Midtown Public Health Office

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Syphilis Serology. Refer to D2074. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API 2023 and 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2023, Event 3 and 2024, Event 2) in the subspecialty of Syphilis Serology. Findings included: 1. Review of the CASPER 0155 report revealed the following results: API Syphilis Serology 2023 - 3rd Event The laboratory received an unsatisfactory score of 0 % for the Syphilis Serology. API Syphilis Serology 2024 - 2nd Event The laboratory received an unsatisfactory score of 0 % for the Syphilis Serology. 2. A review of API 2023 and 2024 proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API 2023 and 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API 2023 and 2024 proficiency testing records, the laboratory director failed to ensure the -- 2 of 3 -- overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2074. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 2/1/2023 and the laboratory was surveyed under 42 CFR part 493 CLIA Requirements. One standard level deficiency was cited. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 the CMS-209 form, competency assessment records, and in interview with the laboratory director, the technical consultant (TC) failed to assess competency for 4 of 7 testing persons (TP) performing gram stains and potassium hydroxide (KOH) preparations in 2022 and 2023. Findings included: 1. Review of the CMS-209 listed seven (7) testing persons for performing gram stains and KOH preparations (moderate complexity testing). The TC did not assess competency for 4 of 7 testing persons. 2. Review of competency assessment records ("Test Validation Form for Provider Performed Microscopy" - for KOH test and "Internal Competency /Proficiency Testing" for gram stain) from 2022 and 2023 for TP's included the following: TP -1 did not have documentation of KOH preparations competency assessment by the TC in 2022; and gram stain competency assessment in 2023 was conducted by the laboratory director who does not qualify as the TC. TP - 4 did not have documentation of KOH preparations competency assessment by the TC in 2022; and gram stain competency assessment in 2023 was conducted by the laboratory director who does not qualify as the TC. TP - 5 gram stain competency assessment in 2023 was conducted by the laboratory director who does not qualify as the TC. TP -7 did not have documentation of KOH preparations competency assessment by the TC in 2022; and gram stain competency assessment in 2023 was conducted by the laboratory director who does not qualify as the TC. The qualified TC listed on 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 2 -- CMS-209 did not conduct and document competency assessments for the above TP's. 3. During an interview on 02/01/2023 at 11:08 am, the laboratory director reviewed and confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 05/13/2021 and remote review of documentation continued on 05/27/2021. The laboratory was found to be in substantial compliance for the specialities/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed on a WebEx call 06/04/2021 with laboratory staff. The process for submitting the corrections was explained. 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 WSLH Proficiency Testing result forms, the laboratory's proficiency testing records, and interview with staff the laboratory failed to document the Laboratory Director or Designee review and evaluation of results for 2 or 4 proficiency testing events in 2020 and 2021. 1. A review of the WSLH Proficiency Testing form reveal "Reviewed By (Lab Director/Designee)". 2. A review of the laboratory's WSLH Proficiency Testing records from 2020 and 2021 revealed the Laboratory Director's or Designee's signature was missing from WSLH PT 2020- BactiReg3 and WSLH PT2021-BactiReg1 results forms. 3. Interview with staff on 05 /13/2021 at 11:41 AM confirmed these findings. 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 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 -- 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 direct observation, review of manufacturer's instructions, and interview with the lab coordinator, the laboratory failed to monitor and document the temperature of stored collection kits in patient room #4, which had storage requirements. Findings included: 1. Review of manufacturer's instructions for collection kits included the following storage requirements: Cobas PCR Media Dual Swab Sample Packet, "Store at 15-30C." Remel Microtest M4RT Transport, "Store product in its original container at 2-30C until used." The Thin Prep Pap Test, "Store PreservCyt Solution between 15C (59F) and 30C (86F)." 2. During an observation in patient room #4 on 05/13/2021 at 11:55 am, the surveyor observed the following collection kits on a cart: Cobas PCR Media Dual Swab Sample Packet, Lot #G09755, expiration date 06-30-22 (quantity of 8) Herpes Culture - "Remel Microtest M4RT Transport", Lot # 183491, expiration date 05/13/22 (quantity of 1) The Thin Prep Pap Test, Lot #9352AA, expiration date 12/18/21 (quantity of 1) The room did not include a thermometer for monitoring temperature to ensure all stored supplies were within manufacturer's defined criteria. 3. During an interview on 05/13/2021 at 11:55 am, the lab coordinator stated she brings in the supplies at the beginning of the day then takes those (unused kits) back to the laboratory. She confirmed there was no thermometer for patient room #4. II. Based on direct observation, review of manufacturer's instructions, and interview with staff and Thermo Scientific Technical staff, the laboratory failed to ensure stored Jembec agar plates were per manufacturer's temperature requirements (2-8C). Findings included: 1. During a laboratory tour on 05 /13/2021 at 12:21 pm, Jembec agar plates were observed stored in the refrigerator. The box of "Remel Jembec System w/(MOD) Thayer Martin Agar" (Lot #271158, expiration 06/01/2021, received 04/28/21) included a Temperature Limitation (Storage Temperature) symbol of "2C - 8C." Review of Remel Jembec System Thayer Martin Agar (Modified) manufacturer's instructions stated, "Refer to the front of the Remel Technical Manual of Microbiological Media for General Information regarding precautions, product storage ..." The Thermo Scientific "Foreword to the Technical Manual of Microbiological Media" on page 3 for Storage stated, "Store plated media products inside their original packaging (cellophane bag and box) at the appropriate temperature indicated on the product label. In order to prevent dehydration, product should not be stored in close proximity to a fan, or for prolonged periods under a laminar flow hood or in a biological safety cabinet ... Allow products to equilibrate to room temperature prior to use. Media products stored at room temperature for daily use must be stored inside the cellophane bag, away from UV light, not under a laminar flow hood and not for extended periods of time ...To ensure maximum performance and recovery after inoculation, optimal environmental conditions must be followed." 2. During an observation in patient room #4 on 05/13/2021 at 11:55 am, the surveyor observed two Jembec Thayer Martin Agar plates on a metal cart (Lot #271158). During an interview on 05/13/2021 at 11:55 am, the lab coordinator stated she brings two plates from the refrigerator to the patient's room at the beginning of the day. If they are unused then she takes those back to the refrigerator at the end of the day. The manufacturer's instructions did not include returning unused agar plates from room temperature conditions back to 2C-8C conditions as an acceptable practice. Note: According to the laboratory's CMS-116 application the operation, hours were Monday through Friday 8 am to 4:30 pm. 3. During a telephone interview on 06/07 /2021 at 1:46 pm, a Thermo Scientific Technical Service Representative stated, that -- 2 of 3 -- once the agar (Jembec) is taken out and has "equilibrated to room temperature" it should be used and unused agar should never return to the refrigerator. Word Key: PCR = polymerase chain reaction C = Celsius F = Fahrenheit 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 direct observation and interview with the Director of Nursing, the laboratory failed to ensure blood collection tubes had not exceeded their expiration date for 14 of 14 tubes. Findings included: 1. During a tour of the phlebotomy room on 05/13/2021 at 9:10 am, there were 14 collection tubes observed with the expiration date "2021-02- 28", as follows: BD Vacutainer gold/yellow top blood collection tubes SST - 5.0 ml, Lot #0049781 Further observation included a list of tests posted on the wall completed off the above tubes (when collected) and sent to a reference laboratory, "HIV/RPR combo, HIV + RPR/TPPA combo, RPR/TPPA combo, RPR only, HIV only." 2. During an interview on 05/13/2021 at 9:15 am, the Director of Nursing reviewed the expiration date and confirmed the above findings. D5785