Infinite Genomics Llc

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: Review of the CMS 209 form, lack of documentation and interviews with laboratory staff, determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the laboratory staff member (#2 on the CMS 209 form) was listed as the technical supervisor, laboratory staff member (#6 on the CMS 209 form) was listed as general supervisor. B) Review of personnel records for laboratory staff member (# 2 on the CMS 209 form) revealed that no competency evaluation for the position of technical supervisor was present for calendar year 2022 or 2023, review of personnel records for laboratory staff member (# 6 on the CMS 209 form) revealed that no competency evaluation for the position of general supervisor was present for calendar year 2022 or 2023. C) Upon request, the laboratory was unable to provide documentation of competency determinations for calendar year 2022 and 2023 for the positions of technical supervisor or general supervisor for the personnel identified above. D) In an interview at 1:00 p.m. on May 29, 2024 the health system staff member (# 2 on the Entrance/Exit Conference Attendance Record) confirmed that competency determinations have not been performed on the personnel designated as technical supervisor and general supervisor. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Review of the laboratory's policy and procedure manual, lack of documentation, and interviews, determined the laboratory failed to follow written Quality Assessment (QA) policies and procedures to monitor, assess and correct problems identified in the laboratory. Findings Follow: A) The laboratory policy and procedure manual states under the policy "Quality Assessment Plan" that "all QA activities will be documented on Quality Assessment Review Form" and "completed forms, supporting documentation, and notations related to QA activities must be submitted by the last day of the scheduled month and retained for at least two years". B) Upon request, the laboratory was unable to provide "Quality Assessment Review" forms for 2022 and 2023 C) In an interview on 01:32 p.m.on 5/29/24, laboratory staff member (#2 as identified on form CMS 209) when asked if the laboratory had the quality assessment calendar and quality assessment review forms for 2022 and 2023, replied "no". 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 review of policy and procedure manuals, temperature logs, and interview with staff, the laboratory failed to follow instructions for operational environment policies for temperature requirements. Findings follow: A) Review of the following procedures: "Respiratory Pathogen Panel (RPP), Wound Plus, Womens Health Plus, Urinary Tract Infection (UTI), Nail Panel, and Sexually Transmitted Infection (STI)" revealed reagents listed in all the procedures have temperature requirements such as: Binding Solution (15C to 25C), Wash solution (15C to 30C), Elution solution (15C to 30C), Nucleic Acid Beads (15C to 30C), and Proteinase K solution (15C to 30C). B) Review of the electronic Temperature/Humidity log for Laboratory Transfer, Extraction and PCR rooms April 16, 2024, revealed no temperatures were recorded. May 29, 2024, revealed no temperatures were recorded. C) During an interview on 5 /29/2024 at 15:42 p.m. the Laboratory Directory listed on the CMS-209 form, confirmed the temperature are not being recorded. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 5/29/24 at 3:28 p.m. one (of one) package of Beckton Dickson (BD) Vacutainer Urine C+S tube (Ref: 364951, Lot: 2069973, expiration date 09/30/2023) was observed in the laboratory, available for use beyond their expiraton date. B) During a tour of the laboratory on 5/29/24 at 3:28 p.m. one (of one) package of BD Vacutainer UA Preservative (Ref: 364957, Lot: 2011946, expiration date 07/2023) was observed in the laboratory, available for use beyond their expiraton date. C) During a tour of the laboratory on 5/29/24 at 3:23 p.m. one (of one) package of Applied Biosystems (ABI) 384-Well Spectral Calibration Plate with TAMRA Dye (Ref: 4432296, Lot: 2305260, expiration date 05/05/2024) was observed in the laboratory, available for use beyond their expiraton date D) During a tour of the laboratory on 5/29/24 at 3:37 p.m. one (of one) package of ABI QuantStudio 12K Flex Openarray Accessories Kit Starter (Ref: 4469586, Lot: 2208388, expiration date 09/15/2023) was observed in the laboratory, available for use beyond their expiraton date E) During a tour of the laboratory on 5/29/24 at 3:23 p. m. one (of one) package of ABI 384-Well Spectral Calibration Plate with NED Dye (Ref: 4432302, Lot: 2305305, expiration date 05/10/2024) was observed in the laboratory, available for use beyond their expiraton date F) During a tour of the laboratory on 5/29/24 at 3:23 p.m. one (of one) package of ABI TaqMan RNase P Fast 384-Well Instrument Verification Plate (Ref: 4455280, Lot: 2305948, expiration date 02/22/2024) was observed in the laboratory, available for use beyond their expiraton date G) In an interview on 05/29/2024 at 3:38 p.m. general supervisor #1, as listed on the CMS-209 form, confirmed that the items, identified above, had exceeded their expiration date and were available for use. 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: Through a review of Laboratory test reports and interview with staff it was determined the laboratory test reports failed to include the Specimen Type. Survey findings include: A. A review of laboratory test reports (three of seven) revealed the laboratory results reports reviewed failed to include the specimen type on the final report. Lab Accession number: 16209, 16148, and 16216. B. In an interview at 14:42 on 5/29/2024 the laboratory director (as listed on the form CMS-209) confirmed the laboratory test report did not include specimen type on the final report. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) -- 3 of 4 -- 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Review of personnel files for four testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize two of four testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for four testing personnel listed on form CMS-209 (Personnel #'s 3,4,5,6 ) the surveyor determined employee numbers 4 and 5 (as listed on the form CMS-209) failed to have written authorization, from the laboratory director, to perform high complexity testing without direct supervision. B) In an interview, at 01:00 p.m.. on 5/29/24, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of written authorizations to test for employee #'s 4 and 5 (on form CMS 209). -- 4 of 4 --

Summary Statement of Deficiencies 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: Through a review of documentation for the four proficiency testing events completed by the laboratory in 2022, lack of documentation, and interviews with staff, it was determined the laboratory testing personnel and director failed to sign the attestation statements for four of four proficiency testing events completed by the laboratory. Survey findings include: A) A review of the proficiency test documentation for 2022 revealed the laboratory performed proficiency testing CAP-COV-A-2022, CAP-BOR- A-2022, CAP-IDBN-A-2022 and API Microbiology 2022 2nd event and the attestations for all events were not signed by the testing personnel or the laboratory director or designee. B) Laboratory employee, identified as #1 on the CMS 209 form, confirmed, in an interview at 10:20 on 7/28/22, that the forms lacked the required signatures. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Through review of laboratory policy and procedure and interview it was determined that the laboratory failed to follow policy pertaining to shipping conditions. Findings follow: A) Review of the laboratory policy and procedure and package insert for TaqPath RT-PCR Covid-19, FluA, FluB Kit revealed that COVID specimens are to be shipped on ice or specimens would be rejected. B) In an interview on 7/28/22 at 10:26 AM , the laboratory staff member, identified as number 1 on a separate employee list, confirmed that the specimens identified above were accepted for testing despite being shipped in storage conditions that failed to meet laboratory policy. Specimens were transported in FedEx non insulated large clinical packages for overnight shipping. C) In an email on 7/28/22 at 2:46 PM , the laboratory staff member, identified as number 1 on the CMS 209 form, confirmed that the specimens identified above were accepted for testing despite being shipped in storage conditions that failed to meet laboratory policy. 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of one of three rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 7/27/22 at 11:30 AM three rooms containing items with a temperature storage requirement , the two main laboratory rooms and a separate storage area separated from the main laboratory by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the main laboratory rooms were presented. C) During a tour of the laboratory on 7/27/22 at 11:30 am, 10 boxes of Thermo-Fisher deep well 96 plates lot # 000313265 expiration date 2023-07-25 and a storage temperature requirement of 15 degrees C. to 30 degrees C. were observed in the separate storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored,. E) In an interview on 7/28/22 at 10:20 am. the laboratory staff member, identified as number one on the CMS 209 form, stated that the daily temperature of the storage room in which the supplies, identified above, were stored had not been monitored and recorded.. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which -- 2 of 5 -- examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of personnel files for fifteen of the fifteen testing personnel listed on the CMS-209 form, lack of documentation as well as interviews with staff, it was determined the laboratory director failed to specify, in writing, the procedures each testing person can perform and whether supervision is required for 15 of the 15 testing personnel. Survey findings follow: A) Review of the personnel files for fifteen testing personnel, listed as #4 through #8 and # 11 though #20 on the CMS 209 form, revealed that no written authorization identifying which tests the individual was authorized to perform with or without supervision was present. B) Upon request, the laboratory was unable to produce written authorization from the laboratory director identifying which tests the personnel identified above were authorized to perform. C) In an interview on 7/27/22 at 3:30 pm the laboratory staff member, identified as number one on the CMS 209 form, confirmed that the laboratory director had not provided written authorization to test for the personnel identified above. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Through a review of the form CMS-209, a review of educational credentials for employees #13, #16, #18, #19, (as listed on the form CMS-209), and interviews with laboratory staff, it was determined four of fifteen testing personnel failed to meet the qualifications for high complexity testing personnel as evidenced by: D6171 - testing personnel failed to meet the educational qualifications for high complexity testing personnel D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or -- 3 of 5 -- medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Through a review of the form CMS-209, a review of credentials for employees #13, #16, #18, #19 (as listed on the form CMS-209), lack of documentation and interviews with laboratory staff, it was determined four of fifteen testing personnel failed to meet the educational qualifications for high complexity testing personnel. Survey findings include: A) During a review of the form CMS-209 it was revealed that the laboratory had fifteen individuals listed as testing personnel (listed as #4 through #8, and #11 through #20). B) Review of the educational credential for testing personnel # 13, as listed on the CMS 209 form, revealed a diploma from the Republic of Phillipines Nueva Elija University of Science and Technology. C) Upon request, the laboratory could not provide a certificate of educational equivalency for the foreign graduate identified above. D) Review of the educational credential for testing personnel # 16, as listed on the CMS 209 form, revealed the employee had no educational credentials -- 4 of 5 -- provided other than a certificate in Histotechnology. E) Review of the educational credential for testing personnel # 18, as listed on the CMS 209 form, revealed the employee had an "unoffical transcript" listing nine semester hours in "clinical laboratory" from Remington University and four semester hours in Biology from the University of Arkansas at Little Rock. F) Review of the educational credential for testing personnel # 19, as listed on the CMS 209 form, revealed a diploma from Tallina Tervishoa Korgkool with an educational equivalency provided by Educational Credential Evaluators of a high school diploma. G) In an interview on 7/27/22 at 3:30 pm, the laboratory staff member, identified as number one of the CMS 209 form, confirmed that the testing personnel identified above lacked the qualifications for high complexity testing and performed such testing at the laboratory. -- 5 of 5 --