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Based on observation, interview, and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients as evidenced by:

1. The governing body failed to ensure Quality Assurance Performance Improvement activities had monitored and collected information of a construction area located in the sterile processing area to ensure the sterility of surgical supplies and packs that had been pre-sterilized were stored in a safe manner. (Cross reference A273, A749)

2. The governing body failed to have an effective Quality Assurance and Performance Improvement (QAPI) program in place to ensure the infection control risk assessment of the obsolete autoclave (equipment used to sterilize instruments) area in the Sterile Processing Department was collected daily and reviewed periodically. (Cross reference A283, A749)

3. The governing body failed to assume the legal responsibility to ensure its quality assurance and performance improvement program addressed the condition of the construction area in the Sterile Processing Department as cited in the original re-certification survey. (Cross Reference A309, A724)

4. The Governing Body failed to ensure the safety of surgical supplies and sterile surgical packs during construction in the department of central sterile processing. (Cross reference A309, A724, and A749)

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care that is in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.



26660

Based on observation, interview, and record review, the hospital failed to:
1. Ensure gowns with metal snaps were not stored in the warming unit with incorrect temperature.

2. Ensure the warming unit was maintained at the correct temperature.

These failures had the potential for patients to receive a burn from the heated metal snaps.

Findings:

1. During a concurrent observation and interview with Registered Nurse (RN) 6, on 5/16/16, at 2:20 PM, in the GI (Gastrointestinal- area where procedures are performed on individuals to examine the food pipe, stomach, and small intestine) laboratory, the temperature on the warming cabinet read 144° (degrees) Fahrenheit (F). Inside the warming cabinet was a patient gown with metal snaps. RN 6 stated "That (gown) shouldn't be in here." RN 6 verified the temperature of the warming cabinet.

2. During an observation on 5/16/16, at 2:45 PM, in the Emergency Room, the warming cabinet (top chamber) temperature read 141° F. The Director of Emergency Services (DES) verified the findings. The DES made no further comment.

The hospital policy and procedure titled: "Warming Parenteral, Irrigation, Peritoneal Dialysis Solution and Patient Care Blankets," revised date 2/2014, indicated: "A. Warming Recommendations 4. Patient Care Blankets a. Patient care blankets can be warmed to temperatures up to 130° F. B. 1. Warming cabinets will be monitored on a daily basis in compliance to recommended temperature ranges."

Based on observation, interview, and review of its infection control and prevention program, the hospital failed to monitor and collect information of a construction area located in the sterile processing area. This failure had the potential to compromise the sterility of the surgical supplies and instruments.

Findings:

During a tour of the hospital's Central Sterile Processing Area, on 5/17/2016, at 9 AM, with the Project Manager for Construction (PM), Epidemiologist (EPI), Sterile Processing Supervisor (SPS), Chief Nursing Officer (CNO), and Director of Preoperative Services (DPS), a plastic barrier, 42 feet long by 12 feet high, which separated a construction area from the rest of the central processing area was observed. Inside the construction area, there were exposed pipes due to missing ceiling tiles. The base of the plastic was not secured to the floor which allowed air to lift the barrier off the floor. There were multiple holes in the plastic barrier which were covered with tape. Air was blowing from the construction area into the Central Sterile Processing area. Directly adjacent to the plastic barrier were a number of stainless steel wire carts containing sterile supplies and surgical packs, waiting to be transported to the operating room for patient use. It was also observed there were several "crash carts" stored directly adjacent to the plastic barrier. When the carts, crash carts and stainless steel storage carts were wiped with a clean white cloth, there was a visible black residue on the cloth, indicating possible contamination of sterile supplies on the carts.

During an interview with EPI, CNO, DPS and the SPS, on 5/17/16, at 9:30 AM, they were not aware of the amount of dust and dirt recovered. The EPI then provided a hospital policy and procedure titled "Infection Control Construction Permit". This permit, dated 3/22/16 and posted next to the construction site, indicated the construction would be completed within two weeks and would be "small scale, short duration" and at "Medium Risk". The purpose of the construction was to repair and fix the leak in the area from a flooding incident occurred in September last year. The work would involve major demolition and new construction of the area and would affect all patients seeking treatment at the hospital (also called Class IV construction requiring the most protective measures to minimize risk of hospital acquired infections). The Permit posted next to the construction was marked as a "Class 2." However, review of the hospital "Infection Control Risk Assessment Tool" revealed Sterile Processing Department was in Group 4, the highest risk area for infection control.

During interviews with the EPI and the SPS, on 5/17/16, at 9:45 AM, the hospital staff stated the daily inspections had not been performed because of the expected short duration of the construction. A state of Immediate Jeopardy was declared because the dust and dirt contamination could not be consistent with sterile surgical supplies and equipment.

Based on observation, interview, and record review, the hospital failed to have an effective Quality Assurance and Performance Improvement (QAPI) program in place to ensure information regarding the infection control risk of the construction area in the sterile processing department was collected daily and reviewed periodically. This failure resulted in the hospital's inability to ensure safe care to its patients.

Findings:

During a tour of the Central Processing Department of the hospital with the Project Manager for Construction (PM), the Epidemiologist (EPI), the Sterile Processing Supervisor (SPS), the Chief Nursing Officer (CNO), and the Director of Preoperative Services (DPS), on 5/17/2016, at 9 AM, a large, 42 feet long by approximately 12 feet high, plastic barrier was observed to the right of the entrance. This area used to house an autoclave (equipment used to sterilize surgical equipment). The PM stated the autoclave was removed from use sometime ago and the room became vacant and unusable. The PM explained during a flooding incident last September, the leak caused some damage to the ceiling tiles and the pipes. The plastic barrier was used to ensure the dust and debris could not escape to the Sterile Processing area. The plastic barrier was found to have multiple tears and not secured to the floor. There was consistent air blowing from the construction area outward to the Sterile Processing Department.

Also observed was an "Infection Control Construction Permit," dated 3/22/16, posted next to the construction area and signed by the EPI, Manager, Plant Operations (MPO), and the Chief Operating Officer/Acting Quality/Risk Management Director COO. The Permit indicated the construction would take about two weeks to complete. The plastic barrier remained in place through 5/16/16. Neither the EPI nor the PM was able to provide an updated Infection Control Construction Permit.

During interviews with the EPI and the SPS, on 5/17/16, at 9:45 AM, both stated the daily inspections had not been done because he (EPI) assumed the work would be done in two weeks. The EPI was not aware of the construction inside the contained area was still ongoing.

The hospital's policy and procedure on "Construction/Renovation and Infection Control", reviewed on 10/2015, under "ENFORCEMENT", read: "A. The Project/Construction Manager and contractor are responsible for daily compliance monitoring per the Daily Monitoring Form... C. The Project/Construction Manager will maintain records of such compliance rounds." The hospital could not provide any completed "Daily Monitoring Form: or other documentation of monitoring of this construction area from 3/22/16 through 5/16/16.



36543

During an observation and concurrent interview with the PM, on 5/16/16, at 9:41 AM, in the Central Sterile Processing and Supply area, a large, approximately 42 feet long by 12 feet high, plastic barrier was observed. The hospital document titled "Infection Control Construction Permit, Attachment B" (ICCP), dated 3/22/16, was posted at the zippered doorway. The ICCP indicated this was a "Group II, Type B" project with an estimated duration of two weeks. The area under the zippered doorway was not sealed to the floor and the plastic wall panels were observed to be bulging outward toward the sterile supplies. Upon entering the construction area, it was observed that several holes in the plastic barrier had been previously repaired with tape while additional holes had not been repaired. A high-efficiency particulate arresting (HEPA) filter (removes particulates from the air) was blowing towards the sterile supply area. The obsolete sterilizer, which had been observed during the 3/2016 survey, had been removed however the exterior wall had not been closed and sealed. The interior wall was stripped down to the studs. The damaged ceiling had been removed, exposing the basement infrastructure including steam pipes. The cement block drains for the steam lines were covered in plastic, and steam was observed to be rising from the major drain and water dripping into a secondary drain. The plastic covering the cement blocks were wet with condensation. Upon removing the plastic, a brownish scorch type discoloration was noted. The PM stated the plastic had been placed by the company, which had removed the damaged wallboard and ceiling tiles, around 3/11/16. No explanation was provided for why the plastic was still in place. She also stated the opening for the sterilizer remained because of the possibility that a new sterilizer would be ordered and that the project had been stalled as they researched various sterilizers.

The hospital policy and procedure titled "Infection Control Risk Assessment Tool (ICRA), Attachment A," dated 10/27/15, indicated under Definition of construction Activity Types "Type C:" Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies. Includes...removal of ceiling tiles, new wall construction; minor ductwork or electrical work above ceiling...any activity that cannot be completed within a single shift and also indicated under Definition of Infection Control Risk Groups, "Group 4 Highest [Risk]:" Sterile Processing."

During a record review and concurrent interview with the EPI, on 5/16/16, at 11:59 AM, he stated the project was completed and the paperwork had been filed. It (the removal of the obsolete sterilizer) only took three days. No explanation of why the plastic barrier remained up or why the ceiling and walls remained open was provided. The EPI was unable to provide any documentation of monitoring of the construction area and stated it was just for three days. The EPI stated the Infection Control Coordinator (ICC) was responsible to monitor the construction area (including barrier integrity) while the project was ongoing. He then restated that the project was completed in three days.

During an interview with the Director of Facilities/Consultant (DFC), on 5/16/16, at 12:04 PM, he stated the project "is not complete." The EPI then stated the ICRA had not been updated.

During an interview with the PM, on 5/17/16, at 8:50 AM, she stated the ICRA was for the entire project and included the abatement (demolition and clean-up) and the removal of the obsolete sterilizer.

The hospital policy and procedure titled Construction/Renovation and Infection Control, dated 10/27/15, indicated under "REPORTING" B. The Project/Construction Manager shall keep members of the Infection Control Risk Assessment Team apprised as to the progress of construction."

Based on observations, interviews, and review of documents, the hospital's governing body failed to assume the legal responsibility to ensure its quality assurance and performance improvement program addressed the condition of the construction area in the Sterile Processing Department as cited in the original re-certification survey.

This failure had the potential to affect the sterility of ready-for-patient-use surgical supplies and sterile surgical packs stored in the Sterile Processing Department and unsafe care to all patients in the hospital.

Findings:

During a tour of the central processing area of the hospital, on 5/17/2016, at 9 AM, with the Project Manager for Construction (PM), the Epidemiologist (EPI), the Sterile Processing Supervisor (SPS), the Chief Nursing Officer (CNO), and the Director of Preoperative Services (DPS), the condition of the old autoclave (equipment used to sterilize surgical tools) area was inspected. It was observed that sterile supplies were stored on numerous stainless steel storage carts and several crash carts outside the construction area. A plastic barrier covered the outside of the construction area to contain the dust and debris caused by the construction. There were several tears in the plastic barrier held together by construction tape. The barrier was not secured to the floor by paper tape and left enough space for air to blow from the construction area to the Sterile Processing Department. The PM stated the duration of the construction should have been only two weeks, starting 3/22/16.

The policy and procedure on "Construction/Renovation and Infection Control" was reviewed on 5/17/16. The hospital's policy and procedure indicated the PM and contractor were responsible for "daily compliance monitoring per Daily Monitoring Form."

During an observation on 5/17/16, at 9:30 PM, when the carts, crash carts and stainless steel storage carts were wiped with a clean white cloth, there was a visible black residue on the cloth, indicating possible contamination of sterile supplies on the carts. The EPI, CNO, the DPS and the SPS were not aware of the amount of dust and dirt generated by the construction.

During interviews with the EPI and the SPS, on 5/17/16, at 9:45 AM, both stated the daily inspections had not been performed because of the expected short duration of the construction.

Based on observation, interview, and record review, the hospital failed to have a care plan (provide direction for the type of care the patient needs) for three (2, 3,and 4) of 30 sampled patients. This failure had the potential for staff not knowing how to provide care for their patients.

Findings:

During an observation on 5/16/16, at 2:55 PM, in the Intensive Care Unit (ICU), there was a sign outside the room of Patient 2 indicating Contact Isolation.

During an interview with Registered Nurse (RN) 12, on 5/16/16, at 3 PM, she stated Patient 2 was on Contact Isolation for C. Diff (Clostridium difficile- is a bacterial infection that causes mild to life-threatening forms of diarrhea).

During a review of the Electronic Medical Record (EMR) for Patient 2, with the Director of Telemetry (DT) she was unable to locate a care plan for Patient 2 being on Isolation. The DT stated "There isn't one."

During an observation on 5/16/16, at 3:35 PM, there was a sign outside of Patient 3's room indicating Droplet and Contact Isolation.

During a review of the EMR for Patient 3, with the DT she was unable to locate a care plan for Patient 3 being on Isolation. The DT stated "There should be one..."

During a observation on 5/17/16, at 12:42 PM, there was a sign outside of Patient 4's room indicating Contact Precautions.

During a review of the EMR for Patient 4, the was no care plan found for Isolation. The DT verified the findings.

Based on observation, interview, and record review, the hospital failed to ensure one medication was administered as ordered for one random observed patient (31). The medication to lower blood sugar, to be administered before meals (breakfast and dinners), was administered after breakfast. As a result, there was a potential for Patient 31 to experience preventable and unwanted side effects, including low blood sugar.

Findings:

During an observation of the medication administration on 5/17/16 starting at 8:40 AM, Registered Nurse (RN) 2 prepared seven medications for Patient 31. One of the medications was Repaglinide (Prandin), a medication to lower blood sugar.

At 8:55 AM, RN 2 entered Patient 31's room and started the administration process. Repaglinide was administered soon after.

Patient 31's clinical record was reviewed with Pharmacist 1 on 5/17/16 at 11:40 AM.

On 5/14/16, Patient 31 was prescribed Repaglinide 5 milligrams (mg) orally twice daily, 15 to 30 minutes before meal.

According to the Medication Administration Record (MAR), the medication was documented as administered at 8:57 AM on 5/17/16.

During an interview on 5/17/16 at 12 PM, the Assistant Director (AD) stated breakfast was delivered between 7:30 and 7:45 AM. The AD stated Patient 31 probably ate her breakfast between 8 and 8:30 AM. The AD acknowledged the medication was administered after breakfast, instead of 15 to 30 minutes before breakfast, as ordered by the prescriber.

According to the hospital's policy, Administration of Medication, revised 4/2016, "Verification of Medication Administration ... Person administering medications shall still complete the manual process of performing the "Eight Rights" (Right Patient...Right Time...)."

Based on observation, interview, and record review, the hospital failed to ensure unused medications were disposed of according to the policy. As a result, during the observation of the medication administration for a random patient (31), Registered Nurse (RN) 2 placed the unwanted medication in the container designed for sharp disposal (such as used needles and syringes), instead of the designated container for pharmaceutical waste disposal.

Findings:

During an observation of the medication administration on 5/17/16 starting at 8:40 AM, RN 2 prepared Repaglinide (Prandin, a medication to lower blood sugar) for Patient 31. The dose was 5 milligrams (mg), and RN 2 had three 2-mg tablets, or 6 mg total. RN 2 cut one of the 2-mg tablet into halves, and administered the dose. RN 2 then placed one-half tablet (1 mg) into the container designed for sharp disposal.

RN 2 confirmed one-half tablet was placed in the container for sharp disposal.

During an interview on 5/17/16 at 9:40 AM, the Director of Pharmacy and Assistant Director stated one-half tablet (unused medication) should have been disposed of in the "blue" container, designed for pharmaceutical waste, and should not have been disposed of in the container designed for sharp disposal.

According to the hospital's policy, Expired, Outdated, Usable, Unusable Medications, revised 4/2016, "Medications ... shall be disposed in hospital-approved disposal bins such as: i. Incineration (Blue)...." The policy did not list the container for sharp disposal as an acceptable choice for pharmaceutical waste.

Based on observation, interview, and record review, the hospital failed to ensure all medications in the crash carts, including intravenous medications, were checked by a pharmacist before locking the crash cart to ensure the contents were accurate. As a result, there was a potential for inaccurate stocking of medications needed during medical emergencies.

Findings:

The crash cart in the Emergency Department (ED) was inspected with the Director of Pharmacy (DOP) and the Assistant Director (AD) on 5/16/16 at 3:30 P.M. The crash cart contained two sealed medication boxes in one drawer, and the intravenous medications in another drawer.

During the inspection, the DOP and the AD stated the pharmacist would place the medication boxes in the crash cart, while the intravenous medications were stocked by Central Supply. They stated the pharmacist would be the last person locking the crash cart, but the pharmacist did not check the intravenous medications to ensure they were accurately stocked. The AD acknowledged the pharmacist should be checking the intravenous solution before locking the crash cart.

According to the hospital's policy, Maintenance and Review of Crash Carts, revised 4/2016, Attachment B (Crash Cart Replacement Flowchart), the pharmacist would place the medication boxes in the crash cart, and be the last person locking the crash cart, indicating it was ready for use. The policy, however, did not require the pharmacist to check the intravenous solutions before locking the crash cart to ensure the medication contents were accurate.

Based on observation, interview, and record review, the hospital failed to ensure compounded sterile (germ-free) medications were labeled with the beyond-use-date (BUD, a date after which a medication should not be used or stored) consistent with the hospital's guidelines (compounding recipe).

As a result, two doses of medications for one randomly reviewed patient (32) were not labeled with the BUD specified by the compounding recipe. These failures had the potential for deteriorated (reduced in quality and or strength) medications to be available for patient use.

Findings:

During a tour of the pharmacy on 5/16/16 at 11:05 AM with the Director of Pharmacy (DOP) and the Assistant Director (AD), two one-liter bags of intravenous (IV, medication administered directly into the vein) solution containing vitamins, folic acid, and magnesium sulfate were in the refrigerator, labeled for Patient 32. The DOP and the AD confirmed they were compounded on 5/14/16 at 10:40 AM, and the BUD was 5/17/16 at 10:40 AM. The BUD was 72 hours.

During a concurrent interview and record review on 5/17/16 at 10:40 AM, with the DOP and AD, they stated the compounded IV solution should have a BUD of 24 hours refrigerated, according to the compounding recipe and record ([Name] Hospital Pharmacy Compounded Product Master Formula Record).

Based on observation, interview, and record review, the hospital failed to ensure expired medications were not available for patient use. As a result, two expired medications were found in the medication refrigerator in the Emergency Department (ED).

Findings:

The medication storage in the ED was inspected with the Director of Pharmacy (DOP) and the Assistant Director (AD) on 5/16/16 at 2:35 PM. The medication refrigerator contained the following medications:

DT (a vaccine), quantity 4, expiration date of 4/4/16; and,
Promethazine suppository (medication to treat nausea, vomiting) 12.5 milligrams (mg), quantity 10, expiration date 7/2015.

The medication storage in the pharmacy for DT and Promethazine suppository was inspected on 5/16/16 at 2:50 PM with the DOP and the AD. Five more doses of DT had the expiration date of 4/4/16.

During an interview on 5/16/16 at 2:55 PM, the AD stated the pharmacy technician was responsible for removing outdated medications in the pharmacy, under the supervision of the pharmacist. In addition, the ED was inspected monthly by a pharmacist, and the last inspection was on 4/25/16. The AD added, the pharmacist was supposed to inspect each medication stored in the ED for outdates.

According to the hospital's policy, Expired, Outdated, Usable or Unusable Medications, revised 4/2016, "The following "unusable" medications shall be removed from use and segregated from usable stock: Expired (outdated)..."

Based on observation and interviews, the hospital failed to ensure sterile packs and supplies used in surgery had been stored in a safe and effective manner. These failures had the potential to place surgical patients at risk to infectious diseases.

Findings:

During a tour of the central processing area of the hospital, on 5/17/16, at 9 AM, with the Project Manager for Construction (PM), the Epidemiologist (EPI), the Sterile Processing Supervisor (SPS), the Chief Nursing Officer (CNO), and the Director of Preoperative Services (DPS), the condition of the old autoclave (equipment used to sterilize surgical tools) area was inspected. It was observed that there were some sterile supplies stored on numerous stainless steel storage carts and several crash carts outside the construction area. There was a plastic barrier covered the outside of the construction area to contain the dust and debris caused by the construction. There were several tears in the plastic barrier held together by construction tape. The barrier was not secured to the floor by paper tape and left enough space for air to blow from the construction area to the Sterile Processing Department.

During an observation on 5/17/16, at 9:30 PM, when the carts, crash carts and stainless steel storage carts were wiped with a clean white cloth, there was a visible black residue on the cloth, indicating possible contamination of sterile supplies on the carts. The Epidemiologist, the CNO, the DPS and the SPS were unaware of the amount of dust and dirt that was generated by the construction.

During a concurrent interview with the EPI and the SPS, on 5/17/16, at 9:45 AM, both stated the sterile supplies, sterile packs, and crash carts were ready for patient use and they were not aware the amount of dust collected on these carts.



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36041




34709

Based on observation, interviews, and a review of documents supplied by the hospital, the hospital failed to:

1. Ensure sanitary environment in central sterile processing. (Cross reference A749)

2. Ensure active surveillance during construction in the Central Sterile Processing department and sterility of surgical packs and instruments being stored in the department during construction. (Cross reference A 749)

3. Ensure staff wore PPE (Personal Protective Equipment) in an isolation room. (Cross reference A749)

4. Ensure family wore PPE when in an isolation room. (Cross reference A 749)

5. Ensure dialysis (treatment for cleansing the blood of toxins) supplies are not stored in an isolation cart. (Cross reference A 749)

6. Ensure staff did not store personal belongings on the dialysis machine. (Cross reference A 749)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective infection control program to ensure safe care was provided in a sanitary environment without placing patients, staff, and visitors at risk of being exposed to infectious diseases.

Immediate Jeopardy (IJ)

Due to the hospitals failure to implement an effective Infection Control Program, on 5/17/16, at 10:35 AM, the Medical Consultant and Survey Team Coordinator verbally notified the Hospital Administrative representatives of the IJ. Present when the IJ was called were the Chief Operating Officer (COO), the Chief Nursing Officer (CNO), the Director of Quality/Consultant (DQC), the Director of Perioperative Services (DPS), the Epidemiologist (EPI), the Health Facilities Evaluator Nurse, the Health Facilities Evaluator, and the Pharmacy Consultant.

The IJ identified widespread dust and dirt soiling in the Central Sterile Processing area and the possible contamination of sterile surgical trays and sterile supplies stored in the area adjacent to the construction area in the department. These findings were presented to the Hospital Administrative representatives.

The IJ was removed on 5/18/16, at 10:15 AM, in the presence of the COO, the Sterile Processing Supervisor, the CNO, the EPI, and the DPS after construction of an effective, solid barrier, between the department of central sterile processing and construction area was completed and all supplies were effectively covered with barriers.



25558

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

1. Ensure sanitary environment in central sterile processing.

2. Ensure active surveillance during construction in the Central Sterile Processing department and sterility of surgical packs and instruments being stored in the department during construction.

3. Ensure staff wore PPE (Personal Protective Equipment) in an isolation room.

4. Ensure family wore PPE when in an isolation room.

5. Ensure dialysis (treatment for cleansing the blood of toxins) supplies are not stored in an isolation cart.

6. Ensure staff did not store personal belongings on the dialysis machine.

These failures had the potential for placing patients, staff, and visitors at risk of being exposed to infectious diseases.

7. Ensure a process was established to prevent healthcare-associated infections* (HAI) when a licensed nurse failed to clean the tip of the insulin pen (an injection device to administer insulin) before administration to one randomly observed patient (1). As a result, there was a potential for Patient 1 to become infected due to contamination during the medication administration process.

*According to the Centers for Disease Control and Prevention (CDC), on any given day, about 1 in 25 hospital patients has at least one HAI. There were an estimated 722,000 HAIs in U.S. acute care hospitals in 2011. About 75,000 hospital patients with HAIs died during their hospitalizations. (http://www.cdc.gov/HAI/surveillance/index.html)

Findings:

1. A tour of the central processing area of the hospital was conducted, on 5/17/16, at 9 AM, with the Project Manager for Construction (PM), the Epidemiologist (EPI), the Sterile Processing Supervisor (SPS), the Chief Nursing Officer (CNO), and the Director of Preoperative Services (DPS). During the tour the presence of a 42 feet long, approximately 12 feet high, plastic barrier separating a space for access to the construction area of the department was observed. There were numerous taped over holes in the barrier, as well as air lifting the base of the barrier, with air blowing from the construction site into Central Sterile Processing. Directly adjacent to the barrier were a number of stainless steel wire carts containing sterile supplies and surgical packs, waiting for transport to surgery for patient use. Several "crash carts" were also being stored directly adjacent to the plastic barrier. When the carts, crash carts and stainless steel storage carts were wiped with a clean white cloth, gross dirt and dust were recovered from the crash cart, sterile supply cart and carts extending along the 42 feet long barrier.

2. During interviews with the EPI and the SPS, on 5/17/16, at 9:45 AM, the hospital staff stated the daily inspections had not been performed because of the expected short duration of the construction.



36543

3. During an observation on 5/16/16, at 9:41 AM, in the Central Sterile Processing and Supply area a large, approximately 42 feet long by 12 feet high, plastic barrier was observed. The hospital document titled "Infection Control Construction Permit, Attachment B" (ICCP), dated 3/22/16, was posted at the zippered doorway. The ICCP indicated this was a "Group II, Type B" project with an estimated duration of two weeks. The area under the zippered doorway was not sealed to the floor and the plastic wall panels were observed to be bulging outward toward the sterile supplies. Upon entering the construction area, it was observed that several holes in the plastic barrier had been previously repaired with tape while additional holes had not been repaired. A high-efficiency particulate arresting (HEPA) filter (removes particulates from the air) was blowing towards the sterile supply area. The obsolete sterilizer, which had been observed during the 3/2016 survey, had been removed however the exterior wall had not been closed and sealed. The interior wall was stripped down to the studs. The damaged ceiling had been removed, exposing the basement infrastructure including steam pipes. The cement block drains for the steam lines were covered in plastic, and steam was observed to be rising from the major drain and water dripping into a secondary drain. The plastic covering the cement blocks were wet with condensation.

During an observation and concurrent interview with the Project Manager (PM) on 5/16/16, at 10 AM, she stated the plastic had been placed by the company, which had removed the damaged wallboard and ceiling tiles, around 3/11/16. No explanation was provided for why the plastic was still in place. Upon removing the plastic covering the drains, brownish scorch type discoloration was noted. She also stated the opening for the sterilizer remained because of the possibility that a new sterilizer would be ordered and that the project had been stalled as they researched various sterilizers.

The hospital policy and procedure titled "Infection Control Risk Assessment (ICRA) Tool, Attachment A," dated 10/27/15, indicated under Definition of Construction Activity Types "Type C:" Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies. Includes...removal of ceiling tiles, new wall construction; minor ductwork or electrical work above ceiling...any activity that cannot be completed within a single shift and also indicated under Definition of Infection Control Risk Groups, "Group 4 Highest [Risk]:" Sterile Processing."

During a record review and concurrent interview with the EPI, on 5/16/16, at 11:59 AM, he stated the project was completed and the paperwork had been filed. It (the removal of the obsolete sterilizer) only took three days. The EPI offered no explanation of why the plastic barrier remained up or why ceiling and walls remained open. The EPI was unable to provide any documentation of monitoring of the construction area and stated it was just for three days. The EPI stated the Infection Control Coordinator (ICC) was responsible to monitor the construction area (including barrier integrity) while the project was ongoing. He then restated that the project was completed in three days.

During an interview with the Director of Facilities/Consultant (DFC), on 5/16/16, at 12:04 PM, he stated the project "is not complete." The EPI then stated the ICRA had not been updated.

During an interview with the PM, on 5/17/16, at 8:50 AM, she stated the ICRA was for the entire project and included the abatement (demolition and clean-up) and the removal of the obsolete sterilizer.

The hospital policy and procedure titled Construction/Renovation and Infection Control, dated 10/27/15, indicated under "REPORTING" B. The Project/Construction Manager shall keep members of the Infection Control Risk Assessment Team apprised as to the progress of construction."

4. During an observation on 5/17/16, at 9:43 AM, in the Emerson unit, Dialysis Registered Nurse (RN) 4 was observed putting on her PPE (gown, gloves and mask) in preparation of performing dialysis (a blood-cleansing procedure, used to treat kidney failure) on an isolation patient. The gown was not tied at the neck or waist. As she bent over, the gown slid off her shoulders and down her arms. She also stated the gown is not large enough to tie.

During an interview with RN 14, on 5/17/16, at 9:58 AM, she stated everyone needs to wear PPE, patient family, technicians, nurses. The gown must be tied and completely cover.

The hospital policy and procedure titled "Transmission-based precautions and Duration of Precautions Recommended for Selected Infections and Conditions," dated 10/27/15, indicated "Wear gown when entering the room if you anticipate that your clothing will have substantial contact [with] the Patient, environmental surfaces or items in the Patient's room... Make sure your clothing does not touch potentially contaminated environmental surfaces or items in the Patient's room to avoid transfer of microorganisms to other patients or environments."

The Centers for Disease Control and Prevention (CDC) document titled "Guideline for Isolation Precautions," dated 2007, indicated "Isolation gowns are used as specified by Standard and Transmission-Based Precautions, to protect the [healthcare worker's] HCW's arms and exposed body areas and prevent contamination of clothing with blood, body fluids, and other potentially infectious material... donning of both gown and gloves upon room entry is indicated to address unintentional contact with contaminated environmental surfaces... Several gown sizes should be available in a healthcare facility to ensure appropriate coverage..." The document further indicates the gown should "fully cover the torso from neck to knees, arms to end of wrist, and wrap around the back and fasten in back at the neck and waist."

5. During an observation and concurrent interview with Family Member (FM) 1, on 5/16/16, at 3:26 PM, FM 1 was observed sitting in a chair next to the patient's bedside without wearing PPE. A sign at the doorway indicated Contact Precautions. FM 1 stated he "was aware of the need to wear PPE. But he was just sitting there, not touching anything."

During an observation and concurrent interview with RN 12, on 5/16/16, at 2:50 PM, a family member was observed in an isolation room providing care. The gown was open in the back. RN 12 stated patient was on contact isolation.

During an observation and concurrent interview with RN 13, on 5/17/16, at 9:43 AM a family member was observed at the patient's bedside wearing only a gown. A sign at the doorway indicated Contact Precautions. RN 13 stated the family member had been provided education on the need for PPE, but had not put it on right away.

During an interview with RN 14, on 5/17/16, at 9:58 AM, she stated everyone needs to wear PPE, patient family, technicians, nurses. The gown must be tied and completely cover.

The hospital policy and procedure titled "Transmission-based precautions and Duration of Precautions Recommended for Selected Infections and Conditions," dated 10/27/15, indicated "Wear gown when entering the room if you anticipate that your clothing will have substantial contact [with] the Patient, environmental surfaces or items in the Patient's room... Make sure your clothing does not touch potentially contaminated environmental surfaces or items in the Patient's room to avoid transfer of microorganisms to other patients or environments."

The Association for Professionals in Infection Control and Epidemiology (APIC) document titled "Isolation Precautions (Transmission-based Precautions)," dated 10/3/14, indicated "Personal protective equipment (PPE): Wear a gown and gloves on room entry."

6. During an observation and concurrent interview with Dialysis RN 4, on 5/17/16, at 9:43 AM, she placed a dialysis filter, dialysis tubing, a 1000 milliliter (ml) bag of fluid for the next dialysis patient into the isolation cart outside the current dialysis patient's room.

During an interview with the Director of Telemetry (DT), on 5/17/16, at 11:20 AM, she stated the "Isolation cart should only have PPE, signage, laundry bags.. There is a list (of contents) on each drawer (of the cart)."

A review of the hospital policy and procedure, titled "Isolation Cart Content", dated 2/25/14, indicated the contents and number of each item to be in the isolation cart: "1 - Isolation Door Signs (4 colors), 1 - MRSA Instructions Booklet (English and Spanish), 1 - Clostridium Difficile Pamphlet (English and Spanish), 5 - Paper bags, 6 - Contamination large bags, 6 - Biohazard zip-lock bags, 1 - Blood Pressure cover, 1 - 02 Oxygen Sensor, 3 - Tempa-Dot sheets (15), 1 - Alcohol, Box, 1 - Isolation Mask, Box, 1 - Stethoscope, Disposable, 2 - Linen Bags (blue), 10 - Isolation gown." There was no indication of storing supplies for another patient.



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7. During an observation on 5/16/16, at 3:35 PM, outside of Room 510, there were two signs posted indicating Patient 3 was on Droplet Isolation and Contact Isolation. The Dialysis RN 3 was taking in the dialysis machine, and hanging on the intravenous pole (attached to the machine) was: 1000 ml bag of sodium chloride, 1 gallon container of dialysate, open tubing, brown color purse (personal of Dialysis RN 3), and a blue and yellow tote bag sat on the machine.

During an interview with Dialysis RN 3, on 5/16/16, at 3:40 PM she stated "Well, I can't carry everything at once. Where should I put it?"

During an interview with Dialysis RN 1, on 5/16/16 at 4:15 PM, she was asked about items kept on the dialysis machine, and stated "Purse and personal items are to be kept in lockers down stairs. Only take in the room what's necessary for treatment."



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8. During an observation of the medication administration on 5/17/16 starting at 8:40 A.M., Registered Nurse (RN) 2 prepared seven medications for Patient 1. One of the medications was insulin detemir (Levemir), an injectable medication to lower blood sugar. Insulin detemir was in a pen (insulin pen), a device that looked like a pen with insulin stored inside.

The insulin pen had a cap at the end, like the cap of the pen. Once the cap was removed, there was a rubber stopper at the end to prevent insulin from leaking out. The stopper would be exposed to dust and other contaminations even when the cap was in place.

According to the Instructions for Use, established by the manufacturer, dated 2/25/15, "A. Pull off the pen cap ... Wipe the rubber stopper with an alcohol swab. B. Attaching the needle...."

RN 2 removed the pen cap, attached the needle to the pen and proceeded to administer the insulin. RN 2 did not wipe the rubber stopper with alcohol before attaching the needle.

Immediately following the administration, RN 2 confirmed he did not clean the rubber stopper of the insulin pen. RN 2 stated he never cleaned the rubber stopper before attaching the needle.

During an interview on 5/17/16 at 9:25 AM, the EPI, who was in charge of Infection Control, stated RN 2 should have cleaned the tip of the insulin pen (rubber stopper) before attaching the needle.

During a subsequent interview on 5/17/16 at 9:35 AM, the EPI stated the hospital did not have a policy addressing this issue.



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Based on interview and record review the hospital failed to:

1. Have a discharge plan for one (3) of 30 sampled patients.

2. Have a discharge plan in a timely manner for one (4) of 30 sampled patients.

This failure had the potential to have patients needs go unmet.

Findings:

1. During an interview with the Director of Telemetry (DT), on 5/17/16, at 4:25 PM, she reviewed the electronic medical record (EMR) for Patient 3. Patient 3 was admitted on 5/13/16 at 5:20 PM. The DT was unable to find a discharge planning assessment.

2. During an interview with the DT, on 5/17/16, at 4:45 PM, she reviewed the EMR for Patient 4. Patient 4 was admitted on 5/6/16, and initial discharge planning assessment was done on 5/12/16 (six days later). The DT verified the findings.

The hospital policy and procedure titled "Discharge Planning" review date 1/2015, indicated "B. Each patient will have a Discharge Planning Assessment completed by Case Management Staff (Case Manager, Social Worker, and/or Discharge Planner) within 24 to 48 hours upon admission..." I. Discharge Planning is an on-going process in which patients are re-assessed... Re-assessment will be done every 4th day from their last assessment."