Zanesville Family Practice Inc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #3, the laboratory failed to establish and follow written policies and procedures for specimen acceptability and rejection of urine specimens collected for Uricult tests. This deficient practice had the potential to affect 1,973 out of 1,973 patients tested under the subspecialty of Bacteriology from 09/20/2023 through 07/29/2025. Findings Include: 1. Review of the laboratory's "Lab Procedure Manual" policies and procedures, approved by the Laboratory Director on 08/21/2023, and provided on the date of inspection, did not find any mention of policies or procedures for specimen acceptability and rejection of urine specimens collected for Uricult tests. 2. The inspector requested policies and procedures for specimen acceptability and rejection of urine specimens collected for Uricult tests from TP #3. TP #3 confirmed the laboratory did not include specimen acceptability and rejection in their policies and procedures and did not have any documentation to provide on the date of the inspection. The interview occurred on 07/29/2025 at 10:30 AM. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: ITEM 1 Based on document review, and an interview with Testing Personnel (TP) #3, the laboratory failed to establish and follow a written procedure for the transport conditions of specimens to be tested at an off-site laboratory. This deficient practice had the potential to affect 53 Bacteriology, 3306 Chemistry, 13 Cytology and 2492 Hematology specimens transported and tested to off-site laboratories from 01/04/2022 through 09/19/2023. Findings Include: 1. Review of the laboratory's policy and procedure titled, "Miscellaneous Specimen Handling", signed and dated by the Laboratory Director on 11/16/2021, provided on the date of inspection, did not find any mention of specimen handling and transport conditions for specimens sent off- site. 2. Review of the "NextGen Lab E-Requisition" sheets provided with the specimens sent off-site for testing, did not find any mention of specimen handling and transport conditions. 3. The Inspector requested a policy and procedure for the specimens transported from the laboratory to an off-site location which includes specimen handling and transport conditions, from TP #3. TP #3 confirmed there was no policy and procedure which included the specimen handling and transport conditions and was unable to provide the requested information. The interview occurred on 09/19/2023 at 11:30 AM. ITEM 2 REPEAT DEFICIENCY Based on record review and an interview with testing personnel (TP) #3, the laboratory failed to follow their established policy and procedure for the Uricult urine culture incubation 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 -- time of 18-24 hours. This deficient practice had the potential to affect 11 out of 95 patients tested under the subspecialty of Bacteriology from 02/27/2023 to 08/17/2023. Findings Include: 1. Review of the laboratory's policy and procedure titled "Urine Culture Procedure", signed and dated by the Laboratory Director on 11/16/2021 and provided on the date of inspection, found the following statements: "Test Procedure: ... 5). Place vial in an incubator in an upright position for 18-24 hours." 2. Review of the laboratory's "Uricult Results" log, provided on the date of the inspection, revealed 11 out of 95 Uricult urine cultures that exceeded 24 hours of incubation time as listed below: DoB Set Up Read 05/15/60 02/27/23 02/28/23 11:45 AM 12:00 PM 12/24/33 05/25/23 05/26/23 9:35 AM 10:00 AM 02/28/60 05/31/23 06/01/23 9:55 AM 10:00 AM 01/08/57 06/07/23 06/08/23 11:00 AM 12:00 PM 11/29/71 06/19/23 06/20/23 8: 33 AM 10:50 AM 04/09/73 06/20/23 06/21/23 8:50 AM 9:55 AM 03/05/51 06/22/23 06/23/23 11:55 AM 12:00 PM 12/24/33 06/22/23 06/23/23 11:55 AM 12:00 PM 10/26 /86 08/02/23 08/03/23 8:00 AM 9:00 AM 05/13/83 08/14/23 08/15/23 7:35 AM 11:25 AM 08/14/42 08/16/23 08/17/23 8:55 AM 9:00 AM 3. TP#3 confirmed the Uricult urine cultures listed above had exceeded the maximum incubation time of 24 hours as stated in the policy and procedure. The interview occurred on 09/19/2023 at 12:20 PM. DoB: Date of birth D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP), the laboratory failed to have written or electronic test requests/orders from an authorized person for three out of three patient medical records reviewed. All patient urine cultures tested from 09/06/2017 to 07/31/2019 had the potential to be affected by this deficient practice. Findings were as follows: 1. Review of three patient medical records, provided on the date of inspection, revealed urine culture results for each patient, however did not find any written or electronic test request/order for the urine culture tests performed, as indicated below: Patient Initials Date(s) of visit MM 01/29/2019, 02/18/2019 MK 06/18/2018, 07/02/2019, 07/30/2019 BW 03/04/2019 2. The inspector requested the laboratory's test requisition and accessioning policy and procedure and the corresponding test requisitions for the above mentioned patients from the TP#5. 3. TP#5 stated the Laboratory Director provided verbal orders for the urine culture testing and confirmed the laboratory did not have any written or electronic test requests/orders available, did not have a test requisition and accessioning policy and procedure established and were unable to provided the requested documentation on the date of the inspection. The interview on 07/31/2019 at 10:35 AM. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) 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 -- Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP), the laboratory failed to follow their established policy and procedure for the Uricult urine culture incubation time for fifteen out of sixty three patient urine cultures tested, of which had the potential to be affected by this deficient practice. Findings Include: 1 Review of the laboratory's "Urine Culture Procedure, 1215 Newark Road Zanesville, OH 43701" policy and procedure, approved, signed and dated by the Laboratory Director on 04/01 /2014, provided on the date of inspection, found the following statements: "Test Procedure: ...5). Place vial in an incubator in an upright position for 18-24 hours." 2. Review of the laboratory's "Uricult Results" log, provided on the date of the inspection, revealed Uricult urine cultures that exceeded 24 hours of incubation as listed below: Chart Number Date/Time Set Up Date/Time Read 4044 02/07/19 7:45 AM 02/08/19 8:30 AM 5653 02/07/19 8:25 AM 02/08/19 8:30 AM 8161 02/12/19 8: 20 AM 02/13/19 9:00 AM 10092 02/13/19 9:30 AM 02/14/19 11:00 AM 10092 03/20 /19 9:35 AM 03/21/19 1:00 PM 5201 06/20/19 11:58 AM 6/21/19 12:55 AM No # 06 /26/19 9:50 AM 06/27/19 1:10 PM No # 07/05/19 7:35* 07/06/19 8:30* No # 07/08 /19 1:20 PM 07/09/19 2:50 PM No # 07/08/19 8:20 AM 07/09/19 2:50 PM No # 07/09 /19 8:05 AM 07/10/19 10:55 AM No # 07/09/19 7:30 AM 07/10/19 10:55 AM No # 07/10/19 8:15* 07/11/19 11:30 AM No # 07/11/19 10:15 AM 07/12/19 10:55 AM No # 07/11/19 9:35 AM 07/12/19 10:56 AM 3. TP#5 confirmed the Uricult urine cultures listed above had exceeded the maximum incubation time of 24 hours as stated in the policy and procedure. The interview occurred on 07/31/2019 at 10:21 AM. * no AM /PM noted on the log D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP), the laboratory failed to document the date and time in which urine culture specimens were collected. All patients tested under the sub-specialty of bacteriology from 09/06/2017 to 07/31 /2019 had the potential to be affected by this deficient practice. Findings were as follows: 1. Review of the Uricult manufacturer's instructions revealed the following statement under the specimen collection and preparation procedure for urine culture paddles: "Specimens should be inoculated onto Uricult Urine Culture-Paddles immediately following collection." 2. Review of three out of three of the laboratory's "Uricult Results" patient logs revealed columns titled "Chart Number", "Patient Name", "Date & Time Set Up", "Initials Set Up", "Date & Time Read", "Initials Read", "Results" and "Charted Initials" and were completed for each patient test, however specimen collection date and time was not recorded. 3. The Inspector requested the laboratory's documentation of urine specimen collection date and time between 09/06/2017 to 07/31/2019 from TP#5. TP#5 confirmed the laboratory did not -- 2 of 3 -- document urine culture specimen collection date and time and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 07/31/2019 at 10:21 AM. 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 record review and an interview with testing personnel (TP), the laboratory failed to include an identification number or unique patient identifier on six out of six patient Uricult urine culture final test reports reviewed. All patients tested in this laboratory from 09/06/2017 to 07/31/2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of six out of six patient Uricult urine culture final test reports, provided on the date of the inspection, found only the patient name listed with no other patient identifiers. 2. TP#5 confirmed the patient's name was the only identifier used on the test reports. The interview occurred on 07/31/2019 at 11:35 AM. -- 3 of 3 --