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Tag No.: A0043
Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:
CFR 482.13 Patient's Rights
CFR 482.42 Infection Control
Tag No.: A0115
Based on observation, medical record review and staff interview, it was determined that the facility failed to protect and promote the rights of each patient.
Findings include:
1. The facility failed to obtain informed consent prior to procedure or treatment. Refer to Tag A-0131.
2. The facility failed to ensure that patient's are provided care in a safe setting. Refer to Tag A-0144.
Tag No.: A0131
Based on medical record review, review of facility policy and procedure and interview with staff, it was determined that the facility failed to ensure that an informed consent was signed prior to a procedure or treatment.
Findings include:
Reference #1: Administrative Policy #1070 titled "Informed Consents" states under Procedure, "A written consent form is used to obtain authorization prior to the procedure or treatment. When completed the form serves as a record and evidence that the patient authorized the procedure and accepted the associated risks as disclosed by the physician."
1. A tour of the Labor and Delivery (LD) Unit was conducted on 1/16/13 at 11:00 AM. Medical Record #14 was reviewed in the presence of Staff #16 and revealed the following:
a. The LD-Flowsheet indicated that pitocin was started on the patient at 8:48 AM. There was no evidence that the Consent for Operations and/or Medical- Procedure form (form 21-744) for a Vaginal Delivery and possible Cesarean Section was signed by Patient #14.
b. The above findings were confirmed by Staff #16.
Tag No.: A0144
A. Based on staff interview and observations made during a tour of the 5 West unit, it was determined that the facility failed to ensure that the psychiatric unit was compliant with suicide prevention regulations.
Findings include:
1. At approximately 11:00 AM on 1/17/13 the 5 West unit was toured in the presence of Staff #43. The following observations were made:
a. The patient bedrooms (Rooms #587, #588, #589, #590, #591, #592, #593, #594, and #595 (the quiet room) were all noted to have a bathroom within the room. Each bathroom had a sink equipped with a high gooseneck spigot and large, paddle type faucets, both of which could support the weight of an individual in a suicide attempt.
b. Staff #43 confirmed the above findings.
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B. Based on observation and staff interview, it was determined that the facility failed to ensure that all patients are provided care in a safe setting.
Findings include:
Reference #1: N.J.A.C. Title 8 Chapter 43G Hospital Licensing Standards 8:43G-19.16 states, "Normal newborn nurse staff qualifications, staff time and availability (f) The normal newborn nursery shall have at least one registered professional nurse present whenever a neonate is in the newborn nursery."
1. During a tour of the Nursery Unit, on 1/16/13 at 11:30 AM, a neonate, Patient #16, was observed alone, in a bassinet within the nursery. This surveyor was in the area of the nursery for approximately 7 minutes, in the presence of Staff #8. There was no staff member present in the nursery during this time.
2. Staff #8 stated that a nurse always needs to be in the nursery whenever there is a newborn present.
3. At 11:45, Staff #18, the nurse manager of the unit, confirmed that there should always be a nurse in the nursery and that the nurse assigned to the nursery was assisting a physician with a circumcision.
4. Staff #8 and Staff #18 stated that they did not have a policy on how the nursery is staffed but that they follow the New Jersey State regulations, which states that a nurse should be present in the nursery when a newborn is in the nursery.
Tag No.: A0405
Based on medical record review, policy review and staff interview on 1/17/13, it was determined that the facility failed to ensure implementation of policies and procedures regarding administering "as needed" (PRN) medication orders with duplicate indication.
Findings include:
Reference #1: Facility policy titled "6.5 PRN Medications" states, "6.5.3 Duplicate Indication: No more than one PRN medication may be ordered for the same indication unless there are specific instructions for escalating therapy or changing to another drug...In the absence of specific instructions, when more than one drug is ordered for the same indication, the first drug ordered will be the first medication to be administered; the second drug ordered will be the second medication administered and so on...Duplicate indication, by different routes: Ordering PRN medications with duplicate indications administered by a different route is acceptable when there are specific instructions for escalating therapy or changing to another drug. Otherwise, no more than one PRN medication may be ordered for the same indication; this includes medications to be administered by a different route...In the absence of specific instructions; When more than one medication is ordered for the same indication and by more than one route, (and one of the routes is oral), the nurse will administer medications by the oral route provided the patient is tolerating other oral medications."
Reference #2: The New Jersey Board of Nursing Statutes 45:11-23 states "...Definitions...The practice of nursing as a registered professional nurse is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician..."
1. Two of two Medical Records (#32 and #33) reviewed contained PRN medication orders with duplicate indications without specific instructions for escalating therapy.
a. Medical Record #32 contained the following orders with the same indication:
i. "Lorazepam 2mg [milligram]/ml [milliliter]1mg IVP [intravenous push] Q6H [every 6 hours] PRN anxiety", administered on 1/17/13 at 9:00 AM.
ii. "Lorazepam 2mg PO [by mouth] Q6H PRN anxiety", administered on 1/16/13 at 9:20 AM.
iii. Both orders have the same indication for use, leaving the decision of which drug to administer to the nurse. This is not in compliance with the Nurse Practice Act (Reference #2), referenced above.
b. Medical Record #33 contained the following orders with the same indication:
i. "Ondansetron 4mg IV [intravenous] Push Q6H PRN nausea/vomiting", administered on 1/17/13 at 3:51 AM.
ii. "Metoclopramide 10mg IV Push Q6H PRN nausea/vomiting", administered on 1/16/13 at 7:48 AM.
iii. Both orders have the same indication for use, leaving the decision of which drug to administer to the nurse. This is not in compliance with the Nurse Practice Act (Reference #2), referenced above.
c. Upon interview, when asked how a nurse would determine which medication to administer when choosing between two PRN orders with the same indication, Staff #36 agreed that the orders needed to be clearer.
2. These findings were confirmed with Staff #6, Staff #33 and Staff #36.
Tag No.: A0450
Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure implementation of its informed consent policy and procedure.
Findings include:
Reference #1: Administrative Policy #1070 titled, "Informed Consents" states under Procedure: "A. The Form 1. A written consent form is used to obtain authorization prior to the procedure or treatment. When completed the form serves as a record and evidence that the patient authorized the procedure and accepted the associated risks as disclosed by the physician. 4. Somerset Medical Center's Consent for Operation, Special Procedures or Treatment (Form 21-744...) will be appropriately completed and signed by the patient..., a physician(s) and a witness... D. Witnesses 1. Any competent individual over 18 years of age may serve as a witness to the signature of the patient... G. When Should Consent Be Obtained 1. Informed consent ...should be discussed sufficiently prior to proposed treatment... Responsibilities of the Physicians, Surgeons, Nurses... B. Nurses on the Patient Unit 1. The responsibility of the Nursing Staff is to ensure that the APPROPRIATE consent form has been filled out...and is signed by the patient...physician and has been witnessed before the patient has the procedure/surgery or treatment is begun. Procedure: b. Prior to the planned procedure/treatment...the nursing staff must: 1. Ensure the consent form has been signed by the patient...and the witness. In the event the consent form is not signed and witnessed, the RN will hold the pre-operative or pre-procedure medication and notify the physician, Department Manager..."
1. A tour of the Labor and Delivery (LD) Unit was conducted on 1/16/13 at 11:00 AM. Medical Record #14 was reviewed in the presence of Staff #16 and revealed the following:
a. The LD-Flowsheet indicated that pitocin was started on the patient at 8:48 AM. There was no evidence that the Consent for Operations and/or Medical- Procedure form (form 21-744) for a Vaginal Delivery and possible Cesarean Section was signed by Patient #14.
b. The above findings were confirmed by Staff #16.
2. During a tour of the Labor and Delivery (LD) Unit on 1/16/13 at 11:05 AM, medical record review for Patient #15 lacked a witness signature on the consent for a Vaginal Delivery and possible Cesarean Section.
a. Staff #17 stated that she/he witnessed the consent being signed by the patient, however, she/he didn't get a chance to sign it.
b. Staff #8 stated that they don't have a consent policy specific to LD, but they adhere to the administrative policy.
Tag No.: A0500
Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure implementation of policies and procedures addressing the review of "as needed" (PRN) medication orders with duplicate indication by a pharmacist.
Findings include:
Reference: Facility policy titled "6.5 PRN Medications" states, "6.5.3 Duplicate Indication: No more than one PRN medication may be ordered for the same indication unless there are specific instructions for escalating therapy or changing to another drug...In the absence of specific instructions, when more than one drug is ordered for the same indication, the first drug ordered will be the first medication to be administered; the second drug ordered will be the second medication administered and so on...Duplicate indication, by different routes: Ordering PRN medications with duplicate indications administered by a different route is acceptable when there are specific instructions for escalating therapy or changing to another drug. Otherwise, no more than one PRN medication may be ordered for the same indication; this includes medications to be administered by a different route...In the absence of specific instructions; When more than one medication is ordered for the same indication and by more than one route, (and one of the routes is oral), the nurse will administer medications by the oral route provided the patient is tolerating other oral medications...6.5.4 Once PRN medications are prescribed, the pharmacist must review the patient's pharmacy medication profile (as with all drug orders) and check for potential problems..."
1. Two of two Medical Records (#32 and #33) reviewed contained PRN medication orders with duplicate indications without specific instructions for escalating therapy.
a. Medical Record #32 contained the following orders with the same indication:
i. "Lorazepam 2mg [milligram]/ml [milliliter]1mg IVP [intravenous push] Q6H [every 6 hours] PRN anxiety", administered on 1/17/13 at 9:00 AM.
ii. "Lorazepam 2mg PO [by mouth] Q6H PRN anxiety", administered on 1/16/13 at 9:20 AM.
b. Medical Record #33 contained the following orders with the same indication:
i. "Ondansetron 4mg IV [intravenous] Push Q6H PRN nausea/vomiting", administered on 1/17/13 at 3:51 AM.
ii. "Metoclopramide 10mg IV Push Q6H PRN nausea/vomiting", administered on 1/16/13 at 7:48 AM.
c. Upon interview, when asked how a nurse would determine which medication to administer when choosing between two PRN orders with the same indication, Staff #33 agreed that the orders needed to be clearer.
2. These findings were confirmed with Staff #6, #33 and #36.
Tag No.: A0505
Based on observation and staff interview, it was determined that the facility failed to implement policies and procedures to ensure that outdated drugs and biological's were not available for patient use.
Findings include:
Reference: Facility policy titled "13.1 Inspecting Drug Storage Areas" states, "13.1.4 All medication storage areas shall be inspected by personnel familiar with proper storage requirements at least every month with documentation that the following requirements are met: ...c. Outdated drugs are promptly removed from stock and returned to the pharmacy."
1. On 1/18/13 at 11:00 AM, the following outdated drugs were observed in the "Center Core Refrigerator" of the Operating Room (OR) Suite:
a. Two sodium chloride 0.9% 1,000ml (milliliter) IV (intravenous) solution bags, expired 8/11.
b. One sodium chloride 0.9% 250ml IV solution bag, expired 6/12.
c. One sodium chloride 0.9% 1,000ml irrigation bottle, expired 8/12.
2. These findings were confirmed by Staff #33 and Staff #37.
Tag No.: A0701
Based on observation, it was determined that the facility failed to ensure that a sanitary environment was maintained in the Operating Rooms (ORs).
Findings Include:
1. On 1/16/13, the positioning blocks observed in OR #1 and OR #4 were observed with cracks in the impervious covering, allowing liquids to be absorbed and prohibiting proper cleaning of the blocks.
2. The ceiling above the instrument decontamination sink had liquid residue spots and stains from apparent ceiling leaks.
Tag No.: A0747
Based on observation, staff interview, and review of documentation, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.
Findings include:
1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to Tag A-0701.
2. The facility failed to implement nationally recognized infection control guidelines. Refer to Tag A-0749.
Tag No.: A0749
A. Based on observation, staff interview, and review of documentation on January 16 and 17, 2013, it was determined that the facility failed to ensure that the infection control and prevention program has adequately implemented facility policies and national guidelines from the Association for the Advancement of Medical Instrumentation (AAMI).
Findings include:
Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2005. ST 79 replaces and supercedes ST 46 by consolidating with 4 other AAMI standards [ST 33, ST 37, ST 42, ST 35] approved 7/10/09.
The AAMI Standard 5.3, Disposition of Sterile items (Issued but not used) states, "Reusable items that have been opened or that have damaged packaging should be unwrapped and reprocessed through decontamination in accordance with departmental policies and procedures."
1. On 1/16/13 at 2:00 PM in the Sterile Processing Department (SPD), Staff #44 was observed opening sterile peel packs of surgical instruments that were processed at least 2 years prior. Upon interview with Staff #44, he/she indicated that if these instruments appear visually clean he/she would repackage and re-sterilize these instruments without sending them through the initial decontamination process.
a. Staff #5 indicated that this is contrary to facility policy and procedure.
Reference #2: AAMI ST 79, section 8.3.4, Paper-plastic pouches states, "Pouches should be used for small lightweight, low profile items... If items are to be double packaged, two sequentially sized pouches should be used (i.e. the sealed inner pouch should fit inside the other pouch without folding)."
1. On 1/16/13 at 11:00 AM in the SPD, observation of sterile peel packs with sterilization process dates from 2002, 2004, and 2007 contained double peel pouches with the interior peel pouch folded, which may compromise the sterility of these items. These peel pouches were observed in the excess equipment storeroom and were available for use.
Reference #3: AAMI ST 79, section 8.4.3 Inspection, states, "Instruments should be carefully inspected for cleanliness and flaws or damage prior to packaging."
1. Staining and tape residues that are impediments to proper cleaning were observed on instruments stored in the SPD. These instruments were available for use.
a. On 1/16/13 at 11:30 AM, several surgical instruments observed in the SPD sterile preparation and packaging area, excess instrument storeroom, and one randomly opened orthopedic major tray opened by this surveyor, were observed to contain a red rust like staining in the equipment lock box and hinged areas of the instruments; the instruments did not appear clean. The orthopedic major tray and sterile instruments in the excess equipment storeroom were available and ready for use.
b. Several instruments observed in the SPD contained color coded identification tape that was worn, dried and beginning to flake off the instrument.
Reference #4A: AAMI ST79:2010 document titled, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 8.9.2, "Storage facilities, Sterile items should be stored in a manner that reduces the potential for contamination...Items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that the sterility is not otherwise compromised. Shelving or carts used for sterile storage should be maintained in a clean condition."
Reference #4B: Facility policy number 3013 in the "Patient Care Manual, Section III - Surveillance, Prevention, and Control of Infection" , Subject: Sterile Items: Packaging and Shelf Life", states, "Procedure: ...5. Store all sterilized items in a manner that will protect the integrity of the package (i.e. if stacking necessary, heavier items should be on the bottom. If prolonged shelf life is expected, plastic sterility maintenance covers will be applied. Rotate stock by date so items first sterilized are pulled first for use). 6. Examine all sterilized items prior to opening to ensure package integrity and appropriate color change of external chemical indicators. If compromise to sterile packing is noted, item will not be used and it must be returned to SPD for reprocessing. 7. Department manager of unit where items are stored or his/her designee will monitor stored sterilized items monthly for integrity of packaging. Event related audit tool is to be used for this purpose. Unit manager will send original of the audit to the SPD manager."
1. Sterilized materials are not stored or monitored in the Operating Room (OR)according to facility policy to ensure sterility at the time of use as observed by the following:
a. On 1/16/13, in the OR sterile storage area, a sterilized Grasper instrument observed in a paper/plastic wrap, with processing date of "Jan 26 05" had several obvious pinholes in the paper wrap.
b. On 1/16/13, in the OR sterile storage area, a sterilized wrapped tray containing a Synthes Compact air driver, with processing date of "Feb 4 12" had broken and rolled-off tape on the wrap seams.
c. The OR sterile storage room was observed with exposed insulation in an area of the ceiling over sterile item storage cabinets, near the Bronchoscope storage cabinet, where a ceiling tile had been moved. Monitoring of storage conditions for sterile items was not documented for identification of potential sources of contamination and assessment for correction.
d. On 1/16/13 at 11:45 AM, sterile peel pouches in the SPD department were observed cramped in storage bins, crimping the package which may compromise sterility.
e. Open wire storage racks storing clean and sterile supplies in SPD were observed on 1/16/13 soiled with an accumulation of dust. Soiled racks were noted in the linen room, decontamination area, and excess equipment storeroom.
f. On 1/16/13, Staff #21 stated that a monthly audit of the stored sterilized items for integrity of packaging was not done in the OR. Staff #21 stated that "Event Related Sterility Audits" mentioned in the referenced policy (#4B) above have not been completed and no such records are maintained regarding sterile items used in OR.
Reference #5A: AAMI ST79:2010 document titled "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 10.5.3.2, "Using biological indicators... If a sterilizer is designed to be used for multiple types of cycles (gravity-displacement at 132?C to 135?C [270?F to 275?F], gravity-displacement at 121?C [250?F], dynamic-air-removal at 132?C to 135?C [270?F to 275?F], "flash" at 132?C to 135?C [270?F to 275?F], "flash" with single wrapper or other packaging), then each sterilization cycle type used should be tested."
Reference #5B: Facility policies titled, "Quality Control Procedures for Sterilization" reviewed January 2, 2001 states, "All testing of sterilizers such as biological and air removal test will be done daily."
Facility policy titled, Subject: "Recall for Processed Equipment" Policy: "Bacteriological studies/Recall of items Sterilized in Sterile", revised September 7, 2006 states, "All loads undergoing terminal steam sterilization in the Operating Room shall be spore tested at least once weekly. Steam spore tests and control tests are incubated and recorded in the Operating Room."
Reference #5C: Manufacturer's Instructions for Use (IFU) for 3M Attest 1291 Rapid Readout Biological Indicator states, "Product Description: The 3M Attest 1291 Rapid Readout Biological Indicator RRBI, (blue cap) is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of the 270?F (132?C), gravity steam sterilization process when used in conjunction with the 3MAttest 190/290 Auto-readers ....Precautions: Do not use the Attest 1291 RRBI to monitor: 1. 270?F (132C) or 250?F (121?C) vacuum assisted steam sterilization cycles."
1. Infection control policies and procedures were not developed and implemented, and manufacturer's instructions and industry standards were not followed for the routine sterilizer efficacy monitoring of immediate-use sterilizers used in the Surgical Department as indicated by the following:
a. On 1/16/13, Staff #22 presented a 3M Attest 1291 RRBI (blue top), specified by manufacturer for monitoring gravity steam (not pre-vacuum) sterilization process, and stated that it is used to monitor OR sterilizers, tested in a pre-vacuum cycle.
i. On 1/16/13, Staff #22 stated that there are no other Biological indicators used to monitor the pre-vacuum cycles that are used routinely in the OR immediate-use sterilizers and that only one 10 minute flash cycle is tested with a Biological indicator.
b. A document was observed attached to the side of the OR sterilizers titled, "Flashing Parameter for Limited Supply Items" lists the time, temperature and sterilizer cycle requirements for specific instruments, including "PreVac 4 minutes at 270?F with no dry time; Flash 10 minutes at 270?F with no dry time; Flash 3 minutes at 270?F with no dry time; Do not Flash. PreVac 4 minutes 270?F with an 8 minute dry time (choose cycle 5)." The facility policies in Reference #5B above do not specify that the correct Biological indicator for the type of cycle tested should be used or that each cycle type that may be used in the OR should be monitored with a Biological indicator.
Reference #6: AAMI ST79, section 9.4 Routine Care states, "Sterilizers should be inspected and cleaned daily according to the manufacturer's written instructions."
1. Closed and open containers available for immediate-use sterilization of instruments in the OR were not maintained clean and in good repair.
a. On 1/16/13, the Riley Flashpak sterilization container observed in OR #1 substerile room was observed soiled with drippings from a white plastic or waxy material adhering to the interior surfaces of the container.
b. On 1/16/13, the metal open sterilization pan observed inside the Getinge Sterilizer #6 was soiled with a black substance. Sides of the metal pan were observed bent, inhibiting proper cleaning.
c. On 1/16/13, Staff #5 stated that all OR policies and procedures regarding sterilization could be found in the SPD and Infection Control Policy manuals. The manufacturer ' s instructions or facility policy for the cleaning of immediate-use sterilizer containers after use were not provided in the SPD Department, OR Department, or Infection Control manuals available for review.
Reference #7: AAMI ST 58:2005 titled, "Chemical Sterilization and high-level disinfection in health care facilities" section 7.3.3 Automated LCS/HLD [Liquid Chemical Sterilant/High Level Disinfection] equipment manufacturer, states, "Health care personnel should follow LCS/HLD equipment manufacturer's instructions for use..."
1. The Steris System 1E equipment processors used in the OR were not monitored according to device manufacturer's instructions for use.
a. Facility Policy Number II-11.5 Subject: Steris General Processing Sterilization, found in the OR Orientation Manual made available for review on 1/17/13 states, "14. Check printout for concentration of 170 or greater, exposure time of 12 minutes and temperature between 50-56?C." In addition, the Steris Sterilization Log Sheet observed completed with documented checks for recent equipment loads in the area of the Steris System 1E processor state,
"Exposure Time 12 minutes." However, the Steris System 1E processor monitoring printouts observed for recent instrument loads document a 6 minute exposure time. The posted policy in the processing room for the Steris System 1E states "Exposure Time 6 minutes."
b. On 1/17/13, Staff #21 stated that Policy Number II-11.5 is an old policy from the previous model of Steris System 1 processor and a new policy has not been developed for the new Steris System 1E processor. In addition, Staff #21 stated that the monitoring log sheets are also from when the Steris System 1 was in use and a new monitoring log sheet with appropriate monitoring parameters listed has not been developed or implemented.
Reference #8: AAMI ST 58:2005 titled, "Chemical Sterilization and high-level disinfection in health care facilities," section 4.3 Training and continuing education states, "Personnel should receive in-service training from the manufacturer for all new instrumentation, devices, and equipment, as well as cleaning, disinfectant, and sterilant solutions, with competency verification after the training."
1. The OR staff using the Steris System 1E equipment processors have not been instructed and competency has not been reviewed for the use and monitoring of the new device.
a. Although the Steris System 1E monitoring printouts for recent instrument loads document a 6 minute exposure time and the posted policy for the Steris System 1E states acceptable exposure time is 6 minutes, the monitoring log sheets have been marked to indicate that a 12 minute exposure time was verified.
b. A self-signed checklist for the "Annual OR Mandatory Education Packet," dated 1/25/12 for OR Staff #22 documents, "Competency Evaluation for Steris System 1 Processor". There was no documentation in the education file for Staff #22 for training or competency for the Steris System 1E.
Reference #9: AAMI ST 58:2005 titled, "Chemical Sterilization and high-level disinfection in health care facilities" section 7.3.1 Medical device manufacturer states, "Health care personnel should follow the device manufacturer's written instructions..."
1. Manufacturer's recommendations have not been obtained regarding the compatibility of instruments processed in the Steris System 1E.
a. Staff #21 stated that a GlideScope is processed in the Steris System 1E. However, manufacturer's instructions for the GlideScope, provided by Staff #21 on 1/16/13, lists the Steris System 1 but does not list the Steris System 1E as an approved reprocessing device for this instrument.
Reference #10: AAMI ST58:2005 document titled, "Chemical Sterilization and high-level disinfection in health care facilities" states that for each high-level disinfection cycle, recorded information including but not limited to: patient's name, name of device, identification of processor, chemical MEC test results, exposure time, date and time of the cycle shall be maintained.
1. Processing information is not maintained for endoscopes reprocessed in the ASP reprocessor to enable equipment traceability in the event of a recall.
a. On 1/16/13, the ASP endoscope reprocessor in the Endoscopy Department was observed with a printer attachment, however, Staff #23 stated that the printer was broken for "for a long time" and has not been repaired.
b. Hand-written records available for endoscope reprocessing done in the ASP endoscope reprocessor do not include all process information, including information that would allow traceability of the scope to the patient on whom it was used.
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B. Based on observation and review of pertinent facility documentation, it was determined that the facility failed to ensure that the prevention of infection among patients and personnel is controlled.
Findings include:
Reference #1: Facility Infection Control Manual, Section III; MRSA [Methicillin Resistant Staphylococcus Aureus] ... Quick Reference Isolation Guide: Contact Isolation: "Gown and Glove to enter room."
Reference #2: Facility Sign: CONTACT PRECAUTION, "...Wear gloves when entering room ... Wear gown when entering room ..."
Reference #3: Patient Care Manual Section: Policy number: "New Approved Awaiting #" SUBJECT: Red Tape for Contact Isolation Rooms states under POLICY, "Patients who are placed in contact isolation will have a red line placed on the floor of the designated area within the room..."
1. On 1/16/13 at 2:40 PM, the Neurology Unit was toured in the presence of Staff #6 and Staff #16. The following observations were made:
a. Room #484 had a Contact Isolation sign posted outside the door that indicated that staff and visitors were to wear gowns and gloves when in this patient's room. There was a visitor in the room and he/she was not wearing gloves or a gown. Staff
#15 stated that this patient had MRSA.
b. Room #491 had a Contact Isolation sign posted outside the door that indicated staff and visitors were to wear gowns and gloves when in this patient's room. There was a visitor in the room wearing a mask but not wearing gloves or a gown. Staff #15 stated that this patient had MRSA.
c. During an interview, Staff #15 stated that visitors need to wear gloves while in the room of patients on contact isolation.
2. On 1/17/13 at approximately 1:15 PM, Unit 2 West was toured in the presence of Staff #27. The following observations were made:
a. Room #281 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
b. Room #283 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
c. Room #281 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
d. Room #278 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
e. Room #272 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
f. Room #271 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
g. Room #270 had a Contact Isolation sign posted outside the door. However, there was no designated area marked off with red tape, as required by the above referenced policy.
h. Room #267 had a designated area marked off with red tape. However, there was no Contact Isolation sign posted outside the door, as required by the above referenced policy.