Janice S Algea, Md

Summary Statement of Deficiencies 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 observation of the laboratory, review of the manufacturer's operator's manual, review of the laboratory's environmental records, and staff interview, the laboratory failed to define humidity ranges that were consistent with the Sight OLO Complete Blood Count (CBC) instrument manufacturer's requirements for instrument operation. The findings include: 1. Observation of the laboratory on 05/20/24 at 12:45 p.m. revealed the Sight OLO CBC instrument (Serial #Q821) used for performing patient testing for CBC with automated white blood cell differential (CBC w/diff). 2. A review of the manufacturer's operators manual revealed a humidity range of 20- 80% for the operation of the Sight OLO instrument. 3. A review of the laboratory's environmental records revealed a humidity requirement of 10-80%. 4. The laboratory director and technical consultant confirmed the survey findings during interview on 05 /20/24 at 2:15 p.m. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and 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 -- when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's package insert, and staff interview, the laboratory failed to label three of three CBC control vials with a corrected expiration date after opening. The findings include: 1. Observation of the laboratory on 05/20/24 at 12:45 p.m. revealed the Sight OLO CBC instrument (Serial #Q821) used for performing patient testing for CBC w/Diff. The controls (three of three) were labeled with an open date of 04/26/24 but no corrected expiration date. Lot numbers observed were OPT2404L, OPT2404N and OPT2404H. 2. A review of the manufacturer package insert revealed the controls were stable for 14 days after opening. 3. The laboratory director and technical consultant confirmed the survey findings during interview on 05/20/24 at 2:15 p.m. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the laboratory's environmental records and staff interviews, the laboratory failed to perform

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, observation of test performance, record review, record request, review of the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), and staff interviews, the laboratory failed to retain Complete Blood Count (CBC) reagent cartridge lot numbers, expiration dates and dates in use for the Sight OLO CBC instrument since patient testing began in June 2021 with approximately 1336 patients reported from June 2021 until the date of the survey on 02/21/23. The findings include: 1. Observation of the laboratory on 02/21/23 at 1:15 pm revealed the Sight OLO CBC instrument (serial #Q821) in use for patient testing. 2. Observation of test performance on 02/21/23 at 1:45 pm revealed the instrument uses individually packaged reagent cartridges. The testing person was observed scanning reagent cartridge information before test performance. 3. Record review revealed patient testing on the OLO Sight CBC instrument began on 06/25/21. 4. Record request on 02/21/23 at 2 pm for reagent lot numbers, expiration dates, and dates in use since patient testing began revealed no records were available. 5. Review of the laboratory's annual test volume as indicated on the Form CMS-116 revealed approximately 891 patients were tested per year, resulting in a calculated number of patients since testing began of approximately 1336. 6. Interviews with the laboratory technical consultant, testing personnel and laboratory director on 02/21/23 at 4:30 pm confirmed the CBC reagent cartridge lot numbers, expiration dates and dates in use 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 -- were not retained by the laboratory. The laboratory director further confirmed she called the Sight OLO technical support hotline on 02/21/23 and the support specialist stated there was no way to retrieve the scanned data from the instrument. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), testing personnel records and interview with the technical consultant, the technical consultant failed to perform interim competencies during the first year of testing for two of four new testing personnel in 2022. The findings include: 1. Observation of the laboratory on 02/21/23 at 1:15 pm revealed the moderately complex Sight OLO Complete Blood Count (CBC) instrument on the counter in use for patient testing. 2. Review of the Form CMS-209 revealed four new testing personnel listed since the last survey was performed who perform moderately complex patient testing for CBCs on the Sight OLO instrument. 3. Review of testing personnel records revealed no interim competencies were performed for testing personnel numbers three and four during the first year of testing in 2022. 4. Interview with the technical consultant on 02/21/23 at 4:30 pm confirmed the survey findings. -- 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: The laboratory failed to maintain satisfactory participation for two consecutive events for the white blood cell (WBC) analyte, resulting in the first unsuccessful proficiency testing (PT) occurrence for the WBC analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 and 2019 proficiency testing (PT) records the laboratory failed to maintain satisfactory performance for the white blood cell (WBC) analyte for 2018 event three and 2019 event one, resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS155 report revealed failing scores for the WBC analyte as follows: 2018 event three=60%, 2019 event one=60%. 2) Review of the 2018 event three PT evaluation report revealed sample numbers QBC-11 and QBC-12 scored as unacceptable, resulting in an overall score of 60%. 3) Review of the 2019 event one PT evaluation report revealed sample numbers QBC-04 and QBC-05 scored as unacceptable, resulting in an overall score of 60%. -- 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 --