Apple Diagnostic Lab

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 Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to document all pertinent information and retain manufacturers' assay information sheets for QC material and Xpert Xpress CoV-2/Flu /RSV plus kits used in Virology testing performed on the Cepheid GeneXpert DX analyzer from 8/29/22 to the date of survey. The finding includes: 1. The laboratory failed to document all pertinent information for Zeptometrix NATrol QC used in Virology testing performed on the Cepheid GeneXpert DX analyzer. 2. The laboratory failed to retain all Certificates of Analysis received for Zeptometrix NATrol QC. 3. The laboratory failed to document all pertinent information for Xpert Xpress CoV-2 /Flu/RSV plus kits used in Virology testing performed on the Cepheid GeneXpert DX analyzer. 4. The TP # 2 listed on the CMS-209 form confirmed on 12/5/23 at 11:45 am that all QC records were not retained. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP) the laboratory failed to review coded results for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Hematology Testing performed with the College of American Pathologists (CAP) in the calendar years 2022 and 2023. The findings include: 1. The laboratory received coded results (Code 26 -Educational Challenge) for Urine Chemistry- General for event U-A- 2023. a) Urine albumin/creati ra samples U-04, 05, 06 received code 26. 2. The laboratory received coded results (Code 27 - Lack of participant or referee consensus) for Urine Drug Testing (Screening) even UDS-A 2023. a) Immunochromatography Medtox Cut-Off 500 sample UDS-05 was coded see note 27. 3. The laboratory received coded results (Code 28 - Response qualifies with a great than or less than sign: unable to quantitative) for S-A 2023 Diagnostic Immunology. a) Antistreptolysin O (ASO) quant sample ASO-02, 04,05 were coded 28, there was no documented evidence of peer group comparison performed. 4. The laboratory received coded results (Code 28 - Response qualifies with a great than or less than sign: unable to quantitative) and unacceptable results for S-B 2023 Diagnostic Immunology. a) Antistreptolysin O (ASO) quant sample ASO-08, 09 were coded 28, there was no documented evidence of peer group comparison performed. b) Rheumatoid Factor (RF) Screening, quant samples RF-07, 10 were graded Unacceptable. 5. The laboratory received coded results (Code 26 -Educational Challenge) for Coagulation, Limited for event CGL-B 2023. a) Prothrombin Time (PT) qual samples CGL-06, 07, 08 ,09,10 received code 26. b) Active Partial thromboplastin Time (PTT), qual samples CGL-06, 07, 08 ,09,10 were graded "see note 26" 6. The laboratory received coded results (Code 26 -Educational Challenge) for Urine Chemistry- General for event U-B- 2023. a) Urine albumin/creati ra samples U-10,11,12 were graded "see note 26" 7. The laboratory received coded results (Code 26 -Educational Challenge) for Blood Cell ID, Photographs for event KP-C 2022. a) Blood Cell ID upgraded sample BCP-26, 27 ,28 ,29, 30 were graded "see note 26" 8. There was no documented evidence that aforementioned coded PT results were reviewed. 9. The TP confirmed on 12/5/23 at 1:15 pm that the laboratory did not review coded PT results. 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 surveyor review of the Cepheid GeneXpert Dx and Sentosa SX101 Operator's Manuals (OM) and Vela ViroKey Virus Total Nucleic Acid Kit package insert, the room temperature and humidity logs and interview with the Technical Supervisor (TS), the laboratory failed to provide accurate acceptable ranges for room temperature and humidity consistent with the manufacturer's requirements in the main laboratory, PCR room #3 and storage area from 4/7/20 to the date of the survey. The findings include: 1. The room temperature and humidity logs used in all rooms stated the acceptable ranges were 15-28C for room temperature and 20-80% for humidity. 2. The OM for the Cepheid GeneXpert Dx located in the main laboratory defined the room temperature requirement as 20-25C. 3. The OM for the Sentosa SX101 located in PCR room #3 defined the room humidity requirement as 55-75%. 4. The package -- 2 of 4 -- insert for the Vela ViroKey Virus Total Nucleic Acid Kits located in the storage area defined the room temperature requirement as 15-25C. 5. The TS confirmed on 12/5/23 at 2:00 pm that the laboratory failed to provide accurate acceptable ranges for room temperature and humidity consistent with the manufacturer's requirements on all room temperature and humidity logs. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control Materials (QCM) and interview with the Testing Personnel (TP), the laboratory failed to appropriately label QCM used for Virology tests performed on the Cepheid GeneXpert DX analyzer from 8/29 /22 to the date of the survey. The findings include: 1. The Positive QCM was observed in a container labeled as "FLU/RSV/SARS Positive Control 3/3/23". It did not indicate an expiration date, lot number, storage requirements or other pertinent information required for proper use. 2. The Negative QCM was observed in an unlabeled container that did not have an identity, expiration date, lot number, storage requirements or other pertinent information required for proper use. 3. The TP #2 as listed on CMS form 209 confirmed on 12/5/23 at 11:30 am that the QC materials used were not labeled appropriately. 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. This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Zeptometrix NATrol QC used on the Cepheid GeneXpert DX analyzer for Virology testing from 8/29/22 to the date of the survey. TP #2 as listed on the CMS-209 form confirmed on 12/5/23 at 1:10 pm that the QC material was not verified before putting into use. -- 3 of 4 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure the QC program was established and maintained from 8/29/22 to the date of the survey. The findings include; 1. The LD failed to ensure there were QC Verification procedures for Virology tests performed on the Cepheid GeneXpert DX analyzer. 2. The LD failed to ensure the laboratory documented all QC procedures performed with all pertinent information. 4. The TP #2 as listed on the CMS- 209 form confirmed on 12/5/23 at 12: 00 PM the LD failed to ensure the QC program was established and maintained. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two out of two events for General Immunology testing with the College of American Pathologists. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for General Immunology tests. The findings include: 1. The laboratory received a 75% in 2-2020 and 73% in 3-2020 score for General Immunology with the College of American Pathologists. 2. The laboratory scored a 0% in 2-2020 and 3-2020 for the following events: Alpha-1 Antitrypsin, Rubella and Antinuclear Antibodies. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with CLIA regulations are maintained. -- 2 of 2 --

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 Technical Supervisor (TS), the laboratory failed to perform CA correctly on two out of two Testing Personnel (TP) in 2018. The findings include: 1. All specialty tests performed by TP were not evaluated. 2. The laboratory did not document what records were reviewed and how assessment was performed. 3. The TS confirmed on 6 /13/18 at 11:00 am that CA was not performed correctly. 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 Technical Supervisor (TS), the laboratory failed to evaluate coded results obtained in 1, 2 and 3 of 2017 and 1of 2018 events for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory did not evaluate Not Graded 2 (lack of consensus) results for Hematocrit, Mean Corpuscular Volume and Red Cell Distribution Width for all samples in each event. 2) The TS confirmed on 6/13/18 at 9:50 am that the laboratory failed to evaluate coded results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of Urinalysis testing twice annually from 12/15/15 to the date of the survey. The TS confirmed on 6/13/18 at 1:00 pm the laboratory did not verify the accuracy of Urinalysisy testing twice annually. 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: a) Based on surveyor review of the Procedure Manual (PM), observation of centrifuge and interview with the Technical Supervisor (TS), the laboratory failed to follow Urine Microscopic procedure from 12/15/15 to the date of survey. The finding includes: 1. The ME procedure stated to "Spin urine specimen for 5 minutes but the laboratory spun for 10 minutes. 2. The laboratory did not have a source for microscopic procedure. 3. The TS confirmed on 6/13/18 at 1:30 pm that the laboratory did not follow the PM instructions. 35471 b) Based on surveyor review of the Procedure Manual (PM), observation of centrifuge and interview with the Testing Personnel (TP), the laboratory failed to follow the Coagulation (Coag) procedure from 12/15/15 to the date of survey. The finding includes: 1. The PM stated to "Spin Coag specimens at "3000 RPMs for 15 minutes" but the TP stated Coag samples were spun at 4000 RPMs for 10 minutes. 2. The TP #2 listed on CMS form 209 confirmed on 6 /13/18 at 1:30 pm that the laboratory did not follow the PM. c) Based on surveyor review of the PM, Quality Control (QC) records and interview with the TP, the laboratory failed to follow the QC verification procedure for QC used on the Coulter LH 750, Sysmex CA 500 and Premier Trinity Biotech 9210 from 12/15/15 to the date of the survey. The findings include: 1. This was cited on the previous survey and the