The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PIONEER MEMORIAL HOSPITAL 564 E PIONEER DRIVE HEPPNER, OR 97836 Aug. 29, 2016
VIOLATION: COMPLIANCE WITH OTHER LAWS Tag No: C0150
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the CAH and its staff were in compliance with applicable State laws and rules:
* Endoscopy and related services were provided in spaces not approved by the SA;
* Building alterations had been made for the expansion of the lab without approval of the SA;
* Non-acute, "LTC" services were provided without approval of the SA;
* There were no systems to ensure contracted personnel met State licensure requirements; and
* Employees who provided nursing care and services were not licensed/certified by the OSBN as required.

The findings identified during the survey reflect the CAH's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

Findings include:

1. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH.

2. Refer to the findings at Tag C154, CFR 485.608(d), Licensure, Certification, or Registration of Personnel.
VIOLATION: LICENSURE OF CAH Tag No: C0153
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, review of documentation in medical records for 9 of 9 patients who underwent endoscopy procedures, review of policies and procedures, review of the CAH annual evaluation, review of SA licensing records, and review of patient census lists it was determined that the CAH failed to ensure that all operations were approved as required by the State of Oregon hospital licensing requirements. OAR 333-515-0050, OAR 333-535-0000, and OAR 333-675-0000 require that a hospital submit building construction plans to the SA, the Oregon hospital licensing authority, for review and approval prior to building construction or alterations, prior to expansion of existing services, and prior to the addition of new services. Those areas may not operate until approval to commence services is received from the SA. The CAH failed to comply as follows:
* OAR 333-535-0115, Endoscopy Facilities, requires that "If diagnostic endoscopy procedures are performed, the following shall apply:" The OAR contains specific requirements for the procedure room, instrument processing facilities, patient holding and recovery area, and soiled utility room. The CAH was not in compliance and provided endoscopy services without the required SA building plans and licensing review and approval;
* The CAH lab had been expanded without the required SA building plans review and approval; and
* In addition, the CAH held itself out as a "Nursing Facility" and provided non-acute "Long-term Care" services for which it is not licensed to provide.

Findings include:

1. A list of patients who received endoscopy services between 08/15/2015 and 08/15/2016 reflected 74 procedures had been performed. A second list provided reflected 82 procedures. The list reflected that both upper and lower endoscopies were performed, tissue was removed for biopsies, and polyps were excised.

The CAH annual evaluation for the period July 2014 through June 2015 included a section titled "Procedures." It reflected that during the period of 2011 - 2012 there were 84 endoscopy procedures performed; during the period of 2012 - 2013 there were 87 procedures performed; during the period of 2013 - 2014 there were 71 procedures performed; and during the period 2014 - 2015 there were 75 procedures performed.

In nine of nine medical records of patients who underwent endoscopy procedures (Patients 6 through 14) between 05/12/2016 and 08/18/2016, documentation by the physician on the electronically generated procedure note revealed "...endoscopy performed in the Hospital endoscopy suite."

During interview with Employee 2 on 08/16/2016 at 1145 he/she stated that generally four endoscopy procedures are conducted two days per month and sometimes more often.

During observation on 08/18/2016 at 1315 Employee 1 was observed hanging endoscopy scopes in a cabinet in the ED. He/she stated that two colonoscopy procedures and one EGD had been conducted that morning. The ED was observed to have one treatment room and two treatment bays, each with a gurney. Employee 1 confirmed that on endoscopy day the ED treatment room was used for the procedure and the two treatment bays were used for patient preparation and post-procedure recovery. He/she stated that when ED patients come in during endoscopy they are examined and treated in an acute care inpatient room. The Employee 1 also indicated that the scopes were processed in another room in the CAH's basement.

The CMS CAH Medicare Database Worksheet was completed with the CEO on 08/19/2016 at 1330. The CEO recorded on the form that the CAH did not have an endoscopy room.

The review of CMS certification records at the SA reflected that the most recent CAH Medicare Database Worksheet completed by the CAH prior to this survey was dated 09/09/2011. The form included a space for "Number of endoscopy procedure rooms." In that space the provider had recorded "0".

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans and licensing review process for the addition of endoscopy services. A procedure room, patient holding and recovery areas, instrument processing facilities, and soiled utility rooms that conformed to the OARs, including mechanical, electrical, and plumbing, were not provided.

2. Observation of the "lab overflow" room, in the same hall as the main lab, was conducted on 08/19/2016 at 1430. During interview at that time the Lab Manager indicated the room had been a conference room at one time and was later used for equipment storage. He/she stated that the lab has been in the process of expanding into the overflow room for some time and "totally moved in a couple of months ago." He/she stated about "two and one/half to three years ago" the water system for a new chemistry machine was installed. He/she sated that "two to two and one/half years ago" the microbiology hood was removed from the main lab and installed in the overflow room. The Manager stated that part of the blood bank was moved into the overflow lab a year ago. The room was observed to contain storage, refrigerators, the microbiology hood, incubator, plumbing for the chemistry machine water system, and other lab equipment.

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans review process for the expansion of the lab.

3. During the entrance conference on 08/16/2016 at 1030 with the CEO and the CNO the CAH's average daily census was described as "less than 1." On 08/16/2016 the CAH census was described as zero for "acute care" and one for "swing-bed." Census information was offered for the attached "nursing facility" that was described as having patients in its "6 or 7 beds." The attached "nursing facility" was not identified as part of the licensed CAH.

During a tour of the CAH on 08/16/2016 a separately distinct unit was observed at the South end of the CAH building. Staff identified that unit as the "nursing facility" and indicated that it was "home" to the residents on that unit. Doors separated the "nursing facility" from the acute inpatient unit.

During an interview with the CEO on 08/16/2016 at 1400 he/she indicated that a previously licensed and Medicare certified "nursing facility" attached to the hospital for many years had closed and that the current "nursing facility" was licensed as part of the hospital. He/she indicated it was his/her understanding that around 2003 a former CEO "got a waiver" for 6 or 7 beds to provide "long-term care" services and it was the only one of its kind in the State. However, the CEO was unable to provide a copy of this document.

A map/floor plan of the CAH was reviewed and reflected distinct separation of the "nursing facility" and the acute inpatient unit. The "nursing facility" had five patient rooms with room numbers 211, 212, 213, 214, and 215.

Review of description of services provided at the hospital in the CAH Annual Evaluations dated June 2015 and June 2013 confirmed that all patient rooms were for single patients.

A list of all hospital patients admitted in the previous six months was reviewed and did not include the patients in the "nursing facility."

A list of "nursing facility" patients admitted within the last year was provided upon request and reflected that those patients were admitted and discharged every month, and that on some months there were up to eight patients in the "nursing facility." For example:
* Patient 32 had an admitted /time of 02/01/2016 at 0932 and a discharge date /time of 02/29/2016 at 2359;
* Patient 33 had an admitted /time of of 02/01/2016 at 0938 and a discharge date /time of 02/29/2016 at 2359;
* Patient 30 had an admitted /time of of 02/01/2016 at 0941 and a discharge date /time of 02/29/2016 at 2359;
* Patient 34 had an admitted /time of of 02/01/2016 at 0942 and a discharge date /time of 02/29/2016 at 2359;
* Patient 35 had an admitted /time of of 02/01/2016 at 0945 and a discharge date /time of 02/29/2016 at 2359;
* Patient 36 had an admitted /time of of 02/01/2016 at 0946 and a discharge date /time of 03/01/2016 at 0745;
* Patient 31 had an admitted /time of of 02/01/2016 at 0947 and a discharge date /time of 02/29/2016 at 0000;
* Patient 37 had an admitted /time of of 02/01/2016 at 0948 and a discharge date /time of 02/29/2016 at 0720; and
* Similarly, for the month of June 2016 the list reflected seven patients (Patients 30, 31, 32, 33, 34, 35, and 36) were admitted to the "nursing facility" on 06/01/2016 and discharged on [DATE] or 06/30/2016.

The current "An Important Message from Medicare About Your Rights" document is printed on letterhead for MCHD that identified providers that include "Pioneer Memorial Hospital & Nursing Facility."

Current policies and procedures for the provision of care and services on the South patient care unit titled "Department: Long Term Care" are printed on templates for "Pioneer Memorial Hospital and Nursing Facility", and are dated as last revised "06/2014."

Additional current policies and procedures for the provision of care and services on the South patient care unit, dated as last revised "03/2015", are titled as "Long Term Care."

Policies and procedures for "Long Term Care" did not clearly delineate the scope and services of those patients as hospital patients or follow a clear organizational methodology. The policies and procedures reflected that the "nursing facility" was a separate entity and not integrated with the hospital. For example:
* Long Term Care is referred to as the "nursing facility" throughout.
* "The facility will make the Statement of Deficiencies (Form CMS-2567), the Statement of Isolated Deficiencies generated by the most recent standard survey, and any subsequent extended surveys...available to residents for their review." "Standard" and "extended" surveys refer to nursing facility surveys conducted by the SA responsible for licensing those facilities.
* "All residents in long-term care facilities have rights..."
* "All residents will be oriented to designated smoking and non-smoking areas...Smoking is permitted only in properly supervised, designated smoking areas." However, observations on 08/16/2016 reflected signage outside of the CAH that identified it was a non-smoking campus.
* "Services provided...Basic Nursing is the general nursing service ordinarily provided in a nursing facility, and includes, but is not limited to, administration of medication and treatments according to provider's orders, assistance in daily life functions, rehabilitative nursing and preventative measures when ordered...Resident gowns are available; however, the resident will be encouraged to be up and dressed, if possible, to enable him/her to participate in the daily rehabilitative and recreational activities...Room, board, and basic nursing care are payable 30 days after billing...Medicare/Medicaid Programs - The facility is certified to provide care under federal and state programs."
* " Pioneer Memorial Long Term Care will only admit and retain residents for whom it can provide adequate care...If a resident requires transfer to an acute hospital, the facility will offer the resident the opportunity of electing to have the bed held for 7 (seven) days...If the bed hold option is exercised, the resident or the resident's representatives is liable to pay reasonable charges...for the bed hold period."
* "Pioneer Memorial Nursing Facility...will maintain licensure under applicable state and local law...The facility currently holds the following licenses: Licenses are posted in public areas and are updated as applicable."
* "Pioneer Memorial Nursing Facility is a department of Pioneer Memorial Hospital and governed by the [MCHD]. The facility will comply with the disclosure requirements set forth herein. The facility will provide written notice the state agency responsible for licensing the facility at the time of change, if a change occurs in: the officers, directors, agents, or managing employees..."
* "Part A residents - For services provided on or after the effective date on which the facility must bill Medicare PPS for Medicare Part A residents, all vendor agreements shall...stipulate that the vendor will bill the facility for services provided to Medicare Part A residents..."
* "All personnel, including hospice and other contracted personnel are required to comply with the policies and procedure set forth in this manual." Hospice services are provided by separately licensed Hospice agencies to patients that are not in a hospital.

Review of the MCHD website on 09/11/2016 advertises the facility as "Pioneer Memorial Hospital & Nursing Facility" and describes "Pioneer Memorial Hospital and Nursing Facility is a 21-bed hospital able to provide a wide range of services...Pioneer Memorial Hospital Long-Term Care...is pleased to offer 24-hour nursing care to chronically ill and frail residents...Located in the hospital...provides a high level of medical care...and skilled nursing care is available at all times."

SA licensing records revealed a letter dated 02/16/2004 from the SA Director for hospital licensing and the SA Director for nursing facility licensing addressed to the CAH's administrator. The letter was in response to a letter from the CAH that indicated the CAH was "discontinuing the nursing home" and was requesting to "provide nursing facility services" in hospital beds. The SA's 02/16/2004 letter contained extensive direction to the provider. As of the date of this report there is no evidence in the SA records to reflect that the provider followed those instructions, that the proposal was approved, or that any "waiver" was issued.

Licensing records from the SA that licenses and certifies nursing facilities in Oregon confirmed that "Pioneer Memorial Nursing Home" closed on 11/05/2003.

ORS 442.470 stipulates that: "Acute inpatient care facility means a licensed hospital with an organized medical staff, with permanent facilities that include inpatient beds, and with comprehensive medical services, including physician services and continuous nursing services under the supervision of registered nurses, to provide diagnosis and medical or surgical treatment primarily for but not limited to acutely ill patients and accident victims."
VIOLATION: LICENSURE/CERTIFICATION/REGISTRATION Tag No: C0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview, review of personnel records and licensure/certification documentation for 5 of 7 employees who provided nursing care and services (Employees 1, 2, 4, 6, and 11), review of medical records and review of other records and documents it was determined that the CAH failed to:
* The CAH failed to maintain evidence of licensure for all personnel for whom licensure was required. The CAH had no records of licensure for contracted pharmacy and rehabilitation staff.
* The CAH failed to develop job descriptions to ensure that all staff who provided nursing care and services were appropriately licensed/certified as required by the OSBN and practiced within the scope of the OSBN license/certificate issued.

Findings include:

1. During interview with the HR Manager on 08/17/2016 at 1100 he/she stated that the CAH maintained no personnel records, including of Oregon licensure, for the CAH's contracted pharmacy, physical therapy, occupational therapy, and speech therapy staff.

2. State of Oregon hospital licensing requirements include:
* OAR 333-510-0002(10) & (11) define nursing staff and nursing staff member as RNs, LPNs, and CNAs.
* OAR 333-510-0020(3) stipulates that nursing staff are to be assigned to the care of patients "in accordance with patient's needs and the specialized qualifications and competence of the nursing staff available."
* OAR 333-510-0020(4)(b) stipulates that "A nursing assistant who works in a hospital must be certified prior to assuming nursing assistant duties in accordance with OAR Chapter 851, division 062."
* OAR 333-510-0020(4)(c) stipulates that "A hospital shall maintain documentation that CNAs whose functions include administration of non-injectable medications, are qualified."
* OAR 333-505-0040(1)(e) stipulates that "A hospital shall...Have a job description for each position that delineates the qualifications, duties, authority and responsibilities inherent in each position.

OAR Chapter 851, Division 062 is the "Standards for Certification of the Nursing Assistant and Medication Aide" set forth by the OSBN that specifies the training and certification requirements for CNA 1s, CNA 2s, and CMAs. Chapter 851, Division 063 sets forth the scope of practice and duties for the CNA 1s, CNA 2s, and CMAs:
* OSBN OAR 851-063-0030, "Authorized Duties and Standards for [CNA 1]", contains a list of tasks that may be performed by a CNA 1 that are related to assisting patients with activities of daily living,
* OSBN OAR 851-063-0035, "Authorized Duties and Standards for [CNA 2]", stipulates "Under the supervision and at the direction of a licensed nurse, a CNA 2 may provide care and assist clients with the following:" The OAR contains an extensive list of tasks that may be performed by a CNA 2 that are not authorized for a CNA 1. Those include, but are not limited to: Applying and adjusting oxygen rate of flow; Applying, removing, and turning on and off CPAP or BiPAP devices; Bladder scanning; and Placing electrodes/leads and running and EKG.
* OSBN OAR 851-063-0070(8), "Authorized Duties and Standards for [CMAs]", allows a CMA (a CNA with medication training) to administer non-injectable medication under the direction and supervision of a licensed nurse.

During review of personnel records with the HR manager on 08/19/2016 at 1045 there was no evidence of CNA 2 or CMA job descriptions. There was no evidence to reflect that job descriptions for nursing staff had been developed to ensure that staff carried out duties and performed tasks in accordance with the scope of practice specific to the license/certificate issued and other qualifications, training, and competencies determined by the hospital to ensure the needs of patients are met in a safe and appropriate manner.

3. During interview with Employee 2 on 08/16/2016 at 1145 he/she stated that he/she was a CNA and duties included Respiratory Aide, Procedure Aide for assisting in endoscopy procedures, sterile processing, PMs for patient care equipment, and EKGs.

* Review of the personnel record of Employee 2 revealed a document titled "[OSBN] Verification of Licensure" that was dated 08/18/2016. The document reflected the employee had a current CNA 1 certificate issued by the OSBN. There was no evidence of a CNA 2 certificate.

* A nursing department job description for the position of "Certified Nurses Aide CNA" was signed and dated by Employee 2 on 02/28/2006. The "Job Summary" and "Essential Functions" specified the following: "While performing direct patient care the CNA shall perform patient care tasks and procedures as assigned and according to the OSBN Nurse Practice Act." The "Education and Experience" section of the job description stipulated that the individual have "Successful completion of Nursing Assistant Course with certification card in hand," however, did not specify they level of certification, CNA 1 or CNA 2. The duties listed on the job description consisted of duties contained on the OSBN authorized duties list for a CNA 1, with the following exception. The job description listed "...processing instrumentation for sterile packs" as a duty of the CNA. That task is not on the OSBN authorized duties list for a CNA 1 or CNA 2.

* A nursing department job description for the position of "Respiratory Aide RT" was signed and dated by Employee 2 on 08/29/2003. The "Job Summary" and "Essential Functions" specified the following: "responsible for maintaining RT equipment in working order, ordering and stocking of RT supplies...writing and/or revising policies and procedures...monitoring quality assurance and improvement...clean equipment as needed, culture equipment as needed per policy...May be called in to set up equipment if needed...Provide inservice education on oxygen use and handling, equipment set up and cleaning...Act as the hospital/nursing liaison with outside contractors for oxygen supplies and is responsible for the equipment that is used for outpatient treatment." The "Education and Experience" section of the job description stipulated that the individual have "Successful completion of Nursing Assistant Course with certification in hand," however, did not specify the level of certification, CNA 1 or CNA 2.

An employee Evaluation Form dated 10/20/2014 reflected that Employee 2 conducted PFTs. During interview with Employee 2 on 08/25/2016 at 1000 he/she stated that his/her job duties included administration of oxygen, performance of pulmonary function testing, and assisting with nebulizer treatments. In regards to nebulizer treatments it was not clear what type or level of assistance was provided and whether he/she administered the medications or not on all occasions for treatments rendered in the ED.

* A nursing department "Documentation of [ECG] training" record for Employee 2 was dated as completed on 05/19/2009. The record reflected "Since radiology staff may not be available within the ten minute goal it is imperative our nursing staff can perform this procedure quickly and accurately...Training will include, but not be limited to...Location and retrieval of ECG machine...Inputting of patient information...Lead placement...Loading of paper...Restoring of ECG machine to radiology." The form was signed by a radiology tech under the statement "The employee listed above has demonstrated the necessary understanding and skills to perform [ECGs]." Placing electrodes/leads and running an EKG is an authorized duty of a CNA 2 and Employee 2 was not certified as a CNA 2.

* During interview with Employee 2 on 08/25/2016 at 1000 he/she stated that he/she functioned as a "Procedure Aide" before, during, and after endoscopy procedures. He/she described those duties to include setting up the endoscopy machine, setting up and prepping the room, holding the scope during procedures while the physician is performing other tasks, placing forceps into the endoscope biopsy port to obtain the specimen or "take a bite out of whatever [the doctor] wants", placing the tissue in the specimen container, and sterile processing of the endoscopy equipment and scopes.

There was no job description for a "Procedure Aide" or training records. During interview with the HR Manager on 08/19/2016 at 1045 he/she stated that the CAH did not have a "Procedure Aide" job description.

* Personnel records revealed that the tasks and duties performed by Employee 2 were outside the scope of his/her current OSBN certification as a CNA 1.

4. Employee 1 was not identified on the CAHs employee list, however, was observed handling endoscopy equipment on 08/18/2016. During interview with Employee 1 on 08/18/2016 at 1315 he/she stated the he/she is a "Procedure Aide" and performs tasks before, during, and after endoscopy procedures, including assisting with the endoscopy and sterile processing of the endoscopy equipment and scopes.

Review of the personnel record of Employee 1 revealed that he/she began working in the CAH as a "Procedure Aide" in November of 2008. There was no job description for a "Procedure Aide" or other job description for any CAH position. There was no training record for duties as a "Procedure Aide." There was no evidence of licensure or certification.

A nursing department "Documentation of [ECG] training" record for Employee 1 was dated as completed on 05/05/2009. Placing electrodes/leads and running an EKG is an authorized duty of a CNA 2 and Employee 1 was not certified as a CNA 2.

A document titled "[OSBN] Verification of Licensure" dated 08/27/2016 reflected that Employee 1 had CNA and CMA certificates that expired on [DATE].

5. Review of the personnel record of Employee 4 revealed a document titled "[OSBN] Verification of Licensure" that was dated 08/18/2016. The document reflected the employee had current CNA 1 and CMA certificates issued by the OSBN. There was no evidence of a CNA 2 certificate.

The personnel record of Employee 4 revealed a nursing department job description for the position of "CNA" that was signed and dated by the employee on 02/05/2009. The duties listed on the job description consisted of duties contained on the OSBN authorized duties list for a CNA 1, with the following exception. The job description listed "...processing instrumentation for sterile packs" as a duty of the CNA. However, that task is not on the OSBN authorized duties list for a CNA 1 or CNA 2 .

The "Education and Experience" section of the job description stipulated that the individual have "Successful completion of Nursing Assistant Course with certification card in hand," however, did not specify the level of certification, CNA 1 or CNA 2.

A generic performance evaluation dated 09/17/2014 contained a note by Employee 4 dated 10/09/2014 that reflected he/she was "more comfortable in the ER during serious situations that involve several people and departments." There were no reference on the CNA job description to duties "in the ER."

During interview with the HR manager on 08/19/2016 at 1130 he/she stated that Employee 4 began working as a "med aide" on 10/24/2011. However, there was no CMA job description in the personnel records to specify on what hospital units the CMA could work, what the duties of the CMA were in the hospital, and what supervision and direction was required.

6. Review of the personnel record of Employee 6 revealed a nursing department job description for the position of "Certified Nurses Assistant" that was signed and dated by the employee on 10/26/2014. The duties listed on the job description consisted of duties contained on the OSBN authorized duties list for a CNA 1. The "Qualifications" section of the job description stipulated that the individual be "Registered by the [OSBN] as a [CNA]," however, did not specify the level of certification, CNA 1 or CNA 2.

A document titled "[OSBN] Verification of Licensure" dated 08/27/2016 reflected that Employee 6 had a current CNA 1 certificate.

7. Review of the medical records of Patients 6 and 7 who had endoscopy procedures on 05/12/2016 revealed that Employee 11 had completed and documented the following care and tasks on the 3 page "Moderate Sedation Nursing Assessment & Procedure/VS Flow Sheet":
* Demographics and history;
* "Pre-Procedure Nursing Assessment";
* "Patient Teaching";
* "Discharge Plan";
* "Patient Preparation and Monitoring";
* IV access and administration of IV fluids;
* "Cardiac Monitor";
* "Suction";
* "Pre-procedure vital signs"
* Recovery vital signs, sedation level, cardiac rhythm, and pain assessment;
* Discontinuation of IV and site assessment;
* Discharge instructions teaching and discharge assessment;
* In the record of Patient 6, "Specimens obtained [zero] x 3."

Employee 11's printed name and signatures on the nursing assessment forms were not followed by a nursing credential such as RN or LPN. Employee 11 was identified as the CAH Housekeeping Manager on the CAH employee list. It was confirmed in an email from the CNO on 09/12/2016 at 1231 that Employee 11 was the Housekeeping Manager and was the individual who had provided the endoscopy services. Review of the OSBN license verification system on 09/03/2016 reflected that Employee 11 was not licensed by the OSBN to provide nursing services.
VIOLATION: EQUIPMENT, SUPPLIES AND MEDICATION Tag No: C0202
Based on observations, interviews, and review of policies, procedures, and other documents and records it was determined that the CAH failed to ensure that ED equipment, supplies, and drugs were always available, and that drugs for use in emergencies were organized and properly labeled to ensure prompt and safe accessibility and availability.

Findings include:

1. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH, that reflects the ED was not available for use on days when endoscopy services were provided.

2. Refer to the findings at Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, that reflects the CAH's failure to properly manage drugs necessary for use in emergencies throughout the CAH.
VIOLATION: PHYSICAL PLANT AND ENVIRONMENT Tag No: C0220
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed and maintained in a safe, clean, and orderly manner for patients and staff:
* Endoscopy services and sterile processing were provided in unapproved spaces;
* During the provision of scheduled endoscopy services in the ED, the ED was not available;
* Construction alterations to the physical plant had been made for the expansion of the lab without approval of the SA;
* There was lack of an organized CAH-wide patient-care equipment preventive maintenance program;
* Drugs and biologicals were not controlled and secured, and outdated and otherwise unusable drugs were available for patient use;
* There was lack of provisions to ensure proper temperature, humidity, and ventilation in appropriate areas;
* There was lack of staff training in handling fire emergencies; and
* There was lack of compliance with the Life Safety From Fire requirements as indicated on the report of the Oregon State Fire Marshal.

The findings identified during the survey reflect the CAH's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 485.623, Condition of Participation: Physical Plant and Environment.

This is a repeat Condition-level deficiency that was previously cited on the provider's most recent survey completed 09/21/2011.

Findings include:

1. Refer to the findings at Tag C221, CFR 485.623(a), Construction.

2. Refer to the findings at Tag C222, CFR 485.623(b)(1), Maintenance - Housekeeping and preventive maintenance.

3. Refer to the findings at Tag C224, CFR 485.623(b)(3), Maintenance - Drugs and biologicals.

4. Refer to the findings at Tag C225, CFR 485.623(b)(4), Maintenance - Clean and orderly.

5. Refer to the findings at Tag C226, CFR 485.623(b)(5), Maintenance - Ventilation, lighting, temperature control.

6. Refer to the findings at Tag C227, CFR 485.623(c)(1), Emergency Procedures - Staff training.

7. Refer to the findings at Tag C228, CFR 485.623(c)(2), Emergency Procedures - Power and lighting.

8. Refer to the findings at Tag C231, CFR 485.623(d)(1), Life Safety From Fire.

9. Refer to the findings at Tag C237, CFR 485.623(d)(7), Life Safety From Fire.
VIOLATION: CONSTRUCTION Tag No: C0221
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed, arranged, and maintained for patient safety and to provide adequate space for the provision of services:
* Endoscopy procedures, including pre-procedure preparations, post-procedure recovery, and equipment and instrument management and sterile processing were provided in spaces not constructed and equipped for those procedures, not approved for those services by the SA, and not adequate to ensure patient safety in an emergency or adherence to infection control practices;
* Building construction/alterations had been made for the expansion of the lab without the required approval of the SA.

Findings include:

1. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH, that reflects endoscopy services were provided in spaces not approved by the SA, and that building construction/alterations had been made for the expansion of the lab without the required approval of the SA.
VIOLATION: MAINTENANCE Tag No: C0222
Based on observation, interview, review of PM documentation and policies and procedures, it was determined that the CAH failed to develop and implement written policies and procedures to ensure that all facility and patient care equipment had been maintained to ensure an acceptable level of safety and quality:
* All facility mechanical and electrical equipment and systems were not clearly identified and there was lack of clear and complete PM documentation; and
* All patient care equipment was not incorporated into a clear and complete inventory and there was lack of clear and complete PM documentation.

Findings include:

1. There were no written facility and equipment PM plans or policies and procedures. During an interview on 08/19/2016 at 1430 the CNO stated there were no such policies and procedures, and in an email from the CNO dated 08/23/2016 at 0839 he/she confirmed that "...we currently do not have...Hospital Equipment PM Policy and Procedure."

2. There was not a complete and current list of all facility mechanical and electrical equipment and systems in the hospital.

A monthly log, most recently completed for "July 16", was titled "Maintenance." The log had a column with a list of facility equipment and systems and it had 31 columns that corresponded to each day of the month for each of the listed items. The logs for January 2016 through July 2016 were reviewed.

The items listed under the "Daily Checks" were:
* "Boilers"
* "O2"
* "Work oders (sic)"
* "Building Temp."
* "Walk ways"
* "Bio"
* "Hall Lights"
* "Fire system"
* "Check Bug Lights"
* "Check for leaks Pt Rm sinks"
* "Paint chips"
* "Garbage, outside"

The items listed under the "Month Checks" were:
* "Ice machines"
* "Water softener"
* "Generateor (sic)"
* "Drain Compressor"
* "Hot water temp."
* "HVAC filters"
* "Suction system"
* "Fire doors"
* "Boiler Cemical (sic)"
* "Negative Air Flow Rm 210"
* "Oil Pumps"

The items listed under "6 Month Checks" were:
* "Clean dryers /3 mo"
* "Clean intake and exaust (sic) vents"
* "Check Laundry machines"
* "Clean Refrigerator coils"

The items listed under "Yearly" were:
* "Light covers"
* "Clean Laundry Cart Wheeles (sic)"

Equipment and systems were not individually listed and there were no SNs or ID numbers or other unique identifiers for each item. There were no policies and procedures or checklists to describe what the specific PM tasks were for each item. There were no policies and procedures to specify what equipment and systems or what parts of those required qualified technicians to conduct PMs to ensure appropriate calibrations and patient safety.

The columns numbered 1 through 31 had checkmarks in them to denote that the daily and monthly checks had been done, generally excluding weekends and holidays although there were several other dates on which there were no checkmarks, such as from 06/22/2016 through 06/27/2016. In addition, there were no maintenance staff signatures or initials on any of the logs to reflect who had recorded the checkmarks. Further, it was not clear what specific tasks the checkmark indicated had been done.

3. During tours conducted throughout the CAH observations of facility mechanical and electrical equipment were made. The equipment lists identified under finding 2 above were reviewed for the equipment observed. Discrepancies identified include:

On 08/16/2016 at 1210 in the isolation ante-room between patient rooms 209 and 210 a portable, electric Miniforce II Hepa Air Filtration System unit was observed. There were no labels, stickers, or other evidence of PMs.

On 08/18/2015 at 1150, in inpatient room 210, maintenance staff were observed to test the negative air flow system. Because required testing mechanisms were not in place, staff proposed to test the ventilation systems using a dry piece of toilet paper. While inside the room and with the door to the hallway and the door to the anteroom closed the toilet paper strip used for the test was observed to barely flutter into the room. During discussion it was proposed that open windows might be impacting the pressure. Once the windows in the room and in the patient bathroom were closed the flutter of the paper into the room was observed to be stronger. However, there was no objective way to measure the pressure or to know if the amount of negative pressure was acceptable.

The negative pressure ventilation system was observed installed in a locked closet in room 210 and through the ceiling of the closet into space above the room. The unit was labeled with an Eco-Air Sureseal label. There were no policies and procedures for the ventilation requirements, operation, and PMs for the negative pressure isolation room. There was no documentation to reflect PMs on that system.

During an interview on 08/18/2016 at 1200 maintenance staff stated that they change filters on the negative pressure isolation system unit but there was no documentation of that. In addition, on 08/18/2016 at 1340 a maintenance staff person confirmed that the hospital had no manufacturer's instructions for the negative pressure ventilation system.

On 08/19/2016 at 1600 in the "LTC" unit shower room a large whirlpool unit was observed. There were no identifiable PMs for the whirlpool.

4. There was not a complete and current list of all patient care equipment in the hospital.

Upon request, two incomplete and outdated patient care equipment lists were provided. The first list was titled "PM Equipment Inventory Listing...For All Risk Types" for MCHD and was dated 10/07/2014. It was generated by the CAH's bio-medical contractor and listed 103 pieces of equipment. It had columns that included the "Tag #", "Description", "Manufacturer", "Model", "Serial #", and "Frequency." The PM frequency for every item was identified as once a year. It was not clear which items were dedicated to the hospital versus the non-hospital MCHD clinics. There were no policies and procedures to confirm that all equipment on the list, ranging from exam lamps and scales to monitors and defibrillators were subject to the same frequency of PMs.

The second list was on a monthly log, most recently completed for July 2016 by Employee 2, titled "Activity Report With Dates By Location." The top row of the log reflected columns identified as "Location", "ID", "Item", and "Serial Number." Equipment was primarily listed by type and not manufacturer, model, or other specific manner. Equipment items were not individually listed and there were no SNs or ID numbers or other unique identifiers for each piece of equipment. The monthly "Activity Report With Dates By Location" reflected for example:

* Equipment in the ER included: "...Thermometer x4...Patient Bedside Monitors x3...Stretchers x 4...Manual BP cuffs...Venascopes x2...Zoll Monitor...Accu-Chek Machine...Glide Scope...iVent...Bi-Pap Machine...Dopplers x3...Tela Strock (sic) Machine...Auto Vent 4000...Oximeter x 2...Colonoscopy Machine...Procedure Scopes..."

* Equipment in the "Hospital" included: "...VS Machines x2 W/A...Accu-Check...K-Pads x3...Patient Monitor X1...Zoll, Monitor...Suction, Portable...Bladder scanner...Nebulizer Machines x4..." Equipment identified in the "LTC" unit included: "...VS Machine Dinomat...Accu-Check Machine...Coagcheck Machine..."

* Equipment in "RT" was "PFT Machine."

The log contained checklists of one to six tasks listed under each type of equipment that included "General Equipment Check", "Battery Check", "Cleaning", "Check Log Book" and "Calibration." There were no policies and procedures to describe what was included in those tasks. There were no policies and procedures to specify what types of diagnostic and therapeutic equipment required bio-medical PMs by a qualified technician to ensure appropriate calibrations and patient safety.

During an interview on 08/25/2016 at 1000 Employee 2 stated that patient care equipment identified on the "Activity Report With Dates By Location" log "moves all the time" between the ED and the inpatient unit or other areas of the hospital. He/she confirmed that there was no system to ensure that an item identified on the log as located in the ED would be exclusively located in the ED.

5. During tours conducted throughout the CAH observations of patient care equipment were made. The equipment lists identified under finding 4 above were reviewed for the equipment observed. Discrepancies identified include:

On 08/16/2016 at 1220 in the inpatient unit and utility room:
* A Stryker bed, #1629, in room 209 had no identifiable PMs.
* A Stryker bed, #FA , in room 207 had no identifiable PMs.
* A CareGuard pump, # , had an "Electrical Safety Test" label reflecting that was completed 12/07/2005 and was due "6/06."
* An Air Pro pump had no labels or inventory numbers and no identifiable PMs.
* An Accumatic Scale, #0643, had no identifiable PMs.
* A VenaFlow Elite, #E , had no identifiable PMs.
* A Gaymar pump, PMH #0065, had an "Electrical Safety Test" label reflecting it was completed 11/15/2007 and was due "5/08."
* A Verathon Bladder Scan, PMH #1270, had no identifiable PMs.
* A Roscoe Nebulizer, SN DA , had no identifiable PMs.

On 08/17/2016 at 1400 in the ED and ED hallway:
* An Ultrasound machine, PMH #1557, had no identifiable PMs.
* A Braun Welch Allyn Ear Thermometer Pro 6000, had no identifiable PMs.
* A Blickman Blanket Warmer, PMH #1621, had no identifiable PMs.
* A Respironics BiPAPAuto M Series, SN H 7196, had no identifiable PMs.
* A Burton Ultraviolet Examining Light, # , had no identifiable PMs.
* A drive Power NebUltra, PMH #1955, had no identifiable PMs.
* An Imex Pocket-Dop II, # , had no identifiable PMs.
* A Huntleigh Fetal Dopplex II, # , had no identifiable PMs.
* A 3M Ranger Pressure Infusor had a Post-It Note attached to it with a handwritten note that read "Not checked by Bio as of yet Do not use [Employee 2]." This machine was available for patient use in the ED hallway and there was no assurance that the informal Post-It Note would remain affixed to the unit.

On 08/18/2016 at 1620 in the lab:
* A Vulcon Technology Clinaseal centrifuge, SN , had a label that reflected an "[Electrical Safety Test]" was done on 06/25/2003 and was due "6/04."
* Refer also to Tag C292, CFR 485.635(c)(4), regarding findings that PMs for lab instruments/machines were not conducted by the contracted company.

On 08/18/2016 at 1315 in the ED:
* Five endoscopy scopes were observed hanging in a scope cabinet.
* Review of the "Endoscope Field Audit Form" dated 09/25/2014 reflected that an Olympus Service Representative had conducted a visual inspection of five endoscopes. For two of the scopes "Anomalies" of the endoscope "Angulation" were identified. However, the form did not reflect any follow-up. During interview with Employee two on 08/18/2016 at 1430 he/she confirmed the 09/25/2014 form was the most current record of inspection of the endoscopes.

On 08/18/2016 at 1400 in the "Sterilization Room":
* A PCI Endo-Flush Endoscope Flushing Pump Model # EFP250, had no identifiable PMs.
* During the observation staff was not sure if PMs had been conducted. In an email from the CNO dated 08/23/2016 at 0839 he/she confirmed that "...we currently do not have...PM records of endobrush machine in sterilization room."
VIOLATION: DRUG STORAGE Tag No: C0224
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure appropriate storage of drugs and biologicals:

Findings include:

1. In the ED on 08/17/2016 at 1430 a bottle of Accu-Check Inform II control solution was observed to be expired 05/31/2016. At the inpatient nurses station on 08/17/2016 at 1630 two bottles of Accu-Check control solution were observed to be expired on [DATE].

2. Refer to the findings at Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, that reflects the CAH's failure to appropriately store, control and secure drugs throughout the CAH to ensure drug integrity and efficacy; to prevent theft, misuse, and tampering; and to ensure outdated and otherwise unusable drugs were not available for patient use.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0240
Based on observations, interviews, and review of documents and records it was determined that the governing body of the CAH failed to ensure that the CAH and its staff were in compliance with all applicable Federal and State laws and regulations and rules that apply to the CAH and to its staff, including the Conditions of Participation for CAHs.

The findings identified during the survey reflect the CAH's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 485.627, Condition of Participation: Organizational Structure.

Findings include:

1. Refer to the Condition-level deficiency at Tag C150, CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

2. Refer to the Condition-level deficiency at Tag C220, CFR 485.623, Condition of Participation: Physical Plant and Environment. This is a repeat Condition-level deficiency that was previously cited on the provider's most recent survey completed 09/21/2011.

3. Refer to the Condition-level deficiency at Tag C270, CFR 485.635, Condition of Participation: Provision of Services.
VIOLATION: CLEAN FACILITY Tag No: C0225
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was maintained in a safe, clean, and orderly manner for patients and staff. Areas in the CAH, including where patient services were provided, were cluttered, disorganized and dirty.

Findings include:

1. On 08/18/2016 at 1345 observations in the "Sterilization Room", where endoscopy equipment and scopes were processed and instruments used throughout the hospital were sterilized, included the following:
* The narrow room had one door, one sink, a vintage autoclave sterilizer unit, and two machines associated with endoscope processing,
* The room was cluttered and disorganized with cabinets and shelves of books, documents, blood pressure cuffs, stethoscopes, patient care supplies, sterile instrument packs, bins of miscellaneous items, supplies in plastic bags and manilla envelopes and boxes of various sizes, cords, office supplies, various household tubs and containers, bottles and gallon containers of numerous household and institutional chemicals and products, and numerous other items.
* A multi-shelf wire rack had a bath towel covering the third rack from the bottom. The "Procedure Aide" present at the time of the observation stated that the endoscopy scopes were placed on that towel after processing to dry. Boxes of clean supplies, including open boxes of PPE disposable masks, were stored on the shelf directly underneath and were therefore subject to drips from the drying endoscopy scopes.
* The cabinet under the sink contained gallon containers of chemicals and the floor of the cabinet was covered with a thick layer of discolored, spilled product.

2. On 08/19/2016 at 1600 observations in the South patient unit whirlpool/shower room included the following:
* A clear plastic bag that contained incontinent pads covered with brown matter was laying on the floor next to the shower stall.
* A bucket with a squeegee and a three shelved rolling cart were stored inside the shower stall. The cart contained numerous items that included: a stack of clean folded linens and towels, a clean incontinent pad, a bottle of "Creme Clean" detergent-based cleaner for cleaning tile and other surfaces, a squeeze tube of patient care hygiene product.
* A woman's purple shirt was hanging from the shower rod.
* An electronic vital sign machine was stored in the room and a hairbrush with numerous hairs tangled in it was laying on top of the machine.
* A rolling desk chair was stored in the room and a disheveled bath towel was laying on the seat.
* A long-handled scrub brush was laying on top of the whirlpool and it was not clear what the use of the brush was.

During interview with the CMA on duty at that time stated that patient rooms 4, 5, 6, 7, and 8 had no showers so that on occassion those patients would use the shower stall in the whirlpool room. It was observed that the shower stall was not maintained in a state of cleanliness and readiness for patient care.
VIOLATION: VENTILATION, LIGHTING, TEMP CONTROLS Tag No: C0226
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure proper temperatures, humidity, and ventilation throughout the facility:
* There was lack of proper temperature and humidity monitoring in the rooms where endoscopy and sterile processing were performed and where endoscopes and sterile instruments were stored. Excessive humidity is conducive to microbial growth and compromises the integrity of wrapped sterile instruments and supplies.
* There was lack of provisions for appropriate negative air flow in the respiratory isolation room and in the room where endoscopy was performed.

Findings include:

1. During interview with the Environmental Services Manager on 08/16/2016 he/she stated that humidity in the hospital was not monitored, including in the ED where endoscopy was performed.

In the ED on 08/18/2016 at 1315 a "procedure aide" was observed placing endoscopes and endoscope parts in a cabinet for storage. The endoscopes were placed in a hanging position and the parts were placed on the bottom of the cabinet.

Manufacturer's instructions provided for the Olympus Evis Exera II Gastrointestinal Videoscope and Evis Exera II Colonovideoscope were reviewed. The "Storage and Disposal" chapter included the following: "Warning: The storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature. Do not store the endoscope in direct sunlight, at high temperature, in high humidity or exposed to X-rays and/or ultraviolet-rays. These could damage the endoscope or present an infection-control risk."

There were no provisions for monitoring temperature and humidity where endoscopes were stored.

2. On 08/18/2016 at 1345 observations in the "Sterilization Room", where endoscopy equipment and scopes were processed and instruments used throughout the hospital were sterilized, numerous sterile packs of surgical instruments were observed to be stored. There were no provisions for temperature and humidity monitoring in the room.

3. There were no written facility temperature and humidity related policies and procedures. During an interview on 08/19/2016 at 1430 the CNO stated there were no such policies and procedures, and in an email from the CNO dated 08/23/2016 at 0839 he/she confirmed that "...we currently do not have...Policy and Procedure for Temperature and Humidity controls throughout."

4. Refer to the findings at Tag C222, CFR 485.623(b)(1), regarding lack of provisions to ensure appropriate negative air flow in the respiratory isolation room and in the room where endoscopy was performed.

5. Refer to the findings at Tag C153, CFR 485.608(c), regarding lack of approved space for endoscopy and sterile processing and negative air flow requirements.
VIOLATION: EMERGENCY PROCEDURES, TRAINING Tag No: C0227
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that all staff were trained to ensure the safety of patients in non-medical emergencies.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.
VIOLATION: EMERGENCY POWER & LIGHTING Tag No: C0228
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure provisions for emergency power as required.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: C0231
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure compliance with applicable Life Safety from Fire codes.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: C0237
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure compliance with requirements for installation of alcohol based hand sanitizers.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.
VIOLATION: PROVISION OF SERVICES Tag No: C0270
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to develop and implement appropriate written patient care policies and procedures for the care and services it provided to ensure the provision of safe and appropriate care.

The findings identified during the survey reflect the CAH's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 485.635, Condition of Participation: Provision of Services.

Findings include:

1. Refer to the findings at Tag C276, CFR 485.635(a)(3)(iv), regarding storage, handling, and control of drugs.

2. Refer to the findings at Tag C278, CFR 485.635(a)(3)(vi), regarding infection control and prevention.

3. Refer to the findings at Tag C291, CFR 485.635(c)(3), regarding identification of services provided under arrangement or agreement.

4. Refer to the findings at Tag C292, CFR 485.635(c)(4), regarding evaluation of services provided under arrangement or agreement.

5. Refer to the findings at Tag C294, CFR 485.635(d), regarding nursing staff duties and assignments.

6. Refer to the findings at Tag C297, CFR 485.635(d)(3), regarding the administration of drugs.

7. Refer to the Condition-level deficiency at Tag C150, CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

8. Refer to the Condition-level deficiency at Tag C220, CFR 485.623, Condition of Participation: Physical Plant and Environment. This is a repeat Condition-level deficiency that was previously cited on the provider's most recent survey completed 09/21/2011.
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure appropriate storage, handling, and control of drugs throughout the facility:
* Drugs, including scheduled drugs, were not controlled and secured to prevent theft, misuse, and tampering;
* Outdated and otherwise unusable drugs were available for patient use, including expired drugs and opened, undated MDVs of injectable drugs;
* High alert drugs were not managed and labeled consistently; and
* The ED and inpatient drug distribution system rendered dugs not readily identifiable and available, and created the potential for medication error.

Findings include:

1. During tour of the "LTC" unit on 08/19/2016 at 1630 the medication cart was observed. Discrepancies between the amount of narcotic cough syrup observed in the bottle and the dosage last recorded on the narcotic record for the cough syrup were identified for prescriptions for two patients.

A bottle of cough syrup containing codeine for Patient 30 was observed to have graduated lines for measuring the amount in the bottle. The bottle was observed to have slightly more than 175cc of liquid in it. However, the "Narcotic Sign-Out Sheet" reflected that the last entry had been documented on 12/31/2015 at 0535 and that 185cc were remaining in the bottle.

A bottle of cough syrup containing codeine for Patient 31 was observed to have graduated lines for measuring the amount in the bottle. The bottle was observed to have 195cc of liquid in it. However, the "Narcotic Sign-Out Sheet" reflected that the last entry had been documented on 02/24/2016 at 0015 and that 205cc were remaining in the bottle.

There was no evidence to reflect those discrepancies had been identified and investigated

2. The 'Triage Narcotic Drawer and RSI Kit Lock Record" was reviewed. There were 29 entries on the record for the time period of 02/29/2016 through 07/19/2016. Fourteen of those entries contained discrepancies that reflected the number of the breakaway lock recorded on the narcotic record as having been placed on the narcotics drawer did not match the lock number found on the narcotics drawer on the next occasion the drawer was accessed. There was no evidence to reflect that any actions had been taken or reports made in response to the lock number discrepancies. There was no evidence to reflect those had been identified and investigated. Examples include:

* On 03/03/2016 at 2030 an RN recorded that the "Reason Lock was removed" was the "Dilaudid & Ativan count off." The lock record reflected that a breakaway lock with number 6 was replaced on the drawer.

The next entry on the record was dated 03/14/2016 at 1700 and the RN recorded that he/she removed breakaway lock number 0. The "Reason Lock was removed" was blank. The lock record reflected that a breakaway lock with number 1.

The next entry on the record was dated 03/20/2016 at 1750 and the RN recorded that he/she removed breakaway lock number 8. The "Reason Lock was removed" was "Used MS & Ativan."

These three sequential entries between 03/03/2016 and 03/20/2016 reflect two discrepancies in a row where staff removed a breakaway lock with a number different than the last lock number recorded on the lock record.

* On 04/20/2016 an untimed entry reflected the "Reason Lock was removed" was an "Outdate [check]." The RN recorded that after accessing the drawer he/she secured the drawer with a breakaway lock number 9291.

The next entry on the record was dated 04/21/2016 at 1500 and the RN recorded that he/she removed breakaway lock number 0. The "Reason Lock was removed" was "Used Dilaudid." The lock record reflected that a breakaway lock with number 6 was replaced on the drawer.

The next entry on the record was dated 05/19/2016 at 2030. The lock removed number was blank, the "Reason Lock was removed" was blank, and the new lock number was blank.

The next entry on the record was dated "05/2[?]", an illegible date as the original number written had been altered, at 0321. The RN recorded that he/she removed breakaway lock number "unlocked 8." The "Reason Lock was removed" was "Found unlocked." The RN recorded that he/she secured the drawer with a breakaway lock number 3.

The next entry on the record was dated "05/21" at 1812. The RN recorded that he/she removed breakaway lock number " 9" or " 9", the number was not clear. The "Reason Lock was removed" was "[Not] used." The RN recorded that he/she secured the drawer with a breakaway lock number 4.

The next entry on the record was dated "6/2" at 0630. The RN recorded that he/she removed breakaway lock number " 9." The "Reason Lock was removed" was "Narc count."

These six sequential entries between 04/20/2016 and 06/02/2016 reflect five discrepancies in a row where staff removed a breakaway lock with a number different than the lock record reflected had been last placed.

* The record reflected that on 06/22/2016 and 06/30/2016 the narcotic drawer was found "unlocked" and no lock number was recorded as having been present.

* During observation of the triage narcotics drawer on 08/17/2016 at approximately 1530 a number of unused red numbered breakaway locks were observed in the drawer with the narcotics and were readily available to all staff who accessed the drawer. Availability of the numbered breakaway locks does not ensure the integrity of the system.

3. A "Narcotic Sign-Out Sheet" was used to track the individual drugs in the ED narcotics drawer. The sheet for Morphine 2mg/ml contained incomplete and unclear entries. An entry dated 04/15/2016 at 1522 did not specify the "Dosage", the "Balance", the "Patient", or the "Doctor" as specified on the form. The entry written through those spaces was "# 9." The next entry was dated 05/29/2016 at 2100. It reflected that a 2 mg dose of the morphine had been "wasted." There was no patient name or any reason or explanation.

The "Narcotic Sign-Out Sheet" for Fentanyl 100mg had numerous writeovers and alterations of the drug dosages and balances.

4. A "Narcotic Count Verification Sign-Off " form was reviewed. It was used to document that the amounts of the narcotics stocked on each unit was counted and verified. It stipulated on the top of the form "Narcotic count to be completed at least once every 24 hours by two members of the nursing staff, verified by signing their names in the space provided." The form consisted of rows numbered 1 through 31 and two columns for two signatures for each row.

The "Narcotic Count Verification Sign-Off " for the ED for the months May, June, July, and August 2016 reflected the narcotic count verification had been conducted as required by two members of the nursing staff on only two occasions, on 07/03/2016 and 08/14/2016. Neither of those entries was timed.

The "Narcotic Count Verification Sign-Off" for the "LTC" unit for the months June and August 2016 reflected that the narcotic count was conducted twice every 24 hour period. However, the records reflected 14 occasions on which the narcotic count had not been verified, including 06/03/2016 and 08/09/2016.

5. The ED "Crashcart Lock Record" was reviewed and revealed that on 03/27/2016, 04/11/2016, and 06/27/2016 the documentation reflected that staff removed a breakaway lock with a number different than the lock record reflected had been last placed. There was no evidence to reflect that any actions had been taken or reports made in response to the lock number discrepancies. There was no evidence to reflect those had been identified and investigated.

6. On 08/18/2016 at 1710 in the CT room the emergency drug kit was observed. The "Minnie Crash Cart" record contained the list of drugs in the emergency kit and spaces for drug expiration dates. It also contained columns for "Initial/Date" for staff who accessed the kit. There were breakaway lock numbers recorded with the majority of "Initial/Date" entries, however, on those occasions there was only one lock number. Therefore it wasn't clear whether that was the lock number removed or replaced, and it was not clear that there were no discrepancies. The record had multiple illegible and altered entries. A bag of white, numbered breakaway locks were observed in the unlocked cabinet drawer directly below the drawer the drug kit was stored in and were readily available to all staff. Availability of the numbered breakaway locks does not ensure the integrity of the system.

7. Observations in the ED on 08/17/2016 at 1430 revealed the following:

* A small bin of drugs had a label on it that contained the following drug names: "Advil", "Aspirin 325 mg", "Aspirin 81 mg Chew", "Benadryl 50 mg", "Nitrostat", "Tylenol", "Zofran 4 mg." There were dozens of individual unit dose packs and other containers of drugs stored in the bin in an unorganized and disorderly manner. The bin contained individual unit doses of Acetaminophen 500 mg unit dose, Acetaminophen 325 mg unit dose, Ibuprofen 600 mg unit dose, Diphenhydramine 25 mg unit dose, Ondansetron disintegrating tablets 4 mg unit dose, Ondansetron tablets 8 mg unit dose, three bottles of pain medications, two bottles of Nitroglycerin, Ondansetron for injection, and Diphenhydramine for injection.

* A small bin with four labels affixed to it that read "Nebulizer Meds", "Xopenex", "DuoNeb", and "Ventolin" was similarly disorganized and disorderly with numerous different inhalants and drugs, that included: Open packages of Levalbuterol Inhalation Solution in at least two different dosages, Ipratropium Bromide Inhalation Solution, Albuterol Sulfate Inhalation Solution, Combination Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, Ventolin HFA.

* A small bin of injectable vials was similarly disorganized and disorderly. Six vials of Diphenydramine for injection were observed in a brown plastic bag that had a handwritten label that reflected the expiration date for the drugs was "4-17." However, observation revealed that two of the vials had a manufacturer's expiration date of "02/2017." A vial of Ceftriaxone was observed in a clear plastic bag that had a handwritten label that reflected the expiration date was "3-17" or 03/31/2017. However, observation revealed that the vial had a manufacturer's expiration date of 03/01/2017.

The process of reviewing the contents of those bins required that they be sorted out on the counter to properly identify the names, doses, and expiration dates. In an ED where timely identification of drugs is critical this was not an acceptable system and created the potential for drug errors.

8. Observations at the inpatient nurse's station on 08/17/2016 at approximately 1630 revealed the following:

* A small bin of drugs for Patient 16 contained two bottles of drugs and approximately 80 individual unit doses of the following medications. It took several minutes to organize the contents of the bin for inventory to ensure the patient's medications were consistent with the physician's orders. The only way to clearly identify all the drugs in the bin was to empty the contents onto the counter for sorting. It contained:
Docusate Sodium 100 mg x 14 individual unit doses with four different lot numbers and expiration dates;
Furosemide 20 mg tablets x 8 individual unit doses with two different lot numbers and expiration dates;
Senna-Lax 8.6 mg tablets x 5 individual unit doses;
Meloxicam 7.5 mg tablets x 5 individual unit doses;
Prenatal Vitamins x 11 individual unit doses with three different lot numbers and expiration dates;
Paroxetine 20 mg tablets x 5 individual unit doses;
Ferrous Sulfate 325 mg tablets x 3 individual unit doses;
Acetaminophen 325 mg tablets x 12 individual unit doses;
Spironolactone 25 mg tablets x 5 individual unit doses;
Vitamin D3 1000 unit tablets x 6 individual unit doses with two different lot numbers and expiration dates;
Simvastin 20 mg tablets x 5 individual unit doses;
A bottle of Nitrostat tablets; and
A bottle of Bystolic 5 mg tablets.

This situation created a potential for drug errors. During interview with two RNs present at the time of the observation they confirmed that the system was not efficient and indicated that when there are several patients on the inpatient unit at one time it is especially problematic.

9. In the ED on 08/17/2016 at 1450 in an unsecured and unlocked wound cart the following was observed:
* Two MDVs of Lidocaine/Epinephrine for injection were open and not dated;
* One MDV of Bupivacaine solution for injection was open and not dated;
* One MDV of Lidocaine HCL for injection was open and dated in handwriting "6/20/16." It was not evident whether that was the date opened or the date the vial was to be discarded; and
* One MDV of Xylocaine for injection was open and illegibly dated in handwriting "8/[?]."

The policy and procedure titled "Use of Multi-Dose Vials (MDV)" dated as last approved "10/2014" stipulated that "After accessing the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial." However, the procedure was unclear and did not specify how the dating of the vial should be recorded and where on the vial it should be recorded. Additionally, it did not specify whether the date recorded should be the date the vial was accessed, or the 28th day on which the vial should be discarded, or both of those dates.

10. Observations in the ED drug refrigerator on 08/17/2016 at 1515 revealed that high-alert drugs with high risk for adverse effects were not labeled consistently:
* A box of MDVs of Succinylcholine Chloride Injection 20 mg/ml, a neuromuscular blocking agent/paralytic, contained a package of neon orange stickers pre-printed with the drug name and alert information that included "Warning Paralyzing Agent."
* Two boxes of MDVs of Rocuronium Bromide Injection 50 mg/5 ml, a neuromuscular blocking agent/paralytic, had a handwritten note in ball point pen ink on each box that read "watch drug name." It was not clear what that meant.

During an interview on 08/19/2016 at 1430 the CNO stated there were no policies and procedures for management of emergency drug kits and high alert drugs, and in an email from the CNO dated 08/23/2016 at 0839 he/she confirmed that "...we currently do not have....High Alert Drugs Policy...Emergency Drug/Kits Policy and Procedure."

11. Observations in the inpatient utility room 08/16/2016 at 1230 revealed the following:
* A Fleet Mineral Oil enema was outdated "9/2015";
* Five Castille Soap packets were outdated "10/2015"; and
* A .9% Sodium Chloride for Irrigation 500 cc was outdated "4/15."

12. Observations in the ED on 08/17/2016 at 1430 revealed the following:
* A box labeled Tropicamide Opthalmic Solution 1% Sterile had a handwritten notation that was "Exp. 1/17." However, the bottle of solution in the box was outdated and had the manufacturer's expiration date identified as "01/16";
* A bottle of Major sterile eye wash solution was open. There was no indication as to when the bottle had been opened and no assurance of its continued sterility; and
* A Chloraprep swab expired "2/16"
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
Based on observation, interview, and review of policies and procedures, and other documents it was determined the CAH failed to ensure appropriate infection control and prevention throughout the facility in regards to:
* Endoscopy procedures;
* Sterile processing and disinfection of equipment and instruments;
* Negative air flow for respiratory isolation and endoscopy;
* Hand hygiene supplies and practices;
* Management of multi-dose medication vials;
* Humidity and temperature;
* Cleaning and disinfection of the patient whirlpool;
* Monitoring of Nosocomial Infections and investigation of infection control incidents; and
* TB Risk Assessment.

The lack of proper management of MDVs of injectable medication is a repeat deficiency cited at Tag C202 on the last recertification survey completed 09/21/2011.

Findings include:

1. On 08/17/2016 at approximately 1500 in the ED the handwashing sink and counter was observed. A three-sided blue plastic bin-type container was placed next to the sink and a printed sign was affixed to the wall above the container that read "Cleaned Instruments." Inside the container were observed two surgical instruments lying on a piece of paper product. It was not clear if those instruments had been cleaned or were waiting to be cleaned. Staff present at the time of the observation were unsure. During interview with Employee 2 on 08/18/2016 at 1435 he/she confirmed that the instruments in the ED were not clean. He/she stated that nursing staff was supposed to scrub the instruments after use with a scrub brush provided at the sink and then soak the instruments with enzymatic cleaner provided at the sink. Employee 2 stated there were no written policies and procedures for that process. On 08/19/2016 at approximately 1500 the same sign and container were observed at the ED sink. The container had a different instrument in it. During the observations on 08/17/2016 at 1500 and again on 08/19/2016 at 1500 there were no scrub brushes or enzymatic cleaner at or near the ED sink.

2. On 08/18/2016 at 1315 Employee 1 was observed hanging endoscopes in an endoscope cabinet in the ED. During interview at that time Employee 1 stated he/she had processed the three scopes and parts used for colonoscopy and EGD in that same room earlier that day, and was returning them to the storage cabinet. He/she was observed to wipe excess water off of the three scopes with a washcloth and used the same cloth for all three scopes before hanging the scopes in the storage cabinet. Employee 1 was observed to place numerous small scope parts on a towel on the floor of the cabinet under the hanging scopes.

Observation in the ED room revealed a work counter with a handwashing sink. Cabinets and drawers were observed below and above the work counter. The cabinets and drawers contained numerous ED exam supplies and equipment. The top of the work counter adjacent to the sink was covered with ED exam supplies and equipment and documents. During interview at that time Employee 1 explained that endoscopy procedures were performed in the ED exam room and during the endoscopy procedures a round plastic bucket was placed in the handwashing sink and the endoscopes partially processed in that bucket after each procedure.

During observation of the endoscopy machine in the ED hallway storage room with Employee 1, an unlabeled, clear plastic squeeze bottle of a blue liquid was observed on the top of a cart.

On 08/18/2016 at 1330 Employee 1 and Employee 2 were observed in the "Sterilization Room" on the lower level of the hospital. During interview Employee 1 explained that the unlabeled bottle of blue liquid observed in the ED hallway storage room was the MediChoice Enzymatic Presoak and Cleaner used to presoak the endoscopes. A gallon container of that chemical was observed in the sterilization room.

Employee 2 indicated that the enzymatic presoak was used in procesMediChoice Enzymatic Presoak and Cleaner sing the endoscopes. He/she pointed to a spot on a large clear plastic tub that was placed on the work counter next to the large utility sink. He/she stated that water was filled to "about" the level his/her finger was pointing to and then "about one to two cups, more like two cups" of the enzymatic cleaner was added. To clarify the amount of water Employee 2 stated it was about "4 gallons, 5 gallons, pretty full." Employee 2 indicated "cold water" was used but did not specify the temperature of the water. The container was observed to not have any markings on it to reflect the level of water.

The MediChoice Enzymatic Presoak and Cleaner manufacturer's instructions printed on the gallon bottle label included: "Directions: For presoak add one (1) ounce or 30 ml of [the product] to one (1) gallon or 3.79 L of water. For best results water temperature is [77 to 120 degrees F], with a soak time according to hospital protocol...For scopes, suction or flush through channels before soaking. Submerge instruments and scopes...Discard used solutions daily or when visibly soiled..."

Employee 2 stated that the endoscopes were flushed with an automatic Endoflush machine installed in the room. There was no evidence on the machine to reflect that PMs had been conducted. Employee 2 stated he/she didn't know what the PM requirements for the machine were or whether PMs had been done. He/she stated that he/she had changed out the hoses a "couple of times because it had been awhile."

Another large clear plastic tub was observed filled with green liquid on the other work counter in the room. Employee 2 indicated that was a solution of Metricide. Metricide is a chemical glutaraldehyde solution for sterilizing and disinfecting. The Metricide manufacturer's instructions stipulated that "Metricide solution is intended for use in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or specially molded polycarbonate plastics." The tub used for the Metricide was observed to be a household type container and there was no indication that it was acceptable for the use of Metricide.

A container of Metri Test strips was observed and Employee 1 indicated those were used to test the concentration of the Metricide. The manufacturer's label on the container had a space labeled "Use within 90 days of opening" and had two lines below that. The first line denoted "Date opened:" in which was handwritten "07/13/16." The second line denoted "Do not use after:" in which was written "11/ /17." That was more than a year beyond the 90 days of opening.

During interview at the time of these observations Employee 2 indicated that the Metricide process included a 45 minute soak. He/she also indicated that a 35 cc syringe was filled with solution and flushed into each channel of the endoscope 3 times.

A multi-shelf wire rack in the room next to the Metricide work counter was observed with a bath towel covering the third rack from the bottom. Employee 2 stated that the endoscopes were placed on that towel after processing to dry. Boxes of clean supplies, including open boxes of PPE disposable masks, were stored on the shelf directly underneath and were therefore subject to drips from the drying endoscopes.

Employee 2 stated that there weren't any written policies and procedures for the sterile processing of the endoscopes.

However, a "Flex Scope Cleaning" policy and procedure dated as last approved 12/2010 was later provided. It reflected that it was written by Employee 2, "Director of Purchasing/Respiratory Aide." The policy and procedure was incomplete and inaccurate including, but not limited to:
* The only direction related to presoak was "After use, Physician will suction out flex scope with Enzymatic Presoak solution."
* It specified that "Metricide Sterilizer" was to be used, however, inconsistent with the practice described by Employee 2, it stipulated "Submerge scope into sterile solution, use 35 cc syringe to inject solution through the channels. Leave to Sterilize for 20 minutes."
* It lacked the post-sterilization wire-rack drying steps described during interview.
* It lacked the steps for transport back to the ED where the endoscopes were stored.
* It lacked direction for hanging of the scopes and storage of the parts.
* It lacked direction for record-keeping and documentation.

A "Metricide 14 Day Metricide Test Strips" log for "July/August" was reviewed. It reflected the test strips used had an expiration date of "2017/11", more than a year beyond the 90 days of opening the test strip container. There were entries for three dates. The entry dated 07/13/2016 reflected the "date to be changed" was 07/13/2016, the "date sloution (sic) changed" was 07/27/2016, and the "Solution tested Q scope" was "Passed all scopes." Similar entries were dated 07/28/2016 and 08/18/2016. The information recorded was not clear.

The "Scope Cleaning Record" log was reviewed and documentation reflected that the endoscopes weren't processed on the date of the procedures:
* The patient list of all endoscope procedures conducted in the last year reflected that on 07/27/2016 two procedures were conducted. The "Scope Cleaning Record" reflected no scopes were processed on 07/27/2016 and that two scopes were processed on 07/28/2016.
* The patient list reflected that on 06/09/2016 three procedures were conducted. The "Scope Cleaning Record" reflected that three scopes were processed but the three entries were not dated.
* The patient list reflected that on 04/14/2016 two procedures were conducted. The "Scope Cleaning Record" reflected no scopes were processed on 04/14/2016.
* The patient list reflected that on 02/18/2016 four procedures were conducted. The "Scope Cleaning Record" did not reflect clearly what scopes were processed on that date. Three entries for 02/18/2016 had been written but were crossed out. One additional entry had a date of "18." .
* The patient list reflected that on 01/07/2016 three procedures were conducted. The "Scope Cleaning Record" reflected no scopes were processed on 01/07/2016.

In addition, the log contained 11 steps to be check marked as completed. Not all steps in the processing were included, such as flushing the scopes with Metricide, nor how many times flushes of water, air, Metricide, and alcohol were to be conducted.

During the observations and interview on 08/18/2016 Employee 2 stated that they "just started" keeping records of the processing.

Refer also to Tag C153, CFR 485.608(c), regarding the provision of endoscopy and sterile processing in unapproved spaces.

3. There was no handwashing sink in the "Sterilization Room" and the wall mounted hand soap dispenser was empty. A small pump dispenser of Johnson & Johnson "Gentle Cleansing Wash" was observed on a counter. During interview with Employee 2 on 08/18/2016 at 1435 in the sterilization room he/she acknowledged the lack of hand soap or hand hygiene products in the room and indicated that he/she uses the utility sink in the room to wash his/her hands or if the sink is full has to use the sink in a room down the hall.

4. On 08/18/2016 at 1705 in the Imaging Department an ultrasound machine was observed. During interview with the Imaging Director/Infection Prevention Officer at that time he/she confirmed that transvaginal probes were used at the CAH and that he/she was unsure what the process for disinfection of those probes was. He/she indicated that the ultrasound technologist was not on-site and was part-time. Other imaging staff in the department present at the time expressed they were unaware how and where the ultrasound probe was processed. Observation in the department at that time, including by the imaging staff who searched throughout, revealed no evidence of equipment or supplies for disinfection of the ultrasound probe. A written policy and procedure titled "Transvaginal/Endovaginal Ultrasonography - General Guidelines" dated as last approved "08/2016" was reviewed. The only reference to processing was "The probe is placed in a disinfectant for a length of time specified by the manufacturer." However, manufacturer's instructions were not provided.

5. On 08/19/2016 at 1620 in the "LTC" unit shower room a large whirlpool unit was observed. The CMA on duty confirmed that the whirlpool was used "daily" and he/she further confirmed that there was no written cleaning procedure for the whirlpool.

6. Observation on 08/19/2016 at 1630 in the "LTC" unit reflected a bottle of hand sanitizer on the medication cart had expired "4/16."

7. The policy and procedure titled "Nosocomial Infections" was dated as last revised "10/08." It contained definitions of nosocomial infection that included "The infection may be acquired in the facility but individuals may not become symptomatic until after they have left the facility."

The policy and procedure titled "Surveillance Monitors" was dated as last revised "10/08." It stipulated "In order to detect nosocomial infections, to detect potential sources of nosocomial infections...the [Infection Control Officer]...and [Infection Control] Committee member(s) will conduct ongoing surveillance." The policy and procedure specified actions to be taken to obtain data about nosocomial infections. It directed that the data gathered be provided "in narrative form for report to the committee and to be included with the minutes as documentation of the [Infection Control] Committee's business."

Review of Infection Control Committee Minutes did not reflect review of data related to nosocomial infections. That term was not evident in the minutes. The only reference to patient infections were:
* 01/27/2016 "Micro Reports: Reviewed all patient infection reports - All appropriate."
* 02/24/2016 "Micro Reports: Reviewed all patient infection reports - All appropriate."
* 03/23/2016 ""Review Micro Reports: Reviewed all patient infection reports - All appropriate."
* 05/31/2016 "Micro Reports: Review of March 2016 Micro reports. Reviewed micro reports all look appropriate. Completed."
* 06/29/2016 "Review Micro Reports: Reviewed all patient infection reports - All appropriate."
* 07/27/2016 "Review June 2016 Micro Reports: Reviewed all patient infection reports - All appropriate - Completed."
There was no more documentation about how many reports, what they were about, how they evaluated, and what was meant by "appropriate.

The last three Annual CAH Evaluations dated June 2013, June 2014, and June 2015 did not identify or address nosocomial infections in the "Infection Control" section of the evaluation and elsewhere in the report.

There was no evidence of policies and procedures or formal systems to identify, track, and monitor nosocomial infections, including systems to identify possible nosocomial infections of patients who underwent invasive procedures including endoscopy procedures.

8. The 05/31/2016 Infection Control Committee Meeting minutes reflected "Re-use of Medical Equipment: An incident of a Urinary Catheter being used twice was brought to my attention. [Infection Control Officer] looked for literature but did not find anything on the subject. I believe the Healthcare worker was talked to about this matter. I am sure this will not happen in the future. Correction: Only 1 Urinary [catheter] was used 2x on same patient. Completed." The information in the report reflected that an adequate investigation and response to the incident had not been conducted.

9. The "Infection Prevention" policy and procedure dated as last revised "10/08" reflected that changes in the frequency of TB testing might change "if the risk category increases for the facility...The risk assessment is completed annually..."

The "Exposure Control Plan for Airborne and Droplet Spread Diseases" was dated as last approved on "03/2013" and the "next review" was to be "03/2014. The plan included the procedures related to TB control in the facility and included a TB Risk Assessment. The policy and procedure stipulated that "The ECP will be reviewed annually and updated as required."

During interview with the Infection Prevention Officer on 08/19/2016 at 1500 he/she confirmed that an annual TB Risk Assessment had not been conducted since 2013.

10. A policy and procedure titled "Colonoscopy Set Up" was dated as originated and approved "02/2016" by Employee 2, an unlicensed staff person. It described the equipment and supplies to be used and how those were to be prepared for the procedure. Step 17 reflected "Fill white container in the sink and add one ounce of..." The only sink in the room was the handwashing sink. Step 38 reflected "If the room is too hot, you may turn on the portable fan to cool it down some." The use of a fan in a procedure room would result in disbursement of contaminants throughout the room and potentially outside of the room, when endoscopy is required to be done in a negative air flow room. Refer to the findings at C153, CFR 485.608(c), Licensure of CAH, that reflects the negative air flow requirements. There was no evidence to reflect that the policy and procedure had been approved by the Infection Control Committee.

11. Refer to Tag C222, CFR 485.623(b)(1), regarding lack of provisions to ensure appropriate air flow in the isolation room.

12. Refer to Tag C225, CFR 485.623(b)(4), regarding areas that were not clean and were cluttered to prevent adequate cleaning.

13. Refer to Tag C226, CFR 485.623(b)(5), regarding lack of temperature and humidity monitoring.

14. Refer to Tag C 276, CFR 485.635(a)(3)(iv), regarding appropriate management of multi-dose injectable medication vials.
VIOLATION: AGREEMENTS - LIST OF SERVICES Tag No: C0291
Based on observation, interview, review of the list of the services furnished under arrangement or agreement, and review of equipment PM and other documents it was determined that the list of all services furnished under arrangement or agreement was not complete. The list did not include all such services, and it did not include descriptions of the nature and scope of the services provided, to include at a minimum:
* The service(s) being offered;
* The individual(s) or entity providing the service(s);
* Whether the services are offered on- or off-site;
* Whether there is any limit on the volume or frequency of the services provided; and
* When the service(s) are available.

Findings include:

1. A document titled "List of services provided under contract, agreement or arrangement" dated 08/16/2016 was reviewed. It consisted of a list of services numbered 1 through 13. Two additional services, blood products and emergency dental treatment, were added during the survey.

The list did not contain descriptions of the nature and scope of services provided. Examples include:
* Item #3 on the list was identified as "Mammography." There was no other information.
* Item #5 on the list was identified as "Dietician services." There was no description of what the specific services were and how often they were provided.
* Item #11 on the list was identified as "Waste Pro Acue Shred." There was no description of the specific services that company provided and how often.

The list was not complete as during the survey additional services provided under contract or agreement were identified.
* The CAH's most recent annual evaluation for the period dated July 2014 through June 2015 identified the following services provided under contract, agreement, or arrangement that were not on the list: Life Flight - Air Ambulance; Airlink - Air Ambulance; MedStar - Air Ambulance; St. Charles Medical Center - EKG reading service; InterPath Lab; Blue Mt. Pathology; Blue Mt. Diagnostic Imaging; Turn-Key Medical; Bio-Tech.
* During interview with the "Respiratory Aide" on 08/16/2016 at 1145 he/she stated that in his/her role for respiratory therapy he/she "works with" a Respiratory Therapist at Good Sheperd Community Hospital in Hermiston, Oregon, a town approximately an hours drive time from Heppner. This arrangement was not on the list.
* During tour of the laboratory on 08/18/2016 at 1620 a Leica Model CM/SL Microscope, a Clay Adams Model 3500 Serofuge, a Precision Scientific Co. Model Incubator, and a Chicago Surgical & Electrical Co. Water Bath with SN 0871 ND were observed. The Lab Manager provided documentation that reflected a company called Scientific Instrument Repair located in Washington State conducted the equipment PM on those instruments/machines as recently as 02/10/2016. That company and service was not on the list of services provided under contract or agreement.
* During interview with the CEO on 08/19/2016 at 1400 he/she stated that a contract with the Scientific Instrument Repair company was not found. In addition, the CEO confirmed that the hospital had other contracts or agreements not on the list that included, but were not limited to: OHSU Medical School; Sumner College Nursing School; Wenatchee Valley College Nursing School; Interpath Reference Laboratory; and EKG interpretation by BMC Group.
VIOLATION: AGREEMENTS - CEO RESPONSIBILITIES Tag No: C0292
Based on observation, interview, review of contract information, review of policies and procedures, review of PM documentation, and review of CAH annual evaluation documentation it was determined that the CAH failed to ensure that services provided under contract, arrangement or agreement were furnished in a manner that enabled the CAH to comply with all applicable CFRs. There was a lack of an organized and methodical system for the evaluation of services provided under contract, arrangement or agreement; services had not been evaluated; and services provided under those arrangements were identified to be deficient during this survey.

This is a repeat deficiency cited at Tag 293 on the previous recertification survey completed 09/21/2011.

Findings include:

1. The "List of services provided under contract, agreement or arrangement" dated 08/16/2016 reflected that "Pharmacy" was a contracted service.

Refer to the findings at Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, that reflects drugs were not appropriately stored, handled, controlled and secured throughout the facility.

2. During tour of the laboratory on 08/18/2016 at 1620 the Lab Manager provided documentation that reflected a company called Scientific Instrument Repair in Washington State conducted the equipment PM on instruments/machines used in the lab. A document titled "Instrument Listing" contained a list of five items. For each item the document reflected that the frequency of "PM per Year" was "2".

Two of the instruments, a microscope and a serofuge, reflected PM documentation twice in 2015 and as recently as 02/10/2016. The other items lacked documentation to reflect PMs two times per year. The last documented PM for a Precision Scientific Co. Model Incubator was 09/13/2014. There was no documentation for a "Chicaco Serg." Model DB E Water Bath on the list. Although there were PM records for a Chicago Surgical & Electrical Co. Water Bath with SN 0871ND that was not on the list, the last documented PM was 10/16/2014.
.
3. The CAH's most recent annual evaluation for the period dated July 2014 through June 2015 identified that services provided under contract, agreement, or arrangement included:
* Pharmacy services
* A contracted ED physician
* Life Flight - Air Ambulance
* Airlink - Air Ambulance
* MedStar - Air Ambulance
* St. Charles Medical Center - EKG reading service
* Providence TeleStroke Network
* Advantage Dental
* InterPath Lab
* Blue Mt. Pathology
* Blue Mt. Diagnostic Imaging
* Turn-Key Medical
* Bio-Tech
* Accu-Shred
The annual evaluation did not include an evaluation of those services.

In addition, the services provided by Scientific Instruments was not identified on the annual evaluation.

4. There was no evidence provided during the survey to reflect that the CAH had methodically or systematically evaluated the services provided under contract, arrangement, or agreement, to ensure that the services complied with all regulatory requirements.

During interview with the CEO on 08/19/2016 at 1415 he/she confirmed that there was no system for formal evaluation of contracted services.
VIOLATION: NURSING SERVICES Tag No: C0294
Based on observation, interview, review of documentation in 9 of 9 medical records of patients who underwent endoscopy (Patients 6 through 14), review of personnel records, and review of policies and procedures and other documents it was determined that CAH failed to develop and implement nursing services policies and procedures to ensure appropriate care and services, and failed to develop job descriptions to ensure the provision of care and services by licensed nursing staff with the appropriate qualifications, training, and competencies, in the following areas:
* Endoscopy services and related tasks, including tissue biopsies;
* Administration of moderate sedation, IV and other medications;
* Nursing assessment, including for moderate sedation;
* EKGs; and
* "Nursing Facility."

Findings include:

1. A policy and procedure titled "Colonoscopy Set Up" was dated as originated and approved "02/2016" by Employee 2, an unlicensed staff person. It described the equipment and supplies to be used and how those were to be prepared for the procedure. Step 34 of the procedure was to "...start the IV using the IV start kit... " Step 35 of the procedure was to "Retrieve the Lactated Ringer...Hang on the IV pole, connect to the patient's IV, and start the IV drip." Step 36 was to "Place the 12 lead electrodes on the patient, and hook up to the monitor..." The policy and procedure did not reflect the credentials of staff authorized to perform the specified tasks.

There were no other policies and procedures related to endoscopy services including for:
* EGD preparation;
* Colonoscopy procedure, including biopsy and polyectomy;
* EGD procedure, including biopsy and polyectomy;
* Post-procedure endoscopy recovery.

There were no job descriptions for staff who performed tasks before, during, and after the procedure, that described the duties, qualifications, training and competencies.

The medical records of Patients 6, 7, 8, 9, 10, 11, 12, 13, and 14 were reviewed. Those patient had colonoscopy or EGD procedures on 05/12/2016, 06/09/2016, 07/13/2016, 07/27/2016, and 08/18/2016. In all nine records:
* The "Informed Consent" for the procedures were not timed to reflect consent had been obtained prior to the procedure.
* The physician's orders for the procedure reflected "Have the following medications available. Versed, Fentanyl, Romazicon, and Narcan. Amount ordered to be given:" The space following the "Amount ordered to be given" was blank. There were no written or documented verbal orders for the drugs administered. The amounts of Versed and Fentanyl documented as administered varied for each patient.
* The "Moderate Sedation Protocol...Post-Anesthesia Recovery Score for Ambulatory Patients" in each record had not been completed and the recovery score was not documented in recovery or discharge documentation.
* Inaccurate information about where the procedure was performed was documented by the physician on the electronically generated procedure note and reflected "...endoscopy performed in the Hospital endoscopy suite."

Review of the records of Patient's 6 and 7, who had endoscopy procedures on 05/12/2016, revealed that Employee 11, the Housekeeping Manager, had completed and documented the following care and tasks on the 3 page "Moderate Sedation Nursing Assessment & Procedure/VS Flow Sheet":
* Demographics and history;
* "Pre-Procedure Nursing Assessment";
* "Patient Teaching";
* "Discharge Plan";
* "Patient Preparation and Monitoring";
* IV access and administration of IV fluids;
* "Cardiac Monitor";
* "Suction";
* "Pre-procedure vital signs"
* Recovery vital signs, sedation level, cardiac rhythm, and pain assessment;
* Discontinuation of IV and site assessment;
* Discharge instructions teaching and discharge assessment.
* In the record of Patient 6, "Specimens obtained [zero] x 3."

During an interview with Employee 1, an unlicensed staff person and a "Procedure Aide", on 08/18/2016 at 1315 he/she confirmed being present and "assisting" during three endoscopy procedures on that day. The medical records of Patients 12, 13, and 14 who had endoscopy procedures on 08/18/2016 were reviewed. There was no documentation in the records to reflect that Employee 1 was present and no documentation to reflect what tasks he/she conducted and what "assistance" he/she provided.

During interview with Employee 2, a CNA 1, on 08/25/2016 at 1000 he/she stated that he/she functioned as a "Procedure Aide" before, during, and after endoscopy procedures. He/she described those duties to include setting up the endoscopy machine, setting up and prepping the room, holding the scope during procedures while the physician is performing other tasks, placing forceps into the endoscope biopsy port to obtain the specimen or "take a bite out of whatever [the doctor] wants", placing the tissue in the specimen container, and sterile processing of the endoscopy equipment and scopes.

There was no job description for a "Procedure Aide" or training records. During interview with the HR Manager on 08/19/2016 at 1045 he/she stated that the CAH did not have a "Procedure Aide" job description.

2. The policy and procedure titled "Moderate Sedation - Sedation Administration" dated as approved "09/2006" reflected "Sedation Administration...Administer sedative as ordered by injecting a minimal amount of medication. Sedative dosage must be individualized and titrated..." The policy and procedure did not reflect the credentials of staff authorized to administer moderate sedation.

The policy and procedure titled "Moderate Sedation - Sedation Assessment by RN, Special Considerations" dated as approved "06/2013" stipulated that "Pre-Sedation Assessment by Registered Nurse...Signed consent for sedation and treatment, must be obtained by and signed by the physician...The RN will thoroughly assess each patient's suitability to undergo moderate sedation at Pioneer Memorial Hospital." Under item 2 of the policy and procedure it reflected "The registered nurse or paramedic assures that the physician performing an invasive procedure, which requires the administration of moderate sedation..." Further, under item 5 it indicated "Drugs will only be administered by a Registered Nurse, Paramedic, Physician Assistant, Nurse Practitioner, or Physician."

The policy and procedure titled "Moderate Sedation" dated as last approved "06/2013" also referred to the provision of moderate sedation services by a paramedic.

OAR 847-035-0030, Emergency Medical Services Providers Scope of Practice, stipulates that a paramedic license authorizes the provision of "pre-hospital" care. That license is not transferable to the provision of nursing care and services in the hospital.

The policy and procedure titled "Moderate Sedation - Post-Procedure Activities" dated as approved "06/2013" stipulated the procedure for recovery, including for maintenance of the IV, assessment and evaluation of patient condition, and discharge. The policy and procedure did not reflect the credentials of the staff authorized to conduct recovery duties.

The policy and procedure titled "Patient Sedation" dated as approved "08/2016" reflected "Sedation should be timed to allow medication to reach an effective level prior to entry into the CT scan room...It is the hospital's responsibility to provide all specially qualified personnel needed...Patients should not be scanned if appropriate personnel are not available." However, the policy and procedure did not identify what the specially qualified and appropriate personnel's credentials and qualifications were.

3. The policy and procedure titled "EKG Policy and Procedure" was dated as last approved "08/2016." The policy required that EKGs be conducted as ordered by a physician. The policy and procedure did not reflect credentials of staff authorized to perform the test.

On 08/16/2016 at 1250 in room 204 an EKG machine was observed. Taped to the machine was a form titled "Progress Notes. On the "Progress Notes" form was a list of handwritten steps numbered 1 through 13 that began with "Dear [first name], Hope this helps you [and a first name] to work on...1. Push off/stop on button...Good Luck Thanks a Lot [author's name] 10/14/07." The instructions on this informal document were not consistent with the steps outlined on the "EKG Policy and Procedure."

There was no job description for nursing staff that included the provision of EKGs.

4. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH, related to the "nursing facility" policies and procedures.

5. Refer to the findings at Tag C154, CFR 485.608(d), Licensure, Certification, or Registration of Personnel, related to the provision of nursing care and services by unlicensed staff.
VIOLATION: NURSING SERVICES - DRUG ADMINISTRATION Tag No: C0297
Based on observation, interview, review of documentation in 9 of 9 medical records of patients who underwent endoscopy procedures (Patients 6 through 14), review of personnel records, review of policies and procedures and other documents it was determined that the CAH failed to ensure that dugs and biologicals were administered and monitored by licensed/certified nursing staff.

Findings include:

1. Refer to the findings at Tag C154, CFR 485.608(d), Licensure, Certification or Registration of Personnel, that reflects drugs were administered and monitored by unlicensed staff.

2. Refer to findings at Tag C294, CFR 485.635(d), Nursing Services, that reflects that drugs were administered and monitored by unlicensed staff.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure its program evaluation and quality assurance program was effective and appropriately evaluated the safety and quality of the services provided, to ensure at a minimum, compliance with applicable Federal and State laws and regulations and rules that apply to the CAH and to its staff, including the Conditions of Participation for CAHs.

The findings identified during the survey reflect the CAH's limited capacity to provide care and services and represent a Condition-level deficiency of CFR 485.641, Condition of Participation: Periodic Evaluation & QA Review.

Findings include:

1. Refer to the Condition-level deficiency at Tag C150, CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

2. Refer to the Condition-level deficiency at Tag C220, CFR 485.623, Condition of Participation: Physical Plant and Environment. This is a repeat Condition-level deficiency that was previously cited on the provider's most recent survey completed 09/21/2011.

3. Refer to the Condition-level deficiency at Tag C270, CFR 485.635, Condition of Participation: Provision of Services.