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Based on observation, review of facility documentation, interviews, contracted service reports and policy review it was determined that the hospital failed to meet the Condition of Participation for Governing Body as evidenced by:


1. The Governing Body did not ensure that services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified include: Quality Assessment and Performance Improvement (QAPI), Pharmaceutical Services, Physical Environment, and Infection Control.


Please refer to A-83, A-263, A-283, A-490, A-492, A-501, A-700, A-701, A-747 and A-749.

1. Based on observation, review of governing body meeting minutes, certification reports from Contractor #1, interviews, and policy review, the Governing body failed to ensure that quality services were rendered by Company #1 who provided pharmaceutical services for the hospital. The findings include:


a. During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy (Contractor #1) and Infection Preventionist (IP) the anteroom of the pharmacy compounding area failed to have a line of demarcation that differentiated dirty from clean. In addition paper notices and materials were affixed to carts, shelving and walls with adhesive tape. Notebooks, an electronic stamping machine, a free standing telephone and a supply of intravenous bags, IV tubing and miscellaneous supplies were stored on the counter, cart and shelving, rendering the surfaces and materials unable to be properly cleaned and/or sanitized.

b. Continued tour of the chemotherapy mixture room identified a chair with unsealed openings on the underside of the chair. The biological safety cabinet (BSC) contained clear adhesive tape along the opening to the BSC and strips of Velcro affixed to the side of the BSC rendering the surfaces unable to be properly cleaned and/or sanitized. Interview with the Director of Pharmacy on 10/24/16 at 9:30 AM stated he/she was not aware of the materials affixed to the BSC. Review of the Guide to Compounding Sterile Preparations in the Pharmacy identified that papers shall not be stored in the chemo and IV prep rooms. Posters and notices shall be laminated if they need to be stored in either of these two rooms.

c. The Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797. Interview with the Director of Pharmacy on 10/25/16 at 9:50 AM stated although he/she was aware humidity levels needed to be monitored, he/she was under the impression humidity and temperature were monitored by the Facilities Department. During a subsequent interview with the Director of Facilities on 10/26/16 at 1:30 PM he/she stated the Facilities Department monitored the temperature and was not aware that humidity warranted monitoring under the USP 797. The hospital policy, "Guide to Compounding Sterile Preparations in the Pharmacy", identified the monitoring of pressure and temperature in the compounding area however the policy did not address monitoring of humidity in the compounding area.

d. During an observation on 10/24/16 at 9:30 AM Pharmacy Technician #1 applied a disposable gown, gloves, mask, cap and booties within the anteroom however the anteroom did not contain a line of demarcation therefore he/she was not able to distinguish the dirty versus clean areas of the room. In addition Pharmacy Technician #1 applied a disposable gown prior to washing his/her hands therefore failing to follow the hospital policy and USP 797. The Hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", directed that the technician and/or pharmacist preparing an admixture shall don shoe covers, wash hands thoroughly up to the elbows for at least 30 seconds then don a disposable gown while in the ante room.

e. During a subsequent observation on 10/25/16 at 9:20 AM Pharmacy Technician #2 applied the disposable gown, cap and booties within the anteroom. A line of demarcation had been established however the line of demarcation was incorrectly placed according to USP 797 therefore he/she was not able to appropriately distinguish the dirty versus clean areas of the room. Subsequently Pharmacy Technician #2 applied his/her gown on the dirty side of the room and then proceeded to wash his/her hands therefore not applying garb according to hospital policy and USP 797.

f. Hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", failed to identify, according to USP 797, the requirement of a line of demarcation therefore the garbing process identified in the policy did not meet the requirements of USP 797.

g. During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy, the pass through door in the mixing room was not fail safe and was operable on both sides at the same time, in addition the entry doors to each room were not interlocking allowing all doors to be open simultaneously. Observations also identified the duct penetrating the ceiling on the BSC was flexible and had tape around it. The light fixtures within the rooms were not sealed with caulk as required. The low air HVAC returns were blocked not allowing proper air exchanges.

h. Governing Body Committee Minutes dated September of 2014 through October of 2016 failed to identify a review of contracted services, specifically Company #1.

Interview with the Chief Nursing Officer (CNO) on 10/27/16 at 9:30 AM, the CNO stated he/she attended the Governing Body Committee meetings and the results of the certification/environmental testing and or updates/concerns related to the pharmacy compounding area and USP 797 were not reviewed during the meetings, with the exception of 6/3/15 at which time a review of the USP 797 policy was conducted. Further interview with the CNO identified he/she was responsible to oversee the pharmaceutical contract to ensure the services provided were in compliance with state/federal law.


2. Based on a review of clinical records, interview, and policy review, the Governing Body failed to ensure that quality services were rendered by a dialysis contractor for one of two patient's (#23) reviewed for hemodialysis. The findings included:
a. Patient #23 was admitted to the hospital on 10/16/16 with COPD exacerbation. A physician's order dated 10/19/16 directed a three (3) hour hemodialysis treatment. Review of the flow sheet dated 10/19/16 identified that 100 cubic centimeters (cc's) of Normal Saline (NS) was administered at 8:40 AM, 9:20 AM, and 10:20 AM absent a physician's order. Record review and interview with the RN contractor for dialysis services on 10/25/16 at 1:30 PM stated there was not a protocol to administer saline absent a physician's order.
b. Review of Patient #23's clinical record identified a physician's order dated 10/21/16 that directed a 3.5 hour hemodialysis treatment. The flow sheet dated 10/21/16 identified that the RN administered 200 cc's of NS at 10:15 AM absent a physician's order. Review of the Medication Policy Including the use of Volume Replacement and/or Volume Expanders directed that no medications are given without an order from the physician or allied health professional.
c. Review of Patient #23's flow sheet dated 10/19/16 identified that the patient had a right IJ catheter in place and post-treatment, the RN instilled 1.9 ml into the arterial port and 2.1 ml into the venous port. Record review and interview with the RN contractor for dialysis services on 10/25/16 at 1:30 PM stated the type of solution instilled was not documented. Further review failed to indicate the RN wrote a nurse's note post treatment in accordance with hospital policy.
Review of the Hemodialysis Treatment Protocol: Care of the Patient, directed that the dialysis nurse will document each treatment in the progress note section of the electronic health record.

Based on tour of the facility, review of facility documentation, and interviews, the facility failed to ensure the Families First Unit was maintained in a safe manner to eliminate risk of newborn abduction. The finding includes:

Cross refernece A- 701


a. On 10/25/16 at 10:45 AM, the surveyor along with the Director of Engineering observed that when the facilty infant abduction system was tested on 10/25/16 the exterior doors locked, and an alarm went to security. The door adjacent to the exit from the Families First Unit into a stairwell released after a delay of 15 seconds while a infant hugs security band was held in the doorway. Interview of the Security Director on 10/25/16 identified that the door was not tied to the Hugs system, the facilities "infant abduction system" as the door only had a delayed egress lock with local alarm and if all staff were not in the proximity of the door the local alarm might not be heard. It was also identified that all doors leaving the unit and by the stairwells were equipped with fire alarm manual pull stations that would release the doors with a Hugs system security band next to the door. The facility was directed to the exceptions in the life safety code for manual pull stations to be located at the nurse station and not by exits and also the exceptions to the locking of doors in a setting that requires a higher degree of security and safety. The Families First stairwell doors and the manual pull stations had been identified previously by security as risks to infant abduction and the previous local Fire Marshal was not willing to allow the code exceptions to be utilized according to facility. The Director of Engineering stated he would contact the local Fire Marshal for clarification.


On 10/25/16, the facility provided the Department with an immediate action plan that identified personnel would be posted at the stairwell doors until the security flaws could be abated.

Based on a review of clinical records, staff interviews and a review of the hospital's policies and procedures for one of three sampled patients' reviewed for a hospital discharge (Patient #39), the facility failed to protect confidential health care information. The finding includes:


a. Review of the clinical record identified Patient #39 was admitted to the Emergency Department (ED) on 5/21/16 at 2:20 PM with complaints of abdominal pain. The patient was examined and an evaluation was conducted. Patient #39 was discharged to home on 5/21/16 at 5:44 PM with a prescription for Oxycodone 5 milligrams (mg) with Acetaminophen 325 mg orally every four hours as needed. The instructions also directed that the patient follow-up with his/her primary care physician within forty eight hours, and return to the Emergency Department (ED) if the patient's pain worsened, a fever or vomiting developed.

Review of the clinical record identified Patient #40 was admitted to the ED on 5/21/16 at 3:11 PM with complaints of urinary retention. The patient was examined and an evaluation was conducted. Patient #40 was discharged to home on 5/21/16 at 9:01 PM with follow-up appointments and instructions to return to the ED for any new or continuing symptoms.

Interview with the hospital HIPAA (Health Insurance Portability and Accountability Act) Officer on 10/27/16 at 2:10 PM identified a breach in health care information occurred on 5/21/16. Patient #40 was provided with the discharge paperwork of Patient #39 that included his/her diagnosis, prescription information and follow up care. The paperwork also identified the name of Patient #39, his/her medical record number, account number, and the name of the provider that treated the patient. The HIPPA officer indicated the breach was identified on 5/21/16 and an occurrence report was written immediately. Patient #39 and #40 were notified on 5/26/16 and Patient #40 was provided the accurate discharge information on 5/26/16. The hospital policy entitled Privacy of Protected Health Information directed in part that upon receipt of notification of a potential breach, the Privacy Officer shall initiate an investigation, conduct a risk assessment and notification shall be made to all the individuals involved. The investigation shall not exceed twenty one business days.

Based on a review of clinical records, staff interviews and a review of the hospital policies and procedures for one of three sampled patients' (Patient #30), reviewed for behavioral restraints, the facility failed to renew the order for four-point restraints in accordance with the hospital policy. The finding includes:

a. Review of the clinical record identified Patient #30 was admitted to the Emergency Department (ED) on 10/23/16 at 12:33 AM for complaints of homicidal and suicidal ideation. Physician's orders dated 10/23/16 at 12:35 AM directed four-point restraints for combative behavior that did not respond to alternate measures. Patient #30 remained in restraints on 10/23/16 until 8:45 AM. Interview and review of the clinical record with Nurse Manager #2 on 10/25/16 at 10:00 AM identified the facility failed to obtain a physician's order for the renewal of four-point restraints on 10/23/16 at 4:35 AM and 8:35 AM. The hospital policy entitled Restraints directed in part that the time period of the order would not exceed four hours. When the original order was about to expire the Licensed Independent Practitioner (LIP), would write a new order or the nurse was directed to notify the LIP and report the results of his/her most recent assessment and request that the original order be renewed for another period of time.

Based on a review of hospital documentation, interviews, contracted service reports and policies it was determined that the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement as evidenced by:


1. The hospital failed to develop specific QAPI indicators to monitor the performance of contracted services (Company #1) and/or ensure the Infection control program effectively monitored high risk area's including but not limited to Pharmacy services.


Refer to A-283

Based on observation, review of facility documentation, interviews, certification reports from Contractor #1, and policy review the hospital failed to develop quality performance improvement activities regarding high risk area's in the hospital that included contracted services (Pharmacy). The findings include:

During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy (Contractor #1) and Infection Preventionist (IP) the anteroom of the pharmacy compounding area failed to have a line of demarcation that differentiated dirty from clean. During an observation on 10/24/16 at 9:30 AM Pharmacy Technician #1 applied a disposable gown, gloves, mask, cap and booties within the anteroom however the anteroom did not contain a line of demarcation therefore he/she was not able to distinguish the dirty versus clean areas of the room. In addition Pharmacy Technician #1 applied a disposable gown prior to washing his/her hands therefore not applying garb according to hospital policy and USP 797. During an observation on 10/25/16 at 9:20 AM Pharmacy Technician #2 applied the disposable gown, cap and booties within the anteroom. A line of demarcation had been established however the line of demarcation was incorrectly placed according to USP 797 therefore he/she was not able to appropriately distinguish the dirty versus clean areas of the room. Subsequently Pharmacy Technician #2 applied his/her gown on the dirty side of the room and then proceeded to wash his/her hands therefore not applying garb according to hospital policy and USP 797. Hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", failed to identify, according to USP 797, the requirement of a line of demarcation therefore the garbing process identified in the policy did not meet the requirements of USP 797.
In addition paper notices and materials were affixed to carts, shelving and walls with adhesive tape. Notebooks, an electronic stamping machine, a free standing telephone and a supply of intravenous bags, IV tubing and miscellaneous supplies were stored on the counter, cart and shelving, rendering the surfaces and materials unable to be properly cleaned and/or sanitized.

Continued tour of the chemotherapy mixture room identified a chair with unsealed openings on the underside of the chair. The biological safety cabinet (BSC) contained clear adhesive tape along the opening to the BSC and strips of Velcro affixed to the side of the BSC rendering the surfaces unable to be properly cleaned and/or sanitized.
The Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797.
a. Review of the Pharmacy and Therapeutics (P&T) committee minutes dated May 2015 through September 2016 lacked evidence that the facility incorporated into the QAPI program the aforementioned concerns and/or reviewed the results of air and surface sampling in the compounding area, glove and media fill testing, surveillance of the environment and staff competencies.
During an interview with the Director of Pharmacy on 10/27/16 at 9:15 AM he/she indicated air and surface sampling of the compounding area was completed by Company #2 and other required testing was compiled by pharmacy staff. The Director of Pharmacy indicated certification/environmental testing results were discussed at P&T meetings however a review of the P&T minutes failed to reflect this information.
During an interview with the CNO on 10/27/16 at 9:30 AM the CNO indicated the results of the certification/environmental testing and or updates/concerns related to the pharmacy compounding area and USP 797 were not reviewed during the P&T meetings and were not reported to him/her as they should have been.
According to the P&T Committee Policy, the P&T committee is responsible to oversee policies and procedures related to all aspects of medication use within the hospital.
A review of the Director of Pharmacy job description indicated the Director plans and directs a wide variety of duties involving responsibility for limited compounding and the supervision and direction of professional pharmacists and support staff. In addition the Director of Pharmacy submits monthly Quality Assurance (QA) reports to appropriate personnel and take into consideration new trends and regulations.
b. Review of the Infection Control Committee minutes dated February 2014 through September 2016 failed to identify that a comprehensive mechanism was in place to identify and monitor potential infections in the compounding area of the pharmacy. Further review of the infection control meeting minutes failed to reflect that the facility analyzed the environmental testing that was conducted to determine implementation of appropriate interventions if needed. The minutes failed to reflect that surveillance rounds were conducted in the compounding area of the hospital and/or that other departments and specialty areas collaborated regarding adherence to the USP 797 guidelines and compliance with Pharmacy policies.
According to the Infection Prevention Program/Plan a component of the plans purpose was to collect and analyze data relevant to epidemiology/infection prevention and review, approve and promote the application of all policies and procedures related to infection surveillance, prevention and control activities in all departments/services. The plan indicated the Infection Preventionist (IP) was responsible for planning, developing, coordinating, implementing and evaluating multiple facets of infection surveillance, prevention and control in coordination with the Hospital Epidemiologist. In addition the IP participates in compliance monitoring activities as required by state, federal and other governing agencies and provides reports and surveillance findings to appropriate committees, departments or individuals.
Interview with the Infection Preventionist (IP) on 10/27/16 at 1:00 PM, the IP indicated in January 2014 he/she was involved in USP 797 implementation in the pharmacy with Drug Control staff. The IP indicated he/she continued surveillance in the pharmacy for 1 year at which time Pharmacist #2 took over USP 797 training and he/she would act as resource and occasionally observe garb application. Upon surveyor inquiry the IP indicated he/she did not review the certification/environmental testing reports from Company #2 therefore reports with the Hospital Epidemiologist were not discussed. The IP indicated these areas would now be a standing agenda item of the Infection Control meetings.
Interview with the Chief Nursing Officer (CNO) on 10/27/16 at 9:30 AM he/she indicated his/her expectation was that the IP and Director of Pharmacy should have been collaborating and discussing infection control issues within the pharmacy.
c. Review of the Quality Assurance Committee Minutes dated January 2015 through September 2016 failed to reflect a review of USP 797 compliance and/or non-compliance pertaining to the contracted services of pharmacy (Company #1).
Interview with the Vice President of Quality on 10/26/16 at 2:50 PM indicated the meeting minutes from the P&T and Infection control committees are brought for review to the Quality Assurance Committee, however, a review of these minutes failed to identify that adherence to USP 797 was an agenda item.
d. Review of the Medical Executive Committee Minutes and Governing Body Minutes from January 2015 through September 2016 failed to identify a review of USP 797 and certification/environmental testing was discussed.
During an interview with the CNO on 10/27/16 at 9:30 AM the CNO indicated the meeting minutes from the Quality Assurance Committee are then brought for review to the Medical Executive Committee/Governing Body therefore USP 797 compliance and/or concerns regarding contracted services relative to pharmacy services (Company #1) were not discussed.
According to the Quality Improvement Committee Charter the Board of Directors has ultimate oversight responsibility to ensure safe, timely and effective care in a patient centered environment.

Based on observation, a review of hospital documentation, contracted service reports, interviews and policies, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services as evidenced by:


1. The hospital failed to ensure that the Pharmacy Director (Contractor #1) effectively supervised the day to day operations of the Pharmacy Department as evidenced by failure to follow policy/procedures, failure to compound medications in a sanitary environment and/or maintain compliance with federal (USP-797) and state laws.

Please refer to A-492 and A-501


On 10/25/16 the facility submitted an immediate action plan to the Department of Public Health that identified the following: revisions to the policy Guide to Compounding Sterile Preparations in the Pharmacy and the compounding anteroom area would have all items not rendered able to be sterilized removed. The immediate action plan indicated a line of demarcation would be established in the anteroom separating dirty from clean and all pharmacy staff compounding medication would receive education regarding appropriate garbing procedures. During a review of the immediate action plan on 10/26/16 the line of demarcation continued to be non-compliant with USP 797 and was subsequently corrected.

Based on observation, review of facility documentation, contractor reports, interviews, and policy review, the hospital failed to provide the necessary supervision of Pharmacy services in accordance with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding (USP-797). The findings include:


Cross reference A-501

a. Review of the Pharmacy and Therapeutics (P&T) committee minutes dated May 2015 through September 2016 lacked evidence that the facility incorporated into the QAPI program the aforementioned concerns and/or reviewed the results of air and surface sampling in the compounding area, glove and media fill testing, surveillance of the environment and staff competencies.
During an interview with the Director of Pharmacy on 10/27/16 at 9:15 AM he/she indicated air and surface sampling of the compounding area was completed by Company #2 and other required testing was compiled by pharmacy staff. The Director of Pharmacy indicated certification/environmental testing results were discussed at P&T meetings however a review of the P&T minutes failed to reflect this information.
During an interview with the CNO on 10/27/16 at 9:30 AM the CNO indicated the results of the certification/environmental testing and or updates/concerns related to the pharmacy compounding area and USP 797 were not reviewed during the P&T meetings and were not reported to him/her as they should have been.
According to the P&T Committee Policy, the P&T committee is responsible to oversee policies and procedures related to all aspects of medication use within the hospital.
b. Review of thirteen (13) staff competencies (6 licensed pharmacists and 7 pharmacy technicians) for sterile compounding during the period of 3/7/16 through 5/2/16 identified that it was not applicable that the observed staff member was aware of a line of demarcation separating clean and dirty sides. Interview with the Director of Pharmacy on 10/27/16 at 9:15 AM identified all staff competencies relative to the compounding process were completed annually (2015 and 2016) however the competencies identified that a line of demarcation was non-applicable therefore was not part of the competency observation. The hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", failed to identify the requirement of a line of demarcation in accordance with USP 797.

Review of the Director of Pharmacy Job Description indicated the Director of Pharmacy plans and directs a wide variety of duties involving responsibility for compounding and the supervision and direction of professional pharmacists and support staff. In addition the Director of Pharmacy submits monthly Quality Assurance (QA) reports to appropriate personnel and takes into consideration new trends and regulations. The job description indicated the Director of Pharmacy reports to the Vice President of Patient Care Services/CNO.

Based on observation, review of facility documentation, interviews, and policy review, the hospital, who compounds sterile pharmaceuticals, failed to maintain a sanitary environment in accordance with USP 797 requirements. The findings include:


a. During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy (Contractor #1) and Infection Preventionist (IP) the anteroom of the pharmacy compounding area failed to have a line of demarcation that differentiated dirty from clean. In addition paper notices and materials were affixed to carts, shelving and walls with adhesive tape. Notebooks, an electronic stamping machine, a free standing telephone and a supply of intravenous bags, IV tubing and miscellaneous supplies were stored on the counter, cart and shelving, rendering the surfaces and materials unable to be properly cleaned and/or sanitized.

b. Continued tour of the chemotherapy mixture room identified a chair with unsealed openings on the underside of the chair. The biological safety cabinet (BSC) contained clear adhesive tape along the opening to the BSC and strips of Velcro affixed to the side of the BSC rendering the surfaces unable to be properly cleaned and/or sanitized. Interview with the Director of Pharmacy on 10/24/16 at 9:30 AM stated he/she was not aware of the materials affixed to the BSC. Review of the Guide to Compounding Sterile Preparations in the Pharmacy identified that papers shall not be stored in the chemo and IV prep rooms. Posters and notices shall be laminated if they need to be stored in either of these two rooms.

During the tour of the compounding area on 10/24/16 the Director of Pharmacy was unable to accurately identify the USP 797 requirements for acceptable contents of the compounding area.

c. The Director of Pharmacy failed to identify that humidity levels were monitored in the room where medications were compounded/stored in accordance with USP 797. Interview with the Director of Pharmacy on 10/25/16 at 9:50 AM stated although he/she was aware humidity levels needed to be monitored, he/she was under the impression humidity and temperature were monitored by the Facilities Department. During a subsequent interview with the Director of Facilities on 10/26/16 at 1:30 PM he/she stated the Facilities Department monitored the temperature and was not aware the humidity warranted monitoring under the USP 797. Hospital policy, "Guide to Compounding Sterile Preparations in the Pharmacy", identified the monitoring of pressure and temperature in the compounding area however the policy did not address monitoring of humidity in the compounding area.

d. During an observation on 10/24/16 at 9:30 AM Pharmacy Technician #1 applied a disposable gown, gloves, mask, cap and booties within the anteroom however the anteroom did not contain a line of demarcation therefore he/she was not able to distinguish the dirty versus clean areas of the room. In addition Pharmacy Technician #1 applied a disposable gown prior to washing his/her hands therefore failing to follow the hospital policy and USP 797. The Hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", directed that the technician and/or pharmacist preparing an admixture shall don shoe covers, wash hands thoroughly up to the elbows for at least 30 seconds then don a disposable gown while in the ante room.

e. During a subsequent observation on 10/25/16 at 9:20 AM Pharmacy Technician #2 applied the disposable gown, cap and booties within the anteroom. A line of demarcation had been established however the line of demarcation was incorrectly placed according to USP 797 therefore he/she was not able to appropriately distinguish the dirty versus clean areas of the room. Subsequently Pharmacy Technician #2 applied his/her gown on the dirty side of the room and then proceeded to wash his/her hands therefore not applying garb according to hospital policy and USP 797.

f. The hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", failed to identify the requirement of a line of demarcation in accordance with USP 797,
therefore, the garbing process identified in the policy did not meet the requirements of USP 797.

g. During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy, the pass through door in the mixing room was not fail safe and was operable on both sides at the same time, in addition the entry doors to each room were not interlocking allowing all doors to be open simultaneously. Observations also identified the duct penetrating the ceiling on the BSC was flexible and had tape around it. The light fixtures within the rooms were not sealed with caulk as required. The low air HVAC returns were blocked not allowing proper air exchanges.

The Director of Pharmacy failed to recognize and correct the aforementioned concerns during day to day operations.

The hospital policy entitled USP 797 Guide to Compounding Sterile Preparations in the Pharmacy, dated May 2015, indicated the pharmacy would compound sterile preparations according to USP 797 to help ensure that compounded sterile preparations are of high quality. These practice standards are a part of the federal requirements for proper medication compounding.

Subsequent to observations made on 10/24/16 and 10/25/16 the facility policy entitled USP 797 Guide to Compounding Sterile Preparations in the Pharmacy, was revised based on USP 797 requirements.

On November 1st and 2nd, 2016, as part of the periodic state Federal Hospital Survey, the Nuclear Medicine and Radiology Department of Bristol Hospital was inspected for compliance with federal and state regulations and acceptable standards of practice.

The inspection consisted of interviews of hospital staff and review of records, procedures, equipment and facilities including the following: (a) in-house physics reports and follow-up corrective actions; (b) personnel dosimetry records; (c) records of receipt of radioactive materials; (d) quarterly inventories; (e) records of area surveys; (f) records of calibration of available radiation detection instrumentation; (g) calibration of dose calibrator, including linearity and constancy determinations; (h) leak check records; and, (i) radiation shielding calculations. The findings include:

a. Bristol Hospital installed a new fluoroscopy machine in 2015 but could not produce a shielding design that demonstrated compliance with NCRP Report no. 147.

R.C.S.A 19-25d-3(c) Shielding requires in part "(1) Each installation shall be provided with primary barriers and/or secondary barriers of such thickness as are computed in accordance with Appendix C, National Bureau of Standards Handbook 76: "Medical X-ray Protection Up to Three Million Volts," or any official revision of or subsequent replacement for this handbook, a copy of which is on file in the state department of environmental protection, state office building, Hartford. "For radiation producing imaging machines installed after November 19, 2004, the regulatory standard for shielding design is National Council of Radiation Protection (NCRP) Report No. 147, "structural Shielding Design for Medical X-Ray Imaging Facilities".

b. Bristol Hospital did not have a conspicuously posted radiation sign on the occupational entrance to their CT room.

c. Several X-Ray radiation signs were obstructed by other material secured to the doors.

R.C.S.A. 19-24-8 (5)(C) requires in part, "Each area or room in which sources of ionizing radiation other than radioactive materials are used shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and appropriate wording to designate the nature of the source or sources of ionizing radiation".

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review it was determined that the hospital failed to meet the Condition of Participation for Environment as evidenced by:


1. The hospital failed to ensure that the physical environment and the overall hospital environment was developed and maintained in such a manner that the safety and well-being of patients are assured.

2. The hospital failed to ensure the Families First Unit was maintained in a safe manner to eliminate risk of newborn abduction.


Please refer to A-701.

Based on tour and observation of the facility on 10/24, 25, 26/2016, review of facility documentation and staff interviews with engineering employees and the Director of Facilities on 10/26 & 28, 2016, the hospital failed to ensure that the physical environment and the overall hospital environment was developed and maintained in such a manner that the safety and well-being of patients are assured. The findings include the following:


a. On 10/25/16 at 10:45 AM, the surveyor along with the Director of Engineering observed that when the facilty infant abduction system was tested on 10/25/16 the exterior doors locked, and an alarm went to security. The door adjacent to the exit from the Families First Unit into a stairwell released after a delay of 15 seconds while a infant hugs security band was held in the doorway. Interview of the Security Director on 10/25/16 identified that the door was not tied to the Hugs system, the facilities "infant abduction system" as the door only had a delayed egress lock with local alarm and if all staff were not in the proximity of the door the local alarm might not be heard. It was also identified that all doors leaving the unit and by the stairwells were equipped with fire alarm manual pull stations that would release the doors with a Hugs system security band next to the door. The facility was directed to the exceptions in the life safety code for manual pull stations to be located at the nurse station and not by exits and also the exceptions to the locking of doors in a setting that requires a higher degree of security and safety. The Families First stairwell doors and the manual pull stations had been identified previously by security as risks to infant abduction and the previous local Fire Marshal was not willing to allow the code exceptions to be utilized according to facility.
The Director of Engineering stated he would contact the local Fire Marshal for clarification.

On 10/25/16, the facility provided the Department with an immediate action plan that identified personnel would be posted at the stairwell doors until the security flaws could be abated.


b. During tour on 10/24 through 10/26/16 it was identified that the facility had no documentation of issues identified during tour had been entered into a work order tracking system. During documentation review and interview of the Director of Facilities and engineering employees on 10/26 & 28/2016, it was identified that the facility lacked a work order management system to enter and track work order's for completion, man hours, corrections made and to identify/produce work order's for upcoming time frames for current and/or overdue preventative maintenance to the infrastructure of the hospital.

c. During tour on 10/24 through 10/26/16 it was identified that the sprinkler head in the Ante room of the Pharmacy was obstructed.

d. During tour on 10/24 through 10/26/16 it was identified that the floor in Central Sterile had missing and/or cracked floor tiles under the rolling storage cabinets and the welded seam floor was cracked in the area of the column where the telephone is located.

e. During tour on 10/24 through 10/26/16 it was identified that the soiled holding room #256 lacked an automatic closing device and the electrical panel across from the same door was obstructed by equipment being stored.

Based on observation, review of facility documentation, contracted service reports, interviews and policy review it was determined that the hospital failed to meet the Condition of Participation for Infection Control as evidenced by:


1. The hospital failed to ensure proper sanitization of the environment in surgical areas and/or the central sterilization department.


2. The hospital failed to ensure that the Infection Control program was comprehensive to include high risk areas including surveillance of the hospital's pharmacy.


Please refer to A-749

1. Based on medical record reviews, review of facility documentation, review facility policies and interviews the facility failed to ensure proper sanitization of the environment in surgical areas and/or the central sterilization department. The findings include:
a. A tour of the operative area was conducted on 10/24/16 with the Director and Manager of Perioperative Services. Observations of 2 of 4 operating rooms (ORs #2 and #4) on 10/24/16 identified rusted and/or chipped paint on equipment rending the equipment unable to be properly sanitized. Interview with Clinical Coordinator of the OR on 10/24/16 at 9:48 AM noted that OR equipment was cleaned using germicidal wipes between surgical cases. The facility policy for routine cleaning directed to wipe all horizontal surfaces according to procedure after a surgical case. The policy further identified that daily terminal cleaning included utility carts, including wheels and case carts.
b. A tour of the post- anesthesia care unit (PACU) was conducted on 10/24/16 with the Manager of Perioperative Services. Observation on 10/24/16 at 10:29 AM indicated that a staff member wheeled a dirty stretcher through the PACU hall following patient discharge and prior to cleaning. Subsequently, the Clinical Performance Improvement Specialist informed the PACU staff member that stretchers must be cleaned at the point of use.
c. A tour of the endoscopy area was conducted on 10/24/16 with the Manager of Perioperative Services. Observation of the scope closets on 10/24/16 at 10:55 AM identified that the roller doors to both closet were in the up position and cleaned scopes were exposed to the environment. Interview with the Manager of Perioperative Services on 10/24/16 at 10:55 AM noted that the scope closets were usually kept closed. The facility policy for cleaning and high level disinfection of flexible scopes identified that endoscopes should be stored in a manner to protect them from contamination.

d. A tour of the central sterile supply department (CSSD) was conducted on 10/24/26 with the Manager of CSS. Observation on 10/24/16 at 12:45 PM noted several missing floor tiles in the department's storage area for sterilized items. An accumulation of dust and debris was also observed behind the roll away storage shelving. Interview with the Manager of CSD on 10/24/16 at 12:50 PM indicated that the environmental services cleaning staff were responsible to clean the department on a daily basis. Review of facility documentation and interview with the Manager of CSD on 10/24/16 at 12:51 PM noted that he/she placed a work order to the Facilities Management Department for tile repair on 8/17 /16. Interview with the Director of Operations on 10/24/16 at 1:21 PM indicated that he/she had not yet acted on the work order request for the tile repair. The facility policy for routine cleaning of the CSSD identified that all storage areas should be routinely and thoroughly cleaned to include daily cleaning of floors via wet mopping.



26703

2. Based on observation, review of facility documentation, interviews, and policy review, the hospital failed to demonstrate that the Infection Control program was comprehensive and included high risk areas such as the pharmacy to ensure a safe environment was maintained when compounding medications. The findings include:

a. During tour of the pharmacy on 10/24/16 at 9:30 AM with the Director of Pharmacy (Contractor #1) and Infection Preventionist (IP) the anteroom of the pharmacy compounding area failed to have a line of demarcation that differentiated dirty from clean. During an observation on 10/24/16 at 9:30 AM Pharmacy Technician #1 applied a disposable gown, gloves, mask, cap and booties within the anteroom however the anteroom did not contain a line of demarcation therefore he/she was not able to distinguish the dirty versus clean areas of the room. In addition Pharmacy Technician #1 applied a disposable gown prior to washing his/her hands therefore not applying garb according to hospital policy and USP 797. An observation on 10/25/16 at 9:20 AM Pharmacy Technician #2 applied the disposable gown, cap and booties within the anteroom. A line of demarcation had been established however the line of demarcation was incorrectly placed according to USP 797 therefore he/she was not able to appropriately distinguish the dirty versus clean areas of the room. Subsequently Pharmacy Technician #2 applied his/her gown on the dirty side of the room and then proceeded to wash his/her hands therefore not applying garb according to hospital policy and USP 797. Hospital policy "Guide to Compounding Sterile Preparations in the Pharmacy", failed to identify, according to USP 797, the requirement of a line of demarcation therefore the garbing process identified in the policy did not meet the requirements of USP 797.

In addition paper notices and materials were affixed to carts, shelving and walls with adhesive tape. Notebooks, an electronic stamping machine, a free standing telephone and a supply of intravenous bags, IV tubing and miscellaneous supplies were stored on the counter, cart and shelving, rendering the surfaces and materials unable to be properly cleaned and/or sanitized.


Continued tour of the chemotherapy mixture room identified a chair with unsealed openings on the underside of the chair. The biological safety cabinet (BSC) contained clear adhesive tape along the opening to the BSC and strips of Velcro affixed to the side of the BSC rendering the surfaces unable to be properly cleaned and/or sanitized.

Review of the Infection Control Committee minutes dated February 2014 through September 2016 failed to identify that a comprehensive mechanism was in place to identify and monitor potential infections in the compounding area of the pharmacy. Further review of the infection control meeting minutes failed to reflect that the facility analyzed the environmental testing that was conducted to determine implementation of appropriate interventions if needed. The minutes failed to reflect that surveillance rounds were conducted in the compounding area of the hospital and/or that other departments and specialty areas collaborated regarding adherence to the USP 797 guidelines and compliance with Pharmacy policies.


According to the Infection Prevention Program/Plan a component of the plans purpose was to collect and analyze data relevant to epidemiology/infection prevention and review, approve and promote the application of all policies and procedures related to infection surveillance, prevention and control activities in all departments/services. The plan indicated the Infection Preventionist (IP) was responsible for planning, developing, coordinating, implementing and evaluating multiple facets of infection surveillance, prevention and control in coordination with the Hospital Epidemiologist. In addition the IP participates in compliance monitoring activities as required by state, federal and other governing agencies and provides reports and surveillance findings to appropriate committees, departments or individuals.

Interview with the Infection Preventionist (IP) on 10/27/16 at 1:00 PM, the IP indicated in January 2014 he/she was involved in USP 797 implementation in the pharmacy with Drug Control staff. The IP indicated he/she continued surveillance in the pharmacy for 1 year at which time Pharmacist #2 took over USP 797 training and he/she would act as resource and occasionally observe garb application. Upon surveyor inquiry the IP indicated he/she did not review the certification/environmental testing reports from Company #2 therefore reports with the Hospital Epidemiologist were not discussed. The IP indicated these areas would now be a standing agenda item of the Infection Control meetings.
Interview with the Chief Nursing Officer (CNO) on 10/27/16 at 9:30 AM he/she indicated his/her expectation was that the IP and Director of Pharmacy should have been collaborating and discussing infection control issues within the pharmacy.

Based on a review of clinical records, staff interviews, and a review of the hospital's policies and procedures for one of three sampled patients' reviewed for a hospital discharge (Patient #39), the facility failed to follow discharge procedures in accordance with the hospital policy. The finding includes:


a. Review of the clinical record identified Patient #39 was admitted to the Emergency Department (ED) on 5/21/16 at 2:20 PM with complaints of abdominal pain. The patient was examined and an evaluation was conducted. Patient #39 was discharged to home on 5/21/16 at 5:44 PM with a prescription for Oxycodone 5 milligrams (mg) with Acetaminophen 325 mg orally every four hours as needed. The instructions also directed the patient to follow-up with his/her primary care physician within forty-eight hours, and return to the Emergency Department (ED) if the patient's pain worsened, a fever or vomiting developed.

Review of the clinical record identified Patient #40 was admitted to the ED on 5/21/16 at 3:11 PM with complaints of urinary retention. The patient was examined and an evaluation was conducted. Patient #40 was discharged to home on 5/21/16 at 9:01 PM with follow up appointments and instructions to return to the ED for any new or continuing symptoms.

Interview with the hospital HIPAA (Health Insurance Portability and Accountability Act) Officer on 10/27/16 at 2:00 PM identified RN #3 provided Patient #40 with the discharge paperwork of Patient #39 that included his/her diagnosis, prescription information and follow up care. The hospital HIPPA officer indicated the result of the investigation identified Patient #39 and #40 had the same first name, the patients were in the ED at approximately the same time and RN #3 indicated he failed to follow the protocol when he discharged Patient #40 that included highlighting his/her name and checking it against the clinical record to ensure it was the right patient and should have. The hospital policy entitled Discharge Planning directed in part to review with the patient instructions for discharge that included prescriptions and medication regimen, orders, treatments, necessary equipment, diet regimen, follow up appointments and specific individualized instructions.

Based on clinical record review and interview for 1 (P#4) of 5 patients reviewed who underwent surgical procedures the facility failed to ensure an immediate operative note was completed after 2 surgical procedures. The finding includes:


a. P#4 had a history of coronary artery disease (CAD) and peripheral vascular disease (PVD) with bilateral lower extremity claudication. P#4 underwent angioplasty of the right external iliac artery with stenting on 9/29/16. The procedure was performed by Medical Doctor (MD) #5. According to anesthesia records the procedure started at 9:13 AM and concluded at 11:35 AM. An operative report was dictated by MD#5 on 9/29/16 at 1:06 PM however the medical record lacked documentation that a brief operative note was completed immediately after the procedure. P#4 was hemodynamically stable and remained stable for several hours until he/she experienced abdominal and back pain with a decrease in blood pressure and bleeding from the left groin insertion site.

P#4 became hemodynamically unstable and was transferred immediately to the operating room for exploration of the left groin and repair of the distal external iliac artery. According to anesthesia records the procedure started at 5:05 PM and concluded at 7:00 PM. An operative report was dictated by MD#5 on 10/1/16 at 6:35 AM however the medical record lacked documentation that a brief operative note was completed immediately after the procedure.

During a review of the medical record with Quality Consultant #1 on 10/27/16 at 10:00 AM he/she identified that the medical record did not contain a brief operative note for either surgical procedure.

According to the hospital rules and regulations for medical staff dated 8/5/15 a brief operative/procedure note must be written in the medical record immediately following the conclusion of the surgery/procedure.

Based on medical record reviews, review of facility documentation, review of facility policies and interviews for one of three patients who had an orbital block (Patient #5), the facility failed to ensure that the anesthesia block procedure was performed on the correct eye. The finding includes:


a. Patient #5 was admitted to the ambulatory surgical center (ASC) on 10/18/16. The operative consent signed on 10/12/16 identified cataract surgery with lens implant left eye. The anesthesia consent dated 10/18/16 identified major/minor nerve block with sedation. Nursing documentation dated 10/18/16 identified that the left eye was marked and at 7:01 AM, the patient's name, date of birth and procedure were confirmed. The procedure note by the Anesthesiologist (MD#1) indicated that immediately after injection, he/she recognized the he/she had performed the block procedure on the right eye instead of the left eye in error. The surgeon and patient were immediately informed of the error and the procedure was postponed and performed on 10/25/16.
Interview with MD #1 on 10/26/16 at 1:12 PM noted that the area above the left eye was clearly marked and the time out procedure was performed. He/she further indicated that after the time- out procedure, he/she left the patient's side to get the block kit and performed the block procedure on the right eye as the nurse documented in the patient record. The facility policy for invasive procedures identified that the time- out is performed immediately prior to starting procedures. Subsequent to the event, the facility submitted an immediate plan of correction to include case review and education that the RN was to view all block injection initiations after the time- out procedure was performed. In addition, the facility is currently identifying the need for policy revision vs creation of a separate policy regarding block procedures.

Based on medical record reviews, review of facility policies and interviews for two of six patients reviewed for anesthesia services (Patients #6 and #7), the facility failed to ensure that anesthesia staff correctly documented the site in which intravenous (IV) anesthesia was administered. The findings include:


a. Patient #6 was admitted to the facility on 10/24/16 for right inguinal hernia repair. Preoperative nursing documentation dated 10/24/16 at 7:20 AM identified that an IV catheter was inserted into the right forearm. Although the post anesthesia care unit also identified that the IV was in the right forearm, anesthesia documentation dated 10/24/16 indicated that anesthesia medications were administered into the right hand IV site in error.

b. Patient #7 was admitted to the facility on 10/24/16 for a gastroscopy. Preoperative nursing documentation dated 10/24/16 at 8:54 AM identified that an IV catheter was inserted into the right antecubital area (arm). Although the post anesthesia care unit also identified that the IV was in the right antecubital area, anesthesia documentation dated 10/24/16 indicated that anesthesia medications were administered into the left hand IV site in error. Interview with the Clinical Performance Improvement Specialist on 10/24/16 at 33:05 PM noted that the hand is the most common site for IVs and automatically populates on the anesthesia record. He/she further noted that the anesthesia provider needed to change the IV site in the electronic medical record if a site other than the hand was used. The facility anesthesia contract identified that anesthesia staff will maintain accurate and complete medical records for all patients treated.

On November 1st and 2nd, 2016, as part of the periodic state Federal Hospital Survey, the Nuclear Medicine and Radiology Department of Bristol Hospital was inspected for compliance with federal and state regulations and acceptable standards of practice. The finding includes:

a. Based upon interviews of Bristol Hospital Management and a review of Quality Assessment and Performance Improvement procedures and minutes, the hospital's nuclear medicine services is not integrated into its hospital-wide Quality Assessment and Performance Improvement (QAPI) program, as required by §482.21.

Cross reference A-536 and A1027.

On November 1st and 2nd, 2016, as part of the periodic state Federal Hospital Survey, the Nuclear Medicine and Radiology Department of Bristol Hospital was inspected for compliance with federal and state regulations and acceptable standards of practice. The inspection consisted of interviews of hospital staff and review of records, procedures, equipment and facilities including the following: (a) in-house physics reports and follow-up corrective actions; (b) personnel dosimetry records; (c) records of receipt of radioactive materials; (d) quarterly inventories; (e) records of area surveys; (f) records of calibration of available radiation detection instrumentation; (g) calibration of dose calibrator, including linearity and constancy determinations; (h) leak check records; and, (i) radiation shielding calculations. The finding includes:

a. Based upon interviews with Hospital Management and review of the job description for the Radiology Director (who also has responsibility for nuclear medicine services), Bristol Hospital does not designate in writing the qualification it requires for the director of nuclear medicine services. In addition, Bristol Hospital was unable to provide documentation that demonstrated through education, experience and specialized training that responsible director is qualified in nuclear medicine.