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Based on interview and review of contract evaluation documentation for 2 of 5 contracts reviewed it was determined that the hospital had not fully developed and implemented a system to ensure that all services provided under a contract, arrangement, or agreement were evaluated by the hospital to ensure that those services were provided in a safe and effective manner and were subject to the same QAPI evaluation as other services provided directly by the hospital.

Findings include:

1. An "ARUP Gateway Agreement" with ARUP Laboratories for reference laboratory testing was dated as effective 12/15/2014. Quarterly reports, consisting of a brief one-page summary, from ARUP to the hospital were provided for the four quarters in 2017. However, there was no documentation to reflect that the hospital had evaluated the services, including the information in those reports.

2. Similar findings were identified for the "Master Service Agreement" with Stericycle.

3. During interview with the COO on 03/09/2018 at 1240 he/she confirmed that there was no documentation of a hospital evaluation of the services provided by ARUP or Stericycle.

Based on observation, interview, documentation in 1 of 10 medical records reviewed of IPs who were Medicare beneficiaries (Patient 6), and review of policies and procedures it was determined that the hospital failed to fully develop and implement written policies and procedures to ensure that all IPs and OPs were informed of their hospital patient's rights as follows:
* OP consent for services processes and documents were not standardized and consistently used.
* Patients were not informed of their rights, or provided information about their rights, in OP areas.
* The IM was not provided to Medicare beneficiaries as required by CFR 405.1205.

Findings include:

1. Regarding OP consent processes and the lack of provision of patient's rights information to OPs:

* Review of the policy and procedure titled "Patient rights and Responsibilities" last revised "July 2017" reflected that "Admitting staff will provide 'The Patient Rights and Responsibilities' brochure to all bedded patients...The Patient Rights and Responsibilities brochures are also available at Information Desks and Admitting areas throughout the facilities." There were no other policies and procedures provided to reflect how OPs were ensured to be informed of their hospital patient's rights.

* Registration staff interviewed at the PSMP OP Rehab Department on 03/06/2018 at 0900 stated that during the registration process patient's sign their name on a "pen pad" to indicate their consent for service. Staff stated that patients are not provided any documents, including information about patient's rights, nor do they receive a copy of what they've signed. During the interview staff provided a copy of the "Consent for Services" document that is electronically signed by patients when they sign their name on the "pen pad." That document contained two pages and 14 items of information related to consent including: "Consent for Service...Use and Disclosure of Information...PH&S Teaching Facilities...Nursing Care...Health Plan Obligation...Assignment of Benefits/Release of Information...Right to Revoke Consent...Financial Assistance at Providence...Financial Responsibility...Personal Belongings and Valuables...Safe Environment...Photographs...Patient Rights and Responsibilities...Nondiscrimination Policy..." The language under the "Patient Rights and Responsibilities" section reflected "I acknowledge that I have received and read the 'Patient Rights and Responsibilities' notice provided by PH&S." Although there was observation of patient's rights brochures in a rack in the hallway leading from the waiting room to the treatment area, observation of the waiting room where rehab patients would wait for treatment revealed no evidence of patient's rights information or brochures.

* Imaging staff interviewed at the PSMP OP Imaging Department on 03/06/2018 at 1015 stated that their was no consent process in place for patients who presented for imaging services, patients were not provided with any consent or patient's rights documents, and that it was planned that they were going to be getting a "pen pad" for signing in patients. Observation of the waiting room where imaging patients waited revealed no evidence of patient's rights information or brochures.

* Registration staff interviewed at the PSVMC Wound Clinic on 03/07/2018 at 1020 stated that OPs who come to the clinic for services sign their name on a "pen pad" to indicate their consent for service. Staff stated that the patient is not provided any documents, including information about patient's rights, nor do they receive a copy of what they've signed. During the interview staff provided a copy of the "Consent for Services" document that is electronically signed by patients when they sign their name on the "pen pad." That document contained six pages and 14 items of information related to consent that were similar to that described in the Rehab Department above, however, it included language related to civil rights and contact information for filing civil rights grievances that were not on the consent form used in the Rehab Department. In addition it included the statement "I acknowledge that I have received and read the 'Patient Rights and Responsibilities' notice provided by PH&S." Observation of the waiting room where OPs would wait revealed no evidence of patient's rights information or brochures.

2. Regarding the lack of IM documentation:

* The IP medical record for Patient 6 reflected he/she was a 72 year-old Medicare beneficiary. Patient 6 was admitted to the hospital as an IP on 02/08/2018 and received the first IM document on 02/09/2018. Patient 6 was discharged from the hospital on 02/18/2018 at 1720. There was no documentation to reflect that a copy of the IM had been provided to the patient or his/her representative thereafter, during the hospitalization no more than two days in advance of the 02/18/2018 discharge.





29708

29708

Based on interview, review of grievance documentation for 1 of 6 patients/patient representatives that submitted a grievance to the hospital (Patient 35), and review of policies and procedures, it was determined that the hospital failed to implement its grievance policies and procedures to ensure it provided each patient/patient representative with a written that contained the required elements including the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. Grievance/complaint documentation was reviewed with the Risk Manager on 03/06/2018 at 0945. A "ORQMD Record Summary" report regarding Patient 35 was provided and reviewed. An entry on the report dated 03/17/2017 at 1248 reflected "[Family member] called to report [he/she] believes [his/her parent] was discharged from the hospital too soon. [Patient] is currently on [his/her] way back to the hospital, via ambulance..."

There was no documentation reflecting a written notice of follow-up investigation and resolution had been submitted to the patient.

2. During an interview with the Risk Manager on 03/06/2018 at the time of the review he/she confirmed no written notice of follow-up investigation and resolution had been submitted to the patient. He/she stated "I don't see one."

3. The hospital policy and procedure titled "Patient Complaints and Grievances" dated as last revised "04/2017" reflected "...Grievance - a 'patient grievance' is a written or verbal complaint (when the verbal complaint about patient is not resolved at the time of the complaint by staff present) by a patient, or the patient's legal representative regarding...Patient care...Abuse or neglect...Issues related to the hospital's compliance with the Center for Medicare and Medicaid Services (CMS) Conditions of Participation (CoP)...The hospital will provide a written response to the patient/patient's legal representative ideally within 7 business days...In the written response to the patient/patient's representative, the following elements will be included...Steps taken to investigate the grievance...Results of the grievance process...Date of completion - can be met by the date of the letter...Name of hospital contact person...and phone number."

Based on observation, interview, review of documentation in 5 of 13 medical records of patients reviewed for provision of nursing services (Patients 21, 22, 23, 26, and 29), and review of policies and procedures, it was determined that the RN failed to supervise and evaluate the nursing care for each patient in the following areas:
* Physician orders for SCUDS were not carried out.
* Physician orders for restraints were not obtained timely.
* Assessments and observation of behavioral health patients in the ED were not conducted in accordance with clearly written and fully developed policies and procedures.

Findings include:

1. The record of Patient 29 was reviewed with the CN and reflected the patient was admitted on 03/05/2018 at 0809 with symptoms of hydrocephalus.

The record reflected a physician order dated 03/05/2018 for "Place sequential compression device bilateral lower extremities...."

* During a tour of the 9E Neurovascular unit on 03/06/2018 at 1640 with the CN, Patient 29 was observed in his/her bed and did not have any lower extremity compression devices on. This was confirmed with the CN at the time of the observation. The CN stated "[His/her] SCUDS are not on."

2. The record of Patient 26 was reviewed with the Clinical Informatics Specialist on 03/07/2018 at 0945. The record reflected the patient was admitted on 03/03/2018 at 1849 with a diagnosis of acute respiratory failure.

The record reflected soft wrist restraints were initiated on 03/03/2018 at or around 2300.

The record reflected a physician order dated 03/04/2018 at 0906 for "Restraint for non-violent behavior...R upper extrem L upper extrem...Continuous X 24 Hours." However, the order for the restraints was 10 hours after the soft wrist restraints were applied, and there was no previous order for the restraints. This was confirmed with the Clinical Informatics Specialist at the time of the review.

* The policy and procedure titled "Restraints and Seclusion" dated as last revised "06/2016" reflected "...Initiation of the Non-Violent, Non-Self-Destructive Restraint...An RN must obtain an order from the LIP upon application of the restraint or immediately thereafter."

3. An undated checklist titled "Critical Steps for All Emergency Department Behavioral Health Patients" was provided and reviewed. The checklist included information related to frequency of BARS assessments, patient observations, and preparation of patient rooms as follows:
* The "Room" section reflected "...If Room is Being Broken Down Document Safety Section That Room Was Broken Down..."
* The "EDT/MHT" section reflected "...Break down room if needed and document* (See handout)...Round on Patients, Q 15 [minute] checks."
* The "Ongoing" section reflected "...Behavioral Documentation As Needed Throughout Stay In ED...Behavioral Observation...BARS Assessment Q 4 Hours (0200/0600/1000/1400/1800/2200)..."

4. The ED record of Patient 21 was reviewed and reflected the 13-year old patient presented to the ED on 02/26/2018 at 1622 with a chief complaint of "Suicidal."

The Technologist notes dated 02/26/2018 at 1638 reflected the patient was "roomed" in ED Room 44. There was no documentation reflecting the room was "broken down" in preparation for the patient in accordance with the "Critical Steps for All Emergency Department Behavioral Health Patients" above.

The RN notes dated 02/26/2018 at 1927 reflected "...assumed care. See 'Close Observation for Pt Safety' for constant obs."

The RN notes reflected a BARS Assessment was documented 02/27/2018 at 0826. The next BARS Assessment was not documented until 02/27/2018 at 1400.

The RN notes dated 02/27/2018 at 1636 reflected "Safety: sitter at the bedside..." It was unclear how frequently the patient was being observed at this time (e.g. constant observation, a Q 15 minute observation, etc.).

The RN notes reflected a BARS Assessment was documented 03/01/2018 at 0209. The next BARS Assessment was not documented until 03/01/2018 at 1000, 8 hours later.

The RN notes dated 03/01/2018 at 1048 reflected the patient was transferred to ED Room 48. There was no documentation reflecting the room was assessed or "broken down" for safety.

The RN notes dated 03/01/2018 at 1150 reflected "Safety Assessment...sitter at the bedside..." It was unclear how frequently the patient was being observed at this time.

The RN Behavioral Health Assessment dated 03/01/2018 at 1814 reflected:
* "Thoughts of Suicide: Yes"
* "Intent: Continuous thoughts (pt states [he/she] is thinking of SI and ways to do it here." It was unclear how frequently the patient was being observed at this time.

The RN Safety Assessment dated 03/01/2018 at 1841 reflected "...sitter at the bedside" and "safety attendant." It was unclear how frequently the patient was being observed at this time.

The RN Behavioral Health Assessment dated 03/01/2018 at 2036 reflected:
* "Thoughts of Suicide: Yes"
* "Intent: Fleeting thoughs (sic)"
* "Plan: to use blankets but pt states it is less than before." It was unclear how frequently the patient was being observed at this time.

The RN notes reflected a BARS Assessment was documented 03/03/2018 at 1405. The next BARS Assessment was not documented until 03/03/2018 at 1904.

The RN notes reflected a BARS Assessment was documented 03/05/2018 at 0920. The next BARS Assessment was not documented until 03/05/2018 at 1447.

Review of "Close Observation For Patient Safety" forms from 02/26/2018 at 1645 through 03/01/2018 at 2245 reflected entries related to the patient's behaviors at 15 minute intervals. However, it did not reflect if or when the patient was observed more frequently than every 15 minutes. There was no information to reflect if or when the patient was observed more frequently than every 15 minutes.

The record contained no nursing care plan or other information reflecting frequency of patient observations needed on an ongoing basis, based on the nursing assessment.

5. During interview on 03/05/2018 at 1445 the Children's ED NM stated BARS assessments were to be completed every 4 hours. He/she confirmed the record of Patient 21 did not reflect BARS assessments were completed every 4 hours. In regards to patient observations, he/she stated there was no care plan, physician orders or other information used on a consistent basis to reflect the frequency of patient observations.

6. The record of Patient 23 was reviewed and reflected the 15-year old patient presented to the ED on 02/25/2018 at 2243 with a chief complaint of "...aggressive behavior...self harms with screws and refused to take [his/her] medications and refusing to eat." Similar findings were identified related to lack of BARS, room "breakdown", observations, and care planning.

7. The record of Patient 22 was reviewed and reflected the 12-year old patient presented to the ED on 02/09/2018 at 1719 with a chief complaint of "...Ingestion (Peds - Intentional)". Similar findings were identified related to lack of BARS, observations, and care planning.

8. During tour of the ED on 03/05/2018 at 1745 with the Children's ED NM and other hospital staff, the following observations were made from the corridor near the nurse station:
* The doors to ED Rooms 44, 45 and 48 were observed open. A hospital individual was observed in the corridor near ED Rooms 44, 45, and 48. The individual was walking slowly between each of the 3 rooms. The individual did not go inside any of the 3 rooms during the observation. It was stated by staff present that the individual was making observations of the 3 patients in those rooms.
* Observation from outside patient ED Rooms 44, 45 and 48 reflected the patients in those rooms were not visible from all angles of the corridor.
* Observation from the corridor outside ED Room 48 reflected Patient 21 was in the room. A family member was also observed in the room. A wall mounted television and several coat hooks were observed attached to the wall inside the room.
* A tote containing items that had been removed from ED Room 48 was observed on a cart in the corridor outside the room. Items inside the tote included but were not limited to a telephone and telephone cord, a wire basket, a plastic bag with a pull cord closure, and various other cords and cables.
* It was stated by staff present that the patients in ED Rooms 44, 45 and 48 did not require continuous observation.

9. During an interview on 03/07/2018 at 1330 that included several hospital staff including the Children's ED NM, it was confirmed that Patient 22 was in room 45, Patient 23 was in room 44, and Patient 21 was in room 48 at the time of the observation in finding 8. above. It was stated the standard was that all behavioral health patients were observed every 15 minutes at a minimum, and the determination of whether a patient needed more frequent observation was based primarily on BARS assessments and if the patient had "intent and means" to cause harm to him/herself. However, it was acknowledged that hospital policies and procedures did not clearly reflect that information.

10. The undated document titled "Securing Non-BH Rooms for BH Patients in the Emergency Department" was reviewed. The document listed 22 items that were to be removed from the room as follows:
* Chairs, Sharps Containers*, Laundry Carts, Step Stool, Wall Mounted Clocks*, Gloves, Monitors, Cables, Cords, BP Cuffs, Oto-Opthalmalmoscope, Manual BP Cuffs, Computer Scanner, Garbage Cans, and Bedside Carts, Oxygen Tanks from Beds, Rolling Stool, IV Poles, Emesis Bags, Call Light, Suction Set Up, Oxygen & Medical Air Meters, and Ambu Bags. The document reflected that "*Some of these items will be secured to the wall or permanently mounted. In these cases leave in room." It also reflected "Leave in the room: Computers if mounted to wall or on counter...Document in the EPIC chart that room break down has occurred...Any items left in hallway need to be monitored by staff." The list did not include consideration of the wall mounted TV and coat hooks observed in ED Room 48 reflected in finding 8. above.

11. A policy and procedure titled "ED Practice Guideline: Behavioral Health Patients" dated as last revised "01/2015" reflected:
* "...This practice guideline describes essential components of assessments and intervention...Implementation of the guideline and removal of the guideline...should be reflected in documentation by...the patient's primary nurse..."
* "Place the patient in an appropriate location, with consideration of safety needs to include...Observation needs..."
* "Based on the patient assessment and nursing judgment the patients' immediate safety needs should be addressed, including appropriate setting for treatment and consideration of observation needs."
* "The key element of an adequate close observation is direct visual observation of the patient. Staff must be close enough to the patient to view respirations, and observe the head and neck of the patient. Using a flashlight or approaching the side of the bed may be necessary to fully observe the patient. The identity of the patient must also be ensured. Consider Continuous observations for patients needing more frequent supervision than 15 minute observations...Continuous and/or frequent observations need to be documented in the Behavioral Health Assessment section of the patient record."
* "Receiving RN...Upon arrival of ALL behavioral health patients to their room, the receiving RN completes and documents the following...Removal of...items in the patient care area that can have the potential to cause injury/harm to patient or staff."
* "Primary RN...Determine environmental needs and place patient in appropriate location and safe environment...Determine observations needs."

The policy did not clearly reflect the stated practice that all behavioral health patients would be observed every 15 minutes at a minimum.
The policy did not include reference to BARS assessments or how that would be considered in relation to determining frequency of patient observations.
The policy lacked information about various observation considerations such as when a family member was present in the room.
The policy lacked details about the practice of removing items from a patient room for safety purposes, including items that should be removed, and how that would be assessed and determined for individual patients.

Based on interview, medical record documentation for 11 of 13 BTs administered for 5 of 6 patients (Patients 2, 3, 6, 7 and 8), and review of policies and procedures it was determined that the hospital failed to fully implement its policies and procedures related to documentation and vital sign monitoring of patients during BTs.

Findings include:

1. The policy and procedure titled "Blood and Blood Products: Consent, Administration, and Transfusion Reaction - Adult, Pediatric and Neonate" dated as last revised "06/2017" was reviewed. It stipulated:
* "All RBC blood products are to be infused within four hours from the time of release from Blood Bank/Transfusion Services."
* "Record a full set of pre-transfusion vital signs (Temperature, Blood Pressure, Heart Rate, Respiratory Rate) in Epic Blood Administration Flow Sheet. NOTE: Patient's vital signs should be assessed and recorded within approximately 60 [minutes] of starting the transfusion."
* "The transfusionist documents the following in Epic:...Transfusion Start and end time..."* "After the initial 15 minutes, obtain another set of vital signs to include temperature, blood pressure, pulse, and respiration."
* "When the transfusion is complete, document the following in the Epic Blood Administration Flow Sheet:...Full set of vital signs...Transfusion End time."

2. Regarding BT start times, documentation of 2 BTs for Patient 8 reflected they were not clear. For example, documentation on the BT flow sheet for one BT reflected that on 02/23/2018 the BT was started at 1845, while documentation in the "Order Info" field reflected a BT start time at 1814. Blood bank documentation reflected that the blood unit was released from the blood bank at 1851, after both recorded start times in the record.

Documentation on the BT flow sheet for the second BT reflected that on 02/23/2018 the BT was started at 2045, while documentation in the "Order Info" field reflected a BT start time as 2015. Blood bank documentation reflected that the blood unit was released from the blood bank at 2234, after both recorded start times in the record.

3. Regarding the initial 15 minute vital signs, documentation of 6 BTs for Patients 2, 3, 6, and 7 reflected they were not recorded until between 24 minutes and 155 minutes after the documented transfusion start time. For example, in the BT record of Patient 3 documentation reflected a BT was started on 02/07/2018 at 1148. The first documented vital signs were recorded on 02/07/2018 at 1359, 131 minutes after the transfusion start.

4. Regarding BT end times, documentation of 3 BTs for Patients 2 and 8 reflected they were not recorded. For example, in the BT records for Patient 2 documentation reflected one BT was started on 01/07/2018 at 1252 and a second BT was started on 01/07/2018 at 1341. The BT "End" time space for both was blank, and the electronic medical record reflected that the "Status" for both units was still "Tranfusing" on the date of this review.

5. Regarding the vital signs at the end of the BT, documentation of 2 BTs for Patients 3 and 8 reflected they were not timely. For example, in the BT record for Patient 3 documentation reflected a BT was started on 01/24/2018 at 1238 and ended at 1326. There were no vital signs documented between 1255 and 1413, 47 minutes after the end of the BT.

6. Regarding completeness of vital signs, documentation of 3 BTs for Patients 3 and 8 reflected that full sets of vital signs were not documented. For example, BT documentation for Patient 8 reflected a BT was started on 02/23/2018 at 1845. A set of vital signs recorded at 1845 lacked Patient 8's blood pressure. Documentation of a second BT for Patient 8 reflected it was started on 02/23/2018 at 2045. A full set of vital signs was recorded at 2045. Although vital signs were taken at 2100, 2200, and 2300 none of those included a temperature. Patient 8's temperature was not taken again until 02/24/2018 at 0800.

7. Regarding timeliness of BT administration, documentation of 3 BTs for Patient 3 reflected that the BTs were not completed within four hours of the time the units were released from the blood bank, or the time the transfusion was documented as ended was not accurate. For example, BT documentation reflected that a BT was started on 02/07/2018 at 1148 and was ended on 02/07/2018 at 2110, more than nine hours after the transfusion was started. A second BT was started on 02/07/2018 at 1425 and was ended on 02/10/2018 at 1542, three days later.

Based on observation, interview and review of policies and procedures it was determined the hospital failed to implement its policies and procedures to ensure that OP specimens collected for testing were handled as required.

Findings include:

1. During tour of the PSMP OP Lab Service Center on 03/06/2018 at 1000 the following observations were made:

* Two clear containers filled with yellow/amber colored liquid were observed in the refrigerator in the specimen processing room. Those specimens were labeled only with the patients' names and date of births. There was no other information on the specimen containers including the type of specimen and the date and time collected. During interview with the site Supervisor at the time of the observation he/she stated that proper procedure was to date and time the specimens.

* At approximately 1005 two centrifuges were observed in the specimen processing room to each be full of gold topped blood collection tubes. Observation of the labels on some of the individual collection tubes revealed they had been drawn for a variety of tests. The blood collected in at least two of the tubes was for "HCVreflx" or Hepatitis C Antibody. Those two tubes were labeled with a draw time of 0745, two hours and 20 minutes prior to the observation. During interview at the time of the observation the site Supervisor confirmed that according to directions the specimens should have been refrigerated within two hours of collection.

2. Review of specimen handling directions from the "Test Catalogue" provided by the site Supervisor reflected for the Hepatitis C Antibody test: "Collect Two 5.0 mL Gold Top Tube...Allow both samples to clot fully for 30 minutes at room temperature, Centrifuge within 2 hours of collection, Label one tube for HCV Antibody and label second tube for Reflex HCV Quant PCR, Refrigerate...Storage/Transport Temperature: Refrigerated (2-8[degrees Celsius]), Stability (from collection to initiation): Ambient: unacceptable..."

3. Review of the policy and procedure titled "Positive Patient & Sample Identification" dated as last revised 01/19/2018 reflected that for "Outpatient Identification...Write the collection date, time, and the collector identification on the label."

Based on observation, interviews, and review of PM records it was determined that the hospital failed to ensure that all facilities and equipment were maintained to ensure an acceptable level of quality and safety in the following areas:
* Kitchen
* Laboratory
* Sleep Lab
* Pharmacy entry corridor near ED

Findings:

1. During tour of the kitchen on 03/05/2018 at 1600 the following observations were made:
* An ice machine located next to the dishwashing room was observed to have a broken screen-type filter placed on top of the machine; and the vent on the front of the machine was covered with a thick layer of dust.
* A large Hobart commercial steel mixer stand and bowl was observed with peeling, cracked, and rusted surfaces at the base and other numerous areas, including inside the bowl.
* The floor tiles at the entryway to the walk-in freezer were broken and damaged and resulted in a deep, wide gouged area that exposed broken cement and rock-like material lying beneath the tile.
* Floor tiles in other areas of the kitchen were cracked and broken.
* Ceiling, plumbing, and floor surfaces in the walk-in freezer were covered with thick layers of ice, including on open and closed food container surfaces.

2. During tour of the PSMP OP Lab Service Center on 03/06/2018 at 0955 a household-type desk fan was observed stored in a cabinet in one of the phlebotomy rooms. There was no inventory number, PM sticker, or other evidence that the fan had been evaluated for safety. During interview with the PMM on 03/09/2018 at 1145 he/she stated that there was no PM documentation for the fan and anything that plugs into the wall must have an initial electrical safety test and should have an initial safety test sticker on it.

3. During tour of the PSVMC main Lab on 03/06/2018 at 1550 a large multi-compartment specimen freezer was observed. When the door was open it revealed that the lower left joint between the threshold and the door jamb was broken and exposed materials, including insulation, contained beneath the surface. The freezer compartments and the specimens stored in them were covered with thick layers of frost and ice.

4. During tour of the Sleep Lab on 03/07/2018 at 1100 a bright yellow flammable liquid safety cabinet was observed in the disinfection room. The inside shelf surfaces were peeling, rusted, degraded and in significant disrepair from use and chemical spills. In addition, the cabinet floor underneath the sink in the disinfection room was stained and cracked.

5. Observations in the "pharmacy entry" corridor near the ED with the QM on 03/05/2018 at 1350 revealed numerous cracked, peeling and visibly dirty floor tiles near the corridor walls. The floor molding was also visibly dirty and in disrepair, including areas where the molding was missing.




29708

Based on observation, interview, documentation in 3 of 13 hospital staff TB testing records reviewed (Staff 4, 9, and 11), review of policies and procedures, and review of sterile processing records and other documentation it was determined that the hospital failed to ensure it fully developed and implemented systems for infection prevention in the following areas:
* Cleaning and food storage procedures in the kitchen were not followed.
* TB testing for medical staff and employees was not timely.
* Isolation precautions were not followed.
* Endoscope reprocessing was not in accordance with manufacturer instructions.

Findings include:

1. Regarding kitchen food sanitation practices:

* During tour of the kitchen on 03/05/2018 at 1600 the following observations were made: Surfaces throughout the kitchen, including in dry food, refrigerated, and freezer storage, were covered with a thick accumulation of trash, dirt, grime, debris, food scraps and crumbs, dried food and liquid splatter and streaks. Those surfaces included: The floor and baseboards throughout including underneath storage shelves, carts, work counters, and equipment; Walls; Countertops; Shelves; Wheeled carts; Metal encased electrical outlet fixtures; surface of and the area around the standing Hobart mixer.

In addition, food products in dry food, refrigerated, and freezer storage were observed to be in open/unsealed or unlabeled containers or plastic bags. For example: An open and sealed bag of a type of grains was observed in dry storage without any label or markings; An open cardboard box labeled as lentils contained dried lentils that were not protected in a plastic bag or other sealed container within the box; Open and unsealed bags of what was described by dietary staff at the time of the observation as different cheeses, were observed without any labels or markings in refrigerated storage; Open and unsealed bags of a type of fish fillets was observed in freezer storage; A large open container of what appeared to be blueberries as well as numerous other misc. bags of food products were observed in freezer storage without labels identifying what the food product was and when it had been placed in storage.

* During a second tour of the kitchen on 03/07/2018 at 1200 the following observations were made: More observations were made similar to those above in other parts of the kitchen not observed during the tour on 03/05/2018. For example: Kitchen equipment and parts and pieces of equipment were stored on a shelf under a work counter next to food bins. Hold ovens and a blast chiller were located next to those shelves. All those surfaces, inside and out and including door hinges, were covered with an accumulation of dirt and food debris.

Additionally, wheeled carts were observed stored with dirty wheels up on top of the hold ovens and blast chiller so that food passing in and out of that equipment was passing under the wheels.

Numerous bags of open, unsealed or unlabeled grains and baking goods were observed stored in three large white wheeled bins. The inside and outside bin surfaces were covered with food matter and dried spills and splatter.

*Review of the policy and procedure titled "Food Storage" dated as last revised "10/17" reflected that: "Food products are keep (sic) in designated storage areas and protected from contamination by storing the food...In a clean, dry location...Where it's not exposed to splash, dust, or other contamination...All items that are not in their original containers must be labeled...Food storage containers...Use containers that are durable, leak proof, and able to be sealed or covered...Keep all storage areas clean and dry. Clean floors, walls and shelving in coolers, freezers, dry-storage areas and heated holding cabinets on a regular basis...Wrap or cover food...food prepped in-house and stored longer than 24 hours must be labeled with common name of food and date marked...All items will be rotated from back to front according to expiration date..."

*Review of the policy and procedure titled "Sanitation and Safety" dated as last reviewed "1/18" reflected that: "Effective sanitation and safety is a continuous responsibility and function of every employee...Work areas and equipment will be thoroughly cleaned and sanitized after each shift or meal as appropriate...Cleaning and maintenance of the kitchen floors is completed by EVS daily...An outside vendor will deep clean floors and grout on a quarterly basis...All employees are responsible for cleaning duties as outlined on the job description, cleaning checklists and/or assigned by the Coordinator/Supervisor."

2. Regarding TB testing:

*The hospital policy and procedure titled "TB Exposure Control Plan" dated as implemented "03/2013" and last revised "01/2018" reflected that "...TB screening and follow-up...in accordance with the annual risk assessment (Infection Prevention) and published guidelines from CDC" would be provided.

*The CDC "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Setting, 2005" was provided with the "TB Exposure Control Plan." That document stipulated that "All HCWs should received baseline TB screening upon hire..."

*The "TB Annual Screening Required for...PSVMC" dated 04/20/2017 reflected that "In 2016 PSVMC...had an increase in the number of confirmed positive...TB cases...Effective January 2017 all providers, caregivers and volunteers who work at...PSVMC ministries will again be required to have an annual TB test."

* Credentialing records reflected Physician 4 had a work start date of 12/12/2014. TB testing records reflected the first TB testing for Medical Staff 4 occurred on 03/21/2016.

* Personnel records reflected Employee 9 had a work start date of 11/27/2017. TB testing records reflected the first TB testing for employee 9 occurred on 02/07/2018.

* Personnel records reflected Employee 11 had a work start date of 02/15/2016. TB testing records reflected TB testing for employee 11 occurred on 02/10/2016 but had not occurred annually since that time.

3. Regarding isolation precautions:

a. During tour of the 9E Neurovascular unit on 03/06/2018 beginning at 1540 with the Regional Director of Accreditation and Risk Manager the following observations were made:

* The outside of patient room 924 was observed. A "Contact Precautions" sign was attached to the door and included the following instructions: "STOP...Visitation by Those 12 Years Old or Younger is Discouraged Check with Nurse before entering room...Everyone Must...Clean hands when entering and leaving room...Doctors and Staff Must...Gown and Glove at door...Use patient dedicated or disposable equipment. Clean and disinfect shared equipment." Although the sign was attached to the door, the door to the room was open and the sign was not readily visible upon room entry from all angles of the hall.

* The outside of patient room 972 was observed. A "Contact Enteric Precautions" sign was attached to the door and included the following instructions: "STOP...Visitation by Those 12 Years Old or Younger is Discouraged Check with Nurse before entering room...Everyone Must...Wash or gel hands when entering room, soap and water upon leaving...Doctors and Staff Must...Gown and Glove at door...Use patient dedicated or disposable equipment. Clean and disinfect shared equipment." Although the sign was attached to the door, the door to the room was open and the sign was not readily visible upon room entry from all angles of the hall.

b. During tour of the 9W Medical A unit on 03/06/2018 beginning at 1400 with the Regional Director of Accreditation and Risk Manager the following observations were made:

* The outside of patient room 906 was observed. A "Droplet Precautions" sign was attached to the door and included the following instructions: "STOP...Visitation by Those 12 Years Old or Younger is Discouraged Check with Nurse before entering room...Everyone Must...Clean hands when entering and leaving room...Wear surgical mask..." A "Contact Enteric Precautions" sign was also observed attached to the door. The door to the room was open and neither of the signs were readily visible upon room entry from all angles of the hall.

* The outside of patient room 962 was observed. A "Contact Precautions" sign was attached to the door. The door to the room was open and the sign was not readily visible upon room entry from all angles of the hall.

* These findings were confirmed with staff present at the time of the observations.

* The hospital policy and procedure titled "Standard And Transmission-Based Precautions" dated last revised "05/2017" reflected "Isolation precautions for specific patient conditions are required in addition to Standard Precautions. These 'Transmission-based Precautions' are to be used for patients known or suspected to be infected or colonized with pathogens that can be transmitted by contact with dry skin, contaminated surfaces, airborne, or droplet...Use appropriate precaution signage to alert health care workers and visitors when additional infection control precautions are required. Some diseases may require more than 1 sign...Signage must be posted outside a patient's room..."

4. Regarding endoscope reprocessing practices:

During tour of the endoscope reprocessing area with the Endo Tech on 03/09/2018 at 1120 the following observations were made:

* Two Medivators AERs referred to by staff as "Scope Wash #1" and "Scope Wash #2 used for reprocessing endoscopes were observed with the Endo Tech on 03/09/2018 at 1120. The AERs were observed to each have two open containers of Rapicide disinfectant solutions connected to them. The two containers of Rapicide connected to AER "Scope Wash #1" had "3/7/18" and initials hand written on the top of each of the containers. The two containers of Rapicide connected to AER "Scope Wash #2" had "3/7/18" hand written on the top of each of the containers. It was unclear what those dates represented. The containers each had a manufacturer label on the side of the containers with spaces for recording "Date Opened" and "Discard Open Solution By" dates. There was no information recorded in those spaces on any of the containers connected to the AERs. There was no other information reflecting when the containers were opened or when they should be discarded. This was confirmed with the Endo Tech at the time of the observation.

* Review of the Rapicide disinfectant manufacturer instructions observed on the disinfectant container reflected the following: "The product may be used for twenty-one days (21) days after the containers are opened. DO NOT use after that time has expired."

* A blank manufacturer checklist for the Medivators AERs titled "Filter Change Log Medivators DSD Edge Endoscope Reprocessing System" dated copyright "2012" was provided and reviewed with the Biomed Tech. The Biomed Tech stated that the checklist reflected the manufacturer's instructions for changing the various filters in the AERs.

The checklist reflected AER filters were to be changed and cleaned as follows:
* 1 Micron water filters and 0.45 Micron water filters change when "Pressure below 40 PSI or Every 3 Months";
* 0.2 Micron water filter change "Every 6 months (MAX)";
* "Air Filters" change "Every 3 Months"; and
* "Reusable Mesh Disinfectant Filter...Clean Every Month."

* The AERs "Filter Change Log" with entries recorded between May 2017 through March 2018 was reviewed with the Endo Tech on 03/09/2018. The log was designed to reflect documentation of specified criteria, including water filter, air filter and mesh disinfectant filter changes/tasks to ensure the AERs functioned appropriately.

The log had a column for recording "Air Filters (quarterly)" and "Date/Initial." The column had the following entries recorded: "8/3/17", "11/20/17" and initials, "Due 3/18", and "3/18". There was no information on the log reflecting which of the two AERs the air filter change pertained to. Further, there was no assurance the filters were changed quarterly in accordance with manufacturer's instructions. This was confirmed with the Endo Tech at the time of the log review. This was confirmed with the Endo Tech at the time of the log review.

The log had a column for recording "Reusable Mesh Disinfectant Filter (monthly)" and "Date/Initial." The column had the following entries recorded: "5/15/17" and an individual's initials, "[change] in July," "8/31/17," "9/15/17" and initials, a lined through entry and initials, "11/6/17" and initials, "12/6/17" and initials, "1/13/18" and initials, "2/11/18" and "3/11/18". There was no information about which of the two AERs the mesh filter task pertained to, and it was unclear what task was being performed. There was no assurance the mesh filters were cleaned every month in accordance with manufacturer's instructions.

Similar findings were identified during review of log entries recorded between May 2017 through March 2018 for 1 Micron water filter, 0.45 Micron water filter, and 0.5 Micron water filter changes. For example, there was no information about which of the two AERs the water filter change entries pertained to. Further, in regards to 1 Micron and 0.45 Micron water filters, there was no documentation in the logs to reflect pressure (PSI) was checked and considered with respect to filter changes in accordance with manufacturer's instructions.

The policy and procedure titled "Reprocessing of Flexible Endoscopes with High-Level Disinfection" dated last revised "10/2016" reflected "The reprocessing protocol outlines basic steps to clean and perform high-level disinfection of flexible endoscopes. Endoscope manufacturer's instructions should always be consulted...Flexible endoscopes that require sterilization will follow manufacturer guidelines for storage and reprocessing."


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