The Joint Commission Standards Taking Effect on July 1, 2013

Transcription

1 The Joint Commission Standards Taking Effect on July 1, 2013 Stacy Olea, MBA, MT(ASCP), FACHE Field Director, Accreditation and Certification Operations The Joint Commission Oakbrook Terrace, Illinois, USA May 30, 2013 Today s Presentation Identify the new and revised standards that go into effect on July 1, Recognize the CLSI guidelines that can be used to assist your laboratory in achieving compliance. 2 1

2 Process Evaluation began in August Thirty-three changes were submitted for a six-week field evaluation in June Pilot testing occurred at four medical centers in July Process (cont d) Changes were reviewed by the Laboratory Professional and Technical Advisory Committee consisting of representatives of major laboratory professional associations. Changes were approved by the Standards and Survey Procedures Committee of the Board of Directors. 4 2

3 Appendix B Addresses laboratory-developed tests (LDTs) The US Food and Drug Administration defines LDTs as a class of in vitro diagnostics that are manufactured, including being developed and validated, and offered, within a single laboratory. 5 Appendix B (cont d) LDTs are currently CLIA-regulated by both proficiency testing and quality control testing requirements. LDTs are highly complex procedures. Abbreviation: CLIA, Clinical Laboratory Improvement Amendments. 6 3

4 Guidelines to Best Practices Six footnotes reference CLSI documents. Two footnotes reference AABB s Standards for Blood Banks and Transfusion Services and Technical Manual. One footnote references The Bethesda System for Reporting Thyroid Cytopathology. One footnote references the Cancer Program Standards DC EP 1 Added procedure requirement Precautions for specimen collection, including preventing cross-contamination of primary samples and sample portions shared between testing centers Reference: 42 CFR

5 IM EP 2 Note Note: Only the staff authorized by the organization to perform laboratory tests are allowed to modify laboratory test results in a patient s clinical record. Emphasizes data ownership in laboratory information system (LIS) 9 IM EP 1 Added validation criteria for assessing functionality in all environments of the LIS that include the following: Data capture Data display Data transmission Data retention Additional information can be found in CLSI documents AUTO08-A: Managing and Validating Laboratory Information Systems and AUTO12-A: Specimen Labels: Content and Location, Fonts, and Label Orientation 10 5

6 IM EP 3 Added requirement to validate middleware after the following: Modification of hardware Installation of new software Following restoration of data files Currently more than 15 middleware systems 11 LD EP 10 Review of unmodified procedures is required every two years by the laboratory director or designee. Reminder: Immunohematology procedures must be reviewed by an individual qualified as a technical supervisor in immunohematology. 12 6

7 PI EP 5 Added to include ISO definition of quality management system A management system to direct and control an organization with regard to quality Additional information can be found in CLSI document QMS01-A4: Quality Management System: A Model for Laboratory Services Abbreviation: ISO, International Organization for Standardization. 13 QSA EP 2 Basic requirement for remedial action is unchanged. Language changed to align with CLIA regulation 42 CFR Individual unacceptable proficiency testing results Late submission of proficiency testing results (score is zero) Nonparticipation in the proficiency testing event (score is zero) Lack of consensus among all laboratories participating in the proficiency testing event (score is ungraded) 14 7

8 QSA EP 9 Documentation of the verification of water quality is required. Certificates of Analysis are acceptable. Certificates must cover all water quality specifications for your procedures. 15 QSA EP 4 Added language:.. and on each new batch of media, and on each new lot number and shipment of antimycobacterial agent(s) Aligns with language of CLIA Regulation 42 CFR

9 QSA EP 6 All stool specimens from patients diagnosed with acute community-acquired diarrhea are simultaneously cultured for O157 Shiga toxinproducing Escherichia coli (STEC) on selective and differential agar and assayed for non-o157 STEC with a test that detects Shiga toxins or the genes encoding these toxins. Testing may be performed at a reference laboratory. Reference MMWR; October 16, 2009 : 17 QSA EP 1, 2, and 3 Written policies and procedures are required for the collection, transport, processing, and interpretation of blood cultures. Procedures for manual blood culture are required when used as a backup to an automated system. Incorporate results of performance improvement activities relating to blood culture contamination. Additional information can be found in CLSI document M47-A: Principles and Procedures for Blood Cultures. Reminder: If both automated and manual systems are used, correlations must be performed every six months (QSA ). 18 9

10 QSA EP 1, 2, and 3 EP 1 defines the recommended volume of blood to be drawn for each blood culture based upon approved clinical guidelines, manufacturers requirements, and instrument specifications. EP 2 specifies the frequency of inspection of manual blood cultures and documentation of inspection results. After 12 to24 hours of incubation at 35 C Twice daily for days one and two Daily for days three to seven EP 3 establishes guidelines for collection, transport, and processing to minimize contamination and support infection prevention and control activities. 19 QSA EP 9 Requires the definition of staff responsible for the provision of blood, blood components, tissue, derivatives, and services Includes contracted staff providing services within the organization Specify the director, technical supervisor(s), and general supervisor(s)

11 QSA EP 8 Deleted redundant with QSA EP 4 21 QSA EP 8 Requires written policies and procedures that address the transfusion of plasma components containing a significant amount of incompatible ABO antibodies or unexpected red cell antibodies Additional information can be found in the current editions of the AABB s Standards for Blood Bank and Transfusion Services and Technical Manual 22 11

12 QSA EP 3 Requires policies and procedures for neonatal transfusion and related activities Requires a policy to address emergency transfusions and patient referral if the organization does not perform neonatal transfusion Additional information can be found in the current editions of the AABB s Standards for Blood Banks and Transfusion Services and Technical Manual 23 QSA EP 2 Laboratory follows an approved clinical guideline when performing urine tests on specimens that meet acceptability. Additional information can be found in CLSI document GP16-A3: Urinalysis A defined system is required to address handling, testing, and reporting urine specimens that exceed stability requirements (for example, room temperature urine more than two hours old and refrigerated urine more than four hours old)

13 QSA EP 3 Requires guidelines and policies to test pediatric urine specimens for reducing substances Does not require testing for reducing substances Assess the clinical need of patient population. Form policy based on clinical needs assessment. 25 QSA EP 3 Note Minor language change for clarification No change in requirements or intent 26 13

14 QSA EP 6 Bullet 3 Replace histopathology report with previous (normal or negative) gynecological specimens from the previous five years. The laboratory determines the causes of any cytology discrepancies when comparing the following: a current high-grade squamous intraepithelial lesion, adenocarcinoma, or other malignant neoplasm with previous (normal or negative) gynecological specimens from the previous five years. 27 QSA EP 2 Clarify the need to select a minimum of 10% negative gynecological cytology cases for quality control. Replace cytotechnologist with each primary screener. Clarify that the primary screeners are not made aware of which slides will be reexamined

15 QSA EP 1 and 2 Clarify the need to correlate nongynocological cytology findings with histopathology findings. 29 QSA EP 1 Clarify that an individual qualified as a cytology technical supervisor (without the need to have the title assigned by the organization) reviews and confirms all nongynecological cytology slides

16 QSA EP 1 Clarified language relating to the use of standardized nomenclature No change in requirement or intent Added reference to The Bethesda System for Reporting Thyroid Cytopathology 31 QSA EP 1-6 New standard addressing quality control requirements for chromosomal microarray analysis Written quality control and testing procedures that must be followed Probe specificity Assessment of the genomic copy number Assay resolution Study limitations, including copy number variation 32 16

17 QSA EP 6 The laboratory interpretive reports for cytogenetic testing include the following information: band resolution for constitutional cases. 33 QSA EP 1 and 2 Hematology-specific quality control requirements removed Requirement moved to QSA EP 3 Two levels of quality control are performed each day of testing. Levels should cover clinically significant portion of reportable range. Does not apply to coagulation quality control 34 17

18 QSA EP10 Requires policy and procedure relating to collection of plasma-based coagulation specimens Additional information can be found in CLSI document H21-A5: Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays 35 QSA EP 10 Requires cancer pathology reports in synoptic format Additional information can be found in Cancer Program Standards 2012: Ensuring Patient-Centered Care by the Commission on Cancer of the American College of Surgeons at

19 QSA EP 11 Requires the evaluation of semen specimens to be based on approved clinical guidelines, with documented results Additional information can be found in CLSI document POCT10-A: Physician and Nonphysician Provider-Performed Microscopy Testing,and in the current edition of the World Health Organization Laboratory Manual for the Examination and Processing of Human Semen 37 Review Identified the new and revised standards that go into effect on July 1, 2013 Recognized the CLSI guidelines that can be used to assist your laboratory in achieving compliance 38 19

20 CLSI Quality Initiatives Laboratory Quality Management System (LQMS) Certificate Program Earn an online certificate of achievement in LQMS 13 CE credits awarded by P.A.C.E. The Key to Quality includes fundamental information for implementing and sustaining a quality management system (QMS). 39 Questions 40 20

21 Thank You You may now disconnect 41 21