HospitalInspections.org

Based on document review and interview, the Governing Body failed to maintain oversight responsibility for services provided at the facility. Specifically, the Governing Body failed to ensure: 1) oversight of contracted services 2) patients are provided care in a safe setting; 3) Laboratory Services are organized and adequately staffed to meet the needs of its patients.

These failures affected the effectiveness and safe delivery of care, and may have placed patients at risk for potential harm.


Findings include:
See Tag A 0083
See Tag A 0115
See Tag A 0576

Based on document review and interview, the Governing Body did not monitor and supervise services provided by contract laboratory providers. The failure to monitor the effectiveness and safety of contracted laboratory services places patients at risk for harm.
This finding was noted in three (3) of 10 contracts reviewed.


Findings include:

Review of the Hospital-wide Quality Assurance Program for 2015, noted that the three (3)laboratory contracted services were not included in the monthly quality assessment reports for the Pathology and Clinical Laboratory, and data for the contracted services were not submitted in the quarterly reports to the Governing Body.

At interview with Staff M, Laboratory Administrator, on 4/7/16 at 1:45 PM, she acknowledged there is no established mechanism for review of contracted laboratory services.

Based on observation, document review, and interview, the facility failed to ensure: 1) use of appropriate restraints; 2) Security Officers who apply and monitor patients in restraints are trained in the use of appropriate restraints; 3) Security Officers who apply and monitor patients in restraints are trained in the use of First Aid and are certified in the use of Cardiopulmonary Resuscitation (CPR).

Findings include:
See Tag A 154
See Tag A 196
See Tag A 206

Based on document review and interview, the facility did not ensure timely response to patients' grievances. This finding was evident in six (6) of six (6) grievance files reviewed (File #s 1 through 6).

Findings include:

Review of six (6) of six (6) grievance files identified patient complaints, that were received by the facility and the written response to the complainants were dated 20 to 30 days after receipt of the complaints.


Review of the policy titled, "Managing Grievances and Complaints," last reviewed 8/2015, revealed the facility established a timeframe within 30 days to complete the process for complaint investigation, and to provide a written response to the complainant.
This 30 day timeframe does not meet the regulatory requirement of 7 days as an appropriate and timely response to grievances.

During interview with Staff Q, Vice President Quality and Risk Management on 4/5/16 at approximately 1:00 PM, she acknowledged the facility has not met regulatory requirements for timely resolution of grievances.

Based on review of document and staff interview, the facility did not ensure patients' rights to receive care in a safe setting. Specifically, the facility did not use appropriate intervention to restrain patients. This finding was noted in three (3) of three (3) patient incidents reviewed.

This failure may have placed patients at risk for psychological and physical harm.

Findings include:

Review of three (3) of three (3) documented Incidents, identified that patients were handcuffed by Security Officers as a mean to resolve incidents with patients who were agitated, aggressive and or verbally abusive.

During interview with Staff F, Security Supervisor, on 4/7/16 at approximately 10:55 AM, he acknowledged the use of handcuffs. He stated that after an incident on 9/8/15, where a Security Officer was injured by a patient during an attempt to restrain the patient, use of handcuffs were restricted to Security Supervisors only.

Based on document review and interview, the facility did not ensure that Security Officers who assist with the application of restraints, are trained in the implementation of restraints.
This finding was evident in seven (7) of seven (7) Security Officers personnel files reviewed (Staff A, B, C, D, E, F, and G).


Findings include:

Review of facility's Incident #2, dated 10/12/15, authored by Staff C, Security Officer noted, Patient #2 became aggressive, enraged, picked up a 30 pounds chair and threw it against the wall. The patient was handcuffed with the help of two (2) other Security Officers. Staff C noted the patient was placed in four-point restraints with the assistance of the nurse and two Emergency Medical Technicians.

Review of Incident #5, dated 12/5/15, noted Security Officers responded to Code Blue (Workplace violence/assault) on Hall 2 (Psychiatric Unit), where Patient #5 was noted to be violent and had attacked two (2) patients. Security Officer noted, "Security was able to put him (Patient #5) in four-point restraint, and he was medicated."


Review of the personnel files for Security Officers (Staff A, B, C, D, E, F, and G), identified that the officers had no training and competencies in the implementation of restraints.

During interview with Staff F, Security Supervisor, on 4/7/16 at approximately 10:55 AM, he confirmed the use of manual hold by Security Officers to restrain agitated and combative patients. Staff F confirmed that Security Officers were not trained in the implementation of restraints.

Based on document review and interview, the facility did not ensure that Security Officers who assist with the application of patient restraints, are trained in the use of First Aid techniques and certified in the use of Cardiopulmonary Resuscitation.
This finding was noted in seven (7) of seven (7) Personnel files (Staff A, B, C, D,E, F, and G).

Findings include:

Review of seven (7) of seven (7) Personnel files for Security Officers identified there was no evidence of training and competencies in First Aid and in the use Cardiopulmonary Resuscitation.

At interview with Staff F, Security Supervisor, on 4/7/16 at approximately 11:00 AM, he confirmed that training in First Aid and in the use of Cardiopulmonary Resuscitation, was not provided to Security Officers.

Based on document review and interview, the facility did not implement its Quality Assurance and Performance Improvement (QAPI) Plan to ensure the collection of data and monitoring of the quality of services provided by contracted services.
This finding was noted in three (3) of 10 clinical contracts reviewed.


Findings include:

Review of Pathology and Clinical Laboratories monthly quality assurance (QA) reviews for September 2015 to February 2016, identified that the QA review did not include data from the three (3) Laboratory contracted services.

Review of Hospital-Wide Quality Assurance Program for 2015, noted that laboratory contracted services was not included in the Laboratory QA quarterly reports, which were submitted to the Governing Body in 2015.

This is not in compliance with the hospital-wide QAPI plan for 2015 which stated that data would be collected monthly to monitor the performance of contractors/vendors providing direct patient care, treatment, or services.


At interview with Staff M, Laboratory Administrator, on 4/7/16 at 1:45 PM, she stated the Director of Laboratory Services conducts reviews of Contracted Services and issues recommendation for renewal of contracts. She acknowledged the review of contracted services is not data driven and there is no established mechanism for their review.

Based on observation, document review, and interview, the facility failed to: 1) develop policies and procedure to establish consistency for in-house preparation of reagents/stains, and to determine an appropriate "use by" or expiry date for each reagent formulation; 2) provide adequate staffing to ensure prompt delivery and supervision of Laboratory Services; 3) ensure laboratory equipment is maintained in working order.

These failures may have negatively impacted the accuracy and quality of laboratory services provided to patients.

Findings include:

See Tag A 724.


Tour of the Pathology Laboratory on 4/1/16, and Microbiology Laboratory on 4/4/16, with Staff K, Director of Laboratory Services, and Staff L, Laboratory Technologist, revealed the following:

Review of six (6) sampled reagents prepared in-house found that each bottle of reagent/stain had been reused for multiple preparation of the same product and as a result had multiple preparation and expiration dates listed on the bottle. This finding regarding reuse of bottle for reagent preparations were noted for Acid Orecin, Potassium Ferrocyanide, Aniline Blue, Hematoxylin Certified, Potassium Manganate, Gold Chloride, and several other reagents prepared in-house
At Interview with Staff K, Director of Laboratory Services, on 4/1/16, at approximately 11:30 AM, he stated there are no written policies for the reuse of bottles for multiple preparations, and added that a bottle is reused for reagent powder or concentrates with the same lot number until the reagent/stain is exhausted.


Upon surveyor's request on 4/1/16, Staff K Director of Laboratory Services,and Staff L, Laboratory Technologist, did not provide manufacturers' guidelines to support the facility's practice of reuse of reagent/stain bottles.



The inspection of reagent bottles revealed expiry dates issued for each reagent were inconsistent, and varied with each preparation.
For example; Acid Orecin prepared on 9/27/15 was issued a six-month expiry date (3/27/16); however, the next in-house preparation of Acid Orecin on 3/10/15 was issued an expiry date of one year (3/10/16).
Similar finding was noted for Potassium Ferrocyanide that was initially prepared on 12/2/14, and issued a three-month expiry date (3/2/15). Three subsequent preparations of Potassium Ferrocyanide on 3/2/15, 5/19/15, and 11/11/15 had three-month, seven-month, and six-month expiry dates respectively.



Review of laboratory policies and procedures manual, revealed there were no readily available protocols to determine the expiry dates for laboratory reagents prepared in-house from reagent powder and concentrates.
Documents submitted for review on 4/7/16 included copies of textbooks pages and manufacturers' guidelines for preparation of some of the reagents. The review of these documents revealed the recommendation in the textbooks and manufacturers' guidelines were not implemented by the facility. For example; Potassium Ferrocyanide (Iron Stain) prepared in-house on 11/17/15 was assigned an expiry date of six months (5/16/16); however textbook reference notes that Iron Stain is "Preferably freshly prepared just before use." The manufacturer guidelines also notes, "Working Iron Stain Solution is prepared by mixing equal volumes of Potassium Ferrocyanide Solution and Hydrochloric Acid Solution; use once and then discard."


Review of a letter dated 4/5/16 from a manufacturer of laboratory reagents, in response to the facility's inquiry concerning Certified Hematoxylin powder notes, "The expiration date of the dry product is five years from the date of packaging as indicated on the product. Once the product is reconstituted, the individual institution will determine the expiration of the specific formulation for their usage."

Although Certified Hematoxylin powder was listed as one of the reagent powder used by the facility, there was no policy and procedure for reconstitution of the reagent, and no expiry date recommended for specific formulation used by the facility.

At interview with Staff M, Laboratory Administrator on 4/7/16 at 2:30 PM, she acknowledged the expiry date recommended by the manufacturer of Potassium Ferrocyanide was not implemented by the facility. Staff M stated she could not produce written policies and procedures for the Certified Hematoxylin powder.


Review of the document, "Immunology Test Result " for the Microbiology Lab, identifed that batched immunology testing were not completed timely in accordance with the facility's policy. The test report revealed that 15 of 19 immunology test results were not available within 48 hours, and four (4) of the 15 were completed after 10 days of receipt.
The facility's policy titled, "Turnaround Time and Delays In Reporting," last revised 2014, states, "Immunology testing is performed in batches and is available within 48 hours of receipt."



Review of the document titled, " Electronic Clinical Laboratory Reporting System," (ECLRS) data, showed the facility is not timely in reporting communicable diseases within 24 hours of diagnosis as mandated under the Public Health Law (PHL 2101).
The report showed that six (6) of six (6) reports of confirmed communicable diseases that met reporting criteria, were reported between three (3) days to 24 days. For example; patient's blood culture that was positive for Streptococcus Pneumoniae on 3/14/16, was reported 24 days later on 4/3/16. Another positive blood culture for Streptococcus Pneumoniae on 3/13/16, was reported 21 days later on 4/3/16. A blood culture positive for Streptococcus, Group B on 3/4/16, was reported 5 days later on 3/9/16.


Review of Microbiology staff schedule for April 2016, noted the schedule had not been completed for the 2nd, 3rd and 4th weeks for April.
At Interview with Staff N, Microbiology Supervisor on 4/4/16 at 11:15 AM, he stated the following: microbiology schedule is made on a day-by-day basis because he has to pull from a list of per diem/temporary workers, with full-time jobs elsewhere. The name of the staff is written on the schedule only after the staff has made a commitment to work for the day. He reported he is unable to complete some of his supervisory duties as he is often by himself in Microbiology lab and responsible for testing duties, which is a priority over other supervisory duties.

At interview with Staff O, Lead Technologist on 4/4/16 at 1:20 PM, she confirmed that staffing is inadequate. She stated she supervises Core Laboratory (Chemistry, Hematology and Urine Analysis) until a supervisor is hired. She reported that in addition to her supervisory role, she is also responsible for testing of specimen.

Review of a list of the laboratory staff noted, 16 of the 20 Laboratory Technologists were per-diem and part time workers. There were four vacant positions for Laboratory Technologist and one Laboratory Supervisor.

At interview with Staff P, Chief Executive Officer on 4/1/16, he acknowledged that there are vacancies in the Laboratory Department, but reported that recruitment and staff retention has been difficult.

Based on document review and interview, the facility did not implement its policy and procedure to ensure laboratory equipment is maintained in good repair. This finding was noted in three (3) of seven (7) laboratory equipment reviewed.


Findings include:

Review of service reports for the Clinical Coagulation Analyzer revealed Preventive Maintenance (PM) was completed on 10/15/12. Subsequently, there were eight (8) instances of repair job done on the equipment prior to the current PM on 3/23/16. There were no PMs done on the equipment in 2013, 2014, and 2015.

Review of service report for Clinical Microbiology Analyzer revealed no PM on the equipment after 4/9/14.

There was no documented evidence for the PM of "Instrumented Blood Culture Systems," used in the Microbiology Lab.

At interview with Staff M, Laboratory Administrator, on 4/7/16 at 2:30 PM, she acknowledged that routine PM of some laboratory equipment was not completed timely.
Staff M reported that the facility no longer has service contract for annual preventive maintenance. She stated that repair of equipment is done upon request by laboratory staff.