Dialysis Clinic Inc Donor Services Dba New Mexico

Summary Statement of Deficiencies D0000 During a recertification survey completed on 01/29/2020 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 493.1250 Analytic Systems 493.1403 Laboratory Director, moderate complexity 493.1409 Technical Consultant, moderate complexity D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on the review of 2018-2019 quality control records, product receipt records, laboratory policies, and interviews with staff the laboratory failed to perform and document 2 levels of quality controls for 3 of 6 shipments of i-Stat Chem 8+ cartridges as required by the manufacturer. The laboratory reported performing 144 Chem 8+ panels (Sodium, Potassium, Chloride, BUN, Creatinine, Glucose, Ionized Calcium, Hematocrit, and Hemoglobin) in a 12 month period. Findings are: A. Review of the manufacturer's instructions, i-STAT 1 Quick Reference Guide for the i- STAT 1 Handheld and i-STAT Chemistry Cartridges for use with a CLIA Certificate of Waiver indicated "Control Testing Frequency Test one cartridge from each lot in each shipment upon receipt. Test a single cartridge from the refrigerator monthly. Select cartridge in the following order: CHEM 8+, 6+, Crea, EC4+, Glucose, E3+" B. Review of the laboratory's iSTAT Testing Work Instruction dated 10/16/2016 indicated: "6.2.7.2 Quality Control(QC) Testing: 6.2.7.2.1 The OR.520.F03 - iSTAT QC Log will be used to document all cartridge QC results. Cartridge QC will be completed with each lot number in the shipment by a designated staff member. 6.2.7.2.1.1 Complete with the cartridge type, lot number, received date, quantity and temperature strip ok section. 6.2.7.2.1.2 Use one sheet for each cartridge 6.2.7.2.1.3 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Document the control name, lot#, level, expiration date and current CLEW for each solution. 6.2.7.2.1.4 Once testing is complete and results determined to be in range, sign and date the Lot/Shipment accepted by line." C. During interview on 01/23/2020 at 01:40 pm, the Quality Compliance Coordinator stated no new lots of cartridges had been received since the last documented external quality controls from the manual quality control log on 06/28/2019. D. During interview on 01/27/2020 at 01:05 pm, the laboratory's former trainer stated: 1. manual quality control record keeping was discontinued in June 2019; 2. he did not verify paper results with the electronic results. E. Review of the laboratory's product receipt records and the external (liquid) quality control records (manual and electronic records) revealed no documentation of external quality controls for the following lots of Chem 8+ cartridges: Lot H18292 expiration date 04/17/2019 2 boxes of 25 cartridges received on 12/11/2018. Lot H19024 expiration date 07/23/2019 2 boxes of 25 cartridges received on 03/27/2019 Lot H192538 expiration date 03/08/2020 3 boxes of 25 cartridges received on 10/18 /2019 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 the review of 2018-2019 quality control records, product receipt records, discard log, laboratory policies, and interviews with staff , the laboratory failed to meet the Condition for Analytic Systems. The laboratory reported performing 167 pH (measure of acidity) tests, 167 pCO2 (partial pressure of carbon dioxide), and 167 pO2 (partial pressure of oxygen) tests in a 12 month period. Findings are: A. The laboratory failed to perform and document 2 levels of quality controls for 3 of 6 shipments of i-Stat Chem G3 cartridges used for blood gas testing. See D5447 B. The laboratory failed to establish and follow an effective quality assessment program. See D5793 D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of 2018-2019 quality control records, product receipt records, discard log, laboratory policies, and interviews with staff the laboratory failed to perform and document 2 levels of quality controls for 3 of 6 shipments of i-Stat Chem G3 cartridges used for blood gas testing. The laboratory reported performing 167 pH -- 2 of 6 -- (measure of acidity) tests, 167 pCO2 (partial pressure of carbon dioxide), and 167 pO2 (partial pressure of oxygen) tests in a 12 month period. Findings are: A. Review of the laboratory's iSTAT Testing Work Instruction dated 10/16/2016 indicated: "6.2.7.2 Quality Control(QC) Testing: 6.2.7.2.1 The OR.520.F03 - iSTAT QC Log will be used to document all cartridge QC results. Cartridge QC will be completed with each lot number in the shipment by a designated staff member. 6.2.7.2.1.1 Complete with the cartridge type, lot number, received date, quantity and temperature strip ok section. 6.2.7.2.1.2 Use one sheet for each cartridge 6.2.7.2.1.3 Document the control name, lot#, level, expiration date and current CLEW for each solution. 6.2.7.2.1.4 Once testing is complete and results determined to be in range, sign and date the Lot/Shipment accepted by line." B. During interview on 01/23/2020 at 01:40 pm, the Quality Compliance Coordinator stated no new lots of cartridges had been received since the last documented external quality controls from the manual quality control log on 06/28/2019. C. During interview on 01/27/2020 at 01:05 pm, the laboratory's former Trainer stated: 1. manual quality control record keeping was discontinued in June 2019; 2. he did not verify paper results with the electronic results. D. Review of the laboratory's product receipt records and the external (liquid) quality control records (manual and electronic records) revealed no documentation of external quality controls for the following lots of G3 cartridges upon receipt of the shipments: D19060 expiration date 10/29/2019 1 box of 25 cartridges received on 05 /17/2019 D19171A expiration date 02/17/2020 2 boxes of 25 cartridges received on 08 /01/2019 D19249 expiration date 05/05/2020 2 boxes of 25 cartridges received on 10 /18/2019 3 unused cartridges from this lot were found in the laboratory, available for use, on 01/23/2020 at 01:40 pm. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 The following deficiencies were cited during a certification survey completed on March 8, 2018 for the federal requirements of 42 CFR Part 493 for Laboratories. 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 the review of 2016-2017 proficiency test records, personnel records, CMS Personnel Report Form 209, laboratory policy and interview with the technical consultant, the laboratory failed to ensure that the proficiency samples were tested by the same personnel that performed patient testing. The laboratory reported 34 patients (donors) were tested in a 12 month period for blood gases using the iSTAT chemistry analyzer. Findings are: 1. Review of the 2016-2017 submission forms and attestation statements revealed only one signature, that of the technical consultant for 3 of 3 test events in 2017 and 2 of 3 test events in 2016. 2. During interview on 3/08/2018 at 2: 45 pm, the technical consultant stated that she tested the proficiency samples. She also stated that there was one time, while training a new testing person, that the samples were tested by someone else. 3. Review of CMS Personnel Report Form 209 completed by the laboratory indicated a total of 9 testing personnel and the technical consultant. 4. During interview on 3/08/2018 at 3:00 pm, the technical consultant was asked for the hire dates of the testing personnel. 7 of 9 testing personnel had been employed by the laboratory prior to January 2017 but there was no record of their participation in proficiency testing in 2016 or 2017. 5. Review of the laboratory's policy "iSTAT Testing Work Instruction" revealed the laboratory did not follow 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 -- written policy regarding proficiency testing. In section 6.2.7.4.2.3 the policy stated "Proficiency testing specimens will be handled in the same way as donor specimens." The laboratory director was not available for interview. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of 2016-2017 proficiency testing records, personnel records, CMS Personnel Report Form 209, laboratory policy, and interview with the technical consultant, the laboratory director or designee failed to attest, in writing, that the proficiency samples were tested by the same personnel that performed patient testing. The laboratory reported 34 patients (donors) were tested in a 12 month period for blood gases using the iSTAT chemistry analyzer. Findings are: 1. Review of the 2016- 2017 submission forms and attestation statements revealed only one signature, that of the technical consultant, for 3 of 3 test events in 2017 and 2 of 3 test events in 2016. The only signed attestation statement was for the 1st event of 2017. All other attestation statements were blank. 2. During interview on 3/08/2018 at 2:45 pm, the technical consultant stated that she performed the testing, completed the submission forms, and discarded the forms after the results were submitted to the proficiency agency. 3. Review of CMS Personnel Report Form 209 completed by the laboratory indicated a total of 9 testing personnel and the technical consultant. 4. During interview on 3/08/2018 at 3:00 pm, the technical consultant was asked for the hire dates of the testing personnel. 7 of 9 testing personnel had been employed by the laboratory prior to January 2017 but there was no record of their participation in proficiency testing in 2016 or 2017. 5. Review of the laboratory's policy "iSTAT Testing Work Instruction" revealed the laboratory did not follow the written policy regarding proficiency testing. In section 6.2.7.4.2.3 the policy stated "Proficiency testing specimens will be handled in the same way as donor specimens." The laboratory director was not available for interview. -- 2 of 2 --