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Based on observation and interview the Hospital failed to provide care in a safe environment by allowing patient access to a rooftop patio ( secured and gated area with a fence) which had an unlocked security gate leading to an open unsecured roof. Unsupervised access to roof tops pose a safety threat to patients, staff and visitors who seek opportunities to commit self harm. Findings include:

During a tour of the 3rd floor of the Hospital on 7/15/19, at 10:00 A.M., the Surveyors observed a door leading to an outside secured patio area. The Unit Director said that patients and visitors could visit the patio whenever they would like and the door leading to the patio was not locked. The Surveyors and the Unit Director entered the patio and observed an unlocked gate from the patio which lead onto the open unsecured roof. The Surveyor opened the gate and walked onto the roof of the Hospital with the Unit Director. The Unit Director said she was unaware if the gate was normally locked. There was no fence around the unsecured roof area and from the edge of the roof was a direct fall to two stories below.

The Surveyors then toured the Sleep Lab located next to the outdoor patio. The Surveyors observed room 1 in the sleep lab had a window that could open 30 inches and that was 40 inches wide and opened to a rooftop two stories below. The Surveyors observed the window in room 2 of the sleep lab which opened 30 inches and was 40 inches wide with no screen and opened directly to the outdoor patio. The outdoor patio was secure with a fence but had an unsecure gate that lead to a unfenced roof top that dropped two stories to another roof top.

The Sleep Lab supervisor said that the patients are scheduled overnight for sleep studies and are monitored through video cameras. The Sleep Lab supervisor said that there is one staff member scheduled for two patients and that patients are left unmonitored if staff has to tend to the needs of the other patient.

The Director of Maintenance was interviewed at 12:30P.M. The Director of Maintenance said that a contractor unlocked the gate access to the roof and removed the lock leaving the area accessible to patients. The Director of Maintenance and the Unit Director both acknowledged that there was not a plan in place to monitor access to the roof when the gate is unlocked or a plan to monitor the gate to ensure it is locked at all times when patients and visitors are accessing the roof patio for safety.

Based on interviews and records review, the Hospital failed to ensure that all personnel involved in restraint application had the appropriate training. Findings include:

On 7/15/19 at 10:30 A.M., the Surveyor observed the Security Manager/Safety Officer closely monitoring two psychiatric patients in the emergency room (ER). The Surveyor asked the Security Manager/Safety Officer if all of the Safety Officers had training in restraint as well as Basic Life Support and Basic First Aid. The Security Manager/Safety Officer said that all Safety Officers were involved in restraint application if needed and they all had this training.

On 7/16/19 at 10:00 A.M., the Surveyor observed the Unit Coordinator monitoring two psychiatric patients who were on constant observation. The Surveyor asked the Unit Coordinator if he had the appropriate training to monitor these patients and if he assisted in restraint application. The Unit Coordinator said that he assisted in the application of restraints and had taken the Crisis Prevention Institute training course. The Surveyor asked the Unit Coordinator if he was also certified in Basic Life Support and had Basic First Aid training. The ER Unit Coordinator said that he was.

The Surveyor reviewed the personnel file/education record for the Emergency Department Unit Coordinator on 7/17/19 at 10:00 A.M. The personnel file indicated that the Unit Coordinator had taken an annual restraint use course but was not certified in Basic Life Support nor had training in Basic First Aid techniques, as required.

The Surveyor interviewed the Nurse Educator on 7/17/19 at 11:15 A.M. The Nurse Educator reviewed the Safety Officers education records with the Surveyor. The Nurse Educator confirmed that the Safety Officers education records indicated that all Safety Officers were CPI and Basic Life Support certified but were not trained in Basic First Aid.

Based on interview and document review, the hospital failed to set priorities for its performance improvement activities that focused on high-risk or problem prone areas, that could negatively affect the health outcomes, patient safety and quality of care for patients receiving intravenous chemotherapy by failing to conduct Environmental Monitoring (air and surface microbial resampling) as of 07/30/19, approximately two weeks after the survey team made the hospital aware of the contamination in the chemotherapy clean room. Findings include:

The Surveyor interviewed the Pharmacy Director on 7/17/19 at 12:45 P.M. The Pharmacy Director said that the Environmental Monitoring Report, dated 5/15/19, had a cover page that indicated that the facility met acceptance criteria of "within normal limits" and had no unacceptable organisms. The Pharmacy Director said he did not recognize this error in the report and failed to review page four and page ten of the report that indicated an air sample taken in the buffer area of 72 microbial counts (62 fungal, 10 bacterial) and a surface sample taken outside the Biosafety Cabinet of 12 microbial counts (3 fungal, 9 bacterial), respectively.

The Surveyor interviewed the Pharmacy Director again on 7/22/19 at 1:00 P.M. The Pharmacy Director stated that a deep cleaning had occurred on 7/17/2019 and Environmental Monitoring by a 3rd party certifier was scheduled to be conducted on 07/25/19 to include bacterial and fungal surface and air testing of the entire chemotherapy cleanroom.

On 7/30/2019, during an interview, the Pharmacy Director stated the Environmental Monitoring that had been scheduled for 7/25/19 did not occur (3rd party certifier canceled on the facility) and that no further action to schedule the re-sampling had been done to date (7/30/2019).

Based on review of staffing in the operating room and review of the Medical Staff Bylaws, the Hospital's Medical Staff and Governing Body failed in its responsibility consistent with State Law, including scope of practice laws, to determine which types of categories of non-physician practitioners may be privileged to provide care to Hospital patients. The Medical Staff failed to appropriately credential and approve the practice of one Certified Surgical Technologist/Surgical Assistant (CTSA) #1 as a practitioner. Findings include:

State hospital licensure law found at 105 CMR 130.860 describes a surgical technologist as any person who provides surgical technology services who is not licensed or registered under M.G.L. c. 112, §§ 2, 16, 74 or 74A or who is not an intern, resident, fellow or medical officer who conducts or assists with the performance of surgery.

According to the Hospital's Medical Staff Bylaws, dated September 27, 2018, ARTICLE IV- CATEGORIES OF STAFF MEMBERSHIP; in Section 3 included support staff which include allied health professionals such as speech pathologists, licensed massage therapists and others who are permitted by law and who may be permitted by the Hospital to provide patient care services in the the Hospital, "who are licensed or registered by the Commonwealth of Massachusetts as required and who meet the basic qualifications for privileges may be accorded specified practice privileges in the Hospital limited to their areas of competence".

These providers must have a staff sponsor, are not eligible for medical staff membership, pay medical staff dues, are subject to the Medical Staff Bylaws rules and regulations and are responsible to the Governing Body. Appointment procedures and delineation of privileges shall be in accordance with the medical staff bylaws.

In 2015, the Hospital appointed a certified surgical technologist assistant (CSTA #1) as a registered nurse (RN) First Assistant without any documentation of nursing education, licensure or competency. The Hospital reappointed CSTA #1 again as an RNFA in 2017 for two more years before reappointing CSTA #1 as a CSTA in 2/2019.

The Commonwealth of Massachusetts does not license or register certified surgical technologist assistants and defines the scope of practice of surgical technologists in 105 CMR 130.860, which does not allow for the practice of surgery.

The Hospital appointed CSTA #1 outside of its bylaws which state the appointment to the support category required the professional individual to be licensed or registered with in the state and allowed practice privileges that were outside of the scope of practice in state licensure regulations or surgical technologists.

Based on record review and interview, the Hospital failed to ensure physicians' medical entries in the medical records for 6 of 32 (#1, #3, #4, #8, #11 and #12) patients reviewed were legible. Findings include:

Orders, progress notes, nursing notes or other entries in the medical record that are not legible may be misread or misinterpreted and may lead to medical errors or other adverse patient events.

Review of the Hospital's Medical Records Documentation Policy, revised November 2016, indicated that all entries made in the medical record shall be legible and properly authenticated, including the individual's professional credentials.

1. For Patient #8, the anesthesia pre-surgical evaluation was not completely legible.

Review of the anesthesia pre-surgical evaluation, dated 7/15/2019, indicated that the review of systems had a 0 clearly indicated under cardiovascular, drugs, respiratory but only squiggle lines indicated under metabolic, Central nervous system evaluation (CNS), gastro-intestinal, renal and a totally illegible mark under smoking history.

During an interview on 7/15/2019 at 10:30 A.M., Registered Nurse #3, the charge nurse of the obstetrics unit, said the form was mostly illegible.

2. For Patient #1, who had a cesarean section on 7/12/2019, review of the hand written brief post operative note, dated 7/12/2019 and timed 2:00 P.M., did not have any patient identifiers on the form to indicate which patient the form belonged to.

The form was found in Patient #1's medical record.

During an interview on 7/15/2019 at 11:00 A.M., the Birth Center charge nurse said the form should have had a sticker label with the patient's name, medical record number and date of birth on it.



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3) The Surveyor reviewed the medical record of Patient #3 on 7/15/19. The Surveyor was unable to read the Physician Progress Notes or the signature on those notes since Patient #3's admission on 7/9/19.

The Provider was later identified as Physician #3

4) The Surveyor reviewed the medical record of Patient #4 on 7/15/19. The Surveyor was unable to read the Physician's Progress Note or the signature on the notes since Patient #4's admission on 7/9/19.

The Provider was later identified as Physician #3

5) The Surveyor reviewed the medical record of Patient #11 on 7/15/19. The Surveyor was unable to read the Psychiatry Physician's Progress Note or the signature on the notes since Patient #11's admission on 7/6/19.

The Provider was later identified as Physician #3

6) The Surveyor reviewed the medical record of Patient #12 on 7/15/19. The Surveyor was unable to read the Psychiatry Physician's Progress Note or the signature on the notes since Patient #12's admission on 7/10/19.

The Provider was later identified as Physician #3

The Surveyors interviewed the Director of Psychiatric Services and Registered Nurse #4 at 11:00 A.M. on 7/15/19. The Director of Psychiatric Services and Registered Nurse #4 said that they could not read the Psychiatry Physician's Progress Notes. The Director of Psychiatric Services said that although the Hospital considered utilizing speech recognition software to remedy this problem, they have not done so as of 7/15/19.

Based on record review and interview, the Hospital failed to ensure that for 3 of 3 patients ( #1, #10 and #20), who required informed consents for procedures and treatments, in a total sample of 32, the informed written consents were properly executed; and for 32 of 32 patients, the Hospital failed to adhere to State requirements in the Hospital's policy and procedure for informed consent for HIV testing and release of results which were obtained on every patient at the time of admission in the overall consent to treat. Findings include:

The Hospital's informed consent policy indicated the anesthesia consents required an additional informed consent other than the general informed consent for treatment. When the surveyor asked on 7/16/2019, if there was a different procedure or policy for obtaining anesthesia or surgical consents, the Chief of Quality said that surgery and anesthesia follow the same policy and procedure for general consents but have a different form. Further review of the policy and procedure for consents indicated that the person giving the general consent form to the patient shall witness the patient's signature at the time consent is obtained.

The informed consent procedure indicated the attending provider or the provider performing the procedure has the responsibility for providing the information to the patient regarding the medical treatment and, if at all possible, should be the individual obtaining the signed consent.

1. For Patient #1, who had a cesarean section on 7/12/2019, the anesthesia consent, dated 7/12/2019 at 11:30 A.M., did not specify the type of anesthesia planned for the C-Section.

Review of the hand written brief post operative note for Patient #1, dated 7/12/2019, signed by the surgeon and timed 2:00 P.M., did not have any patient identifiers on the form to indicate which patient the form belonged to.

During an interview on 7/15/2019 at 11:00 A.M., the Birth Center charge nurse said the form should have had a sticker label with the patient's name, medical record number and date of birth on it.



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2. Surveyors met with the 3rd floor Charge Nurse on 7/15/19, at 10:00 A.M. The Charge Nurse said that Patient #20 was scheduled to have surgery on 7/16/19 for osteomyelitis of the right foot great toe.

Surveyors reviewed Patient #20's medical record and the document titled Informed Consent Anesthesia. Patient #20 signed the Informed Consent Anesthesia document on 7/15/19. There was no indication which type of anesthesia that Patient #20 would receive for surgery on the Informed Consent. The Informed Consent Document was not signed by the Physician or any other staff members.

3. During an interview on 7/16/2019 at 2:30 P.M., the Chief of Anesthesia said that the anesthesia providers are to circle the type of anesthesia (regional, general,etc) planned with the patient on the consent form and they should sign the consent form when consent is obtained from the patient or family for a minor.



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2.) According to the Massachusetts Clinical Advisory, titled Routine HIV screening and changes to Massachusetts law governing consent, updated June 5, 2013, indicated that with the elimination of the requirement for written informed consent for HIV screening and the allowance of verbal informed consent, the expectation is maintained that the individual being tested be provided with information about the test and the opportunity to ask questions and receive clarification of the purpose of the test. There is no requirement to document verbal consent, but providers may choose to document verbal consent in the patient's medical record or client file.

Obtaining written consent to care generally includes a release of medical information to insurers (for billing purposes) or to other treating providers and is generally obtained during the initial engagement to care. The revised c. 111, § 70F defines "written informed consent" as a written consent form for each requested release of the HIV test results.

Review of the General Consent to Treat (undated) indicated that HIV testing would be performed (on the person signing the general consent) if an Hospital staff member had an unprotected blood or body fluid exposure and the results would be released to the exposed individual.

The Surveyor interviewed the Registration Manager at 11:10 A.M. on 7/17/19 and reviewed the form titled General Consent to Treat. The Registration Manager said the form was completed by the patient and the registration clerk when the patient registered. The Registration Manager said that no additional clinical information was provided during registration.

The Surveyor interviewed the Director of Medical Records at 11:25 A.M. on 7/17/19. The Director of Medical Records provided the Surveyor with the Authorization to Release Protected Health Information Consent, dated 4/4/19, which indicated a separate signed consent category for HIV results.

3.) The Surveyor reviewed the Hospital's policy for Informed Consent on 7/17/19. According to the Hospital's policy informed consent must be obtained for therapeutic or diagnostic procedures that are invasive or carry substantial risks.

The Surveyor reviewed Patient #10 who received routine dialysis treatments at an outside facility. Dialysis services are provided to inpatients at the hospital, who require them, by a contracted renal dialysis service not by the hospital itself.

Dialysis treatments were continued while Patient #10 was hospitalized; however no informed consent was obtained for this procedure to be provided by the contract service which included cannulation (invasive) of his/her existing fistulas. Hemodialysis carries risks such as infection, bleeding, hypotension, sepsis, bacteremia and sudden cardiac death which is the leading cause of death for people on dialysis.

Based on observations, document review and interviews, the Hospital failed to ensure pharmaceutical services provided clean and sanitary environment for the compounding of patients' chemotherapy medications, properly trained pharmacy staff and pharmacy staff abiding by standards of practice consistent with USP <797>. Findings include:

1. The Pharmacy Director failed to review an Environmental Monitoring Report, sampled on 5/15/19 and reported 5/23/19, that indicated bacterial and fungal contamination in the buffer room of the chemotherapy cleanroom and as a result failed to take action; the pharmacy director failed to routinely evaluate the performance and competencies of pharmacy staff.

The Hospital failed to identify microbial contamination (fungal and bacterial) from an Environmental Monitoring Report sampled on 5/15/19 for the cleanroom of the cancer center pharmacy. As a result, corrective action did not occur in a timely manner (immediately after the data was reported to the Hospital on 5/23/19). The Pharmacy Director was not aware of the microbial contamination in the cleanroom until the Surveyor discovered the data during the Survey on 7/17/2019.

Refer to A tags 0492 and 0501.

2. The pharmaceutical service failed to perform the compounding of chemotherapy medications under the supervision of a pharmacist who maintained standards of practice consistent with USP <797> (United States Pharmacopeia) which is the authoritative guidance regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding.


Refer to A-0501

Based on observations and interviews, the Pharmacy Director failed to review an Environmental Monitoring Report, sampled on 5/15/19 and reported 5/23/19, that indicated bacterial and fungal contamination in the buffer room of the chemotherapy cleanroom and take action; the pharmacy director failed to routinely evaluate the performance and competencies of pharmacy personnel.

Findings include:

1. The Pharmacy Director failed to review an Environmental Monitoring Report, sampled on 5/15/19 and reported 5/23/19, that indicated bacterial and fungal contamination in the buffer room of the chemotherapy cleanroom.

The Surveyor interviewed the Pharmacy Director on 7/17/19 at 12:45 P.M. The Pharmacy Director said that the Environmental Monitoring Report, dated 5/15/19 had a cover page that indicated that the facility met acceptance criteria within normal limits and had no unacceptable organisms. The Pharmacy Director said he did not recognize this error in the report and failed to review page four and page ten of the report that indicated an air sample taken in the buffer area of 72 microbial counts (62 fungal, 10 bacterial) and a surface sample taken outside the Biosafety Cabinet of 12 microbial counts (3 fungal, 9 bacterial), respectively.

Acceptable levels for air sampling are a total microbial count of no more than 10 and for surface sampling a total microbial count of no more than 5.

2. The Pharmacy Director failed to evaluate and monitor all pharmacy personnel to ensure adequate training and competencies were completed and staff followed all safety procedures for drug handling as outlined under USP <797>.

On 7/16/19 at 1:45 P.M., the Surveyor observed Pharmacist #2 handle hazardous medication vials (unopened) without the use of chemotherapy gloves.

On 7/16/19 at 1:45 P.M., the Surveyor observed that the chemotherapy cleanroom was not supplied with sterile chemotherapy gloves. The clean room had sterile gloves without chemo-rated protection.

The Surveyor interviewed Pharmacy Technician #1 on 7/16/19 at 1:45 P.M. Pharmacy Technician #1 said that the staff compounding hazardous medications in the cleanroom are using sterile gloves without chemo-rated protection.
Pharmacy Technician #1 said that gloves are donned inside the Biosafety Cabinet (BSC), exposing bare hands into the Primary Engineering Control (PEC) where compounding occurs. This can increase risk of contamination of the compounded drugs and can expose pharmacy personnel to possible hazardous drug particles.

3. On 7/22/2019, during an interview, the Pharmacy Director stated that a deep cleaning of the chemotherapy clean room had occurred on 7/17/2019 and Environmental Monitoring by a 3rd party certifier was scheduled to be conducted on 07/25/19 to include bacterial and fungal surface and air testing of the entire chemotherapy cleanroom.

On 7/30/19, the Pharmacy Director stated that the Environmental Monitoring that had been scheduled for 7/25/19 did not occur (3rd party certifier canceled on the facility) and that no further action to schedule the re-sampling had been done to date (7/30/2019).

The microbial status of the clean room remains unknown as of 7/30/2019.

Based on observations, document review and interviews, the pharmaceutical service failed to perform the compounding of medications under the supervision of a pharmacist who maintains standards of practice consistent with USP <797> (United States Pharmacopeia) which is the authoritative guidance regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding. Findings include:

Review of the Hospital Pharmacy Policy, titled Sterile Compounding, dated 5/2019, indicated that "all sterile preparation requirements for preparing compounded sterile drugs/products will be followed, as outlined in USP General Chapter <797>."

1. According to USP <797>, the temperatures in a cleanroom must be 68 degrees Fahrenheit (20 degrees Celsius) or lower. On 7/16/19 at 1:45 P.M. the surveyor observed temperatures in the chemotherapy cleanroom ranging between 72 and 73 degrees Fahrenheit.

2. According to USP<797>, staff are required to use chemotherapy gloves during the handling of chemotherapy drugs. On 7/16/19 at 1:45 P.M. the Surveyor observed Pharmacist #2 handle hazardous medication vials (unopened) without the use of chemotherapy gloves.

On 7/16/19 at 1:45 P.M. the Surveyor observed that the chemotherapy clean room was not supplied with sterile chemotherapy gloves. The clean room had sterile gloves without chemo-rated protection.

On 7/16/19 at 1:45 P.M. the Surveyor spoke with Pharmacy Technician #1 who verified that the employees compounding hazardous medications in the clean room are using sterile gloves without chemo-rated protection.

3. According to USP <797>, pressure monitoring (measuring of air movement between rooms (negative and positive pressure air flows)), must be monitored in classified spaces (rooms with measured particles of filtered air) at a minimum of daily. This is done to limit air contamination from outside spaces and to prevent hazardous drugs from moving to outside air spaces and exposing staff and other people and to prevent microbial growth in classified air spaces.

On 7/16/19 at 1:45 P.M. the Surveyor observed no visual pressure monitoring systems throughout the entire chemotherapy clean room.

During an interview on 7/16/19 at 1:45 P.M., the Pharmacy Director said the pharmacy is not monitoring appropriate air pressures within the buffer room and anteroom spaces (classified spaces).

4. According to USP <797> personal protective equipment (PPE) should include double gloving with sterile chemo-type gloves when compounding chemotherapy drugs in a BSC (Biosafety cabinet). On 7/16/19 at 1:45 P.M. the Surveyor spoke with Pharmacy Technician #1 who stated that gloves are donned inside the BSC, exposing bare hands into the Primary Engineering Control (PEC) where compounding occurs. This may introduce bacteria and fungi into the BSC and/or potentially contaminate intravenous (IV) products as well as expose technicians to hazardous drug particles.

5. According to , microbial air contamination greater than 10 CFU (colony forming units) in an ISO class 7 room (buffer room), requires immediate remediation to bring the levels back into acceptable range.

On 7/17/19 at 12:45 P.M. the surveyor reviewed the Environmental Monitoring report of the pharmacy buffer room, with a sampling date of 5/15/2019, which indicated an air sample (just outside the leftside of the BSC hood within the buffer room classified space) result of 72 total microbial counts. This air sample consisted of 10 bacterial counts and 62 fungal counts. This is well above the current action level of no more than 10 total counts of microbial contamination for an air sample taken in the buffer room.

On 7/17/19 at 12:45 P.M. the surveyor reviewed the Environmental Monitoring Report of the pharmacy buffer room, with a sampling date of 5/15/2019. The report indicated a surface sample (just outside the rightside of the BSC hood exterior surface within the buffer room classified space) result of 12 total microbial counts. This surface sample consisted of 9 bacterial counts and 3 fungal counts. This is well above the current action level of no more than 5 total counts of microbial contamination for a surface sample taken in the buffer room.

During an interview on 7/17/19 at 12:45 P.M. the Pharmacy Director said he was unaware of both of these microbial contaminations and no corrective action as a result of this microbial contamination had been conducted.

On 7/17/19 at 12:45 P.M. the Environmental Monitoring report of the pharmacy buffer room, with a sampling date of 5/15/2019, did not indicate any microbial air or surface testing in the anteroom, a classified space of the pharmacy.

Based on observation, staff interview and documentation, the hospital failed to establish policies and procedures for the inpatient pediatric satellite unit to ensure food service was adequate to prevent the potential for food borne illness. The findings include:

1. On 7/16/19 during an interview with the FSD (food service director) and the Operations Manager, the surveyor inquired about the meal service procedures for the inpatient pediatric psychiatric satellite unit. The FSD and the Operations Manager indicated that the main kitchen of the hospital supplies the nourishments and meals to the satellite unit. For nourishments, the hospital sends supplies to the unit twice weekly based on a food requisition slip. For breakfast, the patients choose their meals from the food items stocked in the unit's kitchenette. For lunch and supper, the hospital transports these two meals meals to the unit daily via courier.

2. On 7/17/19 the surveyor observed the lunch meal procedure for the inpatient pediatric psychiatric satellite unit. The hospital kitchen staff prepared and packaged the lunch meal in the main hospital kitchen. At 10:44 A.M., the kitchen staff placed the hot food (hamburgers, french fries) for the patients, into pans and then into an insulated covered container. Staff placed cold foods (a sandwich for 1 patient) into an individual disposable container and then into an insulated covered container with added ice packs. Staff placed a frozen microwavable dinner for 1 patient and a salad into an insulated covered container with ice packs.

At 10:46 A.M. the FSD (food service director) transported the food containers to the loading dock for pick up by the courier. At 11:06 A.M. the courier arrived. After the courier returned empty food containers to the main kitchen, he returned to the loading dock and placed the food containers into his vehicle. At 11:19 A.M., the courier drove to the inpatient unit located approximately 10 minutes from the hospital. At 11:31 A.M., the food arrived at the satellite unit. The courier transferred the food containers to a transport cart and brought the food up to the unit via the elevator.

At 11:34 A.M., when the food arrived on the unit, a staff member brought the food to the dining room/kitchenette and placed the hot food on the counter and the cold food into the refrigerator. The staff member did not uncover the hot food until the patients arrived for the meal at approximately 12:00 Noon.

3. During observation of the lunch service, the surveyor inquired about checking the food temperatures. The staff member indicated that the unit did not have a food thermometer to check the food temperatures.

4. The surveyor observed the dining room/kitchenette had a dishwasher. The staff member indicated that serving utensils and baking sheets are washed in the dishmachine. The surveyor inquired about the operation of the dish machine and if staff monitor the dishmachine to ensure that the serving utensils and baking sheets are effectively sanitized. The director of the unit did not have any information about the proper operation of the dishmachine.

5. On 7/17/19 at 1:15 P.M. during an interview, the FSD and the Operations Manager acknowledged the Food and Nutrition Department does not have policies and procedures to ensure the food service for the in-patient pediatric satellite unit was adequate to prevent the potential for food borne illness by monitoring holding food temperatures NS proper dish machine washing and sanitizing water temperatures.

Based on observation, documentation review and interview, the hospital failed to ensure that menus meet the nutritional needs for patients on the inpatient pediatric psychiatric satellite unit including 1 sampled patient ( #26 ), in a total inpatient pediatric pscyhiatric population of 8 patients. Findings include:

1. On 7/16/19 at 11:30 A.M., the surveyor requested to review the week's menu for the patients on the inpatient pediatric satellite unit.

The breakfast menu did not include a planned breakfast meal except on the two weekend days. The Dietitian and the Operations Manager said that during the week the patients on the satellite unit choose breakfast from food items stocked in the unit's kitchenette. The food items include: fresh fruit, juice, milk, cereals, breads, peanut butter and yogurt. The Saturday and Sunday breakfast menus listed hot foods such as pancakes, bacon, scrambled eggs and sausage but did not list portion sizes and did not include any beverages such as milk and juice.

The lunch menus did not list any beverages and did not include portion sizes. The Saturday lunch menu listed "tossed salad, sliced tomato, lettuce, wraps". This meal did not indicate a good source of protein or the type of wrap to be served.

The supper menus planned by the Dietitian included a variety of balanced meals but the menus did not list any beverages and portion sizes.

2. Patient #26 had a physician's order for a Gluten Free Diet secondary to Celiac Disease.

Review of Patient #26's breakfast menu for the week indicated no planned breakfast menu to meet the patient's individual nutritional needs for a gluten free diet. The Dietitian said that gluten free bread is sent over with the food requisition twice per week and as needed.

Review of Patient #26's lunch menu for the week listed "gluten free turkey and cheese sandwich" and "carrots" for lunch each day with no variation. The menu did not list any other food items such as beverages, fruits and desserts.

Review of Patient #26's supper menu for the week listed entrees only. The menu did not include beverages, fruits and desserts. The Sunday and Friday supper menus were identical and listed: gluten free pasta and marinara sauce. This meal did not include a protein food.

Patient #26's menu for the week was written on the "vegetarian menu" sheet. The vegetarian menu sheet listed alternate meals such as grilled cheese, pizza, sandwiches, ravioli, macaroni and cheese and ziti. The menu sheet did not indicate that gluten free pasta and bread had to be used in the preparation of these foods to meet the nutritional needs of Patient #26.

Based on observation and interview, the hospital failed to maintain the Food Service Department in a manner to ensure an acceptable level of safety and quality. Findings include:

1. On 7/15/19 at 10:30 A.M. and 1:30 P.M. during a tour of the Food Service Department with the Food Service Director (FSD), the surveyor observed the following:

a. In the dry food store room, the surveyor observed that the air duct foil insulation in the room was in poor condition. The foil insulation was ripped, torn, taped and hanging down in spots. The insulation to the left of the entrance door had pieces of torn insulation hanging and these pieces were in close proximity to food items stored on the top shelf.

b. In the dish room, the high temperature dishmachine had water leaking resulting in water pooling in at least three spots under the dishmachine. A drainage pipe from the machine had a corroded finish and it could not be determined if the water was leaking from the drain lines or condensation.

The FSD (food service director) present with the surveyor during the tour acknowledged the above conditions.

Based on observation and interview, the hospital failed to ensure food products in the main food store room were stored under appropriate lighting, temperature and ventilation conditions based on nationally accepted standards. Findings include:
1 During a tour of the main kitchen on 7/15/19 at 10:40 A.M., the surveyor observed the food store room had dim lighting. The four ceiling lights in the store room did not provide adequate illumination to all areas of the store room. The shelving to the left of the entrance door was in darkness as well as other corners in the room. The surveyor used a flash light to inspect the corners of the room due to the inadequate lighting. The Operations Manager indicated that it is difficult to do inventory in the store room due to the inadequate lighting.

2. During the tour, the surveyor did not observe any temperature monitoring mechanism in the food store room. The store room contained dry food items including canned goods, baking supplies and cereals. Dry foods should be stored between 50 degrees F. (Fahrenheit) and 70 degrees F. to maximize the shelf life of the dry food products according to United States Department of Agriculture guidelines. On 7/15/19 at approximately 1:30 P.M., the FSD (food service director) put a thermometer in the dry food store room to monitor the room temperature.

Observations of the food store room thermometer on 7/15/19 at 2:30 P.M., 7/16/19 at 12:25 P.M. and 7/17/19 at 9:00 A.M. indicated the food store room temperature registered 78 degrees F (Fahrenheit) to 80 degrees F. These readings exceed the USDA guidelines for proper storage temperature of dry food goods.

The hospital failed to ensure there was proper lighting, ventilation and temperature controls in the dry food storage room.

Based on observations of 5 of 5 staff (Physicians #2, #3 #4, Registered Nurses (RN) #1, #2) , records review of 3 Respiratory Therapists (RT) #2, #4 and #5 and one RN (#2) and interviews the Hospital failed to consistently adhere to Infection Control policies and practices including hand hygiene, personal protective equipment, equipment sanitation, medication management, respiratory protection and pool sanitation. Findings included:

1.) The Hospital policy titled Hand Hygiene, dated 2/2018, indicated that hand hygiene was required after touching the patient's surroundings.

The Surveyor observed Physician #3 in the Intensive Care Unit (ICU) at 10:55 A.M. on 7/15/19. Physician #3 and Registered Nurse (RN) #1 were in Patient #5's room interacting with him/her. Both Physician #3 and RN #1 had repeated contact with Patient #5's environment. When Physician #3 and RN #1 exited Patient #5's room neither performed hand hygiene as required by policy.

2.) The Hospital policy titled Isolation Precautions, dated 5/2009, indicated that all personal protective equipment was to be removed at the doorway before leaving the patient's room. The Surveyor observed Physician #4 in the Intensive Care Unit at 11:10 A.M. on 7/15/19. Physician #4 wore a set of gloves while he examined Patient #5. Physician #4 left the patient's room and proceeded to the Nurses station while he continued to wear his gloves. He had a brief conversation with staff then removed his gloves and performed hand hygiene.

The Surveyor again observed Physician #4 in the Intensive Care Unit at 11:25 A.M. on 7/15/19. Physician #4 wore a set of gloves while he examined Patient #6. Physician #4 exited the patient's room wearing his soiled gloves and put his gloved hand into a box of alcohol swabs and proceeded to clean his stethoscope.

3.) The Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration.

CDC has indicated that for all persons who assist others with blood glucose monitoring and/or insulin administration of the following infection control requirements:
· Fingerstick devices should never be used for more than one person
· Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer ' s instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared.

The Surveyor observed RN #2 perform point of care glucose testing for Patient #6 in the ICU at 11:30 A.M. on 7/15/19. After performing the test, RN #2 replaced the glucometer to the holder ready for its' next use. The Surveyor asked RN #2 how often the glucometer was cleaned and she called the laboratory point person to be certain. RN#2 said it was to be cleaned between each use and proceeded to clean the glucometer as required. Rn #2 failed to clean the glucometer after use before replacing it in the clean holder, increasing the potential of cross contamination.

4.) RN #2 was required to administer insulin after she performed glucose testing. RN #2 followed policy to draw up the medication and have the insulin checked by a second RN. When RN #2 went to deliver the medication to Patient #6 she uncapped the syringe using her teeth which is unsafe and unsanitary.

5.) According to the Centers for Disease Control and Prevention (CDC) a respirator fit test (a test that will show if a tight-fitting respirator can be worn by a person without having any leaks) is required before a respirator can be worn thenthe fit test must be repeated yearly or after any physical changes that may affect the fit (weight gain/loss, dental work, etc.)

The Surveyor reviewed the N95 fit testing documentation for RNs and Respiratory Therapists who were included in the Respiratory Protection Team. An N95 mask (respirator) is a safety device that covers the nose and mouth and helps protect the wearer from breathing in potential pathogens and viruses).

A sample of eight Health Care Workers records were reviewed on 7/17/19 and four of the eight sampled had not been N95 fit tested for greater than two years (RN #2, Respiratory Therapist #2, #4 and #5).

6.) The hospital had a therapeutic rehabilitation pool located at the local YMCA. The Surveyor interviewed the Director of Rehabilitative Services while touring the local YWCA at 2:00 P.M. on 7/16/19. The Director of Rehabilitative Services said that the Hospital had a contract with the pool facility for years and ran an aquatic program using the Hospital's rehabilitation staff. The Director of Rehabilitative Services said that she routinely checked the pools sanitation log. The Director of Rehabilitative Services said that rarely she would be contacted by the YWCA staff saying that there was a delay in services because of a sanitation concern. The Director of Rehabilitative Services said there was no formal report to the Hospital's Infection Control staff about pool sanitation abnormalities even though there had been some over the past several months.

The Surveyor reviewed the Infection Control Committee Minutes from the past calendar year. There was no evidence of oversight or reporting of the sanitation conditions of the pool to the committee.



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2. Staff failed to follow aseptic techniques when preparing intravenous medications for injection per Centers for Disease Control (CDC) Standards which state that the access diaphragm (rubber stopper in the top of the medication bottle that staff puts the needle through) of vials should be cleansed using friction and a sterile 70% isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swabs. The diaphragm should be allowed to dry before inserting any device into the vial. This is to prevent cross contamination of intravenous medications and decrease blood stream infections.

During observations in the Operating Room (OR) on 7/16/2019 at 10:20 A.M., the surveyor observed Certified Registered Nurse Anesthetist (CRNA) #1 preparing medication for sedation of Patient #14 prior to surgery.

CRNA #1 removed a vial of 2 milligram (mg) per 2 milliliters (ml) of Versed (a sedative) and without wiping off the septum of the vial with alcohol, withdrew the contents into a syringe and labeled the syringe. CRNA #1 the removed a vial of Fentanyl (a narcotic) and without wiping off the septum of the vial with alcohol, withdrew the contents into a syringe and labeled the syringe.

Prior to the start of surgery, CRNA #1 administered partial doses of both the Fentanyl and Versed to the patient via intravenous route.

During an interview, right after the observation, the perioperative Nurse Manager said the CRNA should have wiped the septums of each vial with a alcohol pad prior to withdrawing the contents of each vial.

3. During observation of a breast reduction surgical procedure for Patient #10, in OR #5 on 7/16/2019 at 10:20 A.M., during the time out procedure, the surveyor observed that the surgeon's (Physician #2) hair was not fully covered under the hair bonnet. The hair was exposed across the entire length of the forehead.

The surveyor told the circulating room Registered Nurse (RN) who took no action. The surgeon proceeded to operate on the patient with her hair exposed over the surgical field, increasing the risk of infection.

During an interview on 7/16/2019 at 2:00 P.M., the perioperative Nurse Manager said all hair should be contained under a hair bonnet during surgery for all staff in the OR.

4. On 7/15/2019 at 12:45 P.M., the surveyor observed hemodialysis RN #1 cleaning a recently used hemodialysis machine while a patient was waiting in a bed next to the machine, to return to the nursing floor. HDRN #1 was only wearing gloves while disinfecting the machine. He did not have a gown, mask or eye protection on.

Review of the dialysis contractor's policy for personal protective equipment, dated 2/14/2018, indicated that during chemical disinfection of the dialysis machine (use bleach to disinfect) staff are required to wear a fluid resistant gown, gloves and face shield with mask or eye protection with mask.

On 7/16/19 at 11:30 A.M., the surveyor observed a used intravenous (IV) bag draining in the sink located in Station A where a patient was receiving Hemodialysis. There was another sink in Station B. Both sinks had dialysate hoses wrapped around the faucets and water spout that drained into a separate pipe. Neither sink was designated as clean or dirty or as a handwashing sink.

When surveyor asked HDRN #2 which sink was the handwashing sink, she said it did not matter, that they used both. She then promptly got up and washed her hands in the sink with the IV bag draining in it.

Infection control practices in a HD unit require a designated handwashing sink to prevent cross contamination with used contaminated patient supplies such as IV's, dialysate jugs, dirty meters, or other disposable patient use items to decrease the chance of spread of blood borne infections in the unit.

Based on records reviewed and interviews, the Hospital failed to delineate surgical privileges and ensure competence for one of one Surgical Technologist/First Surgical Assistant (CSTA) and for two of two Registered Nurse (RN) First Assistants (RNFA #1 and #2) as required. Furthermore, the Certified Surgical Technologist Assistant was practicing outside of his/her state defined scope of practice by suturing. Findings include:

According to the State Regulations at 130.860: Surgical Technology Definitions, a surgical technologist is any person who provides surgical technology services who is not licensed or registered under M.G.L. c. 112, para. 2, 16, 74 or 74A or who is not an intern, fellow, or medical officer who conducts or assists with the performance of surgery. The surgical technology scope of practice is defined as:

(1) collaboration with an operating room circulator prior to a surgical procedure to carry out the plan of care by preparing the operating room, gathering and preparing sterile supplies, instruments and equipment, preparing and maintaining the sterile field using sterile and aseptic technique and ensuring that surgical equipment is functioning properly and safely;
(2) intraoperative anticipation and response to the needs of a surgeon and other team members by monitoring the sterile field and providing the required instruments or supplies;
(3) performance of tasks at the sterile field, as directed in an operating room setting, including:
(a) passing supplies, equipment or instruments;
(b) sponging or suctioning an operative site;
(c) preparing and cutting suture material;
(d) transferring and irrigating with fluids;
(e) transferring, but not administering, drugs within the sterile field;
(f) handling specimens;
(g) holding retractors; and
(h) assisting in counting sponges, needles, supplies and instruments with an operating room circulator.

The regulations do not provide for surgical technologists to operate as assistants to perform surgical tasks such as placement of suture ligatures and /or ties, closure of all wound layers as per the surgeon's directive, dissecting tissue with surgical instruments, use of electrocautery to cut tissue, insertion of drainage tubes and use and application of surgical instruments needed for hemostasis.

Review of the personnel and credentialing file for CSTA (certified surgical technologist assistant) #1 indicated that she was hired in 2015 and initially appointed as an RNFA to the Department of Surgery and given membership to the Medical Staff as support staff. Review of the personnel file indicated CSTA #1 never had any nurses license or professional training as a registered nurse.

On 4/30/2017, CSTA #1 was credentialed and approved by the Board of Trustees again for a two year appointment as a RNFA without the proper qualifications (No RN License and no RN competencies.) The file did contain a certification and evidence of training as a certified surgical technologist assistant from an out of state program. There were no surgical competencies in the file to establish what the CSTA was competent to perform in the OR.

Delineation of privileges were not evident for the credentialing period of 2015- 2019. On 2/28/2019, a new appointment letter was sent to CSTA #1 indicating she was reappointed to the medical staff for a two year period, effective 4/30/2019, as a certified surgical technologist with membership in the medical staff as a support staff.

The signature reappointment page for the 4/30/2019 appointment period indicated the CSTA #1 subspecialty was RN first assistant not certified surgical technologist assistant. This page has approvals signed off by the Chief of Surgery on 1/22/2019, the Credentialing Committee on 2/1/2019, the Medical Executive Committee on 2/8/2019 and Governing Body on 2/28/2019.

All actions were erroneous on the parts of all committees since the CSTA was not a RN first assistant and no delineation of privileges for her role were approved.

The credentialing packet did contain a job description which described the nature of the practice of the CSTA. The job description indicated that for certified surgical technologist there is a requirement that the applicant must be a graduate of an accredited surgical assisting program and be certified by the National Board of Surgical Technology and Surgical Assisting. There was no requirement that the technologist act within the state hospital licensure requirements which defines the scope of practice for a surgical technologist.

The job description included clamping, ligation and cutting of tissue per the surgeon's directive, insertion of drainage tubes, use of electrocautery, open and/or closure of surgical sites under professional supervision, placement of sutures, ligatures and ties, and closure of all wound layers as per the surgeon's directive. The actions of the medical staff and credetialing committe had approved the CSTA as an RNFA not a CSTA on 2/28/2019 so the job description did not match the job category she was approved for.

The job description was signed off by the Chief of Surgery.

Per the Medical Staff appraisal procedures in the Medical Staff Bylaws, each individual practitioner's training, education, experience, and demonstrated competence must be evaluated upon application for privileges at the hospital.

There were no competencies for these surgical practices to ensure the CSTA was knowledgeable and competent to perform these tasks before granting her these privileges.

2. For RNFA #1 and #2, review of the credentialing records indicated there was no delineation of surgical privileges for what parts of surgery they were allowed to perform based on competencies and education in accordance with Medical Staff Bylaws.

a. Review of the RNFA #1 credentialing file indicated he was reappointed to the medical staff Department of Surgery for two years on 12/31/2018 as a RNFA.

RNFA #1's file indicated he graduated from an RNFA program in 2011. There was no surgical competencies in the file, no request for privileges and no delineation of privileges. There was a statement from his supervising physician that his work was satisfactory.

b. Review of the credentialing file for RNFA #2 indicated she was reappointed to to the medical staff as a member of the Department of Surgery for two years on 7/23/2019 as a RNFA.

RNFA #2's file indicated she graduated from an RNFA program in 2011. There was no surgical competencies in the file, no request for privileges and no delineation of privileges. There was a statement from her supervising physician that her work was satisfactory.

The file contained a job description signed by the Chief of Surgery on 4/25/2019. The job responsibilities listed were:

1. recognizes safety hazards and initiates corrective action
2. applies principles of asepsis and infection control
3. applies knowledge of surgical anatomy, physiology and operative technique relative to the operative procedure
4. performs positioning, prepping and draping of patients (done by RN circulator too)
5. provided hemostasis by clamping blood vessels, coagulating bleeding points, ligating vessels and by other means (not defined) as directed by operating physician
6. provides exposure through appropriate use of instruments, retractors, suctioning and sponging techniques
7. handles tissue as directed by operating physician during procedure
8. performs wound closure as directed by operating physician, sutures the peritoneum, fascia, subcutaneous tissue and skin.
9. applies surgical dressings
10. assists with transferring the patient from the OR.

c. During an interview on 7/17/2019 at 10:00 A.M., the Chief of Quality said that the job description serves as the delineation of privileges for the RNFA and CSTA. Review indicated the job descriptions were only approved by the Chief of Surgery and not Medical Executive Committee, the Credentialing Committee and the Board of Trustees which approves all other delineation of privileges for appointment to the Medical Staff.

Based on record review and interview, obstetrics staff failed to follow Hospital policy for completing the four phase time out protocol for one (Patient #1) surgical patient, in a total sample of five surgical patients, in a total sample of 32. Findings include:

Review of C-Section operating room procedure indicated that the Hospital uses a universal time out protocol that has four phases; phase one is a time out done pre-op with the patient either in the patient room (OB) or in the pre-operative area. Identification, procedure, history, site confirmation, allergies etc. area all confirmed with the patient. The second phase is in the OR to confirm, all the safety requirements, right patient, planned procedure etc. The final time out is done while the prep is drying just before incision and includes correct patient, procedure verified, consent, anesthesia consent, confirm allergies, antibiotics given, DVT prophylaxis, concerns, equipment needed in room, fire risk assessment, medications and irrigants on field, blood products available and agreement on sharp handling and verify internal monitors have been removed.

The final phase at the end of surgery is a safety debriefing which includes: procedure performed in records; count status for sponges, needles and instruments is confirmed with all team members; specimens are labeled with patient identifiers, name of specimen, location and laterality and verified with surgeon; surgeon, RN and anesthesia review key medical/surgical concerns for recovery and management of patient; teams reviews Estimated Blood Loss, fluids, blood products and urine output; IV orders for recovery room (confirm Pitocin dose), equipment/supply concerns and wound classification.

Each step in each phase is initialed as done and the circulating nurse that signs that the time out occurred with all team members involved and dates and times each phase.

Review of the medical record indicated Patient #1 had a planned Cesarean section (C-section) on 7/12/2019. Review of the Operating Universal Protocol (time out) documentation, dated 7/12/2019, indicated that the circulating nurse did not initial and sign the safety debriefing section as being completed by the surgical team at the end of the surgery except for the line item that the procedure performed is recorded.

Based on policy review, record review and interview, the Hospital did not include in their surgical consents whether, qualified medical practitioners who are not physicians will perform important parts of the surgery and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges by the Hospital for two of two Registered Nurse First Assistants (RNFA #1 and RNFA #2) and for one Certified Surgical Technician Assistant (CSTA #1).Findings include:

1. During an interview on 7/16/2019 at 9:20 A.M., RNFA #2 said she had worked as a RN first assistant for 30 years and her duties included assisting with anesthesia as needed.

Review of RNFA #2 credentialing file indicated no privileges to assist with anesthesia.

On 7/16/2019 at 10:30 A.M., the Surveyor observed RNFA #1 assist during the breast reduction surgery for Patient #14. RNFA #2 was observed to dissect tissue from the underlying structures of the left breast while the surgeon worked on the right breast.

During an interview on 7/16/2019 at 10:00 A.M., the Perioperative Manager indicated they had a Certified Surgical Technician Assistant (CSTA #1) on the OR staff who was away on vacation and not available.

2. Review of the Hospital's consent policy only indicates that surgical procedures require an additional consent. On 7/16/2019, the Surveyor asked for any policies and procedures for surgical consents and the Chief Quality Officer said that surgical services uses the same informed consent policy that was provided to the survey team.

Review of the informed consent policy did not specify the content of written informed consent or how the provider was to document informed consent in the clinical record.

Review of Patient #14's surgical consent for bilateral breast reduction did not contain any information that RNFA#1 was going to be performing parts of the surgery to include dissection of the breast tissue and wound closure. The consent only mentioned the name of the surgeon performing the procedure and "whomever he/she may designate as his/her assistant to perform upon [patient] the following operation/procedure [name of surgery]." Review of the surgeon's progress notes did not indicate that the surgeon informed the patient of the RNFA's participation in the surgery.

The consent was obtained in the surgeon's office on 6/25/2019 and was not signed by the surgeon at that time only by the patient and a witness who did not indicate a licensure status on their signature. The surgeon signed the consent on the day of surgery, 7/16/2019 at 9:40 A.M.

During an interview on 7/16/2019 at 11:30 A.M., the Perioperative Manager said they do not put the RNFAs or the CSTA in the surgical consents with the parts of the surgery they will be performing.