed the RO Product Pressure readings fell below the documented acceptable range for 42 of the 60 readings (5/1/17, 5/4/17, 5/5/17, 5/8/17, 5/10/17, 5/12/17, 5/15/17 (2 readings), 5/17/17, 5/19/17, 5/22/17, 5/24/17, 5/26/17, 5/29/17, 5/30/17, 5/31/17, 6/1/17, 6/2/17, 6/5/17, 6/7/17, 6/9/17, 6/12/17, 6/14/17, 6/16/17, 6/19/17, 6/23/17, 6/28/17, 6/30/17, 7/3/17, 7/5/17, 7/6/17, 7/7/17, 7/10/17, 7/12/17, 7/14/17, 7/17/17, 7/19/17, 7/21/17, 7/24/17, 7/26/17, 7/28/17, and 7/31/17).

The documentation did not reflect any biomed personnel notification of the RO product pressure reading falling below the acceptable range.

During an interview on 8/3/17 at approximately 10:28 AM, CSA RN A reported she documented Biomed notification on the logs anytime the readings fell outside the acceptable range.

6. During an interview on 8/4/17 at approximately 11:07 AM, the CSA Biomed Operations Manager acknowledged the logs showed multiple entries where the RO Product Pressure fell below the acceptable range without any Biomed notification. The CSA Biomed Operations Manager reported the RO Product Pressure would identify if enough water would flow to the dialysis machine for a dialysis treatment. Following consultation with CSA RN A, the CSA Biomed Operations Manager identified the readings for the RO product pressure were being performed incorrectly. The CSA Biomed Operations Manager acknowledged the readings were outside the acceptable parameters and staff should have notified the Biomed personnel of those readings. The hospital Director of Rehab and Wellness Liaison was present during the interview on 8/4 17 and did not have any questions.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on review of policies and procedures, CDC (Centers for Disease Control and Prevention) MMWR (Morbidity and Mortality Weekly Report) Recommendations and Reports, documentation, observation, and staff interview, the hospital administrative staff failed to ensure that the CSA (Contracted Services A) staff followed the approved infection control practices in accordance with CSA's policies and procedures in regard to hand hygiene, glove use, disinfecting equipment following use at 1 patient dialysis station and prior to taking it into another patient dialysis station, disinfecting the central line catheter (CVC) connections prior to disconnection from the bloodlines, and wearing a protective gown during the dialysis machine set-up.

Failure to follow approved infection control techniques to minimize cross contamination could potentially expose the hospitalized dialysis patients to bacterial contaminants and cause adverse outcomes including severe illness and/or death.

The hospital reported 5 patients were admitted to the hospital that required acute hemodialysis services at the time of the survey. Findings for observation of 2 of 2 patient treatments on 8/3/17 (Patient D2 and Patient D4) where approved infection control techniques were not followed include:

1. Review of CSA's policy titled "INFECTION CONTROL IN THE HOSPITAL DIALYSIS SETTING" Policy: 7-03-01, with a revision date of August 2017, included in part, "PURPOSE: To promote a safe, clean environment for all patients and teammates of the dialysis unit and to reduce the risk of spreading infections or bloodborne pathogens in a hospital dialysis setting. NOTE: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. .. Gloves should be worn when: * Potential for exposure to blood, dialysate and other potentially infectious substances ...Gloves should be changed when: ...Going from a "dirty" area or task to a "clean" area or task ...* After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's dialysis delivery system ...If electronic thermometers ...are used, measures will be taken to prevent cross contamination between patients. ...the device outer casing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient. ..."

Review of CSA" policy titled "HAND HYGIENE" with a revision date of April 2013 included in part, "PURPOSE: To prevent the spread of microorganisms and cross contamination between teammates, patients and equipment. ...Hands will be washed upon entering the hospital/facility, prior to gloving, after removal of gloves, between patients ...after patient and contaminated machine contact, between patients, before touching clean areas such as countertops ..."

Review of CSA's procedure titled "CENTRAL VENOUS CATHETER (CVC) PROCEDURE" Procedure: 7-04-02A, with a revision date of August 2017 included in part, "...UPON COMPLETION OF DIALYSIS ...Scrub CVC limbs/dialysis line connection with alcohol prep pad large enough to cover the circumference of the CVC limb, four per limb totaling 60 seconds. (15 seconds per pad)..."

2. Review of CDC MMWR Recommendations and Reports titled "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients," dated April 27, 2001 included in part, "... The hemodialysis machine and its components also can be vehicles for patient-to-patient transmission of bloodborne viruses and pathogenic bacteria. The external surfaces of the machine are the most likely sources for contamination... Contact transmission is the most important route by which pathogens are transmitted in health-care settings, including hemodialysis units... Contact transmission can be prevented by hand hygiene (i.e., hand washing or use of a waterless hand rub), glove use, and disinfection of environmental surfaces... Hands should always be washed after gloves are removed... If hands are not visibly soiled, use of a waterless antiseptic hand rub can be substituted for hand washing... Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel..."

3. Observation on 8/3/17 beginning at 9:00 AM in the acute hemodialysis treatment room showed CSA RN (Registered Nurse) A wearing a gown and gloves at dialysis station #2.
CSA RN A removed the gown and gloves, did not sanitize hands, went to the automatic medication dispenser, opened the door, reached inside, and obtained 2 bags of normal saline. CSA RN A then took the 2 bags of normal saline to dialysis station #2 and hung the saline on the intravenous pole connected to the hemodialysis machine. Without sanitizing hands, CSA RN A went to dialysis station #3 and placed the blood pressure cuff on Patient D2's arm. CSA RN A left dialysis station #3, removed the protective gown, sanitized hands and went behind the nurses' station to fill 2 medicine cups with water. CSA RN A went to dialysis station #2 without wearing a gown, gave Patient D4 a medicine cup filled with water, turned toward the dialysis machine and placed the bloodlines into the hemodialysis machine.

At approximately 9:30 AM, Physician A arrived at the acute hemodialysis treatment room. Physician A did not sanitize hands upon entering the acute dialysis treatment room. Physician A went to dialysis station #3 where Patient D2 was receiving dialysis. Physician A placed his hands on the side rails of the cart Patient D2 was laying on, and spoke with the patient.

CSA RN A picked up a portable phone from a counter/ledge above the nurses' station, dialed the phone and took it to dialysis station #3. At 9:32 AM, CSA RN A put on a protective gown and returned the portable phone to the counter/ledge above the nurses' station counter. Observation did not show CSA RN A disinfect the phone.

At 9:32 AM, CSA RN A retrieved the thermometer from the counter/ledge above the nurses' station. CSA RN A obtained Patient D2's temperature and returned the thermometer to the counter/ledge above the nurses' station without disinfecting the thermometer.

At approximately 9:33 AM, Physician A turned from Patient D2 and began typing on the computer keyboard at dialysis station #3. Physician B entered the dialysis treatment room and began speaking with Physician A. Physician A turned from the computer keyboard and both Physician A and Physician B placed their hands on the side rail of the cart Patient D2 was laying on. At 9:36 AM, Physician A left dialysis station #3 and went to the nurses' station, sat at the nurses' station and began typing on the computer keyboard. Physician A did not sanitize hands after leaving dialysis station #3 and before going to the nurses' station.

CSA RN A returned Patient D2's blood at the end of the dialysis treatment. CSA RNA scrubbed the dialysis CVC connections between the catheter limbs and the dialysis bloodlines with alcohol pads. Observation showed CSA RN A scrubbed each catheter limb/bloodline connection with 2 alcohol pads for 4 to 5 seconds with each pad.

4. During an interview on 8/3/17 at 9:44 AM, CSA RN A pointed at the nurses' station and stated, " That is considered my clean area." At 9:49 AM, CSA RN A reported someone from CSA had performed an infection control observational audit on 8/2/17. At 9:55 AM, CSA RN A reported she followed CDC recommendations.

5. Observation on 8/3/17 at approximately 10:02 AM showed CSA RN A picked up the portable phone that had been returned to the counter/ledge above the nurses' station without disinfection at 9:32 AM with ungloved hands and took the phone into the clean supply room. CSA RN A then left the clean supply room and placed the phone back on the counter/ledge.

At approximately 10:04 AM, CSA RN A without sanitizing gloves, donned gloves, protective gown and face shield. CSA RN A then went to dialysis station #2 and disinfected Patient D4's dialysis access. CSA RN A removed gloves, failed to sanitize hands, donned clean gloves and inserted the dialysis needles into Patient D4's dialysis access.

At approximately 10:15 AM, CSA RN A did not sanitize hands, donned gloves, picked up the thermometer from the counter/ledge above the nurses' station, went to Patient D4 and obtained the temperature for Patient D4. Without sanitizing the thermometer, CSA RN A returned the thermometer to the counter/ledge above the nurses' station.

At 10:22 AM, CSA RN A failed to sanitize hands, went to station #3 and donned gloves.

6. During an interview on 8/4/17 at 10:26 AM, CSA Group Hospital Services Administrator reported during the provision of hemodialysis services the dialysis staff are required to sanitize hands before and after glove use, the staff followed CDC recommendations, staff should disinfect equipment prior to taking it into a dialysis station, staff should wear a protective gown during the dialysis set-up, the CVC connections should be disinfected a total of 60 seconds with 4 alcohol pads, and all personnel including physicians should sanitize hands after leaving a dialysis station prior to entering a clean area.

Upon request CSA Group Hospital Services Administrator and CSA Hospital Services Administrator provided the infection control audit performed by CSA staff on 8/2/17. Review of the audit showed all goals were met and the auditor had not identified any deficient infection control practices. CSA Group Hospital Administrator Services and CSA Hospital Services Administrator acknowledged the CSA infection control audit performed on 8/2/17 and the infection control observations conducted during the survey were not consistent.

CSA Group Hospital Services Administrator and CSA Hospital Services Administrator acknowledged the findings. The hospital Director of Rehab and Wellness Liaison was present during the interview on 8/4/17 that began at 10:26 AM with CSA Group Hospital Administrator Services and CSA Hospital Services Administrator and did not have any questions.


27303


I. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure the central sterilization staff members followed the manufacturer's directions for 1 of 1 bottle of Metricide OPA Plus test strips. The hospital's administrative staff identified approximately 18 times during June 2017 that the hospital staff used Metricide OPA in the central sterilization area.

Failure to follow the manufacturer's directions resulted in the staff leaving the bottle of Metricide OPA Plus open, potentially resulting in the test strips failing to display an accurate reading. Failure of the testing strips to accurately display the minimum effective concentration of the active ingredient in Metricide OPA could potentially result in the Metricide OPA Plus lacking sufficient strength to kill all infectious organisms (bacteria, viruses, or fungi) and potentially spread infections between patients.

Findings include:

1. Observations during a tour of the central sterilization processing area on 7/18/17 at 9:50 AM revealed 1 of 1 bottle of Metricide OPA Plus test strips. The bottle was sitting on a shelf with the lid off the container. The bottle contained 68 test strips, with a new bottle containing 100 test strips. Review of the bottle's label revealed in part, "STORAGE IMPORTANT: Keep cap tightly closed."

2. Review of the "High level disinfection logbook - Metricide OPA" revealed the central sterilization staff members last used the Metricide OPA Plus test strips on 7/17/17 (the day prior to the observations).

3. During an interview at the time of the tour, the Sterile Processing Clinical Supervisor stated he did not know when the staff last used the bottle of Metricide OPA Plus test strips. The Sterile Processing Clinical Supervisor acknowledged the findings and agreed the central sterilization staff members should have placed the lid on the bottle of Metricide OPA Plus test strips after they used the bottle.