Drs Dabbs & Hyland P C

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on reviews of the Selective Strep Agar (SSA) and Bacitracin Differentiation Disc (BDD) Instructions for Use (IFU) and an interview with the Testing Personnel 1 (TP1), the laboratory failed to follow manufacturer's requirement for the incubator temperature on the Culture Presumptive Group A Strep by Bacitracin testing The surveyor noted the incubator temperature recordings had been outside manufacturer's specification from the date of the last survey, 05-23-2023 to the date of the current survey, 06-05-2025. The findings include: 1) A review of the Temperature Logs revealed the incubator temperatures were outside the manufacturer's required incubation temperature. The laboratory's temperature log revealed the range of 34-38 degrees Celsius from 2023-2025. 2) A review of the Hardy Diagnostics SSA IFU and the BDD IFU revealed the manufacturer's specification to incubate inoculated media for 18-24 hours at 35 degrees Celsius in 5-10 percent CO2. The manufacturer did not specify a range for the incubation temperature. 3) The TP1 confirmed the above findings during the exit conference on 06-05-2025 at 3:25 PM. 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 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 -- 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 reviews of the Temperature Logs, Selective Strep Agar (SSA) and A disc package inserts and an interview with the Testing Personnel 1 (TP1), the laboratory failed to ensure the incubator temperature for the Culture Presumptive Group A Strep by Bacitracin testing was within the laboratory's acceptable limits. The surveyor noted the incubator temperature was out of range for 6 of the 31 days in August 2024. The findings include: 1. A review of the Temperature Logs revealed the incubator temperatures were outside the laboratory's specified ranges of 34-38 degrees Celsius for the following days in 2024: A) August 1-2, B) August 5-6, C) August 9, D) August 30. 2. During the temperature logs review at approximately 1:35 PM, the surveyor requested to see the incubator manual to confirm what range of incubator temperature was required but TP1 could not find it. She stated 34-38 degrees Celsius had been used since the last survey and she was never questioned about it. 3. At approximately 3:08 PM, TP1 notified the surveyor she confirmed the incubator temperature range via the internet because the manufacturer's manual was still unavailable. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. This STANDARD is not met as evidenced by: Based on reviews of the Selective Strep Agar (SSA) media Quality Control (QC) logs, the patient records, and an interview with the Testing Personnel 1 (TP1), the laboratory utilized expired media for patient testing. The surveyor noted the expired materials were used for 2 of the 31 days in August 2024. The findings include: 1. A review of the SSA media QC logs revealed the laboratory had opened and utilized expired media for patient testing for the following days: A) Lot 630552, Expiration date of 08-20-2024, opened and used on 08-22-2024 B) Lot 631374, Expiration date of 08-28-2024, opened and used on 08-29-2024 2. A review of the patient records revealed a total of 13 patients were tested with the expired media, eight patients on 08- 22-2024 and five patients on 08-29-2024. 3. During an interview with the TP1 on 06- 05-2025 at approximately 3:25 PM, TP1 confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the personnel records, laboratory's competency assessment form and an interview with the Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to ensure competency assessments for Testing Personnel (TP) performing moderate complexity testing included all six CLIA minimal regulatory requirements. The surveyor noted six of the six requirements were missing on the annual competencies from 2023-2025. The findings include: 1. A review of the 2023-2025 personnel records revealed TP competency assessments for Testing Personnel listed on the CMS 209 form (Laboratory Personnel Report) had no documentation on six of the six CLIA minimal regulatory requirements. The surveyor noted the six missing requirements were as follows: (1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. (2) Monitoring the recording and reporting of test results. (3) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (4) Direct observation of performance of instrument maintenance and function checks. (5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (6) Assessment of problem-solving skills. 2. A review of the laboratory's competency assessment forms revealed the laboratory had two separate forms for evaluations, one for non-waived and the other for waived testing. Four of the six minimal CLIA requirements were only included on the annual TP waived testing evaluations. 3. The TP1 confirmed the above findings during the exit conference on 06-05-2025 at 3:25 PM. -- 3 of 3 --

Summary Statement of Deficiencies D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with Testing Personnel #1, the Laboratory Director failed to ensure the laboratory submitted results within the timeframes specified by the proficiency testing program. This was noted on one of nine 2022 API PT surveys. The findings include: 1. A review of the API PT records revealed the laboratory received a score of zero percent on Microbiology 2022-Event #1 (for Throat Cultures and Urine Colony Counts) due to "Failure to Participate". 2. A review of the API Microbiology 2022-Event #1 records revealed the culture results were dated 3/21/2022, however the API PT instructions specified the due date was 3/2/2022 at 11:59 PM. 3. During an interview on 5/23/2023 at 2:15 PM, Testing Personnel #1 confirmed the Microbiology 2022-Event #1 results were submitted late because she had written the wrong due date on her calendar. SURVEYOR ID# 32558 Licensure and Certification Surveyor 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 a review of the CASPER reports and American Proficiency Institute (API) proficiency testing records, the laboratory failed to successfully participate in proficiency testing (PT) for White Blood Cell (WBC) Differential for two of three events, Event #1 and #3, 2022. These failures result in an initial unsuccessful PT participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports and American Proficiency Institute (API) proficiency testing records, the laboratory failed to satisfactorily perform for two of three events (Event #1 and #3, 2022) the White Blood Cell (WBC) Differential. The findings include: 1. A review of the CASPER #155 revealed the laboratory scored the following: a) Event #1, 2022, WBC Differential 67 % b) Event #3, 2022, WBC Differential 73 % 2. APT PT records confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of Cold Agglutination Test records and an interview with Testing Personnel #1, the laboratory failed to verify the accuracy of Cold Agglutination Test at least twice annually. This was noted from February 2021 to June 2021. The findings include: 1. A review of the Cold Agglutination Test records revealed a lack of accuracy verification being performed at least twice annually. 2. During an interview on 07/06/2021 at 12:45 PM, Testing Personnel #1 confirmed the laboratory had not verified the accuracy of Cold Agglutination Test. [CLIA non-regulated analytes (not found in Table I of the manual) should be verified at least twice annually]. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology maintenance records, a review of the Horiba Micros 60 Procedure, and an interview with Testing Personnel #1, the laboratory failed to document weekly maintenance. This was noted from February 2021 to May 2021. The findings include: 1. A review of the Hematology maintenance records 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 -- revealed the weekly concentrated cleaning cycle was not documented as being performed, except for 04/26/2021 ( February 2021 to May 2021). 2. A review of the Horiba Micros 60 Procedure revealed in section 7 page 48 under Maintenance and Service Menu "Weekly Maintenance: Concentrated Cleaning Cycle - a concentrated cleaning cycle must be performed with Minoclair solution once weekly..." 3. During an interview on 07/06/2021 at 1:30 PM, Testing Personnel #1 stated the weekly maintenance was being performed but not documented on the maintenance form. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Cold Agglutination Test quality control (QC) records, a review of the procedure manual, and an interview with Testing Personnel #1, the laboratory failed to document quality controls performed for Cold Agglutination Test. This was noted from February 2021 to June 2021. The findings include: 1. A review of the QC records for the Cold Agglutination Test revealed no quality control was being documented. 2. A review of the procedure manual revealed in step 5 of the Cold Agglutination Procedure "Use of a normal sample is used as a negative control and is useful for interpretation of test. A control should be performed each day a patient test is performed. A positive control is not required for for this test." 3. During an interview on 07/06/2021 at 12:45 PM, Testing Personnel #1 confirmed a negative control is run with a patient test but is not documented. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Urine Culture (screens for growth/no growth) and Dermatophyte Screen quality control (QC) records and an interview with Testing Personnel #1, the laboratory failed to performed checks of each batch of media for its ability to support growth and no growth for Urine Culture screens and Dermatophyte Screens. This was noted from February 2021 to June 2021. The findings include: 1. A review of the QC records for the Urine Culture (screens for growth/no growth) and Dermatophyte Screen revealed each batch of media was not being checked for its ability to support growth and inhibit specific organisms. A sterility check was being -- 2 of 3 -- performed for Urine Cultures on the Uricult CLED/EMB. 2. During an interview on 07 /06/2021 at 12:45 PM, Testing Personnel #1 confirmed sterility checks are performed on Uricult CLED/EMB (Urine Cultures); but each batch of media is not checked for its ability to support growth and inhibit specific organisms. At 1:10 PM, Testing Personnel #1 confirmed each batch of Myosel Agar (Dermatophyte Screen) is not checked for its ability to support growth and inhibit specific organisms. -- 3 of 3 --