Uams Cancer Institute Dermatology Oncology Clinic

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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: Through review of the CMS 209 form, personnel records, and interview conducted on 2/22/2023 it was determined that the competency of the testing personnel was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of personnel files for two of two testing personnel revealed that the annual evaluation of the competency of the testing personnel (number two on the CMS 209 form) was documented only once dated May 2021 and no other documentation of testing personnel competency was presented. B) Upon request, the laboratory was unable to provide other competency evaluations of the testing personnel (number two on the CMS 209 form) subsequent to the evaluation identified above. C) In an interview on 2 /22/2023 at 9:37 a.m. the testing personnel (number two on the CMS 209 form) said that no other competency evaluations were present and available. 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: Through a review of proficiency test results of 2021 and 2022, lack of documentation, as well as interviews with laboratory director, it was determined the laboratory failed 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 -- to document evaluation of proficiency testing performance in the general laboratory systems. Survey findings follow: A. The laboratory failed to produce records proficiency testing for of 2021 and 2022. B. The surveyor requested documentation of for proficiency testing for of 2021 and 2022, no documentation was provided. C. In an interview on 2/22/2023 at 9:26 A.M., Laboratory Director confirmed that no Proficiency Testing are recorded. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of personnel records, lack of documentation, and interview it was determined that the laboratory director failed to specify in writing the examinations and procedures that personnel are authorized to perform for two of two testing personnel for which records were presented. Findings follow: A) Upon review, personnel files for testing personnel (numbers 2 and 3 on form CMS-209) did not contain written authorization by the laboratory director to perform procedures and examinations. B) Upon request, the laboratory was unable to provide written authorization by the laboratory director to perform procedures and examinations for testing personnel identified as numbers 2 and 3 on form CMS-209. C) In an interview on 2/22/23 at 09:37 a.m., testing personnel (numbers 2 and 3 on form CMS-209) when asked if other personnel records were available for review stated, " All records are in the personnel binder". -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through a review of the laboratory policies and procedures, lack of documentation, and interviews with laboratory staff, it was determined the procedures had not been approved and signed by the current laboratory director. Survey findings include: A. During a review of the laboratory policies and procedures, it was observed that the last signature of approval was dated 1998 and was signed by a previous director. There was no documentation in the policies and procedures that they had been approved by the current laboratory director. B. In an interview, at 9:40 a.m. on 5/6 /2021, laboratory employee #2 (as listed on the form CMS-209) confirmed the approval of the policies and procedures was not signed by the current laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory used Eosin Y stock solution when it had exceeded it's expiration date. Survey findings include: A. During a tour of the 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 -- laboratory at 10:09 a.m. on 5/6/2021, the surveyor observed one bottle of Eosin Y Stock Solution (lot #1601411) in the lower cabinet next to the Cryostat. The Eosin Y Stock Solution expiration date, as listed on the bottle, was 1/21/2018. B. In an interview, at 10:15 a.m. on 5/6/2021, laboratory employee #2 (as listed on the form CMS-209), stated that the expired bottle is currently in use and confirmed that no other bottles of Eosin Y Stock Solution were available in the laboratory. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory, lack of policies and procedures, and interviews with laboratory staff, it was determined the laboratory director failed to provide a safe environment in which employees are protected from chemical and biological hazards. Survey findings include: A. At the time the surveyor entered the laboratory (9:20 a.m. on 5/6/2021) the surveyor observed the following items on the laboratory counter: a diet coke and insulated drink tumbler, a package of hamburger buns, two bags of potato chips, a bag of Doritos, a bottle of barbeque sauce, a 32 ounce package of pulled pork, a water pitcher with water, and a crock pot slow cooker (which was on the counter next to the Cryostat). There were no signs posted that designated the counters were for food only. B. In an interview at 9:34 a.m. on 5/6/2021 laboratory employee #1 from the Form CMS-209 stated that the counter with the food was designated as a clean space. The surveyor requested the policy that designates the area as a clean space but laboratory employee #1 stated there was no policy. C. At 10:09 a.m. on 5/6/2021 the surveyor observed the following chemicals with hazardous warning labels stored in cabinets above the counter on which food was observed: Acetone, detachol, Azure B Stock, and Buffer Solution pH 6.0. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Through a review of laboratory employee personnel records, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed to document competency evaluations for two of two personnel who performed grossing of tissue. Survey findings include: A. In an interview with the laboratory director (9:59 a.m. on 5/6/2021), he stated that the histotechs (employees #2 and #3 as listed on the form CMS-209) perform grossing of tissue specimens. B. Through a review of personnel records for laboratory employees #2 and #3 it was determined there were no competency assessments available for 2019, 2020, or 2021 for two of two testing personnel performing grossing of tissue specimens. The documentation -- 2 of 3 -- presented to the surveyor was labeled "Position Classification Questionaire" and did not include the required elements of a competency assessment. C. In an interview at 9: 50 a.m. on 5/6/2021 laboratory employee #2 stated that competency assessments weren't documented. -- 3 of 3 --