Central Wyoming Skin Clinic

Summary Statement of Deficiencies 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 review of proficiency testing documentation and staff interview, the laboratory failed to ensure potassium hydroxide (KOH) preparations for the observation of fungal elements was verified for accuracy at least twice annually for 2 of 2 years reviewed (2024, 2025). The laboratory performed approximately 100 patient KOH preparations annually. The findings were: 1. Review of the laboratory's proficiency testing documentation showed the laboratory was enrolled in the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing program for KOH slides under the subspecialty of mycology. The following concerns were identified: a. Review of the 2024 proficiency testing documentation showed the laboratory scored a 66% on the first testing event and a 100% on the second testing event. Review of the Proficiency Failure

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, staff interview, lack of documentation, and policy and procedure review, the laboratory director and/or the testing personnel (TP) failed to attest to the routine integration of proficiency tests into the patient workload for 3 of 3 American Academy of Family Physicians (AAFP) and 2 of 2 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing events reviewed from January 2022 through December 2023. The findings were: 1. Review of the AAFP 2022-A, AAFP 2022-B, and AAFP 2022-C proficiency testing records for the potassium hydroxide (KOH) slide preparations the attestation statement failed to include the signatures of TP #1 and TP #2. 2. Review of the WSLH 2023-Micro QA1 proficiency testing records showed for the KOH slide preparation the attestation statement failed to include the signature of TP #1. 3. Review of the WSLH 2023- Micro QA2 proficiency testing records showed for the KOH slide preparations the attestation statement failed to include the signature of the laboratory director. 4. Interview with the office manager on 1/10/24 at 4:01 PM revealed she was unaware signatures were required on the proficiency testing attestation statements. 5. Review of an undated and unsigned "Proficiency Testing Policy" provided by the laboratory showed "Results will be recorded on the provided report form, which will be signed by the testing personnel and the director." 6. The laboratory director acknowledged the deficiency during a telephone interview on 1/10/24 at 4:39 PM. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of personnel files, review of the CMS 209 Laboratory Personnel Report, lack of documentation, and staff interview, the laboratory directory failed to complete an annual competency assessment for 1 of 1 (testing personnel (TP) #3). The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed TP #3 was listed as performing high complexity testing. 2. Review of the personnel file for TP #3 showed a hire date of January 2022 for the position of histotechnician. Review of the "Employee Evaluation & Wage Review" annual evaluation showed "37. Lab- Completes cases with accuracy & urgency, does not leave cases unmarked or unfinished" was marked as "Exceeds" and was signed by the office manager. Further review showed the evaluation failed to include the direct observation of specimen processing, the monitoring and reporting of test results, review of quality control records; direct observation of the performance of instrument maintenance and function checks, an assessment of grossing competency, and an assessment of problem solving skills. 3. Review of the laboratories policies and procedures showed no policy had been developed for the competency assessment of high complexity testing personnel. 4. Interview on 1/10/24 at 1:39 PM with the office manager confirmed she had signed the annual employee evaluation with input from the laboratory director; however, there was no documentation of the laboratory director's input. Further interview at 4:01 PM with the office manager confirmed a competency assessment policy and procedure for high complexity testing personnel was not available. 5. The laboratory director acknowledged the deficiency during a telephone interview on 1/10/24 at 4:39 PM. 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 review of the American Academy of Family Physicians (AAFP) and the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 5 of 5 testing events from January 2022 through December 2023. The findings were: 1. Review of the AAFP 2022-A, AAFP 2022-B, AAFP 2022-C, WSLH-Micro QA1, and WSLH-Micro QA2 proficiency testing records failed to show documentation the laboratory director (LD) had reviewed the results. 2. Review of the WSLH-Micro QA1 results showed the laboratory scored a 66% on the KOH slide preparation. There was no documentation the laboratory had evaluated the test result. 4. Interview with the office manager on 1/10/24 at 4:01 PM revealed she was unaware of the requirement. 5. Review of an undated and unsigned "Proficiency Testing Policy" provided by the laboratory showed "...The graded report will be reviewed immediately and submitted to the director and/or technical consultant for review...Every unsuccessful challenge will be investigated to determine the root cause.

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS-209 Laboratory Personnel report, review of personnel records, and staff interview, the laboratory director failed to ensure policies and procedures were established for monitoring 1 of 3 testing personnel (nurse practitioner (NP) #1) who conducted preanalytical, analytical, and postanalytical phases of testing for two consecutive survey cycles (2020, 2022). Refer to D6103. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of the CMS-209 Laboratory Personnel report, review of personnel records, and staff interview, the laboratory director failed to ensure policies and procedures were established for monitoring 1 of 3 testing personnel (nurse practitioner (NP) #1) who conducted preanalytical, analytical, and postanalytical phases of 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 -- mycology testing (potassium hydroxide) to ensure they were competent and maintained their competency to perform and report test results promptly and proficiently for 1 of 2 years reviewed (2021). The findings were: 1. Review of the CMS-209 Laboratory Personnel Report showed NP #1 was listed as "testing personnel" which performed moderately complex testing. Interview with the office manager on 2/2/22 at 10:30 AM revealed NP #1 performed 3 potassium hydroxide tests in 2021. 2. Review of NP #1's personnel record showed no evidence a competency assessment was completed in 2021. 3. Interview with the office manager on 2/2/22 at 12 PM confirmed the laboratory had not developed a policy and procedure for completing the competency assessments on testing personnel, and had failed to complete an assessment for NP #1 in 2021. THIS IS A REPEAT DEFICIENCY, last cited on 1/30/20. -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of documentation and interview with staff, the laboratory failed to verify dermatophyte culture and histopathology testing at least twice a year for 2 of 2 years of testing reviewed, (2018 and 2019). The laboratory performed approximately 20 dermatophyte test media (DTM) cultures and 2700 histopathology biopsy and frozen section tests per year. Findings include: 1. The laboratory failed to document they verified the accuracy of dermatophyte presence or absence by culture using media with chloramphenicol and gentamicin for inhibition of bacterial contaminates and red color indicator, Dermatophyte Test Media (DTM), for dermatophyte presence or absence at least twice a year in 2018 and 2019. 2. The laboratory failed to document histopathology biopsy and Mohs surgery frozen section specimens diagnostic test accuracy was verified at least twice annually in 2018 and 2019. 3. In an interview conducted on 01/30/2020 at approximately 3:45 P.M., staff stated they failed to document histopathology cases sent to reference laboratories for test accuracy verification and failed to verify DTM culture accuracy at least twice a year in 2018 and 2019. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and 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 -- proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory director failed to ensure policies and procedures were established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of histopathology and mycology testing to assure they are competent and maintain their competency to perform and report tests results promptly and proficiently for 2 of 2 test systems, mycology culture, and potassium hydroxide (KOH) tests for two of two testing personnel, and for histopathology diagnosis for one testing person. Findings include: 1. The laboratory lacked a procedure to monitor and document that testing personnel were competent to perform dermatophyte test media culture interpretation, KOH slide interpretation for the presence or absence of fungal elements for two testing persons, and for histopathology biopsy diagnosis of skin pathology and frozen section slide interpretation for the presence or absence of previously diagnosed tumor cells for one person. 2. In an interview on 01/30/2020 at approximately 3:30 P.M., the laboratory director confirmed the laboratory did not have a policy and procedure for professional testing personnel competency. -- 2 of 2 --

Summary Statement of Deficiencies 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 patient test requests review, accession log review, lack of documentation, and interview with staff, the laboratory failed to document the specimen date and time of receipt from off-site clinics. The laboratory received 13 of 22 specimens reviewed from clinic visits from Gillette, Riverton, Thermopolis, and Rawlins without recording the time specimens were received into the laboratory. Findings include: 1. Patient test requests included the date the specimens were collected at the off-site clinics. The laboratory accession log recorded the date specimens were accessioned into the laboratory test system. 2. The laboratory failed to document the date and time the specimens arrived at the laboratory from the off-site clinics. 3. In an interview with staff on 04/04/2018 at approximately 12:30 P.M., staff stated that specimens were returned to the laboraotry when staff returned from the clinic visits. Laboratory staff accessioned specimens the next working day as the date specimens were received. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to 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 -- ensure they provided written instructions to one client sending referral specimens for histopathology processing and diagnosis. Findings include: 1. The laboratory lacked a copy of written instructions provided for histopathology specimen collection, preservation and transportation of specimens sent from one laboratory located in Colorado referring specimens for testing. The number of specimens received was not determined. 2. In an interview conducted on 04/04/2018 at approximately 10:45 A.M., staff stated the laboratory received referral specimens from one laboratory. Staff also confirmed they did not have written instructions available to provide to the referral laboratory. 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: Based on package insert review, lack of documentation, and interview with staff the laboratory failed to ensure Dermatophyte Test Media (DTM) incubation temperature ranges were maintained during the two week incubation period for culture media for 2 years of testing reviewed (April 2016 to April 2018). The laboratory tested approximately 5 to 10 cultures per month. Findings include: 1. DTM package inserts state media incubation range is at a room temperature range of 65 to 75 degrees F. 2. The laboratory failed to document the culture's room temperature incubation temperature was monitored to ensure the cultures were incubated within the DTM manufacturer's instructions. 3. In an interview conducted on 04/04/2018 at approximately 12:00 noon, staff confirmed they did not monitor the temperature of the room where cultures were incubated for up to two weeks for determination of presence or absence of dermatophytes. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on media quality control records review and interview with staff, the laboratory failed to check the sterililty of each new lot number or shipment of dermatophyte test media (DTM) for two years of mycology test records reviewed. The laboratory performed approximately 10 cultures per month. Findings include: 1. DTM quality -- 2 of 3 -- control record review failed to include documentation the laboratory checked each new lot number of media to verify media sterility prior to patient specimen inoculation for media received from April 2016 to April 2018. The laboratory received approximately 2 media shipments per year. 2. In an interview with staff on 04 /04/2018 at approximately 11:00 A.M., staff confirmed sterility checks were not performed for media shipments received from April 2016 to April 2018. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on patient test reports review and interview with staff, the laboratory failed to ensure the laboraotry test system had a signature system to ensure the electronic signature on histopathology test reports reviewed from 05/06/2016 to 03/02/2018 were accessible only to personnel that qualified as histopathology diagnostic personnel. Findings include: 1. Test reports reviewed for 16MG-0339, 16SB-0703, 16SB-100, 16MG-05271, 16MG-0926, 17SB-0028, 17SB-0414, 17SB-0263, 17SB- 0619, 17SB-0860, 17SB-0028, 17MG-0261, 17MG-0550, and 17MG-0728, included a type printed note the histopathology microscopic diagnosis report was electronically signed by the director and the technical supervisor by name without a time stamp, followed by another signature of a staff member that did have an electronic timestamp who was not qualified to sign histopathology test reports. 2. In an interview with staff on 04/04/2018 at approximately 2:00 P.M., staff confirmed the reporting system prior to January 2018 failed to ensure the test reports were signed using password protected electronic signature available only to personnel qualified to sign histopathology microscopic test reports. THIS IS A REPEAT DEFICIENCY. -- 3 of 3 --