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Based on record reviews, and staff interviews, the Nursing Service failed to ensure the patient needs were met by an ongoing assessments of the patient's care needs as evidenced by:
1) failing to have documented evidence the Licensed Practical Nurse and/or a Registered Nurse reassessed hypoactive bowel sounds in all four quadrants on 12/31/12 at 7:50 p.m. (1950) and on 01/06/13 at 7:00 (1900) as per the "Reassessment" policy for 1 of 31 medical records reviewed, #2, and
2) failing to have physician's order to admit patients on the GI (gastrointestinal) unit as per policy for 2 of 2 focused medical records reviewed on the GI unit out of a total sample of 31 medical records, (#28, #29). Findings:

1)
Review of the medical record for Patient #2 revealed the patient was admitted on 12/22/12 with the admitting diagnosis of possible small bowel obstruction.

Review of the "Nursing Narrative" notes dated/timed 12/31/12 at 7:50 p.m. (1950) read, "Abd (abdomin) firm and distended. BS (bowel sounds) hypoactive X (times) 4 (four) quads (quadrants)". Review of the "Nursing Narrative" notes dated/timed 01/06/13 at 7:00 p.m. (1900) read in part, "BS - hypoactive X 4 quads".

Further review of the medical record revealed there was no documented evidence the patient's (#2's) hypoactive bowel sounds in all 4 quads were reassessed by the Licensed Practical Nurse and/or a Registered Nurse on 12/31/12 and/or on 01/06/13.

In an interview on 01/09/13 from 2:45 p.m. through 2:50 p.m., the Director of Nursing (DON), S2 and the Charge Nurse, S11Registered Nurse both verified there was a change in Patient #2's bowel sounds on 12/31/12 at 7:50 p.m. and on 01/06/13 at 7:00 p.m. S2 and S11 both indicated there should be a reassessment of Patient #2's hypoactive bowel sounds by the Licensed Practical Nurse and/or Registered Nurse on 12/31/12 and 01/06/13 as per protocol. S2DON further indicated the Licensed Practical Nurse and Registered Nurse failed to reassess a change in the patient's (#2's) conditions on 12/31/12 and/or on 01/06/13 as per policy.

The policy titled, "Assessment/Reassessment", Policy number: GNP A-1, Page 1 - 2, Effective date of March, 1987, Last reviewed date of August, 2011, Last revised date of March, 2010, indicated its purpose was to properly assess patients to determine care, treatment, and services that will meet the patient's continuing needs. Patients are reassessed as necessary based on changes in his/her conditions. Reassessment is completed and documented by either an RN or LPN anytime there is a change in the patient's condition.

2)
Patient #28:
Review of the medical record for Patient #28 revealed she had an EGD and Coloscopy special procedure performed on 01/08/13. Review of the "Procedure Sedation Nursing Flowsheet" dated/timed 01/08/13 at 8:40 a.m. (0840) revealed Patient #28 was admitted on the unit, vital signs were taken, and a saline heplock was inserted in the patient's left hand by the nursing staff. Review of the "Physician Order" dated/timed 01/08/13 at 10:06 a.m. indicated to admit the patient to the unit. Further review revealed there was no physician order to admit the patient (#28) prior to the patient arriving on the unit as per policy.

Patient #29:
Review of the medical record for Patient #29 revealed she had a Colonoscopy special procedure performed on 01/08/13. Review of the "Procedure Sedation Nursing Flowsheet" dated/timed 01/08/13 at 7:30 a.m. (0730) revealed the patient (#29) was admitted on the unit, vital signs were taken, and a saline heplock was inserted in the patient's right forearm by the nursing staff. Review of the "Physician Order" dated/timed 01/08/13 at 8:49 a.m. (0849) indicated to admit the patient (#29) to the unit. Further review revealed there was no physician order to admit the patient (#29) prior to the patient arriving on the unit as per policy.

In an interview on 01/11/13 at 10:00 a.m., at 10:25 a.m., and at 11:09 a.m., the Assistant Director of Nursing, (ADON), S6; the Program Coordinator Nursing Performance Improvement, S9; and the Charge Nurse GI Unit, S12Registered Nurse (RN) all confirmed Patient #28 and #29 were admitted on the GI Unit without a physician's order. At this time, S12RN, Charge Nurse indicated the nursing staff use the referral forms as a physician order to admit a patient on the unit. The Charge Nurse, S12RN agreed the referral form is not a physician order to admit the patients on the GI unit. S12RN, Charge Nurse indicated the nursing staff failed to ensure there was a physician order to admit patients to the unit prior to providing them (#28, #29) nursing care as per policy.

Review of the policy titled, "How a Physician Schedules a Patient for Special Procedures"; with no policy number, Page number 14; Effective date of October, 1991; Last revised date of January, 2009; Last reviewed date of November, 2012; indicated its purpose was to explain the protocol to be followed by a physician who wishes to schedule a patient for special procedures. Admit orders must be completed on each outpatient scheduled for GI Procedure. Inpatients need procedure orders written on the chart.

Review of the Medical Staff Rules & Regulations, Article 1 Admissions section, page 5 of 44, Section 1.5 Admission orders indicated admitting orders/pre-admitting orders must specify admitting physicians, provisional diagnosis and admission status and any proposed surgical procedures.

Based on records review and interview the hospital failed to ensure that all patient medical record entries were dated and/or timed in accordance with the hospital's medical staff rules and regulations for 3 of 31 sampled patients in a total sample of 31 (#1, #9, #14). Findings:

Review of the hospital's Medical Staff Rules and Regulations dated 6/29/12 reflected all medical record entries must be dated and timed.

Patient #1
Record review revealed Patient #1 was admitted to the hospital on 12/28/12 with a primary diagnosis of Warm Antibody Hemolytic Anemia.

Further review of the medical record reflected a physician's order dated 1/7/13; however, there was no time documented for the order. Further review of the record reflected there were three progress notes completed that were not dated and/or timed.

Patient #9
Review of the medical record for Patient #9 reflected a progress note dated 1/08/13 that was not timed.

Patient #14
Review of the medical record for Patient #14 reflected there were physician's orders and progress notes that were dated but not timed.

During an interview with S6, Assistant Director of Nursing (ADON) on 1/8/13 at approximately 2:10 p.m., she revealed all progress notes and physician's orders should be dated and timed.

Based on record review and interview the hospital failed to ensure informed consent forms for procedures and treatments were properly executed by failing to have a written consent signed for 1 of 5 focused records reviewed for procedure consents in a total sample of 31 (#14). Findings:

Review of the medical record for Patient #14 reflected a consent form for a bronchoscopy procedure was completed and signed by S5, M.D. on 1/3/13 at 0840. Further review reflected the consent had not been signed by the patient or person authorized to consent for the procedure.

There was no documented evidence in the record to reflect that the patient or the person authorized to consent had been informed of the procedure prior to the procedure being completed.

Review of the Physician's progress note dated 1/4/13 at 10:00 a.m. revealed documentation to reflect patient #14 had the procedure on the above date (1/14/13) at 8:00 a.m.

Interview with S6, ADON on 1/8/13 at approximately 2:05 p.m. confirmed there was no documented evidence to reflect the patient or the patient's family member/authorized person had been informed and consented to the procedure prior to the procedure being completed.

Based on observation and interview the hospital failed to ensure equipment was maintained at an acceptable level of quality as evidenced by 5 of 6 phlebotomy chairs in the laboratory having tears/cracks where patients placed their arms for blood draws. These tears/cracks made the chairs unable to be decontaminated as any blood/body fluids would penetrate the foam interior of the arm rest. Findings:

In an observation made on 01/11/13 at 9:00 a.m. with S13RN, QA, it was noted that 5 of the 6 phlebotomy chairs in the laboratory used for outpatient blood draws had tears/cracks in the left arm cushion where patients placed their arm for blood draws.

In an interview on 01/11/13 at 9:00 a.m. with S13RN, QA, she confirmed the covering on the phlebotomy chairs had tears/cracks and should be replaced so the chairs could be properly disinfected.

Review of a hospital policy, number 104-Safety Management, effective October 2000, last revised July 2012, presented as current hospital policy, read in part: "Subject: Hazard Surveillance Program...Policy: It is the policy of University Medical Center to conduct regular survey of all areas of the organization to determine whether the current activities used to manage the environment of care are effective...Procedure:..3. Safety/hazard surveys of all patient care areas of the facility will be performed on a semi-annual basis..."

Based on record reviews, observations and staff interviews, the Surgical Services failed to assure the decontamination process for all surgical instruments was followed by the Central-Sterile Workers as evidenced by: 1) the Central-Sterile Worker, S7 failing to soak the surgical instruments (appendectomy, hand set #2) in the Prolystica Enzymatic cleaner for two (2) minutes as per the Decontamination policy and as per the Enzymatic cleaner's manufacturer's instructions, and failing to rinse the surgical instruments with water after cleaning them with the Enzymatic solution as per the decontamination policy and
2) the Central-Sterile Worker, S10 failing to soak the surgical instruments (metaport) in the Prolystica Enzymatic solution for 2 minutes as per the decontamination policy and as per the enzymatic manufacturer's instructions. Findings:

During an observation of the Decontamination Process on 01/09/13 from 10:12 a.m. through 10:35 a.m. with Central-Sterile Manager, S8 and Program Nursing Performance Improvement, S9, the Central-Sterile Worker, S7 was observed wearing a hairnet, gloves and a gown while completing the decontamination process on a set of surgical instruments from a cart labeled, "#3". Further observation revealed S7 was not wearing a mask and/or eye protection at this time. At 10:30 a.m., S7 was observed removing an appendectomy surgical instrument tray set from the top shelf of cart "#10". Further observation revealed S7 did not remove gloves, gowns, and/or hairnet after completing the decontamination process of these surgical instruments in cart "3". At 10:32 a.m., S7 was observed removing a pair of surgical scissors from sink #1the surgical instruments from the metal tray and placed them into sink #1. At 10:32 a.m., S7Central-Sterile Worker indicated sink #1 had two (2) squirts of Prolystica Enzymatic cleaner in it. S7 further indicated there is no dwell/soak time the surgical instruments are to be in the enzymatic solution. Further observation revealed the Central-Sterile Worker, S7 was observed removing the surgical instruments from sink #1, inspecting each instrument, scrubbing each instrument, and placing each of the instruments into another metal container that was located on the left side of the sink area from 10:32 a.m. to 10:35 a.m. There was no observation S7Central-Sterile Worker rinsed the surgical instruments with water from 10:12 a.m. to 10:35 a.m. At this time, the Central-Sterile Manager, S8 confirmed the findings. The Central-Sterile Manager, S8 indicated S7 failed to soak the surgical instruments in the enzymatic cleaner as per policy.

During another observation on 01/09/13 from 10:45 a.m. through 10:47 a.m. with S8Central-Sterile Manager, the Central-Sterile Worker, S7 was observed donned in a gown, hairnet, and gloved. There was no observation of S7 wearing a mask and/or eye protection during this observation. Further observation revealed S7 removed a hand set tray labeled "#2" from the top shelf of cart "#10". At 10:46 a.m., S7 stated the indicator was left in the set with the towels folded (closed) indicating this set was not used during the procedure. S7 was observed placing the instrument tray into the washer without performing the decontamination pre-washing process from 10:45 a.m. to 10:47 a.m. At this time, the Central-Sterile Worker, S7 indicated these instruments do not go through the pre-washing decontamination process because they were not used during the surgical procedure. At 10:55 a.m., S7 and S8 both reviewed the manufacturer's label on the bottle of the enzymatic cleaner. Both S7 and S8 indicated all instruments are to be soaked in the cleaner for a minimum of 2 minutes. S7 and S8 both indicated the appendectomy instruments and hand set instruments were not soaked in the enzymatic solution for a minimum of 2 minutes as per the manufacturer's instructions.

In an interview on 01/09/13 at 11:00 a.m., the Central-Sterile Manager, S8 reviewed the "PPE" policy. At this time, S8 indicated the Central-Sterile Worker, S7 failed to wear a mask and/or eye protection during the decontamination processing of the appendectomy and hand set instruments as per policy.

Another observation of the decontamination process was conducted on 01/09/13 from 12:10 p.m. through 12:35 p.m., Central-Sterile Supervisor, S10 donned gloves, applied a hairnet, gowned and face mask. Further observation revealed S10 emptied sink #1 and filled it with six (6) eight (8) ounce bottles of hydrogen peroxide. From 12:15 p.m. to 12:30 p.m., S10 was observed removing metaport instruments from cart "#1" and placed them in sink #1 that was filled with hydrogen peroxide. Further observation revealed S10Central-Sterile Supervisor inspected each instrument, scrubbed it and placed it into another tray that was located on the left side of sink #1. At 12:30 p.m., S10 indicated there is no soak/dwell time for the instruments to soak in the hydrogen peroxide. S10 further indicated all instruments are cleaned in the hydrogen peroxide solution. The Central-Sterile Supervisor, S10 confirmed there was no enzymatic cleaner solution in sink #1. At this time, the Central-Sterile Supervisor, S10 indicated the surgical instruments are not soaked/cleaned in the enzymatic cleaner instead they are cleaned with hydrogen peroxide solution. S10 denied knowledge of what the decontamination process required for the usage of cleaning/soaking all surgical instruments in the enzymatic cleaner and/or hydrogen peroxide. At 12:34 p.m., S10 read the manufacturer's label on the bottle of enzymatic cleaner indicating all instruments are required to soak in the cleaner for a minimum of 2 minutes as per the manufacturer's instructions. The Central-Sterile Supervisor, S10 indicated at this time she failed to follow the manufacturer's instructions on the enzymatic cleaner for the instruments to soak in the cleaner. At this time, S10 read the decontamination policy indicating she failed to follow the decontamination policy for all instruments to soak in the enzymatic solution as per the manufacturer's instructions. At 12:30 p.m. and at 12:35 p.m., the Central-Sterile Manager, S8 denied knowledge S10Central-Sterile Supervisor failed to follow the decontamination process to soak all surgical instruments in the enzymatic cleaner and to rinse each instrument with water. The Central-Sterile Manager, S10 indicated S7Central-Sterile Worker failed to rinse all instruments with water after cleaning them with the enzymatic solution as per policy.

The policy titled, "Routing of Contaminated Supplies/Instruments", with no policy number, Effective date of November of 1982, Page number: V.6.6-6b, Last revised date on September of 1994, Last reviewed date in 2011, Reference date of 2012, indicated all central sterile employees will gown, glove, mask, and wear eye protection. The contaminated instruments are brought to the Decontamination for Decontamination Process. The instruments are cleaned with the hospital approved cleaning agent, and rinsed with water. Instruments are then processed through the Washer-Decontaminator.

Review of the policy titled, "PPE", Policy number: VII.1, Effective date on May of 2003, last revised section left blank on the policy, last reviewed date in 2012, indicated before cleaning all instruments and reusable equipment, all Central-Sterile Workers will gown, glove, mask, and use eye protection.

Further review of the policies titled, "Routing of Contaminated Supplies/Instruments" and/or "PPE" revealed there was no documented evidence the policy indicated the Central-Sterile Workers were to wear a hairnet.

Review of the manufacturer's instructions for Prolystica Enzymatic Cleaner revealed a section titled, "Manual/Ultrasonic application" read as follows: Soak minimum of 2 to 5 minutes.

Based on record review, observation, and interview, the Anesthesia Services failed to ensure the scope of services offered for the anesthetics' medications used during surgical procedures were provided in a safe manner as evidenced by having expired medications (Neostigmine, Labetalol, Succinylcholine and/or Phenylephrine) in 3 of 4 anesthetic carts, (OR #a, OR#b, OR#c). Findings:

An observation of the surgery department was conducted on 01/09/13 from 2:00 p.m. through 2:10 p.m. of the anesthesia carts in OR#a (operating room number a), OR#b, and OR#c with S3Surgery Director and S4CRNA (certified registered nurse anesthetist), Chief Nurse Anesthesis. At 2:05 p.m., OR#a was observed with three (3) opened/used vials of Neostigmine Methylsulfate injection (5mg/10ml), Labetalol Hcl injection (100mg/20ml), and Succinylcholine chl (chloride) injection (200mg/ml) in the top drawer of the anesthesia cart. Further obervation of the vials revealed they were labeled as follows: Neostigmine vial had an expiration date of 01/07/13, Labetalol vial had an expiration date of 12/18/12, and Succinylcholine vial had an expiration date of 12/31/12. At 2:07 p.m., there was a vial of opened/used Neostigmine Methylsulfate injection (5mg/10ml) with no expiration date recorded on it-this section on the label was left blank in the top drawer of the anesthesia cart in OR#b. At 2:10 p.m., OR#c was observed with a vial of Phenylephrine injection 1% (percent) (10mg/ml) with an expiration date of 12/12/12. During this same observation of the anesthesia carts in OR#a, OR#b, and OR#c, S4CRNA confirmed OR#a had three (3) opened/used vials of Neostigmine Methylsulfate (01/07/13), Labetalol (12/18/12), and Succinylcholine (12/31/12) were expired. S4CRNA further confirmed OR#b had a vial of opened/used Neostigmine Methylsulfate with no expiration date recorded on it. S4CRNA verified OR#c had an expired vial of Phenylephrine (12/12/12). The Chief Nurse Anesthesis, S4CRNA indicated the vials of Neostigmine, Labetalol, Succinylcholine and/or Phenylephrine were expired medication vials available for patient administration during a surgical procedure. S4CRNA further indicated the staff failed to ensure the expired medication vials of Neostigmine, Labetalol, Succinylcholine and/or Phenylephrine were not available for administration to patients as per policy.
Review of the policy titled, "Hospital Medications Policy", Nursing Administration -002, Effective date of September 2000, Last Revised date of November of 2012, Approved date of 11/06/12 indicated Multi-dose Vials must be dated and initialed upon opening to ensure proper storage. The multi-dose vials are disposed of when empty or within 28 days of opening.
The policy titled, "Multidose Vials for Injection, Policy #: 4.4.7a, Effective date of 09/01, last reviewed date of 08/09, with no last revised date recorded-this was left blank on the policy, indicated if multidose vials are use they must be discarded when the vial has been opened for more than 28 days. The date and initial the vial upon initial entry.