Spiriplex, Inc

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 review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to follow written policies and procedures to assess technical supervisor (TS) and general supervisor (GS) competency for one of one individual serving as the TS and GS. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed the same individual serving as both the TS and the GS for laboratory. 2. Review of laboratory policies and procedures revealed the procedure titled "Employee Training and Competency", which stated, under "6. Laboratory Supervisor-Laboratory Director will evaluate Lab Supervisor for competency as follows: "6.1 Is the Supervisor available to test personnel at all times testing is performed? Whether on site or by phone is acceptable. "6.2 Must provide regular on-going supervision of testing personnel. "6.3 Must monitor test analyses through adjustments and QC [Quality Control] to ensure acceptable levels of performance. "6.4 Reviewed QC prior to patient analysis and reviews patient results for release. "6.5 Fulfills responsibilities as delegated by the Laboratory Director. "6.6 Resolves any technical issues in laboratory. "6.7 Provides orientation and training to test staff personnel. "6.8 Annually, evaluates and documents the performance of all laboratory testing staff. "6.9 Performs Quality Assurance monitors on regular basis. "6.10 Report all findings and nonconformance to the Laboratory Director." 3. Review of laboratory records, including personnel files containing employee competencies, revealed a lack of competencies for one of one individual serving as the TS and GS. 4. Interview with the LD on 09/17/2026, at 1:31 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 -- pm, confirmed the laboratory failed to follow written policies and procedures to assess TS and GS competency for one of one individual serving as the TS and GS. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory system for 24 of 24 months reviewed. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Management Plan", which stated, under "6. Quality Indicators", "6.1 The Quality Management Committee will determine what areas need to be surveyed outside of those monitors scheduled throughout the year. Problems may be identified by regular review of the laboratory's data sources by establishing monitors, setting criteria, and measuring actual practice against criteria. Monitors may at times be removed and replaced with other monitors. "6.2 Personnel Training and Competency 6.2.1 Annual review in January .... "6.3 Proficiency Testing .... "6.4 Internal Quality Control [QC] 6.4.1 Review monthly QC reports with LD 6.4.2 Responsible person: Laboratory Manager 6.4.3 Internal QC (monitoring of test results by using controls within acceptable ranges) shall be reviewed weekly, monthly and at the periodic QA [Quality Assurance] meetings. The LO [Laboratory Owner] shall evaluate and decide any remedial action to be taken. 6.4.4 Data Source and Acceptance Criteria: a) Monthly Levy-Jennings charts, shifts and trends reviewed by LO with recommendations b) Remedial Action Reports, reviewed at the periodic QA meetings for unusual events, procedures updated accordingly. c) Acceptable threshold: 95% "6.5 Maintenance of Equipment Used to Perform Laboratory Tests 6.5.1 Responsible person: Laboratory Manager [LM] 6.5.2 Visual check of equipment is done daily by testing personnel. Preventative maintenance is performed daily and/ or per run, weekly, and monthly on all equipment according to manufacturer's specifications. a) Daily, weekly, and monthly preventative maintenance logs will be reviewed. b) Repair records, excessive calls to customer service resulting in repair by the field engineer must be investigated and resolved with the manufacturer. "6.6 Effectiveness of Policies and Procedures 6.6.1 Responsible person: Laboratory Director 6.6.2 All policy and procedure manuals shall be reviewed annually by the LO and updated as necessary by the LM to reflect current practice. New policies may be generated based on the review. "6.7 Data Entry Tracking 6.7.1 This task can be done several times per year especially during new hires and training periods. 6.7.2 Responsible person: Laboratory Manager 6.7.3 Randomly select 10 requisitions and check the entered information to make sure that all the information was entered properly. If errors are found, they will be discussed with the employee that entered the information and another random check will occur within 30 days. If at the second check errors are found, the issue will be brought to the LD's attention and LO with LM will decide if the data entry tasks are appropriate for the employee." 2. Review of laboratory records revealed a lack of documentation of quality assurance checks performing in the laboratory for the previous 24 months -- 2 of 3 -- reviewed. 3. Interview with the LD on 09/17/2026, at 1:33 pm, confirmed the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory system for 24 of 24 months reviewed. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with Chief Executive Officer (CEO), the laboratory failed to enroll in an approved proficiency testing (PT) program for high complexity Immunoglobulin E antibody testing from 2020 to the date of survey (11/28/2022). Finding Include: 1. Surveyor review of proficiency testing records failed to reveal documentation of the laboratory's enrollment in a Centers for Medicare & Medicaid Services (CMS) approved PT program for testing Immunoglobulin E antibodies for three of three testing years (2020, 2021, and 2022). 2. Interview with CEO on 11/28/2022 at 12:30 p.m., revealed the laboratory did not participate in CMS approved PT due to the unavailability of dried blood stain samples required for testing. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. 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 -- This CONDITION is not met as evidenced by: Based on review of laboratory records, Laboratory Personnel Report (CMS-209) and interview with Chief Executive Officer (CEO), the laboratory failed to ensure one of one general supervisors (GS) listed on the CMS-209 form met the qualification requirements for GS and provided day-to-day supervision of testing personnel and the reporting of high complexity immunology testing. (Refer to D6142 and D6143) D6142 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to- day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results. This STANDARD is not met as evidenced by: Based on review of laboratory records, Laboratory Personnel Report (CMS-209), and interview with Chief Executive Officer (CEO), the laboratory failed to provide day-to- day supervision of testing personnel and the reporting of high complexity immunology testing. Findings Include: 1. Review of the laboratory qualifying records for the general supervisor (GS) listed on the CMS-209 revealed the laboratory failed to ensure the GS was qualified to perform day-to-day supervision of high complexity Immunoglobulin E Antibody testing and testing personnel for one of one testing year (2022). Refer to (D6143) D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) 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; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a -- 2 of 3 -- medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on review of laboratory records, Laboratory Personnel Report (CMS-209), lack of documentation, and interview with Chief Executive Officer (CEO), the laboratory failed to ensure one of one general supervisors (GS) was qualified for high complexity immunology testing. Findings Include: 1. Review of the master's degree and Bachelor of Science degree for one of one GS listed on CMS-209 (11/28/2022) revealed the GS failed to meet qualification requirements for supervising high complexity Immunoglobulin E Antibody testing. a. Master of Health Administration b. Bachelor of Science in Business 2. The laboratory failed to have college transcript records on file to confirm the required credit hours in biology and chemistry to qualify the GS. 3. On 11/28/2022 at 1:23 p.m., CEO confirmed the laboratory did not have college transcripts on file for the GS listed on the CMS-209 form. -- 3 of 3 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, record review and an interview with the testing personnel (TP) and Owner, the laboratory failed to establish a maintenance protocol to check the accuracy of all equipment used in General Immunology testing. Findings: 1. On 08/28 /20 at 10:20 AM during a tour of the laboratory, the surveyor observed a 2 table top centrifuges: S/N-1931501462 and S/N-216765, used by the TP. 2. The laboratory's procedures' manual and maintenance logs were reviewed. 3. The procedures' manual failed to include in it's maintenance policy the servicing and calibrating of the 2 (two) centrifuges. 4. The maintenance logs showed the 2 centrifuges had not been serviced or calibrated for accuracy during the years of 2018 through 2020. 5. On a recertification survey conducted 08/28/20 at 1:00 PM, the TP and Owner confirmed the above findings. 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 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor College of American Pathologist (CAP); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on July 01, 2019 at 8:01 AM revealed that the unsatisfactory PT performance was a 3rd Subsequent PT failure that occurred during calendar years 2018 and 2019. See D2084. D2084 GENERAL IMMUNOLOGY 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor College of American Pathologist (CAP); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the subspecialty of General Immunology and Immunoglobulin (IgE). Findings include: 1. Review of PT CASPER Report 155 on July 01, 2019 at 8:01 AM, revealed that the unsatisfactory PT performance was the 3rd-Subsequent PT failure that occurred during calendar years 2018 and 2019 as listed below. (1st-Subsequent PT failure) DIAGNOSTIC IMMUNOLOGY General Immunology EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% Immunoglobulin E (IgE) EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% (2nd-Subsequent PT failure) DIAGNOSTIC IMMUNOLOGY General Immunology EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% Immunoglobulin E (IgE) EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% (3rd-Subsequent PT failure) DIAGNOSTIC IMMUNOLOGY General Immunology EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% EVENT-1, 2019 = 0% Immunoglobulin E (IgE) EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% EVENT-1, 2019 = 0% 2. During PT Desk review on July 01, 2019 and phone communication with the PT vendor CAP at 1:50 PM, the 3rd-Subsequent PT failing scores were confirmed. -- 2 of 2 --

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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on February 01, 2019 at 8:01 AM revealed that the unsatisfactory PT performance was a subsequent -not the first, that occurred during calendar year 2018. See D2084. D2084 GENERAL IMMUNOLOGY 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the subspecialty of General Immunology and Immunoglobulin (IgE). Findings include: 1. Review of PT CASPER Report 155 on February 01, 2019 at 8:01 AM, revealed that the unsatisfactory PT performance was a subsequent -not the first, that occurred during calendar year 2018 as listed below. DIAGNOSTIC IMMUNOLOGY General Immunology EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% Immunoglobulin E (IgE) EVENT-1, 2018 = 0% EVENT-2, 2018 = 40% EVENT-3, 2018 = 40% 2. During PT Desk review on February 01, 2019 and phone communication with the PT vendor CAP at 9:18 AM, the Subsequent PT failing scores were confirmed. -- 2 of 2 --

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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor College of American Pathologists (CAP); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty Diagnostic Immunology. Findings include: 1. Review of the CASPER Report 155 on October 02, 2018 and communication with the PT vendor CAP on 10/03/17 at 2:45 PM, the initial unsuccessful PT performance was confirmed under the Subspecialty of General Immunology and analyte Allergen-Specific Immunoglobulin E (IGE) during event 1 and 2 of 2018. See D-2084. 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor College of American Pathologists (CAP); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty Diagnostic Immunology. Findings include: 1. Review of the CASPER Report 155 on October 02, 2018, the initial unsuccessful PT performance was confirmed under the Subspecialty of General Immunology and analyte Allergen-Specific Immunoglobulin E (IGE) as described below: GENERAL IMMUNOLOGY EVENT -1, 2018 (0% Unsatisfactory) EVENT -2, 2018 (40% Unsatisfactory) EVENT -1, 2018 (IGE = 0% Unsatisfactory) EVENT -2, 2018 (IGE = 40% Unsatisfactory) 2. During a phone communication with the PT vendor CAP on October 03, 2018 at 2:45 PM, confirmed the PT failing scores. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --