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Based on interview and review of documentation it was determined that the hospital failed to ensure that all hospital operations were licensed as required by the State of Oregon hospital licensing requirements. OAR 333-500-0025, Indorsement of Satellite Operations, allows a hospital to provide services at off-campus "satellite" locations when all required licensing requirements have been met. The hospital is currently operating an unlicensed satellite location for the provision of sleep center and respiratory therapy services.

Findings include:

1. The review of Oregon hospital licensing records maintained by OHA HCRQI reflected that SCMC Redmond had no satellite locations associated with or approved for its hospital license.

2. An untitled document received in response to a request for a list of all hospital satellite locations was reviewed. It identified St. Charles Sleep Center and St. Charles Pulmonary Clinic at 655 NW Jackpine Avenue in the city of Redmond and identified the types of services as "Sleep Disorders Care and Treatment" and "Resperatory (sic) Outpatien (sic) Therapy".

3. The online program MapQuest reflected that the sleep center is approximately 1/2 mile from the hospital.

4. During interview on 04/07/2015 at 1130 the DPCS stated that the hospital operated a sleep center for the provision of outpatient services off the hospital's campus and billed Medicare for those services.

The hospital CEO, the CCO, the CNO, and the DCRM were interviewed on 04/09/2015 at 1445 for completion of the CMS Hospital Database Worksheet. During the interview the CEO confirmed that the hospital currently operates the St. Charles Sleep Clinic at 655 NW Jackpine Avenue in the city of Redmond. During the interview it was revealed that the hospital had been operating the sleep center since 2008 and had been billing Medicare for the provision of those services.

Based on interview, documentation in 5 of 5 contracts or agreements reviewed (Contracts 1 through 5) and hospital policies and procedures, it was determined that the hospital failed to develop and implement a system to ensure that 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 pertaining to the contracted service. Contract language did not clearly include that provision and did not specify how the hospital would evaluate the contractor's services to ensure compliance; and there was no evidence that the hospital had evaluated the services of the contractors.

Findings include:

1. Contract 1, the "Restated Linen Service Agreement As Amended December 18, 2002" between the hospital and Southern Oregon Linen Service (SOLS) 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 if or how the hospital would evaluate the services of the contractor. Further, there was no evidence that the hospital had evaluated the linen services provided by SOLS.

2. Contract 4, the "Physical Therapy Services Agreement" between the hospital and Rebound Physical Therapy, effective 01/01/2012, 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 if or how the hospital would evaluate the services of the contractor. Further, there was no evidence that the hospital had evaluated the therapy services provided.

3. Contract 5, the "Hospital Referral Testing Agreement" between the hospital and Pathology Associates Medical Laboratories, LLC, effective 01/01/2015, 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 if or how the hospital would evaluate the services of the contractor. Further, there was no evidence that the hospital had evaluated the laboratory services provided.

4. Similar findings were identified in relation to the review of agreements with Central Oregon Magnetic Resonance Imaging for MRI services, and Cascade Medical Imaging for CT and other radiology services.

5. The policy and procedure titled "Contract Review", with an effective dated of 11/26/2007, was reviewed. The purpose was for describing "the process for developing and reviewing contracts prior to acceptance." It stipulated that "Contracts will be periodically reviewed (annually at a minimum)." However, the document did not specify how compliance with the COPs would be ensured and how the services provided under the contract or agreement would be evaluated.

6. On 04/10/2015 the QMPS stated that there were no records of evaluation of services provided for Contracts 1, 4, and 5 above.

Based on interview, documentation in 5 of 5 contracts or agreements reviewed, (Contracts 1 through 5) and hospital policies and procedures, it was determined that the hospital failed to ensure that its QAPI program included all services furnished under contract or arrangement.

Findings included:

* Refer to Tag A083, CFR 482.12(e) Contracted Services which reflects the hospital's failure to ensure that all services provided under contract or agreement were evaluated to permit compliance with federal COPs.

* During an interview conducted 04/10/2015 at 1100 the QIC stated that linen and MRI services provided under contract were monitored by department managers, and if there was a problem identified then it would be added to a quality report.

* During an interview conducted 04/10/2015 at 1130 the Assistant VP of Ancillary & Support Services stated he/she was not aware of a formal quality review process of the hospital's contracted linen service.

Based on interview, documentation reviewed in 2 of 2 medical records that were reviewed for chest tube and indwelling urinary catheter management (Patients 1 and 2), it was determined the hospital failed to ensure the RN developed and kept current a nursing plan of care related to the chest tube and catheter.

Findings include:

1. Review of the medical record of Patient 1 revealed the patient was admitted on 03/28/2015 at 0955 for a pneumothorax and chest tube insertion. There was no evidence in the record that a nursing plan of care had been developed to address the patient's respiratory condition, including management of his/her chest tube.

The RN notes dated 03/28/2015 at 1605 reflected the patient "arrived...from ED. Chest tube in place to left upper chest. Set to suction. On remote monitor...Pt currently rates chest discomfort at 6/10..."

The RN notes dated 03/29/2015 at 0734 reflected "Pt had times of respiratory distress and desaturation to 80's... Assumably they were r/t inadequate respirations/guarding r/t rib [fractures] and pain..."

The RN notes dated 03/31/2015 at 1805 reflected "pt very intolerant to exertion at this time. 02 sats dropped to 75 [percent] on 1 liter with exertion, increased 02..."

The RN notes dated 04/01/2015 at 0030 reflected "Awoke patient for assessment and found [him/her] disoriented to time, place and situation...Chest tube troubleshooting found leak at the connection of the chest tube...Upon close inspection of the chest tube dressing, it was found to be nearly saturated with serosanguinous fluid..."

The RN notes dated 04/04/2015 at 1749 reflected "patient with ongoing pneumothorax...patient knocked over chest tube [drainage system]...Patient is on continuous pulse oximetry and desats to 70 [percent] with any exertion in bed...anxious regarding poor improvement."

The RN notes dated 04/06/2015 at 1051 reflected "Lungs sound quite diminished...emphysema is profound...extensive nature of pt's lung disease causing difficulty in resolution of this acute problem."

The RN notes dated 04/06/2015 at 1354 reflected "Pt has not had significant progress, and chest CT done on weekend...showed still sm-mod pneumothorax and severe emphysema..."

The RN notes dated 04/08/2015 at 0612 reflected "Pt...c/o left lateral chest pain from chest tube. Minimal drainage from chest tube no fluctuation. Anterior breath sounds diminished throughout..."

These findings were confirmed during an interview with the DPCS on 04/08/2015 at 1120. He/she acknowledged that there should have been a nursing plan of care developed to address the patient's respiratory condition and chest tube.

2. Review of the medical record of Patient 2 revealed the patient was admitted on 04/04/2015 at 1833 with a diagnosis of seizures.

Review of the RN notes on the "Daily Focus Assessment Report" dated 04/04/2015 at 1954 reflected "Foley [urinary] Catheter Clear Yellow."

The RN notes dated 04/05/2015 at 0745 reflected "Assessment...WDL Except Foley Catheter Clear Amber."

The RN notes dated 04/06/2015 at 2035 reflected "...Foley Catheter...amber, concentrated.

The RN notes dated 04/07/2015 at 0552 reflected "Foley Catheter...Cloudy...tea colored."

There was no evidence in the record that a nursing plan of care had been developed and kept current to address the patient's catheter and changes in urine color and clarity. In addition, there was no documentation in the record reflecting when the urinary catheter was inserted, the type and size of the catheter, or a physician's order for the catheter.

These findings were confirmed during an interview conducted with the DPCS and an RN on 04/07/2015 at 1700.

Based on interview, review of documentation in 1 of 2 medical records of patients who had blood transfusions (Patient 12), and review of policies and procedures, it was determined that the hospital failed to ensure that documentation of 3 of 3 blood transfusions was complete and reflected all aspects of the transfusion process and monitoring in accordance with hospital policies and procedures.

Findings include:

1. Review of the medical record of Patient 12 revealed the patient was admitted to the hospital for dehydration on 03/26/2015. The patient subsequently received three blood transfusions in accordance with physician's orders.

A "Transfusion Record" form reflected that a unit of blood was checked out of the laboratory blood bank for transfusion on 03/27/2015 at 1107. The following sections of the form were blank:
* "Start Transfusion Start Date";
* "Start Transfusion...Time";
* "Blood Warmed";
* "Symptoms for Reaction...Skin Changes...Cardiovascular changes...New Pain...Respiratory Changes...Urinary Changes...Other New Signs/Symptoms..."
* Pulse and BP for the vital signs recorded at 1230 on that date.
* "Stop Date"; and
* Stop "Time".

A "Transfusion Record" form reflected that a unit of blood was checked out of the laboratory blood bank for transfusion on 03/29/2015 at 1003. The following sections of the form were blank, incomplete, or unclear:
* The patient's temperature for the vital signs recorded at 1045 had been altered and the author of the alteration and when the alteration occurred was not recorded;
* "Post Transfusion" time and vital signs were blank;
* The "Time" the blood bank was called to notify them the patient had developed signs of a possible transfusion reaction had been altered and the author of the alteration and when the alteration occurred was not recorded.

A "Transfusion Record" form reflected that a unit of blood was checked out of the laboratory blood bank for transfusion on 03/29/2015 at 1143. The transfusion start time was recorded as 1230, 47 minutes after the unit was removed from the blood bank. Additionally, the following sections of the form were blank, incomplete, or unclear:
* The "Verify Patient & Unit (Must complete immediately before beginning transfusion)" section of the form contained 7 criteria to be verified and evaluated. None of those 7 items were check-marked in the boxes provided as having been verified.
* The "Verify Patient & Unit (Must complete immediately before beginning transfusion)" section of the form contained space for two RNs to sign that they verified and evaluated the 7 criteria together. One of those spaces was for the "Transfusionist" and the other for the "Witness". The "Transfusionist" space was blank.
* Although the "Start Transfusion...Time" was 1230, the "Vital Signs...1 Hour After Start" were recorded at 1345;
* Although the "Start Transfusion...Time" was 1230, the "Vital Signs...2 Hours After Start" were recorded at 1450;
* "Symptoms for Reaction...Other New Signs/Symptoms...[temperature greater than or equal to 38 degrees Celsius" was recorded as "[No]", however the patient's recorded temperature at 1230 was 38.5; at 1245 was 38.6; and at 1345 was 38.4;
* "Post Transfusion" time and vital signs were blank;
* "Stop Date" was blank;
* Stop "Time" was blank; and
* There was no documentation on the form to reflect who performed the blood transfusion.

2. The hospital policy and procedures titled "Blood Component Transfusion, Administration of", with an effective date of 07/09/2014, was reviewed. It included the following requirements: "Blood Bank Transfusion Record accompanies the blood/component from blood bank...Used as record of transfusion...Vital signs taken/recorded on this form as per printed instructions...Hang blood/component within 30 [minutes] of leaving blood bank...Return blood product to Blood Bank at first sign of delay. In the event the product cannot be hung immediately, it must be returned within 30 minutes for proper temperature control." The procedure further stipulates "Two RNs will verify the physician's order...At the patient's bedside the same two nurses will verify the blood/component information with the patient's arm bands (hospital and red blood bank), with the bag tag, blood unit, and blood transfusion record...Document the patient and unit verification on the Transfusion Record and sign as transfusionist/witness...Record Transfusion starting time and date and if blood is being warmed...Record transfusion Stopped time and date...Record all transfusion reaction signs and symptoms as either [Yes] or [No] on the transfusion record and mark whether reaction is suspected."

The hospital protocol titled "Patient Care Protocol - Nursing - Pre-Transfusion Verification", with an effective date 07/21/2014, was reviewed. The "Purpose" of the protocol was written as "Verification of critical elements prior to the start of transfusion of blood products." The protocol contained 11 requirements which included: "Two nurses will verify the physician's order...With the patient, the same two nurses will verify the blood/component information with the patient's arm bands...with the bag tag, blood unit, and blood transfusion record...The two nurses will also compare the Unit number, ABO group, Rh type, and the expiration date between the bag tag, blood unit, and transfusion records...Document the above check on the Transfusion Record..."

3. Medical record reviews were conducted with the CRC on 04/10/2015 beginning at 1345. During interviews at that time the CRC confirmed the incomplete blood transfusion documentation in record 12.

Based on interview, review of documentation in 5 of 18 medical records (Patients 7, 9, 11, 12, and 18), and review of policies and procedures, it was determined that the hospital failed to ensure that the medical records were dated, timed, authenticated and contained complete information documented by the individuals responsible for the services. Entries related to admission consent, newborn APGAR and assessment, anesthesia, blood transfusions, and discharge instructions were not clear or complete.

Findings include:

1. Review of the medical record of Patient 7 reflected the patient was a newborn and was delivered on 04/08/2015 at 0251. The record lacked lacked documentation of an evaluation of the newborn's APGAR scores as required by hospital policy.

2. Review of the medical record of Patient 9 reflected the patient was a newborn and was delivered on 04/07/2015 at 0827. The first documentation of an assessment of the newborn's eyes recorded 04/08/2015 at 2000 reflected "Eye, Ear, Nose, Throat...WDL" and was not documented at the time of delivery and every 6 hours as required by hospital policy.

* Review of the policy titled "Care of the Newborn Infant," dated effective 06/25/2014 reflected "Evaluate the Apgar score at 1 minute and 5 minutes of age...Perform head-to-toe assessment and document newborn admission assessment...Physical Assessment Newborn...Head-Face-Ears-Eyes-Mouth...The face will appear symmetrical and without drooping of the eyes and mouth...Perform head-to-toe assessment q 6 hrs."

3. Review of the medical record of Patient 11 revealed the patient was admitted to the hospital on 04/02/2015 and underwent surgery to repair his/her fractured right hip on 04/04/2015. The "Anesthesia Patient Evaluation Form" was dated "4-215 (sic)" and the space for "Licensed Practitioner's Signature" was blank. There was no signature or authentication on the form to reflect the author of the entries on the form.

Although the "Anesthesia Record" form reflected the date of surgery and the name of the anesthesiologist/anesthetist, the form was not authenticated to reflect the author of the entries nor dated to reflect when the form was complete.

Date and time entries on the "Pre-Anesthetic Note" had been altered and did not reflect the author of the alterations or when those alterations occurred.

The year portion of the date the "Post-Anesthesia Evaluation Note" was completed was not legible. In addition, the Note contained six evaluation criteria to be assessed after surgery and anesthesia. The outcome for three of those was not documented: "Cardiovascular function and Hydration status satisfactory"; "Mental status recovered: patient participates in evaluation"; and "Pain control satisfactory". The spaces next to each of those criteria were blank.

4. Review of the medical record of Patient 12 revealed the patient was admitted to the hospital for dehydration on 03/26/2015. The patient subsequently received three blood transfusions and developed signs of a possible reaction during the second transfusion. The "Primary Transfusion Reaction Workup" form, dated as completed on 03/30/2015 at 1330, included a section labeled "Imputability". An entry in that section recorded next to the verbiage "Probable" had been scribbled out and fully obliterated. The date that alteration occurred was not recorded.

Also refer to Tag A409, CFR 482.23(c)(4), which reflects the hospital's failure to ensure that blood transfusion documentation was complete in the record of Patient 12.

5. Review of the ED medical record of Patient 18 reflected that the patient presented to the hospital with a chief complaint of a "Foley catheter problem" on 02/28/2015 at 2355. There was no documentation in the record to reflect that the patient consented to treatment on admission to the ED on the hospital's admission consent document. In addition, the space for "Patient/Guardian's Signature" on the "Dysuria - AfterCare...Instructions..." form was blank. There was no documentation in the record to explain those omissions.

6. Medical record reviews of records 11, 12, and 18 were conducted with the CRC on 04/09/2015 beginning at 1615 and 04/10/2015 beginning at 1345. During interviews at those times the CRC confirmed the incomplete and unclear documentation in those records.


29708

Based on observation, interview, review of policies and procedures and other documentation, it was determined that the hospital failed to fully develop and implement its policies and procedures to ensure that drugs and biologicals were appropriately controlled, distributed, and stored throughout the facility:
* Emergency drug carts and kits containing emergency and back-up drugs were not managed and maintained throughout the hospital to ensure the security and integrity of the contents;
* Drugs in all departments were not under the control of the pharmacy; and
* Outdated drugs were observed.

Findings include:

1. During tour of the third floor M/S unit on 04/07/2015 at 1210 an emergency code cart was observed located in an open space at the nursing station. The "Code Cart Check Sheet" reflected that the breakaway "lock"(also sometimes referred to as a "seal") number on the cart at the time it was last checked by an RN on 04/07/2015 at 0150 was 6023928. The "lock" number recorded by an RN the day prior to that on 04/06/2015 at 0200 was 6023933. The RN who made the entry on 04/07/2015 made the following note under the column heading "Lock Change and Why": "Yes, Found that way." There was no further explanation, or indication as to what action the RN took upon discovering the "lock" number had changed without a documented reason.

During interview with the RT Director on 04/07/2015 at 1250 he/she stated that an RT had changed the "lock" between 04/06/2015 and 04/07/2015 but had failed to record that and the reason at the time. He/she stated "it slipped through..."

2. During tour of the CT room in the radiology department on 04/07/2015 at 1235 a handheld tool box type drug kit was observed. It was labeled "Radiology Contrast Reaction Emergency Kit". On the outside of the box was attached a list of six medications with the drug strength, form, and quantity. The kit had a green breakaway "lock" observed placed through the lock holes on the box. The "lock" did not contain a number and the date "10/1/15" was manually written on it. There was no indication on the box or on the list to what that date referred to. There was no log for routine inspection of the kit to ensure the security and integrity of the contents at the time it should be needed.

3. During tour of the outpatient rehabilitation department on 04/07/2015 at 1630 the following observations were made:
* A "Sentry Safe" household lock box was observed. A label observed on the box contained the one word "Iontophoresis". Inside the box were observed 3, 1 ml vials of Dexamethasone 10 mg/ml for injection.
* A tube of "Double Antibiotic Ointment... Bacitracin Zinc Polymyxin B" was observed in the rehabilitation department supply room. It contained an expired date of "Oct 2010".

4. During tour of the ED on 04/08/2015 at 1330 the following observations were made:
* The code cart located across the hall from the holding/seclusion room was observed to have a pink label affixed to the outside of the cart. The documentation on the label reflected that the next drug in the cart to expire was "Magnesium" and the expiration date was noted as "6/15". However, observation of the contents of the cart revealed an IV bag of Lidocaine Drip 250 ml. that had expired "Mar15".
The Adult Crash Cart Contents list, observed inside a drawer of the cart, was reviewed. The list consisted of three pages of medications and supplies. It contained approximately 122 handwritten entries throughout the form, most did not include the author of the entries. Approximately 57 of those handwritten entries had been altered and entirely scribbled out so that the original entry was not readable. The Lidocaine Drip IV bag row of the form contained three scribbled out entries and a fourth entry in the margin of the form that was not clearly legible and with difficulty could be discerned as "3/15".
* A cart described as a "nurse server" was located in the holding or psychiatric seclusion/holding room. It contained numerous supplies, including 6 single use syringes of .9 [percent] sodium injection; betadine swabs; and lubricating jelly packets which had expired "4/2014" and "5/2014." It was not clear how this cart which contained medications would be managed in the case of a mental health patient admission to the holding/seclusion room.
* An open EENT bedside handtray placed on a cart in a hallway was observed to contain a 15 ml. bottle of Proparacaine hydrochloride ophthalmic solution .5 [percent].

5. During tour of the FBC on 04/08/2015 at 1500 Room 111 was observed and was described as the "code cart back-up room". That room was formerly a patient room. The room was accessible from the FBC corridor through a door into a small anteroom outside of the former patient room. Neither the door between the corridor and the anteroom, or the door between the anteroom and the patient room were observed to be locked. A housekeeping cart was observed in the anteroom.

Inside the room was observed numerous shelves filled with supplies and two "back-up code carts." Each cart had a breakaway red, numbered plastic "lock" attached to the medication drawer. The number on the pediatric code cart "lock" was 6023936, and the number on the adult code cart "lock" was 6023926. However, there was no log or corresponding documentation to reflect whether or not the number on the "locks" was consistent with the numbers on the "locks" placed on the back-up carts at the times they were re-stocked and determined ready for use.

6. During tour of the FBC on 04/09/2015 at 1110 a red handheld tool box type drug kit was observed in the "inner nursery room". A green breakaway "lock", without a number, was observed in place securing the box closed. The "lock" had "4-13-15" written on it. There was no log or other documentation to reflect that the kit was routinely monitored and inspected to ensure the security and integrity of its contents.

7. During tour of surgical services on 04/08/2015 at 1340 the following observations were made:
* An unlabeled and unmarked locked metal box was observed mounted on the wall outside of OR 2. The box was described to contain anesthesia drugs for use in the event the automated machine generally used during surgery, was not functional. The metal box was unlocked with a key by staff and contents observed. Inside the metal box were two trays, each covered with a clear lid and secured with a green breakaway "lock". The contents included 25 anesthesia drugs, including such controlled drugs as Propofol and Fentanyl. The green "lock" did not contain a number. On the green "lock" on one tray was the date "4/26/15". Inside the box observed through the clear lid were a number of drugs, a list of anesthesia drugs, and a red breakaway "lock" without a number.
* During the tour in OR 4 observations were made of a clear Plexiglas "emergency box" attached to the sides of the Pyxis anesthesia unit. It was observed to contain several MDVs of anesthesia drugs, including Propofol, and a pre-filled syringe. The box was secured with a green, breakaway lock, without a number, on which "5/5/15" had been written.

lt was not clear how the system of unnumbered, breakaway "locks", that provided no accountability and could be obtained both outside and inside the hospital, would prevent tampering and ensure the security and integrity of the anesthesia drugs.

During interview with a pharmacist on 04/08/2015 during the surgical services tour, he/she stated that pharmacy checked the anesthesia drugs daily but had not maintained documentation of those checks.

8. During tour of surgical services on 04/08/2015 at 1435 a cart labeled as a MH emergency cart was observed in a hallway with a yellow breakaway "lock" in place to secure the drawers. The number on the lock was 0128111. The "MH Cart Check Log" located on top of the cart was observed and reflected that lock number had been placed on 04/06/2015 by an RN for the reason "[check] sterile water." The prior entry on the log was dated 04/06/2015 and reflected that lock number 028157 had also been placed on that day for the reason "[check] sterile [water] supply." There was no explanation for why the cart was accessed two times on one day to check the sterile water. The entry prior to that was dated 04/01/2015 and reflected lock number 0128114 had been placed for the reason to "update Dantrium." The entry prior to that was dated 03/02/2015 and reflected a different lock number. None of the entries on the log reflected the time. The log contained a total of nine entries for the year 2015, made by four different staff, with each entry reflecting the cart was opened and a new lock with a different number placed. The last entry recorded in 2014 was on 10/09/2014, reflecting approximately a 3 month time period during which the cart was not checked for integrity. On 01/12/2015 the lock number was changed for "outdates". The next day, on 01/13/2015 the lock number was again changed for "outdates". On 02/02/2015 two lock numbers were recorded in the one space as being changed for "outdates". However, there was no evidence that the cart was checked on a more frequent basis to ensure that the number of the last lock recorded on the log was in place and intact. The system failed to ensure the integrity of the drugs inside the cart as multiple individuals had access to the numbered locks and the log reflected no evidence of routine inspection for lock integrity.

9. During tour of the PACU on 04/08/2015 at 1655 the emergency code cart was observed. A long metal rod was in place vertically from top to bottom of the cart designed to prevent the drawers from being opened when it was in place. The top of the rod was observed to be attached to the cart with a loosely affixed red breakaway "lock". The "lock" was numbered with 6023955. During the observation the long metal rod was pulled up out of the hole in which the bottom of the rod was placed and maneuvered to be positioned horizontally in such a manner that the rod was not blocking any of the drawers and the drawers could be fully opened.. The loosely affixed nature of the breakaway "lock" allowed the maneuvering of the rod and opening of the drawers without breaking the "lock". The rod was then returned to its position of appearing to secure the drawers without needing to have a new breakaway numbered "lock" attached. This failure in the system created a situation where drugs could be accessed for unauthorized purposes without detection.

10. The hospital policy and procedure titled "Inpatient Pharmacy Supply of Adult and Pediatric Code Cart Medications", effective date 06/30/2014, was reviewed. It reflected that "Central Processing (CP) is responsible for the rotation of code carts to the various departments. Each time a cart is opened, CP will promptly replace it with a restocked cart...Pharmacy will supply the medications kept in drawer 2 and the medicated drips in drawer 5 in the adult code carts...A tamperproof plastic bag will enclose the medication exchange trays..whenever a code cart is opened and medications are used, the tamperproof bag must be split open...When medications are used, the medication exchanged tray(s) will be returned to the pharmacy for replacement by the CP department....Once the pharmacist replaces the used drug tray(s) and any other times that may have been used, CP will seal the cart with a numbered tag for later use and record the number on the "Crash Cart Inventory" sheet...Each exchange tray will be dated with the expiration date of the item that will expire first. The code cart expiration date will be kept consistent with the drug expiration dating by the CP department...All sealed carts will be stored in CP. Only the exchange trays will be stored in the pharmacy.."

The hospital policy and procedure titled "Daily Code Cart Inspection and Testing All Campuses", effective dated 07/24/2014, was reviewed. It reflected that the "code cart is inspected and defibrillator/monitor is tested every 24 hours...Inspect that: lock is intact, and dated and initialed...For each cart, items are checked and noted on the Code Cart Checklist. Confirm that items are present and no supplies are beyond any printed expiration dates...

The hospital policy and procedure titled "Pharmacy Inspections of Nursing Units", effective date 06/30/2014, stipulated that pharmacy personnel "shall inspect all areas where medications are stored on a bi-monthly basis...During the inspection the technician will assure that...Drugs are properly stored and labeled...No unapproved medications are present...expired medications are discarded and replaced...The code Carts are sealed and in date and contain a list of medication on the outside of the Code Cart...All Kits are sealed and in date and contain a list of medications on the outside of the Code Cart..."

The hospital policy and procedure titled "Medication Handling, Labeling, Packaging, and Storage", effective dated 06/30/2014, was reviewed. Under "Anesthesia" it stipulated that "All medications shall be secured in the anesthesia tray when no licensed personnel is in the room. At no time shall medications be left unsecured...Anesthesia Controlled Substance boxes shall remain in possession of anesthesia provider, secured in anesthesia tray or replaced in mail box and the mail box locked...All unopened multiple dose vials and syringes shall be discarded at the end of the day and replaced with new containers daily".

The hospital policy and procedure titled "Pyxis Anesthesia Systems", effective date 06/30/2014, was reviewed. It contained a section titled "Emergency Access Procedures" which reflected that "In the event the Pyxis Anesthesia System is inaccessible, emergency drug trays will be utilized...Emergency drug trays will be located within secured key lock boxes...Use of the emergency access box will be communicated to the pharmacy manager...will be refilled upon notification of use." The procedure did not include or address the systems for ensuring the security and integrity of those medications, including who had access to the keys used to open the lock boxes, where those keys were stored, the use of red and green unnumbered breakaway "locks", and documentation of monitoring of those systems. In addition, the policy and procedure did not address the clear Plexiglas emergency boxes mounted on the side of the anesthesia units.

There were no policies and procedure provided which specified actions to take in the event of "lock/seal" number discrepancies.

11. During interview on 04/08/2015 at 1010 the pharmacist stated that the pharmacy has "oversight" of the drugs on the code carts, however, he/she stated the RT department manages the cart "post-procedure". He/she stated that after a code, RT returns the used drug drawer to pharmacy and takes a new drug drawer to place in the cart. The pharmacist stated that there were no red, numbered "locks" stored in pharmacy and he/she didn't know who had those. The pharmacist did locate two yellow, numbered "locks" in the pharmacy during the interview. However, he/she indicated not being sure why those were in the pharmacy or what they were used for.

12. During interview with the RT Manager on 04/08/2015 at 1425 he/she stated that normally the stock of red numbered "locks" was maintained in the "code cart back-up room" and that he/she was unable to show the surveyor the stock of numbered "locks" for the hospital as there were none left in the "code cart back-up room." He/she stated there were only two numbered "locks" left in the hospital at that time. One had been found in the RT Director's office and the other had been found in another department office. He/she stated that more numbered "locks" would have to be sent from another hospital. The RT Manager further acknowledged that the "code cart back-up room" was not locked and therefore the "locks" were stored in a room that was accessible to all staff, including housekeepers, and visitors.

13. During interview with the QMPS on 04/10/2015 at 1540 he/she stated that the Pharmacy Director confirmed that the pharmacy had no record that Dexamethasone for injection was stored in the rehabilitation department as described under finding number 3 above.

Based on observation, interview, review of PM documentation and policies and procedures, it was determined that the hospital failed to fully implement its systems to ensure that all electrical and bio-medical patient care equipment had been maintained to ensure an acceptable level of safety and quality:
*All patient care equipment available for use had not been incorporated into hospital inventory and PM inspection schedules as applicable; and
* Outdated and "retired" patient care equipment was in use or available for patient use.

Findings include:

1. During tours conducted throughout the hospital observations of equipment without inventory numbers or PM labels were made. PM records for those items were reviewed with Biomedical and PM staff.

*During tour of the radiology department on 04/07/2015 at 1235 a GE Warmer for CT contrast media was observed. There was no inventory tag or PM label on the unit.
During interview with the FSM on 04/10/2015 at 0930 he/she confirmed there were no PM records for the item.

* During tour of the ED on 04/08/2015 at 1330 a Phillips Burton exam lamp was observed on the EENT cart. There was no inventory tag or PM label on the unit.
During interview with the FSM on 04/10/2015 at 0930 he/she confirmed there were no PM records for the item.

* During tour of the FBC on 04/08/2015 at 1445 a Mini GE Telemetry unit with an inventory number of R02409 and a PM label with a last inspection date of "4/2012" was observed.
During interview with the FSM on 04/10/2015 at 0930 he/she stated that the number could not be found in the PM system and there were no current PM records for the item.

* During the tour of the FBC on 04/08/2015 a Mark 10 Respirator was observed in the bathroom of Room 111, along with two Ohmeda Ohio Ped Aerosol Tents, one with an inventory tag number of R00037 and the other R00038.
During interview with the BMES on 04/09/2015 at 1300 he/she stated the Mark 10 Respirator was not found in the PM system; and the Ohmeda Tent records reflected the last PM inspections on both units was 12/14/2005.

* During tour of the outpatient rehabilitation department on 04/07/2015 at 1650 a Master Bottle Warmer and several TENS units with no inventory tags or PM labels; and a NOMAD Molift (ceiling hoist used for patient transfer) with inventory number of 26881 and no PM label were observed.
During interview with the FSM on 04/10/2015 at 0930 he/she confirmed there were no PM records for those items, including the 12 TENS units.

* During the tour of the rehabilitation department an Omron BP Monitor was observed with no inventory tag or PM label.
During interview with the BMES on 04/09/2015 at 1300 he/she stated that the item was not found in the system and there were no PM records for that item.

* During the tour a Biodex 400 treadmill with an inventory number of R02761 was observed. It had a PM label affixed to it with an inspection date of 01/2015 and the inspection due date was blank. During interview on 04/09/2015 at 1300 with the BMES he/she stated that the PM records were incomplete and the records showed the item was "retired" on 08/11/2010.

* During the tour a therapy exercise mat table with an inventory number of TAR0015 was observed. It had a PM label with no inspection due date.
During interview on 04/09/2015 at 1300 with the BMES he/she stated that the PM records reflected that the item was last inspected on 11/10/2010 and was "retired" on 11/16/2010.

* During tour of the surgical services department on 04/08/2015 at 1530 a Medivators Edge endoscope reprocessor was observed with no inventory tag or PM label.
During interview with the FSM on 04/10/2015 at 0930 he/she stated that the item was not found in inventory or the PM system.

* During the surgical services tour a Lantheus Vialmix machine was observed with no inventory tag or PM label.
During interview with the FSM on 04/10/2015 at 0930 he/she stated that the item was not found in inventory or the PM system.

2. The policy and procedure titled "Preventative & Corrective Maintenance Processes", effective date 07/02/2014, was reviewed. It reflected "Facilities and Equipment: To include, but not limited to, all owned and leased buildings, property, facility-related installed and portable equipment, specialized machinery and related systems and infrastructure that insure safe, efficient and continuous operation of the facility...A complete inventory of all SCHS equipment...has been completed and is included in the department's maintenance program. Any new equipment entering the facility is evaluated for entry into inventory and any equipment removed from services is removed from the inventory. Appropriate strategies are developed to ensure effective, safe and reliable operations and maintenance of all facilities and equipment in the inventory."

The policy and procedure titled "Inspecting, Testing, and Maintenance Criteria for Medical Equipment", effective date 06/26/2014, was reviewed. It specified that "Clinical devices, whether part of a system or an individual piece of equipment, are included in the equipment inventory if it meets the criteria listed in this procedure. All clinical equipment is initially evaluated for inclusion in the hospital medical equipment management program based upon the five risk criteria...Whenever new equipment is received by the Medical Center, it is evaluated for inclusion into the medical equipment management program inventory using the criteria described above and an initial inspection is performed." The document reflected that all equipment would be assigned a priority number from 1, high priority with at least semi-annual testing, to 5, lowest priority with little or no risk to patients. "These devices are not included in the management program but may remain on the clinical equipment inventory." The document stipulated that "A label will be placed on a clinical device...This label will specify that the device is 'Approved for use by St. Charles Biomedical Services'. If it needs to be re inspected by a specific date it will also indicate the 'date inspected', 'inspected by', and 'inspection due date'...Devices that do not require a periodic inspection will indicate "initial inspection only."

The policy and procedure titled "Service, Repairs, and Receipt of Medical Equipment", effective date 02/26/2015, was reviewed. It specified that "If an item of clinical equipment is sent out for service, the device will be inspected by Biomedical Services upon receipt of the item and prior to hospital use...All loaner, rental, evaluation, or physician owned medical devices used in the Operation Suite will be submitted to Biomedical Services for electrical safety checks and inspection prior to hospital use."

3. On 04/10/2015 at 0930 during the PM record review with the FSM he/she stated that there were gaps in the system.

Based on observation, interview, and review of the medical record for Patient 2 who had an indwelling urinary catheter, policies and procedures, and other documents, it was determined the hospital failed to fully develop and/or implement policies and procedures for infection prevention in the following areas:
* Isolation precautions;
* Disinfection of whirlpool tubs;
* Indwelling urinary catheter management;
* Disinfection of blood glucose meters;
* Storage of mops;
* Sterilization processes; and
* Humidity and temperature monitoring.

Findings included:

1. During a tour of the third floor M/S unit conducted on 04/07/2014 at 1230 with the DPCS the outside of patient room 314 was observed. An "Enteric Precautions" sign was observed hanging on the door frame. The sign reflected the following: "Stop...Everyone Must: Includes doctors, all other providers, all staff, family members and visitors...Wash Hands with soap and water when Leaving...Gown and glove at door. This applies whether or not contact with the patient or the patient's environment is anticipated." A physician was observed to enter the room and sit at the patient's bedside. He/she did not don a gown and gloves before entering the room. Approximately five minutes later, the physician exited the room. The physician did not wash his/her hands with soap and water, or perform hand hygiene of any kind when he/she exited the room.

During a tour of the third floor M/S unit on 04/07/2015 at 1305, the outside of patient room 311 was observed. An "Enteric Precautions" sign was observed hanging on the door frame and included the same language reflected above. A privacy curtain was hanging inside the room near the room entrance. A RN opened the privacy curtain. He/she did not don a gown or gloves prior to touching the curtain.

A policy titled "Guideline for Isolation Precautions," dated effective 12/03/2014 reflected the following: "Contact Precautions-Enteric Precautions...use Enteric Precautions for ...microorganisms that can be transmitted by direct contact with the patient ...or indirect contact (touching) with environmental surfaces...Contact/Enteric: Gown at door for patient or environment contact...Gloves/Hand Hygiene..Enteric: Glove at door...Remove gloves before leaving the patient's environment and perform hand hygiene immediately...Enteric: Hands must be washed with soap and water."

2. Review of the policy and procedure titled "Guideline for Isolation Precautions" dated effective 12/03/2014 reflected "Airborne Respirator (sic) Precautions...Patient Placement: Place the patient in a private room that has monitored negative air pressure in relation to the surrounding areas. At SCMC-Redmond, these rooms are 259 (ICU), 309-310 (MS3)..." The policy did not specify how the negative air pressure would be monitored or how staff would know if the negative air pressure was operating at the time the room was needed for a patient with an airborne infection.

During an interview conducted with the DPCS on 04/10/2015 at 1500, he/she stated "Right now we don't have a visual check for negative pressure rooms."

3. During a tour of the FBC with the FBC Manager on 04/09/2015 at 1110, a whirlpool tub in patient room 128 was observed. The manager stated the FBC had a total of six whirlpool tubs on the unit.

A policy titled "Environmental Services - Infection Prevention and Control" effective 12/15/2014 reflected the following: "...To outline the policy and practices to be followed to ensure adequate and effective environmental cleaning processes designed to prevent the spread of infection at SCHS...Germicide Selection: Always use correct dilutions...of only Infection Prevention Committee-approved germicide solutions according to manufacturer's recommendations."

Manufacturer instructions provided for the whirlpool tub titled "Care and Cleaning - Special Considerations" dated "11/3/2011" was reviewed and reflected the following: "...Add 2 teaspoons of a low-foaming, powder automatic dishwasher detergent and 20 ounces of household bleach (5 [percent] to 6 [percent] sodium hypochlorite) to the water...Success with cleaners and procedures is dependent upon such factors as...using exact measurements of ingredients..."

An undated document provided titled "Cleaning of the Jacuzzi Tubs in [unclear acronym]' was reviewed and reflected the following: "Fill tub with Hot water to just above the jets...Add 2 tablespoons of Cascade dishwashing detergent and 1/2 cup of Bleach to water...This duty is to be done after every use of the tub." The document was inconsistent with the manufacturer's instructions which required 2 1/2 cups of bleach (20 ounces) and 2 teaspoons of dishwasher detergent.

In addition, there was no evidence to reflect that the procedure and solutions used to clean the whirlpool tubs were approved by the infection prevention committee in accordance with hospital policy.

4. A policy provided titled "Indwelling Urinary Devices," dated effective 12/13/2014 reflected "...Drainage tubing will be positioned to prevent dependent loops, enabling free flow of urine and preventing back-flow of urine into the bladder...catheters will be properly secured to the body to prevent movement and urethral traction."

An observation of Patient 2 on the M/S unit was conducted on 04/07/2015 at 1645 with an RN. The patient had an indwelling urinary catheter. The catheter tubing was not secured to anything, and was hanging in a dependent loop along the side of the patient's bed.

An interview was conducted with the RN during the observation. He/she acknowledged that the patient's catheter was not secured and stated that the urinary catheter should have been secured to a Stat Lock device on the patient's leg.

5. A tour of the M/S unit was conducted on 04/07/2015 at 1630. Observation of an RN performing a CBG test on a patient using a multi-patient blood glucose meter was conducted. Observation revealed the RN did not clean the meter prior to entering the patient's room or at any time before he/she conducted the CBG test.
Review of the policy provided titled "Precision Xceed Glucose Meter (CBG, Blood Glucose, Glucometer)" dated effective 06/25/2014 reflected "Clean glucose meter with Super Sani-Cloth prior to entering the patient's room..."

6. During a tour of the surgical services department on 04/08/2015 at 1615, a surgical scrub sink was observed to have a string mop propped against one side of the sink. The mop handle was on the floor and the string mop head was propped against, in contact with, the wall and a shelf of exam gloves that were immediately above the scrub sink. The strings of the mop head were dangling over the scrub sink where OR room staff performed surgical scrubs prior to surgical procedures.

During an interview conducted on 04/09/2015 at 1600, the Infection Control RN stated it was not acceptable to store the mops next to the surgical scrub sinks.

7. In regards to sterilization of surgical instruments, the policy and procedure titled "Sterilization - 3M Attest Biological Indicator, Incubation and Interpretation of Results" dated effective 01/02/2015, was reviewed. It reflected "All biological indicator results, including biological indicator controls, must be included in the sterilization records (i.e., record keeping control). All personnel performing sterilization activities will follow the process for incubation and reading of all biological indicators."

During tour of the sterile processing area of the surgical services department beginning on 04/08/2015 at 1440 the" Steam Sterilizer Daily Logs" were reviewed. Those logs were designed to reflect documentation of daily monitoring of specified criteria, including BIs, to ensure the sterilizers functioned appropriately. The logs were incomplete. Examples are as follows:.
* Documentation on the 04/07/2015 "Steam Sterilizer Daily Log" for Sterilizer #1 reflected that the "Integrator" result for load 4 was not completed;
* Documentation on the 03/25/2015 "Steam Sterilizer Daily Log" for Sterilizer #2 reflected that the "Integrator" result, and the "Indicators Turned" result were not completed;
* Documentation on the 03/26/2015 "Steam Sterilizer Daily Log" for Sterilizer #2 reflected the "Control Test...Time out of Incubator...24 hr Results...Date & Initials" were not completed; and the "Results" were not completed for the "Bio./Attest" load; and
* Similar findings were identified during review of log records for Sterilizer #2 dated 03/30/2015 and 04/07/2015.

During an interview conducted on 04/08/2015 at 1545 the CPT confirmed that the sterilizer logs were not complete.

8. The policy provided titled "Surgical Services IUSS Sterilization" dated effective 09/03/2014, reflected "Immediate use steam sterilization (IUSS) should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization."

During a tour of the surgical services department conducted on 04/08/2015 at 1615, a steam sterilizer used for IUSS and a shelving unit with FlashPak sterilization containers was observed. During an interview conducted at the time of the observation, the OR Manager stated that surgical instruments were placed in the FlashPak containers, underwent IUSS, and then stored in the containers for up to 24 hours before the instruments were used in a surgical procedure.

The stated practice of storing IUSS processed instruments for up to 24 hours was contradictory to the policy which required the IUSS be used only in situations where instruments were needed immediately.

9. A tour of the decontamination area in the surgical services department was conducted on 04/08/2015 at 1530 with the CPT. A 5 gallon container of Prolystica enzymatic solution was observed. The container had been opened and was in use. There was no indication as to when it had been opened or when it would expire. During an interview conducted at that time, the CPT indicated he/she did not know when the container was opened and did not know if the solution had an expiration date.


10. Review of the policy titled "Facility Services HVAC Humidity Procedure," dated effective 02/03/2015 reflected the following: "Temperature and relative Humidity levels are to be maintained between 20-60 [percent] and are actively monitored and alarmed by our Metasys building automation system." The document stipulated "Monitor and maintain recommended ranges of air temperature and relative humidity in the Perioperative and Sterile Processing areas." The policy went on to require that the temperatures of the ORs and sterile processing areas be maintained between 68-73 degrees F, and the cath lab between 70-75 degrees F. The policy required that the humidity of the sterile processing area be maintained between 20-70 percent, and the OR and cath lab between 20-60 percent.

During an interview conducted on 04/10/2015 at 1535, the FSM stated that the hospital's automated system for monitoring temperature and humidity "cycles over itself every 24 hours", and therefore he/she was not able to provide documentation of monitoring records from the system for more than the past 24 hours for review.

However, manual, handwritten logs for temperature and humidity monitoring were provided.

A log titled "Operating Room - Redmond Room Temperature Chart" dated "March 2015" was reviewed and reflected once daily temperature readings for ORs 1, 2, 3 and 4. Although the policy above specified temperature ranges in F, the instructions on the log reflected that the acceptable temperature range was 15-30 degrees C. In addition, temperatures were not recorded on all days, the times the temperatures were taken were not recorded, and whether the temperatures taken were in F or C was not evident.

"Redmond Facilities Services" logs were provided for the weeks of 02/02/2015 to 02/08/2015 and 03/02/2015 to 03/08/2015. Although numerous aspects of the hospital's HVAC system were recorded, there was no evidence that humidity levels were monitored.

"Redmond Facilities Services" log for the week of March 30 through April 5 (the year was not recorded) was reviewed. That log reflected three added spaces not included on the logs in the paragraph above for "AHU-1 Humidity...OR Ret Humidity...C-Sect Humidity". However, it was unclear whether the humidity for each OR, sterile processing, and the cath lab were monitored.

Based on documentation reviewed in 1 of 1 medical record reviewed of a patient who was discharged to a SNF (Patient 3), it was determined the hospital failed to ensure a patient who was discharged to a SNF had been presented a list of Medicare participating SNFs available within the patient's geographic area.

Findings include:

1. Review of the record for Patient 3 reflected he/she was admitted to the hospital on 03/28/2015 at 1659 for nausea and vomiting.

The RN notes documented on the "Progress Note Inquiry" dated 04/06/2015 at 1419 reflected "...SW is working on discharge accommodations for SNF." The LCSW notes dated 04/09/2015 at 1652 reflected the patient was discharged to a SNF on 04/09/2015 at 1130.

There was no documentation in the record to reflect that the patient was presented with a list of Medicare participating SNFs available in a geographic area requested by the patient.