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Based on interview, documentation in 2 of 2 contracts or agreements reviewed (Contracts 1 and 2), and review of hospital policies and other documents, it was determined that the hospital failed to develop and implement a system to ensure all services provided under contract, arrangement or agreement were carried out in a manner which permitted the hospital to be in compliance with the federal COPs and standards pertaining to the contracted service. Contract language did not specify how the hospital would evaluate the contractor's services to ensure compliance with the COPs; and there was no evidence that the hospital had evaluated the services of the contractors.

Findings included:

1. An undated "Administrative Housewide Policy" titled "Contracted Clinical Services Oversight and Management" provided was reviewed. The document had a "Pending" approval and no evidence that it had been approved and was in effect. The document reflected "...The Salem Health Board of Trustees delegates oversight of its Clinical Contracts to the Hospitals' Leaders to ensure that care, treatment, and services provided directly to its patients through Clinical Contracts are provided safely and effectively...Salem Health leaders will monitor the quality and safety of services provided pursuant to a Clinical Contract using appropriate methods, which consider risk reduction, safety, staff competence, and performance improvement."

The document did not specify how or if compliance with the COPs would be ensured for the services provided under contract.

2. A list of contracted services was provided in response to a request for a list of patient care services provided for the hospital under contract.

The list was comprised of the following:
* "Davita" with a scope of service reflected as hemodialysis, peritoneal dialysis, continuous renal replacement therapy,
apheresis, patient/family education;
* "Hanger Prosthetics & Orthotics, Inc." with a scope of service reflected as full range of orthotic and prosthetic services including halos;
* "Marion County" with a scope of service reflected as mental health screening services;
* "Pacific Medical" with a scope of service reflected as supplies of DME products, technicians fit products, and inventory management;
* "Specialty Care Cardiovascular Resources, Inc." with a scope of service reflected as perioperative integrated clinical services (perfusion);
* "Summit Orthotic & Prosthetics, Inc." with a scope of service reflected as full range of orthotic and prosthetic services; and
* "Wave Form Systems, Inc. Universal Healthcare Systems" with a scope of service reflected as shock wave lithotripsy, laser treatment, cryoablation.

2. During an interview with the Director of Patient Safety and Clinical Support on 08/21/2015 at 1400 he/she stated the hospital had no documentation of QAPI monitoring for any of the following contracted services that were on the list provided in finding 1 above:
Hanger Prosthetics & Orthotics, Inc., Marion County, Pacific Medical, Specialty Care Cardiovascular Resources, Inc., Summit Orthotic & Prosthetics, Inc., Wave Form Systems, Inc., and Universal Healthcare Systems.

3. Contract 1, the "Hospital Partnership Agreement" between the hospital and "Pacific Medical ('PacMed')" effective 12/01/2013 was reviewed. It did not contain language which reflected the contractor would furnish services in a manner to comply with the COPs and did not contain language to specify how or if the hospital would evaluate the services of the contractor. There was no evidence that the hospital evaluated the services provided by Pacific Medical.

4. Contract 2, the "Orthotic & Prosthetic Services Agreement" between the hospital and "Hanger Prosthetics & Orthotics, Inc. a Delaware corporation ('Hanger')" effective 06/15/2015 was reviewed. It did not contain language which reflected the contractor would furnish services in a manner to comply with the COPs. It did not contain language to specify how or if the hospital would evaluate the services of the contractor. There was no evidence that the hospital evaluated the services provided by Hanger Prosthetics & Orthotics, Inc.

Based on interview, documentation in 2 of 2 contracts or agreements reviewed (Contracts 1 and 2), and review of hospital policies and other documents, it was determined that the hospital failed to ensure the hospital's QAPI program included QAPI monitoring for each service provided under contract or agreement and had evaluated the services of the contractors.

Findings included:

Refer to the findings at Tag A083, CFR 482.12(e) Contracted Services which reflects that the hospital failed to ensure the hospital's QAPI program conducted QAPI monitoring for each patient care related service that was provided under contract or agreement.

Based on observation, interview, documentation reviewed in 2 of 2 medical records reviewed of patients who had indwelling urinary catheters, and review of policies, procedures and other documents, it was determined the hospital failed to develop and implement its policies and procedures for infection prevention in the following areas:
* Disinfectants and mops used for cleaning patient care areas/items were not managed in accordance with manufacturer instructions and hospital policies and procedures;
* Disinfection of instruments and devices used in the ED were not managed in accordance with manufacturer instructions and hospital policies;
* Indwelling urinary catheters were not managed in accordance with hospital policies and procedures;
* Medication injection practices, MDVs and medication expiration management were not performed in accordance with hospital policies and procedures in the Surgical Services Department; and
* Hand hygiene practices were not conducted in accordance with hospital policies and procedures.

Findings included:

1. The following observations were made in relation to EVS disinfectants and cleaners:

* On 08/19/2015 at 1400 in the 6 Center area, an open container of Virex disinfectant was observed connected to an autodispense system in an EVS closet with the EVS Manager. There was no expiration information on the container. At the time of the observation, the EVS Manager confirmed there was no information on the container reflecting when the disinfectant expired and stated he/she did not know when the disinfectant expired.

* On 08/19/2015 at 1410 on the Medical Unit, a bottle of Steriplex disinfectant was observed on the EVS cart with the EVS Manager. The expiration information on the bottle was illegible.

* On 08/19/2015 at 1440 on the Medical Unit, a container of Dispatch disinfectant wipes was observed in a janitor closet. The expiration information on the container was illegible.

* On a patient care unit on 08/19/2015 at 1445, three undated opened and partially filled bottles of Virex disinfectant were observed in a storage cupboard that was labeled "Shower Supplies." There was no information on the bottles to indicate when the disinfectant was dispensed into the containers and when the disinfectant expired.

Manufacturer instructions for the Virex disinfectant provided were reviewed. The Product Specifications reflected that for disinfectant "Concentrate" the pH should be 10.2 and for "Use Dilution" the pH should be 8.8.

During an interview with the EVS Manager on 08/19/2015 at 1610, he/she stated that pH indicator strips were used annually and "as needed" to check for appropriate dilution of the Virex disinfectant that was used in the hospital. However, he/she stated the hospital was out of the indicator strips and needed to order more. No further information was received related to how the hospital would ensure the disinfectant was appropriately diluted.

* In the ED on 08/19/2015 at 1540, a container of 3M RCT disinfectant that was connected to an autodispense unit was observed in the EVS closet. During an interview with the EVS Manager on 08/19/2015 at 1300, he/she confirmed that 3M RCT disinfectant was used in the ED for cleaning patient care areas.

* An ED document provided titled "Standard Work: EVS cart standard" dated "January 2015" reflected the following: "Since carts in the ED are shared by all three shifts, this Standard Work is designed to ensure the carts are stocked to the same standard at the beginning and end of every shift...Remove any unused mops & rags from the Virex bucket and place in soiled linen bag." The policy contained no information related to the use of 3M RCT disinfectant in the ED, and referenced the use of Virex disinfectant in the ED which was contradictory to the interview above with the EVS Manager who stated that 3M RCT disinfectant was used.

* An Infection Prevention policy and procedure provided titled "Selection & Use of Disinfectants" dated "Effective Date: September 2012" reflected the following: "Disinfection will occur by wiping the entire surface with appropriate (as determined by department procedure or by equipment manufacturer), EPA-registered, hospital-approved disinfectant, following manufacturer's instructions for dilution..."

* An Infection Prevention policy and procedure titled "Selection & Use of Disinfectants" dated "Effective Date: September 2012" reflected the following: "...Disinfection of reusable patient care equipment and environmental surfaces will be done according to the following guidelines...Label disinfectant solutions according to contents and expiration date of solution in the container."

* Interview with EVS and linen/laundry staff on 08/19/2015 at 1630 reflected the hospital used microfiber mops for cleaning floors in patient care areas. In relation to laundering of the microfiber mops, staff present stated "We don't use manufacturer's instructions for microfiber mops."

Manufacturer instructions for the microfiber mops used by the hospital were provided and reflected: "...Commercial Washing: Hot Water Method...Wash in hot water...for 25 mins...Use bleach if necessary...Commerical Washing: Cold Water Method...Wash in cold water...Bleach is required...Commercial Drying...Dry cloths and mops on low heat..."

During an interview with the Accreditation & Patient Safety Manager on 08/21/2015 at 1500, he/she indicated the hospital had no documentation or evidence of input from IC individuals related to laundering the microfiber mops in a manner that was not consistent with manufacturer guidelines.

2. The following observations were made during a tour of the ED on 08/19/2015:

* At 1535, a metal basin was observed in the utility room with the IP Manager, Accreditation & Patient Safety Manager and an RN. The basin had approximately one inch of clear liquid inside it. A sign posted on the wall above the basin reflected the following: "Orthozime: P.P.E. Required...Thank You...Sterile Processing." Staff present at the time of the observation indicated that suture sets and airway management supplies used in the ED were placed in the basin until they were taken to the SPD.

* During an interview conducted with the SP Tech on 08/20/2015 at 0850, he/she stated the hospital used Prolystica enzymatic to soak and pre-clean instruments used in the ED which was contradictory to the sign posted above the metal basin in the ED observed on 08/19/2015 at 1535 which indicated the use of Orthozime. In addition, the SP Tech revealed there was no standard procedure for diluting the Prolystica enzymatic that was used in the ED. He/she stated that staff "eye balled" the contents in the basin when diluting the disinfectant.

* Manufacturer instructions on the Prolystica enzymatic container reflected the following directions for use: "...Fill sink or basin with warm water to the appropriate level...Dilute chemistry 1/8 to 1/2 fl. oz. per gallon (1 to 4 mL per L) of warm water..."

* An Infection Prevention policy and procedure provided titled "Selection & Use of Disinfectants" dated "Effective Date: September 2012" reflected the following: "...Disinfection of reusable patient care equipment...will be done according to the following guidelines...All foreign material must first be removed by cleaning before disinfection can occur; cleaning can be accomplished with water, mechanical action, and detergents or enzymatic products...Institute appropriate use of agent, according to the manufacturer's instructions for dilution..."

3. The following observations related to indwelling urinary catheters were made on 08/20/2015:

* In OR 26 at 0740, observation of an RN performing an indwelling urinary catheter insertion of Patient 1 was conducted. Observation revealed the RN did not secure the catheter tubing to anything and the tubing was observed in a dependent loop along the side of the patient's OR bed. On 08/20/2015 at 1435, Patient 1 was observed in the ICU with the Accreditation & Patient Safety Manager. The patient had an indwelling urinary catheter and the catheter tubing was not secured to anything.

Review of Patient 1's medical record with the Accreditation & Patient Safety Manager reflected that the same catheter was in place during both observations at 0740 and 1435 above. There was no documentation in the medical record to reflect that the catheter tubing was secured at any time.

* In the ICU on 08/20/2015 at 1420, Patient 2 was observed with the Accreditation & Patient Safety Manager. The patient had an indwelling urinary catheter and the catheter tubing was not secured to anything. Observation revealed the catheter tubing was hanging in a dependent loop along the side of the patient's bed.

Review of Patient 2's medical record reflected the catheter was inserted on 08/18/2015 at 1615 but there was no documented indication for the catheter and no physician's order for the catheter in accordance with the Lippincott procedure and the hospital policy below. This was confirmed with the Accreditation & Patient Safety Manager at the time of the record review.

* A Lippincott Procedures document titled "Indwelling urinary catheter (Foley) care and management dated "Revised: October 04, 2013" was reviewed and reflected the following: "When caring for and maintaining an indwelling urinary catheter, follow these recommended guidelines...Keep the catheter properly secured to prevent movement and urethral traction."

* A Lippincott Procedures document titled "Indwelling urinary catheter (Foley) insertion, female" dated "Revised: October 04, 2013" was reviewed and reflected the following: "An indwelling urinary catheter should only be inserted when absolutely necessary because its use is associated with an increased risk of developing a urinary tract infection, with the risk increasing with each of use...Ensure that an indwelling urinary catheter is inserted only for an appropriate indication..." The Implementation section reflected "Verify the doctor's order...Assess the patient to make sure that an indwelling urinary catheter is indicated..." The Documentation section reflected "Document...the indication for catheter use."

4. The following observations related to injection practices were made during a tour of the Surgical Services department on 08/20/2015 beginning at 0700:

* Near OR 26 at 0705, 3 vials of Normal Saline 10 ml were observed in an anesthesia prep cart with the Interim Director of OR and the IP. The information on the vials reflected the contents within the vials expired 06/2015.

* In OR 26 at 0720, 4 open MDVs of injectable medications were observed in an anesthesia cart and were available for use. Those medications were Neostigmine 10mL, 2% Lidocaine HCl 20 mL, Rocuronium Bromide 10 mL, and Glycopyrrolate 5 mL.

* In OR 21 at 0725, the anesthesiologist prepared 3 syringes of injectable medications and did not disinfect the rubber septum on the medication vials prior to piercing them and drawing the medications into syringes. This was observed with the Accreditation & Patient Safety Manager.

* In OR 21 at 0730, the anesthesiologist administered a patient 3 IV medications from a syringe into an IV line in the patient's left arm. The anesthesioligist did not disinfect the IV line port prior to administering any of the medications. This was observed with the Accreditation & Patient Safety Manager.

* In OR 21 at 0755, a 1000 mL IV bag labeled "0.9% Sodium Chloride Injection" was observed. The bag had a label affixed to it that read "Heparin." There was nothing on the IV bag or label to indicate the expiration of the Heparin, or any other information about the medication. This was confirmed with the Accreditation & Patient Safety Manager at the time of the observation.

* In OR 21 at 0800, on the Purfusionist cart, a syringe containing a clear liquid was observed. The syringe had a label affixed to it that read "Heparin" and had a blank line preceding each of the following: "units/ml," "Date," "Time," and "Int." There was nothing on the syringe to indicate the expiration of the Heparin or any other information about the medication. This was observed with the Accreditation & Patient Safety Manager.

* A policy titled "Medication Administration Guidelines" dated "Final Approval: March 2015" reflected the following: "Appropriately label all medication throughout the medication distribution and administration workflow process...If the medication must be drawn up for administration later in the shift (within 1 hour), label it properly with the following information...Affix a Patient Label on the container...The name of the medication...The medication strength or dose in the container or syringe...The expiration time (1 hour after preparation)...The intended route of administration...The initials of the person who prepared the medication...This standard is inclusive of all medications...If unlabeled syringes or medications are found, they must be discarded and NOT used."

For MDVs, the policy reflected the following: "...Use multiple dose vials only for single doses for a single patient. Discard after use."

* A Lippincott Procedures document provided titled "IV bolus injection" dated "Revised: April 05, 2013" reflected the following: "In a perioperative or other procedural setting, if the medication or solution is transferred from the original packaging to another container, or if it isn't to be administered immediately, label the container with the medication name, dosage, strength, quantity, diluent and volume, and expiration date..."

For disinfection of injection ports, the policy reflected the following: "Thoroughly disinfect the needleless injection port with an antiseptic pad using friction, and then allow it to dry...Attach the medication syringe to the injection port and inject the medication, as prescribed..."

5. The following observations related to hand hygiene were made on 08/20/2015:

* In OR 21 at 0740, observation of an RN performing an indwelling urinary catheter insertion of a patient was conducted. After the RN inserted the catheter, he/she handled and touched the patient's skin and gown, the outside of a wall mounted glove box, a computer "mouse," a phone, and the inside of his/her scrub shirt pocket. The RN changed his/her gloves 4 times during these activities but did not perform any hand hygiene. This was observed with the Accreditation & Patient Safety Manager.

* On the M/S unit at 1610, observation of an RN performing a PICC line flush was conducted. The observation revealed the RN wore gloves for the procedure and then touched a computer keyboard, a computer "mouse" and a took a pair of scissors out of his/her pocket. He/she did not remove the gloves and did not perform hand hygiene during this observation.

* A document provided titled "Standard Work: Hand Hygiene," dated "12/2/14" reflected the following: "Hand hygiene will be performed in all indications below regardless of the fact that gloves are used or not...After body fluid risk...Contact with medical devices...After patient contact...After contact with patient surroundings - even without touching the patient..."