The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MILFORD HOSPITAL, INC 300 SEASIDE AVENUE MILFORD, CT 06460 Jan. 10, 2017
VIOLATION: GOVERNING BODY Tag No: A0043
The Condition of Participation for Governing Body has not been met. The Governing Body failed to ensure that Pharmaceutical Services met current standards for compounding of intravenous (IV) medications, and failed to ensure that Conditions of Participation for Quality Assessment and Performance Improvement (QAPI), Physical Environment and Infection Control were met.


Please refer to A 263, A283, A315, A490, A491, A492, A700, A701, A702, A709, A724, A747, and A756.


Based on hospital document reviews, interviews, observations and policy reviews, the Governing Body failed to ensure that previously cited (6/11/15) state non-compliance related to compounding IV medications were corrected to ensure that Pharmaceutical Services were compliant with USP 797 standards. The findings include:

The hospital provided a plan of correction in response to the 6/11/15 violation letter. The plan identified that a consultant evaluated the pharmacy for USP 797 compliance, archetectural drawings were rendered, and the expected (renovation) start date was Fall 2015. Despite providing this plan of correction to remediate the identified non-compliance, a tour of the pharmacy on 11/29/16 identified that no remediation had been done and IV's continued to be compounded in a space that was not USP 797 compliant.


Review of the Governing Body meeting minutes for the period of 1/1/15 through present (11/2016) was completed. The minutes dated 5/27/15 indicated that a state survey was completed in late April, 2015 but failed to address areas of non-compliance with Pharmaceutical Services. Subsequent minutes dated 8/26/15, 2/24/16, 5/25/16 and 8/24/16 also failed to address areas of non-compliance with Pharmaceutical Services.

In addition, review of the Pharmacy and Therapeutics (P&T) meeting minutes for the period of 2/23/15 through present indicated that meetings were held every other month. The meetings were held 2/23/15, 4/6/15, 6/1/15, 10/5/15, 12/7/15, 2/1/16, 4/11/16, 6/13/16 and 10/17/16. The meeting dated 6/1/15 (after the non-compliance was identified) failed to address the identified non-compliance. Review of the subsequent meeting minutes failed to address the areas of non-compliance with Pharmaceutical Services.

Review of hospital meeting minutes, documentation and interview with the CEO on 11/30/16 identified that the previously identified areas of non-compliance with Pharmaceutical Services were not remediated and that the hospital's pharmacy continued to be non-compliant with USP 797.


The hospital provided an action plan on 12/14/16 for the provision of IV compounded medications that included compounding only low risk medications with a 1 hour Beyond Use Date (BUD), purchase of pre-mixed IV solutions, contracting with subject matter experts, and design of a USP 797 compliant space. The hospital will consult with appropriate State regulatory agencies as appropriate.
VIOLATION: QAPI Tag No: A0263
The Condition of Participation for QAPI has not been met. Based on observation, review of hospital policy, hospital documentation and interviews with hospital personnel, the hospital failed to develop quality assessment and performance improvement (QAPI) activities for pharmaceutical services despite being cited (6/11/15) for failure to maintain USP 797 standards in the pharmacy's IV compounding area, and failed to ensure that QAPI meetings were conducted quarterly in accordance with Medical Staff bylaws.

Please refer to A283 and A315
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on observation, review of hospital policy, hospital documentation and interviews with hospital personnel, the hospital failed to develop quality assessment and performance improvement (QAPI) activities for pharmaceutical services despite being cited (6/11/15) for failure to maintain USP 797 standards in the pharmacy's IV compounding area, and failed to ensure that QAPI meetings were conducted quarterly in accordance with hospital policy and hospital expectations. The findings include:

Review of the hospital QAPI meeting minutes for the period of time of 1/1/15 through present (11/2016) indicated that meetings were held on 4/1/15, 7/17/15, 12/11/15, 7/22/16 and 10/28/16. Review of the meeting minutes dated 7/17/15 identified that a (State) survey had been conducted however, the minutes failed to identify the findings related to pharmacy non-compliance with USP 797, and failed to develop QAPI indicators for environmental monitoring (EM) of the pharmacy in accordance with USP 797.
Review of hospital documentation and interview with the Pharmacy Director on 11/30/16 failed to reflect that QAPI indicators were developed and monitored to ensure compliance with pharmacy USP 797 standards.
In addition, interview with the QAPI coordinator on 11/28/16 at 12:30 PM indicated that meetings were not held for an extended period of time due to a change in personnel and the meetings should have be held quarterly.

Review of the Medical Staff bylaws indicated that the Performance Improvement (PI) committee will make recommendations to the Executive committee and shall meet quarterly.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on observation, review of hospital policy, hospital documentation and interviews with hospital personnel, the hospital failed to ensure that QAPI meetings were conducted quarterly in accordance with hospital policy and hospital expectations. The findings include:

Review of the hospital QAPI meeting minutes for the period of time of 1/1/15 through present (11/2016) indicated that meetings were held on 4/1/15, 7/17/15, 12/11/15, 7/22/16 and 10/28/16.
Interview with the QAPI coordinator on 11/28/16 at 12:30 PM indicated that meetings were not held for an extended period of time due to a change in personnel and the meetings should have be held quarterly.

Review of the Medical Staff bylaws indicated that the Performance Improvement (PI) committee shall meet quarterly.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
The Condition of Participation for Pharmaceutical Services has not been met. Based on hospital document reviews, interviews, observations and policy reviews, the Pharmacy Department failed to ensure that previously cited (6/11/15) state non-compliance related to compounding IV medications were corrected to ensure that Pharmaceutical Services were compliant with USP 797 standards and failed to ensure that pharmacy compounding personnel were assessed and evaluated for competence to compound medications utilizing aseptic technique as per USP 797.

Please refer to A491 and A492
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on hospital document reviews, interviews, observations and policy reviews, the Pharmacy Department failed to ensure that previously cited (6/11/15) state non-compliance related to compounding IV medications were corrected to ensure that Pharmaceutical Services were compliant with USP 797 standards. The findings include:

1. An observation was made on 11/29/16 during a state licensure survey of the hospital pharmacy and identified that the medication compounding area was located in the pharmacy without the benefit of a segregated space, without a demarcation and/or room for preparation of CSPs. Observation and interview with the Pharmacy Director on 11/29/16 identified that the BSC was not in a designated space, either demarcated or room, but within the general pharmacy. No buffer area and/or anteroom was identified. Boxes were located on the shelves surrounding the BSC. The sink was adjacent to the BSC.

Review of documentation identified that the hospital was previously cited for non-compliance with USP 797 standards related to the pharmacies IV compounding area. The hospital provided a plan of correction in response to the 6/11/15 violation letter. The plan identified that a consultant evaluated the pharmacy for USP 797 compliance, archetectural drawings were rendered, and the expected (renovation) start date was Fall 2015. Despite providing this plan of correction to remediate the identified non-compliance, a tour of the pharmacy on 11/29/16 identified that no remediation had been done and IV's continued to be compounded in a space that was not USP 797 compliant.


USP 797 standards identified that the segregated compounding area would contain a device that provided unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding. Additionally, BSCs shall be located within a restricted access ISO Class7 buffer area. Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. The policies and procedures will be determined by the scope and risk levels of the aseptic compounding activities utilized during preparations of CSPs (USP 797).
Review of hospital documentation and interview with the Pharmacy Director on 11/29/16 identified that low risk CSPs were compounded in the hospital pharmacy. Review of hospital policy, review of hospital documentation and interviews with the Pharmacy Director and the CEO on 11/30/16 failed to reflect that the pharmacy compounding area was renovated and/or compliant with USP 797.

2. The hospital's plan of correction (POC) dated 6/24/15 had indicated that pharmacy personnel were reeducated regarding sterile compounding. Review of hospital documentation and interview with the Pharmacy Director on 11/29/16 identified that the Director was new to the position in April 2016 and that he/she was unaware of the 6/24/15 POC. Review of the current Protocol for the use of the Biological Safety Cabinet (BSC) identified that the policy had not been revised since August 2011. The Protocol noted that activity around the BSC area was to be kept at a minimum during the admixture preparation and identified that personnel must wash hands with soap and water prior to commencing admixture preparation and that latex gloves, while not mandatory, were suggested. The policy failed to reflect donning and doffing of PPE as per USP 797. Additionally, the POC indicated that ten random observations of the compounding process would be conducted per month for a period of four months. Review of documentation and interview with the Pharmacy Director failed to reflect that the observations were conducted.

3. Review of hospital documentation identified that the performance test report was completed for the laminar flow BSC every 6 months. Review of the USP Summary of Sample of Analysis Results (ISO 5) dated 11/25/15 identified that an air sample had an actionable result of 2 CFU of Aspergillus sydowii Cladosporium. The remedial action plan had included to change filters, revision of airflow, and retest. Although a retest on 12/15/15 indicated that the air was retested and had no colonies detected, no further testing was completed until May 2016. Additionally, no envrionmental testing of the surrounding environment was performed, as well as temperature and/or humidity.

According to USP 797 standards, highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs and shall be immediately remedied , regardless of CFU count, with the assistance of a competent microbiologist, infection control professional or industrial hygienist (USP 797). Certification of the rooms involve airborne non-viable particle counting, determination of ISO (International Organization for Standardization) classification, airflow testing and smoke pattern test, room pressurization, HEPA filter leak test, general temperature and humidity. USP 797 identified certification that each ISO classification area (ISO 8, ISO 7, ISO 5) is within established guidelines shall be performed no less than every 6 months and whenever the device or room is relocated or altered or major service to the facility is performed.

4. The Protocol for the use of the BSC and Hood Cleaning policies and procedures (P & P) indicated that cleaning and sanitizing was to be performed at the beginning of each shift per procedure; all items were removed and surfaces cleared of loose material and residue; 70% isopropyl alcohol was used to sanitize areas and must be exposed to clean air flow for 30 seconds prior to use; sign your name in the appropriate box and that there should be at least one full cleaning per day. Interview with the Pharmacy Director and review of the Daily Hood Cleaning Log dated September - November 2016 identified that the Log failed to reflect signatures, (only initials) and that on September 13, 2016 the log failed to reflect that the cleaning was performed as per P & P.

5. Review of the Environmental Services NPA Check List/Daily Reports dated 6/2/15-9/30/15 identified that the pharmacy was cleaned, but failed to identify the type of cleaning of the compounding area. The Report indicated that the following was completed daily: damp dust counters, clean sink, empty trash, dry and wet mop floor, vacuum Director's carpet. Documentation and interview with the Pharmacy Director failed to reflect pharmacy cleaning after 9/30/15. USP 797 identified in part, that the compounding facility shall have written, properly approved standard operating procedures designed to ensure the quality of the environment in which a CSP is prepared. Activities and tasks carried out within the buffer area shall be limited to only those necessary when working within the controlled environment. Only the furniture, equipment, supplies and other material required for the compounding areas and they shcall be nonpermeable, nonshedding, cleanable and resistant to disinfectants. Nonessential objects that shed particles shall not be brought into the buffer area, including pencils, cardboard cartons, paper towels and cotton items. The surface of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices and nonshedding thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate. Walls, ceilings and shelving in buffer/clean area shall be cleaned monthly. The floors in the buffer area or clean area, ante-area and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily and mopping shall be performed by trained personnel using approved agents and procedures described in a written SOP. Documentation and interviews failed to reflect the hospital had a written SOP for the pharmacy compounding area and/or that the area was cleaned and/or maintained according to USP 797.
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on review of hospital policy, review of hospital documentation and interviews with hospital personnel, the hospital failed to ensure that pharmacy compounding personnel were assessed and evaluated for competence to compound medications utilizing aseptic technique as per USP 797. The findings include:


Review of hospital documentation and interview with the Pharmacy Director on 11/30/16 indicated that pharmacy personnel who compounded medications watched a sterile compounding video in 2015, completed a personal aseptic technique test and had a PPE competency review. The documentation dated 2016 indicated that the personnel watched the video, completed a quiz and media fill. Review of USP 796 identified in part, that ...all compounding personnel shall successfully complete an initial competency evaluation and glove fingertip/thumb sampling procedure (0 CFU) no less than three times before initially being allowed to compound CSPs and annally thereafter. Although documentation indicated that the compounding personnel completed a media fill, the documentation and interview with the Pharmacy Director failed to reflect that the pharmacy personnel had completed a gloved fingertip sampling competency after donning PPE annually as per USP 797.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
The Condition of Participation for Physical Environment has not been met.

The hospital failed to ensure that the conditon of the physical plant and overall hospital environmment was developed and maintained in a manner that provided for the safety and well-being of patients based on non-compliance with USP 797 in the pharmacy, and failed to ensure that the physical environment was constructed and/or maintained in to ensure compliance with current life safety standards.


Please refer to A701, A702, and A709
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observations, review of hospital policy, review of hospital documentation and interviews with hosptial staff, the hospital failed to ensure that the physical environment of the pharmacy met USP 797 standards. The findings include:

a. Review of hospital documentation identified that the performance test report was completed for the laminar flow BSC every 6 months. Review of the USP Summary of Sample of Analysis Results (ISO 5) dated 11/25/15 identified that an air sample had an actionable result of 2 CFU of Aspergillus sydowii Cladosporium. The remedial action plan had included change filters, revision of airflow and retest. Although a retest on 12/15/15 indicated that the air was retested and had no colonies detected, no further testing was completed until May 2016. Additionally, no envrionmental testing of the surrounding environment was performed, as well as temperature and/or humidity.

According to USP 797, highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs and shall be immediately be remedied , regardless of CFU count, with the assistance of a competent microbiologist, infection control professional or industrial hygienist (USP 797). Certification of the rooms involve airborne non-viable particle counting, determination of ISO (International Organization for Standardization) classification, airflow testing and smoke pattern test, room pressurization, HEPA filter leak test, general temperature and humidity. USP 797 identified certification that each ISO classification area (ISO 8, ISO 7, ISO 5) is within established guidelines shall be performed no less than every 6 months and whenever the device or room is relocated or altered or major service to the facility is performed.

b. Review of the Environmental Services NPA Check List/Daily Reports dated 6/2/15-9/30/15 identified that the pharmacy was cleaned, but failed to identify the type of cleaning of the compounding area. The Report indicated that the following was completed daily: damp dust counters, clean sink, empty trash, dry and wet mop floor, vacuum Director's carpet. Documentation and interview with the Pharmacy Director failed to reflect pharmacy cleaning after 9/30/15. USP 797 identified in part, that the compounding facility shall have written, properly approved standard operating procedures designed to ensure the quality of the environment in which a CSP is prepared. Activities and tasks carried out within the buffer area shall be limited to only those necessary when working within the controlled environment. Only the furniture, equipment, supplies and other material required for the compounding areas and they shcall be nonpermeable, nonshedding, cleanable and resistant to disinfectants. Nonessential objects that shed particles shall not be brought into the buffer area, including pencils, cardboard cartons, paper towels and cotton items. The surface of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices and nonshedding thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate. Walls, ceilings and shelving in buffer/clean area shall be cleaned monthly. The floors in the buffer area or clean area, ante-area and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily and mopping shall be performed by trained personnel using approved agents and procedures described in a written SOP. Documentation and interviews failed to reflect the pharmacy compounding area was cleaned and/or maintained according to USP 797.

c. Based on additional observations and interviews with hospital staff on 01/10/17, the hospital failed to ensure that the physical environment of the pharmacy met USP 797 standards.
1. The dedicated inline exhaust fan for the Biological Safety Cabinet was controlled by a manual Vari-Speed controller to adjust the hood exhaust;

2. The exhaust duct attached to the Biological Safety Cabinet had vent holes cut into it and the mechanical piping above the ceiling was not secured to the fan and or sealed at each joint;

3. There was an electrical receptacle located within the Biological Safety Cabinet which was corroded not providing a clean environment;

4. The pharmacy staff were utilizing Non-Steryl Isopropyl Alcohol for daily cleaning in and around the Biological Safety Cabinet.
VIOLATION: EMERGENCY POWER AND LIGHTING Tag No: A0702
Based on observations made during tour of the hospital, the hospital failed to ensure that Emergency and Standby Power Systems were installed as required in NFPA 70 "National Electrical Code" and failed to ensure that Emergency and Standby Power Systems were being inspected and maintained as required in NFPA 110 "Standard for Emergency and Standby Power Systems". The findings include:

a. On 11/28/16 at 10:05 AM the surveyor, accompanied by an employee of the Maintenance Department, observed that installation of the 375 KW generator does not comply with the standards set forth by section 445.14 of NFPA 70. i.e: power cables installed from the generator to electrical distribution panels are coiled and stored under the generator exposed to exterior weather elements and possible unauthorized tampering.

b. On 11/28/16 at 10:40 AM the surveyor observed during documentation review that facility staff failed to exercise the emergency generator to the minimum standard set forth by section 6-4.2 of NFPA 110 requiring that the generator be exercised at a capacity not less than 50% of the total EPSS load or not less than 30% of the EPS nameplate rating, whichever load is greater, for a minimum of 30 minutes monthly.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0709
Based on observations made during tour of the hospital, the hospital failed to maintain the hospital in a manner to ensure life safety from fire. The findings include:

a. The facility did not ensure that hazardous areas were either separated by construction providing at least a one hour fire resistance rating or protected by an automatic extinguishing system, where the sprinkler option is used the areas shall be separated by smoke resisting partitions and self-closing doors as required by 19.3.2.1.
On 11/28/16 at 1:40 PM the surveyor, accompanied by an employee of the Maintenance Department, observed that the West Basement mechanical storage room ceiling and walls had numerous penetrations, voids, and missing pieces of drywall, negating the assembly's ability to resist the passage of smoke as required by the referenced LSC standard.

b. The facility did not ensure that means of egress are continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency. No furnishings, decorations, or other objects obstruct exits, access to, egress from, or visibility of exits.
On 11/28/16 at 11:00 AM the surveyor, accompanied by an employee of the Maintenance Department, observed that the West Basement egress corridor is being utilized for storage of cleaning equipment, furniture, and office supplies, not meeting the requirements of the referenced LSC standard.

c. The facility did not ensure that corridors were separated from use areas by walls constructed with at least a 30 minutes rating as required by the referenced LSC.

On 11/28/16 at 11:10 AM the surveyor, accompanied by an employee of the Maintenance Department, observed that the West Basement egress corridor walls have missing pieces of drywall and penetrations, not meeting the requirements of the referenced LSC standard.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observations during tour with hospital staff, the hospital did not ensure that the physical environment provided an acceptable level of safety and well-being for patients, staff, and visitors. The findings include:

On 11/28/16 at 10:55AM the surveyor, accompanied by an employee of the Maintenance Department, observed within the Behavioral Health Holding Rooms within the Emergency Department the following conditions existed: Non-institutional fire sprinkler heads in use, non-tamper proof hardware on all electrical switch plates and receptacles, wall damage, floor damage and marring.
VIOLATION: INFECTION CONTROL Tag No: A0747
The Condition of Participation for Infection Control has not been met.

Based on observation, review of hospital documentation, review of reports, interviews and policy review, the hospital failed to ensure that the quality assessment and performance improvement (QAPI) program addressed infection control problems identified in the pharmacy department to ensure that the IV compounding area was cleaned, tested and certified in accordance with USP 797 and/or that the pharmacy culture testing was reported, reviewed and incorporated into the hospital's infection prevention program.


Refer to A756