Mervin G Wolff Md

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: . Based on record review and interview with the Laboratory Director, the laboratory failed to follow written policies to assess laboratory personnel competency for 2 (September 2019 to September 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Laboratory Director Responsibilities" policy revealed a section stating, "Ensure all personnel have appropriate training and demonstrate competency in performing test operations." 2. A review of the laboratory's records revealed a lack of documentation of competency assessments between September 2019 and September 2021. 3. An interview on 9/9/21 at 2:30 pm with the Laboratory Director confirmed the laboratory did not follow its procedure to assess the competency of laboratory personnel. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: 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 -- . Based on observation and interview with the Laboratory Director, the laboratory failed to ensure the expiration date, reflecting the change in stability once the quality control material was opened, was labeled on quality control samples for the current set of 3 vials in use. Findings include: 1. A review of the laboratory's "Adherence to Procedures regarding expired Medonic M controls" policy revealed a section stating, "Label opening date on each control. Discard controls after 7 days of opening. No patient testing allowed with expired controls." 2. An observation on 9/9/21 at 11:51 am revealed the quality control materials in the refrigerator were not labeled with the new expiration date reflecting the stability of opened quality control vials according to the laboratory's policy. 3. An interview on 9/9/21 at 2:30 pm with the Laboratory Director confirmed the quality control vials did not have the expiration date on the labels reflecting the new expiration date once opened. 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: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure control materials were not used when they exceeded their expiration date for 1 (12/21/20) of 51 testing dates reviewed. Findings include: 1. A review of the laboratory's "Adherence to Procedures regarding expired Medonic M controls" revealed a section stating, "Verify Lot Numbers and Expiration Dates of controls prior to testing. Discard expired controls." 2. A review of the laboratory's quality control testing records revealed an "EC" flag on the reports indicating the quality control materials were expired for testing on 12/21/20 under the 220082 lot number. 3. A review of the laboratory's quality control inserts revealed the 220082 lot of quality control materials had an expiration date of 12/18/20. 4. An interview on 9/9/21 at 2:30 pm with the Laboratory Director confirmed the laboratory did not ensure quality control materials were not used when the expiration date had been exceeded. ***This is a repeated deficiency from the 8/27/21 recertification survey.*** -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to retain 6 (21705-5, 21708-2, 21712-2, 21803-0, 21806-2, and 21811-3) of 10 manufacturer's package insert reviewed from 9/29/17 to 8/27/19. Findings include: 1. Record review revealed the laboratory was using Boule "CDS Control Diff" control material. 2. Record review of the "Clinical Diagnostic Packing Lists" forwarded to the physicians office when requested and faxed to the surveyor on 8/29/19 revealed 6 of the 10 shipments the laboratory did not have documentation of the manufacturer's package insert as follows: a. 21705-5 b. 21708-2 c. 21712-2 d. 21803-0 e. 21806-2 f. 21811-3 3. During the interview on 8/27/19 at approximately 12:45 p.m., the LD confirmed he has taken the manufacturer's package inserts home and not returned them to the office. 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: . Based on record review, patient log review, and interview with the Laboratory 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 -- Director (LD), the laboratory was using Boule "CDS Control Diff" hematology control material that exceeded the manufacturer's expiration date for 6 (21705-5, 21708-2, 21712-2, 21803-0, 21806-2, and 21811-3) of 10 lots used between 9/27/17 to 8/27/19. Findings include: 1. Record review of the daily quality control printouts at approximately 12:46 p.m. revealed 6 (21705-5, 21708-2, 21712-2, 21803-0, 21806-2, and 21811-3) of 10 quality control lots flagged as "EC = expired controls" on the daily printouts on the following dates: a. 2017 1. 9/29/17 - low control lot #21705-5 2. 10/2/17 - normal and high control lot #21705-5 3. 12/28/17 - normal control lot # 21708-2 b. 2018 1. 5/3/18 - 6/12/18 - low, normal, and high controls lot# 21712-2 2. 8 /6/18-8/7/18 - low, normal, and high controls lot# 21803-0 3. 11/1/18 - 11/2/18 - low, normal, and high controls lot# 21806-2 c. 2019 1. 4/11/19 - 6/21/19 - low control lot# 21811-3 2. Review of the patient testing log showed 70 patients were tested on the above dates. 3. During the interview on 8/27/19 at approximately 1:00 p.m., the LD confirmed the daily quality control printouts revealed the lot numbers had expired. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: . Based on policy review, surveyor review of calibration records, and interview with the Laboratory Director (LD), the laboratory failed to follow and document calibration procedures for 1 (due 05/2019) of 4 semi-annual calibrations reviewed for 2017, 2018 and 2019. Findings include: 1. The "Quality Assurance Policy" states "calibration will be performed every 6 months." 2. Review of the calibration records revealed the laboratory did not have any documentation to show the calibration due 05/2019 was performed. 3. During the interview on August 27, 2019 at 10:47 a.m. the LD confirmed the laboratory had not performed the calibration procedures every six months. -- 2 of 2 --