Family Practice Group, Pa

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 proficiency testing (PT) documentation from the American Proficiency Institute (API) and an interview with the technical consultant (TC) on 4/23 /2024, the laboratory director failed to review PT results in 2022, 2023 and 2024. The findings include: 1. A review of PT documents for 2022 from API identified that the laboratory director failed to review and evaluate results for urine microscopic examination for events two and three. 2. A review of PT documents for 2023 from API identified that the laboratory director failed to review and evaluate results for urine microscopic examination for events one, two and three. 3. A review of PT documents for 2024 from API identified that the laboratory director failed to review and evaluate results for urine microscopic examination for event one. 4. An interview with the TC on 4/23/2024 at 8:51 am confirmed that the laboratory director failed review the above PT results. 5. The laboratory reports performing 1842 urine microscopic examinations 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 1 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of laboratory patient reports and an interview with the laboratory supervisor on 5/11/2022, the laboratory failed to include the name and address of the performing laboratory and specimen source for the reported tests. The findings include: 1. A review of laboratory patient test reports for urinalysis, potassium hydroxide (KOH) slides and wet mounts identified that the laboratory failed to include the name and address of the the performing laboratory since the implementation of their new electronic medical record system in April of 2021. 2. A review of laboratory patient test reports for KOH slides and wet mount testing identified that the laboratory failed to include the specimen source since the implementation of their new electronic medical record system in April of 2021. 3. An interview with the laboratory supervisor on 5/11/2022 at 10:20 am confirmed the above findings. 4. The laboratory performs 1353 urinalysis, KOH slides and wet mounts annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory 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 -- performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of laboratory patient reports and an interview with the laboratory supervisor on 5/11/2022, the laboratory failed to include the reference or normal range for the reported analytes on the final patient report. The findings include: 1. A review of laboratory patient reports identified that the laboratory failed to include the reference or normal ranges for leukocyte esterase, nitrate, protein, glucose, ketones, urobilinogen, bilirubin, occult blood, white blood cells, red blood cells, casts, mucous, yeast, crystals, bacteria, and epithelial cells for urinalysis testing since the implementation of their new electronic record system in April 2021. 2. A review of laboratory patient reports identified that the laboratory failed to include the reference or normal range for yeast, trichomonas, and clue cells for potassium hydroxide (KOH) slides and wet mount testing since the implementation of their new electronic record system in April 2021. 3. An interview with the laboratory supervisor on 5/11/2022 at 10:20 am confirmed the above finding. 4. The laboratory reports performing 1353 urinalysis, KOH an wet mounts annually. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records of urine sediment from American Proficiency Institute (API), policies and procedures and an interview with the laboratory lead on 3/9/2021, the laboratory failed to examine PT samples using the laboratory's routine methods. The findings include: 1. A review of urine sediment PT records from API for hematology/coagulation 2020 3rd event identified that two testing personnel examined both of samples, US-05 and US-06, before the submission date. 2. A review of the laboratory's "Urine Sediment Examination" procedure identified that the laboratory does not routinely use more than one testing individual to perform urine sedimentation examinations. 3. An interview with the laboratory lead on 3/9/2021 at 9:30 am confirmed that multiple testing personnel examine both PT samples prior to the submission date for training and competency purposes. 4. The laboratory reports performing 1065 urine sedimentation examinations annually. 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: 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 -- Based on a review of patient test records and an interview with the laboratory lead on 3/9/21 the laboratory failed to retain patient test records for urine sedimentation examinations for at least two (2) years. The findings include: 1. A review of patient test records identified that the laboratory failed to retain transcribed results for urine sediment examinations that are then input into the patient electronic record. 2. An interview with the laboratory lead on 3/9/21 at 10:36 am confirmed that the laboratory discards the transcribed results after they are input into the patient electronic record. 3. The laboratory reports performing 1065 urine sedimentation examinations annually. 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 record review of proficiency testing from American Proficiency Institute (API) and an interview with the laboratory lead on 3/9/2021, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) and semen analysis at least twice annually. The findings include: 1. A review of proficiency testing records from API identified that the laboratory failed to verify the accuracy of KOH and semen analysis biannually for 2019 and 2020. 2. An interview with the laboratory supervisor on 3/9 /2021 at 9:55 am confirmed that the laboratory failed to verify the accuracy of KOH and semen analysis biannually for 2019 and 2020. 3. This deficient practice was identified during the previous inspection on 4/10/18 for failure to verify the accuracy of KOH and semen analysis. 4. The laboratory reports performing 35 KOH and semen analysis annually. D5785

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory supervisor, the laboratory director failed to sign the attestation statements from the American Proficiency Institute (API) for the urine sediment analysis for 2017 events 2 and 3. Findings: 1. An API PT document review, revealed the laboratory director failed to sign the attestation statements for the urine sediment analysis for the 2017 events 2 and 3. 2. An interview on April 10, 2018 at 11:50 AM, with the laboratory supervisor, confirmed the laboratory director failed to sign the PT attestation statements in 2017. 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. 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 record review and an interview with the laboratory supervisor, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) and semen analysis at least twice annually since the last survey on September 8, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH and semen analysis at least twice annually since the last survey. 2. An interview on April 10, 2018 at 11:45 AM, with the laboratory supervisor, confirmed the laboratory failed to document the accuracy of KOH and semen analysis at least twice annually since the last survey. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a record review of final patient reports and an interview with the laboratory supervisor, the laboratory failed to indicate the name and the address of the reference laboratory where laboratory tests were reported on patients for the period reviewed between February 2018 through March 2018. Findings: 1. A review of patient laboratory test reports, revealed the name and address of the reference laboratory where tests were performed failed to be included on the patient's test reports. 2. An interview on April 11, 2018, at 12:15 PM, with the laboratory supervisor, confirmed the name and address of the reference laboratory failed to be indicated on patient laboratory reports. 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 a records review and an interview with the laboratory supervisor, the technical consultant failed to evaluate the competency assessments of the 5 testing personnel performing urine sediment exams, potassium hydroxide (KOH), and semen analysis since the last survey on September 8, 2016. Findings: 1. A review of personnel records revealed the technical consultant failed to evaluate the competency assessments on the 5 testing personnel listed on the CMS-209 Personnel Report form. 2. An interview on April 10, 2018 at 11:45 AM, with the laboratory supervisor, confirmed the technical consultant failed to perform the competency assessments on the testing personnel. -- 2 of 2 --