Skin Cancer Center Of Fairfield County

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory director (LD) failed to establish and follow polices/procedures for new testing personnel (TP) to evaluate and assess their skills necessary to perform laboratory testing in the subspecialty of Histopathology. Findings include: 1. Record review on 3/4/21 of laboratory's TP#2 competency records dated 3/18/19 and 9/18/20 for MOHS procedures revealed that the LD checked off TP#2 competency skills as "Demonstrates the ability to independently perform the following duties: Gross Specimens:- Maintain patient /specimen identification. Label specimen and corresponding map. Cut and orient specimens. Ink specimen." 2. Record review on 3/4/21 of TP#2 educational qualification documents revealed TP#2 did not meet the educational qualification requirements for performing high complexity testing as per CLIA regulations. 3. Record review of additional documents of MOHS maps on 3/5/21 revealed TP#2 did not perform grossing of the tissue samples. 4. Telephone staff interview with TP#1- Laboratory Supervisor on 3/5/21 at 11:00 AM confirmed: a. TP#2 never performed grossing of tissue specimens. b. The LD inadvertently checked off TP#2 competency records for grossing of specimens listed in line item 1 above. c. Only personnel performs grossing of tissue specimens are LD and TP#1. 5. Record review on 3/9/21 of a statement dated 3/9/21 by the LD revealed TP#2 never performed any grossing of tissue samples and the competency records for TP#2 were checked off by mistake. 6. 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 -- Telephone staff interview with the LD on 3/10/21 at 9:55 AM confirmed he/she checked off TP#2 competency assessment records for grossing of tissue samples by mistake. 7. The laboratory performs 762 MOHS procedures annually. -- 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: Based on record review and staff interview, the laboratory failed to verify the accuracy for potassium hydroxide (KOH) preparation testing bi-annually. Findings include: 1. Record review of laboratory's proficiency testing records on 4/24/18, revealed the laboratory failed to provide evidence or documentation of bi-annual accuracy for the KOH preparation test in 2016 and 2017. 2. Staff interview with testing personnel #1 on 4/24/18 at 10:30 AM confirmed the laboratory failed to have a system in place to verify the accuracy for KOH preparation testing bi-annually in 2016 and 2017. 3. The laboratory performs 50 KOH preparations tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document maintenance for laboratory equipment to ensure accurate and reliable test results. Findings include: 1. Record review of the Olympus BH2 microscope maintenance on 4 /24/18 revealed the last preventative maintenane (PM) was performed in March 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 -- 2016. 2. Record review of the laboratory's PM policy on 4/24/18 revealed PM on all equipment is to be performed annually. 3. Staff interview with the testing personnel #1 on 4/24/18 at 11:00 AM confirmed that annual PM and function checks for the above microscope was overlooked and not performed in 2017. 4. The laboratory performs 50 KOH preparation tests annually. -- 2 of 2 --