Jackson Clinic, Pa Of Huntingdon,The

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 direct observation, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), the laboratory procedure manual, lack of documentation, review of maintenance records, and staff interview, the laboratory failed to follow its' testing personnel policy for training and competency assessments for one of one new testing persons for the use of the Sysmex XP 300 Complete Blood Count with automated white blood cell differential (CBC w /Diff) instrument. The findings include: 1. Laboratory observation on 03/19/25 at 9:45 a.m. revealed the Sysmex XP 300 used for patient testing for CBC w/Diff. 2. A review of Form CMS-209 revealed one new testing person since the last survey date (testing person two). 3. A review of the laboratory's testing personnel policy revealed the following statements: "Technical personnel whose duties affect test data qualify will have the appropriate training for their position and job duties." "Each technical position will have specified job duties and a checklist to ensure each duty or performance level is attained before releasing the employee from the department training program. The written result/checklist of the training will be filed in the individual's personnel file." It also stated that the competency of testing personnel would be evaluated at least semiannually during the first year the individual tests patient specimens and then annually thereafter. 4. On the survey date (03/19/25), there was no documentation of training, semi-annual, or annual competency assessment for testing person two for use of the Sysmex XP300 CBC w/Diff instrument. 5. A review of the laboratory maintenance records for the Sysmex XP 300 revealed the initials of testing person two beginning on 03/21/24. 6. The technical consultant confirmed the 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 -- survey findings during a phone interview on 03/24/25 at approximately 3:00 p.m. and confirmed that testing person two performed patient testing for CBC w/diff using the Sysmex XP 300 instrument. 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. This STANDARD is not met as evidenced by: Based on direct observation, a review of the Sysmex XP 300 operator's manual, the Sysmex XP 300 maintenance records, the laboratory procedure manual, and staff interview, the laboratory failed to identify and correct problems with documentation of weekly maintenance for five of 13 months reviewed for the Sysmex XP 300 CBC w /Diff instrument in 2024 and 2025. The findings include: 1. Laboratory observation on 03/19/25 at 9:45 a.m. revealed the Sysmex XP 300 used for patient testing for CBC w /Diff. 2. A review of the Sysmex XP 300 operator's manual revealed a weekly maintenance requirement to "Clean SRV tray." 3. A review of the laboratory's maintenance records revealed the following: The SRV tray cleaning was not documented on a weekly basis for July, August, October, and December 2024, or for February 2025. The technical consultant had reviewed all months, and no

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 observation of the laboratory, review of the laboratory procedure manual, testing personnel competency assessment records, and staff interview, the laboratory failed to follow its' own policy for assessing testing personnel competency in 2022 and 2023 for two of four competency assessment documents reviewed. The findings include: 1. Observation of the laboratory on 12/06/23 at 12:10 pm revealed a microscope in use for performing patient testing for urine microscopy and wet prep, and a Sysmex XP-300 (serial #4227) in use for performing patient testing for Complete Blood Count (CBC). 2. Review of the laboratory procedure manual revealed testing personnel competency would include the six elements required in Subpart M (direct observation of patient testing, monitoring the recording and reporting of test results, review of worksheets, proficiency testing results and preventive maintenance, direct observation of instrument maintenance and function checks, blind testing to include either internal blind sample or external proficiency testing samples, assessment of problem solving skills). 3. Review of the annual competency assessments performed for testing person one in 2022 and 2023, revealed no documentation of direct observation of patient testing, direct observation of instrument maintenance, monitoring of result recording and reporting, review of worksheets, proficiency testing results and preventive maintenance records for urine microscopic, wet prep and CBC; no documentation of assessment of test performance with blind samples for CBC. 4. Interview with the technical consultant on 12/06/23 at 4:25 pm confirmed the laboratory failed to follow its' own policy for testing personnel competency assessment when it did not document competency using all six 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 -- requirement elements for the annual competencies performed for testing person one in 2022 and 2023. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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, interview with the lead testing person, and subsequent interview with the laboratory director, the laboratory failed to retain intermittent worksheets used for recording urine microscopy and vaginal wet prep results in 2021. The findings include: 1. Observation of the laboratory on August 27, 2021 at approximately 8:45 am revealed a microscope on the counter in use for patient testing for urine microscopy and vaginal wet prep. The testing person performing urine microscopic testing demonstrated recording the urine microscopic results on an intermittent worksheet. 2. Interview with the lead testing person on August 27, 2021 at approximately 9 am revealed that an intermittent worksheet is used for recording results for urine microscopy and vaginal wet prep. The worksheet is then shredded after the results are entered into the electronic medical record. 3. Subsequent interview with the laboratory director on August 27 2021 at approximately 1:30 pm confirmed results for urine microscopy and vaginal wet prep were being recorded on an intermittent worksheet which was then discarded. The intermittent worksheet was not retained for two years. 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 --