Hayden H Franks Md Pa

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory documents, patient test records, and confirmed in an interview, the laboratory failed to document Hematoxylin and Eosin (H&E) staining materials for intended reactivity each day of patient testing for 10 random patients reviewed in February, April, May, and June of 2022. The findings include: 1. In the laboratory walk-through on 2/8/2023 at 10:45 hours, the surveyor noted an H&E staining station used for patient testing. 2. Review of the laboratory policies and the laboratory vertical section specimen log did not include instructions or documentation of tissue stain acceptability for H&E. Surveyor queried if the information could be found in a separate place, and none was provided. 3. Review of random patient final reports in February, April, May, and June have the following 10 patients on days where there was no documented H&E stain acceptability: February 2022: patients Procedure Date: 2/14/2022 Path Number: 22-0543 Path Number: 22- 0534 Path Number: 22-0551 Path Number: 22-0533 April 2022: 2 patients Procedure Date: 4/18/2022 Path Number: 22-1429 Path Number: 22-1430 May 2022: 2 patients Procedure Date: 5/23/2022 Path Number: 22-1998 Path Number: 22-1990 June 2022: 2 patients Procedure Date: 6/13/2022 Path Number:22-2316 Path Number: 22-2320 4. In an interview on 2/8/2023 at 11:45 hours, in the office, the histo-tech confirmed that the H&E stain acceptability had not been documented for the above days where patients had been tested. 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 D0000 . The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (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: . I. Based on surveyor observation, review of laboratory environmental logs, and confirmed in interview, the laboratory failed to have a system in place to monitor the temperature for four of four reagents stored for histopathology. 1. During the tour of the facilities at 09:10 hours on 12/2/2021 the surveyor observed the following reagents in a flammable cabinet, in a closet, in a patient exam room. Eosin Y Hematoxylin 7211 Clear-Rite 3 PolarStat - Frozen Embedding Material 2. Based on review of laboratory environmental records the laboratory failed to have a temperature monitor in place for storage area for above reagents. 3. In an interview at 09:15 hours on 12/2/2021, in the patient exam room, the laboratory personnel confirmed that there was no temperature monitor in place for the storage of the above reagents. II. Based on review of the instrument instruction manual, laboratory environmental logs, and confirmed in interview, the laboratory failed to monitor humidity for the Leica CM1510S Cryostat, for eleven of eleven months reviewed. 1. Review of the instruction manual for the Leica CM1510S Cryostat (V1.4) Section 4. 'Setup', subsection 4.1 'Installation site requirements' lists the following humidity installations 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 -- requirements that must be met. "relative humidity max. 60%" With an informational note stating, "high room temperature and excessive air humidity at the installation site affect the cooling capacity of the cryostat." 2. Based on review of the laboratory's 'Temperature Monitor Log - Refrigerator, Freezer, Cryostat' for January through November 2021 the laboratory failed to monitor the humidity for the Leica CM1510S Cyrostat for eleven of the eleven months reviewed. 3. In an interview at 11:30 hours on 12/2/2021 with laboratory personnel at confirmed that the laboratory did not record the relative humidity for the Leica CM1510S Cryostat. . -- 2 of 2 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: I. Based on review of laboratory documentation for 2017, 2018 and 2019 and staff interview, the laboratory failed to verify the accuracy of frozen section examinations at least twice annually. Findings: a. Review of laboratory Pathology Frozen Section logs for 2017, 2018 and 2019 showed a log sheet indicating accuracy verification by peer review for five cases in 2018. No records were found for 2017 or 2019. b. In an interview at the site on 06-06-2019, the clinic manager confirmed that no peer review documentation for 2017 and 2018 was present or could be offered at the time of the survey. II. Based on surveyor observation, review of laboratory documentation for 2017, 2018 and 2019 and staff interview, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) mycology and mineral oil scabies preps performed at the site. Findings: a. In the course of the survey it was noted that a nurse practitioner (testing person 2-CMS form 209) was employed by the practice. In an interview at the site on 06-06-2019, when asked if he performed any testing, clinic manager stated that testing person 2 did occasionally perform KOH or mineral oil prep examinations on patient specimens. b. Documentation of semiannual accuracy verification for this testing was requested. No such documentation was available or could be offered during the survey. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring 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 -- that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of laboratory documentation and staff interview, the laboratory technical supervisor (CMS form 209) failed to evaluate the competency of the testing person performing KOH and mineral oil prep examinations at the site. Findings: 1. In the course of the survey it was revealed that testing person 2 had been performing KOH and mineral oil prep examinations on patients at the site. In an interview at the site on 06-06-2019, the clinic manager estimated that testing person 2 performed an average of 40 such tests a year. Refer to D5219. 2. Competency verification documentation for testing person 2 was requested. No such documentation was available or could be offered during the survey. -- 2 of 2 --