Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical consultant (TC) #3, the TC failed to assess the competency of 2 of 10 testing personnel (TP) that performed microbiology, clinical chemistry, hematology and urinalysis testing from 04/07/2022 to the date of the survey. Findings include: 1. On the day of survey, 01/10/2024 at 10: 34 am, the laboratory could not provide competency assessment records performed on site for 2 of 10 TP (CMS 209 TP # 9 and #10) that performed microbiology, clinical chemistry, hematology, and urinalysis testing from 04/07/2022 to the date of the survey. 2. .TC#3 confirmed the findings above on 01/10/2024 at 01:30 pm. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of annual competency assessment records, and interview with technical consultant #3 (TC), the TC failed to document the assessment of problem solving skills for 1 of 10 TP that performed microbiology, urinalysis, chemistry, and hematology testing for the competency assessment performed on 01/18/2023. Findings: 1. On the date of the survey, 01/10/2024 at 10:23 am, review of the annual 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 -- competency assessment performed on 01/18/2023 revealed the TC failed to document the assessment of problem solving skills for 1 of 10 TP (CMS 209 TP #8) that performed the following testing from January 2022 to January 2023 : - Potassium Hydroxide (KOH) preps - Wet mounts - Pinworm - Fecal Leukocytes - Urine microscopic examinations - iStat Chem 8+ cartridge routine chemistry/hematology testing 2. TC #3 confirmed the findings above on 01/10/2024 at 01:30 pm. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, the Lab P.M Checklist, quality control records, and interview with technical consultant #3 (TC), the testing personnel (TP) failed to document the P.M quality control (QC) performed for urinalysis, hematology and microbiology testing on 07/01/2022. Findings include: 1. The laboratory's Urinalysis-Microscopic Examination of Urine procedure states, "In Pennsylvania, techs will review urine sediment chart in the lab for confirming the elements in the microscopic urinalysis examination each day of testing." 2. The laboratory's Lab P.M Checklist states, "Review urinalysis sediment chart, fecal leukocyte, wet mount, KOH and pinworm QC photos daily." 3. On the day of the survey, 01/10/2024 at 11:30 am, review of the laboratory's quality control records revealed that the TP failed to document the daily P.M quality control performed for urine sediments, fecal leukocytes, wet mount, potassium hydroxide (KOH) and pinworm testing on 07/01 /2022. 4. TC #3 confirmed the findings above on 01/10/2024 at 01:30 pm. -- 2 of 2 --