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Based on records reviewed and interviews, the Condition of Participation (CoP): Governing Body was not met as evidenced by the hospital's Governing Body's failure to ensure a system was in place to verify assessment and consultation services, from a crisis agency, were furnished by individuals determined to meet minimum qualification that were determined by the hospital's Governing Body. In addition, the hospital's Governing Body failed to ensure that there was a system in place to evaluate the services provided in 3 out of 5 randomly selected contracts (Contract #1, #2, and #3).

Findings:

1. During the review of 10 patient records in the Emergency Department (ED), it was noted that the hospital utilized Crisis Agency #1 to provide psychiatric assessments to three ED patients reviewed (ED Patient #3, #4, and #8). The "Crisis Assessment" included demographic information, a description of the presenting problem, information obtained during the interview with the patient, an assessment summary, and a risk/lethality assessment. One of the records (ED Patient #8) indicated the crisis assessment was completed by an individual who was a Mental Health Rehabilitation Technician/Crisis Service Provider (MHRT/CSP). The other two records (ED Patient #3 and #4) indicated the assessment was completed by a specific crisis worker; however, the crisis worker's credentials/title were not included in the assessment documentation.

On 11/6/18 at 8:30 AM, during the review of ED Patient #3's record, the Registered Nurse (RN) - Regional ED Director was asked about the qualifications of the individual who conducted the crisis assessment. She indicated that she did not know the individual's qualifications but would find out. At 8:45 AM, she indicated that she assumed that human resources looks at the credentials of the crisis workers.

On 11/7/18 at 8:03 AM, the Physician Director of the ED was interviewed via phone. She was asked what the role of the crisis worker was. She indicated that they would look for available beds for patients; they have the ability to have longer conversations with patients to obtain a more in-depth history; the staff's background is social work; they add an extra layer to the assessment process; the physicians "rely" on the opinion of the crisis worker; the crisis worker will contact the Psychiatrist to discuss the patient; the crisis workers are not members of the medical staff; they are all trained as professional social workers; and she was not sure where their credentials would be and did not know the credentials of the crisis workers.

On 11/7/18 at 10:52 AM, the RN - Regional ED Director gave the surveyor a list of the crisis workers who provided services at the hospital. This list contained the names of 11 crisis workers. The credential column indicated that all staff were MHRT/CSPs; one staff's credentials also indicated the individual was a Licensed Social Worker; one staff's credentials also indicated the individual was a Licensed Clinical Social Worker; and one staff's credentials also indicated the individual was a Licensed Clinical Professional Counselor. It was noted that the credentials of the two crisis workers who provided crisis assessments to ED Patients #3, #4, and #8 were MHRT/CSP only.

A designation of MHRT/CSP indicates the individual has completed a program recognized in the State of Maine only. The MHRT/CSP Certification applies to MaineCare (Medicaid) "other qualified mental health professionals" providing services to adults, excluding residential services. This includes providers of community support services, case management services, intensive case management services, assertive community treatment, and day support services as outlined in Chapter II of the MaineCare Benefits Manual, Section 17.

On 11/7/18 at 11:24 AM, the Crisis Agency Manager was interviewed. She verified that the list of crisis workers given to the surveyor was accurate and she verified the credentials of the staff.

The surveyor had requested and reviewed the contract between the hospital and the Crisis Agency. The contract, given to the surveyor, did not indicate the qualifications of the crisis workers who would be providing services in the ED.

On 11/8/18 at 8:45 AM, the President and Chief Executive Officer (CEO) were interviewed. When asked if the Governing Body had determined the qualifications of the crisis workers, the CEO indicated he did not believe that the board of trustees determined the crisis worker's qualifications; the qualifications of crisis workers were maintained by the Maine Department of Health; and the hospital had deferred to the provider of the service (Crisis Agency #1) to ensure staff were qualified; and he indicated that he expected that the LCSWs were credentialed by the state.

2. Standard: §482.12(e) Contracted Services also known as A-0083 - Based on contract reviews and interviews, the governing body failed to ensure that there was a system in place to evaluate the services provided in 3 out of 5 randomly selected contracts (Contract #1, #2, and #3). Please see A-0083 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on contract reviews and interviews, the Governing Body failed to ensure that there was a system in place to evaluate the services provided in 3 out of 5 randomly selected contracts (Contract #1, #2, and #3).

Findings:

The hospital's "Contract Review, Approval and Signing" policy, approved 10/18/2017 and reviewed by the Governing Body on 3/20/2018, indicated, "Any agreement with an organization, group, agency or individual for direct or indirect patient services or personnel to be provided for the benefit of CHA's [Coastal Healthcare Alliance] patients must subject to review by CHA's Quality Assurance program."

1. A review of Contract #1, dated 11/02/2017, was conducted and it was noted. This contract involved "HVAC Control Services-Automation". Contract #1 indicated "Through implementation of our Quality Assurances process, [Contract #1] will ensure that our delivered services are of the highest quality. We will meet with you to discuss our performance and your satisfaction with the quality of service that is being provided under your [Contract #1] agreement. We will discuss the performance of your systems, your facility, and make recommendations for improvements."

On 11/07/2018 at 1:30 PM, the Director of Maintenance was interviewed, via phone, and he confirmed that there was no quality assurance program review process in place for the services provided by Contract #1.

2. A review of Contract #2, dated 7/09/2017, was conducted and it was noted that the contract did not include a quality assurance program review process. This contract involved the provision of of health services by health care providers.

On 11/07/2018 at 12:40 PM, the Director of Quality Risk and Safety was interviewed. She provided the "Contract Review, Approval and Signing" policy stating this policy was created in part because the hospital had identified, in October 2017, that there was a problem related to contracts not addressing the appropriate quality assurance review process. She concluded by stating that they haven't been able to address all the contracts yet due to the large number of them. She confirmed that this contract, that involved the provision of health services, had not been reviewed as of 11/7/18 and that there was no quality assurance process established yet.

3. A review of Contract #3 was conducted and it was noted that the contract did not include a quality assurance program review process. Contract #3's company provided cleaning services to seven areas of the hospital (the Neurology Department; the Surgery and Wound Healing Center; the Ear Nose and Throat/Dr. Chamberlain area; the Infectious Disease area; the Internal Medicine area; the Surgical Skin Center; and the Diabetes and Nutrition Center).

On 11/07/2018 at 1:15 PM, during a telephone interview, the Director of Environmental Services confirmed that there is no quality assurance program review process in place for Contract #3.

Based on records reviewed and interviews, the Condition of Participation (CoP) for Patient Rights was not met as evidenced by the hospital's failure to ensure each patient presenting to the Emergency Department (ED) was informed of his/her rights in advance of care for 3 of 10 sampled ED patients (ED Patient #1, ED Patient #3, and ED Patient #9) and the hospital's failure to ensure patients have the right to privacy in 18 rooms that can be monitored via camera on the Medical Surgical units (9 on Med-Surg North and 9 on Med-Surg South). At one point during the survey, 6 of the 18 rooms on the Med-Surg units were occupied by patients.

Findings:

1. Standard: §482.13(a)(1) Patient Rights: Notice of Rights also known as A-0117 - Based on interviews and record reviews, the hospital failed to ensure each patient presenting to the Emergency Department (ED) was informed of his/her rights in advance of care for 3 of 10 sampled ED patients (ED Patient #1, ED Patient #3, and ED Patient #9). Please see A-0117 for details.

2. Standard: §482.13(c)(1) Patient Rights: Personal Privacy also known as A-0143 - Based on observations, interviews, and document review, the hospital failed to ensure patients have the right to privacy in 18 rooms that can be monitored via camera on the Medical Surgical units (9 on Med-Surg North and 9 on Med-Surg South). At one point during the survey, six of the room on the Med-Surg units were occupied by patients. Please see A-0143 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on interviews and record reviews, the hospital failed to ensure each patient presenting to the Emergency Department (ED) was informed of his/her rights in advance of care for 3 of 10 sampled ED patients (ED Patient #1, ED Patient #3, and ED Patient #9).

Findings:

On 11/6/18 at 8:46 AM, Registration Staff #1, in the presence of the Regional ER Director, stated that patient rights was not discussed and documented every time the patient presented to the ED.

On 11/7/18 at 10:27 AM, the Director of Patient Access stated that patients were supposed to be offered information about patient rights every time they presented to the hospital and this should be documented.

A review of ten records of patients who presented to the ED between 8/5/18 and 10/22/18 was conducted to determine if the patient or patient's representative was informed of the patient's rights prior to care whenever possible. The review results were as follows:

1. ED Patient #1 presented to the ED on 8/5/18. The "Patient Rights - Outpatient Pen Bay" section of the "document" list, dated 5/10/18, indicated "patient refused". There was no evidence that the patient or his/her representative was informed of his/her rights on 8/5/18 when he/she presented to the ED.

On 11/7/18 at 11:16 AM, the Director of Patient Access confirmed there was no evidence that this patient or his/her representative was offered a copy of the patient rights during the 8/5/18 presentation to the ED.

2. ED Patient #3 presented to the ED on 9/24/18. The "Patient Rights - Outpatient Pen Bay" section of the "document" list, dated 8/14/18, indicated "patient refused". There was no evidence that the patient or his/her representative was informed of his/her rights on 9/24/18 when he/she presented to the ED.

On 11/7/18 at 11:21 AM, the Director of Patient Access confirmed there was no evidence that this patient or his/her representative was offered a copy of the patient rights during the 9/24/18 presentation to the ED.

3. ED Patient #9 presented to the ED on 10/8/18. The "Patient Rights - Outpatient Pen Bay" section of the "document" list, dated 9/27/18, indicated "patient refused". There was no evidence that the patient's representative was informed of his/her rights on 10/8/18 when he/she presented to the ED.

On 11/7/18 at 11:20 AM, the Director of Patient Access confirmed there was no evidence that this patient's representative was offered a copy of the patient rights during the 9/27/18 presentation to the ED.

Based on observations, interviews, and document review, the hospital failed to ensure patients have the right to privacy in 18 rooms that can be monitored via camera on the Medical Surgical units (9 on Med-Surg North and 9 on Med-Surg South). At one point during the survey, six of the rooms on the Med-Surg units were occupied by patients.

Findings:

On 11/5/18 at 12:50 PM, the surveyor and the Outpatient and Speciality Services Quality Specialist both observed two computer monitor screens, in Medical/Surgical South Nursing Station, that displayed 18 patient rooms of which four of the rooms had patients in them. At that time, the Nursing Station was not occupied by staff and the monitors could be viewed by anyone who came into the Nursing Station.

On 11/5/18 at 1:00 PM, the Special Care Unit (SCU) Registered Nurse (RN) stated that those monitors should be off unless the Nursing Station was occupied. The SCU RN accompanied the surveyor to the Medical/Surgical South Nursing Station and shut off the monitors. She again stated that those monitors should have been shut down if the Nursing Station was not occupied.

On 11/5/18 at 1:20 PM, Patient #1 in Room #47, was interviewed. When asked if he/she knew there was a camera in his/her room, he/she stated no.

On 11/6/18 at 8:40 AM, an interview was conducted with the hospital Regional Privacy Officer. When asked how many rooms had cameras, she stated 15 rooms and a few rooms in the Emergency Department (ED). When asked what the criteria was for who was assigned to rooms with cameras, she stated safety, fall risk, and dementia were the criteria. She added that nothing was recorded with those cameras, it was only live feed. She confirmed that those monitors on Medical/Surgical South Nursing Station should have definitely been shut off when the Nursing Station was unoccupied. She added that the cameras observed being on, in the unoccupied nursing station, should never have happened. The Privacy Officer was asked if patients were aware that there was a camera in their room and she stated that the legal department said it was not a requirement to inform the patient about the camera because the camera was necessary for the patient's safety.

On 11/6/18 at 9:20 AM, the Privacy Officer stated that there was no written policy and procedure at this time regarding cameras in the rooms. She explained that there were six cameras on Medical/Surgical North and nine cameras on Medical/Surgical South. She further explained that the need for a camera room was not specifically documented in the patient's record, documentation of issues regarding concerns for patient safety such as a fall assessment and mental status assessment would be documented. She ended by stating that the practice was to advise a patient that they will be in a camera room.

On 11/7/18 at approximately 12:30 PM, a document presented to the surveyor, prepared by the Regional Senior Director of Support Operations, stated that all cameras had the ability to be turned on to record or turned off to use for monitoring. The document stated that there were 18 cameras between North and South Medical/Surgical Units.

On 11/7/18 at approximately 1:00 PM, Patient #1's record was reviewed. There was no documentation that the criteria identified by the Regional Privacy Officer was used as rationale for placing Patient #1 in a room with a camera.

On 11/8/18 at 1:35 PM, surveyors observed two computer monitor screens, in Medical/Surgical South Nursing Station, that displayed 18 patient rooms of which six of the rooms had patients in them. The screen for Room #26 displayed Patient #2 naked from the waist down and he/she was bathing. At that time, the Nursing Station was occupied by staff who had their backs to the monitors. When the staff were asked who monitored the screens, one RN stated that the Clinical Support Specialist (CSS) would do that but she was on the Med/Surg North covering for the CSP who was at lunch. When asked if the patients in the six rooms knew they were being monitored by the camera, one RN stated they should be made aware but didn't know for sure. No one covered the computer monitor screen of Room #26.

On 11/8/18 at 1:40 PM, surveyors observed two computer monitor screens in the Medical/Surgical North Nursing Station. The CSS was sitting in front of the monitors. When the CSS was asked when the individual screen would be covered, she stated when someone was bathing. It was brought to the attention of the CSS, by the surveyors, that Patient #2 in Room #26 appeared to be bathing. The CSS stated, "Oh, I guess I have not been paying attention. I didn't see the basin and didn't realize the patient was taking a bath". When asked what should happen if a patient was taking a bath, the CSS stated, "I would cover the screen with a sticky". The CSS then covered the screen of Room #26 with a sticky note. The CSS added that patients are on camera because of a fall hazard, alcohol withdrawal, suicide, and patient safety. Patient #2 was admitted for diarrhea. The CSS also stated that when they need a room for an admission any patient can be put in the camera rooms.

Video monitoring of patients on a medical-surgical units would not be considered violating the patient's privacy, as long as there existed a clinical need, the patient/patient's representative was aware of the monitoring, and the monitors were located so that the monitor screens were not readily visible to visitors or the public. The cameras located on these units violated the patients right to privacy as evidenced by the fact that cameras were observed on in an area that was unoccupied, the monitor screens had the potential to be observed by unauthorized individuals, and the privacy officer stated patients did not have to be informed about the cameras.

Based on records reviewed and interviews, the Condition of Participation (CoP) for Quality Assurance Performance Improvement (QAPI) was not met as evidenced by the hospital's failure to have a system in place to ensure the humidity and temperatures in Operating Rooms (ORs) were maintained within acceptable standards for 4 of 4 ORs (OR #1, #2, #3, and #4).

Findings:

The hospital has adopted the recommendations of the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE), and the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) for the acceptable standards for the relative humidity (20 - 60 percent) and temperatures (68 to 75 degrees Fahrenheit) in the ORs.

A review of the humidity and temperature records for the four ORs for the months of August, September, October, and November 1-6, 2018 was conducted. The humidity was outside the identified range of 20 - 60 percent on 85 of 736 occasions and the temperature was lower than 68 degrees Fahrenheit on 671 of 736 occasions between 8/1/18 and 11/6/18. Please see A-0726 for additional details.

A review of the contract for the Heating Ventilation and Air Conditioning (HVAC) Control Services - Automation, dated 11/02/2017, was conducted. The contract indicated that there would be a quality assurance process. However, on 11/07/2018 at 1:30 PM, the Director of Maintenance was interviewed, via phone, and he confirmed that there was no quality assurance program review process in place for this contract.

On 11/8/18 at 12:20 PM, in an interview with the Physical Plant Director, the surveyor was informed that both he and the OR Manager received a daily report from the vendor supplying temperature and humidity recordings.

Based on this information, the CoP for QAPI was not met as hospital personnel received reports of the humidity and temperature recordings, there was no system in place to monitor the reports, the services the contracted service provided to the hospital was not monitored, and the hospital did not take action to correct the problem with the low humidity and low temperatures; thus placing patient at potential increased risk for infection.

Based on review of documents and interviews, the hospital failed to ensure that the medical staff conducted appraisals of 3 of 3 physicians who had requested privileges in emergency ultrasound.

Findings:

The hospital's policy and procedure titled "Pen Bay Medical Center Policy & Procedure, Department, Emergency Medicine, Policy Subject, Additional Privileges in Emergency Medicine: Focused ED Ultrasound, effective 2011" was reviewed. This policy/procedure, which was signed by the Chair of Emergency Medicine and the Chair of the Credentials Committee, indicated the following under "Maintenance/Renewal of Privileges"

"1. Applicant must demonstrate current competence and evidence of the performance of at least 10 ultrasound interpretations/application (5 for ultrasound guided procedures), in the past 24 months based on results of ongoing professional practice evaluation and outcomes.

2. Applicant is responsible for maintaining a procedural log and a copy/recording for each study, as outlined above, for the ultrasound procedures performed.

3. Applicant is responsible for scheduling time with the Director, EM Ultrasound for a procedural log and study quality review.

4. Director, EM Ultrasound will submit written documentation to the Chair, Emergency Medicine describing the successful quality & study review completion.

5. EM Chair will perform a standard document review, approve/disapprove and submit to the Chair, Credentials Committee, per standard."

Between January 2018 through November 7, 2018, six emergency physicians were re-credentialed by the medical staff. Three of these physicians requested additional privileges in emergency ultrasound. The credentials files for the three (3) emergency physicians, who were re-credentialed in 2018 and requested renewal of ultrasound privileges, were reviewed. There was no evidence in any of the three files that indicated the following: the applicant had demonstrated current competence and evidence of the performance of at least 10 ultrasound interpretations/application (5 for ultrasound guided procedures), in the past 24 months based on results of ongoing professional practice evaluation and outcomes and the Director, EM Ultrasound submitted written documentation to the Chair, Emergency Medicine describing the successful quality & study review completion. The Chair of Emergency Medicine signed the privilege requests for the renewal of ultrasound privileges for the three Emergency Physicians who requested renewal of focused emergency ultrasound privileges. However, there was no evidence in the credentials files that the Chair of Emergency Medicine considered the competence of the applicant, or the quality of the ultrasounds scans performed, or the absence of the documentation and review of the requested procedures as described in the ED Ultrasound credentialing policy.

On 11/7/18 at approximately 10:45 AM, the Co-Chair of Emergency Medicine was interviewed during the review of his credential file. His credential's file was one of the three emergency physicians whose ultrasound privileges were renewed in 2018. He confirmed that there was no evidence during the credential process that he had performed at least ten of the ultrasound examinations for the procedures requested in the prior 24 months and that a copy of a recording for each study for the ultrasound privileges was requested. He also confirmed that there was no meeting with the Director EM Ultrasound for a procedural log and study review for the three (3) emergency physicians requesting renewal of ultrasound privileges.

On 11/7/18 at 11:30 AM, the Credentialing Coordinator confirmed that the documentation specified by the policy was not contained in the credential files.

On 11/7/18 at approximately 11:45 AM, the Chair of the Credentials Committee was interviewed. He confirmed that the Credentials Committee did not discuss or consider that the three emergency physicians requesting renewal of emergency ultrasound privileges had no documentation of continuing competence in the requested procedures as described in the ED credentialing policy.

Based on record reviews and an interview, the hospital failed to ensure that all medications were administered as ordered for 2 of 30 sampled inpatient records (Patient #28 and Patient #29).

Findings:

1. Patient #28 had an order for one milligram of Clonazepam to be administered four times daily. The Medication Administration Record (MAR) indicated that this medication order was to be started on 11/1/18 and end on 11/5/18. Documentation on the patient's MAR indicated indicated the fourth dose of Clonazepam was due to be administered on 11/4/18 at 7:00 PM. However, there was no evidence that the patient received the fourth ordered dose of Clonazepam on 11/4/18.

On 11/7/18 at 9:47 AM, the Nurse Manager of the Psychiatric Addiction Recovery Center (PARC) confirmed there was no documentation that indicated the patient received Clonazepam on 11/4/18 at 7:00 PM.

2. Patient #28 had an order for Senna to be administered every night. The Medication Administration Record (MAR) indicated that this medication order was to be started on 10/31/18 and end on 11/5/18. There was no evidence that the patient received the ordered Senna on 11/4/18.

On 11/7/18 at 9:47 AM, the Nurse Manager of the PARC confirmed there was no documentation that indicated the patient received the ordered Senna on 11/4/18.

3. Patient #29 had an order for Nystatin-Triamcinolone Cream to be applied topically twice a day. The MAR indicated that this medication order was to be started on 11/2/18 at 10:00 PM. There was no evidence that the patient received the ordered medication at 8:00 AM on 11/5/18.

On 11/7/18 at 9:47 AM, the Nurse Manager of the PARC confirmed there was no documentation that indicated the patient received the ordered Nystatin-Triamcinolone Cream on 11/5/18 at 8:00 AM.

4. Patient #29 had an order for Neomycin-Bacitracin-Polymyxin Ointment to be applied daily. The MAR indicated that this medication order was to be started on 11/3/18. There was no evidence that the patient received the ordered medication at 8:00 AM on 11/5/18.

On 11/7/18 at 9:47 AM, the Nurse Manager of the PARC confirmed there was no documentation that indicated the patient received the ordered Neomycin-Bacitracin-Polymyxin Ointment on 11/5/18 at 8:00 AM.

Based on records reviewed and interviews, the Condition of Participation (CoP) for Physical Environment was not met as evidenced by the hospital's failure to ensure that crash carts were checked to ensure supplies were available in case of any emergency for 2 of 10 crash carts (Cardiac Testing Department's crash cart and Surgical Services' crash cart) and the failure to ensure the humidity and temperatures in Operating Rooms (ORs) were maintained within acceptable standards to inhibit microbial growth and reduce risk of infection in 4 of 4 ORs (OR #1, #2, #3, and #4)

Findings:

1. Standard: §482.41(c)(2) Facilities, Supplies, Equipment Maintenance also known as A-0724 - Based on record reviews and interviews, the hospital failed to ensure that crash carts were checked to ensure supplies were available in case of any emergency for 2 of 10 crash carts (Cardiac Testing Department's crash cart and Surgical Services' crash cart). Please see A-0724 for details.

2. Standard: §482.41(c)(4) Ventilation, Light, Temperature Controls also known as A-0726 - Based on document reviews and interviews, the hospital failed to ensure the humidity and temperatures in Operating Rooms (ORs) were maintained within acceptable standards to inhibit microbial growth and reduce risk of infection in 4 of 4 ORs (OR #1, #2, #3, and #4). Please see A-0726 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on observations and interviews, the hospital failed to ensure that crash carts were checked to ensure supplies were available in case of any emergency for 2 of 10 crash carts. In addition, the hospital failed to ensure equipment was in good repair to ensure safety in 1 of 4 Operating Rooms (OR #1).

Finding:

The hospital's "Code Cart, Maintenance of" policy and procedure indicated, the following: Nursing Daily Routine - Nursing staff will confirm integrity of carts by direct observation of the secured lock and comparing the lock number with the most recently recorded number on the Code Cart Checklist and Nursing staff will confirm the presence of Code Sheets and Post Code documentation form, Ambu bag, arrest board, and will conduct 02 [oxygen] tank pressure check and defibrillator check, in accordance with manufacturer's instructions.

1. On 11/5/18 at 9:20 AM, a review of the "Crash Cart Checklist" for the crash cart located on the Cardiac Testing Department was completed. There was no evidence that the cart had been checked on 10/11/18 and 10/26/18 and no checks were completed on weekends for any months in 2018. A Cardiac Care Technician confirmed that these checks had not been completed at the time of the review. She also added that the department was not open on weekends and the crash cart went to the Obstetrics each night and weekends.

On 11/5/18 at 1:22 PM, an interview was conducted with the Charge Nurse on Obstetrics. She stated that the crash cart from the Cardiac Testing Department were housed in that department nights and on weekends. When asked if the crash cart checks were completed by her staff, she stated no. She stated that they are not trained to check those crash carts. She added that the staff only does neonatal resuscitation and they check that crash cart.


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2. On 11/5/18 at 12:47 PM, a review of the "Crash Cart Checklist" for the crash cart located in Surgical Services was completed. There was not evidence that the cart had been checked on the weekends in October 2018 or the first weekend in November 2018. At the time of the observation, the Director of Preoperative Services stated crash cart checks were not completed on weekends as there were no elective surgeries on weekends, only emergency surgeries.

Based on document reviews and interviews, the hospital failed to ensure the humidity and temperatures in Operating Rooms (ORs) were maintained within acceptable standards to inhibit microbial growth and reduce risk of infection for 4 of 4 ORs (OR #1, #2, #3, and #4).

Findings:

The hospital's "Infection Prevention and Control Measures - Anesthesia" policy (#7080-009), last reviewed in 4/2017, indicated that "the relative humidity shall be maintained at 20 to 60 percent, as recommended by the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE), and the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE)". In addition, the policy indicated "temperatures of operating rooms shall be maintained at 68 to 75 degrees F [Fahrenheit] (FGI Guidelines 2014, ANSI/ASHRAE/ASHE Standard 170-2008)".

The humidity and temperature records for the four ORs were reviewed for the months of August, September, October, and November 1-6, 2018. The humidity and temperature were recorded on 92 days between 8/1/18 and 11/6/18 and measurements were completed twice daily at 7:00 AM and 5:00 PM for a total of 736 recordings.

Between 8/1/18 and 11/6/18, the humidity was outside the identified range of 20 - 60 percent on 85 of 736 occasions. The humidity levels were as follows:

- In September 2018, the humidity was low on six (6) occasions (one day) and the low recordings ranged from 14.21 to 19.25.

- In October 2018, the humidity was low on 69 of 70 occasions (13 days) and the low recordings ranged from 10.65 to 19.4 with the majority of the occasions being recorded below 15.

- From 11/1/18 through 11/6/18, the humidity was low on nine (9) occasions (2 days) and the low recordings ranged from 12.59 to 19.96.

Between 8/1/18 and 11/6/18, the temperature was lower than 68 degrees F on 671 of 736 occasions. The temperatures were low in August 2018 on 235 occasions; in September 2018 on 190 occasions; in October 2018 on 198 occasions; and from 11/1/18 through 11/6/18 on 48 occasions. The lowest recorded temperature was 63.25 degrees F in OR#1 on 9/7/18.

According to "Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organization January 2015", which was a collaboration of professional organizations including those identified in this hospital's policy, the following were potential risks related to humidity:

a. "Relative humidity can impact the shelf life and product integrity of sterile supplies".

b. "Relative humidity may affect the operation of some electro-medical equipment used in the OR, particularly with older model electro-medical equipment. This equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration. Larger electrostatic discharge (ESD) pulses may create a risk of destruction of parts, premature failure, and erratic behavior of software that is "confusion" from ESD pulses. And, in an environment where humidity is low, a person can more easily become "charged" and receive an electrostatic shock when coming in contact with medical equipment".

c. "It is uncertain for how long the humidity for supplies can be below the manufacturer's recommended minimum level before the equipment or product is affected".

On 11/8/18 at 11:30 AM, the Director of Perioperative Services and Director of Quality were informed, by the surveyor, that temperature and humidity records were outside the identified ranges and they confirmed the findings.

On 11/8/18 at 12:20 PM, in an interview with the Physical Plant Director, the surveyor was informed that both he and the OR Manager receive a daily report of the temperature and humidity recordings from the vendor; that Surgical Services' staff have been overriding the temperatures; and that the vendor involved in air filtration control would be requested to remove the temperature override option.

Based on the above information, the hospital failed to ensure humidity and temperatures were maintained within current acceptable standards of practice placing patients at increased risk for infection and/or harm.

Based on observations and interviews,the hospital failed to have a system to ensure the maintenance of a sanitary environment to prevent potential infections in 10 of 15 patient care areas (Dietary Services, Medical/Surgical Units, Intensive Care Unit, Obstetrical Unit, Emergency Department, Psychiatric Addiction Recovery Center, Surgical Services, Physical Therapy, Cancer Care Unit, and Cardiopulmonary area).

Findings:

1. On 11/05/2018 between 11:15 AM and 11:25 AM, a kitchen staff member was observed to handle a patient's menu, then handle cheese and bread, then handle menus again, then handle a slice of meat. At no time during this observation did the kitchen staff member change her gloves. This finding was confirmed by the Nutrition Services Director (NSD) at the time of the observation.

2. On 11/05/2018 at 11:45 AM, the kitchen food preparatory sink was observed not to have functional air gap. This finding was confirmed, with the Nutrition Services Director at the time of the observation.

3. A total of six ice machines were observed to be lacking air gaps; therefore, creating on opportunity for the back flow of waste water into the ice machine. The observations were as follows:

a. On 11/05/2018 at 11:45 AM, no functional air gap was observed on the drain line of the ice machine in the kitchen. This finding was confirmed, with the Nutrition Services Director, at the time of the observation.

b. On 11/07/2018 at 2:10 PM, no functional air gap was observed on the drain line of the ice machine in the Medical Surgical South Kitchenette. This finding was confirmed, with the Maintenance Director, at the time of the observation.

c. On 11/08/2018 at 9:00 AM, no functional air gap was observed on the drain line of the ice machine in the Medical Surgical North Kitchenette. This finding was confirmed, with the Maintenance Director, at the time of the observation.

d. On 11/08/2018 at 9:30 AM, no functional air gap was observed on the drain line of the ice machine in the Intensive Care Unit (ICU). This finding was confirmed, with the Maintenance Director, at the time of the observation.

e. On 11/08/2018 at 11:30 AM, no functional air gap was observed on the drain line of the ice machine in the Obstetrical Unit (OB). This finding was confirmed, with the Maintenance Director, at the time of the observation. On 11/09/2018 at 12:13 PM, the Maintenance Director confirmed, in a phone call with the surveyor, that he had opened up the wall and there was no functional air gap present in the ice machine in the OB Unit.

f. On 11/08/2018 at 1:00 PM, no functional air gap was observed on the drain line of the ice machine in the Emergency Department Supply Room. This finding was confirmed, with the Maintenance Director, at the time of the observation.

4. On 11/5/18 at 12:10 PM, two stools that had two inch tears in the vinyl were observed in OR #1. This finding was confirmed with the the Director of Preoperative Services at the time of the observation.

5. On 11/05/2018 at 2:20 PM, two holes and an unfinished wall patch were observed in the Shower Room of Room 68 on the Psychiatric Addiction Recovery Center (PARC). This finding was confirmed, with the Outpatient and Specialty Services Quality Specialist, at the time of the observation.

6. On 11/07/2018 between 6:45 AM and 2:45 PM the following was observed:

a. Broken and/or stained rubber bumpers on two carts in the OR core hallway and on three carts in the Central Sterilization Clean Room of the Surgical Services.

b. Paint was peeling and missing many area of the floor in the Central Sterile "dirty" area of the Surgical Services area.

c. The arm pads were cracked on two pairs of crutches in the housekeeping storage room in the physical therapy area.

d. Laminate was broken and/or missing along the edge of the sink cabinet in the restroom of Room 0110, on the wooden wheeled carts in Rooms #7 and #19, and on a cabinet near the sink in Room #8 in the ICU.

e. Fabric covered "bulletin" boards in Rooms #8, #10, #13, #16, #18, #19,#20, #50, #51, and #52.

f. A light brown material was adhered to the side of the wooden drawer cart in Rooms #12, #14, #16, #17, #18, and #48; Room #136 in the Cancer Care Unit; and Rooms #118 and #126 in the OB Unit.

g. The floor tiles were broken around a floor drain in Room #53.

h. Torn and open seams on the mattresses on the roll away beds located in Room #087 Storage Room on the Medical Surgical Unit.

i. The fabric was worn and open on the corners of the back of a chair in Rooms #135 and #137 in the Cancer Care Unit.

j. Rusted wheel castors, which could not be easily cleaned and sanitized, in the following areas: on the back table, an IV pole, and an anesthesia pole in OR #1; on the back table, a kick bucket, a trash cart, and on an Intravenous (IV) pole in OR #2; on the linen cart, the back table, and on the base of a stool in OR #3; on an IV pole, a kick bucket, and an anesthesia pole in OR #4; on two carts, an ortho-pump cart, a med-vac pole, and a solution cart in the OR core hallway; on four carts in the Central Sterilization Clean Room; on IV poles in Bay #10 and #11 in the Day Surgery area; on two IV poles in the housekeeping storage room in the physical therapy area; and on IV poles in Rooms #31 and #40 on the Medical/Surgical Unit.

k. Rusted surfaces, which could not be easily cleaned and sanitized, in the following areas: on the base of a stool in OR #3; on the seat of a maternity chair in OR #1; on toilet supports in the bathrooms of Rooms #22 and #57; and on the base of a compression sleeve cart in the Soiled Utility Room on the Medical/Surgical Unit.

The above findings were confirmed, with the Maintenance Director, at the time of the observations.

7. On 11/08/2018 between from 8:30 AM and 1:45 PM, rusted wheel castors, which could not be easily cleaned and sanitized, were observed in the following areas: on IV poles in Room #1 and #5 in the ICU; on an IV pole in Rooms #136 and #137 and on two IV poles in Room #136 in the Cancer Care Unit; and on an IV pole in the Cardiopulmonary Storage Room #1102.

The above observations were confirmed, by the Maintenance Director, at the time of the observations.

Based on records reviewed and interviews, the Condition of Participation (CoP) for Surgical Services was not met as evidenced by the hospital's failure to ensure current standards of practice in relation to the humidity and temperatures in Operating Rooms (ORs) were maintained in 4 of 4 ORs (OR #1, #2, #3, and #4). This failure had the potential to place patients at increased risk for infection and harm.

Findings:

The hospital's "Infection Prevention and Control Measures - Anesthesia" policy (#7080-009), last reviewed in 4/2017, indicated that "the relative humidity shall be maintained at 20 to 60 percent, as recommended by the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE), and the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE)". In addition, the policy indicated "temperatures of operating rooms shall be maintained at 68 to 75 degrees F [Fahrenheit] (FGI Guidelines 2014, ANSI/ASHRAE/ASHE Standard 170-2008)".

The humidity and temperature records for the four ORs were reviewed for the months of August, September, October, and November 1-6, 2018. The humidity and temperature were recorded on 92 days between 8/1/18 and 11/6/18 and measurements were completed twice daily at 7:00 AM and 5:00 PM for a total of 736 recordings.

Between 8/1/18 and 11/6/18, the humidity was outside the identified range of 20 - 60 percent on 85 of 736 occasions. The humidity levels were as follows:

- In September 2018, the humidity was low on six (6) occasions (one day) and the low recordings ranged from 14.21 to 19.25.

- In October 2018, the humidity was low on 69 of 70 occasions (13 days) and the lows ranged from 10.65 to 19.4 with the majority of the occasions being recorded below 15.

- From 11/1/18 through 11/6/18, the humidity was low on nine (9) occasions (2 days) and the lows ranged from 12.59 to 19.96.

Between 8/1/18 and 11/6/18, the temperature was lower than 68 degrees F on 671 of 736 occasions. The temperatures were low in August 2018 on 235 occasions; in September 2018 on 190 occasions; in October 2018 on 198 occasions; and from 11/1/18 through 11/6/18 on 48 occasions. The lowest recorded temperature was 63.25 degrees F in OR#1 on 9/7/18.

According to "Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organization January 2015", which was a collaboration of professional organizations including those identified in this hospital's policy, the following were potential risks related to humidity:

a. "Relative humidity can impact the shelf life and product integrity of sterile supplies".

b. "Relative humidity may affect the operation of some electro-medical equipment used in the OR, particularly with older model electro-medical equipment. This equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration. Larger electrostatic discharge (ESD) pulses may create a risk of destruction of parts, premature failure, and erratic behavior of software that is "confusion" from ESD pulses. And, in an environment where humidity is low, a person can more easily become "charged" and receive an electrostatic shock when coming in contact with medical equipment".

c. "It is uncertain for how long the humidity for supplies can be below the manufacturer's recommended minimum level before the equipment or product is affected".

On 11/8/18 at 11:30 AM, the Director of Perioperative Services and Director of Quality were informed, by the surveyor, that temperature and humidity records were outside the identified ranges and they confirmed the findings.

On 11/8/18 at 12:20 PM, in an interview with the Physical Plant Director, the surveyor was informed that both he and the OR Manager receive a daily report from the vendor supplying temperature and humidity recordings; that Surgical Services staff had been overriding the temperatures; and that the vendor involved in air filtration control will be requested to remove the temperature override option.

Based on the above information, the hospital failed to ensure Surgical Services were provided within current acceptable standards of practice placing patients at increased risk for infection and/or harm. The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.