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115 WEST SILVER STREET

WESTFIELD, MA 01085

GOVERNING BODY

Tag No.: A0043

Based on observations, staff interview and review of documentation, the Hospital failed to have an effective Governing Body (GB) who is legally responsible for the conduct of the Hospital by failing to ensure the Hospital delivered the services on its state license or notifying the state in a timely manner that those services would no longer be available at the Hospital and the GB failed to ensure its contracted services provided staff who were properly credentialed to provide care in the hospital.
Finding include:

1. Review of the Board of Trustees (GB) meeting minutes,dated 9/12/208, indicated that this Hospital (Hospital #1), over the past three years, has affiliated with Hospital #2 and all service lines have been integrated with Hospital #2 except nursing.

During an interview on 3/11/2019, the Hospital Administrator said that the pediatric six bed unit had been closed for over three years. When asked if the Department of Public Health, who licenses the Hospital, had been notified in writing as required, the Administrator said she would check. Later, the Administrator said she spoke with the Hospital lawyer who said the lawyer had spoken with someone previously at DPH but had no written notice to show as evidence.

On 3/12/2019, at 10:00 A.M., the Surveyor observed the closed pediatric bed spaces with the Director of Patient Care Services. Of the four pediatric rooms, Room 215 was converted to the dialysis suite, Rooms 214 and 218 were unused and vacant two bed rooms and room 217 had been converted to the Nursing Administration Office.

The Surveyor interviewed the Chief Medical Officer (CMO) at 10:30 A.M. on 3/12/2019. The CMO said that the six bed licensed Intensive Care Unit (ICU) had been transitioned over six months ago to an intermediate care unit and no longer cared for ICU level patients. The CMO said the unit would not care for any patient who would require a ventilator. The State Hospital License indicated six ICU beds.

Review of the Medical Staff Executive Committee (MSEC) meeting minutes indicated that the ICU moved to intermediate or step down care in 9/2018.

On 3/13/2019 at 2:00 P.M., the Hospital Administrator said the Department of Public Health, who licensed the Hospital, was not notified of this change in the status of the ICU beds.

During the entrance conference on 3/11/2019 at 9:00 A.M., the Hospital Administrator said that the Hospital is currently not providing dialysis services as the contracted service was terminated on January 1, 2019 and they are trying to replace the contract.

Review of the MSEC meeting minutes, dated 10/3/2019, indicated that the contracted dialysis services terminated the contract in October 2018 and the plan was to not admit a patient to the Rehabilitation Unit unless they were able to be transported to their outpatient dialysis unit.

In further interview on 3/13/2019, the Hospital Administrator said the Department of Public Health had not been notified of the discontinuance of the dialysis service as they were trying to replace it; however, the service had not been provided since 10/1/2018.

Review of the Hospital's public website indicated that intensive care remains as a service provided by this Hospital.


2. Based on review of staffing in the operating room and review of the medical staff by laws, the Hospital 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 when the Medical Staff failed to credential and approve the practice of two Certified Surgical Technologists/Surgical First Assistants as practitioners.

See A-0339

3. Based on record review and interview, the Hospital credentialing process failed to hold the contracted Emergency Room services accountable for ensuring one Nurse Practitioner (NP #1) working in the Emergency Room, was properly credentialed in accordance with the Hospital's medical staff by laws to have Pediatric Advanced Life Support (PALS) and Advanced Cardiac Life Support (ACLS) certification.

See A-O341

4. Based on observations, records reviewed and interviews, the Hospital failed to provide well organized surgical services in accordance with acceptable standards of practice when it failed to ensure a general surgeon was consistently available on-call to perform emergent or urgent surgical procedures; the Hospital used Surgical Technologists to perform parts of surgery without authorization of the Governing Body and not consistent with State Law, without knowledge of the patient and outside of the scope of practice of Surgical Technologists' in the state.

See A-094, A-0941, A-0945 and A-0955

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0206

Based on records reviewed and interviews, the Hospital failed to ensure that all staff who apply restraints or seclusion, monitor, assess or provide care for a patient in restraint or seclusion received education and training in the use of first aid techniques as well as training and certification in the use of cardiopulmonary resuscitation (CPR). Findings include:

The Surveyor interviewed the Nurse Coordinator at 8:37 A.M. on 03/13/19. The Nurse Coordinator said that Hospital staff authorized to apply restraints included security personnel and Constant Companions (staff employed to provide 1:1 supervision to patients). The Nurse Coordinator said security personnel and Constant Companion staff were not required by the Hospital to have CPR certification or first aid training.

The Surveyor interviewed the Security and Support Services Director at 11:00 A.M. on 03/11/19. The Security and Support Services Director said that security personnel did not have first aid training.

The Surveyor interviewed Patrol Officer #1 at 9:30 A.M. on 03/11/19. Patrol Officer #1 said he had CPI (Crisis Prevention Institute; nonviolent crisis interventions including the application of restraints) training and Basic Life Support (BLS) certification. Patrol Officer #1 said he did not have first aid training.

The American Heart Association (AHA) indicates that BLS training does not include first aid techniques.

Review of the Hospital's Restraints, Non-Psychiatric Units policy and procedure, revised 03/2018, indicated that it included guidelines for staff on the appropriate use and monitoring of all patient restraints. The Policy did not indicate that staff involved in the use of patient restraints would receive education and training in the use of first aid techniques as well as training and certification in the use of CPR.

Review of the Hospital's Patient Care and Treatment policy and procedure, reviewed 10/2018, indicated that it did not include for staff involved in the use of patient restraints to receive education and training in the use of first aid techniques as well as training and certification in the use of CPR.

Documentation provided by the Hospital indicated the employment of 13 security personnel, including the Security Supervisor, Patrol Officer #1, Patrol Officer #2, and Patrol Officer #3.

Review of the Hospital's Job Description - Leader, dated 07/21/17, indicated that the Security Supervisor had the primary responsibility for the competency of assigned security officers. The Description indicated that any job requiring CPR must have a minimum of Health Care Provider CPR training (CPR and AED) unless otherwise specified in the Certification section. The Certification section did not indicate any alternate specifications.

Review of the Security Supervisor's personnel file indicated that he was hired in January 2017. The file indicated that, on 01/26/17 and 02/19/19, he demonstrated competencies including the set-up of CPI/restraint, Hospital emergency codes, including the code indicating the need for a patient restraint and restraint procedures. The file did not indicate that the Security Supervisor was educated and trained in the use of first aid techniques, or trained and certified in the use of CPR.

Review of the Hospital's Job Description - Employee, dated 03/13/17, indicated that the Patrol Officer duties included, but were not limited to, response to emergency codes and the handling of disruptive situations, including the employ of crisis intervention techniques and the demonstration of understanding of restraint protocols. The description indicated that any job requiring CPR must have a minimum of Health Care Provider CPR training unless otherwise specified in the Certification section. The Certification section did not indicate any alternate specifications.

Review of Patrol Officer #1's personnel file indicated that he was hired in January 2017. The file indicated that on 01/26/17 and 02/15/19, he demonstrated competencies including: the set-up of CPI/restraint, Hospital emergency codes, including the code indicating the need for a patient restraint and restraint procedures. The file did not indicate that the Security Supervisor was educated and trained in the use of first aid techniques, or trained and certified in the use of CPR.

Review of Patrol Officer #2's personnel file indicated that he was hired in January 2017. The file indicated that on 01/24/17 and 02/21/19, he demonstrated competencies including: the set-up of CPI/restraint, Hospital emergency codes, including the code indicating the need for a patient restraint and restraint procedures. The file did not indicate that the Security Supervisor was educated and trained in the use of first aid techniques, or trained and certified in the use of CPR.

There was no documentation to support that the Hospital ensured that all staff involved in the use of patient restraints also had CPR certification and first aid training.

ELIGIBILITY & PROCESS FOR APPT TO MED STAFF

Tag No.: A0339

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 when the medical staff failed to credential and approve the practice of two Certified Surgical Technologists/Surgical First Assistants as practitioners.
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.

Review of the Medical Staff Bylaws, dated as reviewed last on 11/13/2018, did not indicate the Certified Surgical Technologists/Surgical First Assistants were approved to be practitioners in the Hospital nor were they privileged to provide surgical services beyond the scope of a surgical technician to Hospital patients. The Bylaws defined Associate Health Professional as an individual other than a licensed physician applying for or exercising delineated clinical privileges at the associated health professional staff level. The Bylaws further defined clinical privileges as meaning the permission granted to an individual to perform at the Hospital those diagnostic, therapeutic, medical or surgical services specifically delineated to him/her.

Review of the operating room schedules indicated there were two Certified Surgical Technologists/Surgical First Assistants. The category of Certified Surgical Technologists/Surgical First Assistants is not recognized in this state.

Review of the personnel files for the two Certified Surgical Technologists/Surgical First Assistants indicated they had not been credentialed by the medical staff to practice surgery in the Hospital as required.

Review of the job description in the Certified Surgical Technologists/Surgical First Assistant #1's personnel file indicated the surgical technician could perform the following surgical procedures as examples: application of chemical hemostatic agents (medications administered into wounds to stop bleeding), clamping and/or cauterizing of vessels or tissues, tying or ligating vessels or tissue, use of electrocautery mono and bi-polar (application of a needle heated by an electric current to destroy or cut tissue), closure of wound all layers and insertion of drainage tubes per surgeon's directive. The job description did not indicate who or what department approved the job description only that Certified Surgical Technologists/Surgical First Assistants "performs designated tasks in accordance with Hospital policy and appropriate laws and regulations."

See A-0945

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on record review and interview, the hospital credentialing process failed to hold the contracted Emergency Room services accountable for ensuring one Nurse Practitioner (NP #1) working in the Emergency Room, was properly credentialed in accordance with the Hospital's Medical Staff Bylaws.
Findings include:

Hospital Medical Staff Bylaws dated, 11/13/2018, indicated that a practitioner who is or will be providing professional services pursuant to any employment or other contract between the practitioner and the Hospital or affiliated entity must meet the same membership qualifications, must be evaluated for appointment, reappointment and clinical privileges in the same manner, must fulfill all the obligations of his or her Medical Staff category and must abide by all Medical Staff and Hospital Bylaws, policies, procedures, standards, rules and regulations with respect to Medical Staff membership and the exercise of clinical privileges as any other applicant or Medical Staff member.

Review of Hospital contracted services indicated that the contracted emergency room physician services to include nurse practitioners (NPs) and physician assistants (PAs) were provided by a contract service. Review of the contract indicated that the physician's in the Emergency Room were required to have Advanced Cardiac Life Support (ACLS) and Pediatric Advance Life Support (PALS) certification.

The Surveyor interviewed Emergency Department (ED) Nurse Practitioner #1 at 11:15 A.M. on 3/11/19. ED Nurse Practitioner #1 said that she was not certified in ACLS or PALS.

Credential files for Nurse Practitioner #1 indicated that NP #1 was most recently appointed to the Active Medical Staff on 2/1/18 and is due for reappointment before 2/1/20. The credentialing files indicated she did not have ACLS or PALS.

The Surveyor interviewed the Chief of Emergency Medicine on 3/13/19 at 12:20 P.M. The Chief of Emergency Medicine said that all ED physicians are required to be certified in ACLS and PALS but the nurse practitioners or physician assistants are not required to have these certifications.

This is not consistent with the requirements of appointment to the Medical Staff for all practitioners providing professional services by contract who must meet the same membership qualifications and must abide by all Medical Staff and Hospital Bylaws, policies, procedures, standards, rules and regulations.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on observations and interview the Hospital failed to adhere to their policies and accepted standards of care for patient positioning for one (Patient #35) out of 38 sampled patients.

Findings include:

The Hospital's policy titled "Patient Positioning, Supine or Prone"(no date) indicated that pulling or sliding the patient can result in shear or friction injury to the patient.

Surveyors observed Nurse #13 change Patient #35's wound dressing at 9:47 A.M. on 3/19/19. Nurse #13 entered Patient #35's room, explained to Patient #35 that she was going to change his/her dressing. Nurse #13 asked Patient #35 to roll onto his/her left side and then pulled the pull sheet under Patient #35 to position the his/her body. During the dressing change Nurse #13 proceeded to pull the draw sheet from underneath Patient #35 on two more separate incidents creating a shearing action between Patient #35's body and the pull sheet.

Surveyors met with the Assistant Nurse Manager at 9:00 A.M. on 3/19/19. The Assistant Nurse manager acknowledged that the policy and expectation for nurses who position patients is to use the pull sheet to lift the patient and not to pull it out from under the patient. The Assistant Nurse Manager said that Nurse #13 should have used another staff member to assist in positioning Patient #35.

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on observation, record review and interview, Hospital staff failed to provide appropriate intravenous (IV) care consistent with Hospital policies and procedures to two (Patient #1 and Nonsampled Patient A) patients observed in a total sample of 38 patients.
Findings include:

The Surveyor requested the Hospital's policy on IV care on 3/13/19. The Hospital provided the policy and procedure titled, "BH Guide to Intravascular Access for Adults and Pediatrics" stating this was their IV care policy. The policy and procedure came from an affiliated hospital (Hospital #2).

According to the policy and procedure, all IV starts will be labeled with start date, catheter gauge and inserter's initials. All peripheral IVs will be covered with a clear occlusive dressing.

1. On 3/11/2019 at 12:15 P.M., the Surveyor observed Patient #1 while sitting in the bedside chair. The patient had a peripheral IV in the right antecubital (elbow) space in which IV Lasix (a diuretic) was running via a pump at 10 milliliters per hour. The insertion site of the IV was not covered by an occlusive dressing but had two strips of clear plastic tape that were loose. The site was not labeled with the date, catheter gauge and inserter's initials as required.

On 3/12/2019 at 8:55 A.M., the Surveyor returned to Patient #1's bedside and observed that the IV was no longer in the right antecubital space. Patient #1 stated that staff went to check it the night before and "it fell right out" and needed to be restarted. The new IV was placed in the right forearm and was observed to be properly labeled.

2. On 3/12/2019 at 9:10 A.M., the surveyor observed Nonsampled Patient A while he/she was lying in bed. The patient had an IV running with 10 mEq of potassium (nutritional supplement) through a pump into the left antecubital space. Nonsampled Patient A said the IV was put in while she/he was in the Emergency Room. The IV was taped with two pieces of clear tape and had a date of 3/10/2019 written on it but no gauge of the needle inserted or initials of the inserter as required.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, records reviewed and interviews the Hospital failed to consistently adhere to their policies and accepted standards of care for the employee respiratory protection program for three registered nurses reviewed (RN #10, RN #11 and RN #12) and for performance of hand hygiene for two staff (Cook #1 and Nurse #38). In addition, facility dietary staff failed to ensure safe and adequate sanitation practices were maintained to minimize the risk for food borne illness. Findings included:

1.) The Surveyor toured the Intensive Care Unit (ICU) at 10:25 A.M. on 3/11/19. The Surveyor interviewed Registered Nurse (RN) #12 about the Respiratory Protection policies in the ICU. RN #12 said that all of the staff in the ICU were "fit tested" (A fit test is a protocol conducted to verify that an N95 respirator is both comfortable and correctly fits the user.) yearly during the staff's birthday month. RN #12 said she could don an N95.

The Surveyor interviewed RN #11 in the ICU at 10:40 A.M. on 3/11/19. RN #11 said she would be able to don an N95 also.

The Surveyor toured the peri-operative area at 8:00 A.M. on 3/12/19. The Manager of the Operating Room (OR) said his staff were all fit tested to the N95 annually during their birthday month.

The Surveyor interviewed RN #10 in the Post Acute Care Unit containing the bronchoscopy suite at 9:30 A.M. on 3/12/19. RN #10 said that she could assist with a bronchoscopy because she was fit tested to the N95 mask.

The Surveyor reviewed the personnel records for RN #10, #11 and #12 at 1:00 P.M. on 3/13/19. RN #10 and #11 records indicated that they had had been fit tested that day.

An additional random sample of twelve personnel records indicated of twelve staff included in the Hospital's respiratory protection team, seven had evidence of fit testing prior to Survey and five had been fit tested on 3/13/19.




31240

2.) Review of the Food Services Department that included observations and interviews, indicated the facility dietary staff failed to ensure safe and adequate sanitation practices were maintained to minimize the risk for food borne illness.

Review of the facility's Disposable Glove Use Policy, revised 1/2018, indicated the following;
-Hands must be washed before putting on and removing disposable gloves when working in the kitchen.
-Disposable gloves must be changed and hands washed when the gloves are dirty or ripped, and when moving from one task to another.

Review of the facility's Trayline/Taste Temperature Policy, revised 1/2017, indicated the following;
-Two temperatures must be noted on the form, a beginning and either a mid-point or ending temperature. Take immediate action if temperatures indicate a violation of Hazard Analysis Critical Control Point (HACCP) procedures.
-The Taste/Temperature Record is completed prior to and throughout the meal assembly process.

A. During an observation on 3/11/19 at 12:20 P.M., Cook #1 was observed placing an uncooked hamburger patty on a grill using his right gloved hand. The Surveyor observed him remove his right glove using his left gloved hand. He did not wash his hands and only donned a new glove to his right hand. The cook was then observed handling additional food items with both gloved hands.

B. During an observation of the main kitchen on 3/11/19 at 12:50 P.M.with the Food Service Director (FSD), the following concerns were observed;
-The outside of the large soup kettle was dirty with dried on food spills.
-The wall behind and next to the pot sink was dirty with dried food splashes.
-Multiple pans on the drying rack were stacked together wet and had pooled water in their rims.
-A gallon bottle of soy sauce, one third filled, was stored on a shelf. The label indicated to refrigerate after opening.
-There was a box of hamburger patties and sausages, open to the air, stored on a shelf in the freezer.

C. During an observation of lunch service on 3/12/19 at 11:30 A.M., with the Clinical Nutrition Director and FSD, the following concerns were observed;
-Review of the facility's 3/12/19 Taste and Temperature Report indicated a start time of 11:30 A.M. and hot entree food temperatures were documented. Additionally, mid temperatures were also documented. The report also indicated quality checks were done at the start of service and mid service. Cook #1 said the mid temperatures documented were only estimates of what he thought the temperatures would be and were not actual recorded temperatures.
-During the lunch meal service, Cook #1 was observed moving between meal service and handling non-food items with his gloved hands. While wearing the same gloves he was observed wiping his hands on a rag, using a pen, opening packets of precooked foods, and using stove top equipment. He returned to the tray line to serve food without changing his gloves, washing his hands and donning new gloves. When returning to the tray line he was observed touching food with the same dirty gloves.

D. During an observation of the main kitchen on 3/12/19 at 2:17 P.M., with the FSD, the following concerns were observed;
-The outside of the soup kettle remained dirty with food splashes.
-The wall behind and next to the pot sink remained dirty with food splashes.
-Pans were stacked together while wet on a storage rack.
-The same box of hamburger patties and sausages remained stored on the shelf in the freezer, and were still open to the air.

During an interview on 3/12/19 at 2:35 P.M., the FSD said Cook #1 should not have documented food temperatures that had not actually been obtained. The FSD said the cook should not have handled or touched food with his dirty gloved hands. The FSD said the cook should have taken his dirty gloves off, washed his hands and donned new gloves after moving between tasks during the meal service. The FSD said proper sanitation, cleaning and hand hygiene would be reviewed with the staff.



37331

3. Review of the Hospital's policy titled "Dressing: Dry and Moist to Dry" (no date) indicates that after a wound is cleaned the nurse will remove gloves, perform hand hygiene, and don clean gloves to place the dry dressing.

The Surveyor observed Nurse #13 change Patient #35's wound dressing at 9:47 A.M. on 3/19/19. Nurse #13 entered Patient #35's room, explained to Patient #35 that she was going to change his/her dressing. Nurse #13 donned gloves, removed Patient #35's dressing and assessed the wound as a Stage II pressure injury. Without changing gloves and performing hand hygiene, Nurse #13 then proceeded to clean the wound with a moist gauze and disposed of the gauze. Nurse #13 then opened the clean dressing and placed it on Patient #35's wound.

The Surveyor met with the Assistant Nurse Manager on 3/19/19 at 9:00 A.M. The Assistant Nurse Manager acknowledged that the policy and expectation for nurses who provide wound care is that they wash their hands and change gloves after cleaning a wound ( a dirty task) and before placing a clean dressing.

OPO AGREEMENT

Tag No.: A0886

Based on record review and staff interview, the Hospital failed, for five of five deceased patient records (Deceased Patient Record #1, #2, #3, #4 and #5) to ensure that the Organ Procurement Organization (OPO) was notified timely when the death of a patient was imminent. Findings include:

The Hospital policy, Organ and Tissue Donation: Death/Dying/Organ Donation, revised 9/2017, indicated that, when death is imminent, the Registered Nurse/Licensed Practical Nurse caring for the patient will contact the OPO to determine whether the dying or deceased patient is a suitable candidate for donation.

Review of five deceased patients' medical records indicated that the patients were all removed from life support and the OPO was not notified until after the Physician pronounced the patient's death.

Deceased Record #1 indicated that the OPO was notified after the Patient was removed from life support and the physician pronounced death on 1/1/19.

Deceased Record #2 indicated that the OPO was notified after the Patient was removed from life support and the physician pronounced death on 1/31/19.

Deceased Record #3 indicated that the OPO was notified after the Patient was removed from life support and the physician pronounced death on 2/2/19.

Deceased Record #4 indicated that the OPO was notified after the Patient was removed from life support and the physician pronounced death on 1/31/19.

Deceased Record #5 indicated that the OPO was notified after the Patient was removed from life support and the physician pronounced death on 2/22/19.

The Surveyor interviewed Nurse #4 at 11:00 A.M. on 3/12/19. Nurse #4 said that the nurses do not call the OPO until after the physician has pronounced the patient's death.

The Surveyor interviewed the Director of Inpatient Services, who is responsible for the Hospital's OPO program, at 11:45 A.M. on 3/12/19. The Director of Inpatient Services said that as soon as a patient's death is pronounced, the nurse is expected to call the OPO and inform them of the death.

The Surveyor interviewed Nurse #5 at 8:45 A.M. on 3/13/19. Nurse #5 said that the nurses call the OPO after the physician has pronounced a patient's death.

The Surveyor interviewed the Director of Inpatient Services at 9:10 A.M. on 3/13/19. The Director of Inpatient Services said that the nurses always wait until the physician pronounces death and they don't follow the policy because it's the culture of the Hospital to wait until pronouncement of death.

SURGICAL SERVICES

Tag No.: A0940

Based on observations, records reviewed and interviews, the Hospital failed to provide well organized surgical services in accordance with acceptable standards of practice.
Findings included:

The Hospital failed to ensure a general surgeon was consistently available on-call to perform emergent or urgent surgical procedures. The Hospital used Surgical Technologists to perform parts of surgery without authorization of the Governing Body, without knowledge of the patient and not consistent with state law regarding what Surgical Technologist were allowed to do.

1. The Hospital failed to consistently meet the surgical needs of patients requiring emergent or urgent surgical procedures by providing an on-call general surgeon and numbers of qualified personnel necessary to furnish the surgical services offered by the Hospital in accordance with acceptable standards of practice and failed to provide specialized training to meet the care needs of the pediatric population.

See A-0941

2. The Hospital failed to delineate surgical privileges and ensure competence for one of one Surgical Technologist/First Surgical Assistants as required.

See A-0945

3. The Hospital failed to provide a disclosure of surgical staff participation as a Surgical Technologist First Assistant for this patient's surgical procedure for one (Patient #32) of one appropriate surgical record, in a total sample of 38.

See A-0955

ORGANIZATION OF SURGICAL SERVICES

Tag No.: A0941

Based on records reviewed and interviews the Hospital: 1.) failed to consistently meet the surgical needs of patients requiring emergent or urgent surgical procedures by providing an on-call general surgeon and numbers of qualified personnel necessary to furnish the surgical services offered by the Hospital in accordance with acceptable standards of practice and 2.) failed to provide specialized training to meet the care needs of the pediatric population.
Findings included:

1.) The Surveyor reviewed the Hospital's surgical on-call schedule at 4:00 P.M. on 3/11/19. The Hospital's surgical on-call schedule, dated January thru March 2019, indicated that one of the general surgeons assumed numerous on-call surgical shifts and three other surgeons assumed rotating weekend call. The Hospital's surgical on-call schedule further indicated that "BMC" (Hospital #2) assumed all of the remaining surgical on call coverage.
For example:
In January 2019, there were 12 days with no general surgery coverage after 5:00 P.M. On four days, there was only phone coverage after 5:00 P.M. One surgeon took six straight days with 24 hours general surgery coverage.
In February 2019, there were seven days with no general surgery coverage after 5:00 P.M. On four days, there was only phone coverage after 5:00 P.M. One surgeon took seven straight days with 24 hours general surgery coverage.
In March 2019, there were nine days with no general surgery coverage after 5:00 P.M. and four days with only phone coverage after 5:00 P.M. One surgeon took seven straight days of 24 hour general surgery coverage followed by five days of general surgery coverage until 5:00 P.M.

The Surveyor interviewed both the Director of Surgical Services and the Manager of the Operating Room (OR) at 7:15 A.M. on 3/12/19. The Manager of the Operating Room said that the OR on-call schedule provided anesthesia coverage, a Surgical Tech, an OR Registered Nurse (RN) and a second RN for pre-operative and post-operative care available 24/7/365. The Manager of the Operating Room said one of the Hospital's general surgeons provided the "lion's share" of Hospital coverage and much of the remaining surgical coverage was provided by another Hospital (Hospital #2) approximately ten miles away. The Manager of the Operating Room said the last urgent/emergent OR case was performed in December 2018. The Manager of the Operating Room said that cases were usually booked from 7:00 A.M. until 3:00 P.M. and the OR was generally on-call by 5:00 P.M.

The Director of Surgical Services said she was unaware of any notification to the local ambulance company of the times that the Hospital was being covered by Hospital #2. The Director of Surgical Services said the urgent orthopedic cases might undergo surgery during on-call hours as determined by the orthopedic surgeon. The Director of Surgical Services said a potential surgical patient in the Emergency Department did not have a surgical consult here at the Hospital but that she believed a phone consult took place from the Emergency Department Physician to the surgeon at the receiving Hospital prior to transfer to Hospital #2.

The Surveyor interviewed the Director of Surgical Services again at 8:00 A.M. on 3/13/19. The Director of Surgical Services said that the surgical coverage arrangement had been in place since the Hospital became affiliated with Hospital #2, a couple of years earlier.

2.) The Surveyor toured the Peri-operative area 7:15 A.M. until 11:15 A.M. on 3/12/19 and interviewed both the Director of Surgical Services and the Manager of the Operating Room (OR). The Manager of the Operating Room said that the surgical service did include pediatric plastic surgery and that staff training and education included annual pediatric training.

The Surveyor reviewed the training and education record for RN #10, a Post-Anesthesia Nurse at 1:00 P.M. on 3/13/19. RN #10's record indicated a recent review of adult and pediatric airway assessment but she had no additional pediatric specialty training.

The Surveyor reviewed the training and education record for Surgical Technologist/First Assistant #1 at 1:15 P.M. on 3/13/19. Surgical Technologist/First Assistant #1's record indicated a recent review of adult and pediatric airway assessment but she had no additional pediatric specialty training.

The Surveyor requested additional pediatric centered training for the OR staff from the Quality Manager but she said there were no additional records.

SURGICAL PRIVILEGES

Tag No.: A0945

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 as required. Furthermore, the role of Surgical Technologist/First Surgical Assistant was practicing outside of her state defined scope of practice by suturing.

1.) The Surveyor interviewed Surgical Technologist/First Surgical Assistant (STFA #1) at 9:40 A.M. in the Operating Room (OR). The STFA #1 said she had been with the Hospital for a number of decades. The STFA #1 said she started out as a Surgical Technologist but learned to be a First Surgical Assistant and as soon as the certification exam was available, she sat for the exam and became certified. The STFA #1 said that in order to maintain her certification she was required to have a certain amount of yearly continuing education to maintain her certification.

The Surveyor requested all of the available information on the STFA #1 for review on 3/13/19. The Hospital provided a job description and the STFA #1's certification but no surgical privileges or competencies were made available for review.

2.) The Surveyor observed the preparation of Operating Room (OR) #2 for a planned procedure for Patient #32. The Surveyor observed the pre-procedure activities and observed the time out process completed by the Surgical Team.

The Surveyor left OR Room #2 and was almost immediately followed by Patient #32's surgeon who said that the procedure was very quick.

The Director of Surgical services said the surgeon was correct that the type of surgery performed on Patient #32 takes only a few moments and that now STFA #1 would be closing (suturing) the incision.

According to the State Regulations at 130.860: Surgical Technology Definitions, the scope of practice included:

(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.

Based on interview, the Hospital's Surgical Technologist/First Surgical Assistant was outside of her scope of practice when she sutured Patient #32's surgical incision.

INFORMED CONSENT

Tag No.: A0955

Based on records reviewed and interviews the Hospital failed to provide a disclosure of surgical staff participation (a Surgical Technologist First Assistant) for this patient's surgical procedure for one of one appropriate surgical record (Patient #32), in a total sample of 38. Findings included:

The Surveyor observed the preparation of Operating Room (OR) #2 for a planned procedure for Patient #32. The Surveyor observed the pre-procedure activities and observed the time out process completed by the Surgical Team.

The Surveyor left OR Room #2 and was almost immediately followed by Patient #32's surgeon who said that the procedure was very quick.

The Director of Surgical services said the surgeon was correct that the type of surgery performed on Patient #32 takes only a few moments and that now Surgical Technologist/First Assistant #1 would be closing (suturing) the incision.

The Surveyor reviewed the Surgical Consent for Patient #32 at 10:30 A.M. on 3/13/19. The Surgical Consent form allows for the practitioner's name and assistant to be completed prior to the patient signing the form. The Surgical consent did not include Surgical Technologist/First Assistant #1 as a surgical assistant as required.

The Surveyor interviewed the Director of Surgical Services at 1:45 P.M. on 3/13/19 to discuss completion of the informed consent and the Director of Surgical Services said she realized that the Surgical Technologist/First Assistant #1 had participated in the procedure but it was not apparent in Patient #32's medical record.

ORDERS FOR OUTPATIENT SERVICES

Tag No.: A1080

Based on interview and record review it was determined the Hospital failed to ensure the Hospital had policies/procedures and Medical Staff Bylaws adopted by the Medical Staff and approved by the Governing Body for non-credentialed providers who were ordering outpatient treatments for their patients.

Findings include:

The Surveyor interviewed the Program Director for Rehabilitation Services at 11:00 A.M. on 3/11/19. The Program Director said when referrals or orders were received from non-familiar providers, the Outpatient Office Staff would call the provider's office for verification. The Program Director said there were no policies or procedures, he was aware of, which outlined the process for non-credentialed providers who ordered Out-patient Services.

The Medical Staff Bylaws were reviewed at 10:00 A.M. on 3/13/19. The Medical Staff Bylaws did not indicate the medical staff and the Governing Body adopted and permitted a process to allow non-credentialed providers to order specific outpatient services for their patients and whether or not it applied to all Hospital outpatient services, or whether there were specific services for which orders may only be accepted from practitioners with medical staff privileges. For example, the Hospital may prefer not to accept orders for a regimen of outpatient chemotherapy or outpatient therapeutic nuclear medicine services from a referring physician who does not hold medical staff privileges. In such cases, the Hospital's policy must make these exceptions clear to the general authorization for accepting orders from referring practitioners.

The Surveyor interviewed the Chief Medical Officer at 10:30 A.M. on 3/14/19. The Chief Medical Officer said he was unaware the Medical Staff Bylaws, Rules and Regulations did not contain a process for the Hospital to accept outpatient treatment orders from non-credentialed Providers.