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.
| ALLEGHENY VALLEY HOSPITAL | 1301 CARLISLE ST NATRONA, PA 15065 | June 20, 2019 |
| VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS | Tag No: A0726 | |
| Based on review of facility policies, facility documentation, and staff interviews (EMP), it was determined the facility failed to ensure proper ventilation in all appropriate areas of the hospital. Findings include: Review of policy "Air Handling and Ventilation Systems Maintenance" last revised July 2017, revealed, "A. The Utility Systems Management Program shall include the correct design, installation and maintenance of the hospital's air handling and ventilation system serving areas specifically designed to control airborne contaminants. 1. Areas of paramount concern include pressure relationships, air exchange rates and filtration efficiencies. 2. Specifically designed areas include operating rooms, special procedure rooms for patients who have been diagnosed or suspected of having an airborne communicable disease, protective environment rooms, clinical laboratory, pharmacy and sterile supply rooms. B. The design parameters shall follow the Guidelines for Design and Construction of Hospitals and Outpatient Facilities by the Facilities Guidelines Institute, 'Ventilation Requirement for Areas Affecting Patient Care in Hospitals and Outpatient Facilities', and 'Filter Efficiencies for Central Ventilation and Air Conditions Systems in General Hospitals.' ... " Review of Guidelines for Design and Construction of hospitals, Ventilation of Health Care Facilities, revealed, "... 7. Space ventilation - hospital spaces. ... 7.1 General Requirements. The following general requirements shall apply for space ventilation: a. Spaces shall be ventilated according to Table 7-1." Review of facility documentation for room air change test summary revealed the survey is being performed on ORs, PACU, Central Supply CPD, and Decontamination room. No documentation of other areas affecting patient care as required by Table 7-1 were noted. Interview with EMP1 on June 19, 2019 at 9:30 am revealed room air exchange testing is not performed on all required areas listed in the Guidelines for the Design and Construction of Hospitals. |
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| VIOLATION: OPERATING ROOM POLICIES | Tag No: A0951 | |
| Based on review of facility documentation, observation, and employee (EMP) interviews it was determined the facility failed to follow policies that adhere to aseptic and sterile surveillance practice for one of one observation and two of two medical records (MR18 and MR19). Findings include: Review of facility policy and procedure "Surgical Attire" last review 02/2020, revealed " B. Restricted area: is defined as a designated space contained within the semi-restricted area that is accessible only through a semi-restricted area. The restricted area includes operating rooms in which surgical or other invasive procedures are performed. ... M. personnel must cover head and facial hair, including sideburns and necklines, when in the semi-restricted and restricted areas of the surgical suite. All facial hair must be contained within a beard cover when personnel are in the semi-restricted and restricted areas." "Cleaning and Care of Surgical Instruments Policy Statement: ... C. Cleaning/decontamination procedure ...1. When instruments are returned, rinse immediately and thoroughly under running cold tap water. 2. Cleaning and decontaminating should occur as soon as possible after instruments and equipment are used to prevent the formation of biofilm and for sterilization to be effective. 3. Preparation for decontamination should begin at the point of use. 4. All instruments opened in the operating room or procedure room shall be decontaminated whether or not they have been used. 5. Surgical instrument, medical device, and equipment manufacturers' validated instructions should be followed regarding the types of cleaning agents that are to be used for decontamination. ... 8. When manually cleaning instruments should be washed in a manner that provides proper decontamination ... 10. Manual cleaning ... 11. Mechanical cleaning should be accomplished by ultrasonic cleaners, washer decontaminators/disinfectors, or washer sterilizers. ... G. Packaging: ... H. The manufactures's written, validated instructions for handling and reprocessing will be obtained and evaluated to determine the ability to adequately clean and reprocess the equipment." 1. During MR2 surgical case on June 18, 2019, at approximately 10:30 AM, EMP7, EMP8, EMP9 and EMP10 were observed wearing head covering without fully covering their head hair. EMP2 and EMP3 confirmed the above findings during observation. 2. Review of MR18 revealed "05-13-2019 10:30 ... Location Operating Room ... Surgical Technician was examining trays to ensure sterility, found a piece of bone among the screws and our table was now contaminate - bioburden." Further review revealed "05-13-2019 10:45 ... Location Operating Room ... The Surgical Technician lifted the tray and the nurse was checking the wrap for sterility and found a chunk of bone on the drape. The case was then contaminated." Continued review revealed "05-13-2019 10:45 ... Location Operating Room ... The Surgical technician was checking the tray for sterility and found blood in the depth gauge. The tray was then contaminated. Surgical tech noted the bioburden on the depth gauge " 5. Review of MR19" revealed "06-06-2019 10:30 ... Location Operating Room ... During set-up for scheduled case, discovered that a tray needed for the case was contaminated (foreign material found on implement in tray). Case was delayed and scheduled for later time that day in order to sterilize trays that were needed for the case." Interview with EMP1 on June 20, 2019, at 9:25 AM confirmed the above findings and revealed "We are working really hard on this." |
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| VIOLATION: INFORMED CONSENT | Tag No: A0955 | |
| Based on review of facility documentation, medical records (MR), and staff interview (EMP) it was determined the facility failed to ensure a properly executed informed consent was in the patient's medical record before surgery for two of two medical records reviewed (MR4 and MR5). Findings include: Review of facility policy and procedure "General and Informed Consent" last revised June 2019, revealed "7. Informed Consent - Informed Consent is a process, not a form. It is the communication between the patient and Physician. Consents the exchange of information resulting in the patient agreeing to undergo a specific medical or surgical intervention. The signatures on the consent form are the required documentation of that communication and consent." 1. Review of MR4 revealed "05-30-2019 ... 12:54 ... The[sic] informed that the patient had consented to removal of a groin mass. When the doctor made teh[sic] incision it was noted that it was a hernia not a mass. The surgeon repaired the hernia. The nurse stated that the suroen[sic] did inform the patient family." Further review revealed a consent form "1. Dr. ... has permission to perform the following procedure "excision right groin mass " Continued review revealed no documented evidence of an informed consent for repair of a hernia. Interview with EMP6 on June 19, 2019, at 2:00 PM confirmed the above findings and revealed " No there is no consent for repair of a hernia." Continued interview on June 20, 2019, at 10:05 AM revealed "There is no documentation on the medical record the doctor talked with the family." 2. Review of MR5 revealed "04-18-2019 ... 1700 ... Discovered that procedure was performed without consent after patient was discharged from the hospital. ... Manager from orthopedics is going to phone family to determine if Dr. ... obtained their consent verbally since the ulcer was discovered while the patient was in the OR ... phoned the son and he did tell her that Dr. ... made him aware of the ulcer and what he did after surgery." Further review revealed "1. Dr. ... has permission to perform the following procedure(s): ... debridement possible explant R(right) bipolar hemiarthroplasty and placement of articulating antibiotic space" Continued review revealed no documented evidence of an informed consent for debridement of a wound on the patient's right heel." Interview with EMP6 on June 19, 2019, at 2:00 PM when asked if there was a consent for debridement of the right heel confirmed the above findings and revealed "No" Continued interview on June 20, 2019, at 10:05 AM revealed "There is no documentation on the medical record the doctor talked with the family." |
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| VIOLATION: OPERATIVE REPORT | Tag No: A0959 | |
| Based on a review of medical records (MR), facility policies, and staff interviews (EMP), it was determined that the facility failed to ensure that operative reports were written according to facility policy for four of eight medical records reviewed (MR10, MR11, MR12, and MR13). Findings include: Review of facility's Medical Staff Rules and Regulations, last revised February 2018, revealed, "Section 3.10. Operative/Invasive Procedure Records: ... (c) A detailed operative/invasive procedure report shall be written or dictated immediately following surgery and shall contain: ... (2) the technical procedures used, including the technique, use of drains, fluid loss and replacement; ... " Review of MR10, MR11, MR12, and MR13 revealed no documentation of fluid loss in the operative report. Interview with EMP1 on June 20, 2019 at 10:30 am confirmed the above findings. |
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