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Based on observations, interviews, review of the CAH's list of locations, review of patient appointment information, review of OARs and review of SA licensing records it was determined that the CAH failed to ensure that the CAH was in compliance with applicable Federal and State laws and rules:
* Off-campus and on-campus outpatient services were provided without the required SA review, approval and licensure, including at locations that were in excess of mileage allowed for Oregon hospital satellite locations.

This Condition-level deficiency reflects the CAH's limited capacity to provide safe and appropriate care and services.

Findings include:

1. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH, that reflects that outpatient services were provided in off-campus and on-campus spaces not approved and licensed by the SA.

Based on observations, interviews, review of the CAH's list of locations, review of patient appointment information, review of OARs and review of SA licensing records it was determined that the CAH failed to ensure that all operations were approved and licensed as required by the State of Oregon hospital licensing requirements. The OARs allow an Oregon hospital to provide services at off-campus satellite locations that do not exceed a distance of 35 miles from the hospital. The OARs 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 and licensure to commence services is received from the SA. The CAH failed to comply as follows:
* The CAH commenced provision of outpatient immunization, reproductive health, substance use and mental health services at four off-campus locations without the required SA review, approval and licensure. Three of those locations were at a distance of 102 miles from the CAH.
* The CAH commenced provision of outpatient physical rehabilitation services at an off-campus location without the required SA review, approval and licensure. The location was at a distance of 46 miles from the CAH.
* The CAH commenced provision of outpatient physical rehabilitation services in on-campus space previously licensed as a SNF without the required SA review, approval and licensure.

Findings include:

1. a. OAR 333-500-0010(46) reflects: "'Satellite' means a building or part of a building owned or leased by a hospital, and operated by a hospital in a geographically separate location from the hospital, with a separate physical address from the hospital but that is within 35 miles from the hospital, through which the hospital provides: (a) Outpatient diagnostic, therapeutic, or rehabilitative services; (b) Psychiatric services in accordance with OAR 333-525-0000 ..."

b. OAR 333-500-0025(4) requires: "A satellite shall be subject to a plans review and must pass life safety code requirements."

c. OAR 333-500-0045(1) requires: "A hospital proposing to make alterations or additions to an existing facility or to construct a new facility shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Division for preliminary inspection and approval or recommendations with respect to compliance with Division rules and compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified."

d. 333-675-0000(1) requires: "Any person proposing to make certain alterations or additions to an existing health care or residential care facility, or to construct new facilities must, before commencing such alteration, addition or new construction, submit plans and specifications to the Oregon Health Authority, Public Health Division, Facilities Planning and Safety, 800 NE Oregon Street, Suite 465, Portland, OR 97232 for plans approval or recommendations with respect to compliance with rules authorized by ORS 441.025, 443.420 and for compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified."

2. a. Review of the list of the CAH's on-campus and off-campus locations where CAH services were provided was received on 06/18/2019 at 1210 and reviewed. That list reflected that the CAH provided services at seven locations that included the following:

* "Lake County Public Health" at 100 N D St., Lakeview, Oregon.
Services provided "WIC, Immunization clinic, Reproductive Health."

* "North Lake Health District" at 87520 Bay Rd., Christmas Valley, Oregon 97641.
Services provided: "Substance Use Disorder (SUD), Mental Health."

* "Lake District Wellness Center, Christmas Valley, Lake County Annex" at 87127 Christmas Valley Hwy., Christmas Valley, Oregon 97641.
Services provided: "Substance Use Disorder (SID), Mental Health."

* "Lake County Public Health, North Lake: County Annex" at 87127 Christmas Valley Hwy., Christmas Valley, Oregon.
Services provided "WIC, Immunization clinic, Reproductive Health."

b. Internet on-line distance information reflected that the CAH locations in Christmas Valley, Oregon were 102 miles and approximately one hour and 50 minutes drive-time from LDH.

c. The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans review and licensure process for the provision of outpatient services provided at those locations listed above.

3. a. During interview with the RD on 06/19/2019 at 1630 he/she stated that outpatient rehabilitation services were provided on Tuesdays and Thursdays at an off-campus CAH location at the "Inner Court Family Center" on "James St." in Paisley, Oregon. The RD stated that those services at that location "developed organically" and had been provided over the previous three years.

The RD further stated that he/she could not generate a list of the patients seen at that location and that the medical records reflected that all patients received their rehabilitation services at the CAH's main campus.

b. The off-campus rehabilitation location in Paisley, Oregon disclosed by the RD was not included on the list of the CAH's on-campus and off-campus locations that had been received on 06/18/2019 at 1210.

c. On 06/20/2019 at 1130 the RD provided the following written information: "Paisley ICFC: 723 Chewaucan Paisley, Oregon 97636 - Not sure on start date exactly, we have been seeing patients on and off, as we were up in Paisley for Home Health visits. Depends on the number of patients and if we have had therapists available. More frequently over the past 2.5-3 years."

d. Review of the outpatient rehabilitation services electronic schedule log for the dates 07/24/2016 through 06/22/2019 revealed the following:
* On at least 207 Tuesdays and Thursdays during that time period the schedule reflected that a PT was scheduled "In Paisley."
* The 207 days showed time blocked off for travel time between LDH and Paisley.
* The 207 days reflected that the number of patients scheduled per day ranged from two to seven.
* The 207 days revealed the names, or partial names because of the nature of the printed electronic log, of scheduled patients who had received services, who had canceled for various reasons or who were "no show no call."

e. The provision of rehabilitation services at the Paisley, Oregon location was discussed with the CEO on 06/19/2019 at 1625 and on 06/20/2019 at 1015. The CEO confirmed that services had been provided at that location as described by the RD. He/she stated that the CAH's HHA had patients in that part of the State and that the therapists would travel that distance to see HHA patients. The CEO indicated that they determined that as they had therapists traveling to that area it would be beneficial to CAH outpatient rehab patients who lived in that area to receive the services in that area and not have to travel to the CAH.

During the interview the CEO stated that he/she had not been to that location and had never seen it.

f. Internet on-line distance information reflected that the CAH location at 723 Chewaucan, Paisley, Oregon was 46 miles and approximately 50 minutes drive-time from LDH.

g. The Internet Facebook page for the "Inner Court Family Center" contained photographs of the center that showed it to be an older, one-level, single family residence type of structure. The website Zillow confirmed that and reflected that "723 Chewaucan St, Paisley, OR is a single family home."

h. The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans review and licensure process for the provision of an outpatient rehabilitation clinic in Paisley, Oregon.

4. a. The on-campus "pediatric" rehabilitation space in a room labeled as Room 312 was toured on 06/19/2019 beginning at 1725 with the RD and the following observations were made:

* The interior of the former patient room was observed to contain remaining elements of inpatient rooms that included two overbed light fixtures affixed to a wall where two patient beds were previously placed.

* The bathroom in the room was cluttered and disorganized with a variety of clean and dirty items stored on the sink, under the sink, next to the toilet and on the floor. Those items included: a soiled linen hamper that was stored in front of the toilet, a long and bulky rehabilitation item with a long round dowel attached to it by carabiners and heavy handles was laid on the floor, a stepladder was leaned up against the wall immediately next to the open toilet seat, a variety of linens and items were stored on a shelf above the open toilet seat, multiple drinking cups and water bottles were placed on the sink along with two toothbrushes.

b. During interview with the RD at the time of the observation he/she confirmed that Room 312, that was located in a hallway of the former SNF attached to the hospital, was a former SNF patient room. The RD stated that prior to the move to Room 312 approximately six months before, the pediatric rehabilitation services had been provided in Room 305, across the hall in another former SNF patient room. The RD stated that pediatric rehabilitation services had been provided in those spaces for approximately two years.

c. These findings were shared with the CEO on 06/19/2019 and no additional information was provided.

d. The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans review and licensure process to add that former SNF space to the CAH's license.

Based on observations, interviews, review of the CAH's list of locations, review of patient appointment information, review of OARs and review of SA licensing 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:
* The CAH commenced provision of outpatient immunization, reproductive health, substance use and mental health services at four off-campus locations without the required SA review and approval. Three of those locations were at a distance of 102 miles from the CAH.
* The CAH commenced provision of outpatient physical rehabilitation services at an off-campus location without the required SA review and approval. The location was at a distance of 46 miles from the CAH.
* The CAH commenced provision of outpatient physical rehabilitation services in on-campus space previously licensed as a SNF without the required SA review and approval.

Findings include:

1. Refer to the findings at Tag C153, CFR 485.608(c), Licensure of CAH, that reflects that outpatient services were provided in off-campus and on-campus spaces not approved by the SA. Services were not provided in spaces constructed, arranged and maintained to ensure the safety and well-being of patients.

Based on observation, interview, review of documentation in the medical record of a patient (Patient 14) who was in seclusion for violent or self destructive behaviors, review of annual restraint training documentation for 5 of 5 nursing staff (Employees 6, 7, 8, 9 and 10), review of restraint training materials, review of medication error and infection prevention documentation and review of policies and procedures it was determined that the CAH failed to ensure that safe and appropriate care and services were provided in accordance with written patient care policies in the following areas:
* Management of drugs and prevention of errors
* Infection control and prevention
* Wound care
* Use of physical restraints and seclusion
* Staff training related to physical restraints and seclusion

Findings include:

1. Refer to the Standard-level deficiencies cited at Tags C276 and C278 under this Condition of Participation that reflects that practices and procedures related to drug management and infection control and prevention were not in accordance with written policies and procedures.

2. a. During tour of the outpatient wound care clinic adjacent to the rehabilitation department on 06/19/2019 at approximately 1700 with the RD and wound clinic staff the following observations were made:
* Refer to Tag C276 that reflects that wound care dressings and ointments were outdated or had been provided for patient use directly from a drug company representative and had not been ensured for quality by the hospital pharmacy or purchasing departments.
* An electric Schuco-Vac suction machine was observed with a PM sticker that reflected it was last inspected on "10-2016" and the next "Inspection due 09-2017."
* A cardboard box overflowed with numerous manufacturer's wound vac system packages and was labeled "(small home V.A.C.) ActiV.A.C Cannister (sic) Exp. 6/18 Use First."

b. At the time of the tour the RD stated that the wound care clinic operated on Mondays, Wednesdays and Fridays "all day," that RNs and PTs provided wound care services and that he/she was responsible for the oversight and supervision of the clinic. The RD stated that the services provided included "sharps debridement," "wound vac," "pulse lavage," and "compressive wraps."

The RD provided two hospital-wide policies and procedures titled "Medical Infectious Waste Disposal" and "Cleaning and Transporting Contaminated Instruments Procedure" as the policies and procedures for the wound care services. The RD stated that there was no written scope of services and no other written policies and procedures for the CAH's outpatient wound care services and clinic.

There were no policies and procedures for the provision of wound care services that included, but were not limited to: scope of the wound care services provided, sharps debridement, use of wound vacs, pulse lavage, compression wraps, management of wound care drugs and supplies, physician's orders for wound care services, wound care plans of care, documentation of services, etc.



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3. a. Restraints/seclusion were not used in accordance with a written modification to Patient 14's plan of care. The medical record of Patient 14 was reviewed and reflected the patient presented to the ED on 06/16/2019 with a chief complaint of "Anxious and Depressed and Paranoid."

* Physician notes dated 06/16/2019 at 2211 reflected "...Pt became agitated when talking to police. Threatened to hurt neighbor and placed on police hold...has had thoughts of suicide in the past...Past Medical History...PTSD and paranoid schizophrenia...chronic methamphetamine use along with former heroin user...Patient is noncooperative so history is limited...[He/she] is very agitated...[He/she] does have some areas, especially on [his/her] right hand, where [he/she] has some wounds...[He/she] will be placed in a (sic) 107 under locked conditions. [He/she] will only have a mattress and safety gown."
* RN notes dated 06/17/2019 at 0615 reflected "...Patient is in the room with the door locked...at times hitting the glass on the door and screaming..."
* RN notes dated 06/17/2019 at 0700 reflected "...yelling and screaming. [Physician] would like a medication to be given for the patients (sic) agitation...This RN gave the injection, patient was yelling profanities and threatening everyone in the room with violence and harm. Patient did kick out...and [his/her] foot did connect with [RN's] hip...door was locked again."
* RN notes dated 06/17/2019 at 1310 reflected "Two staff members to unlock door and put lunch tray in room. Pt angry and yelling at staff about how we locked [him/her] up in prison...All belongings in locked closet, Mattress on floor, security blanket only, pt sitting on mattress, naked."
* RN notes dated 06/17/2019 at 1319 reflected "...yelling and banging on door...angry when [he/she] sees sitter."
* RN notes dated 06/18/2019 at 0108 reflected "...Restricted to room."
* RN notes dated 06/18/2019 at 1842 reflected "Demanding, Demeaning, Belligerent, Excessive/Inappropriate Display of Anger towards this RN in the last 2 days...Aggressive, Uncooperative...Mental Health Hold-Locked...Restricted to room..."

b. Although the medical record reflected the patient was in seclusion, there was no documentation that reflected the patient's plan of care was modified to address the seclusion. This was confirmed during an interview with the CNO on 06/18/2019 at approximately 1500.

4. a. Restraint and seclusion P&Ps and training materials did not include the various types of restraints used and available for use.

b. During tour of the ED with the CNO on 06/18/2019 at 1610, Procare Personal Limb Holder wrist restraints were observed available for use in room 402.

c. During a tour of M/S on 06/19/2019 at 1145 with the CNO the following observations were made:
* Patient 14 was observed in a locked seclusion room.
* A canvas belt restraint, Protective Hood spit masks, canvas locking buckle wrist and ankle restraints, Procare Personal Limb Holder wrist and ankle restraints, and steel locking chain ankle cuffs were observed available for use in the seclusion room anteroom. During interview with staff present at the time of the observation, it was stated the ankle cuffs were for "law enforcement" to use.

d. The P&P titled "Seclusion & Restraint Policy and Procedure (Includes Mental Health Holds)," dated last revised "02/12/2019" was reviewed and reflected:
* The "Definitions" section referenced the following:
- "Mechanical Restraint"
- "Chemical Restraint"
- "Seclusion"
- "Behavioral Restraint or Seclusion"
- "Non-Behavioral Health (Medical) Restraint"
- "Enclosure Bed"
- "Mittens"
- "Lap Hugger"
- "Law Enforcement Restraints: The use of handcuffs, manacles, shackles, other chain-type restraint devices, or other restrictive devices applied by non-hospital employed or contracted law enforcement officials for custody, detention and public safety reasons."
* "Nursing Care...RN's may assess the need for restraints, and apply, monitor and remove restraints, following manufacturer's guidelines. LPN's and CNA's may apply and monitor restraints as delegated, following manufacturer's guidelines. Restraints may be removed by Medical Provider, RN or LPN as soon as behavior requiring the restraint has subsided or changed."
* "RN must document a description of...Modification in plan of care as patient condition changes."
* "Staff Education and Training: For all forms of seclusion and restraint: Non-violent Behavioral Impeding Medical Healing Standards and Violent and/or Self Destructive Behavior."
* "Nurses responsible for applying seclusion or restraint receive annual training, utilizing hospital provided restraints and seclusion education and demonstration of competency..."

e. The restraints observed available for use in the CAH were not clearly identified in the CAH's restraint/seclusion P&P above. For example:
* There was no information in the P&P that reflected the specific types of restraints that were available and approved for use.
* The observations reflected belt restraints, spit masks, canvas locking wrist and ankle restraints, and soft wrist and ankle restraints were available for use. However, the P&P included no reference to those specific types of restraints or that those were approved for use.
* The P&P defined handcuffs as "applied by non-hospital employed or contracted law enforcement officials for custody, detention and public safety reasons." However, there was no assurance handcuffs would not be used by CAH staff as the P&P did not prohibit CAH staff from using handcuffs. Further, observations reflected locking steel ankle cuffs were available for use and those were not included in the P&P.
* The P&P did not ensure appropriate CAH staff were trained in providing first aid techniques and CPR to a patient in restraint and/or seclusion who is in distress or injured (For example, a patient found hanging in a belt restraint, a restrained patient choking on food, a secluded suicidal patient found hanging, a secluded suicidal patient who has cut him/herself).

f. During an interview with the CNO on 06/20/2019 at 1300, the CNO stated the CAH had no list of restraints that were available and approved for use in the CAH.

5. a. Staff authorized to apply restraints lacked annual restraint and seclusion training and competencies as required by CAH P&Ps.

b. Staff restraint/seclusion training materials provided were reviewed and were inconsistent and did not include staff training and demonstrated competencies for the restraint types observed available for use. For example, documentation in skills day training materials titled "Acute Nursing Skills Day" dated 08/20/2018 referenced use of "Mental Health Restraints, "Behavioral Restraints," "Non-Behavioral-'Medical Restraint,'" but did not include the specific restraint devices observed available for use. The training documentation did not include belt restraint, spit masks, canvas locking wrist and ankle restraints, soft wrist and ankle restraints and ankle cuffs.

c. During an interview with the CNO on 06/20/2019 at 1745 during the exit conference, the CNO confirmed the CAH's restraint/seclusion training and competencies documentation did not specify the types of restraints that were available for use in the CAH.

d. Staff training records were reviewed and lacked documentation of annual restraint and seclusion training and competencies that include the restraints observed available for use.

e. Staff training records for Employee 6, RN with hire date 06/13/2017 reflected:
* A "[Crisis Prevention Institute]" document reflected the employee "passed" a class on 09/12/2017, but did not reflect any information related to the content of the class. There was no further documentation of annual restraint and seclusion training and competencies completed by Employee 6.
* Training materials for "Acute Nursing Skills Day" dated 08/20/2018 made references to "Mental Health Restraints, "Behavioral Restraints," and "Non-Behavioral-'Medical Restraint,'" but did not include the belt restraint, spit mask, canvas locking wrist and ankle restraints, and soft wrist and ankle restraints that were observed available for use in the CAH. The schedule for the "Acute Nursing Skills Day" included "Restraint (PPT and Practice)" and "Hold Patients" and the sign in sheet was signed by Employee 6. However, there was no information related to the specific types of restraints that were included in the skills day, and no documentation that reflected demonstrated competencies for restraints and seclusion were completed, including the specific types of restraints observed available for use in the CAH. There was no further documentation of annual restraint and seclusion training and competencies completed by Employee 6.

* The schedule for "1st Quarter Skills Day" dated "February 8, February 21, and March 11, 2019" reflected "ED/Mental Health Assessment," but no other information about the content of the training. The sign in sheet for "RN Skills Day" dated 02/21/2019 was signed by Employee 6. However, there was no documentation that reflected restraint and seclusion training and competencies were included in the training and completed by Employee 6, including the specific types of restraints observed available for use in the CAH. The documentation was unclear, incomplete and lacked evidence of annual restraint and seclusion training and competencies completed by Employee 6.

f. Staff training records Employee 7, RN with hire date 09/29/2016 reflected:
* A "[Crisis Prevention Institute]" document reflected the employee "passed" a class on 02/21/2017, but did not reflect any information related to the content of the class.
* A one page "Swank" electronic tracking form reflected the employee completed "Safety Storm: Alpha 2017," "Safety Storm: Beta 2017," "Safety Storm: Gamma 2017," "2017 Acute Nursing Training," and "2017 Annual Training" on 08/09/2017. A hand written note on the form reflected "1/2 [hour] of MH Review." There was no further information related to the content of the training and review.
* A sign in sheet for "RN Skills Meeting," dated 05/30/2018 was signed by Employee 7. A hand written note on the sheet reflected "No agenda given."
* A one page "Swank" electronic tracking form reflected the employee completed "Safety Storm 2018: Beta," "Safety Storm: 2018: Alpha," "Safety Storm: 2018: Gamma," "2018 Annual Training," and "2018 Acute RN and LPN." A hand written note on the form reflected "1/2 [hour] MH Review." There was no further information related to the content of the training and review.
* The documentation contained the same training materials and sign in sheet, signed by Employee 7, for the "Acute Nursing Skills Day" dated 08/20/2018 as identified above.
* A sign in sheet for "Acute RN Skills Day" dated 10/26/2018 was signed by Employee 7. The "Speaker:" section was followed by "...mock code, skills practice...mental health...." A schedule titled "4th Quarter Education/Skills Days - 2018" was attached to the sign in sheet. It reflected "1230-1330...Mental Health - [name]." There was no reference to restraints or seclusion.

* A sign in sheet for "RN Skills Day" dated 02/08/2019 was signed by Employee 7. The "Speaker:" section was followed by "Multiple." A schedule titled "1st Qtr Skills Days" dated "February 8, February 21, and March 11, 2019" was attached to the sign in sheet. It reflected "2:45PM...ED/Mental Health Assessment." There was no further information related to the content of the skills day.

g. Similar findings related to lack of annual restraint and seclusion training and competencies were identified during review of staff training records for the following staff:
* Employee 8, RN with hire date 07/29/2014;
* Employee 9, RN with hire date 09/06/2011; and
* Employee 10, RN with hire date 04/19/2016.

Based on observation, interview, review of medication error documentation, review of emergency drug documentation and review of policies and procedures it was determined that the CAH failed to ensure safe and appropriate storage, handling, control and administration of drugs:
* Medication errors were not investigated to identify causes and prevent recurrence.
* Drugs and biologicals that were available for patient use were expired or otherwise unusable.
* Narcotic and emergency drugs were not managed and controlled to prevent theft, misuse, and tampering.

Findings include:

1. a. The P&P titled "Adverse Event Reporting" dated as last revised "03/2018" was reviewed and included the following:
* "The facility has a risk management process that evaluated and identifies trends that may represent potential or real harm for patients, staff and visitors."
* "Incident Reports are to be completed by any staff having knowledge of any unusual occurrence ... Incidents may include ... medication errors ..."
* "Generally, each manager is responsible for reviewing and investigation incident reports in their department ... Depending on severity of impact and sometimes volume of reports, an incident ... should always be addressed in some fashion by a manager or designee."
* "The facility will, whenever possible ...
- Investigate the event within 48-72 hours with documentation.
- Develop a plan of action ...
- Inform/educate appropriate individuals on the changes.
- Evaluate the effectiveness of the changes."

b. Review of the "Incident and Adverse Events" log for the period June 2018 through June 2019 revealed a total of documented 74 medication errors. The "EventType" was identified as "Medication Event" and the "SubEventType" was identified as "Medication Error." The log did not track what kind of "error" had occurred. For example: wrong drug administered, wrong patient received medication, wrong dose administered, etc. Forty of the medication errors were identified as having occurred in the ED and 33 were in "Acute."

c. Review of medication error documentation reflected that all incidents had not been investigated and action plans implemented that were based on the findings of the investigation to prevent recurrence. Examples include, but are not limited to:

* Incident documentation reflected that on 06/08/2019 a bag of antibiotics that had been hung in a patient room for administration at 0111 was found at approximately 0700 later that morning to have not been started and had not been given as ordered. The only follow-up documented was on 06/12/2019, more than 72 hours after the incident, and reflected "[name] was nurse that hung the med. Will notify [him/her] of the omissions." There was no investigation to attempt to identify how the error occurred to prevent recurrence.

* Incident documentation reflected that on 03/23/2019 a patient received a third bag of IV magnesium in error. The error was discovered when the third bag was nearly infused. A magnesium level was taken and found to have increased from 1.4 to 2.5 from the three bags. The documentation reflected the error resulted in "increased length of stay, temporary harm to person." The only follow-up documentation was on 03/28/2019, five days after the incident, and reflected "will [f/u] with [RN] and also [second RN] to be sure [he/she] had a Provider order for the [magnesium] level." There was no investigation to attempt to identify how the error occurred to prevent recurrence.

* Incident documentation reflected that on 03/18/2019 medication ordered as part of a "Detox Protocol" was omitted and the patient did not receive the ordered medication. The only follow-up documentation was on 03/28/2019, ten days after the error, and reflected "plan f/u with nurse assigned to pt at time order was written and also nurse responsible for 24 h chart check after it as written." It was not clear how that "f/u" would prevent recurrence of the error. There was no plan of action based on findings of an investigation that identified the causes for the error.

* Incident documentation reflected that on 02/22/2019 a patient was administered a narcotic medication at the wrong time. There was no follow-up, investigation or corrective action documentation.

d. During interview with the PD and CNO on 06/19/2019 at 1025 regarding medication errors the PD stated that there was "really no documentation" of investigations of medication errors. He/she stated that the error is "corrected" at the time the error is identified and that is documented on the incident report. The PD stated that he/she did not participate in QA activities "... as much as I should be. I don't remember the last time I went to a meeting." He/she further acknowledged that he/she reported some QA information to the CRM "verbally" and not in writing.

During further interview with the PD on 06/20/2019 at 1130 he/she confirmed that although pharmacy had been conducting some QA activities, the pharmacy had not reported to the QA committee since 2015. The PD stated that he/she reviewed medication errors every day and took immediate action to correct. He/she stated that the number of medication errors were reported at monthly department head meetings but they had no process for systematic evaluation of the errors otherwise.

2. Drugs and biologicals that were available for patient use were expired or otherwise unusable. Examples include:

a. During tour of the respiratory therapy department on 06/18/2019 at 1640 the following observations were made:
* A bottle of Betadine Solution was found to have "[Expired]" on "02/15."
* A pre-filled syringe of .9% Sodium Chloride Injection was found to have "[Expired]" on "1 SEP 2009."

b. During tour of the rehabilitation department on 06/19/2019 at 1650 the following observations were made:
* A bottle of solution was identified as "Acetic Acid 5% Gallipot Lot: 0310270D09" on a hand-made label. There was no other information on the bottle and no manufacturer's label. During interview with the department manager at the time of the tour he/she stated that they no longer had the original manufacturer's container that included other information about the solution including the expiration date.

c. During tour of the wound clinic on 06/19/2019 at 1710 the following observations were made:
* A large tube of Hydrophilic Wound Dressing had "[Expired] 1/2018."
* The expired Hydrophilic Wound Dressing, a bottle of Medline Advanced Wound Care cleanser, a tube of Silvasorb Gel, a container of Medline Skintegrity, a tube of Therahoney Gel and Cyanoacrylate Skin Protectant applicators were observed on the wound cart and counter. Staff present disclosed those items had been brought to the hospital's wound clinic by a drug company representative. Staff stated that they had not received those from the hospital pharmacy or purchasing departments.
* A box of "Granufoam Bridge" dressings was "[Expired] 2/18."
* A box of "Granufoam Small" dressings was "[Expired] 8/18."
* A box of "Granufoam Ag Small" dressings was "[Expired] 9/18."


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3. Narcotic and emergency drugs were not managed and controlled to prevent theft, misuse, and tampering. Examples include:

a. Observations with the CNO on 06/18/2019 at 1500 in ED treatment room 402 revealed the following:
* Two emergency cardiac kits were observed in a locked cupboard. The outside of the kits were labeled with a list of emergency medications that were normally kept inside the kits as follows:
"Epi 1 mg...ASA 81 mg 4 Tabs...Clopidogrel 75 mg...ASA 325 mg...NTG 0.2 mg...NTG 0.4 Tabs...Nitro Bid 2% Ont...Lipitor 40 mg...Heparin 5,000U...Furosemide 100 mg 40 mg...Pantoprazole 40 mg...Famatidine 20 mg...Odansetron 4mg...Atropine 1 mg...Endoxaparin 60 mg...Metoprolol 25mg...Metoprolol 50 mg...Metoprolol 5 mg..."
Both kits had a lid with a snap closure and a blue breakaway lock (seal). However, the snap closures were broken on both kits and the lid was observed to be easily lifted and the container accessed with the lock (seal) remaining intact. The ability to easily access the drugs without breaking the lock (seal) did not ensure drug availability and created the risk of theft, misuse, and tampering. These observations were confirmed with the CNO on 06/18/2019 at 1620.

* A metal box was observed in the same cupboard as above. The box had a red breakaway (lock) with #5106251 on it. The box contained the following narcotic and other emergency medications:
Morphine 10 mg/ml vial, 3 vials
Midazolan (Versed) 2 mg/ml vial, 6 vials
Mepiridine (Demerol) 25 mg/ml, 5 vials
Lorazepam (Ativan) 1 mg Tab, 10 tablets
Ketamine (Ketalar) 500 mg/10ml vial, 1 vial
Fentanyl (Duragesic) 100 mcg/2ml vial, 6 vials

A list of medications on a half sheet of paper with the heading "Emergency Room Controlled Substance List" was taped to the outside of the metal box. The list indicated that the inside of the box contained the following medications:
"Ativan 1 mg Tab"
"Demerol 100mg/ml Injection"
"Fentanyl 100mcg/2ml Injection"
"Morphine 10mg/ml Injection"
"Nubain out [lined through]" followed by "20mg/ml Injection"
"Valium out" followed by "10 mg/2ml Injection"
"Versed out" followed by "10 mg/10ml Injection"
"Stadol [lined through]" followed by "2 mg/2ml Injection"
Undated, unauthenticated hand written entries on the side of the list reflected "RSI Kit" and "Ketamine." Another entry was lined through with a black sharpie and was illegible. The list of medications did not match the contents inside the box or the medications on the "Emergency Department Narcotics Sheet" log. For example, the list of medications taped to the outside of the box reflected that the box contained "Demerol 100mg/ml Injection." However, observations of the inside of the box and review of the "Emergency Department Narcotics Sheet" log reflected the box contained Mepiridine (Demerol) 25 mg/ml, 5 vials. This discrepancy created the risk of staff obtaining and administering the wrong dose of medication. This was confirmed with the CNO on 06/18/2019 at the time of the observations.

A log titled "Emergency Department Narcotics Sheet" dated "June 2019" that was used to verify the medications inside the metal box was reviewed. The log had columns for recording "Date...Patient Name...Physician...Discard/Dose...Narcotic Box Lock #...RN Signature." The log included a list of the same medications that were observed inside the metal box above. The information recorded on the log was unclear, incomplete and inconsistent with the observations of the box. For example: The last entry on the log was dated "6/11" but did not include the year. The "Patient Name" reflected "opened for critical pt (sic) didn't use anything." The name of the patient was not recorded. The column for recording "Physician" was blank. The column for recording "Discard/Dose" was blank. The "Narcotic Box Lock #" was recorded as "6251" and was not 5106251 as observed above.

b. Observations on M/S with the CNO on 06/19/2019 at 1210 revealed the following:
* An emergency crash cart with breakaway lock (seal) #5106230 on the outside of it was observed. The top drawer of the cart had the following emergency drugs inside it: "Calcium Chloride 100 mg/ml...50% Dextrose Injection 25 grams (0.5 g/ml)...8.4% Sodium Bicarbonate Injection 50mEq (1 mEq/mL)...Amiodarone 300 mg Bolus...Epinephrine Injection 1mg/10mL (0.1mg/mL) pre-filled syringe..."

A checklist titled "Lake District Hospital Acute Floor Crash Cart" dated "June 2019" that was used to verify the M/S crash cart breakaway lock (seal) and lock number, was reviewed. The checklist had spaces for recording the "Crash Cart Lock #" each day and staff initials on "Days" and "Nights" to verify that the breakaway lock (seal) was in place. The lock number recorded on the checklist did not match the lock number observed on the cart, and the checklist was incomplete. Examples included but were not limited to:
* The last lock number on the checklist was recorded on 06/18/2019 and it was "6230" and not "5106230" as observed above. There was no documentation that explained the reason for the discrepancy.
* The space on the checklist for recording the lock number and staff initials for "Drawer Lock in placed (sic) [checked]" was blank on 06/05/2019 and 06/06/2019 on "Days;" and 06/13/2019 on "Nights." There was no documentation that explained the reason for the missing checks.

The following P&Ps were provided in response to a request for P&Ps that addressed management of emergency medications:
* "Emergency Medication: Dispensing Medications in the Emergency Department," dated last reviewed 08/13/2018;
* "Floor Stock Control," dated last reviewed 08/13/2018; and
* "Unit Inspections," dated last reviewed 05/21/2019.
Review of the P&Ps reflected no information related to the emergency crash cart checklists, logs, lists, and breakaway lock (seal) processes identified above.

29708


Based on observations, interview, review of event and IC documents for 13 of 13 who experienced infections or IC related events (Patients 19-31), review of policies and procedures and other documentation, it was determined that the hospital failed to ensure that infection prevention policies and procedures had been fully developed and implemented. Procedures and processes to prevent cross-contamination and to ensure infection prevention had not been enforced in the following areas:
* Investigations of patient infections, including SSIs were unclear, incomplete and lacked follow up interventions to prevent reoccurrence.
* Policies and procedures related to sterilizer BI testing in SPD had not been implemented.
* Policies and procedures related to endoscope storage and AER sterilant testing processes had not been developed and implemented in accordance with manufacturer instructions.
* Outpatient chemotherapy services were not included in the CAH's IC program.
* A water-borne pathogens program had not been fully developed and implemented.
* Policies and procedures for the wound care services and clinic had not been developed.
* Hand hygiene products in use were expired.

Findings include:

1. Regarding investigations of patient infections:

a. The P&P titled Infection Surveillance Procedure," dated reviewed 02/15/2018 reflected:
* "The following procedure is to be used to identify healthcare acquired infections in patients and to monitor for possible patterns or potential problems, and to report, investigate and intervene as indicated."
* "Purpose...To determine if interventions can be implemented to prevent or lessen the risk of identified infections...To continuously improve patient outcomes...To identify mandatory or pertinent infections for reporting to Public Health Department..."
* "Targeted and total surveillance will be performed by reviewing monthly facility microbiology reports, Emergency Department admission and discharge records, to identify signs and symptoms on admit and diagnosis at discharge information obtained from patient follow-up calls, physician and surgeon follow-up post-discharge, and data collection during daily clinical huddles."
* "Surgical Site Infections (SSI's) as identified by either targeted or total surveillance are investigated for possible future prevention potential."

b. Review of monthly "Infection Control Report" documentation was unclear, incomplete and patient infections, including SSIs, lacked investigation and follow up actions. Examples included but were not limited to:
* The March 2017 report reflected "...1 symptomatic UTI reported to NHSN not catheter associated" in March 2017. Documentation provided in response to a request for the CAH's investigation of the infection reflected Patient 26 was admitted to the CAH on 03/09/2017 and experienced a UTI on 03/12/2017. The documentation consisted of a NHSN form that included primarily information from the medical record, and copies of the medical record. There was no further documentation that reflected an investigation was conducted following identification of the infection, and no IC follow up actions. This was confirmed during an interview with the IPCH on 06/19/2019 at 1540.

* The May 2017 report reflected "Hospital Acquired Infections by service...Swing Bed...1," and "...1 symptomatic UTI reported to NHSN not catheter associated" in May 2017. Documentation provided in response to a request for the CAH's investigation of the infections reflected:
- Patient 24 was admitted to the CAH on 04/28/2017 and experienced a UTI on 05/01/2017. The documentation consisted of a NHSN form that included primarily information from the medical record, and copies of the medical record.
- Patient 25 was admitted to the CAH on 05/23/2017 and experienced a "Urine System Infection (USI)" on 05/29/2017. The follow up documentation consisted of a NHSN form that included primarily information from the medical record, and copies of the medical record.
There was no further documentation that reflected an investigation was conducted following identification of the infections, and no IC follow up actions. This was confirmed during an interview with the IPCH on 06/19/2019 at 1540.

* The August 2018 report reflected the CAH had one HAI in August 2018. Documentation provided in response to a request for the CAH's investigation of the infection reflected Patient 20 was admitted to the CAH on 08/17/2018, underwent an "Appendix surgery" on 08/17/2018, and experienced a SSI on 08/28/2018. The documentation consisted of a NHSN form that included primarily information from the medical record, and copies of the medical record. There was no further documentation that reflected an investigation was conducted following the SSI, and no follow up actions. There was no further documentation that reflected an investigation was conducted, and no IC follow up actions developed and implemented to prevent similar events. This was confirmed during an interview with the IPCH on 06/19/2019 at 1540.

* The November 2018 report reflected the CAH had one HAI in November 2018. However, documentation provided in response to a request for the CAH's investigation of infections in November 2018 reflected:
- Patient 19 was admitted to the CAH on 11/06/2018 and experienced a SSI following a cesarean section procedure on 11/07/2018. The documentation consisted of a NHSN form that included primarily information from the medical record, and copies of the medical record. There was no further documentation that reflected an investigation was conducted following identification of the infection, and no IC follow up actions developed and implemented to prevent similar events, if appropriate. This was confirmed with the IPCH on 06/19/2019 at 1540.
- Patient 28 underwent a cesarean section procedure on 11/02/2018 and experienced a SSI described as "Organ/Space...endometritis" on 11/10/2018. The documentation consisted of copies of the medical record and a NHSN form. The NHSN form reflected:
The "Date Admitted to Facility:" and "Location:" sections were blank.
The "Infection present at the time of surgery..." section reflected "No."
The "...Readmission to facility where procedure was performed" section was checked.
There was no further documentation that reflected an investigation was conducted following identification of the infection, and no IC follow up actions developed and implemented to prevent similar events, if appropriate. This was confirmed with the IPCH on 06/19/2019 at 1515.
- Similar findings were identified related to Patient 23 who experienced a BSI on 11/28/2018. Review of the investigation documentation reflected it was unclear and incomplete.

Similar findings related to lack of investigation and IC follow up actions were identified during review of monthly "Infection Control Report" documentation for January 2017 related to Patients 21 and 22. Patient 21 was admitted to the CAH on 11/22/2016 and experienced a UTI on 01/24/2017; and Patient 22 was admitted to the CAH on 01/14/2017 and experienced a UTI on 01/24/2017. This was confirmed during an interview with the IPCH on 06/19/2019 at 1540.

Review of patient Event documentation reflected:
* An Event document for Patient 27 was reviewed and reflected "received influenza vaccine on...11/23/18...Pt seen...11/25/18, in ED for injection site redness and swelling. Treated with Keflex for cellulitis...Resulted in increased length of stay, temporary harm to person." The "Initial actions taken" and "Contributing factors" reflected "No Answer." There was no documentation that reflected:
- An investigation was conducted following identification of the infection.

* An Event document for Patient 29 with "Event Date" 05/21/2019 was reviewed. The event was categorized as "IV/CL complication...Phlebitis." The description reflected "[Student nurse] pulled IV due to inflammation. Pt told [LPN] that [he/she] saw white stuff at the top of the IV catheter before it was dc'd. THIS IV HAS BEEN IN PLACE SINCE MAY 11. When I restarted pt IV, [he/she] told me [he/she] cannot move [his/her] left wrist due to pain at wrist since the IV got bad. [His/her] tissue at the left wrist is swollen and inflamed." The "Contributing factors" reflected "...long term IV site." The "Manager's Actions" dated 06/20/2019 at 1210 reflected "5/22-Investigation started..." and 06/20/2019 at 1213 "...investigation and outcome incomplete at this time."

* An Event document for Patient 31 with "Event Date" 01/18/2019 was reviewed. The event was categorized as "IV/CL complication...Extravasation." The description reflected "50 ml of IV contrast extravasated during initial part of CT exam. IV and exam stopped, IV removed heat pack applied. Radiologist and Physician notified. Per Radiologist patient rescheduled same day for 2pm. Patient sent home additional heat pack and prep instructions for exam at 2pm." The "Contributing factors" reflected "Other...Patient stated [he/she] had 'bad veins' due to IV drug use." A handwritten document attached to the Event document reflected "...started IV in Rt AC. Good flash back and flushing - but unable to draw blood back...[name] flushed the 2nd time - good flush. [Name] was in room for injection of 50 ml Omni 350. Pt said it burned a little but did not complain of pain...saw swelling of upper arm-instructed [name] to stop saline going in...took IV out and placed hot pack. Called radiologist who said if [his/her] renal function was good we could proceed. Pt. declined and chose to return...instructed to keep warm towels on arm...." There was no documentation that reflected:
- If applicable IC P&Ps were carried during the procedure.
- The CAH's IP or other applicable IC staff were informed of the event.
- If IC follow up actions were developed and implemented to prevent similar events, if applicable.

* An Event document for Patient 30 with "Event Date" 04/19/2019 was reviewed. The event was categorized as "IV/CL complication...Extravasation." The description reflected "Patient came for CT angio runoff (sic)...Patient was extremely difficult IV start. [RN] attempted one time in left arm and the vein blew. I attempted two times on Right arm and both times the vein blew from hand flush...third attempt was successful on left inner arm...Went to injection contrast and the vein blew while injecting. The patient received 29 cc of contrast in [his/her] arm...warm compress was immediately used and massage of soft tissue..." The "Contributing factors" reflected "No Answer." There was no documentation that reflected:
- If applicable IC P&Ps were carried out during the procedure.
- The CAH's IP or other applicable IC staff were informed of the event.
- If IC follow up actions were needed to prevent similar events.

During an interview with the CNO on 06/20/2019 at 1300, the CNO confirmed there was no further documentation of IC investigations of Events involving Patients 27, 29, 30 and 31.

2. Regarding BI testing in SPD:

a. Observations during tour of SPD on 06/20/2019 with the SS NM and SPT revealed:

* At 1620, a steam sterilizer used to sterilize surgical instruments was observed. The SPT stated that the sterilizer was evaluated for sterilizing conditions by using a combination of indicator testing including BIs.

* At 1635, in the surgical instrument storage area, a stainless steel container was observed with the SS NM and SPT. The label on the outside of the container reflected the container had been sterilized on 05/22/2019, the sterilizer load number was 052204, and the contents inside the container was "Lap Chole Set #2." During an interview with staff present at the time of the observation, it was stated the container had laparoscopic surgical instruments inside it.

* Review of BI log records with the SPT on 06/20/2019 at 1640 reflected no BI test documentation for sterilizer load number 052204 on 05/22/2019 that contained laparoscopic surgical instruments. This was confirmed during an interview with the SPT on 06/20/2019 at the time of the BI log records review. The SPT stated a BI test should be completed and documented for every load of surgical instruments that are sterilized and he/she acknowledged that a BI test was not documented for load number 052204.

b. The P&P titled "Instructions for Use of Biological Indicator Tests," dated last reviewed "6/20/19" was reviewed and reflected:
* "The test comes in a pack. The pack is...placed into the sterilizer...After the pack has been through the sterilization process, it is removed and allowed to cool, before being placed in the incubator...A Control, a non-processed activated test, must be used each day that tests are placed in the incubator...Both the test and control are examined at 4 minutes and 24 minutes (sic) documented on the "Attest 3M Biological Monitoring System" log, in computer."
* "Biological monitoring will be completed each AM Mon through Fri except holidays minimum. And with each load."

3. Regarding endoscope processes:

a. Observations during tour of SPD on 06/20/2019 with the SPT revealed:

* At 1645, in the endoscope reprocessing room, a Steris AER and an open container of "Verify Chemical Indicator For 540 Sterilant" strips were observed. The SPT stated the AER was used to reprocess endoscopes and the indicator strips were used to check the sterilant that was used inside the AER. The container of indicator strips reflected they were "For routine monitoring of STERIS automated liquid chemical sterilant processing system that employ S40 Sterilant Concentrate." The space on the container for recording the "Date Opened" was blank and there was no other information that reflected when it was opened and therefore the integrity of the strips could not be assured. This was confirmed with the SPT at the time of the observation.

* At 1700, an endoscope storage closet with approximately seven endoscopes hanging vertically inside it was observed. Several endoscope accessories/items were observed directly below the scopes on the bottom of the closet creating the possibility of exposing the accessories/items to moisture or other contaminants. Inside the closet "Stanly Inner Space" manufacturer's instructions for the closet were observed posted. The instructions reflected "Ventilated Scope Cabinets...For proper scope storage, lift the video head above the holder and place the umbilical cord in the formed channel. Rest the endoscope as shown." This was followed by a picture of two endoscopes hanging vertically from prongs at the top of the closet. There was no information in the posted manufacturer's instructions that permitted endoscope parts/items to be stored on the bottom of the closet.

b. The P&P titled "Endoscope Cleaning Procedure," dated last revised 02/06/2019 was reviewed and reflected:
* The only reference to endoscope storage was "Scope is now ready to be stored in drying cabinet." There was no information that reflected consideration of manufacturer's instructions for the storage closet, endoscopes or endoscope accessories. During an interview with the SS NM at the time of the observations, the SS NM stated the CAH had no P&Ps for endoscope storage, including for the endoscope storage closet.

4. Regarding OP chemotherapy:

a. During tour of OP Chemotherapy with the CNO and on 06/19/2019 at 1115, the following observations were made:
* The area was located in "Chemo/Bio" Room 117.
* Two recliners were observed in the room for the provision of chemotherapy services.

b. The P&P titled "Outpatient Infusion Procedure," dated "Date Issued" 12/14/2016, provided in response to a request for the CAH's scope of service document for OP Chemotherapy was reviewed and reflected:
* "Lake District Hospital will coordinate the following type of outpatients...IV antibiotic therapy...IM antibiotic therapy...Medi Port Maintenance and Flushing...PICC Line Maintenance...Blood Products...Specialty Injections...Biologic infusion therapy...Chemotherapy...IV Fluids...IV Steroids...SQ infusion therapy...Misc IV infusion therapy...Wound Care...Pain Management...TPN...Enteral Nutrition..."
* "Performed in the Emergency Department...IV antibiotic therapy...IM antibiotic therapy...Medi Port Maintenance and therapy...PICC Line maintenance...Blood products...IV fluids...IV steroids...Specialty injections...SQ infusion therapy...Misc IV infusion therapy...Wound Care...Pain Management...TPN...Enteral Nutrition..."
* "Performed by the Surgery Department in the Infusion Room...Biologic infusion therapy...Chemotherapy"

Review of the CAH's "Infection Prevention Risk Analysis/Assessment 2018," the undated "Infection Control Plan," and the IC "Quality Improvement Report" dated 04/17/2019 reflected no reference to OP Chemotherapy.

During an interview with the CEO and Chemo NM on 06/19/2019 at 1115, they stated OP Chemotherapy services were provided to 2-3 patients per week and included "low level" chemo infusions and injections, Remicade infusions, and Ocrevus infusions. The CNO stated no IC risk assessment had been conducted, no IC indicators had been established, and no quality measures had been determined and incorporated into the hospital's quality program relative to the CAH's OP Chemotherapy services. The CNO stated "We don't do anything."

5. Review of the CAH's waterborne pathogen program documentation reflected it was unclear, incomplete and lacked evidence of an organized waterborne pathogens program and follow-up actions. Examples included but were not limited to the following:

a. Review of the "Water Management Program Team Meeting" minutes dated 05/14/2018 reflected:
* "The purpose of the meeting was to establish the Water Management Program team, and determine what actions needed to be taken next."
* "It was determined that approximately 20 tests would need to be taken each quarter. It was decided that each quarterly testing would focus on a particular area of the hospital. The point of entry will be tested every quarter. One test will be taken from each of the outlying facilities." There was no information that specified the testing protocols and acceptable ranges for control measures, and how those would be carried out.
* "The team acknowledged they would be the ongoing members, and agreed to meeting quarterly..." Although the meeting minutes reflected the team would meet quarterly, documentation of the next Water Management Program team meeting was not until 04/18/2019, nearly a year later. This was confirmed during an interview with the PAA on 06/20/2019 at 1220.
* "The team discussed the need to flush water lines that were not used on a regular basis. There are showers, sinks and toilets that are not used regularly. These areas need to be flushed at least once per week...[CNO] stated [he/she] would have a night CNA go through the Acute area once per week and flush all toilets, and run all faucets and showers that had not been used during the week...will have have someone run all sinks and flush all toilets in building C on a weekly basis until the building is occupied...Staff will be notified in buildings A and B of the process. Environmental Services will run all the faucets in conference rooms once per week...[PAA] will produce a log for tracking this activity." Review of water line flush logs for the past year reflected the documentation was unclear and incomplete. Examples included but were not limited to the following:
- The "Faucet and Toilet Flushing Log - West Wing," dated 05/06/2019 was reviewed. The instructions on the log reflected "To be completed weekly in unoccupied areas. Run faucets and showers for 2 minutes. Turn hot and cold on full. Run faucets with pivot handles at center position. Flush toilet." The log included a list of 11 rooms with toilets and/or sinks to be run/flushed with spaces for recording date and initials. There was no information on the log that reflected if the water lines in any of the 11 rooms had or had not been used on a regular basis. For Room 316 the log reflected "Locked" for "toilet" and "sink" and was not initialed to indicate a water flush had been completed. There was no information that reflected what was meant by "Locked." There was no documentation that reflected whether Room 316 toilet and sink water were flushed or not flushed. Similar findings were identified related to lack of water flush for Room 316 on logs dated 03/04/2019, 03/11/2019, 03/27/2019, 04/01/2019, 04/08/2019, 04/15/2019, 04/22/2019, 04/29/2019, and 05/15/2019.
- The "Faucet and Toilet Flushing Log - West Wing" dated 11/21/2019 was reviewed. The log included the same instructions as above." The log included 3 rooms/areas to be run/flushed with spaces for recording date and initials. Those were "Clean Utility," "Kitchen Sink," and "Soiled Utility." The "Soiled Utility" area on the log was scribbled over and "324" was handwritten next to it. There was no information that reflected why soiled utility was scribbled over and "324" was written in. The log lacked documentation that the soiled utility room water flush was completed or the water line had been regularly used and therefore the water flush was not needed. Similar findings were identified related to scribbled over entries and lack of documentation of West Wing soiled utility room water flushes for 33 out of 33 weekly log records dated between 06/04/2018 through 01/14/2019.
- Review of log records reflected no documentation that reflected faucets were run in conference rooms as planned.

b. A "Hazard Analysis" document dated copyright "2019" was provided by the PAA. The PAA stated the document was the CAH's waterborne pathogen risk assessment. The document was reviewed and reflected a list of 14 "Water Systems," of which 10 were identified as "Significant potential for Legionella growth and transmission." Those included:
* Public water main taps
* Water supply points of building entries
* Central domestic water heating systems
* Buildings with water heaters at or near points of use
* Bottled water dispensers
* Points of domestic water use
* Carbon filters on lines supplying water to ice machines.
* Filters on domestic cold or hot water supply
* Softeners providing soft water for domestic hot or cold water systems
* Decorative fountains

c. Review of "Control Measures" and "Monitoring" documentation for the water system risks the CAH had identified reflected they were not carried out in all cases. Examples included:
* The "Control Measures" identified for ice machines reflected:
* "Control Measure: Clean and disinfect ice machines as often as needed, at least twice yearly."
* "Monitoring: Yearly update list of all ice machines, identifying them by number and location, and ensure cleaning is scheduled. Log cleaning dates."
* "Frequency of compliance verification: Every 180 days"
* "Limits: Must be cleaned per manufacturer's instructions or CDC recommendations, whichever is more stringent, as often as needed, at least twice yearly."

A list of CAH ice machines provided reflected ice machines were located in the following areas/departments:
* "ER Nourish"
* "Acute Nourish"
* "Strieby Conf Rm"
* "Cafeteria"
* "Staff Breakroom"
* "Rehab"
* "OR"
* "Kitchen"
* "OB"

Ice machine cleaning records provided were reviewed and reflected ice machines were not cleaned and disinfected at least twice yearly in accordance with the established monitoring and control measures. For example, no cleaning/disinfection records were provided for ice machines in the following CAH areas/departments:
* "Strieby Conf Rm"
* "Cafeteria"
* "Rehab"
* "Kitchen"
* "OB"
This was confirmed during an interview with the PAA on 06/20/2019 at 1310.

d. The "Control Measures" identified for water dispensers reflected:
* "Control Measure: Store and use dispensers and bottles in non-dusty, cool, and well ventilated places, away from sunlight and other heat sources."
* "Monitoring: Inspect locations quarterly."
* "Frequency of compliance verification: Every 3 Months"
* "Limits: Must be located in clean and cool place."
* "Due Date for Next Verification or Performance: 4/21/2019"

During an interview with the PAA on 06/20/2019 at 1220, the PAA revealed:
* Water dispensers were located in the cafeteria, employee break room, Strieby conference room, M/S nutrition room, and "Lake Specialty Clinic."
* The CAH's waterborne pathogens program did not include a list of locations of water dispensers.
* The PAA confirmed the due date for verification of the control measures was 04/21/2019 and therefore was over due.

e. The "Control Measures" identified for "decorative fountains--draining when out of service" reflected:
* "Control Measure: Drain fountains to be out of service for more than 3 days."
* "Monitoring: Record date out of service and date drained."
* "Frequency of compliance verification: Every 3 Months"
* "Limits: Three days maximum before draining."
* "Due Date for Next Verification or Performance: 3/28/2019"
* "Status: Overdue"

On 06/19/2019 at 1730 a four tier decorative water fountain was observed in the courtyard outside the conference room. Each tier of the fountain was appeared to be dry with a visible water line, and dry leaves and other debris inside each of the tiers. A water hose or pipe was observed protruding from the surface of the top tier.

Review of an undated "Potable Flow Diagram" of the CAH campus reflected the decorative water fountain observed above was not included on the diagram.

Review of a list of "Decorative (Ornamental) Fountains" reflected only one decorative fountain described as "Decorative Fountain...Outdoor...Location Description: Between Bldg B and C."

During an interview with the PAA on 06/20/2019 at 1220, the PAA revealed:
* The decorative fountain located in the courtyard was out of service.
* There was no documentation that reflected the date the fountain was taken out of service.
* There was no documentation that reflected that the fountain had been drained.
* The list of "Decorative (ornamental) Fountains" above did not include the fountain observed in the courtyard above.
* The "Potable Flow Diagram" of the CAH campus did not include the decorative water fountain observed in the courtyard above.

f. The "Control Measures" identified for "Domestic Water System Maintenance...stagnation, dead legs, abandoned piping" reflected:
* "Control Measure: Remove or routinely flush accessible piping that is no longer used."
* "Monitoring: Conduct survey for abandoned piping yearly and ensure all applicable piping is scheduled for removal or monthly flushing."
* "Frequency of compliance verification: Every 365 days"
* "Limits: Remove easily accessible dead piping...Or, monthly flush the dead piping for 30 seconds or long enough to remove 10 pipe volumes, whichever is longer."
* "Date Compliance Last Verified: 4/2/2018"
* "Due Date for Next Verification or Performance: 4/2/2019"
* "Status" Overdue"

During an interview with the PAA on 06/20/2019 at 1220, the PAA stated there was no documentation that reflected if the CAH's water system had stagnation, dead legs, or abandoned piping and if so, corrective actions carried out. The PAA confirmed the due date for conducting a survey for abandoned piping was due on 04/02/2019 and therefore was overdue.

g. The "Control Measures" identified for "Domestic Water Shutdowns and Incidents" reflected:
* "Control Measure: Implement appropriate Legionella risk reduction measures in plumbing systems during shutdowns and temporary building area closures and in response to incidents such as discolored water at several outlets, water main breaks, water pressure shock, and boil water advisories."
* "Monitoring: Conduct training at least once yearly. Record procedures implemented per incident including dates and times, flush data, and disinfectant levels as applicable."
* "Frequency of control measure task: Every 365 days...Training per year. Procedures per incident."
* "Frequency of compliance verification: Every 1 years (sic)"
* "Limits: Must be prepared to respond quickly and appropriately. Yearly training and planning for each incident must include a discussion of...(a) factors such as susceptibility of occupants, duration of shutdown, portion of system shut down, systems (e.g. hot, cold, or both) affected, and potential water pressure shock, (b) facility-specific options based on drainability of shutdown portion, disinfection systems or taps available, disinfection regulations, and (c) need for advice from Legionella specialist."

During an interview with the CNO on 06/20/2019 at 1310, the CNO stated no staff training related to water shutdowns and incidents had been done.

h. The P&P titled "Water Management Program," dated last revised 04/09/2019 was reviewed and reflected:
* "A water management plan will be in place to conduct and track testing and treatment of Lake District affiliated facilities' water systems...The plan is governed by committee and carried out by committee members and their departments...The Water Management Plan Committee will meet annually to review water testing results, policy, and changes in governmental mandates..."
* "A daily operation log and maintenance manual is to be maintained by Plant Operations. Sampling of water from designated system locations is to be conducted quarterly by a third party technician under the supervision of Plant Operations. Sampling test results will be logged by Plant Operations. Records on repairs, alterations, operating terms, monitoring, disinfection and inspections of water systems are to be recorded by Plant Operations." The P&P was not fully developed as it did not clearly reflect the CAH's water management plans and documentation requirements including but not limited to the following:
- The P&P did not include a facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens could grow and spread in the facility's water system.
- The P&P did not specify testing protocols, acceptable ranges for control measures, and testing locations.
- The P&P did not ensure documentation of the results of testing and corrective actions taken when control limits were not maintained.
- The P&P did not include staff training requirements.

6. Refer to the deficiency cited at Tag C271 that reflects the findings related to the lack of written policies and procedures for the provision of wound care clinic services rendered by RNs and PTs.

7. Hand hygiene products in use were expired:

a. During tour of the imaging department on 06/18/2019 at approximately 1250 the following observation was made in the DEXA Scan room:
* A bottle of Purell hand sanitizer was observed to be "[Expired] 03/2019."

b. During tour of the rehabilitation and wound care departments on 06/19/2019 at approximately 1700 the following observations were made:
* A bottle of Purell hand sanitizer was observed to be "[Expired] 02/2017."
* A container of Endure hand soap above a sink was observed to be expired "9/18."
* A bottle of "Chloroxyenol 3% Surgical Hand Scrub" was observed to be expired "7/18."

Based on interview and review of the list of the services furnished under arrangement or agreement 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 included:

1. An untitled and undated list of contracted services was provided and reviewed. The document contained three items:
* "Pharmacy Amerisource Bergan - Pharmacy Health Solutions."
* "Radiology reads Central Oregon Radiology Associates"
* "Pathology Central Oregon Pathology"

There were no other services listed and there was no other information provided.

2. During interview with the CNO on 06/18/2019 at 1500 he/she confirmed that the list was not complete and that other services were provided under contract or arrangement that included:
* Biomedical equipment PMs.
* Individual ED physicians.
* Hazardous waste management and disposal services.

3. During interview with the laboratory manager on 06/18/2019 beginning at 1540 he/she stated that the laboratory used other services that were provided under contract or arrangement that included:
* Quest Reference Laboratory for numerous tests not within LDH's capabilities.
* Precision Instruments for microscope PMs.
* American Red Cross for blood.

Based on interview and review of QA/QI documentation it was determined that the CAH failed to develop and implement policies and procedures to ensure that services provided under contract, arrangement or agreement were furnished in a manner that enabled the CAH to comply with the COPs. There was no process for the evaluation of services provided under contract, arrangement or agreement and those services had not been evaluated.

Findings include:

1. Refer to the deficiency cited at Tags C336 and C337 that reflects the lack of QA/QI documentation for services provided under contracts or arrangements.

2. There was no other documentation provided to reflect that the CAH's contracted services had been evaluated.

3. This finding was reviewed with the CEO on 06/20/2019 at 1730 and no additional information was provided.

Based on interview, review of program evaluation and QA/QI documentation and review of policies and procedures it was determined that the CAH failed to develop and implement an effective periodic evaluation and quality assurance program that ensured the provision of safe and appropriate care and services in all areas of its operations, including compliance with applicable Federal and State laws and regulations and rules that applied to the CAH.

Findings include:

This Condition-level deficiency reflects the CAH's limited capacity to provide safe and appropriate care and services.

Findings include:

1. Refer to the Standard-level deficiencies cited at Tags C331, C336 and C337 under this Condition of Participation that reflect the CAH's failures to ensure it evaluated its programs and services at least annually and included an effective quality assurance program.

Based on interview, review of program evaluation documentation and review of policies and procedures it was determined that the CAH failed to develop and implement an effective periodic evaluation and quality assurance program that ensured the provision of safe and appropriate care and services in all areas of its operations, including compliance with applicable Federal and State laws and regulations and rules that applied to the CAH.

Findings include:

1. Review of documentation of annual program evaluations since the last Medicare recertification survey in July 2015 reflected that the only complete evaluation was a 26-page document titled "Critical Access Hospital (CAH) Program Evaluation Report" for "Reporting Period: January 1 - December 31. 2017."

2. A two-page document titled "Annual Critical Access Hospital Program Review December 19, 2018" did not clearly reflect the elements of a program evaluation for 2018. For example:
* It reflected that in preparation for the meeting a staff person had "compiled a draft LHD Critical Access Hospital Program Evaluation Report."
* It reflected "The 2017 Emergency Department Volume was reviewed and the transfer data was discussed."
* It reflected "The final Evaluation report will be posted to the website upon completion."
* The 2017 evaluation referenced in Finding 1 above was attached to the document.

The document did not contain the CAH's statistics, evidence of review results of its policies and procedures, evidence of review of QA/QI activity results, and the evaluation of its total program.

3. During interview with the CEO's administrative assistant on 06/18/2019 at 1210 he/she confirmed that lack of annual program evaluation and stated that the 2018 evaluation had not been completed as of the date of this survey.

4. Refer to the deficiencies cited at Tags C150, C153, C221, C271, C276, C278 and C292 that reflect the failure of the CAH to evaluate the care and services provided as part of is program evaluation.

Based on interview, review of QA/QI documentation and review of policies and procedures it was determined that the CAH failed to ensure its QA program was fully developed, implemented, effective and included evaluation of all patient care services and other services affecting patient health and safety.

Findings include:

1. The P&P titled "Quality Improvement Policy" dated as last revised 02/01/2017 and due for its next review on 01/23/2019 was reviewed and included the following:
* "Quality and Patient Safety Committee ... This committee meets at least quarterly to evaluate the Processes and Outcomes of quality improvement activities within the reporting department. The evaluation should include assessing the quality improvement activities and recommending methods of improvement."
* "Evaluate and assess the effectiveness of the quality improvement program to ensure that patient care services affecting patient health and safety are evaluated as a part of the program. These evaluations may include but are not limited to: Contractual Services: ... Pharmacy. Lake Health District provided services: ... anesthesia, behavioral health ... cardiopulmonary, clinics, diagnostic imaging, dietary, ... emergency department, health information and management services, ... housekeeping, infection prevention ... laboratory, nursing services, obstetrics, pulmonary rehab, ... rehab, surgery, sleep lab and swing bed program."
* "Managers will: ... Report on the specific indicators quarterly to the Quality and Patient Safety Committee in the form of written reports ... Identify and analyze problems and opportunities, take appropriate actions or make process changes. Monitor any changes ... Promote development of standards of care and criteria to objectively measure the quality and safety of care/service rendered ... Evaluate the performance of clinically contracted services and report the results of evaluation to the QPSC."

2. Manuals that contained the quarterly QA/QI committee meeting minutes and attachments for 2015 to 2019 were reviewed and included the following:
* Pharmacy (a contracted service) - No reports.
* Chemotherapy - No reports.
* Infusion - No reports.
* Wound Care - No reports.
* Swing Bed - No reports.
* Clinics - No reports.
* Pulmonary Rehabilitation - No reports.
* DME - No reports.
* Risk - No reports since July 2016
* Rehabilitation - No reports since October 2017.
* Laboratory (with multiple contracted services) - Only reports submitted April 2017, July 2017 and April 2018.
* Anesthesia - No reports since January 2018.
* Cardiopulmonary - No reports since April 2018
* Sterile Processing - No reports since July 2018.
* Surgery- No reports between July 2018 and April 2019.
* EVS - No reports between January 2018 and January 2019.
* "Acute" - No reports between July 2018 and January 2019.

3. a. "Quality Improvement and Patient Safety Meeting Minutes" for 1st quarter of 2019 reflected that the following departments were not represented and/or did not provide a report:
* Cardiopulmonary
* Dietary
* EVS
* ED
* Infection Control
* Laboratory (with multiple contracted services)
* OR
* PACU
* Pharmacy (a contracted service)
* Radiology
* Rehabilitation
* Sleep Lab
* Sterile Processing
* Wellness Clinic

b. "Quality Improvement and Patient Safety Meeting Minutes" for 4th quarter of 2018 reflected that the following departments were not represented and/or did not provide a report:
* Anesthesia
* Cardiopulmonary
* Laboratory
* OR
* PACU
* Pharmacy
* Radiology
* Rehabilitation
* Sleep Lab
* Sterile Processing
* Wellness Clinic

c. "Quality Improvement and Patient Safety Meeting Minutes" for 3rd quarter of 2018 reflected that the following departments were not represented and/or did not provide a report:
* Cardiopulmonary
* Laboratory
* Medical Records
* Pharmacy
* Radiology
* Sleep Lab
* Sterile Processing
* Wellness Clinic

4. The "Quality Improvement and Patient Safety Meeting Minutes" reflected that not all services provided by the CAH that impacted patient health and safety had been included in the program. Examples include: Equipment PM and contracted Bio-medical services, contracted hazardous waste and disposal services.

5. Refer to the deficiencies cited at Tags C150, C153, C221, C271, C276, C278 and C292 that reflect that the QA program was not effective to evaluate the care and services provided, identify areas of non-compliance and opportunities for improvement, and implement effective action plans.

Based on interview, review of QA/QI documentation and review of policies and procedures it was determined that the CAH failed to ensure its QA program was fully developed, implemented, effective and included evaluation of all patient care services and other services affecting patient health and safety.

Findings include:

1. Refer to the deficiency cited at Tag C336 that reflects the QA/QI program did not include all patient care services and other services affecting patient health and safety provided by the CAH.