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Based on a review of documentation and hospital policies and procedures, and based on interviews with facility staff members, it was determined that in two of two records reviewed, Patient #1 and Patient #2, the hospital failed to assure that patients, or patients' representatives, received an appropriate, timely, and formal written response from the hospital, including the name of a hospital contact person, steps taken on behalf of the patient to investigate the grievances, the results of the grievance process, and the date of completion, in response to grievances that were lodged verbally.

Findings include:

On 06/27/11 at approximately 1030 hours, a document titled : "UOR (Unusual Occurrence Report) Event Type" and "Report period: April 1, 2011-April 30, 2011" was reviewed. The Quality Management Coordinator stated that this reflected all UORs received for the month of April 2011. This document contained the following information:

"4/21/11 12:10 Infection Prevention / Patient, (name) was being drawn by phlebotomist. (His/her) two-year old (child), (Patient #1) was waiting in the draw area. (Patient #1) found sharps container on the ground and was able to stick (his/her) hand into the opening before anyone could stop (Patient #1). (Patient #1) received a needle stick from a contaminated needle."

The Quality Management Coordinator stated that the UOR information had been the result of an employee filing the information into a computerized system. Additional documentation surrounding the investigation, assessment, mitigation, and resolution of this incident was requested. The following type-written, undated, unsigned documentation was received on 6/28/11 at 1125 hours as a result of that request:

"4-21-11 Infection Prevention
QM (Quality Management) arranged for child to be seen in ED (Emergency Department) for evaluation/treatment. Lab (laboratory) opened sharps container in question and found all syringes/needles were capped, so child could not have gotten a needle "stick." This info (information) was shared with ED. Sharps container then attached to wall, where it had been temporarily removed for installation of a computer swing arm."

The Quality Management Coordinator stated that this document had been authored by him/her on the day of this interview/investigation. She also stated that s/he was not aware that the mother of Patient #1 had telephoned the hospital regarding this incident. S/he stated that if the mother had called, it would have been "logged on the complaint database." The Quality Management Coordinator stated that an interpreter's services, via telephone, had been used to obtain information from the mother of the child on the day of the injury, while the mother and child were still at the laboratory location, and that the problem had been "resolved at the time of the concern," and therefore was not considered a grievance.

A copy of the "Complaint Database" was requested and received on 06/27/11 at 1035 hours. The Quality Management Coordinator stated that this was a log of "calls of concern," and stated that these were considered "complaints, not grievances." S/he explained: "If someone calls us with a concern, it is a complaint. If someone writes us, it is a grievance." The Quality Management Coordinator further clarified that if a concern had been lodged verbally in person, that this would also be considered a complaint, and not a grievance.

The Complaint Database for April of 2011 revealed the following information:

Contact Log Case Report for Patient #2 revealed that the patient had been discharged from the hospital 4/19/11, and placed a "call of concern" on 4/21/11. Patient #2 reported that s/he was not given the opportunity to review the results of imaging studies with her physician, was not given the chance to ask questions, and was told to "just read the printed instruction," and "no one gave me a chance to ask questions in the ED."

In an interview with the Quality Management Coordinator on 06/28/11 at 1310 hours, s/he confirmed that no additional contact log case reports were present on the Complaint Database, and specifically no additional calls of concern on 04/21/11. The Quality Management Coordinator presented the copy of an electronic message from the Quality Management Coordinator to two staff members concerning Patient #2. The email, dated "April 21, 2011, 11:49 A.M. " contained the following information:

"Seems like we need to give every patient a chance to ask questions... she says she asked to get more information from the doctor, but was just redirected to the instruction sheet."

The Coordinator also confirmed that a written response to Patient #2 had not been sent by the hospital, as this had not been considered a grievance.

The Coordinator stated that there had been no grievances filed in April of 2011, and that the last one had been filed in March of 2011.

A review of hospital policies and procedures revealed the following:

Policy No. 205.00 "PATIENT COMPLAINTS AND GRIEVANCES" with an effective date of December 2010 contained the following information:

"B. In the event a patient/patient's representative is dissatisfied with and aspect of their care, they will be afforded a process to express their concerns and for those concerns to be investigated and addressed."

and

"2. If a verbal patient complaint cannot be resolved at the time of the complaint by staff present, is postponed for for later resolution, is referred to other staff for later resolution, requires investigation and/or requires further actions for resolution, then the complaint becomes a grievance."

and

"C. Grievance - A written or verbal complaint (when the verbal complaint regarding patient care is not able to be resolved at the time of the complaint by staff present) by a patient of the patient's representative regarding:
1. Patient care;
2. Abuse or neglect;
3. Issues related to the hospital's compliance with the CMS Hospital Conditions of Participation."

Policy No. 105.00 "RIGHTS AND RESPONSIBILITIES OF PATIENTS" Effective: January 2011, which contained the following:

"The patient has the right to:"

"2. Be well informed about your illness or injury, possible treatments, and the likely outcome of those treatments. Your physician has the responsibility to discuss this information with you or your chosen representative."

"8. Receive care in a safe setting..."

Centers for Medicare and Medicaid Services defines a "grievance" as "a formal of informal written or verbal complaint that is made to the hospital by the patient, or the patient's representative, regarding the patient's care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with CMS Hospital Conditions of Participation (COPs), or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489."

By this definition, it is the determination that the legal representative for Patient #1, and Patient #2 filed grievances.

On 4/21/11, the hospital failed to recognize and fully document a grievance related to a needle stick injury sustained as a result of the hospital's failure to provide a safe environment. The hospital also failed to provide the legal representative for Patient #1 with a written notice of its decision, the name of a hospital contact person, steps taken on behalf of the patient to investigate the grievance, and results of the grievance process, and the date of completion.

As well, the hospital failed to provide this same written notice to Patient #2 who filed a verbal grievance that his/her rights related to the hospital's failure to fully inform a patient about his/her injury had been violated.

Based on a review of the medical record for one patient who lodged a verbal grievance with the hospital, and based on hospital documentation and an interview with a hospital staff member, it was determined that the hospital failed to assure that a patient's right to be informed of his/her health status was upheld.

Findings include:

A copy of the "Complaint Database" was requested and received on 06/27/11 at 1035 hours. The Complaint Database for April of 2011 contained the following information:

Contact Log Case Report for Patient #2 revealed that the patient had been discharged from the hospital 4/19/11, and placed a "call of concern" on 4/21/11. Patient #2 reported that s/he was not given the opportunity to review the results of imaging studies with her physician, was not given the chance to ask questions, and was told to "just read the printed instruction," and "no one gave me a chance to ask questions in the ED."

In an interview with the Quality Management Coordinator on 06/28/11 at 1310 hours, the Quality Management Coordinator presented the copy of an electronic message from him/herself to two staff members concerning Patient #2. The email, dated "April 21, 2011, 11:49 A.M. " contained the following information:

"Seems like we need to give every patient a chance to ask questions... she says she asked to get more information from the doctor, but was just redirected to the instruction sheet."

Additional documentation regarding the resolution of this patient's concern to include communications with staff members providing care and discharge instructions to patients was requested. The Quality Management Coordinator stated that s/he was not aware of additional documentation, and confirmed that a written response to Patient #2 had not been sent by the hospital.

Based on a review of patient records, documentation, hospital policies and procedures, and based on interviews with facility staff members, it was determined that in one of two records reviewed, Patient #1, the hospital failed to assure a safe setting in which to provide care.

Findings include:

Please refer to the findings in Tag A 0123.

Based on a review of documentation and hospital policies and procedures, a review of 1 medical record, and based on an interviews with facility staff members, it was determined that in 1 of 1 patient records (Patient #1) the hospital failed to assure that infection control hazards were identified and mitigated in all areas of the hospital.

Findings include:

In an interview with the Clinic Manger on 06/27/11 at 1045 hours, the Clinic Manager stated that the Healing Place was a Family Medicine practice which was "run by Providence Medical Group," and which offered laboratory services "downstairs" on the first floor of the building for patients of the Healing Place. S/he stated that the laboratory was operated and governed by Providence Hospital, which was a different management group than the Providence Medical Group. The Clinic Manager stated that s/he was not aware of any infection control-related incidents that had occurred in the laboratory in April of 2011, but that the procedure was for a staff member to complete an "Unusual Occurrence Report (UOR)" which was then submitted "online." The Clinic Manager explained that for incidents which occurred in the hospital or in the laboratory, UORs were submitted to "the Quality Department," but that for incidents which occurred in the clinic, reports were submitted to Providence Medical Group. Confirmation was obtained from the Clinic Manager that the laboratory in the Healing Place building was considered part of the hospital, and an unusual incident occurring there would have been submitted to the Quality Department of Providence Hospital.

In an interview with the Coordinator of Point of Care Testing on 06/27/11 at 1210 hours, the Coordinator stated that it was "the hospital's expectation that all sharps containers are kept secure at all times," so that injury and exposure to potentially infectious materials would not occur.

A review of hospital policy No: EC315 titled "Waste Management" was reviewed, and was found to contain the following information:

"b. Sharps containers must be kept secure at all times by securing to a wall bracket, keeping containers in a locked area, or keeping containers under surveillance by PSA (Providence Service Area) staff."

During an observation of the laboratory located on the first floor of the Healing Place building on 06/27/11 at 1230 hours, one red plastic sharps container was noted to be secured to the wall via a bracket, and one red plastic sharps container, measuring 21 inches high by 13 inches wide by 10 inches deep had been placed unsecured on a low table in the laboratory next to chair. The top of the sharps container had a rectangular opening, which measured approximately 2 inches by 8 inches. Both sharps containers were of similar size, style, and volume. The sharps container on the table was approximately 1/4 full of needles and syringes, all of which appeared to have been used.

On 06/27/11 at approximately 1030 hours, a document titled : "UOR Event Type" and "Report period: April 1, 2011-April 30, 2011" was reviewed. The Quality Management Coordinator stated that this reflected Unusual Occurrence Reports for the month of April 2011. This document contained the following information:

"4/21/11 12:10 Infection Prevention / Patient, (name) was being drawn by phlebotomist. (His/her) two-year old (child), (Patient #1) was waiting in the draw area. (Patient #1) found sharps container on the ground and was able to stick (his/her) hand into the opening before anyone could stop (Patient #1). (Patient #1) received a needle stick from a contaminated needle."

In an interview on 06/28/11 with the Quality Management Coordinator at 1040 hours, s/he stated that s/he recalled this incident, and confirmed that the sharps container had been on the floor. The Coordinator stated that s/he had received a call from the laboratory regarding a needlestick injury, requesting permission to send Patient #1 to the emergency room for evaluation of that injury. The Coordinator stated that s/he had facilitated that visit to the emergency room, and that Patient #1 had sustained "bruised fingers from pushing (his/her) hand into the sharps container." S/he stated that the laboratory personnel had "removed the lid from the sharps container" in question and had confirmed that "all needles were capped." This statement was clarified to included the use of safety needles with automated or manually triggered sheaths to cover used needles. The coordinator stated that the laboratory staff reported this finding to the emergency room physician, and that the physician "deduced that (Patient #1) did not have a needle stick."

A copy of the emergency room record for Patient #1 was requested and received, and was found to contain the following information:

"Admit Date 4/21/11"
"Admit Time 14:22"
"Diagnosis NEEDLE PRICK"

"SKIN PED: puncture site noted at base of right 4th digit, no noted bleeding, family states poked with needle at Healing Place pta (sic), when pt (patient) reached hand in sharps container, Inspection: puncture."

and

"TRIAGE (Thu April 21, 2011 14:27 BCM2)

"ASSESSMENT: Triage Assessment performed, History of present illness or injury: Needle stick to base of right 4th finger. Was at Healing Place clinic. Sharps box was on floor, child reached in large hole in top. This occurred 3 hours prior to arrival."

This entry into the medical record was digitally signed by a Registered Nurse (RN).

"NURSING PROCEDURE: DISCHARGE NOTE
TIME: Patient discharged at 1600"

and

"PAST MEDICAL HISTORY
NOTES: Nursing notes reviewed, Agree with nursing records, Medication list reviewed"

and

"ED VISIT SUMMARY (Fri Apr 22, 2011 14:02 SDH)
REPORT: The child placed her hand in a sharps container sustaining an abrasion to her fourth finger. The clinic opened the sharps container and every syringe had a cap on it. The abrasion was cleansed and dressed with a Band-Aid and antibiotic ointment."

This medical record contained a digital signature of a Medical Doctor (MD) on "(Fri Apr 22, 2011 14:03 SDH)"

The medical record reflected that an RN triaged the patient and noted a puncture wound to the hand of Patient #1. The medical entry by an MD in the patient's record, 23.5 hours after the RN's entry, reflected that Patient #1 had sustained an "abrasion."

In an interview with the Infection Prevention Nurse on 06/28/11 at 1300 hours, the Infection Prevention Nurse stated that s/he was the sole member of his/ her department, and that s/he was also aware of this incident. S/he stated that part of his/her job was to survey each hospital department for situations like an unsecured sharps container, and that a needlestick injury could occur even with a "capped" or safety needle. The Infection Control Nurse stated that there was not a "freestanding protocol" which would guide the care of a visitor who sustained a needle stick injury, but that this was addressed in the hospital's "algorithm", which was typically used for an employee who had sustained a potential exposure to blood born pathogens. The Infection Control Nurse stated that this algorithm would have been used to guide the treatment of a visitor to the hospital who had received a needle stick injury.

At 06/28/11 at 1330 hours, a document titled: "Algorithm.doc 1/28/09" was received, which reflected that a Health Care Worker (HCW) whose exposure which was caused by skin penetration by an item contaminated with blood would have been referred to an "outpatient draw (blood drawing) station." This algorithm was reviewed with the Quality Management Coordinator on 07/01/11 at 1145 hours.

Information received from a physician working at an unrelated clinic at the time of this complaint intake revealed that Patient #1 was brought to the physician's clinic to evaluate a puncture wound, and that blood tests had been conducted to evaluate the transmission of an infectious disease.

A printed copy of an electronic mail dated May 05, 2011 5:41 PM from the Assistant Administrator of Nursing and Patient Care Services to the Quality Management Coordinator and other staff members contained the following:

"We had a problem with a child receiving a needle stick at the Healing Place lab. Their containers look very large and are placed on the floor, giving easy access to little hands. Are there other containers we could use that would be mounted on the wall?"

The hospital failed to control infection control hazards within the hospital by leaving an unsecured sharps container on the floor and within easy reach of Patient #1, and failed to mitigate the potential transmission of blood born pathogens by delaying for three hours evaluation and treatment of a needle stick injury sustained by Patient #1 who reached into that sharps container, and by failing to follow their own policy and procedure for addressing a potential blood born pathogen exposure caused by that injury, as documented by the emergency room nurse who triaged Patient #1.