Microphase Clinical Laboratory

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the temperature records, the Hitachi Chemical AP 3600 Allergy analyzer, and an interview with the General Supervisor, the Laboratory failed to document room temperature and humidity for the Hitachi AP 3600 Allergy analyzer since the date of implementation on 8/24/2023 to the date of the current survey on 6/25 /2025. 1. A review of the temperature records revealed the laboratory failed to document room temperature and humidity for the Hitachi AP 3600 Allergy analyzer since the date it was implemented on 8/24/2023. 2. A further review of the Hitachi AP 3600 Allergy user manual revealed, "Environmental requirements: Room Temperature (15-33 degrees Celsius) and Humidity (10-85%)." 3. During an interview on 6/25/2025, at 11:53 AM, the General Supervisor confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually 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 -- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the General Supervisor, the Technical Consultant/ General Supervisor failed to evaluate annual competencies for Testing Personnel performing high and moderate complexity testing. This was noted for four out of four Testing Personnel previously qualified since the date of the last survey (4/27/2023) to the date of the current survey (6/25/2025). The findings include: 1. A review of the personnel records revealed no evidence of evaluation by the Technical Consultant/ General Supervisor for annual competency assessments of Testing Personnel #1-4. 2. During an interview on 6/25/2025, at 9:44 AM, the General Supervisor confirmed the above findings. -- 2 of 2 --

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: Based on a review of the 2021-2022 American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Technical Supervisor, the laboratory failed to ensure the Laboratory Director signed the attestation statements for two of ten survey events. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2022 Microbiology 2nd Event. b) 2022 Microbiology 3rd Event. 2. During an interview on April 27, 2023, at 11:38 AM, the Technical Supervisor 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 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the 2019-2021 API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Technical Supervisor, the surveyor determined the laboratory failed to document reviews of returned proficiency testing evaluations for fourteen of fourteen PT surveys. The surveyor further noted the laboratory failed to ensure ungraded analytes were reviewed and a self-evaluation was performed and documented. The findings include: 1. A review of the returned survey results for the API 2019-2021 surveys, including seven Bacteriology surveys, six Mycology surveys, and one SARS COV-2 antibody survey revealed no documentation of review (as indicated by a signature and date). 2. A review of the 2019-2021 Bacteriology surveys revealed ungraded results for Urine Culture "MIC /ZONE Diameter" (antibiotic sensitivities), (2019-Event #3, 2020-Events #1, #2, #3, and 2021 Event #1), however the laboratory had failed to document a comparison of their results with the peer group to ensure their results were acceptable. The surveyor further noted the laboratory failed to perform and document a self-evaluation for ungraded Educational Identification / Susceptibility challenges which instructed the laboratory to "See Data Summary". 3. During an interview on 5/12/2021 at 1:10 PM, the Technical Supervisor confirmed he always looked at the results, but failed to document his review on the surveys. The surveyor also reviewed the CLIA requirement to perform and document a self-evaluation of any ungraded results. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the installation and validation for the Quidel Solana, and an interview with the Technical Supervisor, the laboratory failed to ensure the manufacturer's performance specifications for accuracy and precision were verified, and the Laboratory Director's review and approval documented before patient testing began. This affected one of one new instruments in use at this facility. The findings include: 1. A review of the validation procedures for the Quidel Solana revealed several pages of qualitative test results run in 2020-2021 for the following assays: A) SARS COV-2 B) RSV (Respiratory Synctial Virus) C) Bordetella (pertussis and parapertussis) D) hMPV (human Meta Pneumo Virus), and E) Streptococcus However, there was no documentation the data was analyzed and evaluated to confirm the accuracy and precision of the instrument as stated in the manufacturer's performance specifications. 2. The validation and installation records also failed to include the Laboratory Director's signature and date indicating review and approval of the new test procedures before patient testing began on 1/19/2021. 3. During an interview on 5/12/2021 at 3:20 PM, the Technical Supervisor explained the laboratory had run validation samples supplied by the manufacturer, Quidel; the laboratory had obtained expected results. The surveyor explained the laboratory must collate the raw data and demonstrate their results were comparable to those established by the manufacturer for accuracy and precision. . 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 a review of personnel listed on Form CMS-209, a lack of personnel files, and an interview with the Technical Supervisor, the surveyor determined the Technical Supervisor failed to ensure two of three new testing personnel had documentation of training for high-complexity testing completed before performing patient testing. The findings include: 1. A review of Form CMS-209 revealed three new testing personnel (TP) had been hired since the previous survey on 12/6/2018. The Technical Supervisor provided educational documentation, however he had no training or other records for TP #4 and #5. 2. During an interview on 5/12/2021 at 1: 45 PM, when asked about the job responsibilities for the new testing personnel, the Technical Supervisor stated TP #4 performed molecular diagnostic testing on the new Quidel Solana, and TP #5 worked PRN (as needed) in Bacteriology. The Technical -- 2 of 3 -- Supervisor confirmed he did not have documentation of training for the new testing personnel. SURVEYOR IS #32558 Licensure and Certification Surveyor -- 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 a review of the laboratory test menu, the proficiency testing (PT) records and an interview with the Technical Supervisor, the surveyor determined the laboratory failed to enroll in an approved proficiency testing program for moderate- and high-complexity regulated tests in 2017. The findings include: 1. During the initial tour of the laboratory on 12/7/2018 at approximately 9:35 AM, the Technical Supervisor included on the test menu the following Microbiology specialties: Mycology: Fungal Cultures for growth or no growth, and Bacteriology: Cultures for Identification and Antibiotic Susceptibility testing However, upon the surveyor's request for the laboratory records at approximately 9:45 AM, the Technical Supervisor explained he had not performed any proficiency testing in 2017 because he had forgotten to renew the order with API (American Proficiency Institute). 2. A review of the proficiency testing records revealed the laboratory had used API as the PT provider thru 2016, and then no other PT was performed until Mar 2018. Thus, the above noted findings were confirmed. . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, the proficiency testing (PT) records and an interview with the Technical Supervisor, the surveyor determined the Laboratory Director failed to ensure the laboratory was enrolled in an approved proficiency testing program for moderate- and high-complexity regulated tests in 2017. (Refer to D2000.) . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a lack of documentation in the personnel file for Testing Personnel #2 and an interview with the Technical Consultant (also the Technical Supervisor), the surveyor determined the Technical Consultant failed to ensure the 2017 annual competency evaluation was performed and documented for one of two testing personnel (TP) who perform moderate- and high-complexity patient testing. The findings include: 1. A review of the Form CMS-209 Laboratory Personnel Report revealed two testing personnel performing moderate and high complexity patient testing employed by the facility since the previous survey. 2. A review of the personnel file for TP #2 revealed no documentation of an annual competency evaluation in 2017. 3. In an interview on 12/6/2018 at 11:00 AM, the Technical Consultant (also the Technical Supervisor) confirmed he had failed to document a 2017 competency evaluation for TP #2. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --