Saint Francis Lab - Sf Cancer Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/07/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory services technical manager and the lead technologist at the conclusion of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead technologist and laboratory services technical manager, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for 1 of 6 Hematology events reviewed. Findings include: (1) On 07/07/2021, the surveyor reviewed proficiency testing records for the second and third events in 2019; the first, second, and third events in 2020; and the first event in 2021. The following was identified for 1 of 6 Hematology events: (a) Third 2020 Hematology Event for Blood Cell Identification - 1 of 5 results (BCI-11) had not been graded by the proficiency testing program - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the participant summary report to evaluate their result. (2) The surveyor reviewed the records with the lead technologist and laboratory services technical manager. Both stated on 07/07/2021 at 11:15 am, the laboratory had not evaluated the result that were not graded by the proficiency testing program. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 a review of records, manufacturer's instructions, observation, and interview with the lead technologist and laboratory services manager, the laboratory failed to ensure materials were stored as required for 1 of 1 month. Findings include: (1) On 07 /07/2021 at 13:10 pm, the surveyor observed the contents of the laboratory freezer. The following calibration verification materials were being stored in the freezer, with the manufacturer's storage requirements: (a) Validate Calibration Verification /Linearity GC4 Test kit, lot #14AK269200 - Used to perform calibration verification procedures for Direct Bilirubin and Total Bilirubin testing. The storage requirement was -10 to -25 degrees C (Centigrade); (b) Validate Calibration Verification/Linearity Test kit, lot #13AQ262200 - Used to perform calibration verification procedures for ALT (Alanine Aminotransferase), Alkaline Phosphatase, Amylase AST (Aspartate Aminotransferase), CK (Creatine Kinase), GGT (Gamma-Glutamyl Transferase), and LD (Lactate Dehydrogenase) testing. The storage requirement was -10 to -25 degrees C . (2) The surveyor reviewed temperature records from 06/01/2021 through 06/30 /2021. The documented temperatures were colder than -25 C (the coldest temperature allowed for the materials) during 1 of 1 month as follows: (a) June 2021 - 30 of 30 documented temperatures were colder than -25 degrees C. The documented temperatures ranged from -28.5 to -33.7 degrees C. (3) The surveyor reviewed the records with lead technologist and laboratory services manager. Both stated on 07/07 /2021 at 04:0901:30 pm, the freezer temperatures were unacceptable as shown above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead technologist and laboratory services technical manager, the laboratory failed to ensure two levels of quality control were performed as stated in the QCP portion of the IQCP for 14 of 15 days reviewed. Findings include: (1) On 07/07/2021 at 09:10 am, the lead technologist stated the following to the surveyor: (a) The laboratory used two iSTAT 1 analyzers -- 2 of 3 -- (serial numbers 374934 and 374527) to perform Ionized Calcium testing using the Chem 8+ Cartridge; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as effective on 01/01/2016) and identified the QCP (Quality Control Plan) required two levels of external QC (Quality Control) materials be performed monthly and with new lot numbers or shipments of test cartridges; (3) The surveyor then reviewed QC records for testing performed from 06/23/2020 through 06/07/2021 and identified for 14 of 15 days, instead of performing two levels of QC material (level 1 and level 3) on each analyzer monthly, the laboratory had tested one level of QC material on each analyzer (level 1 tested on serial number 374934 and level 3 tested on serial number 374527) monthly; (4) The surveyor reviewed the records with the lead technologist and laboratory services manager and asked if there was additional documentation to prove that two levels of QC material were being tested on each analyzer monthly. The lead technologist and laboratory services manager stated to the surveyor on 07/07/2021 at 12:00 pm, two levels of QC had not been tested on each analyzer monthly. 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 a review of records and interview with the lead technologist and laboratory services technical manager, the laboratory failed to ensure patient test reports included the address of the laboratory location where the testing was performed. Findings include: (1) On 07/07/2021 at 09:05 am, the lead technologist stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Abbott Ruby analyzer; (b) CMP* testing was performed using the Abbott ci4100 analyzer. (2) The surveyor reviewed patient CBC and CMP reports (CBC testing performed on 07/07/2021 at 12:53 pm and CMP testing performed on 07/07/2020 at 11:43 am. The reports did not include the address of the laboratory location; (3) The surveyor reviewed the reports with the the lead technologist and laboratory services technical manager. Both stated on 07/07/2021 at 01:40 pm, the reports did not include the address of the laboratory location. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/20/19. The findings were reviewed with technical consultant/technical supervisor #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1413; D6033: Technical Consultant 493.1447; D6108: Technical Supervisor 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 a review of records and interview with technical consultant/technical supervisor #1, the laboratory failed to retain patient records for at least 2 years. Findings include: (1) At the beginning of the survey, technical consultant/technical supervisor #1 stated to the surveyor CBC (Complete Blood Count) testing was performed using the Cell-Dyn Emerald; (2) Later during the survey, the surveyor reviewed patient testing records with the following identified: (a) Records previous to 02/13/19 were not available (3) The surveyor ask technical consultant/technical supervisor #1 if patient records before 02/13/19 could be located; (4) Technical consultant/technical supervisor #1 stated to the surveyor the patient testing records before 02/13/19 for CBC testing could not be located. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- This STANDARD is not met as evidenced by: Based on a review of records, written policy and interview with technical consultant /technical supervisor #1, the laboratory failed to follow their written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) The surveyor asked technical consultant/technical supervisor #1 if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. Technical consultant/technical supervisor #1 provided the policy for the surveyors review; (3) The surveyor reviewed the policy which required annual competencies be performed for the technical consultant and general supervisor based on job responsibilities. (4) The surveyor asked technical consultant/technical supervisor #1 if annual competencies based on job responsibilities had been performed during the review period. Technical consultant/technical supervisor #1stated annual competencies had not been performed. 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 a review of records and interview with technical consultant/technical supervisor #1 the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following failure was identified, in which