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Based on records reviewed and interview the Governing Body (GB) failed to ensure contracts with outside services allowed the GB to have overall responsibility for the quality and safety of the services provided under contract.

Findings included:

During the interview, at 9:30 A.M. on 4/11/2022, the Chief Executive Officer said Laboratory Services and Radiology Services were corporate Contracted Services.

The contracted services, titled: 1.) Laboratory Corporation of America Holdings, dated 10/1/2018, indicated a contracted service for laboratory services; 2.) Portable Services Agreement, dated 3/1/2021, indicated a contracted service for x-ray services and 3.) Advanced Pharmaceutical Consultants, dated 11/1/2021, indicated a contracted service for pharmacy services, indicated that the services were contracted with Acadia (the Corporation and a non-Hospital entity). These three contracted services did not indicate a properly execueted contract between the Hospital (Haverhill Pavilion Behavioral Health) and the Contracted Service which would allow the Hospital Governing Body to have responsibility for the quality and safety of the contracted service provided to Hospital patients.

Based on observation, record review and interview, the Hospital failed to protect and promote each patient's rights by providing care in a safe setting. Findings include:

The Hospital failed for 1 (North Unit) of 3 units to provide care in a safe setting without ligature and self-harm risks when there was a plastic trash bag in a patient bathroom (used to suffocate), exposed water pipes in the kitchen/group room for multiple days with unattended psychiatric patients (ligature risk) and a broken plastic enclosure leaving electric cords in the TV room accessible to unattended psychiatric patients (ability to harm self or others). In addition, the Hospital failed to prevent easy access to bed alarms with a cord for 2 patients (Patients #1 and #2) out of a total sample of 30 patients on one of three psychiatric units.

Refer to TAG: A-0144.

Based on observation and interview the Hospital failed to provide care in a safe setting on 1 (North Unit) of 3 inpatient psychiatric units and failed to prevent easy access to bed alarms with a cord for 2 patients (Patients #1 and #2) out of a total sample of 30 patients on one of three psychiatric units. Findings include:

Review of the Hospital's Sharps and Potentially Dangerous Items Policy, dated 3/24/21, indicated to provide a safe environment for all patients, staff and visitors and to minimize access to items which have the potential for harm to self and others; plastic bags were banned from the units.

Review of the Hospital's Risk Assessment, dated 2/25/22, indicated to prevent self-harm and injury, in an area that had a sink, the sink was securely mounted to the wall and all supply and waste plumbing were concealed and inaccessible. The assessment also indicated that to prevent ligature risk and security risk if damaged; Patients would be monitored while in group room areas. Cabinets were anchored to the wall to prevent tipping. Work orders were submitted for any damage to cabinets that occurred. Finally, the risk assessment indicated that for patient/staff injury through misuse or self-harm, televisions, DVDs and all other electronic entertainment equipment were enclosed with a Lexan cover secured to the cabinet.

1. On 4/11/22 at 9:40 A.M., during an environmental tour of the North Unit a large plastic trash bag was identified in a bathroom in the entrance to the seclusion room.

During an interview with the Director of Nurses, on 4/11/22 at 9:40 A.M., she said that patients do used this bathroom, with the door shut, when other bathrooms were unavailable and she didn't know why someone would put a plastic trash bag in the barrel since they were not allowed.

2. On 4/11/22 at 9:45 A.M., during an environmental tour of the North Unit, the dining room/group room kitchen cabinets were found to be broken and unlocked. The broken cabinets left the supply and waste plumbing exposed to patients. Further, it was identified that there were multiple patients unattended in the room at the time of the environmental tour. Leaving them vulnerable to ligature and safety risk while in the dining room unattended.

During an interview with the Director of Nursing, on 4/11/22 at 9:45 A.M., she was unable to identify why the cabinets were broken and unlocked.

3. On 4/12/22 at 8:25 A.M., during an environmental tour of the North Unit, the TV room was identified to have a broken Lexan cover, leaving the electric cords accessible to patients while watching TV unattended. Leaving potential for patient/staff injury through misuse or self-harm.

During an interview with Risk Manager #1, on 4/12/22 at 8:45 A.M., she said that she would have the identified patient safety risks addressed immediately by the maintenance staff members.

The observations identified during environmental rounds of the North Unit pose significant risk to patients and staff for self-injurious and unsafe behavior.

4. For Patients #1 and #2, call bell cords were observed on the floor of the patients' room which could be accessed by any patient.

The Surveyor observed, on 4/11/22 at 10:07 A.M., 1:42 P.M., and 3:48 P.M., a bed alarm with a cord attached lying on Patient #1's roommate's (Patient #2) unoccupied bed. The door to the room was open and the cord was visible from the hallway and accessible to patients.

Review of Patient #1's medical record failed to indicate an order or an assessment that the Patient was safe to be in a room with a bed or chair alarm with a cord.

During an interview, on 4/11/22 at 1:45 P.M., Registered Nurse (RN) #1 said some items that could be considered hazardous included bed alarms and chair alarms. RN #1 said patients needed orders for bed alarms and chair alarms and their roommate's also needed an order indicating they were safe to be in a room with someone with a bed or chair alarm.

During an interview, on 4/12/22 at 7:55 A.M., the Director of Nursing said the bed alarm cord on the bed unattended was a potential risk to other patients.

Based on records reviewed and interviews, the Hospital's Quality Assessment and Performance Program failed to ensure data collected for Medical Transfer, Change in Condition events were analyzed for effectiveness, safety of services and quality of care.

Findings included:

The Governing Board (Governing Body) Bylaws, dated 1/2022, indicated the Governing Board was ultimately accountable for the safety and quality of care, treatment and services provided by the Hospital. The Bylaws indicated the primary function of the Governing Board was to assure the Hospital and its Medical Staff provided quality medical care. The Bylaws indicated the Governing Board received and evaluated periodic reports from the Medical Staff to oversee, and make decisions regarding quality assessment and improvement and the provision of quality patient care at the Hospital.

The Bylaws of the Medical Staff, dated 3/17/2022, indicated the Medical Staff had the responsibility to account to the Board (Governing Board) patient care processes and outcomes rendered by Medical Staff Members to practice at the Hospital through analysis of patient care processes and outcomes through a valid and reliable quality management program.

The Hospital Report, dated 3/29/2021 through 3/17/2022, indicated approximately 106 Medical Transfer, Change in Condition patient events (that was, patients transferred to an acute care hospital for non-psychiatric evaluation).

The Surveyor observed the Hospital Report indicated four themes regarding Medical Transfer, Change in Condition patient events that may improve the effectiveness, safety of services and quality of care. The Hospital Report indicated the following three themes: 1.) events regarding gastrointestinal signs and symptoms including dehydration, 2.) events regarding cardiovascular, including signs and symptoms of stroke and respiratory events, and 3.) mental status changes.

During the interview, at 12:50 P.M. on 4/12/2022, Risk Manager #1 said the Quality Assessment and Performance Program tracked Medical Transfer, Change in Condition events, however the QAPI Program did not analyze the events.

During the interview, at 1:30 P.M. on 4/12/2022, the Chief Executive Officer said medical transfers were not reviewed (that was, the Medical Staff did not analyze Medical Transfer, Change in Condition events for effectiveness, safety of services and quality of care).

Medical Executive Meeting Minutes, dated 3/2021 through 3/2022, indicated no indication of medical review or analysis of Medical Transfer, Change in Condition events for effectiveness, safety of services and quality of care or for opportunities for improvement.

Based on observation, record review and interview, the Hospital failed to ensure assessments were completed and physician orders were obtained for a bed alarm with a cord for 2 patients (Patients #1 and #2) out of a total sample of 30 patients on one of three psychiatric units.

Findings included:

Review of the Hospital policy titled "Falls Management Program", revised 5/11/21, failed to indicate measures to be implemented with the use of fall alarms for patients in the Hospital.

1. Patient #1 was admitted to the Hospital, on 4/4/22, with diagnoses including psychosis, post-traumatic stress disorder, suicidal ideations and command auditory hallucinations.

The Surveyor observed, on 4/11/22 at 10:07 A.M., 1:42 P.M., and 3:48 P.M., a bed alarm with a cord attached lying on Patient #1's roommate's (Patient #2) unoccupied bed. The door to the room was open and the cord was visible from the hallway and accessible to patients.

Review of Patient #1's medical record failed to indicate an order that the Patient was safe to be in a room with a bed or chair alarm with a cord.

During an interview, on 4/11/22 at 1:45 P.M., Registered Nurse (RN) #1 said some items that could be considered hazardous included bed alarms and chair alarms. RN #1 said patients needed orders for bed alarms and chair alarms and their roommate's also needed an order indicating they were safe to be in a room with someone with a bed or chair alarm.

During an interview, on 4/11/22 at 4:05 P.M., the Staff Educator said both a patient and his/her roommate needed an order for a bed or chair alarm due to the potential risk of strangulation. The Staff Educator said that Patient #1 did not have an order to be in a room with a bed alarm.

During an interview, on 4/12/22 at 7:55 A.M., the Director of Nursing said the bed alarm cord on the bed unattended was a potential risk to other patients.



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2. Patient #2 was admitted to the Hospital, on 4/6/22 with diagnoses of major depressive disorder with suicidal ideation and anxiety disorder.

The Surveyor observed, on 4/11/22 at 10:07 A.M., 1:42 P.M., and 3:48 P.M., a bed alarm with a cord attached lying on Patient #2's unoccupied bed. The door to the room was open and the cord was visible from the hallway and accessible to patients.

Review of Patient #2's medical record failed to indicate assessment or physician's order indicating the Patient was safe to have a bed alarm while in the Hospital. Review of Patient #2's Nursing Reassessments indicated the patient had the bed alarm in placed since 4/7/22.

During an interview, on 4/11/22 at 1:45 P.M., Registered Nurse (RN) #1 said some items that could be considered hazardous included bed alarms and chair alarms. RN #1 said patients needed orders for bed alarms and chair alarms and their roommate's also needed an order indicating they were safe to be in a room with someone with a bed or chair alarm. RN #1 said Patient #2 did not have an order for the use of the bed alarm and said she would discuss it with the Hospital provider.

During an interview, on 4/11/22 at 4:05 P.M., the Staff Educator said both a patient and his/her roommate needed an order for a bed or chair alarm due to the potential risk of strangulation.

Based on observation, record review and interview the Hospital Pharmaceutical Services failed to ensure proper medication storage.

Findings included:

The Surveyor observed, at 10:30 A.M. on 4/12/2022, a medication refrigerator on a patient care unit: 1.) With an orange sticker label with the following information: Drugs Only - No Food, and 2.) The Unit Medication Room Refrigerator Temperature Log, dated 4/7/2022, indicated the Hospital identified the refrigerator temperature must be maintained between 36 to 44 degrees Fahrenheit and the recorded medication refrigerator temperature was 46 degrees Fahrenheit. The Medication Refrigerator Temperature Log indicated staff instructions and required documentation on the Medication Refrigerator Temperature Log regarding procedures when the medication refrigerator temperature was out of the acceptable range. The Medication Refrigerator Temperature Log indicated no comments in the Comments area of the Log.

During the interview, at 10:30 A.M. on 4/12/2022, Registered Nurse #3 said the Medication Refrigerator contained the medications, insulin and Ativan (a medication for anxiety), and (the food items were) Ensure (a dietary supplement) and prune juice.

Based on observations and interviews, the Hospital pharmacy failed to have a system in place that alerted pharmacy staff if/when the refrigerator for refrigerated medications fell out of range during times when pharmacy staff were not present.

Findings include:

The Surveyor observed the local, digital thermometer measuring the temperature for the refrigerator that housed (stored) refrigerated medications in the pharmacy. During review of the manufacturer's manual of the digital thermometer with the pharmacy director, it was identified that although there was a local alarm to the thermometer, the thermometer's alarm would sound and/or beep for up to only 12 hours.

The Surveyor interviewed the pharmacy director, at 9:00 A.M. on 04/11/2022. The pharmacy director said pharmacy hours were Monday through Friday 8:00 A.M. until 3:30 P.M. The pharmacy director said pharmacy hours on Saturday/Sunday/holidays were 8:00 A.M. until 1:00 P.M.

As the pharmacy was not a 24/7 pharmacy, personnel may be absent for up to 19 hours (if weekend or holiday), at least 7 hours over the thermometer alarm threshold. The lack of 24/7 temperature monitoring increased the risk that pharmacy staff may not be aware if the refrigerator fell out of the required range for refrigerated medications.

Based on observation and interview, the Hospital failed to maintain proper function of the mechanical dishwasher in the kitchen to effectively sanitize.

Findings include:

Review of the Food and Drug Administration (FDA) food code, dated 3/7/2022, recommended that for mechanical dishwashing machines, the temperature ranges from 165 degrees Fahrenheit to 180 degrees Fahrenheit. The food code included the following:

- Hot water mechanical operations by being cycled through equipment that is set up as specified under §§ 4-501.15, 4-501.112, and 4-501.113 and achieving a utensil surface temperature of 71 degrees C (160 degrees F) as measured by an irreversible registering temperature indicator; or

- Chemical manual or mechanical operations, including the application of sanitizing chemicals by immersion.

Review of the Hospital policy, titled Equipment, dated 06/2020, indicated the following:

- The machine was run according to the manufacturer's instructions.

- The machine maintained a final sanitizing rinse of at least 180 degrees Fahrenheit or more.

During an observation, on 4/11/2022 at 12:45 P.M., the dishwasher read at a temperature of 127 degrees Fahrenheit for the wash cycle and 170 degrees Fahrenheit for the rinse cycle. The minimum temperature for the dish machine was 150 degrees Fahrenheit for the wash cycle and 180 degrees Fahrenheit for the rinse cycle for proper sanitation.

During an interview, on 4/11/2022 at 12:46 P.M., the Food Service Director said that the machine gauges might be broken, but that he was not sure and would complete a plan of correction. The plan of correction included switching to paper utensils and plates until the dish machine gauges were fixed.

Based on observation, record review and interviews, the Hospital failed to implement an appropriate and effective Infection Control Program for the prevention, control, and investigation of infections and communicable diseases. Findings include:

1. Hospital staff failed to ensure that 2 of 2 staff (Registered Nurses (RN) #3 and #4) observed, were knowledgeable and practiced proper disinfection of a shared point of care glucometer (blood glucose testing device) between patients, placing patients at risk for contracting potential blood borne diseases such as hepatitis B and C and Human Immunodeficiency Virus (HIV).

2. Hospital staff failed to maintain proper sanitation related glove use in food service increasing the risk of food borne illnesses.

3. Hospital staff failed to maintain the appropriate Parts Per Million (PPM) to chemically sanitize kitchen equipment.

Refer to TAG: A- 749.

Based on observation, record review and interview, Hospital staff failed to 1.) ensure that 2 of 2 staff (Registered Nurses (RN) #3 and #4) observed, were knowledgeable and practiced proper disinfection of a shared point of care glucometer (blood glucose testing device) between patients, placing patients at risk for contracting potential blood borne diseases such as hepatitis B and C and Human Immunodeficiency Virus (HIV), 2.) maintain proper sanitation related to glove use and 3.) maintain the appropriate Parts Per Million (PPM) to chemically sanitize kitchen equipment.

Findings included:

1. For Patient #23, the Hospital failed to ensure proper infection control practices were maintained during a finger stick blood sugar procedure by two nurses or two separate occasions.

Review of the Centers for Disease Control (CDC), entitled, Infection Prevention during Blood Glucose Monitoring and Insulin Administration, dated 3/2/11 included the following:

Recommended Practices for Preventing Bloodborne Pathogen Transmission during Blood Glucose Monitoring and Insulin Administration in Healthcare Settings:

- Whenever possible, blood glucose meters should be assigned to an individual person and not be shared.

- If blood glucose meters must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions, to prevent carry-over of blood and infectious agents.

Review of the Hospital's policy entitled, Manufacturer's Blood Glucose Monitoring System , Glucometer Procedure Steps, not dated, indicated that staff were to disinfect monitor between patient uses using Germicidal Disposable wipes.

A. During observation of a finger stick blood sugar test on the West Unit, on 4/11/22 at 4:15 P.M., RN #4 was observed using a blood glucose meter that was used for multiple patients, without using the appropriate disinfecting procedure, per the Hospital policy for cleaning and disinfecting blood glucose meters.

RN #4 was observed preparing to obtain a finger stick blood sugar reading for Patient #23. The Nurse took the blood glucose meter out of a black pouch, performed hand hygiene and applied gloves. She placed a new testing strip in the blood glucose meter and proceeded to perform the blood glucose test. After obtaining this patient's blood sugar, RN #4 disposed of the contaminated lancet, removed her gloves and performed hand hygiene. Without disinfecting the blood glucose meter, RN #4 placed the meter back into the black pouch and said she was done with this procedure.

During an interview on 4/11/22 at 11:05 A.M., the Surveyor asked RN #4 if there was a process for disinfecting the blood glucose meter. RN #4 said that she wasn't aware of a policy and said she would test two patients and would then probably disinfect the meter.

B. During observation of a finger stick blood sugar test on the West Unit, on 4/12/22 at 11:30 A.M., RN #3 was observed using a blood glucose meter that was used for multiple patients, without using the appropriate disinfecting procedure, per the Hospital policy for cleaning and disinfecting blood glucose meters.

RN #3 was observed preparing to obtain a finger stick blood sugar reading for Patient #23. The nurse took the blood glucose meter out of a black pouch, performed hand hygiene and applied gloves. He placed a new testing strip in the blood glucose meter and proceeded to perform the blood glucose test. After obtaining this patient's blood sugar, RN #3 disposed of the contaminated lancet, removed his gloves and performed hand hygiene. Without disinfecting the blood glucose meter, RN #3 placed the meter back into the black pouch and proceeded to administer other medications for Patient #23.

During interview, on 4/12/22 at 11:45 A.M., the Surveyor asked RN #3 if there was a process for disinfecting the blood glucose meter. RN #3 said he wasn't entirely sure but he said he believed they disinfect the meter once every 24 hours at night. RN #3 said that there was one glucose meter that they used for all the patients. He said he believed there were three diabetics (patients with diabetes) on the unit.

During review of RN #3's personnel record indicated a packet dated, 12/5/21, which contained multiple competencies and written tests. RN #3 completed a written test for glucometer testing on 12/5/21. The written test did not include disinfection of the blood glucose meter. Further review indicated that RN #3 did not complete the competency portion of the Blood Glucose Testing procedure which did included proper disinfection of the blood glucose meter.

During an interview, on 4/12/22 at 2:15 P.M., the Infection Control Nurse said that the expectation for glucometer use is to clean with the red top Sani wipes after each patient and the 11-7 staff was also expected to wipe the machine down as well. She acknowledged the nurse's competency packet was incomplete and undated and that only the written test portion had been completed. She said that she did observe RN #3's competency skills at a competency day but did not sign them off due to the amount of staff competencies being done and how large the competency packet was.




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2. Review of the Food and Drug Administration (FDA) food code, dated 01/2022, indicated the following regarding sanitary glove use in food service:

Washing hands thoroughly, including scrubbing with soap (or other effective surfactant) and running water that satisfies the requirements of § 112.44(a) (as applicable) for water used to wash hands, and drying hands thoroughly using single-service towels, sanitary towel service, electric hand dryers, or other adequate hand drying devices:

(i) Before starting work;

(ii) Before putting on gloves;

(iii) After using the toilet;

(iv) Upon return to the work station after any break or other absence from the work station;

(v) As soon as practical after touching animals (including livestock and working animals), or any waste of animal origin; and

(vi) At any other time when the hands may have become contaminated in a manner that is reasonably likely to lead to contamination of covered produce with known or reasonably foreseeable hazards;

(vii) If you choose to use gloves in handling covered produce or food contact surfaces, maintaining gloves in an intact and sanitary condition and replacing such gloves when no longer able to do so.

Review of the Hospital policy, titled Food Preparation and Service, dated 08/2020, indicated the following to prevent contamination of food:

- Gloves were worn at all times while prepare food.

During an observation on, 4/11/2022 at 11:32 A.M., the cook who was serving the line put a pair of single-use gloves on and proceeded to open the refrigerator door, which contaminated the single-use gloves. The cook then proceeded to serve a piece of ham and touched the ham directly with the contaminated gloves. The cook continued to chop up zucchini with a knife and scooped the zucchini with the same, contaminated gloved hands. The cook then changed his gloves without performing hand hygiene in between.

3. Review of the facility policy titled Emergency Dishwashing/Manual Procedures Dietary, undated, indicated the following:

- Sanitize all items in third sink by using Quat ammonium mixed according to manufacturers directions using 200 PPM for 1 minute.

During an observation on 4/11/2022 at 9:40 A.M., the 3-bay sink contained quaternary ammonia and, when tested, read 50 PPM.