College of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence

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1 Attachment A College of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence August 31, 20XX Reference Number: 2365 CAP Number: Dr. Denise Driscoll AU ID: General Hospital Pathology Laboratory 390 N. Cary Port Charles, NY Dear Dr. Driscoll: The Commission on Laboratory Accreditation has determined that it is necessary to conduct an inspection of your laboratory to validate compliance with accreditation requirements due to a complaint filed against the laboratory. The allegations of non-compliance are: 1. A concern with the manner of reporting critical results. 2. Expired reagents and controls are being used in Hematology and Coagulation. 3. Reporting patient results without quality control in Hematology and Coagulation. Standard IV of the Standards for Laboratory Accreditation - Inspection Requirements states "The inspection shall be done at intervals and in a manner determined by the Commission on Laboratory Accreditation." The inspection will be performed using the Team Leader, Laboratory General, and the Hematology-Coagulation checklists. The laboratory will be invoiced an additional fee to cover the cost of this inspection. The fee will be based on the complexity of the disciplines inspected. Adrienne Malta, MBA, MT(ASCP) has been assigned to inspect your laboratory. A copy of the Inspector Summation Report (ISR) and deficiency response forms will be left with you after the inspection. Responses to deficiencies must be received within 10 calendar days unless otherwise notified by the College of American Pathologists. If you require verbal confirmation of the inspection date and/or team leader's name, you can contact the Laboratory Accreditation Program at , option 2. Sincerely Amy Daniels Investigations Manager Laboratory Accreditation Program Ref: CXNRINSPNO

2 Attachment B

3 Attachment B A complaint filed with the CAP can be initiated either in writing or verbally; however, all complaints must contain enough detailed, factual information to enable the College to follow up with an investigation. Complaints may be submitted anonymously and are kept confidential. CAP requests that those filing a complaint provide their names, addresses, and telephone numbers; however, this information is not required. CAP also asks in what way, if any, they have a connection to the laboratory. For example, is the person filing the complaint a patient, an employee, or a former employee? Depending on the nature of this complaint, the investigation may proceed in any one of a variety of ways. This may include a request for information from the laboratory, a search of past inspection and proficiency testing results, an announced inspection of the laboratory, or an unannounced inspection. Once the process of gathering information is completed, the CAP Laboratory Accreditation Complaints Committee will consider the evidence and determine whether the grounds for the complaint have been substantiated. The Committee will also consider recommendations for what remedial action, if any is required, should be taken. In addition, depending on the nature of any identified deficiencies, the Accreditation Committee will determine if the laboratory should be placed on probation or whether its accreditation should be revoked. CAP recognizes that no two laboratories are exactly alike. Therefore, the committee-determined course of action is tailored specifically to address individual problems discovered during investigations. Please note that these are merely guidelines and hypothetical examples. All accreditation decisions are made by CAP on a case-by-case basis. In addition, substantiated complaints, as well as plans for correction and changes in accreditation status are shared with appropriate state and federal agencies. Among the more common findings are:

4 Attachment B Investigators may conclude that a complaint is either in error or cannot be substantiated. Under circumstances such as these, the investigation would be closed and the laboratory s accreditation status would not be affected. During the course of the investigation of a substantiated complaint, the laboratory may have resolved its identified problem. Resolution of a straightforward problem concludes the investigation without affecting the laboratory s accreditation. Serious problems can result in probation for a section or for an entire laboratory. This means that the laboratory has not completely addressed the issues involved in the complaint to CAP s satisfaction. However, the nature of the issue is not believed to pose a substantial risk to either patients or laboratory workers. Testing can continue during this probation, and CAP will continue to evaluate the laboratory until such time that the probation is lifted or accreditation is revoked. Accreditation may be suspended for sections of a laboratory CAP feels has deficiencies that potentially pose a substantial risk to harm patients or laboratory personnel. This step is normally taken when CAP believes that these deficiencies cannot be corrected within a specific, designated time period. In the case of the most serious problems, CAP may revoke laboratory accreditation. CAP will inform CMS, appropriate state regulatory agencies, and other appropriate accrediting organizations as to the change in accreditation status and the results of the CAP complaint investigation. A laboratory that has its accreditation denied or revoked has the right to request the Accreditation Committee of the CAP Council on Accreditation to reconsider its decision. This request must be made within 30 days from the time the laboratory is notified of the decision to deny or revoke accreditation. Accompanying this request to reconsider, laboratories may provide additional information to the Accreditation Committee. If the reconsideration request is denied, or if the original decision is upheld, the laboratory has 30 days in which to appeal that decision to the Council on Accreditation. It is important to note that neither a request for reconsideration by the Accreditation Committee or the CAP Council on Accreditation will stay the denial or revocation of accreditation. If a decision of denial or revocation of accreditation is overturned, the appropriate government agencies and accrediting organizations will by notified of the decision.

5 Attachment B All complaints are treated as confidential and the identity of the complainant is not released by the CAP. Important note: The College has a strict whistleblower protection policy. Any institution found to have retaliated or harassed a person who has filed a complaint with the College faces revocation of its CAP accreditation. No. The CAP treats complaints regarding laboratory quality as confidential. In order to protect the identity of the person(s) filing a complaint, the date the complaint is filed is kept confidential. Yes, in fact, all CAP accredited laboratories are required to report any adverse media attention they receive. Failure to do so is in violation of the College s Terms of Accreditation. CAP will only investigate complaints associated with its Laboratory Accreditation Standards and/or Checklist requirements. The College does not investigate complaints such as billing fraud, fee-for-service issues, employee hiring practices, and/or result interpretation as it relates to the general practice of medicine. It is the intent of CAP to work collaboratively with the laboratory director in order to address any quality concerns. When a complaint is received, the director will be notified and will be involved in the resolution process. CAP will keep the identity of the complainant strictly confidential. The nature of the complaint and as necessary, relevant details needed to process and resolve the complaint will be shared with the laboratory director. The identity of the complainant will be kept confidential. The best way to make investigations go smoothly is to COOPERATE. Laboratories should respond to information requests quickly and completely, fully cooperate with any CAP inspectors or complaint investigators and recognize that the process of investigating a complaint can help improve lab operations and testing quality. The waiting period is six months. At the conclusion of the complaint investigation, CAP will send a letter indicating that investigation is completed to both the laboratory director and the complainant. MCD0513-A/pdf/909/39534

6 Attachment C College of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence MEMORANDUM TO: FROM: DATE: Inspection Team Leader Amy Daniels, Investigations Manager August 15, 20XX RE: Complaint Investigation General Hospital Pathology Laboratory Port Charles, NY Reference Number: 2365 CAP Number: AU ID: The information contained within this document is intended for review by the College of American Pathologists inspectors for purposes of the CAP inspection. This document may contain confidential material, which may not be shared with the laboratory director or any laboratory staff during this CAP inspection. Any review, retransmission, dissemination or other use of this information by persons or entities other than the intended recipient is prohibited. Below is information relating to a Laboratory Accreditation Program investigation of this laboratory. As part of your inspection, please review this data, paying particular attention to the allegations listed below to ensure that the laboratory is employing the procedures or processes that are appropriate to meet the College's standards. 1. Allegation #1 - A concern with the manner of reporting critical results. The complainant raised concerns that critical results throughout the laboratory were not being called to the appropriate caregiver. Review the laboratory's policy for calling critical results and confirm that staff have read and understand the policy. Question the staff regarding this policy to confirm understanding. (COM.30000, COM.30100) Review patient reports and the laboratory's documentation system to verify that the calling of critical results has been appropriately documented. (COM.30000) Please document your findings. Five staff members were asked about the critical result calling procedure. They all were aware that they are to contact the caregiver & document the complete name of the person notified, date & time that the results were given as per their

7 Attachment C procedure. Their procedure contains the appropriate reviews & sign-offs. They also have this aspect as part of their annual competency. Five reports were reviewed and all were documented appropriately with date, time, responsible laboratory individual, complete name of person notified and test results. If a concern was identified, list the checklist questions that were cited: none cited 2. Allegation #2 - Expired reagents and controls are being used in Hematology and Coagulation. The concern was raised that expired reagents and controls were used in Hematology and Coagulation from March 10 - March 15, 2011 when the laboratory's shipment was delayed. Review this issue to determine if expired reagents and controls were used. (HEM.24100). If used, and identified by the laboratory, what corrective action was performed? Verify that the laboratory is using appropriately dated reagents and controls while performing patient testing. Please document your findings. The labs CBC & PT controls expired March 15, 2010 and the laboratory actually released results for patients in which the controls had expired. New controls came in March 17, The supervisor was not aware of it until we pointed the error out to her. Currently, all reagents & controls are in date and no other dates have been seen in which expired reagents or controls were used. Since this was not caught before releasing patient results or by the supervisor on review, several deficiencies were cited. If a concern was identified, list the checklist questions that were cited: HEM.24100, HEM.20140, HEM Allegation #3 - Reporting patient results without quality control in Hematology and Coagulation It was alleged that the laboratory began using expired reagents and controls when its shipment was not received, then when it ran out of expired controls, the laboratory did not run controls for a period of 24-hours for Hematology and Coagulation. This allegedly occurred March 16, Review this issue to determine if patient results were reported without quality control testing. (HEM.20140). If this occurred and identified by the laboratory, what corrective action was performed. How many patients were affected? Please document your findings. As related to allegation #2, the lab did report outpatient results using expired controls on March 16, This error was discussed with the Medical Director and they are beginning to determine how

8 Attachment C many patients may have been affected. Approximately 50 patients received CBC s and 25 patients had protimes performed. Their plan is to review patient results and contact the caregivers. The checklist requirement for QC Corective Action is being cited to assure proper follow-up. If a concern was identified, list the checklist questions that were cited: HEM.20140, HEM Please respond in writing to each individual allegation above. Additionally, you must cite any appropriate deficiencies and provide general inspection comments on Part A of the Inspection Summation Report. Please provide us with the inspection date and have the team member investigating the complaint allegations date and sign below. Return the memorandum with the Inspection Summation Report. If you need further information or have any questions, please contact me at 800/ , extension Thank you. Inspection Date: July 20, 2010 Inspector investigating allegations (please print): Adrienne Malta Inspector signature: Lisa Onak Date: July 20, 2010

9 Attachment D College of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence MEMORANDUM TO: FROM: DATE: Inspection Team Leader Amy Daniels, Investigations Manager September 19, 20XX RE: Closed Complaint Investigation Follow-up General Hospital Pathology Laboratory 390 N. Cary Port Charles, NY Reference Number: 2365 CAP Number: AU ID: The information contained within this document is intended for review by the College of American Pathologists inspectors for purposes of the CAP inspection. This document may contain confidential material, which may not be shared with the laboratory director or any laboratory staff during this CAP inspection. Any review, retransmission, dissemination or other use of this information by persons or entities other than the intended recipient is prohibited. Below is information relating to a Laboratory Accreditation Program closed investigation of this laboratory. As part of your inspection, please review this data, paying particular attention to the information listed below to ensure that the laboratory is employing the procedures or processes that are appropriate to meet the College's standards. Please verify that corrective actions have been implemented and sustained by the laboratory for accreditation. 1. Concern #1- A concern with the manner of reporting critical results. Review the laboratory's critical result policy to confirm the manner in which the staff is to call and document critical results. Verify that this process is occurring with all critical results reported in the laboratory. (COM.30000, COM.30100) 2. Concern #2- Expired reagents and controls are being used in Hematology and Coagulation. Review a log of the reagents and controls in Hematology and Coagulation to confirm that no expired reagents and controls have been used when patient results have been reported. Especially verify this issue during times in which shipments may have been delayed. The laboratory informed CAP that they have established an inventory monitoring system that would verify that appropriately dated controls and reagents are being used. Confirm that the laboratory has this practice in place. (HEM.24100) Page 1 of 2 Ref: INSMEMCLSD

10 Attachment D 3. Concern #3- Reporting patient results without quality control in Hematology and Coagulation. Review the laboratory's policy/procedure for the performance of quality control testing and verify that the laboratory is following their policy which is in compliance with the CAP checklist requirements. Verify that patient results are not released until the quality control results have been confirmed to be acceptable. (HEM.20140) Please cite any appropriate deficiencies and comment on your findings in Part A of the Inspector Summation Report. If you need further information or have any questions, please contact me at 800/ , extension Thank you. Enclosure Page 2 of 2 Ref: INSMEMCLSD

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