Naspac 1, Llc - Hainesport

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 the lack of raw data print-out work records (WR) from the Thermo Fisher Scientific Indiko Plus analyzer and surveyor interview with the Testing Personnel #1 (TP #1) on the CMS-209 provided at the time of the survey, the laboratory failed to maintain analyzer WR's for patient's and Quality Control (QC) for routine chemistry and toxicology tests performed on the Thermo Fisher Scientific Indiko Plus analyzer from 10/21/21 to the date of the survey. The finding includes: 1. The TP #1 stated, "The WR's for patient's and QC are saved in the analyzer and Laboratory Information System (LIS)". 2. The laboratory ran and reported approximately 470,000 patients from 10/21/21 to the date of the survey. 3. The TP #1 confirmed on 10/17/23 at 2:00 pm that the laboratory did not maintain the analyzer WR's for patient's and QC. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with Testing Personnel #1 (TP #1) on the CMS-209 provided at the time of the survey, the 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 -- laboratory failed to establish a written procedure for how and when to verify the electronic data transfer from the Thermo Fisher Scientific Indiko Plus analyzer to the Laboratory Information System (LIS) from 10/21/21 to the date of survey. The TP #1 confirmed on 10/17/23 at 1:00 pm that the laboratory did not have the procedure mentioned above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Calibration Material (CM) and interview with the Testing Personnel (TP), the laboratory had expired CM for Toxicology tests run on the Indiko Plus from 9/30/21 to the date of the survey. The findings include: 1. CM was expired as follows: a. DRI Creatine - Detect 2.0 mg/dl calibrator Lot 74082273 expired 9/30/21 b. DRI Creatine - Detect 25 ml calibrator Lot 74082291 expired 9/30 /21 2. Approximately 50 patients were run and reported per day. 3. The TP confirmed on 10/21/21 at 1:50 am that the laboratory used expired QC. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing records and interview with the Testing Personnel (TP), the laboratory failed to evaluate coded results obtained for Toxicology proficiency testing performed with the American Proficiency Institute (API) in the 1st 2018 event. The finding includes: 1. The laboratory did not evaluate code 2 "Not Graded" for USD Opiates - No Consensus - event 1, 2018. 2. The TP #1 listed on CMS form 209 confirmed on 1/29/19 at 10:30 am that the laboratory failed to evaluate coded results. 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 (PM), Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure to verify new QC material used in Toxicology tests before use 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 -- from 2/23/17 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 1/29/19 at 10:00 am the laboratory did not have a procedure to verify new Toxicology QC. -- 2 of 2 --