Naspac 1, Llc Blackwood

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Clinical consultant (CC) the laboratory failed to retain QC assay sheets for Toxicology tests run on the Indiko Plus analyzer from 11/3/22 to the date of the survey. The CC confirmed on 9/11/24 at 10:00 am that the QC assay sheets were not retained. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) procedure and interview with the Clinical Consultant (CC), the laboratory failed to to verify QC material with each new lot and/or shipment of QC for urine toxicology tests performed on the Indiko Plus from 11/3/22 to the date of survey. The GS confirmed on 9/11/24 at 10:20 am that the QC material was not verified before putting in use. 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 surveyor review of the Procedure Manual and interview with Clinical Consultant (CC) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 11/3/22 to the date of survey. The finding includes: 1. The laboratory failed to have a procedure to verify new lots of controls before they were put in use. 2. The CC confirmed on 9/11/24 at 11:40 am that the laboratory failed to have a procedure to verify new lots of controls before they were put in use. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Finial Report (FR), Manufactuers package inserters (MPI), and interview with the Cinical Concultant (CC), the laboratory failed to ensure that the Reference Interval (RI) was accurate for Fentanyl run on the Indoko Plus analuyzer form 11/3/22 to the date of survey. The finding includes; 1. The CC stated that RI's were taken from the Manufactuers reagent insert. 2. The RI on the FR for Fentanyl was >=100 ng/mL 3. The MPI stated the RI for Fentanyl was 2.0 ng/mL 4. The CC confirmed on 9/11/24 at 11:30 am that the laboratory failed to ensure the RI was accurate. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are -- 2 of 3 -- adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Clinical Consultant (CC), the Laboratory Director (LD) failed to ensure that PS procedures for Toxicology tests performed on the Indiko Plus analyzer were adequate from 11/3/22 to the date of survey. The findings include: 1. There was no documented evidence that PS procedures were performed on Fentanyl. 2. The CC confirmed on 9/11/24 at 11:15 am that PS records were not adequate. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for routine chemistry tests from 9/19/19 to the date of survey. the finding includes: 1. The laboratory was enrolled in two out of three events for Creatine and Potential of Hydrogen (pH) with the College of American Pathologists (CAP). 2. The TP confirmed on 11/3/22 at 1:00 pm the laboratory was not enrolled in three PT testing events for the above mentioned analytes. D5783

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on one out of three TP from 4/24/2018 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 9/19/19 at 10:00 am that CA was not performed on TP. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of Personnel Files and interview with the Testing Personnel (TP), the Laboratory Director failed to have training documented for one out of three TP from 4 /24/2018 to the date of the survey. The findings include: 1. There was no 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 -- documentation of training for urine toxicology testing performed on the Thermo Fisher Indiko plus analyzer. 2. The TP #1 listed on CMS form 209 confirmed on 9/19 /19 at 10:00 am that training records were not available. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to maintain copies of all PT records for Urine Drug testing performed with the American Proficiency Institute (API) in the 2- 2017. The finding includes: 1. The laboratory did not have the evaluation page for PT results in event 2-2017. 2. The GS confirmed on 4/24/18 at 10:00 am that all PT records were not maintained. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of the Maintenance Records (MR) and interview with the General Supervisor (GS), the laboratory failed to perform and document maintenance as specified by the manufacturer on the Thermo Fisher analyzer used in Urine Drug Screening Tests from January 2018 to the date of the survey. The findings include: 1. A review of the MR revealed maintenance was not performed as follows: a. Weekly maintenance was not performed in January, February, March and April 2018. b. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Monthly maintenance was not performed in February and March 2018. 2. The GS confirmed on 4/24/18 at 10:15 am that maintenance as specified by the manufacturer was not performed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the General Supervisor (GS), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR from August 2016 to the date of survey. The GS confirmed on 4 /24/18 at 11:30 am that the TRD was not on the FR. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Manufacturers Package Insert (MPI), Final Report (FR) and interview with the General Supervisor (GS), the laboratory failed to ensure the Normal Reference Interval (RI) was correct on the FR for Specific Gravity (SG) tests performed on the Thermo Fisher Indiko Plus from August 2016 to the date of the survey. The finding includes: 1. The upper limit of the RI for SG was 1.035 on the FR but the MPI limit was 1.030. 2. The GS confirmed on 4/24/18 at 11:45 am that the laboratory failed to have the correct RI on the FR. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on surveyor review of the Performance Specification (PS) records and interview with the General Supervisor (GS), the Laboratory Director failed to ensure that PS procedures performed on the Thermo Fisher Indiko Plus analyzer were adequate from August 2016 to the date of the survey. The finding includes: 1. A review of the Precision Statistics revealed that there was no indication if analyte had passed, failed, or was uncertain. 2. The GS confirmed on 4/24/18 at 10:30 am that PS were not reviewed. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Files and interview with the General Supervisor (GS), the Laboratory Director failed to have education records for one out of two Testing Personnel (TP) from August 2016 to the date of the survey. The GS confirmed on 4/25/18 at 9:45 am that there was no education record for one out of two TP. -- 3 of 3 --