Medical Assay Laboratory I

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: a) Based on review of laboratory policies and procedures, competency records, the CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with the technical consultant (TC); the laboratory failed to establish and follow written policies and procedures to assess the competency of one of one TC. Findings Include: 1. Review of laboratory policy and procedure titled "Personnel Competency Evaluation" under the section titled "procedure" stated, "1. Each calendar year, each employee will receive the employee competency checklist. The lab director or designee will decide which procedures each employee is responsible." 2. Review of laboratory competency records revealed that one of one TC identified on the CMS- 209 failed to have competency evaluations documented in 2023 and 2024. 3. Interview with the TC on 06/05/2025, at 11:30 am, confirmed the laboratory failed to complete competency assessment records in 2023 or 2024 for the TC. b) Based on review of laboratory policies and procedures, competency records, the CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with the technical consultant (TC); the laboratory failed to follow written policies and procedures to assess the competency of one of six testing personnel (TP) in the specialty of hematology. Findings Include: 1. Review of laboratory policy and procedure titled "Personnel Competency Evaluation" under the section titled "procedure" stated, "1. Each calendar year, each employee will receive the employee competency checklist. The lab director or designee will decide which procedures each employee is responsible." 2. Review of laboratory competency records revealed that one of six TP identified on the CMS-209 (TP #1) failed to have 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 3 -- evaluations documented for the position in 2023 and 2024. 3. Interview with the TC on 06/05/2025, at 11:30 am, confirmed the laboratory failed to follow written policies and procedures to assess the competency of one of six TP performing coagulation testing in the specialty of hematology. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records, laboratory records, lack of documentation, and interviews with the technical consultant (TC) and laboratory director (LD); the laboratory failed to ensure accuracy of 10 of 10 analytes not evaluated by the PT provider in the specialties of chemistry and microbiology in 2024 and 2025. Findings include: 1. Review of API comparative evaluation summaries for the PT events of 2024 and 2025 revealed the following ungraded PT samples: PT Event: Analyte: # Ungraded: 2024 Event 1 - Chemistry Total Bilirubin Three 2024 Event 2 - Chemistry Iron One 2024 Event 2 - Microbiology Ciprofloxacin One 2025 Event 1 - Chemistry FT3* Five *FT3 = free triiodothyronine 2. Review of laboratory records found no documented review of the ungraded PT analytes in the specialties of chemistry and microbiology in 2024 and 2025. 3. Interviews with the TC and LD on 06/06/2025, at 12:14 pm, confirmed the laboratory failed to ensure accuracy of 10 of 10 analytes not evaluated by the PT provider in the specialties of chemistry and microbiology in 2024 and 2025. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: Based on direct observation, review of the laboratory's test volume worksheet, laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to establish a procedure for four of four virology analytes performed on the Atila Powergene 9600 Real-Time Polymerase-Chain Reaction (RT-PCR) analyzer, affecting 7,818 patients from June 2024 through June 2025. Findings include: 1. Upon a tour of the laboratory on 06/05 /2025, at 2:22 pm, surveyors observed an Atila Powergene 9600 RT-PCR analyzer (Serial Number: MDA6094552290) used for performing respiratory syncytial virus (RSV), Influenza A, Influenza B, and Covid-19 testing. 2. Review of the laboratory's test volume worksheet revealed 7,818 patients had been tested for RSV, Influenza A & B, and Covid-19 from June 2024 through June 2025. 3. Review of laboratory policies and procedures revealed the laboratory failed to have a procedure in place for virology testing on the Atila Powergene 9600 RT-PCR analyzer. 4. Interview with the TC on 06/06/2025, at 9:35 am, confirmed the laboratory failed to establish a -- 2 of 3 -- procedure for four of four virology analytes performed on the Atila Powergene 9600 RT-PCR analyzer, affecting 7,818 patients from June 2024 through June 2025. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the manufacturer's package insert, patient test reports, quality control (QC) records, and interview with the laboratory director (LD); the laboratory failed to ensure positive and negative control materials were tested each day of testing for two of two applicable patients reported utilizing the API 20 E identification system in the subspecialty of bacteriology. Findings include: 1. Review of the manufacturer's package insert for the API 20 E identification system revealed, under "Quality Control", "It is the responsibility of the user to perform Quality Control in accordance with any local applicable regulations." 2. Review of two of two applicable patient test reports and the laboratory's quality control records for the API 20 E identification system revealed the laboratory had not performed QC on the date patient testing was performed. Patient: Date of Testing: Date QC Performed: 123936 07/12/2024 05/15/2024 130460 06/05/2025 03/15/2025 3. Interview with the LD on 06 /06/2025, at 12:14 pm, confirmed the laboratory failed to ensure positive and negative control materials were tested each day of testing for two of two applicable patients reported utilizing the API 20 E identification system in the subspecialty of bacteriology. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) 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 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: Based on review of the laboratory policies and procedures, CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with the technical consultant (TC); the laboratory director (LD) failed to specify, in writing, the responsibilities and duties for one of one TC listed on the CMS-209. Findings include: 1. Review of the laboratory policies and procedures failed to identify documentation that specified, in writing, the responsibilities and duties for one of one TC listed on the CMS-209. 2. Interview with the TC on 06/05/2025, at 11:30 am, confirmed the LD failed to specify, in writing, the responsibilities and duties for one of one TC listed on the CMS-209. -- 3 of 3 --

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 review of the CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the endocrinology analyte Thyroxine (TY) during events two of 2021 and one of 2022. See D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D (Individual Laboratory Profile) and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the endocrinology analyte Thyroxine (TY) in the PT events two of 2021 and one of 2022. Findings include: 1. Review of the CASPER 0155D report revealed that the initial unsuccessful PT performance occurred during API PT event two of 2021 and one of 2022, as listed below. ENDOCRINOLOGY EVENT -2, 2021 TY - 60% Unsatisfactory EVENT -1, 2022 TY - 60% Unsatisfactory 2. Interview via phone with the API representative on 4-1-22 at 9:15 am confirmed the initial unsuccessful PT performance for TY in events two of 2021 and one of 2022. -- 2 of 2 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to perform antimicrobial control drug sensitivity procedures each day of testing (D5507) to ensure sensitivity results are accurate and reliable, affecting 948 patient results. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to check and document the laboratory's zone sizes for control organisms within the manufacturer's established limits each day tests are performed before reporting patient results, affecting 948 patient results. Findings include: 1. The Mueller Hinton Plate 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 -- and Sensitivity Disks Quality Control (QC) worksheets from the months of October 2019, February, June and November of 2020, March, August and December of 2021, the Antimicrobial Susceptibility test Discs package insert, the laboratory's test volume worksheet, the Kirby Bauer Procedure for Susceptibility Testing procedures, and selected patient results were reviewed. 2. On January 27, 2022 at 12:30 PM during a tour of the Microbiology laboratory, the surveyor observed that the laboratory performed antimicrobial sensitivity testing using the Kirby Bauer method. The surveyor then requested to see the 0.5 McFarland turbidity standard used as a reference to adjust the turbidity of bacterial suspensions so that the number of bacteria will be within the manufacturer's standardized range for microbial testing. The general supervisor (GS)-AS stated the laboratory did not use or have the 0.5 McFarland standard. 3. Review of the procedures manual and package insert revealed the following: *Both required the use of the 0.5 McFarland BaSO4 Turbidity Standard and *Step #3 in the procedure manual instructed the testing personnel to "Adjust the turbidity of the active growing broth culture with sterile saline or broth to obtain a turbidity visually comparable to a 0.5 McFarland turbidity standard." *The laboratory failed to utilize the McFarland standard as indicated in the manufacturer's and laboratory procedure for 35 out of 35 weekly sensitivities performed during the months selected for review. 4. The test volume worksheet completed by the laboratory documented that 948 sensitivity tests were performed and reported during the year of 2021. 5. The QC worksheets and seven selected patients' final reports revealed the laboratory failed to perform antimicrobial sensitivity QC procedures for six of seven days sensitivities were reported. 6. Further review of the QC worksheets showed the laboratory performed QC procedures once per week. 7. The QC worksheets and package insert revealed the following: *The laboratory used multiple versions of the QC worksheet to document the pathogenic control organisms' drug susceptibility zones, one QC worksheet was marked "Doctor's Clinical Laboratory", received via email on 03/02/2022. *The QC worksheet provided by GS-AS on the day of survey showed that four of 14 drug concentrations on the worksheets failed to reflect the concentrations stated in the package insert. QC Worksheet microgram(mcg) Manufacturer Ampicillin (AMP) (30 milligram) AMP (10 mcg) Cephalothin (CEP) (10 milligram) CEP (30 mcg) Nitrofurantoin (NTF) (399 mcg) NTF (300 mcg) Trimethoprim/ SXT (1.25/23.75 mcg) Sulfamethoxazole(SXT) (25 mcg) *The control organisms on the worksheet were listed under the wrong control identification number. QC Worksheet Manufacturer S.Aureus (ATCC 25922) and E.Coli (ATCC 25923) S. Aureus (ATCC 25923) and E.Coli (ATCC 25922) *6 out of 14 drugs' acceptable zone ranges on the worksheet failed to reflect the acceptable zone ranges defined in the package insert for the same drugs. QC Worksheet (Acceptable Zones) Manufacturer S.Aureus (25922) & E.Coli (25923) S.Aureus (25923) & E.Coli (25922) AMP (30 milligrm) 27-35 16-22 AMP 10mcg 27-35 16-22 CEP (10 milligrm) 29-37 17-22 CEP 30mcg 29-37 15-21 NTF (399mcg) 18-22 20-24 NTF 300mcg 18-22 20-25 Tetracycline 19-28 18-25 Tetracycline 24-30 18-25 Vancomycin 15-19 NR Vancomycin 17-21 NR SXT (25mcg) 24-32 24-32 SXT 1.25/23.75 24-32 23-29 Amox/Clav. 28-36 19-25 Amox/Clav 28-36 18-24 *The laboratory failed to utilize the correct zones as indicated in the manufacturer's procedure for 35 out of 35 weekly sensitivities performed during the months selected for review. 8. On a Recertification survey conducted on 01/27/2022 at 3:00 PM, the LD and GS confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 6 -- 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to have a director who meets the qualification requirements for high complexity testing (D6078) and provide overall management to ensure test procedures are followed (D6087) and to employ individuals with the appropriate education and experience (D6101) for testing performed in the specialty of Microbiology. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to employ a qualified director who meets the education and experience to provides overall management and direction for the Microbiology and Virology testing performed in the laboratory. Findings: 1. The Laboratory Personnel Report (CMS 209), procedures manuals, and personnel files were reviewed. 2. During a tour of the -- 3 of 6 -- laboratory on January 27, 2022 at 11:55 AM, the surveyor observed the following high complexity tests and test systems being performed: *ATILA SARS-CoV-2 Polymerase Chain Reaction (PCR) assay and the *Microbial isolation, identification, and sensitivity procedures for pathogenic organisms. 3. Review of the educational credential documentation of Staff-CC listed as the laboratory director (LD) revealed they possessed a Masters of Science and a Doctrine of Philosophy. Staff-CC failed to meet the required criteria listed under 493.1443(b) (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; which are ABB - American Board of Bioanalysis, ABB - Public Health Microbiology certification, ABCC - American Board of Clinical Chemistry, ABCC 24 month-Commission on Accreditation in Clinical Chemistry (COMACC) accredited program, ABFT - American Board of Forensic Toxicology (limited to individuals with a doctoral degree)*, ABHI - American Board of Histocompatibility and Immunogenetics, ABMGG - American Board of Medical Genetics and Genomics (formerly ABMG - American Board of Medical Genetics), ABMLI - American Board of Medical Laboratory Immunology, ABMM - American Board of Medical Microbiology, NRCC - National Registry for Certified Chemists (limited to individuals with a doctoral degree)*, 4. Further review of the employee records showed the curriculum vitae (CV) of Staff-CC failed to provide any documentation of previous supervisory experience in a high complexity CLIA certified laboratory. 5. On a Recertification survey conducted on 01/27/2022 at 3:00 PM, the LD confirmed the above findings. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director (LD) failed to ensure laboratory personnel conducting Microbiology testing performed antimicrobial sensitivity methods as required for accurate and reliable results, affecting 948 patients test results. Findings include: 1. The Mueller Hinton Plate and Sensitivity Disks Quality Control (QC)worksheets, the Antimicrobial Susceptibility test Discs package insert, the laboratory's test volume worksheet and the Kirby Bauer Procedure for Susceptibility Testing procedures were reviewed. See D5002 and D5507. 2. The LD failed to ensure the Microbiology technical supervisor (TS) and general supervisor (GS) performed their responsibilities to provide accurate and reliable antimicrobial drug sensitivity testing. See D5002 and D5507. 3. The LD failed to ensure the laboratory had mcfarland standard as required for sensitivity testing. See D5507. 4. The LD failed to ensure TS, GS, and testing personnel followed the Kirby Bauer procedure and performed control procedures each day of patient testing. See D5002 and D5507. 5. The LD failed to ensure the documentation of control procedures included an ongoing process to review and adjust drug discs information as defined by the package inserts for pathogenic drug sensitivity testing. See D5507. 6. On a Recertification survey conducted on 01/27/2022 at 3:00 PM, the LD and GS confirmed the above findings. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) -- 4 of 6 -- The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), and interview, the laboratory director (LD) failed to employ laboratory personnel with the appropriate education and experience to provide consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities for highly complex testing. Findings: 1. The LD failed to employ qualified personnel to perform the responsibilities of a testing personnel (TP). See D6063, D6065 and D6168, D6171. 2. The LD failed to ensure technical supervisor and general supervisor performed their required responsibilities. See D6087. 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: Based on record review, CMS-209 (Laboratory Personnel Report), and interview; the laboratory failed to have individuals who meet the qualification requirements for performing high complexity of testing (D6171) for one out of ten testing personnel (TP). 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 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 -- 5 of 6 -- 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: Based on record review, lack of documentation, and interview, the laboratory failed to ensure laboratory personnel meet the education criteria to perform highly complex testing in the laboratory for one out of ten testing personnel (TP). Findings: 1. The employee files and the Laboratory Personnel Report (CMS-209) were reviewed. 2. The CMS 209 listed Staff-VS as TP in the laboratory. 3. The employee files revealed Staff-VS education credentials were from Antigua and had not been evaluated for United States education equivalency. 4. Further review showed that Staff-VS had received training, competency, and was conducting tests in the specialty of Microbiology. 5. On a Recertification survey conducted on 01/27/2022 at 3:00 PM, the laboratory director confirmed the above findings. -- 6 of 6 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, laboratory testing logs and interview with the laboratory director; the laboratory failed to examine PT samples in the same manner as it tested patients' specimens. Findings include: 1. PT records were reviewed from the 2nd Quarter of 2017 through the 1st Quarter of 2019. 2. Review of laboratory testing logs revealed all syphilis serology and general immunology testing were documented on individual laboratory log sheets. A separate testing log sheet was completed for each individual analyte tested in syphilis and immunology. 3. Testing logs for PT revealed that results for analytes for both syphilis serology and general immunology (ANA) were documented on the same laboratory log sheets. No patients' tests were documented on the PT testing logs. 4. At 10:30 AM on Mary 7, 2019, the laboratory director confirmed the surveyor's findings. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report (CMS 209), policies and procedures manuals, personnel records and interview with the laboratory director; the laboratory failed to establish and follow written policies and procedures to assess consultant competency. Findings include: 1. Review of the CMS 209 submitted to the surveyor on May 7, 2019 revealed that there were persons listed for the following positions in the laboratory: Laboratory Director, Clinical Consultant, Technical Supervisor /Consultant, General Supervisor, High Complexity Testing Personnel, and Moderate Complexity Testing Personnel. 2. Review of the laboratory's policies and procedures manual revealed that there were no individuals who were assigned to the positions of Technical Supervisor /Consultant and General Supervisor. 3. Review of personnel records revealed that there were no competency assessments performed on personnel that pertained to the duties and responsibilities of Technical Supervisor/ Consultant or General Supervisor. Records show that all personnel were given identical evaluations that pertained to test performance, only. 4. At 10:30 AM on May 7, 2019, the laboratory director confirmed the surveyor's findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director; the laboratory director failed to ensure that verification procedures used were adequate to determine the precision of the method used to test coagulation tests. Findings include: 1. At 9:30 AM on May 7, 2019, during the walk through of the laboratory, the laboratory director revealed that the laboratory purchased a new coagulation analyzer. 2. Review of laboratory records revealed that there was no documentation to show that the laboratory verified the precision of its coagulation analyzer. 3. At 2:30 PM on May 7, 2019, the laboratory director confirmed the surveyor's findings. 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 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: Based on review of the procedure's manuals, personnel records and interview with the laboratory director; the laboratory director failed to specify in writing the -- 2 of 4 -- responsibilities and duties of each consultant, supervisor, and which tests everyone is authorized to perform. Finding include: 1. Review of the procedure's manual revealed that there was no documentation, in writing, that described the duties and responsibilities of the following positions: a. Technical Supervisor/Consultant b. General Supervisor c. High Complexity Testing Personnel (specified tests) e. Moderate Complexity Testing Personnel (specified tests) 2. Review of personnel records revealed that the laboratory director did not specified in writing personnel assigned to the following positions: a. Technical Supervisor/Consultant b. General Supervisor 3. At 10:30 AM on May 7, 2019, the laboratory director confirmed the surveyor's findings. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the laboratory director; the technical supervisor failed to be responsible for identifying training needs and assuring that everyone performing tests receives regular in-service training and education for its coagulation testing. Findings include: 1. At 9:30 AM on May 7, 2019, the surveyor performed a walk-through of the laboratory. At that time the surveyor asked the laboratory director if there were any new instrumentation or tests added since the last survey in 2017. 2. The laboratory director told the surveyor that a new coagulation analyzer was added in September 2018. 3. Review of personnel records revealed that there was no documentation to show that testing personnel were trained to perform testing on the new coagulation analyzer for 6 of 6 testing personnel. 4. At 10:30 AM on May 7, 2019, the laboratory director confirmed the surveyor's findings. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review Laboratory Personnel Report - CLIA (CMS 209), personnel records, and interview with the laboratory director, the procedures for evaluation of the competency of the staff did not include assessment of test performance through testing previously analyzed specimens, internal blind testing, or external proficiency testing samples. Findings include: 1. There was one new laboratory person list on the CMS 209. 2. Review of personnel records revealed that there was no documentation to show that the new testing personnel tested previously analyzed specimens, internal blind specimens, or external proficiency testing samples when her competency was -- 3 of 4 -- evaluated 3. At 10:30 AM on May 7, 2019, the laboratory director confirmed the surveyor's findings -- 4 of 4 --