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Based on review of medical records (MR), review of facility policies, and staff (EMP) interview, it was determined the facility failed to monitor a patient restrained for non-violent behavior for one of two medical records reviewed (MR23).

Findings include:

Review of facility policy on June 7, 2019, "Restraints", last reviewed by the facility February 2019, revealed "...Restraints for Non-Violent/Non-Self Destructive (NV/NSD) Behavior...3. Patient Monitoring...III. Other monitoring activities shall be performed at least every two (2) hours, or more frequently if indicated by the condition or behavior of the patient. During monitoring, the patient shall be assessed for: signs of any injury associated with use of restraint, nutrition and hydration needs, circulation, with release of restraint and range of motion every two hours [sic] hygiene and elimination, physical and psychological status and comfort, Readiness for discontinuation or temporary removal from restraint..."

Review of MR23 on June 7, 2019, at approximately 10:45 AM, revealed restraints were applied in the emergency department for non-violent behavior at 1:59 PM and continued until transfer from the facility at 8:49 PM. Further review revealed there was no documentation of monitoring activities during that time.

Interview with EMP2 on June 7, 2019, at approximately 10:55 AM, confirmed monitoring activity should be performed at least every two hours for patients in restraint for non-violent behavior per facility policy. EMP2 also confirmed there was no documentation of monitoring activities of MR23 during the time MR23 was restrained.

Based on review of medical records (MR), review of facility policies and staff (EMP) interview, it was determined the facility failed to perform a one-hour face-to-face assessment on a patient restrained for violent behavior for one of two medical records reviewed (MR21).

Findings include:

Review of facility policy on June 7, 2019, "Restraints", last reviewed by the facility February 2019, revealed "...Restraint for Violent/Self Destructive (V/SD) Behavior...1. Requirement for All Settings...I. c. The provider shall perform a face-to-face assessment of the patient within 1 hour of the initiation of the restraint to evaluate the patient's immediate situation and reaction [sic] the patient's medical and behavioral condition and need for restraint..."

Review of MR21 on June 7, 2019, at approximately 10:30 AM, revealed restraints were applied for violent behavior at 6:19 PM and discontinued at 12:52 AM. Further review revealed there was no documentation of a one-hour face-to-face assessment by a provider.

Interview with EMP2 on June 7, 2019, at approximately 10:45 AM, confirmed a provider did not perform a one-hour face-to-face assessment of MR21 as required by the facility's "Restraint" policy.

Based on review of facility documents, observation and staff interview (EMP), it was determined the facility failed to ensure proper storage, which prevented unauthorized access, of outpatient medical records.

Findings include:

Review of facility's policy "Storage and Destruction of Paper Medical Records," last reviewed by the facility July 19, 2017, revealed: "Policy: Paper medical records will be maintained for a period of time that assures continuity for patient care... Once the identified period has elapsed charts may be removed from the clinical area, boxed and labeled with a destruction date following the procedure below. For purposes of this policy the standard hold for removal is 3 years since last visit unless a specific department needs to have a different length of hold. ... Procedure: Any paper record will be held by the department for at least three years from the date the service was provided. At that time the chart may be removed from the department to designated off site storage. ... Once properly boxed and labeled, managers should arrange transportation to the central storage facility in Sayre. This can be arranged by contacting the Supervisor of Medical Records. Records must be kept in a locked facility at all times..."

Observational tour conducted on June 4, 2019, at approximately 11:15 AM, with EMP5 revealed in the Nuclear Med testing room (where patients are seen for testing) an open shelving unit along the wall containing over 500 unsealed envelopes that contained patient name and medical record numbers on the outside of the envelope and inside test results from the cardiopulmonary department. The unsealed envelopes with the patient name and medical record number were visible from where the patient would be seated for the nuclear medicine testing.

Interview with EMP5 on June 4, 2019, at approximately 11:15 AM, confirmed the open storage shelving unit contained unsealed envelopes with test results and were in an area where patients are seen for nuclear medicine testing.

Observational tour was conducted on June 6, 2019, at 1:30 PM, with EMP9 and EMP10, revealed the 500 unsealed envelopes from the nuclear medicine testing area were moved at some point through the week to a locked general storage area across the hallway.

Interview with EMP9 and EMP10 on June 6, 2019, at 1:35 PM, indicated that nursing, information technology and maintenance all had access to this area. Further interview with EMP9 confirmed the general storage area was not a designated medical records storage area.

Based on review of facility documentation, review of facility policies and staff (EMP) interview, it was determined the facility failed to ensure food safety as evidenced by the lack of corrective actions to address out of range food storage refrigerator temperatures for 73 of 73 cases reviewed and out of range dish washing temperatures for 17 of 17 cases reviewed.

Findings include:

A facility policy for checking refrigerator, freezer and dry storage temperatures was requested of EMP8 on June 5, 2019 and June 6, 2019. No policy was provided.

Review on June 6, 2019, of facility policy "Dishmachine [sic] Temperatures", last reviewed by the facility January 26, 2018, revealed "Policies: Dishmachine [sic] wash and rinse water should be maintained at temperatures that meet the guidelines established by the Food and Drug Administration.* State or local regulations will apply if more strict ...Single-tank, pot, pan, and utensil washer, dual-temperature (either stationary or moving-rack): Wash temperature 1500F Final rinse temperature 1800F - 1940F..."

Review on June 6, 2019, of facility "Record of refrigerator, freezer, dry storage" temperature logs revealed "...Refrigerator storage Min. 34 degrees Max 41 degrees...All refrigerators and freezers have a defrost cycle. During this time the temperature is higher than normal. Retake temperature in 2 hours and record time/temp in Action line. If temperature is still not acceptable upon second reading, notify your supervisor."

Review on June 6, 2019, of the January 2019, PM temperature log for refrigerators, freezers and dry storage revealed temperatures were out of range for the salad refrigerator on January 1, 6, 7, 8, 12, 14, 17, 23, 24, 25 and 30, 2019. Temperatures were out of range for the café refrigerator on January 5, 6, 7, 12, 14, 15, 19, 22, 24, 26, 27, 29 and 30, 2019. Temperatures were out of range for the cook's refrigerator on January 1 and 14, 2019. Temperatures were out of range for the juice refrigerator on January 1, 4, 5, 21 and 24, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the February 2019, AM temperature log for refrigerators, freezers and dry storage revealed temperatures were out of range for the café refrigerator on February 16, 18, and 19, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the February 2019, PM temperature log for refrigerators, freezers and dry storage revealed temperatures were out of range for the salad refrigerator on February 2, 11 and 24, 2019. Temperatures were out of range for the café refrigerator on February 2, 7, 8, 9 and 28, 2019. Temperatures were out of range for the cook's refrigerator on February 2, 11 and 21, 2019. Temperature was out of range for the juice refrigerator on February 22, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the March 2019, PM temperature log for refrigerators, freezers, and dry storage revealed temperatures were out of range for the salad refrigerator on March 1, 2, 3, 4 and 9, 2019. Temperatures were out of range for the cook's refrigerator on March 2, 3, 4, 9 and 23, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the May 2019, PM temperature log for refrigerators, freezers, and dry storage revealed temperatures were out of range for the café refrigerator on May 11, 12, 13, 14, 15, 16 and 20, 2019. Temperatures were out of range for the cook's refrigerator on May 3, 13, 14, 15, 19, 20, 21, 23, 27, 30 and 31, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Interview with EMP8 on June 6, 2019, at approximately 9:00 AM, confirmed there were numerous days in January, February, March and May 2019 when the refrigerator temperatures were out of range and no action was taken. In further interview EMP8 stated if refrigerator or freezer temperatures are out of range, staff are to notify the supervisor. EMP8 confirmed they had not been notified when the temperatures were out of range.

Review on June 6, 2019, of the December 2018, dish machine temperature record revealed on December 31, 2018, the final rinse temperature was out of range during the dinner wash cycle. A recheck of the temperature documented for the final rinse temperature continued to be out of range. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the January 2019, dish machine temperature record revealed the final rinse temperature was out of range for the lunch wash cycle on January 10 and 31, 2019. The wash temperature was out of range for the breakfast and lunch wash cycles on January 31, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the February 2019, dish machine temperature record revealed the wash temperature was out of range for the lunch and dinner wash cycles on February 17, 2019 and the dinner wash cycle on February 18, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the March 2019, dish machine temperature record revealed the final rinse temperature was out of range for the breakfast wash cycle on March 16, 19, 29 and 30, 2019, the lunch wash cycle on March 29 and 30, 2019 and the dinner wash cycle on March 13, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Review on June 6, 2019, of the April 2019, dish machine temperature record revealed the final rinse temperature was out of range for the lunch wash cycle on April 6 and 29, 2019. There was no documentation noting actions taken to address the out of range temperatures.

Interview with EMP8 on June 6, 2019, at approximately 9:30 AM, confirmed there were numerous days in December 2018, January, February, March and April 2019, when the dish machine temperatures were out of range. In further interview, EMP8 stated if dish machine temperatures are out of range, staff are to notify the supervisor. EMP8 confirmed they had not been notified when the dish machine temperatures were out of range.

Based on review of facility documents, observation and staff interview (EMP), it was determined the facility failed to ensure timely preventive maintenance checks of equipment through their contracted services.

Findings include:

Review of facility's "Plan for Performance Improvement & Clinical Excellence," last reviewed and approved by the Board May 2019 revealed: "C. Objectives Our overall goal is to promote excellence in services to meet or exceed our patient expectations and to achieve quality patient outcomes. Objectives include: Promote patient safety (avoiding injury or harm from care that is intended to help them) and reducing risk to all customers of, and within, Towanda Memorial Hospital... F. Roles and Responsibilities Leadership Organizational leaders: ... Ensure patient ... safety issues are given a high priority, Measure and assess the effectiveness of performance improvement activities. Board of Directors: ... Holds the ultimate responsibility for performance improvement activities, and the quality of service provided within the hospital..."

Requested the facility policy on the equipment management program. The policy provided belonged to another hospital. No facility specific policy was provided.

Observational tour conducted on June 4, 2019, at 11:15 AM, with EMP2 and EMP13 revealed two patient-controlled analgesia (PCA) pumps in a clean utility room with inspection stickers that were due to be checked June 2017 and September 2017.

Interview with EMP2 and EMP13 on June 4, 2019, at 11:20 AM, confirmed the preventative maintenance stickers on the PCA pumps indicated the inspections were overdue. EMP3 confirmed the facility does not complete the preventative maintenance checks themselves, a contracted service is responsible for the checks.

Observational tour conducted on June 4, 2019, at approximately 11:10 AM, with EMP5 in the Cardiopulmonary Department revealed a defibrillator and a stress echo machine, both with biomedical stickers which indicated the pieces of equipment were due to be checked April 2019.

Observational tour conducted on June 4, 2019, at approximately 11:25 AM, with EMP5 in the Sleep Lab Department revealed two electroencephalograph machines (non-invasive equipment that records electrical activity of the brain) with inspection stickers that were due to be checked May 2016 and one Res Med (piece of equipment that monitors for sleep apnea) which contained no inspection sticker.

Interview with EMP5 on June 4, 2019, at approximately 11:25 AM confirmed the biomedical checks of equipment are a contracted service and were overdue.

Observational tour conducted on June 5, 2019, at 11:40 AM with EMP12 revealed in the Pharmacy Department a sterile pharmacy compounding enclosed cabinet with inspection certification due April 2019.

Interview with EMP12 on June 5, 2019, at 11:40 AM confirmed the overdue cabinet certification and stated that pharmacy has been mixing intravenous antibiotics in this hood. Further interview with EMP12 related the certification inspection of the cabinet is a contracted service.

Observational tour conducted on June 7, 2019, at approximately 12:10 PM with EMP6 in the Pain Management Department revealed a defibrillator with biomedical inspection due March 2019, a C arm (a medical imagining device) with biomedical inspection due February 2019 and a radiofrequency machine with biomedical inspection due May 2019.

Interview with EMP6 on June 7, 2019, at approximately 12:15 PM, confirmed the biomedical stickers indicated the inspections were overdue.

Interview with OTH1 on June 5, 2019, confirmed that the biomedical inspections in the sleep lab and cardiopulmonary department were overdue.