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Based on review of the Hospital's Quality and Safety data and minutes of meetings from January 2011 - July 2012, observations and staff interview, the hospital failed to integrate data collected from the rehabilitation services into the hospital-wide quality assessment and performance program. Findings include:

Observations through-out the survey, 8/6/12 - 8/9/12 revealed that rehabilitation services were provided to patients as needed. These services included physical therapy and occupational therapy.

On 8/7/12 review of the Hospital's Quality and Safety data and minutes of meetings from January 2011 - July 2012 lacked any information to indicate rehabilitation services submitted data to, or received from, the the hospital's Quality Improvement Organization.

During interview, on 8/7/12 at 10 A.M., the Director of Rehabilitation Services, stated that within the rehabilitation department, data is collected and analyzed, but this data does not get submitted to the hospital-wide quality assessment and performance program.

During interview, on 8/8/12 at 2:15 P.M., the Chief Quality and Safety Officer stated that although the rehabilitation services are incorporated into the Stroke and Orthopedic outcome data, she was unable to show how the hospital monitors the effectiveness and safety of services and quality of care provided by rehabilitation services.

Based on observations, interviews, and review of the Hospital's policies/procedures, logs, and employee health records, the Hospital failed to consistently ensure an acceptable level of infection prevention practice.

A. The Hospital failed to ensure that a high level disinfection (HLD) process (a cleaning process that should destroy all microorganisms, except for bacterial spores) was consistently used to reprocess semi-critical items (items that contact mucous membranes or non-intact skin) in the Ultrasound and Endoscopy Departments.

The following steps in the disinfection process were not performed in accordance with manufacturer's instructions:

1. Observation in the Soiled Utility Room of the Ultrasound Department on 8/7/12 at approximately 8 A.M., revealed manual high-level disinfection using an OPA product (ortho-phthalaldehyde) product was used to reprocess vaginal probes. According to the Ultrasound Technician (US Tech #1), after the disinfection process, the probes were not totally immersed in a large volume of fresh water for at least one minute, and repeated immersions in fresh water for a total of three separate rinses to ensure removal of chemical residue, in accordance with manufacturer's instructions. According to US Tech #1, the probes were rinsed under running water.

2. Observation in the Procedure Room of the Ultrasound Department at the Lahey Clinic North campus on 8/8/12 at approximately 11:30 A.M., revealed manual high-level disinfection using an OPA product (ortho-phthalaldehyde) product was used to reprocess vaginal probes. According to the Ultrasound Technician (US Tech #2), after the disinfection process, the probes were not totally immersed in a large volume of fresh water for at least one minute, and repeated immersions in fresh water for a total of three separate rinses to ensure removal of chemical residue, in accordance with manufacturer's instructions. According to US Tech #2, the probes were rinsed under running water. Also, the probes were rinsed in the handwashing sink of the procedure room instead of a clinical service sink.

3. In accordance with the manufacturer's instructions, the temperature of the disinfectant and the MEC (minimum effective concentration) dipstick test must be completed with each cycle to ensure the minimum temperature and adequate chemical concentration was achieved. Interview with US Tech #1 (on 8/7/12) and US Tech #2 (on 8/8/12) and Endoscopy Technician #1 and #2 (on 8/7/12 at 9:10 A.M.) revealed all technicians were able to articulate that the temperature and MEC measurements were performed for each cycle, however, the documentation of these measurements was logged only once daily instead of with each cycle.


B. The hospital failed to design their employee health screening, specifically the screening of new personnel for tuberculosis (TB), according to national guidelines.
Interview with the Employee Health Nurse Practitioner and the Infection Preventionist on 8/7/12 at 12:30 P.M., revealed the employee health program was using a single Tuberculin Skin Test (TST), instead of using the two-step method of TST. According to the CDC "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005", two-step testing is used for baseline testing of the health care workers (HCWs) upon hire (for those whose initial TST results were negative), as the standard method of determining the TB status of the HCW.


C. The hospital failed to consistently adhere to industry standards for a respiratory protection program, transport of potentially biohazardous equipment, and sharps reduction activities to comply with the Occupational Safety and Health Administration (OSHA) standards.

Findings include:

1. The hospital failed to consistently adhere to OSHA's respiratory protection standard. According to CFR 1910.134(f)(2), the employer shall ensure that an employee using a tight-fitting facepiece respirator is fit tested prior to initial use of the respirator, whenever a different respirator facepiece (size, style, model or make) is used, and at least annually thereafter.

Interview with the Employee Health Nurse Practitioner and the Infection Preventionist on 8/7/12 at 12:30 P.M., revealed that selected hospital personnel were fit tested (a procedure to ensure correct fit of an employee's respirator/mask) at the time of hire. A respirator/mask is used to protect the healthcare worker against diseases spread through the air, e.g., tuberculosis. However, no provision for annual fit testing was included in the hospital program.

Review of the health records of hospital employees on 8/9/12, indicated 7 of the 7 employees on the respiratory protection team had not been fit tested annually as required by OSHA. Seven of seven employee health records reviewed revealed the most recent fit testing dates for the employees were as follows: 2003, 2005, 2007 (3), and 2009 (2).

2. The hospital failed to consistently adhere to OSHA's bloodborne pathogens standard. According to CFR 1910.1030(c)(1)(iv), employers are required to conduct an annual review and update of Exposure Control Plan to reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and document annually their consideration and implementation of appropriate commercially available and effective safer medical devices. Findings include:

Observation in the Central Supply Area on 8/7/12 in the morning, revealed boxes of # 16, 17, 22, 25, 27 and 30 gauge non-safety needles readily available for use. According to the Central Processing Department Supervisor, these non-safety needles were added to the surgical trays as needed and according to the preference of the surgeons.

The hospital failed to specify the circumstances in which sharps injury prevention technology may be excluded and non-safety sharps allowed (e.g., device interfered with medical procedures, the safety feature did not promote employee or patient safety). There was no documentation in the hospital's waiver process to support the continued use of select items lacking sharps injury prevention technology,


3. The hospital failed to consistently adhere to OSHA's bloodborne pathogens standard. According to the Occupational Safety and Health Administration (OSHA) regulations,1910.1030(g)(1)(A), warning labels (i.e., international biohazard symbol or the word "biohazard") shall be affixed to containers used to store, transport or ship blood or other potentially infectious materials, to reduce the risk of exposure to employees or patients. Findings include:

Observation in the Bronchoscopy Suite on 8/7/12 at 9:50 A.M., revealed a mobile bronchoscopy unit. According to the Bronchoscopy Technician, the mobile unit was used to perform procedures in the Operating Room or at a patient's bedside in one of the Intensive Care Units. After use, the soiled scope was placed in a pink bucked and placed in a green bag for transport to the reprocessing area. However, the soiled scope lacked any warning label (i.e. biohazard symbol) to identify it as soiled equipment.

Observation on 8/8/12 in the morning of the Gynecology clinic area located on the Lahey North campus, revealed that hysteroscopes (equipment used to visualize the uterine cavity) were routinely used in the clinic. After use, the soiled scope was placed in a clear container for transport to the reprocessing area. However, the soiled scope lacked any warning label (i.e. biohazard symbol) to identify it as soiled equipment.

4. For Patient #4, the Hospital failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.

Patient #4, admitted in 8/12, had diagnosis of decompensated heart failure and chronic kidney disease.

On 8/7/12 the patient underwent surgery for insertion of a Tessio catheter required for long term maintenance during hemodialysis.

The post anesthesia evaluation was documented as done on 8/7/12 at 9:00 A.M. The evaluation stated the following: "the following parameters have been evaluated: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. " There was no data and no source referenced The impression was "no complications."

5. For Patient #10, the Hospital failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.

Patient #10, admitted in 7/2012, had diagnosis of rectal cancer.

On 7/10/12 and 7/20/12 the patient underwent surgery for problems related to the rectal cancer.

The post anesthesia evaluations were documented as done on 7/10/12 at 6:16 P.M. and on 7/20/12 at 8:30 P.M. The evaluations stated the following: "the following parameters have been evaluated: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. " There was no data and no source referenced The impressions were "no complications."



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Based on record review and interview, the Hospital's anesthesia service failed to complete and document a post anesthesia evaluation for one patient (#27) within 48 hours after surgery and failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation for six patients (#4, #10, #18, #27, #28 and #30 ) in an inpatient post anesthesia sample of 7. Findings include:

1. The Medical Records Policy for documentation of care and completion of medical records indicated that the purpose of the policy was to provide a tool that demonstrated communication for all parties participating in patient care, including but not limited to documentation that contains sufficient information to identify the patient, support the diagnosis, justify treatment and determine the patient's response to care. In addition the record serves as a historical document, a legal document to uphold a standard of care for medical legal review and record keeping to support licensing authorities.

According to the policy, the Post anesthesia Evaluation, indicated that the evaluation would be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services except moderate sedation. The evaluation would be conducted by a practitioner qualified to administer anesthesia and documented in the designated section of the Anesthesia Record or in a progress note. Assessment documentation on the Post Anesthesia Care Unit (PACU) or the Ambulatory Surgery flow sheet can be referenced. The following parameters are to be considered in the post -anesthesia evaluation: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration.

2. For Patient #27, the Hospital failed to complete the Post Anesthesia evaluation in 48 hours as required and failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.

Patient #27, admitted 7/14/12, had diagnoses of coronary artery disease and congestive heart failure.

On 7/19/12, the patient underwent surgery for a coronary artery bypass graft of three vessels. The patient was sent to the Cardiac -Thoracic Unit/ PACU at 11:30 A.M. for recovery. the patient remained intubated, on mechanical ventilated and sedated.

On 8/8/12, the record was reviewed on the Medical Intensive Care Unit (MICU). The only Post Anesthesia Evaluation found in the record was dated 7/27/12, timed 11:34 A.M., done eight days after surgery and outside the 48 hour time frame.. The evaluation stated the following: "the following parameters have been evaluated: evaluation: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration." There was no data and no source referenced . There were three boxes which the practitioner could make a judgment/ assessment based on the evaluation: no complications; post-op sedation required ( pt intubated, patient on Proof , anxiolytic, paralytics, etc) otherwise no apparent anesthetic complications or unexpected findings. This evaluation checked post- op sedation but did not check or circle to indicate if the patient was intubated or what the patient was receiving for medications.

On 8/8/12, at 10:00 A.M., during an interview, the MICU Nurse Manager said the post anesthesia evaluation appeared to be late and she could not find another post anesthesia evaluation, after careful review of the medical record.

3. For Patient #28, the Hospital failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.

Patient #28, admitted on 7/24/12, had diagnosis of esophageal cancer.

On 7/24/12, the patient underwent surgery for a total esophagectomy (removal of the esophagus) and placement of a jejunostomy tube. During the procedure the patient had an estimated blood loss of 500 cubic centimeters (cc's) and received 7 liters of intravenous fluid (IV).

The patient arrived in the surgical intensive care unit (SICU) for recovery at 6:00 P.M. The nursing assessment indicated the patient had a temperature of 99.4 degrees Fahrenheit, an epidural catheter in place (for pain management) and a Foley catheter with a urine output of only 10 cc's, despite large fluid volumes administered in the operating room.

The post anesthesia evaluation was documented as done on 7/24/12 at 6:30 P.M. The evaluation stated the following: "the following parameters have been evaluated: evaluation: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. " There was no data and no source referenced The impression was "no complications." The evaluation did not note the patient's low grade fever or decreased urine output.

On 7/31/12, the patient returned to surgery for a bronchoscopy and incision and drainage of a left neck mass.

The patient returned to the SICU for recovery at 10:35 P.M. The nursing admission assessment indicated the patient had a fever of 102.1 degrees Fahrenheit and had course lung sounds. The patient was intubated, mechanically ventilated and sedated.

The post anesthesia evaluation was done at 11:00 P.M. on 7/31/12. The evaluation stated the following: "the following parameters have been evaluated: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. " There was no data and no source referenced .

The impression by the practitioner was post-op sedation required, otherwise no apparent anesthetic complication, but the practitioner did not check or circle any choices to indicate if the patient was intubated or what the patient was receiving for medications, . The evaluation failed to note the presence of fever and abnormal lung sounds, as noted by the SICU nurse.



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6. For Patient #30, the Hospital failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.
Patient #30, was admitted on 7/30/12, for a live donor liver transplant due to primary sclerosing cholangitis.

On 7/30/12, the patient underwent surgery for a live donor liver transplant and umbilical hernia repair under general anesthesia. On 7/31/12, under general anesthesia, the patient returned to surgery for bleeding status post live donor liver transplant which included exploration, simple suture of liver and retroperitoneal bleeding.

There was only one post anesthesia evaluation for both surgeries with documentation as done at 1:30 P.M. Although there was a date on the form, it was not legible because an anesthesiologist stamped name covered the date.

The evaluation stated the following: "the following parameters have been evaluated: evaluation: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration. " There was no data and no source referenced The impression was "no complications." There was no indication that within 24 hours the patient had general anesthesia twice.

During interview on 8/7/12 at 10:30 A.M., the clinical nurse educator for 6 Central stated that she was unable to determine the date of the post anesthesia evaluation and that there was only one evaluation done.


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7. For Patient #18, the Hospital failed to document sufficient information to determine the patient's response to care in the post anesthesia evaluation, per the Hospital's policy.

Patient #18, admitted in 7/12, had diagnoses of left pleural effusion and empyema.

On 8/2/12, the patient underwent surgery thoracic surgery.

The post anesthesia evaluation was documented as done on 8/2/12 at 4:00 P.M.
The evaluation stated the following: "the following parameters have been evaluated: respiratory function, including respiratory rate, airway patency, and oxygen saturation; cardiovascular function including pulse rate and blood pressure; mental status; temperature; pain; nausea and vomiting; and postoperative hydration." There was no data and no source referenced. The impression was "no complications."