Northeast Correctional Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2021, 2022, and 2023 to date May 11, 2023 and interview with the Director of Nursing (DON), the laboratory showed two of twenty-one full-time testing personnel (TP) participated in the PT process who routinely perform patient testing. Findings: 1. Review of PT records for 2021, 2022, and 2023 to date May 11, 2023 show TP # 1 and TP #2 participated in Chemistry Core PT for 2021, 2022 and 2023. 2. Interview with DON on May 11, 2023 at 10:30 AM, confirmed the laboratory failed to include all personnel who routinely perform patient testing in the PT process. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records for 2021, 2022, and 2023 to date May 11, 2023 and interview with the Director of Nursing (DON), the laboratory failed to maintain a copy of records for proficiency testing (PT), including the signed attestation statement and a copy of the PT program report forms used by the laboratory to record PT results for a minimum of two years. Findings: 1. Review of PT records showed the laboratory failed to provide a signed attestation form for the following PT testing events: 2021 Chemistry Core - first event 2021 Chemistry Core - second event 2021 Chemistry Core - third event 2022 Chemistry Core - first event 2022 Chemistry Core - second event 2. Review of PT records showed the laboratory failed to provide a copy of the PT program report forms used by the laboratory to record PT results for the following PT testing events: 2021 Chemistry Core - first event 2021 Chemistry Core - second event 2021 Chemistry Core - third event 2022 Chemistry Core - first event 2022 Chemistry Core - second event 2022 Chemistry Core - third event 2023 Chemistry Core - first event 3. Interview with DON on May 11, 2023 at 10:30 AM confirmed the laboratory failed to maintain a copy of all records for proficiency testing, including the attestation statement and a copy of the PT program report forms used by the laboratory to record PT results for a minimum of two years. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following condition: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership (2) Name (3) Location (4) Director (5) Technical Supervisor Based on review of CMS 209 personnel roster and interview with testing personnel #3 and #12, the laboratory failed to notify the CLIA State Agency (SA) of a change in the position of laboratory director. Findings: 1. Review of the CMS 209 personnel roster showed a change in the position of laboratory director. 2. Interview with testing personnel #3 and #12 on March 18, 2019 at 11:00 AM confirmed the laboratory director filled the position on November 1, 2018. The laboratory failed to notify the SA of the change in laboratory director. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies, procedures, quality control records, patient records for 2017 and 2018, and interviews with testing personnel #3 and #12, the laboratory failed to follow the procedure for quality control on Troponin I kits (Refer to D5401); failed to have an approved procedure manual (Refer to D5407); failed to monitor and document the room temperature where the Troponin I kits were stored (Refer to D5413); failed to follow, monitor, document, and access the quality control plan for Troponin I kit testing (Refer to D5791). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the procedure manual, quality control (QC) logs, the Individualized Quality Control Plan (IQCP), patient records and interview with the testing personnel #3 and #12, the laboratory failed to follow the procedure for performing external QC monthly for 12 of 21 months, and with each new lot of Troponin I kits prior to patient use. Findings: 1. Review of the procedure manual revealed instruction to perform "QC with each new lot number of Cardiac Status Troponin I kits before using on patient samples." 2. Review of the IQCP revealed the instruction "Two levels of external control will be used once a month or each testing day depending on the volume of testing." 3. Review of the QC logs for April 2017 through March 2019 revealed the laboratory failed to perform QC on a monthly basis for the months of April and December 2017, February through September, November, and December 2018 for Cardiac Status Troponin I test. Review of patient test results showed the laboratory failed to run monthly QC for 24 patients for the months of April and December 2017 and 93 patients for February 2018-December 2018. 4. Review of the QC logs showed the laboratory did not perform QC on the following lot numbers for Troponin testing, 17CTK0033H and 18CTK0026D. Review of patient test results showed 6 patient test reports were reported on lot 17CTK0033H and 33 patient test reports were reported on lot 18CTK0026D. 5. Review of the QC log showed the laboratory failed to perform QC on lot 18CTK0022H prior to testing patient samples. 12 patient test reports were reported on lot 18CTK0022H before QC was performed. 6. Interview with the testing personnel #3 and #12 on March 18, 2019 at 11:00 AM confirmed the laboratory failed to follow the procedure for QC on Troponin I kits. This is a repeat deficiency, previously cited on November 15, 2016. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the procedure manual, and interview with the testing personnel #3 and #12, the laboratory director failed to approve the procedures. Findings: 1. Review of the procedure manual revealed the laboratory director failed to approve the procedures for Troponin I testing. 2. Interview with the testing personnel #3 and #12 on March 18, 2019 at 11:00 AM confirmed the director had failed to document any review of the procedure manual. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper -- 2 of 9 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the manufacturer's inserts, Individualized Quality Control Plan (IQCP), and interview with the testing personnel #3 and #12, the laboratory failed to monitor and document the temperature of the room used to store troponin kits. Findings: 1. Review of the Cardiac Status Troponin I manufacturer's product inserts revealed the product must be stored between 4-30 degrees centigrade. 2. Cardiac Status Troponin reagents were stored in the triage room. 3. Review of the triage room temperature documentation showed the laboratory failed to document room temperature for 2017 and to date March 18, 2019. 4. Review of the Individualized Quality Control Plan(IQCP) revealed "temperatures of spaces involved with storage of the troponin kits should be monitored on a daily basis." 5. Interview with testing personnel #3 and #12 on March 18, 2019 at 11:00 AM confirmed the laboratory failed to document the room temperature in the laboratory where the Cardiac Status Troponin I kits were stored. This is a repeat deficiency, previously cited on November 15, 2016. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control plan (QCP), 2017 and 2018 quality control (QC) logs, and patient records for 2017 and 2018, and interview with the testing personnel #3 and #12, the laboratory failed to maintain the QCP to ensure testing personnel perform two levels of external QC material at the frequency established by the the laboratory. The laboratory failed to perform monthly QC for 12 of 21 months. Findings: 1. The QCP states: " Two levels of external controls will be used once a month or each testing day depending on the volume of testing. Lot numbers and expiration dates of both the controls and test kits used must be documented as well as who performed the control testing and date performed." "When the laboratory discovers a testing process failure, it must determine the impact on patient care, document